Responsibilities. The Joint Development Committee ---------------- shall perform the following functions: (a) Manage and oversee the preparation and implementation of the U.S. Development Plans; (b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States; (d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans; (e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9; (f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting; (g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and (h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 5 contracts
Sources: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)
Responsibilities. The Joint Development Steering Committee shall ---------------- shall perform the following functions:
(a) Manage and oversee the preparation Development and implementation Commercialization of the U.S. Development PlansCollaboration Products in the United States pursuant to the terms of this Agreement;
(b) As early as necessary in each year beginning with Review and approve the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Marketing Plans for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing Plans;
(c) Coordinate Development and Commercialization of the Collaboration Products in the ROW with the Development and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing Committee;
(d) At each meeting of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for each the United States to the budgeted Development Expenses and Marketing Expenses for the United States for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(e) Review and approve the progress of the other committees;
(f) Review and approve the trademarks selected under Section 2.4;
(g) Review and approve "go/no-go" decisions and other matters referred to the Joint Steering Committee, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Products;
(h) Life cycle management of, and intellectual property protection for, the Collaboration Products in the United States;
(i) Approve any and all ** policies and ** in the ** for Collaboration Products, including **;
(j) In accordance with the following Calendar Year so that it can submit procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and
(k) Have such proposed U.S. Development Plans other responsibilities as may be assigned to the Joint Steering Committee no later than ** of such year for review and approval; pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 5 contracts
Sources: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)
Responsibilities. The Joint Development Committee ---------------- JSC shall perform serve as a forum to share Know-How and learnings from each of the following functionsInhaled Collaboration and Vaccines Collaboration. Specifically, the JSC shall:
(ai) Manage provide oversight over the Collaboration Program and oversee facilitate communication and discussion between the preparation and implementation of the U.S. Development Plans;
(b) As early as necessary in each year beginning Committee Parties with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans respect to the Joint Steering Committee no later than ** of such year for review and approvalCollaboration Program; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the omitted portionsSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(cii) Prepare ensure that each of the Development strategy JVRC and develop protocols for clinical studies for JIRC be kept informed of data and Know-How generated under each of the Collaboration Products for Commercialization in Inhaled Plan and Vaccines Plan, respectively, that may have broad applicability or usefulness to both the United StatesVaccines Plan and Inhaled Plan;
(diii) Review review and recommend approve amendments to the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansInhaled Plan and Vaccines Plan and all associated budgets;
(eiv) Coordinate discuss and monitor regulatory strategy and activities for resolve any disputes relating to the Collaboration Products Program, including any disputed matter referred from the JVRC or JIRC;
(v) from time to time but no more often than quarterly during the JSC Term, in consultation with the JIRC, JVRC and JPC, discuss research that has been conducted by UNC and Consultant under the UNC Research Agreement, the UNC Material Transfer Agreement and the Consulting Agreement in the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field, as well as outside the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field that is expected to relate to General Biological Effects, and review results, University Inventions and other inventions generated by all such research. Notwithstanding the foregoing, discussion of research shall occur more often than quarterly as required for GSK to review such research reasonably prior to publication thereof;
(vi) from time to time but no more often than quarterly during the JSC Term, in consultation with the JIRC, JVRC and JPC, review and approve any research to be conducted by Third Parties under agreements between Third Parties and UNC (which agreements may or may not include Liquidia as a party) using PRINT or PRINT Materials supplied by Liquidia in the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field, including the intellectual property provisions of such agreements, in accordance with Article 9Section 5.7;
(fvii) At each meeting of from time to time but no more often than quarterly during the Joint Development CommitteeJSC Term, in consultation with the JIRC, JVRC and JPC, discuss research that has been conducted by Third Parties under agreements between Third Parties and UNC (which agreements may or may not include Liquidia as a party) using PRINT or PRINT Materials supplied by Liquidia outside the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field that is expected to relate to General Biological Effects, and review a comparison of actual Development Expenses for the United States results and inventions generated by all such research, to the budgeted Development Expenses extent Liquidia becomes aware of such research results. Notwithstanding the foregoing, discussion of research shall occur more often than quarterly as required for the United States in the U.S. Development Plan for the year-to-date, as current as practicable GSK to a date immediately review such research reasonably prior to the date of the meetingpublication thereof;
(gviii) Review review and recommend discuss manufacturing and supply requirements and obligations related to PRINT Materials, Research Materials and Research Products. Such discussion shall include matters related to any anticipated delay in manufacturing and supply of PRINT Materials and Research Materials, and the Joint Steering Committee "go/no-go" decisions for impact of such delay on the Development conduct of the Inhaled Plan or Vaccine Plan. The Parties shall also discuss whether such delay shall be addressed by an extension of the Inhaled Collaboration Products Term or Vaccine Collaboration Term or a manufacturing technology transfer as described in Section 5.2(c)(i); provided, that the technology transfer described in Section 5.2(c)(i) shall occur only if the Parties agree that such Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. transfer would be more likely to decrease the delay of conducting the Inhaled Plan or Vaccine Plan than allowing Liquidia to cure such delay in supply;
(ix) track expenses against agreed budgets as set forth in the United StatesVaccine Plan and Inhaled Plan; and
(hx) Have perform such other responsibilities functions as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timein writing.
Appears in 5 contracts
Sources: Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc), Inhaled Collaboration and Option Agreement (Liquidia Technologies Inc)
Responsibilities. The Joint JDCC shall be responsible for overseeing the Development Committee ---------------- and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall perform have the following functionsresponsibilities:
(a) Manage the development and oversee discussion of strategies for the preparation Development and implementation Commercialization of each Co-Developed Product in the U.S. Co-Development PlansTerritory, including allocation of responsibilities for such Development and Commercialization activities;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update reviewing and amend the initial U.S. Development Plans discussing a Marketing and prepare the U.S. Development Plans Sales Plan for each Collaboration Co-Developed Product for in the following Calendar Year so that it can submit such proposed U.S. Co-Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Territory;
(c) Prepare coordinating the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization efforts of both Parties in the United States;Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) Review reviewing and recommend to providing input in the Joint Steering Committee any material amendments or modifications to preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the U.S. Co-Development PlansTerritory;
(e) Coordinate reviewing and monitor regulatory strategy providing input on the short-term and activities long-term sales forecasts for the Collaboration Co-Developed Products in accordance with Article 9the Co-Developed Territory;
(f) At each meeting presenting sales forecasts and the results of all efforts in the Joint Co-Development Committee, review a comparison of actual Development Expenses for the United States Territory to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-dateJSC as needed, as current as practicable to a date immediately prior to the date of the meetingbut no less often than two (2) times per Calendar Year;
(g) Review coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and recommend any other corrective actions related to the Joint Steering Committee "go/noCo-go" decisions for the Development of Collaboration Developed Products in the United StatesCo-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(hl) Have performing such other responsibilities activities as may be assigned delegated to the Joint Development Committee JDCC pursuant to this Agreement Agreement, or as may be mutually agreed upon by mutual written agreement of the Parties from time to timeafter the Approval Date.
Appears in 5 contracts
Sources: Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)
Responsibilities. The Joint Development Steering Committee ---------------- shall perform the following functions:
(ai) Manage and oversee Oversee the preparation and implementation Commercialization of the U.S. Development PlansLicensed Product in the Territory pursuant to the terms of this Agreement. Have joint approval of, designs and protocols (if any) as well as internal publication plans and primary publications of clinical and nonclinical studies featuring a Licensed Product (e.g., publications for major international peer-reviewed journals and conferences);
(bii) As early as necessary in At each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to meeting of the Joint Steering Committee no later than ** of such year for Committee, review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies Net Sales for the Collaboration Products for Commercialization in the United Statesyear-to-date as available;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(eiii) Coordinate and monitor regulatory strategy and activities for the Collaboration Products Licensed Product in the Territory in accordance with Article 9VIII;
(fiv) Review and approve the trademarks selected under Section 2.06;
(v) Discuss the state of the markets for the Licensed Product in the Territory and opportunities and issues concerning the Commercialization of the Licensed Product in the Territory, including consideration of marketing and promotional strategy, marketing research plans, labeling and Licensed Product positioning;
(vi) Life cycle management of, and intellectual property protection for, the Licensed Product in the Territory;
(vii) At each meeting of the Joint Development Steering Committee, review a comparison the status of actual Development Expenses for the United States major Commercialization activities related to the budgeted Development Expenses for the United States Licensed Product in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review Territory and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United Statesany results therefrom; and
(hviii) Have such other responsibilities as may be assigned to the Joint Development Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. Notwithstanding the foregoing, Clinigen (and not the Joint Steering Committee) shall have the authority to establish and adjust pricing, develop go-to-market strategies and develop and implement marketing processes. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 4 contracts
Sources: Commercialization Agreement, Commercialization Agreement (Theravance Biopharma, Inc.), Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJRB will be responsible for:
(a) Manage reviewing NPCDs proposed by either Party for inclusion in the Alliance Program and oversee the preparation determining whether such NPCDs and implementation of the U.S. Development Planswill become Alliance Products;
(b) As early as necessary in each year beginning with developing and implementing the first full Calendar Year after Initial Activities and all subsequent Work Plans and, subject to Section 7.1, allocating responsibility for Alliance Program activities between the Effective DateParties, update taking into consideration their relevant expertise and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.available resources;
(c) Prepare monitoring and reviewing the Development strategy progress of the Alliance Program and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United Statesresults thereof;
(d) Review and recommend recommending to the Joint Steering Committee Parties any material amendments or modifications to the U.S. Development Initial Activities and subsequent Work Plans;
(e) Coordinate and monitor regulatory strategy and activities for facilitating an effective exchange of information between the Collaboration Products in accordance with Article 9Parties regarding the Alliance Program;
(f) At each meeting establishing procedures by which the Parties evaluate on an individual basis potential professional publications which may disclose Confidential Information of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable other Party; [***] indicates material that has been omitted pursuant to a date immediately prior to request for confidential treatment. The omitted material has been filed separately with the date of the meeting;Securities and Exchange Commission.
(g) Review and recommend evaluating additional technologies, assets, products or other commercial opportunities that may be necessary or useful to the Joint Steering Committee "go/noAlliance Program and recommending the acquisition or in-go" decisions for licensing of these opportunities to the Development of Collaboration Products in the United States; andParties;
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon approving Alliance Accounting Policies and any subsequent changes thereto, budgets, allowed budget deviations and levels of expenditure by the Parties in the Alliance Program;
(i) approving termination of Alliance Products and NPCDs pursuant to Section 17.2;
(j) approving the disposition of an Alliance Product(s) to a Third Party, subject to agreement by the Parties as to allocation of compensation for their respective investment in such Alliance Product pursuant to Section 4.13;
(k) approving Party proposals regarding Development, acquisition or distribution of Instruments pursuant to Article VIII;
(l) managing preparation by the Parties of and approving the quarterly statements of Revenues and Allowable Expenses and of Net Investment, as set forth in Sections 9.1 and 9.2, respectively;
(m) managing preparation by the Parties of and approving quarterly and annual combined statements of Revenues, Allowable Expenses and Net Investment of the Alliance Program;
(n) overseeing the Commercialization activities of the Alliance Program;
(o) determining a Target Minimum Sales Price and recommending the average selling price for each Alliance Product in each geographic area specified in Section 1.88;
(p) managing preparation by the Parties of and annually approving a rolling three-year business plan that addresses each of the JRB responsibilities as set forth in this Section 3.2;
(q) consistent with and subject to Articles XI, XII and XIII of this Agreement, overseeing intellectual property used, created by or impacting the Alliance Program, including, without limitation: (i) assigning responsibility for the preparation, filing, prosecution and maintenance of Joint Alliance Patent Rights; (ii) reviewing all invention disclosures arising under or relating to the Alliance Program for the purposes of making patent application filing recommendations to the Parties and for determining proper inventorship and ownership of such inventions; (iii) establishing policies for the filing of foreign patent applications arising from time the Alliance Program; (iv) creating and approving, as necessary, a budget for management of intellectual property issues; (v) determining which Alliance Products should be marked with which Patent Right numbers; and (vi) addressing any other intellectual property issues referred to timethe JRB pursuant to the terms of this Agreement; and [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission.
(r) reviewing the [***] markets assessment set forth in Section 2.4 and determining by June 30, 2007 whether the Alliance Program will fund the Development of products or services to enter such markets in the Alliance Field in Europe and Japan.
Appears in 3 contracts
Sources: Strategic Alliance Agreement (Celera CORP), Strategic Alliance Agreement (Celera CORP), Strategic Alliance Agreement (Celera CORP)
Responsibilities. The Except as specified otherwise in this Agreement, the Joint Development Steering Committee ---------------- shall perform the following functions:
(a) Manage and oversee Discuss the preparation and implementation of overall strategy for the U.S. Development PlansResearch Collaboration;
(b) As early as necessary in each year beginning with Coordinate the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Parties’ activities hereunder;
(c) Prepare Monitor Development and Commercialization of Products in Major Markets pursuant to the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United Statesterms of this Agreement;
(d) Review Serve as a forum for discussion and recommend communication regarding the Development and Commercialization of Products pursuant to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plansthis Agreement;
(e) Coordinate Review and monitor regulatory strategy approve Research Plans and activities for the Collaboration Products in accordance with Article 9any material amendments to Research Plans;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses Review Research Collaboration activities and results for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, previous period and make any strategic recommendations as current as practicable to a date immediately prior to the date of the meetingappropriate;
(g) Review Discuss Development Plans and recommend Marketing Plans (in Major Markets) for Products and any material amendments to such Development Plans and Marketing Plans;
(h) Discuss Development activities for the Joint Steering Committee "previous period;
(i) Establish the JRC and, if applicable, the JDC;
(j) Discuss “go/no-go" ” decisions for and other matters referred to the Joint Steering Committee, including, but not limited to, the continued Development of Collaboration Products in a particular Product;
(k) Review and approve requests by Vitae regarding Research, Development and Commercialization of Non-Core 11▇ ▇▇▇-▇ ▇nhibitors by Vitae pursuant to Section 4.6.1;
(l) Review a summary of life-cycle management of, and intellectual property protection for, Products;
(m) Review and coordinate the United Statesprogress of all Committees other than the Joint Steering Committee;
(n) Use Diligent Efforts to resolve Commercial Conflicts;
(o) Resolve disputes, disagreements and deadlocks unresolved by any other Committee;
(p) Review cost plans relating to any Research; and
(hq) Have Perform such other responsibilities as may be assigned to the Joint Development Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 3 contracts
Sources: Research Collaboration and License Agreement (Vitae Pharmaceuticals, Inc), Research Collaboration and License Agreement (Vitae Pharmaceuticals, Inc), Research Collaboration and License Agreement (Vitae Pharmaceuticals, Inc)
Responsibilities. The Joint Development Committee ---------------- shall perform JSC will oversee and supervise the following functionsoverall performance of the Collaboration Plan and within such scope will:
(ai) Manage Periodically review the Parties’ efforts and oversee progress under the preparation and implementation of the U.S. Development PlansCollaboration Plan;
(bii) Review the Collaboration Program;
(iii) Review any proposed modifications or amendments to the Collaboration Plan and the Collaboration Program;
(iv) Prioritize and oversee execution of specific activities to be performed under the Collaboration Plan and the Collaboration Program;
(v) Review Patent Committee advice with regard to scientific activities to be performed under the Collaboration Plan and the Collaboration Program;
(vi) Review Collaboration Program Advisory Committee advice with regard to scientific activities to be performed under the Collaboration Plan and the Collaboration Program;
(vii) Review and select Product Candidates for additional work as part of the Collaboration Program; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(viii) Review and evaluate Product Candidates for which Development work should be performed as part of the Collaboration Program;
(ix) Review and approve of the regulatory plans and strategies for Product Candidates;
(x) Review all Regulatory Filings with respect to Product Candidates;
(xi) Form such other committees (“Sub-Committees”) as the JSC may deem appropriate. As early soon as necessary in each year beginning with the first full Calendar Year practicable (but not later than sixty (60) days) after the Effective Date, update the Parties will establish a Sub-Committee comprised of three (3) representatives of Celgene, three (3) representatives of Bluebird, and amend ▇▇. ▇▇▇▇▇▇▇ ▇. Brenner (the initial U.S. Development Plans “Collaboration Program Advisory Committee”). The Collaboration Program Advisory Committee will monitor and prepare advise the U.S. Development Plans for each Parties on the conduct and progress of the Collaboration Product for Program. Each Party may replace its representatives on the following Calendar Year so that it can submit such proposed U.S. Development Plans Collaboration Program Advisory Committee at any time upon written notice to the Joint Steering other Party. Any such Sub-Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with (including the Commission. Confidential treatment has been requested with respect Collaboration Program Advisory Committee) may make recommendations to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesJSC but may not be delegated JSC decision-making authority;
(dxii) Review and recommend Address such other matters relating to the Joint Steering Committee activities of the Parties under this Agreement as either Party may bring before the JSC, including any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities matters that are expressly for the Collaboration Products JSC to decide as provided in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United Statesthis Agreement; and
(hxiii) Have such other responsibilities as may be assigned Attempt to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeresolve any disputes on an informal basis.
Appears in 3 contracts
Sources: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Responsibilities. The Joint Development Supply Committee ---------------- shall perform ---------------- the following functions:
(a) Manage and oversee the preparation activities in relation to manufacture and implementation supply of API Compound and Collaboration Products for use in Development and Commercialization and establish procedures and protocols for testing API Compound and Collaboration Products to ensure that such API Compound and Collaboration Products comply with the U.S. Development Plansspecifications (the "Testing ------- Protocol"). The Parties will utilize such Testing Protocol with respect to API -------- Compound and Collaboration Product that they may receive from Product Suppliers to ensure that such API Compound or Collaboration Product meets specifications;
(b) As early as Recommend and coordinate necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans adjustments to the Joint Steering Committee no later manufacturing schedule to ensure it is meeting the needs for all Collaboration Products;
(c) Coordinate allocation of API Compound in the event of a shortage between the United States and the ROW, it being understood that, in the event of a shortage, allocation of API Compound shall be as follows: (i) requirements for use in ** for Commercialization in the ** shall have first priority; (ii) requirements for use in ** for Commercialization in the ** shall have second priority; (iii) requirements for use in ** (other than **) in the ** shall have third priority; (iv) requirements for use in ** (other than **) for Commercialization in the ** shall have fourth priority; and (v) requirements for use in all other ** containing API Compound shall have fifth priority. The foregoing priority allocations may be revised by the Joint Supply Committee based on the relative commercial value of such year **;
(d) Review the quality of the manufacture of the Collaboration Products, reviewing as appropriate reports of the manufacturers of API Compound and Collaboration Products and reports as to the quality of any packaging that bears the relevant trademarks or housemarks of the Parties (as owned by or licensed to the relevant Party under Section 2.4) as prescribed by this Agreement;
(e) Recommend and implement optimal inventory levels and safety stock targets;
(f) Set improvement targets and monitor performance against these targets for review cost, yield, delivery and approvalother appropriate measures;
(g) Establish guidelines to facilitate improved efficiencies and compliance with current Good Manufacturing Practices by Product Suppliers; and ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Supply Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 3 contracts
Sources: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)
Responsibilities. The Joint Development Committee ---------------- responsibilities of the JSC and, as delegated by the JSC to its subcommittees, shall perform the following functionsbe:
(ai) Manage and oversee to provide a vehicle by which the preparation and implementation Parties may share information regarding the overall strategy for the Development of the U.S. Development PlansProduct(s);
(bii) As early as necessary in each year beginning with to generate, approve and implement the first full Calendar Year after the Effective Date, update and amend the initial U.S. Initial Development Plans and prepare the U.S. budgets and Development Plans and budgets for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Subsequent Development Plans of Products, including any clinical trials, and any subsequent amendments to the Joint Steering Committee no later than ** of such year for Development Plan;
(iii) to review and approval; ** = Certain information advise on this page has been omitted and filed separately with any Third Parties used or to be involved in Development (CRO, CMO, etc.);
(iv) to facilitate the Commission. Confidential treatment has been requested exchange of Information between the Parties with respect to the omitted portions.
(c) Prepare the Development strategy activities hereunder and develop protocols for clinical studies to establish procedures for the Collaboration efficient sharing of Information necessary for the Parties to fulfill their respective responsibilities with respect to Development of Products for Commercialization in the United Stateshereunder;
(dv) Review to review and recommend support an overall regulatory strategy established for the Product in the Field in the Territory, and to allocate the Joint Steering Committee any material amendments or modifications to responsibility for regulatory activities between the U.S. Development PlansParties as contemplated by Article 6, below;
(evi) Coordinate to review and monitor regulatory strategy support the Manufacturing Strategy; and to allocate responsibility for manufacturing activities for between the Collaboration Products in accordance with Parties as contemplated by Article 95.1;
(fvii) At each meeting of to discuss and give input regarding the Joint Development Committee, review a comparison of actual Development Expenses for the United States information set forth in Commercialization reports submitted by Lilly to the budgeted Development Expenses for JSC pursuant to Article 4.1, including the United States Commercialization strategy with respect to Products in the U.S. Development Plan for Field in the year-to-date, as current as practicable to a date immediately prior to the date of the meetingTerritory;
(gviii) Review to create such subcommittees as the JSC may find necessary or desirable from time to time, including a Development subcommittee, a Manufacturing subcommittee, a Commercialization subcommittee, a regulatory subcommittee and recommend an intellectual property subcommittee (all such subcommittees, as practicable, to be formed at the Joint Steering Committee "go/no-go" decisions for JSC’s first organizational meeting with the Development exception of Collaboration Products in the United StatesCommercialization subcommittee);
(ix) to oversee the activities of subcommittees created under this Agreement, and to resolve any issues that such subcommittees cannot resolve; and
(hx) Have to perform such other responsibilities functions as may be assigned appropriate to further the Joint Development Committee pursuant to purposes of this Agreement or Agreement, as may be mutually agreed upon determined by the Parties from time to timeParties.
Appears in 2 contracts
Sources: Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD), Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage and oversee the preparation and implementation of the U.S. Development Marketing Plans; Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and ImClone Systems Incorporated.
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(biv) As early as necessary discuss the state of the markets for Products in each year beginning the Territory and opportunities and issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the amount and kind of marketing and selling effort appropriate, in accordance with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Marketing Plans;
(ev) Coordinate review and monitor regulatory approve Non-Registrational Studies, taking into consideration the appropriateness in the context of the overall marketing and promotional strategy and activities for the Collaboration Products Products;
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with Article 9the Marketing Plans;
(fvii) At review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxiii) Review review and recommend approve the general guidelines applicable to particular Products to be followed by ERS in its development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(xv) review and approve the joint publication strategy together with the PDC; Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and ImClone Systems Incorporated.
(xvi) evaluate and determine the existence or non-existence of a Co-Promotion Problem referred to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products JCC in the United Statesaccordance with Section 5.6(e); and
(hxvii) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 2 contracts
Sources: Development, Promotion, Distribution and Supply Agreement (Bristol Myers Squibb Co), Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc/De)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage Develop and oversee subsequently review and make decisions relating to the preparation and Commercialization Plan including a budget for PSMM Expenses;
(ii) Oversee implementation of the U.S. Development PlansCommercialization Plan, throughout the Calendar Year, including managing the budget for PSMM Expenses;
(biii) As early as necessary in each year beginning with Discuss the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans markets for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesTerritory and opportunities and issues concerning Commercialization of Product, including consideration of marketing and promotional strategy, marketing research plans, labelling, Product positioning and Product profile, including [***];
(div) Oversee and coordinate the sales efforts of the Parties;
(v) Review and recommend to make decisions regarding post-Initial Indication Approval Development activities, taking into consideration the Joint Steering Committee appropriateness of any material amendments or modifications to Development activities including line extensions, Clinical Trials for purposes of new indications and Phase IV Clinical Trials in the U.S. Development Planscontext of the overall marketing and promotional strategy for Product;
(evi) Coordinate Review and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9direct all indigent care use of Product;
(fvii) Support the review of and approve Manufacturing, sales and prescription forecasts of Product;
(viii) Review data and reports arising from and generated in connection with Commercialization of Product under the Commercialization Plan, market research studies, actual Product sales, Product prescription trends and Product sales forecasts;
(ix) At each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan for the year-to-daterelevant Commercialization Plan, with such information covering a time period ending as current closely as practicable to a date immediately prior to the date of the meeting;
(gx) Review and recommend approve the general guidelines applicable to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products Product Commercialization to be followed in the United Statesdevelopment of promotional materials and promotional activities to be used by the Parties in the co-promotion of Product;
(xi) Lead the review and direct Product publication strategy, in consultation with the PDC;
(xii) Following review and approval by the Parties’ internal promotional materials review committees, review and approve packaging and related materials, prior to any commercial use; and
(hxiii) Have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 2 contracts
Sources: Collaboration Agreement (Allergan Inc), Collaboration Agreement (MAP Pharmaceuticals, Inc.)
Responsibilities. The Joint JSC shall be responsible for overseeing the conduct and progress of the Research Program, the Development Committee ---------------- of Optimized Lead Compounds, the Development and Commercialization of Co-Developed Collaboration Aptamers and the Development of other Aptamers for which ARCHEMIX is performing Development activities. Without limiting the generality of the foregoing, the JSC shall perform have the following functions:responsibilities: Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.
(a) Manage overseeing the JPT’s, JDC’s and oversee the preparation and implementation JCC’s performance of the U.S. Development Plansits respective responsibilities;
(b) As early as necessary in reviewing and approving each year beginning with the first full Calendar Year after the Effective DateAnnual Research Plan and each Annual Development Plan under which ARCHEMIX is responsible for performing ARCHEMIX Development Activities for a Collaboration Aptamer, update and amend the initial U.S. including, without limitation, a Co-Developed Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Candidate;
(c) Prepare determining, in accordance with Section 4.10.6(b), the ARCHEMIX Co-Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesParticipation Level with respect to a Co-Developed Development Candidate;
(d) Review determining whether to file an IND and recommend whether to the Joint Steering Committee Initiate any material amendments or modifications Clinical Trial, with respect to the U.S. Development Plansa Collaboration Agreement;
(e) Coordinate reviewing and monitor regulatory strategy approving any amendment to each Annual Research Plan approved by the JPT and activities submitted to it for the Collaboration Products in accordance with Article 9its approval;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States reviewing and approving any amendment to the budgeted Development Expenses for the United States in the U.S. an Annual Development Plan that covers a Co-Developed Development Candidate and/or under which ARCHEMIX is responsible for performing Development activities approved by the year-to-date, as current as practicable JPT and submitted to a date immediately prior to the date of the meetingit for its approval;
(g) Review reviewing data, reports or other information submitted to it by the JPT from time to time;
(h) resolving all JPT, JDC and recommend JCC matters that are in dispute;
(i) reviewing and either approving or rejecting any decision of the JPT to nominate any Lead Compound as an Optimized Lead Compound or any decision of the Joint Steering Committee "go/no-go" decisions for the JPT to nominate any Optimized Lead Compound as a Development of Collaboration Products in the United StatesCandidate;
(j) resolving any dispute as to whether a milestone event under this Agreement has occurred; and
(hk) Have implementing a mutually acceptable mechanism for reporting Adverse Events between the Parties for each Development Candidate and Product; and
(l) making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee JSC pursuant to this Agreement or as may be mutually agreed upon by mutual written agreement of the Parties from time to timeafter the Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The Joint Development Committee ---------------- shall perform Assistant Secretary of Defense for Force Management Policy (ASD (FMP)), under the following functionsUnder Secretary of Defense for Personnel and Readiness, shall:
(a) Manage Make the final decision on all for- mal appeals to directives and oversee other guidance submitted by the preparation and implementation of the U.S. Development Plans;school board or Superintendent.
(b) As early as necessary Ensure the Director, DoD DDESS shall:
(1) Ensure the establishment of elect- ed school boards in each year beginning DoD DDESS ar- rangements.
(2) Monitor compliance by the Super- intendent and school boards with appli- cable statutory and regulatory require- ments, and this part. In the first full Calendar Year after event of suspected noncompliance, the Effective DateDirector, update DoD DDESS, shall take appropriate ac- tion, which will include notification of the Superintendent and amend the initial U.S. Development Plans school board president of the affected DoD DDESS arrangement.
(3) Determine when the actions of a school board conflict with an applica- ble statute, regulation, or other guid- ance or when there is a conflict in the views of the school board and prepare the U.S. Development Plans for each Collaboration Product for Su- perintendent. When such conflicts occur, the following Calendar Year so Director, DoD DDESS, shall assist the Superintendent and the school board in resolving them or di- rect that it can submit such proposed U.S. Development Plans actions be discontinued. Such disapprovals must be in writing to the Joint Steering Committee no later than ** of such year for review school board and approval; ** = Certain information on this page has been omitted the Super- intendent concerned and filed separately with shall state the Commission. Confidential treatment has been requested with respect to the omitted portionsspecific supporting reason or reasons.
(c) Prepare Ensure the Development strategy school board for DoD DDESS arrangements shall:
(1) Participate in the development and develop protocols for clinical studies oversight of fiscal, personnel, and educational policies, procedures, and programs for the Collaboration Products DoD DDESS arrange- ment concerned, consistent with this part.
(2) Approve agendas and prepare min- utes for Commercialization school board meetings. A copy of the approved minutes of school board meetings shall be forwarded to the Director, DoD DDESS, within 10 working days after the date the min- utes are approved.
(3) Provide to the Director, DoD DDESS, names of applicants for a va- cancy in the United States;Superintendent’s position after a recruitment has been accom- plished. The school board shall submit to the Director, DoD DDESS, a list of all applicants based on its review of the applications and interviews (either in person or telephonically) of the appli- cants. The list of applicants will be ac- companied by the recommended choice of the school board. The Director will select the Superintendent and will sub- mit written notice with justification to the school board if the recommenda- tion of the school board is not followed.
(4) Prepare an annual written on-site review of the Superintendent’s per- formance for consideration by the ▇▇- ▇▇▇▇▇▇, DoD DDESS. The written re- view shall be based on critical ele- ments recommended by the school board and Superintendent and ap- proved by the Director, DoD DDESS. The school board’s review will be an of- ficial attachment to the Superintend- ent’s appraisal.
(5) Participate in the development of the school system’s budget for submis- sion to the Director, DoD DDESS, for his or her approval as endorsed by the school board; and participate in the oversight of the approved budget, in conjunction with the Superintendent, as appropriate for operation of the school arrangement.
(6) Invite the Superintendent or des- ignee to attend all school board meet- ings.
(7) Provide counsel to the Super- intendent on the operation of the school and the implementation of the approved budget.
(8) Channel communications with school employees to the DoD DDESS Superintendent. Refer all applications, complaints, and other communica- tions, oral or written, to the DoD DDESS Arrangement Superintendents.
(9) Participate in the development of school policies, rules, and regulations, in conjunction with the Super- intendent, and recommend which poli- cies shall be reflected in the School Policy Manual. At a minimum, the Policy Manual, which shall be issued by the Superintendent, shall include following:
(i) A statement of the school philos- ophy.
(ii) The role and responsibilities of school administrative and educational personnel.
(iii) Provisions for promulgation of an annual school calendar.
(iv) Provisions on instructional serv- ices, including policies for development and adoption of curriculum and text- books.
(v) Regulations affecting students, including attendance, grading, pro- motion, retention, and graduation cri- teria, and the student code of rights, responsibilities, and conduct.
(vi) School policy on community re- lations and noninstructional services, including maintenance and custodial services, food services, and student transportation.
(vii) School policy and legal limits on financial operations, including ac- counting, disbursing, contracting, and procurement; personnel operations, in- cluding conditions of employment, and labor management regulations; and the processing of, and response to, com- plaints.
(viii) Procedures providing for new school board member orientation.
(ix) Any other matters determined by the school board and the super- intendent to be necessary.
(10) Under 10 U.S.C. 2164(b)(4)(B), pre- pare and submit formal appeals to di- rectives and other guidance that in the view of the school board adversely im- pact the operation of the school system either through the operation and man- agement of DoD DDESS or a specific DoD DDESS arrangement. Written for- mal appeals with justification and sup- porting documentation shall be sub- mitted by the school board or Super- intendent to ASD(FMP). The ASD(FMP) shall make the final deci- sion on all formal appeals. The Direc- tor, Dod DDESS, will provide the ap- pealing body written review of the find- ings relating to the merits of the ap- peal. Formal appeals will be handled expeditiously by all parties to mini- ▇▇▇▇ any adverse impact on the oper- ation of the DoD DDESS system.
(d) Review Ensure school board operating procedures are as follows:
(1) The school board shall operate from a written agenda at all meetings. Matters not placed on the agenda be- fore the start of the meeting, but ap- proved by a majority of the school board present, may be considered at the ongoing meeting and recommend added to the Joint Steering Committee any material amendments agenda at that time.
(2) A majority of the total number of school board members authorized shall constitute a quorum.
(3) School board meetings shall be conducted a minimum of 9 times a year. The school board President or modifications designee will provide school board members timely notice of all meetings. All regularly scheduled school board meetings will be open to the U.S. Development Plans;public. Executive session meetings may be closed under 10 U.S.C. 2164(d)(6).
(e4) Coordinate and monitor regulatory strategy and activities The school board shall not be bound in any way by any action or statement of an individual member or group of members of the board except when such action or statement is ap- proved by a majority of the school board members during a school board meeting.
(5) School board members are eligible for the Collaboration Products reimbursement for official travel in accordance with Article 9;the DoD Joint Travel Regulations and guidance issued by the Director, DoD DDESS.
(f6) At each meeting School board members may be re- moved by the ASD (FMP) for derelic- tion of duty, malfeasance, or other grounds for cause shown. The school board concerned may recommend such removal with a two-thirds majority vote. Before a member may be re- moved, the member shall be afforded due process, to include written notifi- cation of the Joint Development Committee, review a comparison of actual Development Expenses basis for the United States action, re- view of the evidence or documentation considered by the school board, and an opportunity to respond to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeallega- tions.
Appears in 2 contracts
Sources: Dod Ddess Arrangements, Dod Ddess Arrangements
Responsibilities. The Joint Development Research Committee ---------------- shall perform supervise the following functionsexecution of the Research Plan and administer the Funded Project, and its responsibilities shall include, without limitation:
(a) Manage To periodically review whether there is need to amend or supplement the Research Plan and oversee to recommend changes thereto to the preparation and implementation Steering Committee, as may be reasonably required to meet the goals of the U.S. Development Plans;
(b) As early as necessary in each year beginning with Research Plan and the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than Collaboration; *** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect for redacted portions of this exhibit. This copy omits the information subject to the omitted portionsconfidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.
(b) To recommend to the Steering Committee changes in assays and validation processes for Collaboration Hit Homologs, Special Collaboration Hits and Preferred Mode of Use;
(c) Prepare To recommend to the Development strategy Steering Committee amendments, modifications and develop protocols for clinical studies for supplements to the Research Plan, and changes to validation criteria of Collaboration Products for Commercialization in the United StatesHit Homologs Special Collaboration Hits and Preferred Modes of Use;
(d) Review and recommend At least sixty (60) days prior to the Joint commencement of each Collaboration Year, to review and approve, subject to final approval by the Steering Committee, a detailed research plan for the subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the Discovery Programs to be conducted and the Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the Steering Committee any material amendments or modifications shall automatically constitute an amendment to and part of the U.S. Development PlansResearch Plan;
(e) Coordinate To discuss ways for Monsanto to assist the gene discovery and monitor regulatory strategy identification of Preferred Modes of Use processes, such as by providing Evogene with certain know-how and activities for Monsanto Data, including to periodically review whether there is need to supplement the Collaboration Products [* * *] set forth in accordance with Article 9[* * *] ([* * *]) and to [* * *] to the Steering Committee, as may be reasonably required to meet the goals of the Research Plan and the Collaboration;
(f) At To monitor the parties’ performance of their respective Diligence Obligations (based on the reports to be provided by each meeting party as set forth in Sections 2.8.1 and 2.8.2) and to review and amend the format of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-dateparties’ reports, as current as practicable may be reasonably required in order to a date immediately prior enable the Research Committee to monitor the date parties’ performance of the meetingtheir respective Diligence Obligations;
(g) Review To discuss, at a general level, information provided on Collaboration Hit Homologs and recommend Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks,, the Collaboration Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to the Joint Steering Committee "go/novalidation of the Collaboration Hit Homologs, Special Collaboration Hits and Preferred Modes of Use in the Monsanto Pipeline;
(h) To receive from Evogene information on possible Independent Discovery Rounds, in accordance with Section 4.2.1, and to discuss information provided by Evogene on Internal Non-go" decisions Field Hits which underwent the Core Validation and met the Validated Hit criteria as set forth in Section 4.2.2; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the Development information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.
(i) To review issues relating to Publications resulting from the activities conducted under the Collaboration, in accordance with Section 2.10;
(j) To keep a record of the Collaboration Hit Sets, Special Collaboration Hits, PlaNet Genes, PlaNet ▇▇▇▇ ▇▇▇▇▇▇, RePack Recommendations and GeneDex Recommendations licensed to Monsanto hereunder, and any termination of any such license in accordance with the terms of this Agreement (For the avoidance of doubt, all GeneSpec Genes, including those that are Homologs of Collaboration Products in Hits, shall be recorded as such);
(k) To meet no less than annually to discuss field trial results;
(l) To approve amendments to Evogene Project Hits, as contemplated by Section 1.72;
(m) To approve the United Statesuse of Collaboration Hit Homologs and PlaNet Gene Homologs for Model Plant Validation, as contemplated by Sections 1.134, 5.2.3, 5.2.4(b), 5.2.6(b), 5.4.3(a)(ii), 5.4.3(a)(iv), 5.5.3(a)(ii), 5.5.3(a)(iv) and 5.5;
(n) To amend the forms of Exhibits I, J and Q, pursuant to Sections 2.8.1, 2.8.2 and 5.12.4;
(o) To approve assays for model plant validation of certain Special Collaboration Hits pursuant to Section 4.2.1(a)(v);
(p) To make any other decisions expressly assigned to the Research Committee by this Agreement; and
(hq) Have To exercise such other additional responsibilities as may be assigned delegated to the Joint Development Research Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeSteering Committee.
Appears in 2 contracts
Sources: Collaboration Agreement (Evogene Ltd.), Collaboration Agreement (Evogene Ltd.)
Responsibilities. The Joint Development Committee ---------------- JSC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 4.1.5:
(a) Manage review and oversee the preparation and implementation monitor progress of the U.S. Development PlansCollaboration;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page determine whether Target Validation has been omitted and filed separately with the Commission. Confidential treatment has been requested achieved with respect to the omitted portions.each Selected Target;
(c) Prepare review and approve changes to the Development strategy and develop protocols Tractable Hit Criteria for clinical studies for the Collaboration Products for Commercialization in the United Stateseach Selected Target;
(d) Review and recommend determine whether the applicable Tractable Hit Criteria have been achieved with respect to the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansCompound;
(e) Coordinate review and monitor regulatory strategy and activities approve changes to the Lead Candidate Criteria for the Collaboration Products in accordance with Article 9each Selected Target;
(f) At each meeting of determine whether the Joint Development Committee, review a comparison of actual Development Expenses for the United States applicable Lead Candidate Criteria have been achieved with respect to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingany Compound;
(g) Review review and recommend approve changes to the Joint Steering Committee "go/no-go" decisions Development Candidate Selection Criteria for the Development of Collaboration Products in the United States; andeach Selected Target;
(h) Have determine whether the applicable Development Candidate Selection Criteria have been achieved with respect to any Compound;
(i) serve as a forum for exchange of information and to facilitate discussions regarding the conduct of the Collaboration and the Development of Licensed Compounds, Licensed Products and Diagnostic Products hereunder;
(j) discuss and attempt to resolve any deadlocked issues submitted to it in accordance with the procedures established in Section 4.1.5;
(k) review and approve Research Plans submitted by the JPT;
(l) review and discuss ROFO Packages;
(m) such other responsibilities as may be assigned to the Joint Development Committee JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time; and
(n) review and monitor the transfer and delivery of Know-How and material to GSK that is provided for under Section 5.5. For clarity, the JSC shall not have any authority beyond the specific matters set forth in this Section 4.1.4, and in particular shall not have any power to amend or modify the terms of this Agreement. In any case where a matter within the JSC’s authority arises, the JSC shall convene a meeting and consider such matter within [**] days after the matter is first brought to the JSC’s attention, or, if earlier, at the next regularly-scheduled JSC meeting.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement (Epizyme, Inc.)
Responsibilities. The Joint Development Committee ---------------- shall perform JSC may discharge its responsibilities through one or more subcommittees. The JSC’s responsibilities will include, without limitation, the following functionsfollowing:
(a) Manage and oversee the preparation and overseeing implementation of the U.S. Development PlansPlan;
(b) As early as necessary in each year beginning reviewing and evaluating progress under the Development Plan (including compliance with the first full Calendar Year after Development Budget contained therein and payment arrangements) on a quarterly basis and advising the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans Parties as to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.any necessary amendments thereto;
(c) Prepare allocating and assigning Development activities in the Development strategy and develop protocols for clinical studies for Plan between the Collaboration Products for Commercialization in Parties, consistent with the United Statesterms of this Agreement;
(d) Review approving (or establishing procedures to approve) protocols for pre-clinical studies and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Clinical Trials for Development Plansof Collaboration Products;
(e) Coordinate making modifications to and monitor regulatory strategy performing quarterly monitoring of progress of pre-clinical studies and activities Clinical Trials and proposing additional studies for the Collaboration Products in accordance with Article 9Products;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States reviewing and approving any proposed modifications to the budgeted Development Expenses for Plan, including advising the United States Parties as to whether a Back-Up Compound should be developed in the U.S. Development Plan for the year-to-date, as current as practicable to lieu of a date immediately prior to the date of the meetingCollaboration Compound;
(g) Review coordinating the Manufacture of global supplies of a Collaboration Compound and recommend to the Joint Steering Committee "go/no-go" decisions Collaboration Product for the Development of Collaboration Products in the United States; and(i) Clinical Trials and (ii) Commercialization;
(h) Have such other responsibilities as may reviewing and commenting on Regulatory Submissions relating to Collaboration Products;
(i) facilitating the exchange of all data, information, material or results relating to Development of Collaboration Products;
(j) establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the Pharmacovigilance Agreement to be assigned to entered into in accordance with Section 4.3.5;
(k) facilitating the Joint Development Committee transfer of Know-How pursuant to this Agreement;
(l) developing a strategy for performing Translational Research Activities and Developing a Diagnostic Product, as necessary, under the Development Plan and overseeing implementation of any such strategy;
(m) establishing and overseeing implementation of the Commercialization Plan;
(n) performing such other activities as are contemplated under this Agreement or as may be mutually agreed upon by and that the Parties from time mutually agree shall be the responsibility of the Joint Steering Committee. Notwithstanding the foregoing, in no event shall the JSC or any subcommittee of the JSC have the authority to time(i) reduce or expand the obligations of the Parties under this Agreement; (ii) determine that a breach has occurred under this Agreement; (iii) waive a Party’s rights or obligations under this Agreement; or (iv) make any decision that is specified elsewhere in this Agreement as being made by one or both Parties.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Hutchison China MediTech LTD), License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The Joint Development Committee ---------------- shall perform JSC may discharge its responsibilities through one or more subcommittees. The JSC’s responsibilities will include, without limitation, the following functionsfollowing:
(a) Manage and oversee the preparation and overseeing implementation of the U.S. Development PlansPlan;
(b) As early as necessary in each year beginning reviewing and evaluating progress under the Development Plan (including compliance with the first full Calendar Year after Development Budget contained therein and payment arrangements) on a quarterly basis and advising the Effective DateParties as to any necessary amendments thereto;
(c) allocating and assigning Development activities in the Development Plan between the Parties, update consistent with the terms of this Agreement;
(d) approving (or establishing procedures to approve) protocols for pre-clinical studies and amend Clinical Trials for Development of Collaboration Products;
(e) making modifications to and performing quarterly monitoring of progress of pre-clinical studies and Clinical Trials and proposing additional studies for Collaboration Products;
(f) reviewing and approving any proposed modifications to the initial U.S. Development Plans Plan, including advising the Parties as to whether a Back-Up Compound should be developed in lieu of a Collaboration Compound;
(g) coordinating the Manufacture of global supplies of a Collaboration Compound and prepare the U.S. Development Plans for each Collaboration Product for (i) Clinical Trials and (ii) Commercialization;
(h) reviewing and commenting on Regulatory Submissions relating to Collaboration Products;
(i) facilitating the following Calendar Year so that it can submit such proposed U.S. exchange of all data, information, material or results relating to Development Plans of Collaboration Products;
(j) establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the Joint Steering Committee no later than Pharmacovigilance Agreement to be entered into in accordance [** of such year for review and approval; ** = ] Certain information on in this page document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesSection 4.3.5;
(dk) Review facilitating the transfer of Know-How pursuant to this Agreement;
(l) developing a strategy for performing Translational Research Activities and recommend to Developing a Diagnostic Product, as necessary, under the Development Plan and overseeing implementation of any such strategy;
(m) establishing and overseeing implementation of the Commercialization Plan;
(n) performing such other activities as are contemplated under this Agreement and that the Parties mutually agree shall be the responsibility of the Joint Steering Committee Committee. Notwithstanding the foregoing, in no event shall the JSC or any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting subcommittee of the Joint Development Committee, review a comparison of actual Development Expenses for JSC have the United States authority to (i) reduce or expand the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date obligations of the meeting;
Parties under this Agreement; (gii) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products determine that a breach has occurred under this Agreement; (iii) waive a Party’s rights or obligations under this Agreement; or (iv) make any decision that is specified elsewhere in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement as being made by one or as may be mutually agreed upon by the Parties from time to timeboth Parties.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Hutchison China MediTech LTD), License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The Joint Development Patent Committee ---------------- shall perform the following functions:
, subject to the final decision-making authority of the Person set forth in Section 4.3.6: (a) Manage discuss material issues and oversee provide input to each other regarding the preparation Prosecution and implementation Maintenance of the U.S. Development Plans;
Jounce Patents, Celgene Patents, Collaboration Patents and Joint Collaboration Patents, including recommending whether or not to file a Collaboration Patent in all Core Countries; (b) As early serve as necessary in each year beginning with the first full Calendar Year after the Effective Date, update a forum for exchanging information and amend the initial U.S. Development Plans facilitating discussions regarding patentability and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans freedom to the Joint Steering Committee no later than ** of such year for review operate assessments; and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have perform such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. may be mutually agreed upon by the Parties from time to time, including those matters identified in Sections 7.2 to 7.8. The Patent Committee shall be responsible for coordinating the implementation of each Party’s strategies for the protection of the foregoing intellectual property rights related to Pre-LO Targets, Collaboration Targets, Collaboration Candidates, Development Candidates and Diagnostic Products. For clarity, the Patent Committee shall not have any authority beyond the specific matters set forth in this Section 4.3.4, and in particular shall not have any power to amend, modify, interpret or waive the terms of this Agreement or any Development & Commercialization Agreement, or to alter, increase, expand or waive compliance by a Party with, a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the Patent Committee’s authority arises, the Patent Committee shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the matter is first brought to the Patent Committee’s attention (or, if earlier, at the next regularly scheduled Patent Committee meeting).
Appears in 2 contracts
Sources: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)
Responsibilities. The Except as specified otherwise in this Agreement, the Joint Development Steering Committee ---------------- shall perform the following functions:
(a) Manage and oversee Discuss the preparation and implementation of overall strategy for the U.S. Development PlansResearch Collaboration;
(b) As early as necessary in each year beginning with Coordinate the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Parties’ activities hereunder;
(c) Prepare Monitor Development and Commercialization of Products in Major Markets pursuant to the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United Statesterms of this Agreement;
(d) Review Serve as a forum for discussion and recommend communication regarding the Development and Commercialization of Products pursuant to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;this Agreement; ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(e) Coordinate Review and monitor regulatory strategy approve Research Plans and activities for the Collaboration Products in accordance with Article 9any material amendments to Research Plans;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses Review Research Collaboration activities and results for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, previous period and make any strategic recommendations as current as practicable to a date immediately prior to the date of the meetingappropriate;
(g) Review Discuss Development Plans and recommend Marketing Plans (in Major Markets) for Products and any material amendments to such Development Plans and Marketing Plans;
(h) Discuss Development activities for the Joint Steering Committee "previous period;
(i) Establish the JRC and, if applicable, the JDC;
(j) Discuss “go/no-go" ” decisions for and other matters referred to the Joint Steering Committee, including, but not limited to, the continued Development of Collaboration Products in a particular Product;
(k) Review and approve requests by Vitae regarding Research, Development and Commercialization of Non-Core ▇▇▇ ▇▇▇-▇ Inhibitors by Vitae pursuant to Section 4.6.1;
(l) Review a summary of life-cycle management of, and intellectual property protection for, Products;
(m) Review and coordinate the United Statesprogress of all Committees other than the Joint Steering Committee;
(n) Use Diligent Efforts to resolve Commercial Conflicts;
(o) Resolve disputes, disagreements and deadlocks unresolved by any other Committee;
(p) Review cost plans relating to any Research; and
(hq) Have Perform such other responsibilities as may be assigned to the Joint Development Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 2 contracts
Sources: Research Collaboration and License Agreement (Vitae Pharmaceuticals, Inc), Research Collaboration and License Agreement (Vitae Pharmaceuticals, Inc)
Responsibilities. The Joint Development Committee ---------------- responsibilities of the JSC and, as delegated by the JSC to its subcommittees, shall perform the following functionsbe:
(ai) Manage and oversee to provide a vehicle by which the preparation and implementation Parties may share information regarding the overall strategy for the Development of the U.S. Development PlansProduct(s);
(bii) As early as necessary in each year beginning with to generate, approve and implement the first full Calendar Year after the Effective Date, update and amend the initial U.S. Initial Development Plans and prepare the U.S. budgets and Development Plans and budgets for each Collaboration Product Subsequent Development of Products, including any clinical trials, and any subsequent amendments to the Development Plan;
(iii) to review and advise on any Third Parties used or to be involved in Development (CRO, CMO, etc.);
(iv) to facilitate the exchange of Information between the Parties with respect to the Development activities hereunder and to establish procedures for the following Calendar Year so that it can submit such proposed U.S. efficient sharing of Information necessary for the Parties to fulfill their respective responsibilities with respect to Development Plans of Products hereunder;
(v) to review and support an overall regulatory strategy established for the Product in the Field in the Territory, and to allocate the responsibility for regulatory activities between the Parties as contemplated by Article 6, below;
(vi) to review and support the Manufacturing Strategy; and to allocate responsibility for manufacturing activities between the Parties as contemplated by Article 5.1;
(vii) to discuss and give input regarding the information set forth in Commercialization reports submitted by Lilly to the Joint Steering Committee no later than JSC pursuant to Article 4.1, including the Commercialization strategy with respect to Products in the Field in the Territory;
(viii) to create such subcommittees as the JSC may find necessary or desirable from time to time, including a Development subcommittee, a Manufacturing subcommittee, a Commercialization subcommittee, a regulatory subcommittee and an intellectual property subcommittee (all such subcommittees, as practicable, to be formed at the JSC’s first organizational meeting with the exception of the Commercialization subcommittee);
(ix) to oversee the activities of subcommittees created under this [** of such year for review and approval; ** = ] Certain information on in this page document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect Agreement, and to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee resolve any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United Statesissues that such subcommittees cannot resolve; and
(hx) Have to perform such other responsibilities functions as may be assigned appropriate to further the Joint Development Committee pursuant to purposes of this Agreement or Agreement, as may be mutually agreed upon determined by the Parties from time to timeParties.
Appears in 2 contracts
Sources: Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD), Exclusive License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The Joint JDC shall be responsible for overseeing the Development Committee ---------------- by the Parties of Co-Developed Development Candidates in the Co-Development Territory; provided, that, any such Development is consistent with the global Development Plan for each such Co-Developed Development Candidate, for which MERCK ultimately bears responsibility. Without limiting the generality of the foregoing, the JDC shall perform have the following functionsresponsibilities:
(a) Manage and oversee preparing or directing the preparation and implementation recommending to the JSC for its approval of an Annual Development Plan for each Co-Developed Development Candidate in the U.S. Co-Development PlansTerritory;
(b) As early as necessary in each year beginning monitoring the activities of, and reconciling issues between, the Parties with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans respect to the Joint Steering Committee no later than ** Parties’ respective share of such year for review Co-Development Costs and approvalCo-Development Regulatory Costs incurred with respect to Co-Developed Development Candidates; ** = Certain information on Portions of this page has been Exhibit were omitted and have been filed separately with the Commission. Confidential treatment has been requested with respect Secretary of the Commission pursuant to to the omitted portionsCompany’s application requesting confidential treatment under Rule 406 of the Securities Act.
(c) Prepare preparing or directing the preparation of and approving amendments to JSC-approved Annual Development Plans with respect to Co-Developed Development Candidates as it deems appropriate in furtherance of the objectives of the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization Program as set forth in the United StatesAnnual Development Plan and, if any member of the JDC asserts that any such JDC-approved amendment would change the objectives of such Annual Development Plan, submitting such amendment to the JSC for its consideration;
(d) Review monitoring the progress of each Annual Development Plan with respect to Co-Developed Development Candidates and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plansof each Party’s activities thereunder;
(e) Coordinate and monitor regulatory strategy and activities providing a forum for consensual decision making with respect to the Collaboration Products in accordance with Article 9Development of Co-Developed Development Candidates;
(f) At each meeting of the Joint Development Committeereviewing data, review a comparison of actual Development Expenses for the United States reports or other information submitted by either Party with respect to the budgeted Development Expenses for the United States work conducted in the U.S. Development Plan for of Co-Developed Development Candidates affecting the yearCo-to-date, as current as practicable to a date immediately prior to the date of the meetingDeveloped Territory;
(g) Review and recommend to preparing for the Joint Steering Committee "go/noJSC on at least a semi-go" decisions annual basis a progress report for the Development of Collaboration Products Co-Developed Development Candidates in reasonable detail and providing to the United StatesJSC such additional information as it may request; and
(h) Have performing such other responsibilities activities as may be assigned delegated to the Joint Development Committee JDC pursuant to this Agreement Agreement, or as may be mutually agreed upon by mutual written agreement of the Parties from time to timeafter the Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The Subject to the other terms of this Agreement, the Joint Development Committee ---------------- shall perform oversee the following functionsdevelopment of the Product pursuant to this Agreement, from the commencement of any development efforts through the date on which all NDA Approvals in the Territory for the Product actively being sought have been obtained. After all such NDA Approvals have been obtained, the Parties shall continue to collaborate in complying with all regulatory requirements of maintaining such NDA Approvals (including post- marketing surveillance and adverse event reporting). Without limiting the generality of the foregoing, the Joint Development Committee shall:
(a) Manage plan, supervise and oversee coordinate the preparation and implementation development of the U.S. Development PlansProduct under this Agreement;
(b) As early as necessary in each year beginning with commencing on the Effective Date, discuss and prepare an Annual Development Plan for the first full Calendar Year year of the term of the Joint Development Program and, not later than 90 days after the Effective Date, update and amend the initial U.S. finalize an Annual Development Plans and prepare the U.S. Development Plans for each Collaboration Product Plan for the following Calendar Year so that it can submit such proposed U.S. Development Plans to first year of the term of the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Development Program;
(c) Prepare not later than three months prior to each anniversary of the Effective Date during the term of the Joint Development strategy Program, discuss and develop protocols for clinical studies prepare an Annual Development Plan, and, prior to each anniversary of the Effective Date during the term of the Joint Development Program, finalize an Annual Development Plan for the Collaboration Products for Commercialization in next year of the United Statesterm of the Joint Development Program;
(d) Review and recommend determine whether to the Joint Steering Committee any material approve proposed amendments or modifications to the U.S. any Annual Development PlansPlan;
(e) Coordinate review and monitor determine whether to approve clinical study protocols, the selection of clinical investigators, clinical study write-ups, regulatory strategy submissions, NDAs and activities for the Collaboration Products in accordance with Article 9like relating to the Joint Development Program;
(f) At each meeting review and determine whether to approve the final design of the Joint Development Committee, review a comparison of actual Development Expenses for Cassette and the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingDelivery System;
(g) Review evaluate data from the Joint Development Program;
(h) review all proposed publications and recommend presentations of the Parties pursuant to Section 10.2;
(i) review all studies relating to the Joint Steering Committee "go/no-go" decisions Product and any other studies proposed to be performed in connection with the registration process for the Product under this Agreement;
(j) allocate responsibilities between the Parties, coordinate the activities of the Parties, and review and evaluate progress, all under the Joint Development Program, provided that the Joint Development Committee shall not have authority to make any determination that either Party is in breach of Collaboration Products in its obligations under the United StatesJoint Development Program;
(k) determine, review and amend, from time to time, the Specifications;
(l) provide a mechanism for the exchange of information between the Parties with regard to Know-how and Inventions;
(m) resolve disputes between the Parties with respect to the foregoing; and
(hn) Have have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 2 contracts
Sources: Joint Development, License and Supply Agreement (Inspire Pharmaceuticals Inc), Joint Development, License and Supply Agreement (Inspire Pharmaceuticals Inc)
Responsibilities. The Joint Development Committee ---------------- JSC shall perform the following functionsbe responsible for:
(ai) Manage reviewing and oversee approving the preparation and implementation of initial Global Development Plan prepared by the U.S. Development PlansJDC, including all budgets relating to development activities to be conducted by MERRIMACK hereunder;
(bii) As early periodically reviewing the Global Development Plan and suggesting or approving such updates or amendments to the Global Development Plan as necessary in each year beginning with the first full Calendar Year after the Effective DateJSC deems appropriate, update including all budget amendments;
(iii) as long as MERRIMACK does not opt out of Co-Promotion, reviewing and amend approving the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product Commercialization Plan for the following Calendar Year so that it can submit Co-Promoted Product(s) prepared by the JCC, including all budgets;
(iv) as long as MERRIMACK does not terminate Co-Promotion, periodically reviewing the Commercialization Plan for the Co-Promoted Product(s) and suggesting or approving such proposed U.S. Development Plans updates or amendments to such Commercialization Plan as the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested JSC deems appropriate, including all budget amendments;
(v) providing overall strategic direction with respect to research, development, regulatory and manufacturing activities conducted under the omitted portions.
Global Development Plan, and with respect to commercialization activities conducted under the Commercialization Plan (c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United Statesif any);
(dvi) Review overseeing the JDC and, if applicable, the JCC, and recommend to the Joint Steering Committee any material amendments or modifications to Parties’ progress in the U.S. conduct of activities under the Global Development PlansPlan and the Commercialization Plan (if any) hereunder;
(evii) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review establishing a comparison of actual Development Expenses projected Marketing Authorization application filing date for the United States to (“US Filing Date”) for each Licensed Product, which planned US Filing Date may be periodically updated by the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date JSC based on its reasonable assessment of the meetingclinical progress of such Licensed Product;
(gviii) Review and recommend keeping MERRIMACK apprised, through MERRIMACK’s representatives on the JSC, of the planned US Filing Date for each Licensed Product, including any updates thereto;
(ix) attempting to resolve disputes arising under this Agreement that are referred to the Joint Steering Committee "go/no-go" decisions JSC by the JDC, JCC or either of the Parties (for clarity, the Development of Collaboration Products in JSC shall not have the United Statesauthority to resolve disputes between the Parties regarding whether a Party has fulfilled or breached any obligation under this Agreement); and
(hx) Have performing such other tasks and undertaking such other responsibilities as may be assigned to the Joint Development Committee pursuant to set forth in this Agreement or as may be mutually agreed upon by the Parties from time to timeAgreement.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc), License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Responsibilities. The Joint JMC shall be responsible for (a) overseeing the conduct and progress of the Research Program, and (b) providing a forum for the exchange of information between the Parties with respect to the Development Committee ---------------- of Program Aptamers, Lead Compounds and Clinical Candidates that are, or are eligible for designation as, Co-Developed Products and the Co-Development and Commercialization of Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation; provided however, that the JMC shall perform not be responsible for overseeing the Development or Commercialization of any Products. Without limiting the generality of the foregoing, the JMC shall have the following functionsresponsibilities:
(a) Manage and oversee overseeing the preparation and implementation JPT’s performance of the U.S. Development Plansits responsibilities;
(b) As early reviewing each Annual Research Plan, each Annual Development Plan for Clinical Candidates eligible for designation as necessary Co-Developed Products and for Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation, and, only if ELAN alone (rather than with or through a Sublicensee) is Commercializing a Co-Developed Product, each year beginning with Product Commercialization Plan for a Co-Developed Product in the first full Calendar Year after the Effective Dateapplicable Co-Development Territory(ies), update Indication and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans formulation (including all budgets applicable thereto); provided, that, ELAN agrees to the Joint Steering Committee no later than ** use Commercially Portions of such year for review and approval; ** = Certain information on this page has been Exhibit were omitted and have been filed separately with the Commission. Confidential treatment has been requested with respect Secretary of the Commission pursuant to the omitted portions.Company’s application requesting confidential treatment under Rule 406 of the Securities Act. Reasonable Efforts to include the JMC rights set forth in this Section 2.1.4(b) in each Sublicense Agreement;
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United Statesapproving any Annual Research Plan;
(d) Review directing the preparation of, and recommend to the Joint Steering Committee reviewing each amendment to, any material amendments or modifications to the U.S. Development PlansAnnual Research Plan and/or budget applicable thereto;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9approving any amendment or update to an Annual Research Plan;
(f) At each meeting of reviewing data, reports or other information submitted to it by the Joint Development Committee, review a comparison of actual Development Expenses for the United States JPT from time to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingtime;
(g) Review and recommend to discussing the Joint Steering Committee "go/noprogress of the Commercialization of each Co-go" decisions for the Development of Collaboration Products Developed Product in the United Statesapplicable Co-Development Territory(ies), Indication and formulation in accordance with the applicable Product Commercialization Plan, if ELAN alone (rather than with or through a Sublicensee) is marketing a Co-Developed Product; provided, that, ELAN agrees to use Commercially Reasonable Efforts to include the JMC rights set forth in this Section 2.1.4(g) in each Sublicense Agreement;
(h) resolving all JPT matters that are in dispute;
(i) reviewing any proposal of the JPT to nominate any Collaboration Compound or IL-23 Aptamer as a Lead Compound or any proposal of the JPT to nominate any Lead Compound as a Clinical Candidate; and
(hj) Have making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee JMC pursuant to this Agreement or as may be mutually agreed upon by mutual written agreement of the Parties from time to timeafter the Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The Joint Development Committee ---------------- JSC shall perform have the following functionsresponsibilities:
(ai) Manage Review and oversee approve Development Plans for the preparation and implementation Initial Indication following submission of the U.S. Development Plansinitial New Drug Application for such Initial Indication, the Additional Required Indication and Additional Collaboration Indications in the Field in the Territory;
(bii) As early as necessary Review Regulatory Materials, including those materials for the Initial Indication, the Additional Required Indication and Additional Collaboration Indications;
(iii) Review and agree on Manufacturing plans, including [***];
(iv) Review and approve annual Commercialization Plans for Product to Physician Targets in each year beginning the Field in the Territory;
(v) Establish a process for the review and approval by the Parties of Promotional Materials for Product for Detailing to Physician Targets for use in the Field in the Territory;
(vi) Establish, review and approve budget for Shared Expenses in the Field in the Territory in accordance with the first full Calendar Year after the Effective Dateterms of this Agreement;
(vii) Establish, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee on an annual basis no later than ** July 1, a two (2) year forecast, containing a projection of such year for review annual Product unit sales and approval; ** = Certain information on this page has been omitted and filed separately with associated annual PSMM Expenses reflecting Commercially Reasonable Efforts of the Commission. Confidential treatment has been requested with respect to Parties in Commercializing Product (“Annual Forecast And Budget”), which shall be in a format determined by the omitted portions.
(c) Prepare JSC or mutually agreed by the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesParties;
(dviii) Review Approve recommendations and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting resolve disputes of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review other committees and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United Statesany subcommittees; and
(hix) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by Provide a forum for the Parties from time to timeexchange information and coordinate their respective activities with respect to matters pertaining to Product for Physician Targets in the Field in the Territory.
Appears in 2 contracts
Sources: Collaboration Agreement (Allergan Inc), Collaboration Agreement (MAP Pharmaceuticals, Inc.)
Responsibilities. The Joint Development Committee ---------------- PDC shall not oversee, review, approve or evaluate any of the DURECT Activities. The PDC shall perform the following functions:
(ai) Manage approve and oversee the preparation and implementation of the U.S. Development PlansPlan;
(bii) As early as necessary in at least once each calendar year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no by a date not later than [* * ** of such year for ], review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare approve any amendments or modifications of the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesPlan;
(diii) Review and recommend to at least twice annually, review the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansBudget;
(eiv) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At at each meeting of the Joint Development CommitteePDC, review a comparison of actual Development Expenses for the United States development and regulatory expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gv) Review review and evaluate progress of the development activities; provided that the PDC shall not have authority to make any determination that any Party is in breach of this Agreement;
(vi) review and approve all compassionate use of the Product, Finished Product and Implanter;
(vii) review the publication strategy together with the JCC;
(viii) review and recommend to the Joint Steering Committee "JEC “go/no-go" decisions for ” decisions;
(ix) in connection with clinical trials, approve protocols, trial budget and trial design;
(x) review Regulatory Data and Regulatory Documentation to be provided by DURECT regarding all Product and Implanter development activities outside the Territory (to the extent DURECT is permitted by Third Parties, if applicable, to do so);
(xi) review and, if appropriate, approve development plans, utilizing an approach similar to the Development Plan, with respect to line extensions of Collaboration the Product or Related Products; provided that the PDC shall not approve plans to develop at any one time more than [* * *] such products without the written authorization of DURECT and Endo;
(xii) in good faith consider potential additional line extensions of the Product and Related Products in addition to those considered pursuant to the United Statesforegoing clause (x);
(xiii) coordinate the allocation of responsibilities among the Parties with respect to development of the Product, Finished Product and Implanter based on the Development Plan;
(xiv) consult with the JMC regarding adoption of a Third Party Manufacturing Plan pursuant to Section 8.15;
(xv) determine which portions of protocols, regulatory filings, correspondence to or from regulatory authorities etc., should be redacted before being shared with ALZA; and
(hxvi) Have have such other responsibilities as may be assigned to the Joint Development Committee PDC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: License Agreement (Durect Corp)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage review and approve the annual Marketing Plan developed by Endo;
(ii) oversee the preparation and implementation of the U.S. Development PlansMarketing Plans and approve modifications to the Marketing Plan throughout the year;
(biii) As early as necessary in each year beginning with discuss the first full Calendar Year after state of the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product markets for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization Product in the United StatesTerritory and opportunities and issues concerning the Commercialization of the Product, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues;
(div) Review if applicable under Sections 5.5 and recommend to 5.8, oversee and coordinate the Joint Steering Committee any material amendments or modifications to the U.S. Development Planssales efforts of Endo and DURECT;
(ev) Coordinate review and monitor regulatory approve the Post-Registration Plan, taking into consideration the appropriateness of any development activities including line extensions, clinical trials for purposes of new indications and Phase IV clinical trials in the context of the overall marketing and promotional strategy and activities for the Collaboration Products Product;
(vi) review and direct all indigent care use of the Product;
(vii) review and approve Sales Projections in accordance with Article 9Section 6.3;
(fviii) At review, in consultation with the JMC, the efficacy of the forecasting procedure set forth in Section 8.3, including whether any modifications thereto are necessary following the second anniversary of the First Commercial Sale;
(ix) review data and reports arising from and generated in connection with the Commercialization of the Product, Finished Product and Implanter, including the Marketing Plan, Marketing Budgets, market research studies, and Product, Finished Product and Implanter sales and prescription trends and sales forecasts;
(x) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxi) Review at least once each calendar year by a date no later than [* * *], review and recommend approve the Marketing Plan as updated by Endo;
(xii) review and approve the general guidelines applicable to the Joint Steering Committee "go/no-go" decisions Product to be followed by Endo in its development of promotional materials and promotional activities to be used by Endo in the promotion of the Product, Finished Product and Implanter (such guidelines to be consistent with the then current Marketing Plan applicable to the Product);
(xiii) evaluate and approve use of any technical support representatives;
(xiv) review and direct the publication strategy, in consultation with the PDC;
(xv) in consultation with the PDC, review and approve the Specifications for the Development Finished Product, including the packaging and related materials, prior to Commercial use;
(xvi) develop3 appropriate procedures, pursuant to Section 8.13 and in consultation with the JMC, regarding the manufacture and sale of Collaboration Products in Implanters;
(xvii) review and, if appropriate, approve the United Statessupplemental call plan, if any, submitted by DURECT pursuant to Section 5.8;
(xviii) evaluate and determine whether to market and sell an Implant Kit; and
(hxix) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: License Agreement (Durect Corp)
Responsibilities. The Joint Development Research Committee ---------------- shall perform supervise the following functionsexecution of the Research Plan and administer the Funded Project, and its responsibilities shall include, without limitation:
(a) Manage To periodically review whether there is need to amend or supplement the Research Plan and oversee to recommend changes thereto to the preparation and implementation Steering Committee, as may be reasonably required to meet the goals of the U.S. Development PlansResearch Plan and the Collaboration, and in the event of Monsanto’s exercise of the Research Extension Option;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans To recommend to the Joint Steering Committee no later than changes in assays and validation processes for Collaboration Hit Homologs, Special Collaboration Hits and Preferred Mode of Use; *** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect for redacted portions of this exhibit. This copy omits the information subject to the omitted portionsconfidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.
(c) Prepare To recommend to the Development strategy Steering Committee amendments, modifications and develop protocols for clinical studies for supplements to the Research Plan, and changes to validation criteria of Collaboration Products for Commercialization in the United StatesHit Homologs Special Collaboration Hits and Preferred Modes of Use;
(d) Review and recommend At least sixty (60) days prior to the Joint commencement of each Collaboration Year, to review and approve, subject to final approval by the Steering Committee, a detailed research plan for the subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the Discovery Programs to be conducted and the Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the Steering Committee any material amendments or modifications shall automatically constitute an amendment to and part of the U.S. Development PlansResearch Plan;
(e) Coordinate To discuss ways for Monsanto to assist the gene discovery and monitor regulatory strategy identification of Preferred Modes of Use processes, such as by providing Evogene with certain know-how and activities for the Collaboration Products in accordance with Article 9Monsanto Data;
(f) At To monitor the parties’ performance of their respective Diligence Obligations (based on the reports to be provided by each meeting party as set forth in Sections 2.8.1 and 2.8.2) and to review and amend the format of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-dateparties’ reports, as current as practicable may be reasonably required in order to a date immediately prior enable the Research Committee to monitor the date parties’ performance of the meetingtheir respective Diligence Obligations;
(g) Review To discuss, at a general level, information provided on Collaboration Hit Homologs and recommend Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks, , the Collaboration Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to the Joint Steering Committee "go/no-go" decisions for validation of the Development Collaboration Hit Homologs, Special Collaboration Hits and Preferred Modes of Collaboration Products Use in the United StatesMonsanto Pipeline; and
(h) Have such other responsibilities as may be assigned *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the Joint Development Committee pursuant confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to this Agreement or as may be mutually agreed upon by the Parties from time to timeSecurities and Exchange Commission.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage and oversee the preparation and implementation of the U.S. Development Marketing Plans;
(bii) As early as necessary in each year beginning with oversee and coordinate the first full Calendar Year after sales efforts of ERS and the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesCompany;
(diii) Review review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development approve Marketing Plans;
(eiv) Coordinate discuss the state of the markets for Products in the Territory and monitor regulatory strategy opportunities and activities issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the Collaboration Products amount and kind of marketing and selling effort appropriate, in accordance with Article 9the Marketing Plans;
(v) review and approve the total annual budget for all Phase IV Clinical Trials, but not the budget or protocol for the individual studies themselves which must be approved by the PDC and the JEC pursuant to Section 4.3 (f);
(vi) At review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time; • (x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts; •
(xii) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxiii) Review review and recommend approve the general guidelines applicable to particular Products to be followed in the development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then-current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(xv) review and approve the joint publication strategy together with the PDC;
(xvi) evaluate and determine the existence or non-existence of a Co-Promotion Problem referred to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products JCC in the United Statesaccordance with Section 5.6(e); and
(hxvii) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time."
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement
Responsibilities. The Joint Development Research Committee ---------------- shall perform will supervise performance of the parties’ work under the Collaboration. The Research Committee will have the following functionsresponsibilities:
(a) Manage Discussing, reviewing, suggesting revisions to and oversee approving (subject to final approval by the preparation Steering Committee), no later than sixty (60) days prior to the commencement of each Collaboration Year, a detailed research plan for the subsequent Collaboration Year (“Annual Workplan”). Evogene shall take the lead in preparing such Annual Workplan(s) and implementation in proposing it to the Research Committee. Each such Annual Workplan, upon approval of the U.S. Development PlansSteering Committee, shall automatically constitute an amendment to and part of the Workplan;
(b) As early Establishing (or, as necessary in each year beginning with the first full Calendar Year after case may be, implementing the Effective Date, update and amend decisions taken by the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than related thereto according to Section 2.2.1.3 (b)) infrastructures and procedures for facilitating efficient communication between the parties, including: (i) putting in place necessary IT infrastructures; (ii) deciding on the structure of the reports to be delivered under the Collaboration; (iii) coordinating data transfer; and (iv) establishing procedures for communications regarding patent related issues. Initials Bayer : page 22 of 89 Initials Evogene : *** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect for redacted portions of this exhibit. This copy omits the information subject to the omitted portionsconfidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.
(c) Prepare Reviewing reports delivered under the Development strategy Collaboration, monitoring the parties’ performance of their respective obligations under Section 3 and develop protocols for clinical studies for the Collaboration Products for Commercialization in Workplan, conducting scientific discussions regarding the United Statesresults of the Collaboration, reporting on this towards the Steering Committee to allow the Steering Committee to perform its work under Section 2.2.1.3(c) and providing suggestions to the Steering Committee with respect to future activities;
(d) Review Discussing and recommend deciding on matters that are specifically referred to the Joint Research Committee under this Agreement, such as addressing the justification for and repercussions of failures or delays in the delivery of deliverables to be delivered in accordance with Section 3.1, in accordance with the procedure set forth in Section 3.3.
(e) Periodically reviewing whether there is need to revise or expand the Workplan as may be reasonably required to meet the goals of the Multi-Year Workplan and Collaboration.
(i) Subject to Section 2.2.2.5, the Research Committee will have the authority to amend the Workplan with respect to matters that do not materially change the Workplan, without the approval of the Steering Committee any material Committee, such as changes in Traits within a Trait Class to be addressed in an ATHLETE Collaboration Discovery Round or in an EvoBreed Collaboration Discovery Round or shifting among the Trait Classes to be targeted, or changes in the assays used for validation, provided such changes do not impact the amount of resources allocated to such activity. Any amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for Workplan approved by the Collaboration Products Research Committee in accordance with Article 9;this clause (i) shall be incorporated into the Workplan by reference.
(ii) Subject to Section 2.2.2.5, material changes to the Workplan may be proposed by the Research Committee, but must be approved by the Steering Committee. For illustration purposes, material changes to the Workplan include: (1) changes in the quantity of ATHLETE Collaboration Discovery Rounds or EvoBreed Collaboration Discovery Rounds to be conducted in a Collaboration Year; (2) a shift in the number of Collaboration Genes to be provided among Collaboration Years; and (3) an increase in Model Plan Validation activities. The process for making such proposals to the Steering Committee is set forth in Section 3.2.
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have Exercising such other additional responsibilities as may be assigned delegated to the Joint Development Research Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeSteering Committee.
Appears in 1 contract
Sources: Wheat Collaboration and License Agreement (Evogene Ltd.)
Responsibilities. The Joint Development Executive Committee ---------------- shall perform have the following functions:duties: (
(a) Manage and oversee Oversee the preparation and implementation activities of the U.S. Development PlansMAPP Center, and administer relations w▇▇▇ the Contractor;
(b) As early Maintain a list of End-Use Load Members, and determine the End-Use Load Obligation of each; (c) Maintain a list of Joint Members, and determine the Designating Entities properly represented by such Joint Member; (d) Establish each Member's number of votes; (e) Establish standards and procedures for determining Electric Revenues; (f) Revise as necessary may be appropriate the size threshold applicable to Section 3.17 for participation as a Designating Entity; (g) No later than thirty days prior to the Annual Meeting of the Management Committee, adopt (i) an annual budget for MAPP, including the costs of the Contractor, and any other general and administrative costs, (ii) an allocation of such costs consistent with Section 5.4.2, (iii) the annual dues assessed each Member and each Associate Member, and (iv) an adjustment, if appropriate, in the initial fee upon joining MAPP, which budget, allocations, fees, ▇▇▇ adjustments shall go into effect as of the Annual Meeting of the Management Committee as adopted by the Executive Committee unless revised by the Management Committee; (h) Establish a budget, an allocation of costs, and the dues to be assessed each year beginning with Member and Associate Member, for the Fiscal Year or part thereof first full Calendar Year after following the Effective Date.
(i) Resolve disputes among the Regional Transmission Committee, update the Power and amend Energy Market Committee, and the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested MAPP Reliability Council with respect to the omitted portions.
scope of their authority and responsibilities as specified in this Restated Agreement or by the Management Committee; (cj) Prepare Establish or abolish, and set the Development strategy duties and develop protocols for clinical studies for responsibilities of, such committees or councils, other than the Collaboration Products for Commercialization in the United States;
(d) Review committees and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committeecouncils specified herein, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be appropriate to achieve the purposes of this Restated Agreement; (k) Establish an area relations advisory group; (l) Make such other necessary administrative arrangements pertinent to this Restated Agreement not specifically covered herein, including the establishment of a Fiscal Year; (m) Exercise responsibility for representation of MAPP's interests in regulatory and othe▇ ▇▇▇▇l proceedings; (n) Suspend the membership of any Member that fails to perform its reliability obligations, or otherwise fails to comply with obligations arising under or imposed pursuant to the terms of this Restated Agreement; (o) Appoint the representatives of MAPP to the NERC Board of Trustees; (p) Exercise responsibility for such other matters as are assigned to the Joint Development Committee pursuant to it by this Restated Agreement or as may be mutually agreed upon by the Parties from time Management Committee; and (q) Submit a report of its activities to timethe Management Committee at the Annual Meeting of the Management Committee.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- TELAVANCIN Product Management Team shall perform the following functionsfunctions as approved by the JSC:
(ai) Manage Prepare the Medical Marketing Plan for submission to and oversee review and approval by the preparation JSC, [*] — in every case subject to consistency with the Basic Development Plan and implementation of Basic Commercial Plan (and, consistent with Section 3.05(c), certain decisions ASTELLAS is entitled to make) as further outlined in Section 5.01; [*]=CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
(ii) Prepare and present to the U.S. Development PlansJSC for approval [*], including but not limited to [*] (subject to consistency with the Basic Commercial Plan);
(biii) As early as necessary in each year On an annual rolling basis beginning with the first full Calendar Year after within six (6) months of the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product Medical Marketing Plan for the following Calendar Year so that it can immediately thereafter submit to the JSC such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year Medical Marketing Plan for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(div) Review and recommend Recommend to the Joint Steering Committee JSC any material amendments or modifications to the U.S. Development PlansMedical Marketing Plan during the Calendar Year with respect to the US;
(ev) Coordinate Provide reports to the JSC regarding the state of the markets for Licensed Product and monitor regulatory strategy opportunities and activities for issues concerning the Collaboration Products in accordance with Article 9Commercialization of the Licensed Product, including consideration of [*];
(fvi) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan Review Net Sales for the year-to-date, as current as practicable to a date immediately prior available, and provide reports with assessments and recommendations to the date of the meetingJSC;
(gvii) Review and recommend Regularly review ASTELLAS’ progress to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products [*] in the United StatesStates that is consistent with the Medical Marketing Plan. Such [*] will be undertaken by ASTELLAS; and
(hviii) Have such other responsibilities as may be assigned to the Joint Development Committee TELAVANCIN Product Management Team pursuant to this Agreement or as may be mutually agreed upon by the Parties through the JSC in final, undisputed written minutes from time to time.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Theravance Inc)
Responsibilities. The Joint purpose of the JSC will be to provide a forum for open communication and coordination between the Parties regarding the conduct, progress and results achieved under the Territory Specific Development Committee ---------------- shall perform Plan and to oversee the following functionsCollaboration. Subject to the express rights of the Parties as set forth herein, the role of the JSC is to:
(ai) Manage review, discuss and oversee approve proposals by either Party to amend the preparation and implementation of the U.S. Territory Specific Development PlansPlan;
(bii) As early as necessary in each year beginning with the first full Calendar Year after the Effective Datereview, update discuss and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans approve proposals to add any Additional Program to the Joint Steering Committee no later than ** Collaboration, which approval shall also subsequently require the approval of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesParties themselves;
(diii) Review review the results of the QTPP Testing and recommend to determine if the Joint Steering Committee any material amendments or modifications to QTPP Testing results achieve the U.S. specifications that are set forth in the Territory Specific Development PlansPlan;
(eiv) Coordinate and monitor regulatory strategy and activities coordinate the supply of Materials (including Vector Supply) between the Parties for use under the Collaboration Products in accordance with Article 9Territory Specific Development Plan;
(fv) At each meeting act as liaison between the Parties to ensure open and regular communication channels, and more particularly to ensure the Parties are informed of, and have a forum to discuss, the ongoing progress of the Joint Collaboration;
(vi) review and discuss (but for clarity, not approve) the Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States Product by JW in the U.S. Development JW Territory after Completion of the Phase I Trial;
(vii) review and discuss (but for clarity, not approve) the Commercialization Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingProduct by JW;
(gviii) Review establish such subcommittees and recommend working groups as it may deem appropriate to carry out the Joint Steering Committee "go/no-go" decisions for goals of the Development of Collaboration Products in the United StatesCollaboration; and
(hix) Have perform such other activities as the Parties agree in writing will be the responsibility of the JSC.
(x) Notwithstanding the foregoing, in the event that the Product Developed by JW under the Territory Specific Development Plan will be the same as a TSVT Product (as determined by Regulatory Authorities) (such Product, the “Shared Product”), then the Parties will revise the governance provisions under this Article II to extend the JSC’s responsibilities as may to review and approve any Development and Commercialization of the JW Product by JW, provided that such revision shall be assigned subject to the Joint Development Committee pursuant Parties’ mutual agreement and not subject to this Agreement or as may be mutually agreed upon by the Parties from time to time▇▇▇▇’s final decision-making authority under Section 2.3(d).
Appears in 1 contract
Sources: Collaboration Agreement
Responsibilities. The Joint JSC shall in particular: (i) oversee and provide strategic oversight for the Exploitation of the Licensed Compound and Licensed Products in or for the Licensed Territory under this Agreement and the Manufacture of the Licensed Compound and Licensed Products in or for the Licensed Territory under this Agreement; (ii) provide a forum for and facilitate communications between the Parties with respect to their collaboration; (iii) keep each Party informed of all Development Committee ---------------- shall perform activities related to the following functions:
Licensed Compound to ensure overall alignment of development of the Licensed Compound; (aiv) Manage review and discuss (and in the case of amendments to the Licensed Territory Development Plan, approve) the initial Licensed Territory Development Plan provided by the Company and any updates or amendments to the then-effective Licensed Territory Development Plan and Retained Territory Development Plan, and oversee the preparation execution of each such Development Plan by the applicable Party; (v) review and implementation of discuss any proposed Global Clinical Trial, and decide whether the U.S. Development Plans;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product Parties shall collaborate for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** conduct of such year for review and approvalGlobal Clinical Trial; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested (vi) with respect to any Global Clinical Trial to be collaborated by the omitted portions.
(c) Prepare Parties, discuss and, develop a plan for such Global Clinical Trial to serve as the Development strategy and develop protocols basis for clinical studies for the a Clinical Collaboration Products for Commercialization in the United States;
(d) Review and recommend Agreement or statement of work pursuant to the Joint Steering Committee any material amendments or modifications Master Services Agreement; (vii) keep each Party informed of all Development results and regulatory activities related to the U.S. Development Plans;
(e) Coordinate Licensed Compound and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Licensed Products in the United StatesLicensed Territory, including all matters relating to Regulatory Approvals; and
(hviii) Have discuss a supply strategy to ensure the commercial supply of the Licensed Products for the Licensed Territory; (ix) establish subcommittees as it deems necessary or advisable to further the collaboration of the Parties under this Agreement; (x) oversee the operation of any subcommittees (including the JDC), including resolving any disputed matters arising in such other responsibilities subcommittees; and (xi) perform such other functions as may be assigned appropriate to further the Joint Development Committee pursuant to purposes of this Agreement, as expressly set forth in this Agreement or as may be mutually agreed upon allocated to the JSC by the Parties from time to timein writing.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJCC will:
(a) Manage and oversee the preparation and implementation Commercialization of the U.S. Development PlansShared Products by the Parties in the Field in the Territory;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update develop and amend the initial U.S. Development Plans and prepare the U.S. Development Plans approve a Global Commercialization Plan for each Collaboration Shared Product for the following Calendar Year so that it can and submit such proposed U.S. Development Plans Global Commercialization Plan to the Joint Steering Committee no later than ** of such year JSC for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.discussion;
(c) Prepare amend the Development strategy Global Commercialization Plan for each Shared Product on an annual basis (or more frequently as needed), approve such amendments and develop protocols submit such updated Global Commercialization Plans to the JSC for clinical studies for the Collaboration Products for Commercialization in the United Statesreview and discussion;
(d) Review review, discuss and recommend to approve the Joint Steering Committee initial Regional Commercialization Plans for each Shared Product and any material amendments or modifications to the U.S. Development Plansupdates thereto submitted by Parties;
(e) Coordinate and monitor regulatory strategy and activities select product Trademarks for each Shared Product throughout the Collaboration Products in accordance world consistent with Article 9the Global Brand Strategy;
(f) At each meeting advise the JMC in connection with its oversight of the Joint Development Committee, review a comparison of actual Development Expenses for the United States Manufacturing Working Group with respect to matters relating to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date commercial Manufacture of the meeting;Shared Products; [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would cause competitive harm if publicly disclosed.
(g) Review and recommend to advise the Joint Steering Committee "go/no-go" decisions for JMC in connection with its oversight of the Development commercial Manufacture of Collaboration the Shared Products in the United StatesField in the Territory;
(h) advise the JMC in connection with its review and discussion of any updates to the Global Manufacturing Plan, including the Manufacturing Budget, proposed by the Manufacturing Working Group;
(i) submit the approved updated Global Commercialization Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no later than [***] of each Calendar Year;
(j) advise the JMC in connection with its review, discussion and approval of the Manufacturing process, and any changes thereto, for each Shared Product;
(k) review, discuss and approve any proposed use of a Subcontractor to conduct a Party’s activities under a Global Commercialization Plan, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(hl) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to JCC under this Agreement or as may be mutually agreed upon delegated to the JCC by the Parties from time to timeJSC.
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Responsibilities. The Joint Development Committee ---------------- JPC shall perform the following functions:
(ai) Manage and oversee Consult with THERAVANCE in the preparation and implementation case of the U.S. Development Plans;
Plan and with MYLAN in the case of the Commercialization Plan in connection with such Party's preparing and updating of the Development Plan and Commercialization Plan and their associated budgets in a timely manner (bproviding any comments within thirty (30) As early as necessary in each year beginning with days of the first full Calendar Year after submission thereof by the Effective Date, update applicable Party) and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans them to the Joint Steering Committee no later than ** of such year JSC for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.;
(cii) Prepare At an appropriate and regular frequency, review the Development strategy and develop protocols for clinical studies (and, when appropriate, the Commercialization strategy) for the Collaboration Products for Commercialization Licensed Product in the United StatesField;
(diii) Review and discuss whether or not to recommend to the Joint Steering Committee JSC any material amendments or modifications to the U.S. Development PlansPlan or the Commercialization Plan;
(eiv) Coordinate and monitor regulatory strategy and activities for the Collaboration Products Licensed Product in accordance with Article 97;
(fv) Review and recommend to the JSC operational and other decisions for the Development of Licensed Product in the Field;
(vi) Discuss the state of the markets for Licensed Product and opportunities and issues concerning the Commercialization of the Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, and labeling;
(vii) At each meeting of the Joint Development Committeean appropriate and regular frequency, review a comparison the status of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan all studies conducted on Licensed Product and any results therefrom;
(viii) At an appropriate and regular frequency, review Net Sales of Licensed Product for the year-to-date, as and a current as practicable to a date immediately prior to outlook for Net Sales for the date remainder of the meetingthen-current Calendar Year;
(gix) Review Plan and recommend to the Joint Steering Committee "go/no-go" decisions review all publications described in Section 9.03, and review and approve a publications policy for the Development of Collaboration Products in the United Statessuch publications; and
(hx) Have such other responsibilities as may be assigned to the Joint Development Committee JPC pursuant to this Agreement or as may be mutually agreed upon by the Parties through the JSC from time to time.. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The Joint Development Committee ---------------- responsibilities of the JSC shall perform the following functionsbe:
(ai) Manage and oversee to provide a forum by which the preparation and implementation of Parties may share information regarding the U.S. Development Plansoverall strategy for the Collaboration Programs;
(bii) As early as necessary in each year beginning with to facilitate the first full Calendar Year after exchange of information between the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested Parties with respect to the omitted portions.
(c) Prepare the Development strategy activities hereunder and develop protocols for clinical studies to establish procedures for the efficient sharing of information necessary for the Parties to fulfill their respective responsibilities with respect to the Collaboration Products for Commercialization in the United StatesPrograms;
(diii) Review review, discuss and recommend approve each Research Plan, Global Development Plan and Territory-Specific Development Plan and the Co-Development Plan and Co-Commercialization Plan, and updates or amendments thereto and to share and discuss the Joint Steering Committee any material amendments or modifications to progress of activities under the U.S. Research Plans, Global Development Plans, Territory-Specific Development Plans, Co-Development Plan and Co-Commercialization Plan on a quarterly basis; [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
(iv) to share and discuss the data generated by or on behalf of the Parties in the course of performance towards the goals set forth in the Research Plans, Global Development Plans, Territory-Specific Development Plans, Co-Development Plan and Co-Commercialization Plan;
(ev) Coordinate to coordinate Development and monitor regulatory strategy and activities for Commercialization strategies of the Collaboration Products in accordance Programs, and allocate resources and set timelines for Development and Commercialization activities with Article 9respect to the Collaboration Programs;
(fvi) At to establish an overall regulatory strategy for (1) each meeting [***] Molecule and [***] Product before the Opt-In or (2) any MGNX Option Molecule and MGNX Option Product, in each case of (1) and (2), in the Joint Development Committee, review a comparison of actual Development Expenses applicable Collaboration Territory that is consistent with and complements the worldwide regulatory strategy being implemented by MacroGenics for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingapplicable Collaboration Molecule and Product;
(gvii) Review to establish an overall worldwide regulatory strategy for any [***] Molecule and recommend [***] Product after the Opt-In;
(viii) to create any subcommittees (including the Joint Steering Committee "go/no-go" decisions JRDC and JCC) as agreed in writing by both Parties, to oversee the activities of such subcommittees, and to seek to resolve any issues that such subcommittees cannot resolve;
(ix) to establish an overall strategy for the Development filing, prosecution and maintenance of Collaboration Products MacroGenics Licensed Patents, MacroGenics Licensed Trademarks and Zai Licensed Patents in the United StatesTerritory and any applicable Patent and Trademark term extensions; and
(hx) Have to perform such other responsibilities functions as may be assigned to the Joint Development Committee pursuant to expressly set forth in this Agreement or as may be mutually agreed upon appropriate to further the purposes of this Agreement, as determined by the Parties from time to timeParties.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform During the following functionsTerm, Feehan’s duties and responsibilities will primarily consist of the following:
(ai) Manage and oversee the preparation and implementation Serve as Chairman of the U.S. Development PlansBoard and serve as primary liaison between the Board and management;
(bii) As early Advise and mentor the New CEO;
(iii) Interact with key shareholders as necessary in each year beginning requested;
(iv) Interact with governmental officials (legislators and regulators) as requested;
(v) Assist management, as requested by the New CEO, with the first full Calendar Year development and execution of strategies for enacting favorable pawn legislation in both existing and new states;
(vi) Advise management with the development of Cash America’s annual business plan and budget;
(vii) Monitor monthly performance reports and alert the Board of any unexpected trends in operational or financial performance;
(viii) Advise management in the development of capital allocation strategies;
(ix) Evaluate management’s recommendations for any significant capital investment prior to submission to the Board for approval;
(x) Assist management, as requested by the New CEO, in the assessment and negotiation of any significant transactions;
(xi) Assist management, as requested, with the recruitment of senior leadership talent;
(xii) Visit operating locations, as requested, to provide the Board and management with an independent perspective on operating conditions in the visited locations;
(xiii) Participate, as requested by the New CEO, in periodic management presentations to lenders and analysts; and
(xiv) Perform such other duties as may from time to time be requested by the New CEO or be assigned by the Board or any duly authorized committee thereof. On and after the Effective Date, update the Board may adjust the foregoing responsibilities as the Board, in its sole discretion, deems reasonable and amend appropriate in connection with transitioning ▇▇. ▇▇▇▇▇▇ from the initial U.S. Development Plans Executive Chairman of the Board to a non-executive chairman of the Board. In performing his responsibilities hereunder, Feehan will obey the lawful directions of the Board and prepare any duly authorized committee thereof, and will use his best efforts to promote the U.S. Development Plans for each Collaboration Product for interests of Cash America and to maintain and to promote the following Calendar Year so that it can submit such proposed U.S. Development Plans reputation thereof. In his role as Chairman during the Term, Feehan (i) will be an employee of CAM but will not be an officer of CAI, CAM or any of their affiliates or subsidiaries, (ii) will not have any authority to individually approve expenditures or transactions; or to commit Cash America to any liability or to sign any binding contracts on behalf of Cash America, (iii) will not have the authority to directly hire or fire any officer or other employee of Cash America, and (iv) will not have any direct reports and the New CEO will report directly to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsentire Board.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: Employment Agreement (Cash America International Inc)
Responsibilities. The In addition to overseeing the activities under this Agreement and providing a forum for discussion of such activities, the Joint Development Steering Committee ---------------- shall perform in particular have the following functionsresponsibilities and related decision-making authorities:
(a) Manage oversight and oversee the preparation and implementation discussion of all activities of the U.S. Development PlansParties in the Alliance under this Agreement, including the performance of the Alliance Benefits by Moffitt and the financial and equity contributions by Company;
(b) As early monitoring of existing Projects and the Parties’ activities under the Underlying Agreements to facilitate successful development, management, and performance of each Project, including monitoring and overseeing specific objectives, milestones, timelines, staffing, budgets, and proposed deliverables and considering deviations from and amendments to statement(s) of work from time to time as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.needed;
(c) Prepare determination of the Development strategy scientific scope and develop protocols for clinical studies for direction of Projects undertaken pursuant to the Collaboration Products for Commercialization in Underlying Agreements, irrespective of whether the United StatesAlliance Benefits pursuant to this Agreement are applicable, and discussion and alignment on Project goals, timelines and prioritization of Projects;
(d) Review review and recommend discussion of results generated in Projects (including interim results communicated by competent Project teams to the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansAlliance Managers);
(e) Coordinate conduct and monitor regulatory strategy monitoring of the request for proposal process pursuant to Section 3.5, including (i) creation of a request for proposal; selection of objective review criteria, review, and activities for evaluation of proposals submitted by the Collaboration Products Parties in accordance with Article 9a given Underlying Agreement; (ii) evaluation of the budget for each proposal to ensure that it is consistent with the fair market value of the commitments, rights, goods, and services exchanged between the Parties, and has been established through arms-length negotiations by Moffitt and Company, whereby the Joint Steering Committee shall, in coordination with other appropriate Representatives of the Parties, develop sufficient evidence to support fair market value for all payments to be made under any Project pursuant to such Underlying Agreement; and (iii) review and approval of each statement of work and associated budget prior to execution, as well as any proposals for amendments to a statement of work; provided, however, statements of work and amendments will only become effective upon signature by an authorized representative of each Party;
(f) At each meeting discussion, approval and monitoring of Clinical Trials and Laboratory Studies to be performed by the Joint Development CommitteeParties under the Underlying Agreements, review a comparison determination of actual Development Expenses Clinical Trials for the United States which Moffitt shall manufacture cell therapy products and determination of Clinical Trials or Laboratory Studies with regard to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingwhich Moffitt shall provide Alliance Benefits;
(g) Review serving as an overall information sharing forum with the aim to keep Moffitt informed of the development, manufacturing and recommend commercialization of TIL Products by Company, its Affiliates and their respective Collaboration Partners, including reviewing and discussing of presentations on the Development Plan presented by Company pursuant to Section 6.5;
(h) if there are any unallocated payment amounts at the expiration or termination of a given Underlying Agreement, the Joint Steering Committee "go/no-go" decisions for shall use reasonable efforts to allocate such amounts, in a manner consistent with fair market value, to studies, research or tests that are of mutual scientific interest to the Development Parties and satisfy the agreed objective criteria used in connection with Section 3.5;
(i) addressing of Collaboration Products issues related to publications as well as filing, prosecution and maintenance of Intellectual Property, in each case if escalated;
(j) serving as a forum to facilitate discussions and the United Statesresolution of issues regarding the conduct of the collaboration under the Underlying Agreements or the Alliance under this Agreement or of Disputes; and
(hk) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: Life Science Alliance Agreement (Turnstone Biologics Corp.)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage and oversee the preparation and implementation of the U.S. Development Marketing Plans; Squibb Biologics Company and ImClone Systems Incorporated.
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(biv) As early as necessary discuss the state of the markets for Products in each year beginning the Territory and opportunities and issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the amount and kind of marketing and selling effort appropriate, in accordance with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Marketing Plans;
(ev) Coordinate review and monitor regulatory approve Non-Registrational Studies, taking into consideration the appropriateness in the context of the overall marketing and promotional strategy and activities for the Collaboration Products Products;
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with Article 9the Marketing Plans;
(fvii) At review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxiii) Review review and recommend approve the general guidelines applicable to particular Products to be followed by ERS in its development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(xv) review and approve the joint publication strategy together with the PDC; Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and ImClone Systems Incorporated.
(xvi) evaluate and determine the existence or non-existence of a Co-Promotion Problem referred to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products JCC in the United Statesaccordance with Section 5.6(e); and
(hxvii) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement
Responsibilities. The Subject to oversight by the JSC, the Joint Development Committee ---------------- shall oversee and supervise the Development of the Named Compounds and corresponding Licensed Products in the U.S. In addition, it shall perform the following functions:
(a) Manage and oversee the preparation and implementation of the U.S. Development Plans;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update Review and amend the initial U.S. Development Plans approve updates and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans amendments to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Development Plans;
(c) Prepare Approve the Development strategy strategy, regulatory strategy, formulation and develop manufacturing process development strategy, and protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesClinical Studies as such strategies and protocols are proposed by Pfizer;
(d) Review and recommend coordinate regulatory activities to be undertaken by the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;Parties in accordance with ARTICLE 8.
(e) Coordinate and monitor regulatory strategy and activities for If the Collaboration Products in accordance with Article 9;
(f) At Parties are sharing Net Profit/Net Loss, at each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States Costs to the budgeted Development Expenses for the United States Costs in the U.S. Development Plan for the yearCalendar Year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gf) Review and recommend to the Joint Steering Committee "“go/no-go" ” decisions for the Development of Collaboration Products in the United StatesLicensed Products;
(g) Review activities conducted, if any, by a Party with respect to additional indications for Named Compounds and activities conducted, if any, related to Unnamed Compounds;
(h) Manage and oversee the execution of the Manufacturing Transfer; and
(hi) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. For clarity, and without limiting the foregoing, the JDC shall not have decision-making authority regarding the exercise of a New Collaboration Compound Option, Additional Indication Proposal, or any development plans for Unnamed Compounds. Rather, the JDC shall only provide the non-developing Party a forum at which to review and comment upon research and development plans and results for Unnamed Compounds and to review Additional Indication Proposals.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJMC will:
(a) Manage consistent with the provisions of Section 6.2, designate the team leader and oversee the preparation and implementation other members of the U.S. Development PlansManufacturing Working Group, which team leader and members shall be chosen from among the personnel of the Parties having relevant experience, and allocate the respective roles on the Manufacturing Working Group among such members;
(b) As early as review on a periodic basis and make any necessary changes to the team leader and other members of the Manufacturing Working Group, or the allocation of roles among such members;
(c) oversee the Manufacturing Working Group, in each year beginning consultation with the first full Calendar Year after JDC, with respect to matters relating to the Effective Datepre-clinical or clinical Manufacture of the Products;
(d) oversee the Manufacturing Working Group, update and amend in consultation with the initial U.S. Development Plans and prepare JCC, with respect to matters relating to the U.S. Development Plans for each Collaboration Product commercial Manufacture of the Products;
(e) oversee the Manufacturing Working Group, in consultation with the JDC, with respect to Manufacturing quality matters for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than Products; [** of such year for review and approval; ** *] = Certain confidential information on contained in this page document, marked by brackets, has been omitted and filed separately with the CommissionSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested Table of Contents
(f) oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the omitted portions.
(c) Prepare review of the Development strategy results of regulatory and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review environmental, health and recommend safety inspections and audits related to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting Manufacture of the Joint Development Committee, Products and the review a comparison and discussion of actual Development Expenses for the United States steps taken by CRISPR to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingaddress any deficiencies noted;
(g) Review and recommend to oversee the Joint Steering Committee "go/no-go" decisions for Manufacture of the Development of Collaboration Products in the United States; andField in the Territory, in consultation with the JDC or JCC, as applicable;
(h) Have such other allocate responsibilities as may be assigned for Manufacturing activities with respect to the Joint Development Committee pursuant to this Agreement Products in the Field in the Territory between the Parties;
(i) review, discuss and approve, in consultation with the JDC or the JCC, as may be mutually agreed upon applicable, the initial Global Manufacturing Plan, including the Manufacturing Budget, and any updates or amendments thereto proposed by the Parties from time Manufacturing Working Group, and submit such Global Manufacturing Plan, updates or amendments to time.the JSC for review and discussion;
(j) submit the approved updated Manufacturing Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no later than [***] of each Calendar Year;
(k) review, discuss and approve the Manufacturing process for each Shared Product proposed by the Manufacturing Working Group, and review, discuss and approve any changes to such Manufacturing process proposed by the Manufacturing Working Group, in each case, in consultation with the JDC or JCC, as applicable;
(l) review, discuss and approve any recommendations of the Manufacturing Working Group regarding capacity planning, supply plans and supply continuity planning for the Products;
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform for Commercialization matters will, subject to the following functionsother provisions of this Agreement:
(a) Manage and oversee the preparation and implementation provide a forum for discussion of the U.S. Development Plansobjectives and progress of the Commercialization of the Collaboration Products in the Field in the Territory and exchange and review information and data relating to such Commercialization activities;
(b) As early as necessary in review, discuss and approve an initial Global Commercialization Plan for each year beginning with Collaboration Product (including the first full Calendar Year after the Effective DateGlobal Commercialization Budget), update and amend the initial U.S. Development Regional Commercialization Plans for each Collaboration Product, and prepare any updates or amendments thereto (expected to be made on an annual basis or more frequently as needed), and submit each such Global Commercialization Plan, Regional Commercialization Plan, updates and amendments to the U.S. Development Plans JSC for review and discussion and, if the JXC is unable to reach consensus submit to the JSC for resolution in accordance with Section 2.8;
(c) advise and consult with any Committee responsible for matters related to commercial Manufacturing in connection with responsibilities of such Committee, as appropriate;
(d) allocate responsibilities for the conduct of Commercialization activities under the Global Commercialization Plan to the Partnership Parties, if applicable;
(e) submit the updated Global Commercialization Budget for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than [** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9*];
(f) At each meeting of to the Joint Development Committeeextent allowed under Applicable Law, review a comparison and approve templates of actual Development Expenses for the United States to the budgeted Development Expenses for the United States distribution agreements, pharmacy benefit manager agreements and other subcontractor agreements used in the U.S. Development Plan for the year-to-dateCommercialization of Collaboration Products, as current well as practicable to a date immediately prior to the date of the meetingany material modifications or updates thereto, as set forth in Section 3.3.4(f);
(g) Review review, discuss and recommend approve any proposed use of a Subcontractor to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products conduct a Partnership Party’s activities under a Global Commercialization Plan, as set forth in the United StatesSection 6.1; and
(h) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to it under this Agreement or as may be mutually agreed upon delegated to it by the Parties from time to timeJSC.
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (CRISPR Therapeutics AG)
Responsibilities. The Joint Development Committee ---------------- JSC shall perform the following functions, subject to the final decision-making authority of the Person set forth in Section 5.2.6:
(a) Manage review and oversee the preparation and implementation monitor progress of the U.S. Research Plan and the Pre-Development PlansPlan and serve as a forum for exchange of information and facilitate discussions regarding the conduct of the Research Plan and the Pre-Development Plan, and review and approve amendments to the Research Plan;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with monitor the Commission. Confidential treatment has been requested with respect Parties’ activities pursuant to the omitted portions.Section 2.2.1(a);
(c) Prepare the Development strategy prioritize and develop protocols initiate Prioritized BAC/ADC Programs, including approval of Target Combinations for clinical studies for the Collaboration Products for Commercialization in the United StatesPrioritized BAC/ADC Programs;
(d) Review and recommend to oversee the Joint Steering Committee any material amendments progress of each Prioritized BAC/ADC Program through Nomination of a Collaboration BAC or modifications to the U.S. Collaboration ADC in such BAC/ADC Program as a Development PlansCandidate;
(e) Coordinate after Nomination of a Development Candidate in which none of the binding domains is Directed to [*], oversee the progress of the development of such Development Candidate and monitor regulatory strategy and activities for its corresponding Licensed Products comprising or containing such Development Candidate through Regulatory Approval of a Licensed Product, provided, however, that in the Collaboration Products event such Development Candidate is subsequently deemed to be a [*] DC (in accordance with Article 9the second sentence of Section 1.15) at the time of the First DC IND Clearance Date or Second IND Clearance Date, as applicable, then beginning at such time this Section 5.2.4(e) shall no longer apply to such deemed [*] DC;
(f) At each meeting after Regulatory Approval of a Licensed Product comprising or containing a Non-[*] DC, oversee the commercialization activities of CELGENE and SUTRO with respect to such Licensed Product, including pre-launch and post-launch activities in the CELGENE Territory and the SUTRO Territory and serve as a forum for coordination of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingParties’ global marketing and branding efforts;
(g) Review and recommend determine when the Parties shall commence good faith discussions with respect to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; anda pharmacovigilance agreement;
(h) Have discuss and attempt to resolve any disputes in the JSC and any Subcommittee;
(i) discuss any Production Issue of which CELGENE notifies SUTRO under Section 6.5, as well as the production method for any particular Development Candidate and corresponding Licensed Product(s) comprising or containing such Development Candidate;
(j) such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
(k) For purposes of clarity, the JSC shall not have any authority beyond the specific matters set forth in this Section 5.2.4, and in particular shall not have any power to amend, modify or waive the terms of this Agreement, or to alter, increase, expand or waive compliance by a Party with, a Party’s obligations under this Agreement. In any case where a matter within the JSC’s authority arises, the JSC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than thirty (30) days after the matter is first brought to the JSC’s attention, or, if earlier, at the next regularly-scheduled JSC meeting.
Appears in 1 contract
Sources: Collaboration and License Agreement (Sutro Biopharma Inc)
Responsibilities. The Joint Development Supply Committee ---------------- shall perform ---------------- the following functions:
(a) Manage and oversee the preparation activities in relation to manufacture and implementation supply of API Compound and Collaboration Products for use in Development and Commercialization and establish procedures and protocols for testing API Compound and Collaboration Products to ensure that such API Compound and Collaboration Products comply with the U.S. Development Plansspecifications (the "Testing ------- Protocol"). The Parties will utilize such Testing Protocol with respect to API -------- Compound and Collaboration Product that they may receive from Product Suppliers to ensure that such API Compound or Collaboration Product meets specifications;
(b) As early as Recommend and coordinate necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans adjustments to the Joint Steering Committee no later than manufacturing schedule to ensure it is meeting the needs for all Collaboration Products;
(c) Coordinate allocation of API Compound in the event of a shortage between the United States and the ROW, it being understood that, in the event of a shortage, allocation of API Compound shall be as follows:*** ;
(d) Review the quality of such year the manufacture of the Collaboration Products, reviewing as appropriate reports of the manufacturers of API Compound and Collaboration Products and reports as to the quality of any packaging that bears the relevant trademarks or housemarks of the Parties (as owned by or licensed to the relevant Party under Section 2.4) as prescribed by this Agreement;
(e) Recommend and implement optimal inventory levels and safety stock targets;
(f) Set improvement targets and monitor performance against these targets for review cost, yield, delivery and approvalother appropriate measures;
(g) Establish guidelines to facilitate improved efficiencies and compliance with current Good Manufacturing Practices by Product Suppliers; and ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Supply Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- JSC shall perform the following functions:
(a) Manage Approve the overall strategy and oversee timelines for the preparation Collaboration Program and implementation of the U.S. Development Planscollaborative process including appointing and providing direction to the Joint Project Team.;
(b) As early review and approve: (i) the Joint Development Plan; (ii) division of labor among the Parties; (iii) annual budgets and multiyear expense forecasts formulated by the Joint Project Team; (iv) any expenditure made in connection with purchasing preferred shares of equity in Magainin, or otherwise entering into a debt instrument (for amounts reflecting budgeted activities), as necessary recommended by the Joint Project Team and provided in each year beginning that ________________________________________________________________________________ ** Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has Commission. The omitted portions have been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to certain Stock Purchase Agreement, dated of even date herewith; and the omitted portions.(v) the financial results of the Collaboration Program;
(c) Prepare review and evaluate progress of the activities under the Joint Development strategy and develop protocols for clinical studies for Plan, provided that the Collaboration Products for Commercialization JSC shall not have authority to make any determination that either Party is in the United Statesbreach of this Agreement;
(d) Review review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee approve "go/no-go" decisions and recommendations made by the Joint Project Team;
(e) resolve disputes or disagreements unresolved by any Joint Project Team and any other disputes or disagreements between the Parties with respect to the Collaboration Program;
(f) review marketing plans for the Development of Collaboration Products in the United Statesany Product; and
(hg) Have have such other responsibilities as may be assigned to the Joint Development Committee JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties or any member of senior management from the Parties from time to time.
Appears in 1 contract
Sources: License and Collaboration Agreement (Magainin Pharmaceuticals Inc)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functionsfunctions with the objective of maximizing Net Sales and profitability of the Product, subject to applicable Laws and the Applicable Commercial Practices Policies:
(a) Manage 3.5.1 Discuss the manner in which ▇▇▇▇▇▇ Sales Representatives and oversee Cephalon Sales Representatives will Promote and Detail the preparation Product in the ADHD marketplace based on the available information and implementation data regarding the safety and efficacy of the U.S. Development PlansProduct;
(b) As early as necessary in each year beginning with 3.5.2 Coordinate the first full Calendar Year after the Effective Date, update Co-Promotion and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans Detailing activities related to the Joint Steering Committee no later than ** Product of such year for review the Cephalon Sales Representatives and approval▇▇▇▇▇▇ Sales Representatives in the Territory; ** = Certain information on this page has *Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Commission. Confidential treatment has been requested Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
3.5.3 Discuss the state of the markets for the Product in the Territory and opportunities and issues concerning the Co-Promotion and Detailing of the Product in the Territory;
3.5.4 Discuss marketing support for the Product;
3.5.5 Discuss the pricing of the Product in a manner whereby Cephalon agrees to consider in good faith any ▇▇▇▇▇▇ suggestions with respect to such matters, but Cephalon retains sole discretion with respect to all final pricing decisions relating to the Product;
3.5.6 Discuss issues raised by Sales Representatives relating to Co-Promotion and Detailing of the Product in the Territory;
3.5.7 Discuss incentive compensation programs for the Sales Representatives;
3.5.8 Discuss the Plans and the Marketing Budget in a manner whereby Cephalon agrees to consider in good faith any ▇▇▇▇▇▇ suggestions with respect to such matters, but, subject to Sections 2.3.5, 3.7, 6.4 and 6.6, Cephalon retains final decision-making authority with respect to the omitted portions.
(c) Prepare Plans and the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesMarketing Budget;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States3.5.9 Discuss [**]; and
(h) Have 3.5.10 Having such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time; provided that the JCC shall not have responsibility for (a) any aspect of the marketing, sale or promotion of CONCERTA®, or (b) with respect to the Product, any interactions with customers concerning rebating or discounting of any type or, subject to Section 3.5.5, other terms or conditions of sale or the development or implementation of strategies for the managed care market.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJMC will:
(a) Manage consistent with the provisions of Section 6.2, designate the team leader and oversee the preparation and implementation other members of the U.S. Development PlansManufacturing Working Group, which team leader and members shall be chosen from among the personnel of the Parties having relevant experience, and allocate the respective roles on the Manufacturing Working Group among such members;
(b) As early as review on a periodic basis and make any necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans changes to the Joint Steering Committee no later than ** team leader and other members of the Manufacturing Working Group, or the allocation of roles among such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.members;
(c) Prepare oversee the Development strategy and develop protocols for Manufacturing Working Group, in consultation with the JDC, with respect to matters relating to the pre-clinical studies for or clinical Manufacture of the Collaboration Products for Commercialization in the United StatesProducts;
(d) Review and recommend oversee the Manufacturing Working Group, in consultation with the JCC, with respect to matters relating to the Joint Steering Committee any material amendments or modifications to commercial Manufacture of the U.S. Development PlansProducts;
(e) Coordinate and monitor regulatory strategy and activities oversee the Manufacturing Working Group, in consultation with the JDC, with respect to Manufacturing quality matters for the Collaboration Products in accordance with Article 9Products;
(f) At each meeting oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the review of the Joint Development Committeeresults of regulatory and environmental, review a comparison of actual Development Expenses for the United States health and safety inspections and audits related to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date Manufacture of the meetingProducts and the review and discussion of steps taken by CRISPR to address any deficiencies noted;
(g) Review and recommend to oversee the Joint Steering Committee "go/no-go" decisions for Manufacture of the Development of Collaboration Products in the United StatesField in the Territory, in consultation with the JDC or JCC, as applicable;
(h) allocate responsibilities for Manufacturing activities with respect to the Products in the Field in the Territory between the Parties;
(i) review, discuss and approve, in consultation with the JDC or the JCC, as applicable, the initial Global Manufacturing Plan, including the Manufacturing Budget, and any updates or amendments thereto proposed by the Manufacturing Working Group, and submit such Global Manufacturing Plan, updates or amendments to the JSC for review and discussion; [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would cause competitive harm if publicly disclosed.
(j) submit the approved updated Manufacturing Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no later than [***] of each Calendar Year;
(k) review, discuss and approve the Manufacturing process for each Shared Product proposed by the Manufacturing Working Group, and review, discuss and approve any changes to such Manufacturing process proposed by the Manufacturing Working Group, in each case, in consultation with the JDC or JCC, as applicable;
(l) review, discuss and approve any recommendations of the Manufacturing Working Group regarding capacity planning, supply plans and supply continuity planning for the Products;
(m) select and approve each CMO and contract testing facility to be engaged with respect to each phase of the Manufacture of any Product [***];
(n) determine whether any Manufacturing technology transfer between the Parties is necessary;
(o) review, discuss and approve any proposed use of a Subcontractor to conduct a Party’s activities under the Global Manufacturing Plan, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(hp) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to JMC under this Agreement or as may be mutually agreed upon delegated to the JMC by the Parties from time to timeJSC.
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Responsibilities. The Joint Development Committee ---------------- USJMC shall perform be responsible for overseeing the conduct and progress of the Co-Commercialization of each Co-Commercialized Product in the Co-Commercialization Territory. Without limiting the generality of the foregoing, the USJMC shall have the following functionsresponsibilities:
(a) Manage and oversee preparing or directing the preparation and implementation of by the U.S. Development PlansParties of, each Co-Commercialization Plan for Co-Commercialized Products in the Co-Commercialization Territory, including the budgets with respect thereto;
(b) As early as necessary preparing or directing the preparation by the Parties of each amendment to any Co-Commercialization Plan for Co-Commercialized Products in each year beginning with the first full Calendar Year after Co-Commercialization Territory or the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested related budget with respect to the omitted portions.thereto;
(c) Prepare determining style guidelines and the Development strategy and develop protocols for clinical studies for the Collaboration appearance of Co-Commercialized Products for Commercialization in the United StatesCo-Commercialization Territory, including packaging and promotional materials;
(d) Review determining managed health care strategy and recommend to tactics, including Pricing, rebates, discounts and charge-backs for Co-Commercialized Products in the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansCo-Commercialization Territory;
(e) Coordinate and monitor regulatory strategy and activities for determining the Collaboration Products appropriate use of medical science liaisons in accordance with Article 9support of the Co-Commercialized Products;
(f) At each meeting determining the format and quantities of the Joint Development Committeepromotional sales, review a comparison of actual Development Expenses marketing and educational materials for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the yearCo-to-date, as current as practicable to a date immediately prior to the date of the meetingCommercialized Products;
(g) Review reviewing and recommend to approving any proposals for modifications of existing Co-Commercialized Products, including, without limitation, new formulations after First Commercial Sale and line extensions;
(h) agreeing upon the Joint Steering Committee "go/nodesign and implementation of all Co-go" decisions for Commercialized Product launch activities;
(i) monitoring the Development progress of Collaboration Commercialization of Co-Commercialized Products in the United StatesCo-Commercialization Territory under each Co-Commercialization Plan and of each Party’s activities thereunder;
(j) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Co-Commercialized Products in the Co-Commercialization Territory;
(k) determining appropriate targets for sales force staffing and territory mapping purposes, determining the appropriate level of Detailing effort to be provided by each Party in Co-Commercializing such Co-Commercialized Product and coordinating the Detailing efforts of both Parties with respect to Co-Commercialized Products;
(l) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Commercialized Products;
(m) receiving and providing to the Parties sales reports pertaining to Co-Commercialized Products;
(n) approving all Third Parties to be engaged by either Party to provide representatives to Commercialize Co-Commercialized Products, which approval shall be reflected in the minutes of the USJMC; and
(ho) Have making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee USJMC pursuant to this Agreement or as may be mutually agreed upon by the JSC or by mutual written agreement of the Parties from time to timeduring the Term.
Appears in 1 contract
Sources: License, Co Development and Co Commercialization Agreement (Arqule Inc)
Responsibilities. The Joint Development Committee ---------------- shall perform the following functions:
(a) Manage Determine the direction and oversee the preparation and implementation objectives of the U.S. Development PlansCollaboration;
(b) As early Oversee all aspects of Yakult’s development, implementation and management of the day-to-day activities of the Collaboration pursuant to the terms of this Agreement;
(c) Review and approve the Development Plans, and review and comment on Commercialization Plans for ThermoDox Products and any material amendments thereto;
(d) Review and approve the Development strategy, regulatory strategy, formulation and manufacturing process development strategy, and protocols and milestones for Clinical Studies (with such approval occurring within [ * ]), as necessary such strategies and protocols are proposed to the Committee by Yakult;
(e) Review data and reports arising from and generated in each year beginning connection with the first full Calendar Year after Development and Commercialization of the Effective Date, update ThermoDox Products;
(f) Review and amend the initial U.S. Development Plans coordinate regulatory activities to be undertaken by Yakult in accordance with ARTICLE 8;
(g) Review and prepare the U.S. Development Plans for each Collaboration Product have final approval authority with respect to “go/no-go” decisions for the following Calendar Year so that it can submit such proposed U.S. Development Plans of the ThermoDox Products recommended by Yakult;
(h) Review activities conducted, if any, by a Party with respect to additional indications for ThermoDox Product;
(i) Oversee the integration of new indications to be added to the Joint Steering Committee no later than *Named Indications listed on Schedule 1.53;
(j) Review and update Schedule 1.53;
(k) Review and provide guidance for all pricing decisions (for purposes of coordinating pricing strategies outside of the Territory, only) and managed care contracting strategies to ensure consistency with the Commercialization Plan;
(l) Resolve disputes and other matters concerning the Collaboration contemplated by this Agreement; * of such year for review and approval; ** = Certain information on this page Material has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(cm) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development CommitteeEstimate sales amounts, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States[ * ]; and
(hn) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: Development, Product Supply and Commercialization Agreement (Celsion CORP)
Responsibilities. The Joint Steering Committee shall be responsible for providing oversight and coordinating the Scientific Development, Pre-Clinical Development, clinical Development Committee ---------------- shall perform and cGMP activities related to the following functions:
Research Program and Development Plan, including: (a) Manage maximizing the global opportunity and oversee profitability of the preparation Licensed Product while aligning the strategic, logistical and financial considerations of each Party; (b) reviewing and discussing the implementation of the U.S. Development Plans;
Plan; (c) reviewing, discussing and approving amendments and updates to the Development Plan; (d) directing Development activities for the Licensed Product in accordance with the Development Plan; (e) aligning cGMP manufacturing activities and investments to provide the Licensed Compounds and Licensed Products for Clinical Trials and commercial supply in accordance with the Development Plan; and (f) selecting [***] and [***]. If the Parties mutually agreed to cease Development of a PCC after the relevant IND-enabling activities (including manufacture of such PCC for use in such IND-enabling activities) have been completed under the applicable Development Plan, then the Parties shall replace such PCC, no more than [***] during the Term, each time with a molecule that is Controlled by Ambrx upon mutual agreement, (“Reload Compound”) for Development under this Agreement, including with respect to a Successful Dual IND Filing for such Reload Compound, for no additional consideration under Section 5.1 (Upfront Payment). For clarity, (a) such replacement may only occur up to [***] during the Term, which may be (i) [***]; or (ii) [***]; and (b) As early as necessary in each year beginning with any modifications, reworkings, improvements or upgrades of the first full Calendar Year Initial Compound for which the Parties mutually agreed to cease Development after the Effective Daterelevant IND-enabling activities can be considered as a Reload Compound. After completion of the due diligence of the Patent Rights that Cover such Reload Compound (“Reload Patent Rights”) to the satisfaction of Sino, update and amend Sino shall reassign the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product Specific Patents Rights for the following Calendar Year so that it can submit such proposed U.S. Development Plans replaced Licensed Compound to the Joint Steering Committee no later than ** of such year for review Ambrx, and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect concurrently Ambrx shall assign Reload Patent Rights to the omitted portionsSino.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: Co Development and License Agreement (Ambrx Biopharma Inc.)
Responsibilities. The Except for decisions expressly reserved to the JSC pursuant to Section 2.3 (Joint Development Committee ---------------- shall perform Steering Committee), the following functionsJAC will (a) establish subcommittees and working teams as is necessary to coordinate and conduct its activities hereunder; (b) coordinate with and oversee the activities of any such subcommittees and working teams; and (c) be responsible for coordinating all operational matters regarding the Development, Manufacture and Commercialization of the Products in the Collaboration Territory, including:
(a) Manage the following Development and oversee regulatory matters: (i) reviewing Amgen’s Global Development Plan with respect to the preparation applicable Product in the Collaboration Territory and implementation annual updates (or any other updates) thereto; (ii) preparing the […***…] expense budget for Commercialization activities set forth in the Commercialization Plan, including a schedule of FTE expenses (the “Commercialization Budget”) and annual updates (or any other updates) thereto; (iii) reviewing the clinical research organizations (CROs) to be engaged in conjunction with the development of the U.S. applicable Product and study design and protocols for Clinical Studies in the Collaboration Territory for such Product; (iv) providing for communication and discussion between the Parties to optimize the efficacy and safety of the Development Plansof such Product in the Collaboration Territory; (v) reviewing and monitoring the activities and progress against the Global Development Plan and any Commercialization Plan; (vi) proposing observational research and any payer and economic value evidence generation plans for inclusion in the Global Development Plan; (vii) reviewing requirements for clinical supplies of the Products in the Collaboration Territory; (viii) communicating with the Parties regarding all of the foregoing; and (ix) making such decisions as are specified in Article III (Development and Regulatory) to be made by the JAC;
(b) As early as necessary in each year beginning with the first full Calendar Year after following operations matters: (i) overseeing supply of the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration applicable Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately Collaboration Territory (in accordance with the Commission. Confidential treatment has been requested applicable Quality Agreement); (ii) reviewing the portion of the […***…] Global Development Budget prepared by Amgen for manufacturing activities to be undertaken with respect to Collaboration Activities for such Product in the omitted portions.Collaboration Territory and annual updates (or any other updates) thereto; (iii) reviewing other operational issues relating to the manufacture, quality (based on the quality control data of such Product that Amgen shall provide reasonably in advance of the expected date of filing for Regulatory Approval in the Collaboration Territory) or supply of such Product for the Collaboration Territory and any related devices; (iv) reviewing matters related to the Clinical Studies for the Products in the Collaboration Territory, including inspection and audit findings; and (v) making such decisions as are specified in Article IV (Manufacturing) to be made by the JAC;
(c) Prepare the Development strategy following Commercialization matters: (i) reviewing Amgen’s Global Brand Plan for the applicable Product and develop protocols annual updates (or any other updates) thereto; (ii) reviewing the Commercialization Plan, Commercialization Budget, and Access and Pricing Plan for clinical studies the applicable Product prepared by BeiGene and annual updates (or any other updates) thereto; (iii) establishing a process for reviewing and commenting on Promotional Materials and training materials and programs for each Product for the Collaboration Products for Commercialization Scope; and (iv) making such decisions as are specified in Article V (Commercialization) to be made by the United States;JAC; and
(d) Review overseeing and recommend coordinating other activities described in the definitions of “Development Costs” and “Commercialization and Related Costs,” related to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeTerritory.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- Without limiting the generality of the foregoing, the JSC shall perform have the following functionsresponsibilities:
(a) Manage overseeing the JDC’s performance of its responsibilities, the JFC’s performance of its responsibilities and oversee the preparation and implementation JMC’s performance of the U.S. Development Plansits responsibilities;
(b) As early as necessary in each year beginning with reviewing data, reports or other information submitted to it by the first full Calendar Year after the Effective DateJDC, update JMC and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans JFC from time to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.time;
(c) Prepare resolving all JDC, JMC or JFC matters that are referred to the Development strategy and develop protocols JSC for clinical studies for the Collaboration Products for Commercialization in the United Statesresolution;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee JSC pursuant to this Agreement or as may be mutually agreed upon by mutual written agreement of the Parties from time after the Effective Date; and
(e) the JSC will meet in accordance with Section 2.1.3 for the purpose of (i) serving as a forum for Biotest and/or ImmunoGen, as applicable, to timeupdate each other as to Development and Commercialization progress with respect to Licensed Products, including monitoring the progress of the Development of each Licensed Product in accordance with the Development Plan and the Commercialization of each Co-Developed Product in accordance with the applicable Co-Development Marketing and Sales Plan and reviewing each annual update to each Co-Development Marketing and Sales Plan; and (ii) resolving any matters that require a Unanimous Decision. At each such meeting of the JSC the members of Biotest on the JSC shall provide an update as to Biotest’s general strategy for the Development and Commercialization of each Licensed Product in the Field to the extent applicable. In the event ImmunoGen exercises a Co-Development Option, the members of Biotest and ImmunoGen on the JSC shall provide (i) an Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. update as to the Co-Promotion strategy for the Development and Commercialization of each Co-Developed Product in the Field set forth in the Co-Development Plan and/or Co-Development Marketing and Sales Plan (ii) an update concerning the anticipated timelines on a region-by-region basis for the Development of each Co-Developed Product and Regulatory Filings with respect thereto in the Field in the Territory, (iii) an update concerning the anticipated timelines on a region-by-region basis for the commercial launch of each Co-Developed Product and (iv) sales forecast guidance for each Co-Developed Product in the Field in the Territory; provided, that, in proving such update, the members of Biotest on the JSC shall be entitled to omit discussion of Confidential Information of Biotest that Biotest reasonably determines to be materially sensitive. If there is a material change in such timelines or guidance after any such meeting, Biotest will endeavor to notify ImmunoGen thereof through the convenience of a special meeting of the JSC.
Appears in 1 contract
Sources: Collaborative Development and License Agreement (Immunogen Inc)
Responsibilities. The Joint Development Committee ---------------- responsibilities of the JSC shall perform the following functionsbe:
(ai) Manage and oversee to provide a forum by which the preparation and implementation of Parties may share information regarding the U.S. Development Plansoverall strategy for the Collaboration Programs;
(bii) As early as necessary in each year beginning with to facilitate the first full Calendar Year after exchange of information between the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested Parties with respect to the omitted portions.
(c) Prepare the Development strategy activities hereunder and develop protocols for clinical studies to establish procedures for the efficient sharing of information necessary for the Parties to fulfill their respective responsibilities with respect to the Collaboration Products for Commercialization in the United StatesPrograms;
(diii) Review review, discuss and recommend approve each Research Plan, Global Development Plan and Territory-Specific Development Plan and the Co-Development Plan and Co- Commercialization Plan, and updates or amendments thereto and to share and discuss the Joint Steering Committee any material amendments or modifications to progress of activities under the U.S. Research Plans, Global Development Plans, Territory-Specific Development Plans, Co-Development Plan and Co-Commercialization Plan on a quarterly basis;
(eiv) Coordinate to share and monitor regulatory strategy discuss the data generated by or on behalf of the Parties in the course of performance towards the goals set forth in the Research Plans, Global Development Plans, Territory-Specific Development Plans, Co-Development Plan and activities for the Collaboration Products in accordance with Article 9Co-Commercialization Plan;
(fv) At each meeting to coordinate Development and Commercialization strategies of the Joint Collaboration Programs, and allocate resources and set timelines for Development Committee, review a comparison of actual Development Expenses for the United States and Commercialization activities with respect to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingCollaboration Programs;
(gvi) Review to establish an overall regulatory strategy for (1) each [***] Molecule and recommend to [***] Product before the Joint Steering Committee "go/noOpt-go" decisions In or (2) any MGNX Option Molecule and MGNX Option Product, in each case of (1) and (2), in the applicable Collaboration Territory that is consistent with and complements the worldwide regulatory strategy being implemented by MacroGenics for the Development applicable Collaboration Molecule and Product;
(vii) to establish an overall worldwide regulatory strategy for any [***] Molecule and [***] Product after the Opt-In;
(viii) to create any subcommittees (including the JRDC and JCC) as agreed in writing by both Parties, to oversee the activities of Collaboration Products such subcommittees, and to seek to resolve any issues that such subcommittees cannot resolve;
(ix) to establish an overall strategy for the filing, prosecution and maintenance of MacroGenics Licensed Patents, MacroGenics Licensed Trademarks and Zai Licensed Patents in the United StatesTerritory and any applicable Patent and Trademark term extensions; and
(hx) Have to perform such other responsibilities functions as may be assigned to the Joint Development Committee pursuant to expressly set forth in this Agreement or as may be mutually agreed upon appropriate to further the purposes of this Agreement, as determined by the Parties from time to timeParties.
Appears in 1 contract
Sources: Collaboration and License Agreement (Macrogenics Inc)
Responsibilities. The Joint JSC’s responsibilities will include, among others: (i) approving the Development Committee ---------------- shall perform the following functions:
and Regulatory Plan and any amendments to such plan (a) Manage and oversee the preparation and implementation other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), including, without limitation, approval of the U.S. Development Plans;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans any amendment to the Joint Steering Committee no later than ** Development and Regulatory Plan to undertake Development of such year for review a Combination Product that includes the Licensed Compound and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect another active pharmaceutical ingredient, (ii) approving (or establishing procedures to the omitted portions.
(capprove) Prepare the Development strategy and develop protocols for pre-clinical or clinical studies for the Collaboration Products for Commercialization in the United States;
(dincluding Post-Approval Research) Review and recommend to the Joint Steering Committee any material amendments or modifications to such protocols or studies and amendments thereto (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), (iii) approving any proposed amendment to the U.S. Development Plans;
Launch Plan (eother than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), (iv) Coordinate performing quarterly reviews of progress of pre-clinical and monitor regulatory clinical studies and proposed additional studies, (v) reviewing and commenting on the Commercialization Plan (and amendments thereto) prepared and presented by Astellas, (vi) reviewing and commenting on Regulatory Submissions relating to the Product prepared by Astellas, (vii) facilitating the exchange of data and information relating to the development of the Product in and outside the Territory, (viii) receiving updates on the strategy for Commercializing the Product in the Field in the Territory (including strategies related to reimbursement, advertising and promotion, brand integrity, sales, and launch sequence), (ix) receiving updates on the annual marketing plans and activities for the Collaboration Products Product in accordance with Article 9;
the Field in the Territory, (fx) At each meeting of commenting on the Joint Development Committee, review a comparison of actual Development Expenses target product profile for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-dateProduct (including current and future formulations, as current as practicable to a date immediately prior to the date of the meeting;
indications, and delivery forms, and key labeling claims), and (gxi) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have performing such other responsibilities functions as may be are expressly assigned to the Joint Development Committee pursuant to it in this Agreement or Agreement. The JSC may appoint additional committees as may be mutually agreed upon by the Parties from time Parties. For the avoidance of doubt, the JSC shall not have the authority to timeamend or modify any term or condition, or take any action inconsistent with or in violation of, this Agreement.
Appears in 1 contract
Responsibilities. The Joint Development Steering Committee ---------------- shall perform have the following functionsroles and responsibilities:
(ai) Manage review and oversee approve any material amendments to the preparation Development Plan (subject to Section 3.3(d)). Any proposed material amendment to the Development Plan, including arguments to support such amendment, shall be made available to the Steering Committee with reasonable advance notice and implementation at least five (5) Business Days ahead of the U.S. Development Plansscheduled meeting;
(bii) As early as necessary provide reasonably detailed updates, data and other information regarding Protalix’s progress in each year beginning Developing the Licensed Product in the Field;
(iii) provide updates in respect of any New Use in accordance with Section 2.5;
(iv) discuss the first full Calendar Year after timing of transferring any regulatory filings in the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested Territory with respect to the omitted portions.
(c) Prepare Compound, Drug Substance, Drug Product or Licensed Product from Protalix to Chiesi in accordance with the Development strategy terms of Section 3.6(c), and develop protocols discuss and agree upon appropriate timelines for, and the responsibilities of each Party in respect of, preparing any regulatory filings for clinical studies obtaining Regulatory Approval in any Country in the Territory. As part of such discussions, the Steering Committee shall discuss and agree on appropriate timelines and processes for the Collaboration Products for Commercialization orderly transfer of all medical affairs functions from Protalix to Chiesi in the United Statesaccordance with Section 3.6(d)(iv);
(dv) Review act as a forum pursuant to which the Parties will review and recommend discuss plans and strategies relating to (x) the Development of the Licensed Product in the Field, (y) regulatory matters with respect to the Joint Steering Committee any material amendments or modifications Licensed Product in the Field in the Territory, and (z) Commercialization of the Licensed Product in the Field in the respective territories of the Parties, to the U.S. Development Plansensure aligned communication at medical congresses and other scientific events as well as scientific publication plans;
(evi) Coordinate and monitor modify the division of regulatory strategy and activities for responsibilities as between the Collaboration Products Parties in accordance with Article 9Section 3.6(d)(v);
(fvii) At each meeting subject to the terms of the Joint Development CommitteeSection 8.5, review a comparison and/or approval of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingeach Party’s scientific publication plans;
(gviii) Review oversee any Early Access Programs for the Licensed Product in the Field in the Territory;
(ix) review and recommend agree upon the final version of the Initial Commercialization Plan, in accordance with Section 3.7(a), and review and provide comment upon any proposed revisions to, or any subsequent versions of, the Commercialization Plan (such comments to be considered in good faith by Chiesi);
(x) receiving from Chiesi reasonably detailed updates, data and other information regarding the status and details of any Price Approvals or Governmental Authority and Third Party reimbursement approvals in the Territory, in accordance with Section 3.7(c);
(xi) subject to Section 4.8(c), review and in good faith seek to resolve any disputes regarding any Notice of Non-Conformance issued in respect of a shipment of Drug Substance or Drug Product under the terms of this Agreement;
(xii) subject to Section 7.6(a), discuss any pertinent Third Party Patent Rights and decide upon whether a license to or acquisition of such Third Party Patent Rights or Technology is appropriate;
(xiii) discuss the possibility, from time to time, of sharing Licensed Product positioning and promotional materials for the Licensed Product in the Field, inside and outside the Territory;
(xiv) define the manner and timelines for Chiesi’s access to sites and records of the Ongoing Clinical Studies and [***] conducted by Protalix;
(xv) appoint the Referent Persons in accordance with Section 8.5;
(xvi) establish, if deemed necessary, the creation of a Joint Project Team (“JPT”) to oversee operations or activities. The composition of the JPT will be decided by the Steering Committee according to the Joint Steering Committee "go/notype of activity and decision making in accordance with Section 3.3(d). The JPT shall be comprised of representatives from each Party with appropriate competence and level of decision-go" decisions for making authority. The JPT shall meet with a frequency to be agreed on by the Development of Collaboration Products in the United StatesParties; and
(hxvii) Have such other roles and responsibilities provided for in this Agreement or as may be assigned to the Joint Development Steering Committee pursuant to this Agreement or as may be mutually agreed upon in writing by mutual agreement of the Parties from time to timeParties.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Protalix BioTherapeutics, Inc.)
Responsibilities. The Joint Development Committee ---------------- JPC shall perform the following functions:
(ai) Manage and oversee Consult with THERAVANCE in the preparation and implementation case of the U.S. Development Plans;
Plan and with MYLAN in the case of the Commercialization Plan in connection with such Party’s preparing and updating of the Development Plan and Commercialization Plan and their associated budgets in a timely manner (bproviding any comments within thirty (30) As early as necessary in each year beginning with days of the first full Calendar Year after submission thereof by the Effective Date, update applicable Party) and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans them to the Joint Steering Committee no later than ** of such year JSC for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.;
(cii) Prepare At an appropriate and regular frequency, review the Development strategy and develop protocols for clinical studies (and, when appropriate, the Commercialization strategy) for the Collaboration Products for Commercialization Licensed Product in the United StatesField;
(diii) Review and discuss whether or not to recommend to the Joint Steering Committee JSC any material amendments or modifications to the U.S. Development PlansPlan or the Commercialization Plan;
(eiv) Coordinate and monitor regulatory strategy and activities for the Collaboration Products Licensed Product in accordance with Article 97;
(fv) Review and recommend to the JSC operational and other decisions for the Development of Licensed Product in the Field;
(vi) Discuss the state of the markets for Licensed Product and opportunities and issues concerning the Commercialization of the Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, and labeling;
(vii) At each meeting of the Joint Development Committeean appropriate and regular frequency, review a comparison the status of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan all studies conducted on Licensed Product and any results therefrom;
(viii) At an appropriate and regular frequency, review Net Sales of Licensed Product for the year-to-date, as and a current as practicable to a date immediately prior to outlook for Net Sales for the date remainder of the meetingthen-current Calendar Year;
(gix) Review Plan and recommend to the Joint Steering Committee "go/no-go" decisions review all publications described in Section 9.03, and review and approve a publications policy for the Development of Collaboration Products in the United Statessuch publications; and
(hx) Have such other responsibilities as may be assigned to the Joint Development Committee JPC pursuant to this Agreement or as may be mutually agreed upon by the Parties through the JSC from time to time. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage and oversee the preparation and implementation of the U.S. Development Marketing Plans;
(bii) As early as necessary in each year beginning with oversee and coordinate the first full Calendar Year after sales efforts of ERS and the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesCompany;
(diii) Review review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development approve Marketing Plans;
(eiv) Coordinate discuss the state of the markets for Products in the Territory and monitor regulatory strategy opportunities and activities issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the Collaboration Products amount and kind of marketing and selling effort appropriate, in accordance with Article 9the Marketing Plans;
(fv) At review and approve the total annual budget for all Phase IV Clinical Trials, but not the budget or protocol for the individual studies themselves which must be approved by the PDC and the JEC pursuant to Section 4.3(f);
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with the Marketing Plans;
(vii) review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxiii) Review review and recommend approve the general guidelines applicable to particular Products to be followed in the development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then-current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(xv) review and approve the joint publication strategy together with the PDC;
(xvi) evaluate and determine the existence or non-existence of a Co-Promotion Problem referred to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products JCC in the United Statesaccordance with Section 5.6(e); and
(hxvii) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time."
(f) Section 2.4(d) is hereby deleted in its entirety and replaced with the following:
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc)
Responsibilities. The Joint Development Committee ---------------- shall perform for Manufacturing matters will, subject to the following functionsother provisions of this Agreement:
(a) Manage and in consultation with any Committee responsible for Development matters, oversee matters relating to the preparation and implementation pre-clinical or clinical Manufacture of the U.S. Development PlansCollaboration Product Candidates and Collaboration Products, including quality matters, review of the results of regulatory and environmental, health and safety inspections and Manufacturing audits and the review and discussion of steps to address any deficiencies noted;
(b) As early in consultation with any Committee responsible for Commercialization matters, as necessary applicable, oversee matters relating to the commercial Manufacture of the Collaboration Product Candidates and Collaboration Products, as applicable;
(c) review, discuss and approve, in each year beginning consultation with the first full Calendar Year after the Effective Dateany Committee responsible for Development or Commercialization matters, update and amend as applicable, the initial U.S. Development Plans and prepare Global Manufacturing Plan (including the U.S. Development Plans Manufacturing Budget) for each Collaboration Product for the following Calendar Year so that it can Candidate and Collaboration Product, and any updates or amendments thereto, and submit such proposed U.S. Development Plans Global Manufacturing Plan, updates or amendments to the Joint Steering Committee no later than ** of such year JSC for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect discussion and, if unable to reach consensus, submit to the omitted portions.
(c) Prepare the Development strategy and develop protocols JSC, as necessary, for clinical studies for the Collaboration Products for Commercialization resolution in the United Statesaccordance with Section 2.8;
(d) Review review, discuss and recommend approve the Global Manufacturing Transfer Plan for Collaboration Product Candidates or Collaboration Products in the Territory and any updates or amendments thereto (expected to be made on an annual basis or more frequently as needed), and submit such Global Manufacturing Transfer Plan, updates or amendments to the Joint Steering Committee any material amendments or modifications JSC for review and discussion, and, if unable to reach consensus, submit to the U.S. Development PlansJSC, as necessary, for resolution in accordance with Section 2.8;
(e) Coordinate subject to and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9Section 3.4 and Section 10.3, review, discuss and approve which Partnership Party shall be responsible for the Manufacture of Collaboration Product Candidates and Collaboration Products;
(f) At each meeting of submit the Joint Development Committee, review a comparison of actual Development Expenses updated Manufacturing Budget for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting[***];
(g) Review establish, in accordance with Applicable Law, standards applicable to each Partnership Party’s Manufacturing activities under this Agreement, reviewing each Partnership Party’s (or a Third Party’s on such Partnership Party’s behalf) performance against such standards and recommend conducting technical reviews;
(h) review and approve templates of agreements for use with CMOs and contract testing facilities for the Manufacture of any Collaboration Product Candidate and Collaboration Product, as well as any material modifications or updates thereto, as set forth in Section 3.4.5;
(i) review, discuss and approve any recommendations of the Partnership Parties regarding capacity planning, supply plans and supply continuity planning for the Collaboration Product Candidates and Collaboration Products and make recommendations to the Joint Steering Committee "go/no-go" decisions for JSC as appropriate;
(j) review and discuss whether any Manufacturing technology transfer between the Development Partnership Parties is necessary;
(k) review, discuss and approve any proposed use of a Subcontractor to conduct a Partnership Party’s activities under the Global Manufacturing Plan, as set forth in Section 6.1;
(l) review and share the results of regulatory and environmental, health and safety inspections and audits related to the Manufacture of any Collaboration Product Candidates and Collaboration Products in with the United StatesJSC, as necessary; and
(hm) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to it under this Agreement or as may be mutually agreed upon delegated to it by the Parties from time to timeJSC.
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (CRISPR Therapeutics AG)
Responsibilities. The Joint Development Committee ---------------- Project Team shall perform ensure open communication between the following functionsParties as relates to the development of Compounds and Products as well as:
(a) Manage oversee and oversee coordinate all research and development activities with respect to Compounds under this Agreement, in a manner consistent with the preparation and implementation of the U.S. Development PlansJDP;
(b) As early as necessary in each year beginning evaluate data from the Collaboration Program;
(c) manage the day-to-day activities being conducted under the JDP, allocate responsibilities between the Parties and coordinate the activities of the Parties;
(d) provide a mechanism for the exchange of information between the Parties with regard to Know-how and Inventions;
(e) provide a mechanism for the review of data and results from any discovery efforts either Party is conducting from time to time with respect to Compounds, and recommend Compounds for clinical testing;
(f) review and agree on all relevant proposed publications and presentations of any of the Parties pursuant to Article 9; ________________________________________________________________________________ ** Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has Commission. The omitted portions have been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review prepare clinical and recommend regulatory strategy and review and approve clinical study protocols that the implementing Party shall promulgate and final reports therefor;
(h) prepare or revise Joint Development Plans annually, or as needed more frequently, and refer them (or modifications thereto) to the JSC for approval;
(i) keep the JSC informed on the status of the Collaboration Program and the activities conducted by the Parties thereunder;
(j) promulgate budgets covering the activities under the Collaboration Program and outlined in each annual Joint Steering Committee "go/noDevelopment Plan;
(k) generate cost-go" decisions estimates, quarter by quarter in advance of a quarter, to the JSC covering funding required for a following quarter (for activities of the Development Collaboration Program) through Phase II Clinical Studies and paid in advance of each quarter from such shares of preferred equity as provided in that certain Stock Purchase Agreement, dated of even date herewith;
(l) based upon Magainin's election to share in U.S. profits and losses under Section 8.6, generate a quarterly schedule of preferred stock purchases (or otherwise under a debt-instrument) as provided in that certain Stock Purchase Agreement, dated of even date herewith, which schedule of purchases shall cover and include Magainin's portion of losses incurred that first year post-Regulatory Approval; submitting the same to the JSC for its approval;
(m) ensure that each Party is aware of any ongoing activity of any Party outside the Collaboration Products Program that may impact the Collaboration Program or a Party's diligence obligations hereunder;
(n) resolve disputes and disagreements between the Parties with respect to this Section 5.2, and refer unresolved disputes and disagreements to the JSC for resolution in the United Statesaccordance with Section 4.3; and
(ho) Have have such other responsibilities as may be assigned to the Joint Development Committee JPT pursuant to this Agreement or by the JSC, or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: License and Collaboration Agreement (Magainin Pharmaceuticals Inc)
Responsibilities. The Joint JSC’s responsibilities will include, among others: (i) approving the Development Committee ---------------- shall perform and Regulatory Plan and any amendments to such plan (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), including, without limitation, approval of any amendment to the following functions:
Development and Regulatory Plan to undertake Development of a Combination Product that includes the Licensed Compound and another active pharmaceutical ingredient, (aii) Manage approving (or establishing procedures to approve) protocols for pre-clinical or clinical studies (including Post-Approval Research) and oversee any amendments or modifications to such protocols or studies and amendments thereto (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), (iii) approving any proposed amendment to the preparation Launch Plan (other than amendments required to comply with Applicable Laws or requirements imposed by Regulatory Authorities), (iv) performing quarterly reviews of progress of pre-clinical and implementation clinical studies and proposed additional studies, (v) reviewing and commenting on the Commercialization Plan (and amendments thereto) prepared and presented by Astellas, (vi) reviewing and commenting on Regulatory Submissions relating to the Product prepared by Astellas, (vii) facilitating the exchange of data and information relating to the development of the U.S. Development Plans;
Product in and outside the Territory, (bviii) As early as necessary receiving updates on the strategy for Commercializing the Product in each year beginning with the first full Calendar Year after Field in the Effective DateTerritory (including strategies related to reimbursement, update advertising and amend promotion, brand integrity, sales, and launch sequence), (ix) receiving updates on the initial U.S. Development Plans annual marketing plans and prepare the U.S. Development Plans for each Collaboration Product activities for the following Calendar Year so that Product in the Field in the Territory, (x) commenting on the target product profile for the Product (including current and future formulations, indications, and delivery forms, and key labeling claims, and (xi) performing such other functions as are expressly assigned to it can submit such proposed U.S. Development Plans in this Agreement. The JSC may appoint additional committees as agreed by the Parties. For the avoidance of doubt, the JSC shall not have the authority to the Joint Steering Committee no later than amend or modify any term or condition, or take any action inconsistent with or in violation of, this Agreement. [** *] = Portions of such year for review and approval; ** = Certain information on this page exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJCC will:
(a) Manage and oversee the preparation and implementation Commercialization of the U.S. Development PlansShared Products by the Parties in the Field in the Territory;
(b) As early as necessary in develop and approve a Global Commercialization Plan for each year beginning with Shared Product and submit such Global Commercialization Plan to the first full Calendar Year after the Effective Date, update JSC for review and discussion;
(c) amend the Global Commercialization Plan for each Shared Product on an annual basis (or more frequently as needed), approve such amendments and submit such updated Global Commercialization Plans to the JSC for review and discussion;
(d) review, discuss and approve the initial U.S. Development Plans and prepare the U.S. Development Regional Commercialization Plans for each Collaboration Shared Product and any amendments or updates thereto submitted by Parties;
(e) select product Trademarks for each Shared Product throughout the world consistent with the Global Brand Strategy;
(f) advise the JMC in connection with its oversight of the Manufacturing Working Group with respect to matters relating to the commercial Manufacture of the Shared Products;
(g) advise the JMC in connection with its oversight of the commercial Manufacture of the Shared Products in the Field in the Territory;
(h) advise the JMC in connection with its review and discussion of any updates to the Global Manufacturing Plan, including the Manufacturing Budget, proposed by the Manufacturing Working Group;
(i) submit the approved updated Global Commercialization Budget for the following subsequent Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee JSC for inclusion in the Integrated Budget no later than [** **] of each Calendar Year;
(j) advise the JMC in connection with its review, discussion and approval of the Manufacturing process, and any changes thereto, for each Shared Product;
(k) review, discuss and approve any proposed use of a Subcontractor to conduct a Party’s activities under a Global Commercialization Plan, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(l) perform such year for review and approval; other duties as are specifically assigned to the JCC under this Agreement or as may be delegated to the JCC by the JSC. [** **] = Certain confidential information on contained in this page document, marked by brackets, has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect Securities and Exchange Commission pursuant to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting Rule 24b-2 of the Joint Development Committee, review a comparison Securities Exchange Act of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date1934, as current as practicable to a date immediately prior to the date amended. Table of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.Contents
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage and oversee the preparation and implementation of the U.S. Development Marketing Plans; Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers Squibb Biologics ▇▇▇▇▇▇▇ ▇▇▇ ▇mClone Systems Incorp▇▇▇▇▇▇.
(ii) oversee and coordinate the sales efforts of ERS and the Company;
(iii) review and approve Marketing Plans;
(biv) As early as necessary discuss the state of the markets for Products in each year beginning the Territory and opportunities and issues concerning the commercialization of the Products, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues, to determine in which countries in the Territory to launch Products, the priority for same and the amount and kind of marketing and selling effort appropriate, in accordance with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Marketing Plans;
(ev) Coordinate review and monitor regulatory approve Non-Registrational Studies, taking into consideration the appropriateness in the context of the overall marketing and promotional strategy and activities for the Collaboration Products Products;
(vi) review and approve all pricing decisions and managed care contracting strategies, in accordance with Article 9the Marketing Plans;
(fvii) At review and approve all indigent care use of Products;
(viii) periodically review sales mix of Products sold by ERS through various customer channels;
(ix) review and approve allocations within the Marketing Budgets, from time to time;
(x) review and approve each subsequent marketing budget in accordance with Section 5.2(c);
(xi) review data and reports arising from and generated in connection with the commercialization of the Products, including, but not limited to the Marketing Plans, Marketing Budgets and sales forecasts;
(xii) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxiii) Review review and recommend approve the general guidelines applicable to particular Products to be followed by ERS in its development of promotional materials and promotional activities to be used by ERS and the Company in the promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products);
(xiv) consider and select Trademarks to be used for the marketing and sale of the Products in each country in the Territory;
(xv) review and approve the joint publication strategy together with the PDC; Confidential treatment requested by Bristol-Myers Squibb Company, Bristol-Myers Squibb Biologics ▇▇▇▇▇▇▇ ▇▇▇ ▇mClone Systems Incorp▇▇▇▇▇▇.
(xvi) evaluate and determine the existence or non-existence of a Co-Promotion Problem referred to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products JCC in the United Statesaccordance with Section 5.6(e); and
(hxvii) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc/De)
Responsibilities. The Except for decisions expressly reserved to the JSC pursuant to Section 2.3 (Joint Development Committee ---------------- shall perform Steering Committee), the following functionsJAC will (a) establish subcommittees and working teams as is necessary to coordinate and conduct its activities hereunder; (b) coordinate with and oversee the activities of any such subcommittees and working teams; and (c) be responsible for coordinating all operational matters regarding the Development, Manufacture and Commercialization of the Products in the Collaboration Territory, including:
(a) Manage the following Development and oversee regulatory matters: (i) reviewing Amgen’s Global Development Plan with respect to the preparation applicable Product in the Collaboration Territory and implementation annual updates (or any other updates) thereto; (ii) preparing the [*] expense budget for Commercialization activities set forth in the Commercialization Plan, including a schedule of FTE expenses (the “Commercialization Budget”) and annual updates (or any other updates) thereto; (iii) reviewing the clinical research organizations (CROs) to be engaged in conjunction with the development of the U.S. applicable Product and study design and protocols for Clinical Studies in the Collaboration Territory for such Product; (iv) providing for communication and discussion between the Parties to optimize the efficacy and safety of the Development Plansof such Product in the Collaboration Territory; (v) reviewing and monitoring the activities and progress against the Global Development Plan and any Commercialization Plan; (vi) proposing observational research and any payer and economic value evidence generation plans for inclusion in the Global Development Plan; (vii) reviewing requirements for clinical supplies of the Products in the Collaboration Territory; (viii) communicating with the Parties regarding all of the foregoing; and (ix) making such decisions as are specified in Article III (Development and Regulatory) to be made by the JAC;
(b) As early as necessary in each year beginning with the first full Calendar Year after following operations matters: (i) overseeing supply of the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration applicable Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately Collaboration Territory (in accordance with the Commission. Confidential treatment has been requested applicable Quality Agreement); (ii) reviewing the portion of the [*] Global Development Budget prepared by Amgen for manufacturing activities to be undertaken with respect to Collaboration Activities for such Product in the omitted portions.Collaboration Territory and annual updates (or any other updates) thereto; (iii) reviewing other operational issues relating to the manufacture, quality (based on the quality control data of such Product that Amgen shall provide reasonably in advance of the expected date of filing for Regulatory Approval in the Collaboration Territory) or supply of such Product for the Collaboration Territory and any related devices; (iv) reviewing matters related to the Clinical Studies for the Products in the Collaboration Territory, including inspection and audit findings; and (v) making such decisions as are specified in Article IV (Manufacturing) to be made by the JAC;
(c) Prepare the Development strategy following Commercialization matters: (i) reviewing Amgen’s Global Brand Plan for the applicable Product and develop protocols annual updates (or any other updates) thereto; (ii) reviewing the Commercialization Plan, Commercialization Budget, and Access and Pricing Plan for clinical studies the applicable Product prepared by BeiGene and annual updates (or any other updates) thereto; (iii) establishing a process for reviewing and commenting on Promotional Materials and training materials and programs for each Product for the Collaboration Products for Commercialization Scope; and (iv) making such decisions as are specified in Article V (Commercialization) to be made by the United States;JAC; and
(d) Review overseeing and recommend coordinating other activities described in the definitions of “Development Costs” and “Commercialization and Related Costs,” related to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeTerritory.
Appears in 1 contract
Sources: Collaboration Agreement (Amgen Inc)
Responsibilities. The Joint Development Committee ---------------- USJCC shall perform be responsible for overseeing the conduct and progress of the Co-Commercialization of each Co-Commercialized Licensed Product in the Co-Commercialization Territory. Without limiting the generality of the foregoing, the USJCC shall have the following functionsresponsibilities:
(a) Manage serving as a forum for sharing information of, and oversee discussing each Co-Commercialization Plan for Co-Commercialized Licensed Products in the preparation and implementation of the U.S. Development PlansCo-Commercialization Territory, including amendments thereto;
(b) As early as necessary determining style guidelines and the appearance of Co-Commercialized Licensed Products in each year beginning with the first full Calendar Year after the Effective DateCo-Commercialization Territory, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.including packaging;
(c) Prepare the Development determining managed health care strategy and develop protocols tactics, including Pricing, rebates, discounts and charge-backs for clinical studies for the Collaboration Co-Commercialized Licensed Products for Commercialization in the United StatesCo-Commercialization Territory;
(d) Review and recommend to determining the Joint Steering Committee any material amendments or modifications to appropriate use of medical science liaisons in support of the U.S. Development PlansCo-Commercialized Licensed Products;
(e) Coordinate determining the format and monitor regulatory strategy quantities of promotional sales, marketing and activities educational materials for the Collaboration Products in accordance with Article 9Co-Commercialized Licensed Products;
(f) At each meeting reviewing and approving any proposals for modifications of the Joint Development Committeeexisting Co-Commercialized Licensed Products, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-dateincluding, as current as practicable to a date immediately prior to the date of the meetingwithout limitation, new formulations after First Commercial Sale and line extensions;
(g) Review agreeing upon the design and recommend to implementation of all Co-Commercialized Licensed Product launch activities;
(h) monitoring the Joint Steering Committee "go/noprogress of Co-go" decisions for the Development Commercialization of Collaboration Co-Commercialized Licensed Products in the United StatesCo-Commercialization Territory under the Co-Commercialization Plan and each Party’s activities thereunder;
(i) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Co-Commercialized Licensed Products in the Co-Commercialization Territory;
(j) determining appropriate targets for sales force staffing and territory mapping purposes, determining the appropriate level of Detailing effort to be provided by each Party in Co-Commercializing such Co-Commercialized Licensed Product and coordinating the Detailing efforts of both Parties with respect to Co-Commercialized Licensed Products;
(k) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Commercialized Licensed Products;
(l) receiving and providing to the Parties sales reports pertaining to Co-Commercialized Licensed Products;
(m) approving all Third Parties to be engaged by ARQULE to provide representatives to Co-Commercialize Co-Commercialized Licensed Products, which approval shall be reflected in the minutes of the USJCC;
(n) reviewing and approving Product Promotional Materials related to Co-Commercialized Licensed Products; and
(ho) Have making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee USJCC pursuant to this Agreement or as may be mutually agreed upon by mutual written agreement of the Parties from time to timeduring the Term.
Appears in 1 contract
Sources: License and Co Commercialization Agreement (Arqule Inc)
Responsibilities. The Joint Committee for Development Committee ---------------- shall perform the following functionsmatters will:
(a) Manage and oversee the preparation and implementation provide a forum for discussion of the U.S. objectives and progress of the Research and Development Plansof Collaboration Product Candidates and Collaboration Products by the Partnership Parties in the Field in the Territory and exchange and review scientific information and data relating to such Research and Development activities;
(b) As early submit recommendations to the JSC, as necessary necessary, regarding the advisability of designating a product comprising or employing, in each year beginning with the first full Calendar Year after the Effective Datewhole or in part, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each a Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review Candidate Researched and approval; ** = Certain information on Developed under this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Agreement as an Additional Collaboration Product;
(c) Prepare review, discuss and approve any updates or amendments to the Global Development Plan (including the Development strategy and develop protocols for clinical studies Budget) for the Initial Collaboration Products Product Candidate and Initial Collaboration Product and submit such updates or amendments to the JSC for Commercialization review and discussion and, if unable to reach consensus, submit to the JSC, as necessary, for resolution in the United Statesaccordance with Section 2.8;
(d) Review review, discuss and recommend approve an initial Global Development Plan for any Additional Collaboration Product Candidate or Additional Collaboration Product (including the Development Budget) and any updates or amendments thereto (expected to be made on an annual basis or more frequently as needed), and submit such Global Development Plan, updates or amendments to the Joint Steering Committee any material amendments or modifications JSC for review and discussion and, if the JXC is unable to reach consensus submit to the U.S. Development PlansJSC for resolution in accordance with Section 2.8;
(e) Coordinate and monitor regulatory strategy and activities submit the updated Development Budget for the Collaboration Products in accordance with Article 9[***];
(f) At each meeting of oversee the Joint Development CommitteeProject Team, review a comparison of actual Development Expenses provide clinical and regulatory strategic direction for the United States Collaboration Product Candidates and Collaboration Products to the budgeted Development Expenses for Project Team, and attempt to resolve any matters on which the United States in the U.S. Development Plan for the year-to-date, as current as practicable Project Team is unable to a date immediately prior to the date of the meetingreach consensus;
(g) Review inform and recommend provide guidance to the Joint Steering Committee "go/noJSC, as necessary, regarding any quality or compliance-go" decisions for related risks or pharmacovigilance matters with respect to the Development of the Collaboration Products Product Candidates and Collaboration Products;
(h) allocate responsibilities for the conduct of Clinical Trials under the Global Development Plan to the Partnership Parties;
(i) review and attempt to resolve any disputes regarding the protocol for any Clinical Trial conducted under the Global Development Plan;
(j) review and approve templates of clinical trial agreements, confidential disclosure agreements and other site-facing agreements used in contracting with clinical trial sites for Clinical Trials of Collaboration Products, as well as any material modifications or updates thereto, as set forth in Section 3.1.2(c)(ii);
(k) review and approve statistical analysis plan and team conducting biostatistical analysis pursuant to Section 3.1.2(d);
(l) develop and agree upon the United StatesGlobal Medical Affairs Plan for the Collaboration Products;
(m) advise and consult with any Committee responsible for matters related to clinical Manufacturing in connection with responsibilities of such Committee, as appropriate;
(n) review, discuss and approve any proposed use of a Subcontractor to conduct a Partnership Party’s activities under the Global Development Plan or the Quality Agreement, as set forth in Section 6.1; and
(ho) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to it under this Agreement or as may be mutually agreed upon delegated to it by the Parties from time to timeJSC.
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (CRISPR Therapeutics AG)
Responsibilities. The Joint OSC shall be responsible for setting the overall strategic direction relating to the global Development Committee ---------------- and Commercialization of Licensed Compounds and Products in the Field in the Territory. The specific responsibilities of the OSC shall perform the following functionsbe:
(a) Manage Reviewing and oversee approving the preparation Development Plan and implementation of Development Budget for the United States, and any amendments thereto, submitted by the ODC; provided, further, the OSC shall approve the designation of, or designate, as applicable, those Development Costs which are U.S. Development PlansCosts;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective DateReviewing, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare but not approving, the Development strategy Plan and develop protocols Development Budget for clinical studies for countries in the Collaboration Products for Commercialization in Territory other than the United States;
(c) If Amylin exercises the Co-Commercialization Option, reviewing and approving the Commercialization Plan for the United States and any amendments thereto submitted by the OCC;
(d) Review If Amylin does not exercise, or has not yet exercised, the Co-Commercialization Option, reviewing, but not approving, the Commercialization Plan for the United States and recommend to any amendments thereto submitted by the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;OCC.
(e) Coordinate Reviewing, but not approving, the Commercialization Plan for countries in the Territory other than the United States, and monitor regulatory strategy and activities for any amendments thereto submitted by the Collaboration Products in accordance with Article 9;OCC.
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States Establishing such joint teams and subcommittees as it deems necessary to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingfulfill this Agreement;
(g) Review and recommend Resolving any disputes among such joint teams or subcommittees, including the ODC, subject to the Joint Steering Committee "go/no-go" decisions terms of this Agreement;
(h) Developing and implementing reporting mechanisms for the Development of Collaboration Products in the United StatesODC and OCC; and
(hi) Have Approving and/or deciding such other responsibilities matters as may be assigned provided elsewhere in this Agreement. The OSC shall periodically, but no less than [***], review the results of the Development Plan and Commercialization Plan with respect to Products in the Field in the Territory to ensure, to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by extent reasonably practical, that the Parties from time are meeting their commitments for both human and financial support and are each fulfilling all of their respective contractual obligations. The OSC shall resolve any disputes referred to timeit in accordance with Section 2.1.4 below.
Appears in 1 contract
Sources: License, Development and Commercialization Agreement (Amylin Pharmaceuticals Inc)
Responsibilities. The Joint Development Commercialization Committee ---------------- shall perform have the following functions:
responsibilities: 33 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. (a) Manage establishing the strategy for the Commercialization of Licensed Products in the Field in North America; (b) developing and oversee approving the preparation Commercialization Plan/Budget in accordance with Section 2.5, as well as updating the Commercialization Plan/Budget and amending the Commercialization Plan/Budget from time to time as appropriate; (c) subject to the specific terms and conditions hereof, allocating responsibilities under the Commercialization Plan/Budget to the Parties in accordance with the Parties’ abilities to perform such activities in the most efficient and cost effective manner; (d) overseeing the implementation of the U.S. Development Plans;
(b) As early as necessary in each year beginning with strategy for Commercializing the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Licensed Products for Commercialization in the United States;
Field in North America (d) Review including strategies related to regulatory approvals, reimbursement, advertising and recommend to promotion, brand integrity, sales, and launch sequence as set forth in the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
Commercialization Plan/Budget); (e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(g) Review and recommend to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned providing input to the Joint Development Committee pursuant regarding the target product profile for the Licensed Products and making recommendations regarding changes to the same; (f) approving the licensing of Third Party technology, as described in Section 5.6.3(d); (g) reviewing the Parties’ marketing and promotional activities in North America to ensure that such activities are consistent with the Commercialization Plan/Budget; and (h) performing such other activities as are contemplated under this Agreement or as may be mutually agreed upon by and that the Parties from time to timemutually agree shall be the responsibility of the Joint Commercialization Committee.
Appears in 1 contract
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJMC will:
(a) Manage consistent with the provisions of Section 6.2, designate the team leader and oversee the preparation and implementation other members of the U.S. Development PlansManufacturing Working Group, which team leader and members shall be chosen from among the personnel of the Parties having relevant experience, and allocate the respective roles on the Manufacturing Working Group among such members;
(b) As early as review on a periodic basis and make any necessary changes to the team leader and other members of the Manufacturing Working Group, or the allocation of roles among such members;
(c) oversee the Manufacturing Working Group, in each year beginning consultation with the first full Calendar Year after JDC, with respect to matters relating to the Effective Datepre-clinical or clinical Manufacture of the Products;
(d) oversee the Manufacturing Working Group, update and amend in consultation with the initial U.S. Development Plans and prepare JCC, with respect to matters relating to the U.S. Development Plans for each Collaboration Product commercial Manufacture of the Products;
(e) oversee the Manufacturing Working Group, in consultation with the JDC, with respect to Manufacturing quality matters for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than Products; [** of such year for review and approval; ** *] = Certain confidential information on contained in this page document, marked by brackets, has been omitted and filed separately with the CommissionSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested Table of Contents
(f) oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the omitted portions.
(c) Prepare review of the Development strategy results of regulatory and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review environmental, health and recommend safety inspections and audits related to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting Manufacture of the Joint Development Committee, Products and the review a comparison and discussion of actual Development Expenses for the United States steps taken by CRISPR to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingaddress any deficiencies noted;
(g) Review and recommend to oversee the Joint Steering Committee "go/no-go" decisions for Manufacture of the Development of Collaboration Products in the United StatesField in the Territory, in consultation with the JDC or JCC, as applicable;
(h) allocate responsibilities for Manufacturing activities with respect to the Products in the Field in the Territory between the Parties;
(i) review, discuss and approve, in consultation with the JDC or the JCC, as applicable, the initial Global Manufacturing Plan, including the Manufacturing Budget, and any updates or amendments thereto proposed by the Manufacturing Working Group, and submit such Global Manufacturing Plan, updates or amendments to the JSC for review and discussion;
(j) submit the approved updated Manufacturing Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no later than [***] of each Calendar Year;
(k) review, discuss and approve the Manufacturing process for each Shared Product proposed by the Manufacturing Working Group, and review, discuss and approve any changes to such Manufacturing process proposed by the Manufacturing Working Group, in each case, in consultation with the JDC or JCC, as applicable;
(l) review, discuss and approve any recommendations of the Manufacturing Working Group regarding capacity planning, supply plans and supply continuity planning for the Products;
(m) select and approve each CMO and contract testing facility to be engaged with respect to each phase of the Manufacture of any Product [***];
(n) determine whether any Manufacturing technology transfer between the Parties is necessary;
(o) review, discuss and approve any proposed use of a Subcontractor to conduct a Party’s activities under the Global Manufacturing Plan, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(hp) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to JMC under this Agreement or as may be mutually agreed upon delegated to the JMC by the Parties from time JSC. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to time.Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)
Responsibilities. The Joint Development Commercialization Committee ---------------- shall perform be responsible for the following functionswith respect to all Joint DDCs and Joint Products:
(a) Manage and oversee the preparation and implementation maintaining global oversight of the U.S. Development PlansCommercialization process for all Joint DDCs and Joint Products;
(b) As early as necessary in each year beginning with appointing a global new product pre-launch team at or prior to the first full Calendar Year after commencement of Phase IIIA Studies for such Joint DDC (a "Global New Product Pre-Launch Team"), which shall be responsible for the Effective Datepreparation of the Global Commercialization Framework, update pursuant to Section 7.2.1, for such Joint DDC and amend the initial U.S. Development Plans and prepare transition of such Global Commercialization Framework to the U.S. Development Plans for each Collaboration Joint Commercialization Product for Team and the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.ROW Commercialization Product Team;
(c) Prepare reviewing and approving the Development strategy Global Commercialization Framework for each Joint DDC and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesJoint Product;
(d) Review appointing a joint commercialization product team comprised of an equal number of representatives designated by each of ▇▇▇▇▇▇ and recommend Millennium to the Joint Steering Committee any material amendments or modifications to prepare and implement the U.S. Development PlansCommercialization Plan and prepare the U.S. Commercialization Budget for each Joint DDC and Joint Product in the United States (each a "U.S. Joint Commercialization Product Team") and reviewing recommendations from and advising all U.S. Joint Commercialization Product Teams;
(e) Coordinate approving the appointment by ▇▇▇▇▇▇ of a commercialization product team comprised of representatives designated by ▇▇▇▇▇▇ to prepare and monitor regulatory strategy implement the ROW Commercialization Plan and activities prepare the ROW Commercialization Budget for the Collaboration Products each Joint DDC and/or Joint Product in accordance with Article 9ROW (each a "ROW Commercialization Product Team") and reviewing recommendations from and advising all ROW Commercialization Product Teams;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in reviewing and approving the U.S. Development Commercialization Plan and the ROW Commercialization Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingeach Joint DDC and Joint Product;
(g) Review reviewing and recommend approving the U.S. Commercialization Budget and the ROW Commercialization Budget for each Joint DDC and Joint Product, setting permitted deviations therefrom that do not require an amendment to the Joint Steering Committee "go/no-go" decisions budget, and determining the geographic breakdown for the Development ROW Commercialization Budget;
(h) overseeing the implementation of Collaboration the Commercialization Plans for all Joint DDCs and Joint Products;
(i) monitoring the Parties' compliance with the requirements of the Commercialization Plans;
(j) monitoring the allocation of Commercialization strategic activities between the Parties across all of the Joint Products in the United StatesStates to ensure that such allocation is consistent with the provisions of Sections 7.3 and 7.4;
(k) establishing Co-Promotion Guidelines, if applicable, pursuant to Section 7.6;
(l) developing recommendations with the Joint Manufacturing Committee regarding the manufacturing and supply chain strategy for a Joint DDC and Joint Product, including, without limitation, which Party (or Third Party) shall be responsible for specific activities within the supply chain;
(m) developing procedures regarding the collection, sharing and reporting of adverse information related to such Joint Product on a global basis;
(n) making recommendations to the Joint Executive Committee with respect to any appropriate actions to be taken concerning adverse event information under any Commercialization Plan;
(o) performing duties with respect to Program Diagnostics pursuant to Article 5;
(p) overseeing the preparation of, and approving, protocols for, and otherwise overseeing and monitoring Phase IV Studies under the Commercialization Program; and
(hq) Have performing such other tasks and undertaking such other responsibilities as may be assigned to the Joint Development Committee pursuant to set forth in this Agreement or as may be mutually agreed upon by the Parties from time to timeAgreement.
Appears in 1 contract
Sources: Collaboration and License Agreement (Millennium Pharmaceuticals Inc)
Responsibilities. The Joint Development Committee ---------------- shall perform the following functionsJDC will:
(a) Manage and oversee the preparation and implementation Development of the U.S. Development PlansShared Products and the Research strategy for the Follow-On Products by the Parties in the Field in the Territory;
(b) As early as necessary in each year beginning with review, discuss and approve the first full initial Global Development Plan (including the Development Budget) and any updates or amendments thereto proposed by the Project Team, and submit such Global Development Plan, updates or amendments to the JSC for review and discussion;
(c) submit the approved updated Development Budget for the subsequent Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee JSC for inclusion in the Integrated Budget no later than [** **] of such year each Calendar Year;
(d) oversee the Project Team and attempt to resolve any matters on which the Project Team is unable to reach consensus;
(e) review, discuss and approve clinical and regulatory strategic options for the Shared Products as proposed by the Project Team;
(f) review, discuss and approve the first IND for the Initial Shared Product to be submitted to the applicable Regulatory Authorities in accordance with Section 3.3.1(c);
(g) review and approvalconsult with the JRC regarding the initial Follow-On Research Plan and any updates or amendments thereto proposed by the JRC;
(h) inform and provide guidance to the JSC regarding any quality or compliance-related risks with respect to the Development of the Products;
(i) provide guidance to the Project Team with respect to pre-clinical and clinical quality matters for the Products; [** **] = Certain confidential information on contained in this page document, marked by brackets, has been omitted and filed separately with the CommissionSecurities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested Table of Contents
(j) review, discuss and approve regulatory activities for the Shared Products proposed by the Project Team, including determining the strategy with respect to each material Regulatory Filing or material regulatory interaction with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesShared Products;
(dk) Review and recommend allocate responsibilities for the conduct of Clinical Trials under the Global Development Plan to the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansParties, which allocation will be consistent with Section 3.2 and Section 3.3.2;
(el) Coordinate review, discuss and monitor regulatory strategy and activities for approve changes to the Collaboration Products Project Team membership in accordance with Article 9Section 3.2;
(fm) At each meeting of review and attempt to resolve any disputes regarding the Joint protocol or statistical analysis plan for any Clinical Trial conducted under the Global Development Committee, review a comparison of actual Development Expenses for the United States Plan;
(n) provide guidance to the budgeted Development Expenses for JSC regarding the United States in advisability of designating a Follow-On Product as a Shared Product under this Agreement;
(o) develop and agree upon the U.S. Development Medical Affairs Plan for the year-to-date, as current as practicable Shared Products and determine the number of MSLs to a date immediately prior to be deployed in each jurisdiction in the date of the meetingTerritory;
(gp) Review and recommend consult with the JMC in connection with its oversight of the Manufacturing Working Group with respect to matters relating to the Joint Steering Committee "go/nopre-go" decisions for clinical or clinical Manufacture of the Development Products;
(q) consult with the JMC in connection with its oversight of Collaboration the pre-clinical and clinical Manufacture of the Products in the United StatesField in the Territory;
(r) consult with the JMC in connection with its review and discussion of any updates to the Global Manufacturing Plan, including the Manufacturing Budget, proposed by the Manufacturing Working Group;
(s) consult with the JMC in connection with its review, discussion and approval of the Manufacturing process, and any changes thereto, for each Shared Product;
(t) consult with the JMC and the Manufacturing Working Group in connection with their review of Manufacturing quality matters for the Products and its oversight of Manufacturing quality matters set forth in the Quality Agreement;
(u) consult with the JMC in connection with its review of the results of regulatory and environmental, health and safety inspections and audits related to the Manufacture of the Products and its review and discussions of steps taken by CRISPR to address any deficiencies noted; [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents
(v) review, discuss and approve any proposed use of a Subcontractor to conduct a Party’s activities under the Global Development Plan or the Quality Agreement, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(hw) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Development Committee pursuant to JDC under this Agreement or as may be mutually agreed upon delegated to the JDC by the Parties from time to timeJSC.
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)
Responsibilities. The Joint JDC shall be responsible for overseeing the conduct and progress of the Development Committee ---------------- Program and the Development of Products in the U.S. Territory. For purposes of clarity, where this Agreement provides for the JDC to have oversight over any Development applicable to the U.S. Territory, but not conducted in the U.S. Territory, such oversight shall perform be solely limited to the conduct of the Ongoing Clinical Trial or any other Clinical Trial in the ROW Territory intended to support registration in the U.S. Territory. The JDC shall have the following functionsresponsibilities:
(a) Manage and oversee preparing, or directing the preparation and implementation by the Parties of, that portion of each Global Development Plan applicable to the Development of Products in the U.S. Development PlansTerritory, including the budget with respect thereto;
(b) As early as necessary in preparing, or directing the preparation by the Parties of, each year beginning with amendment to any Global Development Plan for the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare of Products applicable to the U.S. Territory or the budget with respect thereto;
(c) monitoring the progress of the Development Plans for Program under each Collaboration Product Global Development Plan for the following Calendar Year so that it can submit such proposed U.S. Development Plans of Products applicable to the Joint Steering Committee no later than ** U.S. Territory and of such year for review and approvaleach Party’s activities thereunder; ** = Certain information on Portions of this page has been Exhibit were omitted and have been filed separately with the Commission. Confidential Secretary of the Commission pursuant to the Company’s application requesting confidential treatment has been requested under Rule 24b-2 of the Securities Exchange Act of 1934.
(d) providing a forum for consensual decision making with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration of Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications applicable to the U.S. Development PlansTerritory;
(e) Coordinate reviewing and monitor regulatory strategy and activities for circulating to the Collaboration Products in accordance Parties data, reports or other information submitted by either Party with Article 9respect to work conducted under the Development Program;
(f) At each meeting overseeing the conduct of Clinical Trials for the Development of Products applicable to the U.S. Territory, including without limitation the conduct of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingOngoing Clinical Trial;
(g) Review and recommend to allocating responsibility between the Joint Steering Committee "go/no-go" decisions Parties for the Development of Collaboration Products in Products, including responsibility for the United States; andconduct of Clinical Trials for [***], assigning activities and tasks and allocating FTEs between the Parties;
(h) Have reviewing and [***] any material agreement entered into by a Party with a Third Party pursuant to Section 8.2.1 related to Development (except for [***]) applicable to the U.S. Territory;
(i) in conjunction with the JCC, approving the overall strategy for publications and presentations in support of Products in the U.S. Territory as determined by the Publication Committee;
(j) making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee JDC pursuant to this Agreement or as may be mutually agreed upon by the JSC or by mutual written agreement of the Parties from time during the Term;
(k) establishing [***] applicable to timeDevelopment of the Products in the U.S. Territory as described in Section 3.1.3(c);
(l) in conjunction with the JCC, reviewing and approving any proposals for [***] of existing Co-Commercialized Products, including, without limitation, [***] and [***];
(m) reconciling issues between the Parties with respect to the Parties’ respective share of Development Costs with respect to Products;
(n) subject to Sections 12.4.1 and 12.5.2, reviewing adherence of the Development of Product applicable to the U.S. Territory to GSK Internal Policies;
(o) designing (i) the protocol for the [***] Study, (ii) the protocols for the [***](s), and (iii) the protocol for the [***];
(p) establishing the [***] thereof;
(q) discussing the program for [***] conducted by SYNTA to [***] of STA-4783 as described in Section [***] and reviewing the results thereof; Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
(r) establishing any sub-committees or teams as deemed necessary; and
(s) resolving any other disputes raised to the JDC.
Appears in 1 contract
Sources: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)
Responsibilities. The Joint Development Committee ---------------- shall perform JSC may discharge its responsibilities through one or more subcommittees. The JSC’s responsibilities will include, without limitation, the following functions:following:
(a) Manage and oversee the preparation and overseeing implementation of the U.S. Development Plans;Plan;
(b) As early as necessary in each year beginning reviewing and evaluating progress under the Development Plan (including compliance with the first full Calendar Year after Development Budget contained therein and payment arrangements) on a quarterly basis and advising the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans Parties as to the Joint Steering Committee no later than ** of such year for review and approvalany necessary amendments thereto; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare allocating and assigning Development activities in the Development strategy and develop protocols for clinical studies for Plan between the Collaboration Products for Commercialization in Parties, consistent with the United States;terms of this Agreement;
(d) Review approving (or establishing procedures to approve) protocols for pre-clinical studies and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Clinical Trials for Development Plansof Collaboration Products;
(e) Coordinate making modifications to and monitor regulatory strategy performing quarterly monitoring of progress of pre-clinical studies and activities Clinical Trials and proposing additional studies for the Collaboration Products in accordance with Article 9;Products;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States reviewing and approving any proposed modifications to the budgeted Development Expenses for Plan, including advising the United States Parties as to whether a Back-Up Compound should be developed in the U.S. Development Plan for the year-to-date, as current as practicable to lieu of a date immediately prior to the date of the meeting;Collaboration Compound;
(g) Review coordinating the Manufacture of global supplies of a Collaboration Compound and recommend to the Joint Steering Committee "go/no-go" decisions Collaboration Product for the Development of Collaboration Products in the United States(i) Clinical Trials and (ii) Commercialization; and
(h) Have such other responsibilities as may reviewing and commenting on Regulatory Submissions relating to Collaboration Products;
(i) facilitating the exchange of all data, information, material or results relating to Development of Collaboration Products;
(j) establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the Pharmacovigilance Agreement to be assigned to entered into in accordance with Section 4.3.5;
(k) facilitating the Joint Development Committee transfer of Know-How pursuant to this Agreement;
(l) developing a strategy for performing Translational Research Activities and Developing a Diagnostic Product, as necessary, under the Development Plan and overseeing implementation of any such strategy;
(m) establishing and overseeing implementation of the Commercialization Plan;
(n) performing such other activities as are contemplated under this Agreement or as may be mutually agreed upon by and that the Parties from time mutually agree shall be the responsibility of the Joint Steering Committee. Notwithstanding the foregoing, in no event shall the JSC or any subcommittee of the JSC have the authority to time(i) reduce or expand the obligations of the Parties under this Agreement; (ii) determine that a breach has occurred under this Agreement; (iii) waive a Party’s rights or obligations under this Agreement; or (iv) make any decision that is specified elsewhere in this Agreement as being made by one or both Parties.
Appears in 1 contract
Sources: License and Collaboration Agreement (Hutchison China MediTech LTD)
Responsibilities. The Joint Development Committee ---------------- JCC shall perform be responsible for overseeing the conduct and progress of the SYNTA Co-Commercialization Activities and GSK Co-Commercialization Activities for each Co-Commercialized Product in the Co-Commercialization Territory. Without limiting the generality of the foregoing, the JCC shall have the following functionsresponsibilities:
(a) Manage and oversee preparing, or directing the preparation and implementation of by the U.S. Development PlansParties of, each Product Co-Commercialization Plan for Co-Commercialized Products in the Co-Commercialization Territory, including the budgets with respect thereto;
(b) As early as necessary preparing, or directing the preparation by the Parties of, each amendment to any Product Co-Commercialization Plan for Co-Commercialized Products in each year beginning with the first full Calendar Year after Co-Commercialization Territory or the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested related budget with respect to the omitted portions.thereto;
(c) Prepare the Development strategy reviewing and develop protocols approving [***] matters for clinical studies for the Collaboration Co-Commercialized Products for Commercialization in the United StatesCo-Commercialization Territory;
(d) Review reviewing and recommend to approving [***] matters for Co-Commercialized Products in the Joint Steering Committee any material amendments or modifications to the U.S. Development PlansCo-Commercialization Territory, including Co-Commercialization Trademarks;
(e) Coordinate reviewing and monitor regulatory strategy and activities for the Collaboration approving [***] of Co-Commercialized Products in accordance the Co-Commercialization Territory, including [***]; Portions of this Exhibit were omitted and have been filed separately with Article 9;the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
(f) At each meeting of the Joint Development Committeereviewing and approving [***], review a comparison of actual Development Expenses including [***] for the United States to the budgeted Development Expenses for the United States Co-Commercialized Products in the U.S. Development Plan for the yearCo-to-date, as current as practicable to a date immediately prior to the date of the meetingCommercialization Territory;
(g) Review and recommend to determining the Joint Steering Committee "go/noappropriate use of [***] in support of the Co-go" decisions for the Development of Collaboration Products in the United States; andCommercialized Products;
(h) Have determining the format and quantities of promotional sales, marketing and educational materials for the Co-Commercialized Products;
(i) in conjunction with the JDC, reviewing and approving any proposals for [***] of existing Co-Commercialized Products, including, without limitation, [***] after First Commercial Sale and [***];
(j) agreeing upon the design and implementation of all Co-Commercialized Product [***] activities;
(k) monitoring the progress of Commercialization of Co-Commercialized Products in the Co-Commercialization Territory under each Product Co-Commercialization Plan and of each Party’s activities thereunder;
(l) reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the Commercialization of Co-Commercialized Products in the Co-Commercialization Territory;
(m) reconciling issues between the Parties with respect to the Parties’ respective share of Operating Income (Loss) with respect to Co-Commercialized Products in the Co-Commercialization Territory;
(n) preparing or directing the preparation by the Parties of short-term and long-term sales forecasts for Co-Commercialized Products;
(o) determining appropriate targets for sales force staffing and territory mapping purposes, determining the appropriate level for, and allocation of Promotional Efforts to, each Party and coordinating the conduct of Promotional Efforts and sales training of both Parties with respect to Co-Commercialized Products;
(p) overseeing all recalls, market withdrawals and any other corrective actions agreed to by the Parties related to Co-Commercialized Products;
(q) receiving and providing to the Parties sales reports pertaining to Co-Commercialized Products;
(r) subject to Sections 12.4.1 and 12.5.2, monitoring compliance of marketing activities throughout the U.S. Territory with Applicable Laws and GSK Internal Policies, and the corporate governance codes and policies of SYNTA to the extent they do not conflict with GSK Internal Policies and Applicable Laws; Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
(s) reviewing and approving the Commercialization Transition Plan;
(t) in conjunction with the JDC, approving the overall strategy for [***] in support of Products in the U.S. Territory as determined by the Publication Committee;
(u) making such other responsibilities decisions as may be assigned delegated to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the JSC or by mutual written agreement of the Parties from time during the Term;
(v) establishing any subcommittees or teams as deemed necessary; and
(w) resolving any other disputes raised to timethe JCC.
Appears in 1 contract
Sources: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)
Responsibilities. The Joint Development In addition to the matters provided for under the Ex-US Agreement, the Steering Committee ---------------- shall perform have the following functionsroles and responsibilities in relation to the Territory:
(ai) Manage review and oversee approve any material amendments to the preparation Development Plan (subject to Section 3.3(d)). Any proposed material amendment to the Development Plan, including arguments to support such amendment, shall be made available to the Steering Committee with reasonable advance notice and implementation at least five (5) Business Days ahead of the U.S. Development Plansscheduled meeting;
(bii) As early as necessary provide reasonably detailed updates, data and other information regarding Protalix’s progress in each year beginning Developing the Licensed Product in the Field;
(iii) provide updates in respect of any New Use in accordance with Section 2.5 of the first full Calendar Year after Ex-U.S. Agreement;
(iv) discuss the Effective Date, update and amend timing of transferring any regulatory filings in the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested Territory with respect to the omitted portions.
(c) Prepare Compound, Drug Substance, Drug Product or Licensed Product from Protalix to Chiesi in accordance with the Development strategy terms of Section 3.6(c), and develop protocols discuss and agree upon appropriate timelines for, and the responsibilities of each Party in respect of, preparing any regulatory filings for clinical studies obtaining Regulatory Approval in the Territory. As part of such discussions, the Steering Committee shall discuss and agree on appropriate timelines and processes for the Collaboration Products for Commercialization orderly transfer of all medical affairs functions from Protalix to Chiesi in the United Statesaccordance with Section 3.6(d)(iv);
(dv) Review act as a forum pursuant to which the Parties will review and recommend discuss plans and strategies relating to (x) the Development of the Licensed Product in the Field, (y) regulatory matters with respect to the Joint Steering Committee any material amendments or modifications Licensed Product in the Field in the Territory, and (z) Commercialization of the Licensed Product in the Field in the Territory to the U.S. Development Plansensure aligned communication at medical congresses and other scientific events as well as scientific publication plans;
(evi) Coordinate and monitor modify the division of regulatory strategy and activities for responsibilities as between the Collaboration Products Parties in accordance with Article 9Section 3.6(d)(v);
(fvii) At each meeting subject to the terms of the Joint Development CommitteeSection 8.5, review a comparison and/or approval of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingeach Party’s scientific publication plans;
(gviii) Review oversee any Early Access Programs for the Licensed Product in the Field in the Territory;
(ix) review and recommend agree upon the final version of the Initial Commercialization Plan, in accordance with Section 3.7(a), and review and provide comment upon any proposed revisions to, or any subsequent versions of, the Commercialization Plan (such comments to be considered in good faith by Chiesi);
(x) subject to Section 4.8(c), review and in good faith seek to resolve any disputes regarding any Notice of Non-Conformance issued in respect of a shipment of Drug Substance or Drug Product under the terms of this Agreement;
(xi) subject to Section 7.6(a), discuss any pertinent Third Party Patent Rights and decide upon whether a license to or acquisition of such Third Party Patent Rights or Technology is appropriate;
(xii) in the event the Ex-US Agreement expires or is terminated, discuss the possibility, from time to time, of sharing Licensed Product positioning and promotional materials for the Licensed Product in the Field, inside and outside the Territory;
(xiii) define the manner and timelines for Chiesi’s access to sites and records of the Ongoing Clinical Studies and [***] conducted by Protalix;
(xiv) appoint the Referent Persons in accordance with Section 8.5;
(xv) establish, if deemed necessary, the creation of a Joint Project Team (“JPT”) to oversee operations or activities. The composition of the JPT will be decided by the Steering Committee according to the Joint Steering Committee "go/notype of activity and decision making in accordance with Section 3.3(d). The JPT shall be comprised of representatives from each Party with appropriate competence and level of decision-go" decisions for making authority. The JPT shall meet with a frequency to be agreed on by the Development of Collaboration Products in the United StatesParties; and
(hxvi) Have such other roles and responsibilities provided for in this Agreement or as may be assigned to the Joint Development Steering Committee pursuant to this Agreement or as may be mutually agreed upon in writing by mutual agreement of the Parties from time to timeParties.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Protalix BioTherapeutics, Inc.)
Responsibilities. The Joint Development Committee ---------------- shall perform the Within [ * ] following functions:
(a) Manage and oversee the preparation and implementation of the U.S. Development Plans;
(b) As early as necessary in each year beginning with the first full Calendar Year after the Effective Date, update and amend the initial U.S. Parties shall establish a Joint Development Plans and prepare Committee (the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans “JDC”) to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested facilitate discussion with respect to the omitted portions.
(c) Prepare Development of the Development strategy RC48 Licensed Product and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Opt-In Products in accordance with Article 9this Agreement. The JDC will be composed of an equal number of [ * ] from each Party who have direct knowledge and expertise in the Development of products similar to the RC48 Licensed Product. The JDC shall with respect to the RC48 Licensed Product and Opt-in Products:
(i) provide a forum for reviewing and discussing (but, for clarity, not approving) each Party’s Development Plan (and updates or amendments thereto) and receiving the other Party’s comments thereon;
(fii) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses and discuss proposals for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingNew Clinical Trials;
(giii) Review review, and recommend make recommendations to the Joint Steering Committee "go/noJSC regarding, the initial plan for a Collaborative Global Trial (to be included in the Global Development Plan), and any amendments or updates to the Global Development Plan); [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
(iv) review and discuss any interim or final data arising from the permitted Development of the RC48 Licensed Product or any Opt-go" decisions In Product by each Party;
(v) for each New Licensed Product for which Seagen has provided written notice to RemeGen pursuant to Section 2.11(a), review and discuss material data arising from the clinical Development of each such New Licensed Product prior to RemeGen’s exercise of an Opt-In Right for such New Licensed Product;
(vi) provide a forum for discussing the Parties’ respective publication plans and strategies for the Development RC48 Licensed Product and Opt-In Products;
(vii) develop any Technology Transfer Plan, and discuss any proposed amendments or revisions thereto;
(viii) oversee each RemeGen Technology Transfer, Seagen Technology Transfer and Seagen RC48 Technology Transfer;
(ix) oversee, together with the JCMC, any transfers of Collaboration manufacturing Know-How in accordance with Article 6;
(x) develop a procedure for the secure transmission of data to be exchanged between the Parties hereunder;
(xi) coordinate with the JCMC regarding manufacture of the RC48 Licensed Product and Opt-In Products in connection with Development activities;
(xii) facilitate the United Statesflow of information between the Parties with respect to the manufacture of the RC48 Licensed Product and Opt-in Products and coordinate with the JSC as appropriate; and
(hxiii) Have perform such other responsibilities functions as may be assigned to the Joint Development Committee pursuant to expressly set forth in this Agreement or as the JSC may be mutually agreed upon by the Parties request from time to time.
Appears in 1 contract
Sources: License Agreement (Seagen Inc.)
Responsibilities. The Joint Development Committee ---------------- shall perform responsibilities of the following functionsALT include the following:
(a) Manage provide strategic guidance and oversee leadership to the preparation and implementation of the U.S. Development PlansParticipants;
(b) As early as necessary in each year beginning with create and project the first full Calendar Year after the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Project vision;
(c) Prepare empower and support the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesAMT;
(d) Review establish and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plansmaintain a strong performance orientation by championing and recognising outstanding results in all Alliance Objectives;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9support outstanding performance;
(f) At each meeting of set the Joint Development Committee, review a comparison of actual Development Expenses example for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meetingalliance behaviour;
(g) Review ensure corporate management support;
(h) ensure that each Participant contributes its best available personnel and recommend other resources to the Joint Steering Committee "go/noProject;
(i) use best endeavours to ensure that the Participants comply with this Agreement;
(j) co-go" decisions ordinate and monitor the performance of the Participants to ensure that:
(i) the terms and conditions of this Agreement are complied with;
(ii) the Alliance Works are carried out in accordance with this Agreement;
(iii) the Participants, the Alliance Project Manager and the AMT adhere to the Alliance Objectives and the Alliance Principles;
(k) ensure that the Alliance Manager has clear objectives, responsibilities and delegated authority to lead the AMT;
(l) establish the AMT including the appointment of the AMT members, after appropriate consultation with the Participants;
(m) ensure implementation of effective and efficient systems and controls;
(n) set, review and revise limits of delegated authority, as appropriate;
(o) monitor the health and performance of the Project;
(p) endorsing the AMP and any subsequent modifications to it;
(q) review and, where the ALT determines it to be necessary, approve appropriate supplements to the insurances set out in clause 15 of this Agreement;
(r) ensure that appropriate controls, delegations, systems and procedures are embodied within the detailed plans which comprise the AMP and that the requirements of each plan are adhered to;
(s) monitor the performance of the Alliance Manager and the AMT and implement appropriate measures (including corrective actions based on the Alliance Objectives and the Alliance Principles) to correct undesirable trends;
(t) monitor the suitability of the Commercial Framework to achieve the Alliance Objectives and the consistency of it with the principles of the Commercial Framework, and make adjustments where necessary;
(u) review and, if appropriate, approve proposed performance targets (both cost and non-cost) for the Development Project;
(v) review and, if appropriate, approve any Target Adjustment Event;
(w) deal with any Disagreements between Participants;
(x) initiate and/or approve the commitment of Collaboration Products resources to carry out the Alliance Activities and provide corporate support where necessary;
(y) report progress and performance of the Alliance Works to senior management of the Participants;
(z) implement any Directions received from TIDC in the United Statesrelation to any TIDC Reserved Power; and
(haa) Have discharge such other responsibilities as may be assigned to functions of the Joint Development Committee pursuant to ALT set out in this Agreement or as may be mutually agreed upon by the Parties from time to timeAgreement.
Appears in 1 contract
Sources: Project Alliance Agreement
Responsibilities. The Joint Development Committee ---------------- JCC shall perform the following functions:
(ai) Manage review and approve the annual Marketing Plan developed by Endo;
(ii) oversee the preparation and implementation of the U.S. Development PlansMarketing Plans and approve modifications to the Marketing Plan throughout the year;
(biii) As early as necessary in each year beginning with discuss the first full Calendar Year after state of the Effective Date, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product markets for the following Calendar Year so that it can submit such proposed U.S. Development Plans to the Joint Steering Committee no later than ** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization Product in the United StatesTerritory and opportunities and issues concerning the Commercialization of the Product, including consideration of marketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues;
(div) Review if applicable under Sections 5.5 and recommend to 5.8, oversee and coordinate the Joint Steering Committee any material amendments or modifications to the U.S. Development Planssales efforts of Endo and DURECT;
(ev) Coordinate review and monitor regulatory approve the Post-Registration Plan, taking into consideration the appropriateness of any development activities including line extensions, clinical trials for purposes of new indications and Phase IV clinical trials in the context of the overall marketing and promotional strategy and activities for the Collaboration Products Product;
(vi) review and direct all indigent care use of the Product;
(vii) review and approve Sales Projections in accordance with Article 9Section 6.3;
(fviii) At review, in consultation with the JMC, the efficacy of the forecasting procedure set forth in Section 8.3, including whether any modifications thereto are necessary following the second anniversary of the First Commercial Sale;
(ix) review data and reports arising from and generated in connection with the Commercialization of the Product, Finished Product and Implanter, including the Marketing Plan, Marketing Budgets, market research studies, and Product, Finished Product and Implanter sales and prescription trends and sales forecasts;
(x) at each meeting of the Joint Development CommitteeJCC, review a comparison of actual Development Expenses for the United States sales and marketing expenses to the budgeted Development Expenses for the United States expenses in the U.S. Development Plan relevant Marketing Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(gxi) Review at least once each calendar year by a date no later than ***, review and recommend approve the Marketing Plan as updated by Endo;
(xii) review and approve the general guidelines applicable to the Joint Steering Committee "go/no-go" decisions Product to be followed by Endo in its development of promotional materials and promotional activities to be used by Endo in the promotion of the Product, Finished Product and Implanter (such guidelines to be consistent with the then current Marketing Plan applicable to the Product);
(xiii) evaluate and approve use of any technical support representatives;
(xiv) review and direct the publication strategy, in consultation with the PDC;
(xv) in consultation with the PDC, review and approve the Specifications for the Development Finished Product, including the packaging and related materials, prior to Commercial use;
(xvi) develop appropriate procedures, pursuant to Section 8.13 and in consultation with the JMC, regarding the manufacture and sale of Collaboration Products in Implanters;
(xvii) review and, if appropriate, approve the United Statessupplemental call plan, if any, submitted by DURECT pursuant to Section 5.8;
(xviii) evaluate and determine whether to market and sell an Implant Kit; and
(hxix) Have have such other responsibilities as may be assigned to the Joint Development Committee JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.
Appears in 1 contract
Sources: License Agreement (Endo Pharmaceuticals Holdings Inc)
Responsibilities. Subject to the terms and conditions hereof, the Steering Committee shall have ultimate supervisory authority over the Collaboration. The Joint Development Steering Committee ---------------- shall perform have the following functionsresponsibilities:
(a) Manage and oversee the preparation and implementation Approving of the U.S. Development PlansAnnual Workplans proposed by the Research Committee pursuant to Section 2.2.2.3 (with or without modifications);
(b) As early as necessary in each year beginning Overseeing, through updates from and discussions with the first full Calendar Year after Research Committee, the Effective Dateestablishment of infrastructure and procedures for facilitating efficient communication between the parties, update as described in Section 2.2.2.3(b), and amend making decisions on matters escalated by the initial U.S. Development Plans Research Committee relating to such matters;
(c) Monitoring and prepare overseeing activities performed under the U.S. Development Plans for each Collaboration, including reviewing and discussing all reports, notices and other materials relating to the Collaboration Product delivered by the Research Committee to the Steering Committee hereunder;
(d) Discussing and deciding on revisions or expansions to the Workplan proposed by the Research Committee pursuant to Section 2.2.2.3(e)(ii) or recommended by the Research Committee pursuant to Section 3.2, including suggesting and deciding on changes to such recommended amendments or modifications. Any amendments or modifications the Workplan approved by the Steering Committee shall be incorporated into the Workplan by reference; it being understood however, for the following Calendar Year so avoidance of doubt, that it can submit such proposed U.S. Development Plans any decision which would entail a change to the Joint terms and conditions of this Agreement will need to be formalized in an amendment to this Agreement and agreed upon and duly signed by authorized representatives of the parties before it is considered as binding upon the parties;
(e) Discussing and deciding on matters that are escalated to the Steering Committee no later than from the Research Committee under this Agreement, such as decisions under Section 3.3 regarding the justification for and repercussions of failures or delays in the delivery of deliverables to be delivered in accordance with Section 3.1;
(f) Discussing possible expansions of the Collaboration, as per Section 3.2, and other possible strategic collaborations that may be of interest to the parties, it being understood that in the event expansions or other possible strategic collaboration would relate to matters outside the field of Wheat, the matter may be communicated within the respective organizations for further discussions and follow ups outside the Steering Committee with the representatives responsible for the specific subject matter; and Initials Bayer : page 19 of 89 Initials Evogene : *** of such year for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect for redacted portions of this exhibit. This copy omits the information subject to the omitted portions.
(c) Prepare the Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United States;
(d) Review and recommend confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate Securities and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At each meeting of the Joint Development Committee, review a comparison of actual Development Expenses for the United States to the budgeted Development Expenses for the United States in the U.S. Development Plan for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;Exchange Commission.
(g) Review Other matters within the scope of the overall responsibility of the Steering Committee to oversee and recommend manage the Collaboration, for which the Steering Committee jointly decides a discussion/decision is required. The Steering Committee may delegate any additional responsibilities to the Joint Steering Committee "go/no-go" decisions for the Development of Collaboration Products in the United States; and
(h) Have such other responsibilities as may be assigned to the Joint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to timeResearch Committee.
Appears in 1 contract
Sources: Wheat Collaboration and License Agreement (Evogene Ltd.)
Responsibilities. The Joint Development Committee ---------------- PDC shall perform the following functions:: • (i) review and recommend, pursuant to Section 4.3(f), to the JEC for consideration and approval each Clinical Development Plan, including the related Clinical Budget for each Approved Study and Contingent Approved Study included in such Clinical Development Plan; • (ii) review and recommend, pursuant to Section 4.3(f) or 4.3(i), as applicable, to the JEC for consideration and approval each Proposed Study and each Emergency Study proposed to be added as an Approved Study or a Contingent Approved Study to the then-current Clinical Development Plan pursuant to Section 4.3(e) or 4.3(i), as applicable, including the proposed Clinical Budget for such Proposed Study or Emergency Study; • (iii) (A) review and recommend, pursuant to Section 4.3(h), to the JEC that either (1) each of the Contingencies applicable to a Contingent Approved Study has been satisfied and such Contingent Approved Study should become an Approved Study or (2) that at least one of the Contingencies related to a Contingent Approved Study has failed to be satisfied and such Contingent Approved Study should be removed from the Clinical Development Plan; and (B) review and recommend, pursuant to Section 4.3(h), the protocol and updated Clinical Budget for each Contingent Approved Study that shall become an Approved Study;
(aiv) Manage and oversee the preparation and implementation of the U.S. Clinical Development PlansPlans and any Sole-Funded SFI Registrational Studies;
(bv) As early as necessary review and approve or, in each year beginning with the first full Calendar Year after the Effective Datecase of any Material Modification, update and amend the initial U.S. Development Plans and prepare the U.S. Development Plans for each Collaboration Product for the following Calendar Year so that it can submit such proposed U.S. Development Plans recommend to the Joint Steering Committee no later than ** of such year JEC for review and approval; ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect approval any amendment or modification to the omitted portions.
(c) Prepare the Clinical Development strategy and develop protocols for clinical studies for the Collaboration Products for Commercialization in the United StatesPlan;
(dvi) Review and recommend to the Joint Steering Committee any material amendments or modifications to the U.S. Development Plans;
(e) Coordinate and monitor regulatory strategy and activities for the Collaboration Products in accordance with Article 9;
(f) At at each meeting of the Joint Development Committee, PDC review a comparison of the actual Development Expenses for the United States Costs incurred to the budgeted Development Expenses for the United States in the U.S. Development Plan Costs for the year-to-datedate for each Approved Study and each Contingent Approved Study, as current as practicable to a date immediately prior to the date of the meeting;
(gvii) Review review and recommend evaluate progress of each Approved Study or Contingent Approved Study and any Sole-Funded SFI Registrational Studies, provided that the PDC shall not have authority to make any determination that any Party is in breach of this Agreement; •
(viii) review and approve all compassionate use of Products;
(ix) review and approve the Joint Steering Committee "go/no-go" decisions for joint publication strategy together with the Development of Collaboration Products JCC, and take the lead in the United Statescoordinating such joint review and approval; and
(hx) Have have such other responsibilities as may be assigned to the Joint Development Committee PDC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time."
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement