Common use of Responsibilities Clause in Contracts

Responsibilities. The Joint Steering Committee shall ---------------- perform the following functions: (a) Manage and oversee the Development and Commercialization of the Collaboration Products in the United States pursuant to the terms of this Agreement; (b) Review and approve the U.S. Development Plans and 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 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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.

Appears in 5 contracts

Sources: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)

Responsibilities. The Joint Steering Committee JSC shall ---------------- perform the following functions: (a) Manage serve as a forum to share Know-How and oversee the Development and Commercialization learnings from each of the Inhaled Collaboration Products in the United States pursuant to the terms of this Agreement; (b) Review and approve the U.S. Development Plans and 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 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 limitationVaccines Collaboration. Specifically, 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;JSC shall: (i) Approve any provide oversight over the Collaboration Program and all ** policies facilitate communication and ** in discussion between the ** for Collaboration Products, including **; (j) In accordance Committee Parties with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned respect to the Joint Steering Committee 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. Collaboration Program; 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. (ii) ensure that each of the JVRC and JIRC be kept informed of data and Know-How generated under each of the Inhaled Plan and Vaccines Plan, respectively, that may have broad applicability or usefulness to both the Vaccines Plan and Inhaled Plan; (iii) review and approve amendments to the Inhaled Plan and Vaccines Plan and all associated budgets; (iv) discuss and resolve any disputes relating to the Collaboration 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 Section 5.7; (vii) 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 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 results and inventions generated by all such research, to the extent Liquidia becomes aware of such research results. 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; (viii) review and 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 impact of such delay on the 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 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 Vaccine Plan and Inhaled Plan; and (x) perform such other functions as agreed by the Parties in 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 Steering Committee JDCC shall ---------------- perform be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following functionsresponsibilities: (a) Manage the development and oversee discussion of strategies for the Development and Commercialization of the Collaboration Products each Co-Developed Product in the United States pursuant to the terms Co-Development Territory, including allocation of this Agreementresponsibilities for such Development and Commercialization activities; (b) Review reviewing and approve discussing a Marketing and Sales Plan for each Co-Developed Product in the U.S. Co-Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing PlansTerritory; (c) Coordinate Development and Commercialization of the Collaboration Products in the ROW with coordinating the Development and Commercialization efforts of the Collaboration Products both Parties in the United States Co-Development Territory with appropriate 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 Joint Development Committee JDCC informed of key regulatory communications involving key regulatory filings and the Joint Marketing Committee;milestone meetings as specified in Section 4.5.5. (d) At reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each meeting of Co-Developed Product in the Joint Steering Committee, review a comparison of actual Co-Development Expenses and Marketing Expenses for 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 meetingTerritory; (e) Review reviewing and approve providing input on the progress of short-term and long-term sales forecasts for Co-Developed Products in the other committeesCo-Developed Territory; (f) Review presenting sales forecasts and approve the trademarks selected under Section 2.4results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year; (g) Review and approve "go/nocoordinating the Detailing efforts of both Parties in the Co-go" decisions and other matters referred Development Territory with respect to the Joint Steering Committee, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Co-Developed Products; (h) Life cycle management ofoverseeing all recalls, market withdrawals and intellectual property protection for, the Collaboration any other corrective actions related to Co-Developed Products in the United StatesCo-Development Territory; (i) Approve any receiving and all ** policies and ** providing to the Parties sales reports pertaining to Co-Developed Products in the ** for Collaboration Products, including **Co-Developed Territory; (j) In accordance 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 the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committeesa Co-Developed Product to create a Combination Product; and (kl) Have performing such other responsibilities activities as may be assigned delegated to the Joint Steering Committee JDCC pursuant to this Agreement Agreement, or as may be mutually agreed upon by mutual written agreement of the Parties from time to time. ** = Certain information on this page has been omitted and filed separately with after the Commission. Confidential treatment has been requested with respect to the omitted portionsApproval 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 Steering Committee shall ---------------- perform the following functions: (ai) Manage and oversee Oversee the Development and Commercialization of the Collaboration Products Licensed Product in the United States 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); (b) Review and approve the U.S. Development Plans and 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; (dii) At each meeting of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for the United States to the budgeted Development Expenses and Marketing Expenses for the United States Net Sales for the year-to-date, date as current as practicable to a date immediately prior to the date of the meetingavailable; (eiii) Review Coordinate and approve monitor regulatory strategy and activities for the progress of Licensed Product in the other committeesTerritory in accordance with Article VIII; (fiv) Review and approve the trademarks selected under Section 2.42.06; (gv) Review Discuss the state of the markets for the Licensed Product in the Territory and approve "go/no-go" decisions opportunities and other matters referred to issues concerning the Joint Steering CommitteeCommercialization of the Licensed Product in the Territory, includingincluding consideration of marketing and promotional strategy, without limitationmarketing research plans, the continued Development of a particular Collaboration labeling and Licensed Product or the inclusion of Additional Productspositioning; (hvi) Life cycle management of, and intellectual property protection for, the Collaboration Products Licensed Product in the United StatesTerritory; (ivii) Approve any and all ** policies and ** At each meeting of the Joint Steering Committee, review the status of the major Commercialization activities related to the Licensed Product in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements Territory and deadlocks unresolved by the other committeesany results therefrom; and (kviii) Have such other responsibilities as may be assigned to the Joint 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 on this page has been omitted and filed separately with the Commission**CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Confidential treatment has been requested with respect to the omitted portionsCONFIDENTIAL 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 Steering Committee CCC shall ---------------- perform be responsible for overseeing Co-Promotion Activities. Without limiting the generality of the foregoing and except as otherwise specified in a Co-Promotion Agreement, the CCC shall have the following functionsresponsibilities: (a) Manage the development and oversee discussion of strategies for the Development promotion and Commercialization marketing of each Co-Promoted Product to the Collaboration Products Co-Promotion Target Audience in the United States pursuant to the terms Co-Promotion Territory, including allocation of this Agreementresponsibilities for Co-Promotion Activities; (b) Review and approve implementing the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments Product Commercialization Plan with respect to the U.S. Development Plans and U.S. Marketing PlansCo-Promotion Activities for the Co-Promoted Product in the Co-Promotion Territory; (c) Coordinate Development the preparation of short-term and Commercialization of the Collaboration long-term sales forecasts for Co-Promoted 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 CommitteeCo-Promotion Territory; (d) At each meeting presenting sales forecasts and the results of all Commercialization efforts for Co-Promoted Products in the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for the United States Co-Promotion Territory to the budgeted Development Expenses and Marketing Expenses for the United States for the year-to-dateParties as needed, as current as practicable to a date immediately prior to the date of the meetingbut no less often than four (4) times per Calendar Year; (e) Review and approve coordinating the progress Detailing efforts of both Parties with respect to the other committeesCo-Promotion Target Audience in the Co-Promotion Territory with respect to Co-Promoted Products; (f) Review providing a forum for discussing all recalls, market withdrawals and approve any other corrective actions related to Co-Promoted Products in the trademarks selected under Section 2.4Co-Promotion Territory; (g) Review receiving and approve "go/no-go" decisions and other matters referred providing to the Joint Steering Committee, including, without limitation, Parties sales reports with respect to the continued Development of a particular Collaboration Product or Co-Promotion Target Audience pertaining to Co-Promoted Products in the inclusion of Additional Products;Co-Promotion Territory; and (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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have performing such other responsibilities activities as may be assigned delegated to the Joint Steering Committee CCC pursuant to this Agreement, in any Co-Promotion Agreement or as may be mutually agreed upon by mutual written agreement of the Parties from time to time. ** = Certain information on this page has been omitted and filed separately with after the Commission. Confidential treatment has been requested with respect to the omitted portionsEffective Date.

Appears in 3 contracts

Sources: Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc), Collaborative Research and License Agreement (Targacept Inc)

Responsibilities. The Joint Steering 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 progress under the Collaboration Plan; (ii) 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 Development Collaboration Plan and Commercialization 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 Products in 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 United States pursuant to the terms of this AgreementCollaboration Program; (bix) Review and approve of the U.S. Development Plans regulatory plans and the U.S. Marketing Plans strategies for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing PlansProduct Candidates; (cx) Coordinate Development Review all Regulatory Filings with respect to Product Candidates; (xi) Form such other committees (“Sub-Committees”) as the JSC may deem appropriate. As soon as practicable (but not later than sixty (60) days) after the Effective Date, the Parties will establish a Sub-Committee comprised of three (3) representatives of Celgene, three (3) representatives of Bluebird, and Commercialization ▇▇. ▇▇▇▇▇▇▇ ▇. Brenner (the “Collaboration Program Advisory Committee”). The Collaboration Program Advisory Committee will monitor and advise the Parties on the conduct and progress of the Collaboration Products in the ROW with the Development and Commercialization of Program. Each Party may replace its representatives on the Collaboration Products in Program Advisory Committee at any time upon written notice to the United States with appropriate liaison with other Party. Any such Sub-Committee (including the Joint Development Committee and Collaboration Program Advisory Committee) may make recommendations to the Joint Marketing CommitteeJSC but may not be delegated JSC decision-making authority; (dxii) At each meeting Address such other matters relating to the activities of the Joint Steering CommitteeParties under this Agreement as either Party may bring before the JSC, review a comparison of actual Development Expenses and Marketing Expenses including any matters that are expressly for the United States JSC to the budgeted Development Expenses and Marketing Expenses for the United States for the year-to-date, decide 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 provided in the United States; (i) Approve any and all ** policies and ** in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committeesthis Agreement; and (kxiii) Have such other responsibilities as may be assigned Attempt to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. ** = Certain information resolve any disputes on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsan 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 Steering Supply Committee shall perform ---------------- perform the following functions: (a) Manage and oversee the activities in relation to manufacture and supply of API Compound and Collaboration Products for use in Development and Commercialization of the and establish procedures and protocols for testing API Compound and Collaboration Products in to ensure that such API Compound and Collaboration Products comply with the United States pursuant specifications (the "Testing ------- Protocol"). The Parties will utilize such Testing Protocol with respect to the terms of this AgreementAPI -------- Compound and Collaboration Product that they may receive from Product Suppliers to ensure that such API Compound or Collaboration Product meets specifications; (b) Review Recommend and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments coordinate necessary adjustments to the U.S. Development Plans and U.S. Marketing Plansmanufacturing schedule to ensure it is meeting the needs for all Collaboration Products; (c) Coordinate Development and Commercialization allocation of the Collaboration Products API Compound in the ROW with the Development and Commercialization event of the Collaboration Products in a shortage between the United States with appropriate liaison with 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 Development Supply Committee and based on the Joint Marketing Committeerelative commercial value of such **; (d) At each meeting Review the quality of the Joint Steering Committeemanufacture of the Collaboration Products, review a comparison reviewing as appropriate reports of actual Development Expenses the manufacturers of API Compound and Marketing Expenses for the United States Collaboration Products and reports as to the budgeted Development Expenses and Marketing Expenses for quality of any packaging that bears the United States for relevant trademarks or housemarks of the year-to-date, Parties (as current as practicable to a date immediately prior owned by or licensed to the date of the meetingrelevant Party under Section 2.4) as prescribed by this Agreement; (e) Review Recommend and approve the progress of the other committeesimplement optimal inventory levels and safety stock targets; (f) Review Set improvement targets and approve the trademarks selected under Section 2.4monitor performance against these targets for cost, yield, delivery and other appropriate measures; (g) Review Establish guidelines to facilitate improved efficiencies and approve "go/no-go" decisions compliance with current Good Manufacturing Practices by Product Suppliers; 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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. (h) Have such other responsibilities as may be assigned to the Joint 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 Steering 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 Development Prosecution and Commercialization Maintenance of the Jounce Patents, Celgene Patents, Collaboration Products Patents and Joint Collaboration Patents, including recommending whether or not to file a Collaboration Patent in the United States pursuant to the terms of this Agreement; all Core Countries; (b) Review serve as a forum for exchanging information and approve the U.S. Development Plans facilitating discussions regarding patentability and the U.S. Marketing Plans for Collaboration Products freedom to operate assessments; 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 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have perform such other responsibilities as may be assigned to the Joint Steering 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 [** = Certain information on this page has been omitted and filed separately with **] after the Commission. Confidential treatment has been requested with respect matter is first brought to the omitted portionsPatent 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 Joint Steering 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 overseeing implementation of the Development Plan; (b) reviewing and Commercialization of evaluating progress under the Collaboration Products Development Plan (including compliance with the Development Budget contained therein and payment arrangements) on a quarterly basis and advising the Parties as to any necessary amendments thereto; (c) allocating and assigning Development activities in the United States pursuant to Development Plan between the Parties, consistent with the terms of this Agreement; (bd) Review approving (or establishing procedures to approve) protocols for pre-clinical studies and approve the U.S. Clinical Trials for Development Plans and the U.S. Marketing Plans for of Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing PlansProducts; (ce) Coordinate Development making modifications to and Commercialization performing quarterly monitoring of the progress of pre-clinical studies and Clinical Trials and proposing additional studies for 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 CommitteeProducts; (df) At each meeting reviewing and approving any proposed modifications to the Development 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 Collaboration Product for (i) Clinical Trials and (ii) Commercialization; (h) 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 entered into in accordance with Section 4.3.5; (k) facilitating the 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 and that the Parties mutually agree shall be the responsibility of the Joint Steering Committee. Notwithstanding the foregoing, review a comparison of actual Development Expenses and Marketing Expenses for in no event shall 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 JSC or any subcommittee of the meeting; (e) Review and approve JSC have 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 authority 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 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 and all ** policies and ** decision that is specified elsewhere in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee pursuant to this Agreement as being made by one 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 portionsboth 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 Steering Committee JCC shall ---------------- perform the following functions: (ai) Manage and oversee the Development preparation and Commercialization implementation of the Collaboration Products in Marketing Plans; Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and ImClone Systems Incorporated. (ii) oversee and coordinate the United States pursuant to sales efforts of ERS and the terms of this AgreementCompany; (biii) Review review and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing Plans; (civ) Coordinate Development and Commercialization discuss the state of the Collaboration markets for Products in the ROW 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 Development and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteePlans; (dv) At review and approve Non-Registrational Studies, taking into consideration the appropriateness in the context of the overall marketing and promotional strategy for the Products; (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 Steering CommitteeJCC, review a comparison of actual Development Expenses sales and Marketing Expenses for the United States marketing expenses to the budgeted Development Expenses and expenses in the relevant Marketing Expenses for the United States Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting; (exiii) Review review and approve the progress 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 other committeesCompany in the promotion of such Products (such guidelines to be consistent with the then current Marketing Plan applicable to such Products); (fxiv) Review 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 trademarks selected under Section 2.4;joint publication strategy together with the PDC; Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and ImClone Systems Incorporated. (gxvi) Review evaluate and approve "go/nodetermine the existence or non-go" decisions and other matters existence of a Co-Promotion Problem 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 JCC in the United States; (i) Approve any and all ** policies and ** in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees5.6(e); and (kxvii) Have have such other responsibilities as may be assigned to the Joint Steering Committee JCC 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.

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 Steering 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 Development and Commercialization Steering Committee, as may be reasonably required to meet the goals of the Collaboration Products in Research Plan and the United States pursuant Collaboration; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the terms confidentiality request. Omissions are designated as [***]. A complete version of this Agreement;exhibit has been provided separately to the Securities and Exchange Commission. (b) Review To recommend to the Steering Committee changes in assays and approve the U.S. Development Plans and the U.S. Marketing Plans validation processes for Collaboration Products Hit Homologs, Special Collaboration Hits and any material amendments to the U.S. Development Plans and U.S. Marketing PlansPreferred Mode of Use; (c) Coordinate Development To recommend to the Steering Committee amendments, modifications and Commercialization supplements to the Research Plan, and changes to validation criteria of the Collaboration Products in the ROW with the Development Hit Homologs Special Collaboration Hits and Commercialization Preferred Modes of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteeUse; (d) At least sixty (60) days prior to the commencement of each meeting of Collaboration Year, to review and approve, subject to final approval by the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses detailed research plan for the United States subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the budgeted Development Expenses Discovery Programs to be conducted and Marketing Expenses for the United States for Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the year-to-date, as current as practicable Steering Committee shall automatically constitute an amendment to a date immediately prior to the date and part of the meetingResearch Plan; (e) Review To discuss ways for Monsanto to assist the gene discovery and approve identification of Preferred Modes of Use processes, such as by providing Evogene with certain know-how and Monsanto Data, including to periodically review whether there is need to supplement the progress [* * *] set forth in [* * *] ([* * *]) and to [* * *] to the Steering Committee, as may be reasonably required to meet the goals of the other committeesResearch Plan and the Collaboration; (f) Review To monitor the parties’ performance of their respective Diligence Obligations (based on the reports to be provided by each party as set forth in Sections 2.8.1 and approve 2.8.2) and to review and amend the trademarks selected under Section 2.4format of the parties’ reports, as may be reasonably required in order to enable the Research Committee to monitor the parties’ performance of their respective Diligence Obligations; (g) Review To discuss, at a general level, information provided on Collaboration Hit Homologs and approve "go/no-go" decisions Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks,, the Collaboration Hit G2P Data Backpacks, and other matters referred the Project G2P Validation Data Backpacks and to make recommendations with respect to the Joint Steering Committeevalidation of the Collaboration Hit Homologs, including, without limitation, Special Collaboration Hits and Preferred Modes of Use in the continued Development of a particular Collaboration Product or the inclusion of Additional ProductsMonsanto Pipeline; (h) Life cycle management ofTo receive from Evogene information on possible Independent Discovery Rounds, in accordance with Section 4.2.1, and intellectual property protection for, to discuss information provided by Evogene on Internal Non-Field Hits which underwent the Collaboration Products 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 United States;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) Approve any and all ** policies and ** To review issues relating to Publications resulting from the activities conducted under the Collaboration, in the ** for Collaboration Products, including **accordance with Section 2.10; (j) In 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 procedures established in terms of this Agreement (For the avoidance of doubt, all GeneSpec Genes, including those that are Homologs of Collaboration 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 3.1.41.72; (m) To approve the use of Collaboration Hit Homologs and PlaNet Gene Homologs for Model Plant Validation, resolve disputesas contemplated by Sections 1.134, disagreements 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 deadlocks unresolved 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 the other committeesthis Agreement; and (kq) Have To exercise such other additional responsibilities as may be assigned delegated to the Joint Steering Research Committee 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 portionsSteering Committee.

Appears in 2 contracts

Sources: Collaboration Agreement (Evogene Ltd.), Collaboration Agreement (Evogene Ltd.)

Responsibilities. The Joint Steering 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 Development and Commercialization monitor progress of the Collaboration Products in the United States pursuant to the terms of this AgreementCollaboration; (b) Review and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments determine whether Target Validation has been achieved with respect to the U.S. Development Plans and U.S. Marketing Planseach Selected Target; (c) Coordinate Development review and Commercialization of approve changes to 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 CommitteeTractable Hit Criteria for each Selected Target; (d) At each meeting of determine whether the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for the United States applicable Tractable Hit Criteria have been achieved with respect 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 meetingany Compound; (e) Review review and approve changes to the progress of the other committeesLead Candidate Criteria for each Selected Target; (f) Review and approve determine whether the trademarks selected under Section 2.4applicable Lead Candidate Criteria have been achieved with respect to any Compound; (g) Review review and approve "go/no-go" decisions and other matters referred changes to the Joint Steering Committee, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional ProductsCandidate Selection Criteria for each Selected Target; (h) Life cycle management of, and intellectual property protection for, determine whether the Collaboration Products in the United Statesapplicable Development Candidate Selection Criteria have been achieved with respect to any Compound; (i) Approve any serve as a forum for exchange of information and all ** policies to facilitate discussions regarding the conduct of the Collaboration and ** in the ** for Collaboration ProductsDevelopment of Licensed Compounds, including **Licensed Products and Diagnostic Products hereunder; (j) In discuss and attempt to resolve any deadlocked issues submitted to it in accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and4.1.5; (k) Have 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 Steering 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 [** = Certain information on this page has been omitted and filed separately with *] days after the Commission. Confidential treatment has been requested with respect matter is first brought to the omitted portionsJSC’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 Steering Committee JDC shall ---------------- perform be responsible for overseeing the Development 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 have the following functionsresponsibilities: (a) Manage preparing or directing the preparation and oversee recommending to the JSC for its approval of an Annual Development and Commercialization of the Collaboration Products Plan for each Co-Developed Development Candidate in the United States pursuant to the terms of this AgreementCo-Development Territory; (b) Review monitoring the activities of, and approve reconciling issues between, the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments Parties with respect to the U.S. Parties’ respective share of Co-Development Plans Costs and U.S. Marketing Plans;Co-Development Regulatory Costs incurred with respect to Co-Developed Development Candidates; 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. (c) Coordinate preparing or directing the preparation of and approving amendments to JSC-approved Annual Development and Commercialization Plans with respect to Co-Developed Development Candidates as it deems appropriate in furtherance of the Collaboration Products objectives of the Development Program as set forth in the ROW with the Annual Development and Commercialization Plan and, if any member of the Collaboration Products in JDC asserts that any such JDC-approved amendment would change the United States with appropriate liaison with objectives of such Annual Development Plan, submitting such amendment to the Joint Development Committee and the Joint Marketing CommitteeJSC for its consideration; (d) At monitoring the progress of each meeting Annual Development Plan with respect to Co-Developed Development Candidates and of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 meetingeach Party’s activities thereunder; (e) Review and approve providing a forum for consensual decision making with respect to the progress Development of the other committeesCo-Developed Development Candidates; (f) Review and approve reviewing data, reports or other information submitted by either Party with respect to work conducted in the trademarks selected under Section 2.4Development of Co-Developed Development Candidates affecting the Co-Developed Territory; (g) Review preparing for the JSC on at least a semi-annual basis a progress report for the Development of Co-Developed Development Candidates in reasonable detail and approve "go/no-go" decisions and other matters referred providing to the Joint Steering Committee, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Products;JSC such additional information as it may request; and (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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have performing such other responsibilities activities as may be assigned delegated to the Joint Steering Committee JDC pursuant to this Agreement Agreement, or as may be mutually agreed upon by mutual written agreement of the Parties from time to time. ** = Certain information on this page has been omitted and filed separately with after the Commission. Confidential treatment has been requested with respect to the omitted portionsEffective Date.

Appears in 2 contracts

Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)

Responsibilities. The Joint Steering Committee JMC shall ---------------- perform be responsible for overseeing the Co-Promotion of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JMC shall have the following functionsresponsibilities: (a) Manage preparing or directing the preparation of a Co-Development Marketing and oversee the Development Sales Plan containing a Co-Promotion Plan and Commercialization of the Collaboration Products a brand plan for each Co-Developed Product in the United States pursuant Co-Development Territory, such Plan to the terms include allocation of this Agreementresponsibilities for Commercialization activities; (b) Review reviewing and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments approving all Additional Co-Promotion Activities to the U.S. Development Plans and U.S. Marketing Plansbe conducted by either Party pursuant to Section 5.7; (c) Coordinate Development preparing short-term and Commercialization of the Collaboration long-term sales forecasts for Co-Developed Products in the ROW with the Co-Development and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteeTerritory; (d) At each meeting presenting sales forecasts and the results of all Co-Promotion efforts in the Joint Steering Committee, review a comparison of actual Co-Development Expenses and Marketing Expenses for the United States Territory to the budgeted Development Expenses and Marketing Expenses for the United States 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 four (4) times per Calendar Year; (e) Review and approve coordinating the progress Detailing efforts of both Parties in the other committeesCo-Development Territory with respect to Co-Developed Products; (f) Review overseeing all recalls, market withdrawals and approve any other corrective actions related to Co-Developed Products in the trademarks selected under Section 2.4Co-Development Territory; (g) Review receiving and approve "go/no-go" decisions and other matters referred providing to the Joint Steering Committee, including, without limitation, Parties sales reports pertaining to Co-Developed Products in the continued Co-Development of a particular Collaboration Product or the inclusion of Additional ProductsTerritory; (h) Life cycle management of, and intellectual property protection for, consulting the Collaboration Parties in the selection of Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the United States;Co-Development Territory; and (i) Approve any and all ** policies and ** in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have performing such other responsibilities activities as may be assigned delegated to the Joint Steering Committee JMC pursuant to this Agreement Agreement, or as may be mutually agreed upon by mutual written agreement of the Parties from time to time. ** = Certain information on this page has been omitted and filed separately with after the Commission. Confidential treatment has been requested with respect to the omitted portionsEffective Date.

Appears in 2 contracts

Sources: Collaborative Development and License Agreement (Immunogen Inc), Collaborative Development and License Agreement (Immunogen Inc)

Responsibilities. The Joint Steering Committee JCC shall ---------------- perform the following functions: (ai) Manage Develop and oversee the Development subsequently review and Commercialization of the Collaboration Products in the United States pursuant make decisions relating to the terms of this AgreementCommercialization Plan including a budget for PSMM Expenses; (bii) Oversee implementation of the Commercialization Plan, throughout the Calendar Year, including managing the budget for PSMM Expenses; (iii) Discuss the markets for Product in the Territory 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 [***]; (iv) Oversee and coordinate the sales efforts of the Parties; (v) Review and approve make decisions regarding post-Initial Indication Approval Development activities, taking into consideration the U.S. appropriateness of any Development Plans activities including line extensions, Clinical Trials for purposes of new indications and Phase IV Clinical Trials in the U.S. Marketing Plans context of the overall marketing and promotional strategy for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing PlansProduct; (cvi) Coordinate Development Review and Commercialization direct all indigent care use 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 CommitteeProduct; (dvii) 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 Steering CommitteeJCC, review a comparison of actual Development Expenses sales and Marketing Expenses for the United States marketing expenses to the budgeted Development Expenses and Marketing Expenses for expenses in the United States 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; (ex) Review and approve the progress general guidelines applicable to Product Commercialization to be followed in the development of promotional materials and promotional activities to be used by the other committeesParties in the co-promotion of Product; (fxi) Review Lead the review and approve direct Product publication strategy, in consultation with the trademarks selected under Section 2.4PDC; (gxii) Review Following review and approval by the Parties’ internal promotional materials review committees, review and approve "go/no-go" decisions packaging and other matters referred related materials, prior 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committeescommercial use; and (kxiii) Have such other responsibilities as may be assigned to the Joint Steering Committee JCC 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.

Appears in 2 contracts

Sources: Collaboration Agreement (Allergan Inc), Collaboration Agreement (MAP Pharmaceuticals, Inc.)

Responsibilities. The Joint Steering 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 overseeing implementation of the Development Plan; (b) reviewing and Commercialization of evaluating progress under the Collaboration Products Development Plan (including compliance with the Development Budget contained therein and payment arrangements) on a quarterly basis and advising the Parties as to any necessary amendments thereto; (c) allocating and assigning Development activities in the United States pursuant to Development Plan between the Parties, consistent with the terms of this Agreement; (b) Review and approve the U.S. Development Plans and 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 approving (or establishing procedures to approve) protocols for pre-clinical studies and Clinical Trials for Development of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 meetingCollaboration Products; (e) Review making modifications to and approve the performing quarterly monitoring of progress of the other committeespre-clinical studies and Clinical Trials and proposing additional studies for Collaboration Products; (f) Review reviewing and approve approving any proposed modifications to the trademarks selected under Section 2.4Development Plan, including advising the Parties as to whether a Back-Up Compound should be developed in lieu of a Collaboration Compound; (g) Review and approve "go/no-go" decisions and other matters referred to coordinating the Joint Steering Committee, including, without limitation, the continued Development Manufacture of global supplies of a particular Collaboration Compound and Collaboration Product or the inclusion of Additional Productsfor (i) Clinical Trials and (ii) Commercialization; (h) Life cycle management of, reviewing and intellectual property protection for, the commenting on Regulatory Submissions relating to Collaboration Products in the United StatesProducts; (i) Approve any and facilitating the exchange of all ** policies and ** in the ** for data, information, material or results relating to Development of Collaboration Products, including **; (j) In accordance establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the procedures established Pharmacovigilance Agreement to be entered into in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. accordance [** = *] Certain information on in this page document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment with Section 4.3.5; (k) facilitating the 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 and that the Parties 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 (i) reduce or expand the obligations of the Parties under this Agreement; (ii) determine that a breach has been requested with respect to the omitted portionsoccurred 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 Steering Committee JSC shall ---------------- perform the following functionsbe responsible for: (ai) Manage reviewing and oversee approving the initial Global Development and Commercialization of Plan prepared by the Collaboration Products in the United States pursuant JDC, including all budgets relating to the terms of this Agreementdevelopment activities to be conducted by MERRIMACK hereunder; (bii) Review periodically reviewing the Global Development Plan and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material suggesting or approving such updates or amendments to the U.S. Global Development Plans and U.S. Marketing PlansPlan as the JSC deems appropriate, including all budget amendments; (ciii) Coordinate Development as long as MERRIMACK does not opt out of Co-Promotion, reviewing and approving the initial Commercialization of Plan for the Collaboration Products in Co-Promoted Product(s) prepared by 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 CommitteeJCC, including all budgets; (div) At each meeting 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 updates or amendments to such Commercialization Plan as the JSC deems appropriate, including all budget amendments; (v) providing overall strategic direction with respect to research, development, regulatory and manufacturing activities conducted under the Global Development Plan, and with respect to commercialization activities conducted under the Commercialization Plan (if any); (vi) overseeing the JDC and, if applicable, the JCC, and the Parties’ progress in the conduct of activities under the Joint Steering Committee, review Global Development Plan and the Commercialization Plan (if any) hereunder; (vii) establishing a comparison of actual Development Expenses and projected Marketing Expenses 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 and Marketing Expenses for the United States 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; (eviii) Review and approve keeping MERRIMACK apprised, through MERRIMACK’s representatives on the progress JSC, of the other committeesplanned US Filing Date for each Licensed Product, including any updates thereto; (fix) Review and approve the trademarks selected attempting to resolve disputes arising under Section 2.4; (g) Review and approve "go/no-go" decisions and other matters this Agreement that are referred to the Joint Steering CommitteeJSC by the JDC, including, without limitationJCC or either of the Parties (for clarity, the continued Development of JSC shall not have the authority to resolve disputes between the Parties regarding whether a particular Collaboration Product Party has fulfilled 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 breached any and all ** policies and ** in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committeesobligation under this Agreement); and (kx) Have performing such other tasks and undertaking such other responsibilities as may be assigned to the Joint Steering Committee pursuant to set forth in 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 portionsAgreement.

Appears in 2 contracts

Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc), License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)

Responsibilities. The Joint Steering 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 JMC’s performance of its responsibilities; (b) reviewing data, reports or other information submitted to it by the JDC, JMC and JFC from time to time; (c) resolving all JDC, JMC or JFC matters that are referred to the JSC for resolution; (d) making such other decisions as may be delegated to the JSC pursuant to this Agreement or by mutual written agreement of the Parties 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 update 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 the Collaboration Products each Licensed Product in the United States 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 terms Company’s application requesting confidential treatment under Rule 24b-2 of this Agreement; (b) Review and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments Securities Exchange Act of 1934. update as to the U.S. Development Plans and U.S. Marketing Plans; (c) Coordinate Development and Commercialization of the Collaboration Products in the ROW with Co-Promotion strategy for the Development and Commercialization of the Collaboration Products each Co-Developed Product in the United States 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 appropriate liaison with respect thereto in the Joint Development Committee 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 Joint Marketing Committee; (d) At each 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 Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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 portionsJSC.

Appears in 1 contract

Sources: Collaborative Development and License Agreement (Immunogen Inc)

Responsibilities. The Joint Steering 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 Development and Commercialization Steering Committee, as may be reasonably required to meet the goals of the Collaboration Products in Research Plan and the United States pursuant to the terms of this AgreementCollaboration; (b) Review To recommend to the Steering Committee changes in assays and approve the U.S. Development Plans and the U.S. Marketing Plans validation processes for Collaboration Products Hit Homologs, Special Collaboration Hits and any material amendments to the U.S. Development Plans and U.S. Marketing PlansPreferred Mode of Use; (c) Coordinate Development To recommend to the Steering Committee amendments, modifications and Commercialization supplements to the Research Plan, and changes to validation criteria of Collaboration Hit Homologs Special Collaboration Hits and Preferred Modes of Use; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the Collaboration Products in information subject to the ROW with confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Development Securities and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing Committee;Exchange Commission. (d) At least sixty (60) days prior to the commencement of each meeting of Collaboration Year, to review and approve, subject to final approval by the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses detailed research plan for the United States subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the budgeted Development Expenses Discovery Programs to be conducted and Marketing Expenses for the United States for Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the year-to-date, as current as practicable Steering Committee shall automatically constitute an amendment to a date immediately prior to the date and part of the meetingResearch Plan; (e) Review To discuss ways for Monsanto to assist the gene discovery and approve identification of Preferred Modes of Use processes, such as by providing Evogene with certain know-how and Monsanto Data, including to periodically review whether there is need to supplement the progress [* * *] set forth in [* * *] ([* * *]) and to [* * *] to the Steering Committee, as may be reasonably required to meet the goals of the other committeesResearch Plan and the Collaboration; (f) Review To monitor the parties’ performance of their respective Diligence Obligations (based on the reports to be provided by each party as set forth in Sections 2.8.1 and approve 2.8.2) and to review and amend the trademarks selected under Section 2.4format of the parties’ reports, as may be reasonably required in order to enable the Research Committee to monitor the parties’ performance of their respective Diligence Obligations; (g) Review To discuss, at a general level, information provided on Collaboration Hit Homologs and approve "go/no-go" decisions Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks,, the Collaboration Hit G2P Data Backpacks, and other matters referred the Project G2P Validation Data Backpacks and to make recommendations with respect to the Joint Steering Committeevalidation of the Collaboration Hit Homologs, including, without limitation, Special Collaboration Hits and Preferred Modes of Use in the continued Development of a particular Collaboration Product or the inclusion of Additional ProductsMonsanto Pipeline; (h) Life cycle management ofTo receive from Evogene information on possible Independent Discovery Rounds, in accordance with Section 4.2.1, and intellectual property protection for, to discuss information provided by Evogene on Internal Non-Field Hits which underwent the Collaboration Products Core Validation and met the Validated Hit criteria as set forth in the United StatesSection 4.2.2; (i) Approve any and all ** policies and ** To review issues relating to Publications resulting from the activities conducted under the Collaboration, in the ** for Collaboration Products, including **accordance with Section 2.10; (j) In accordance with To keep a record of the procedures established in Section 3.1.4Collaboration Hit Sets, resolve disputesSpecial Collaboration Hits, disagreements PlaNet Genes, PlaNet ▇▇▇▇ ▇▇▇▇▇▇, RePack Recommendations and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned GeneDex Recommendations licensed to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. Monsanto *** = 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. 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 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 use 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 (q) To exercise such additional responsibilities as may be delegated to the Research Committee by the Steering Committee.

Appears in 1 contract

Sources: Collaboration Agreement (Evogene Ltd.)

Responsibilities. The Joint Steering 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 Development Product in the ADHD marketplace based on the available information and Commercialization data regarding the safety and efficacy of the Collaboration Products Product; 3.5.2 Coordinate the Co-Promotion and Detailing activities related to the Product of the Cephalon Sales Representatives and ▇▇▇▇▇▇ Sales Representatives in the United States Territory; **Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the terms Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of this Agreement1934, 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; (b) Review 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 approve Detailing of the U.S. Development Product in the Territory; 3.5.7 Discuss incentive compensation programs for the Sales Representatives; 3.5.8 Discuss the Plans and the U.S. Marketing Plans for Collaboration Products 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 any material amendments 6.6, Cephalon retains final decision-making authority with respect to the U.S. Development Plans and U.S. the Marketing PlansBudget; (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 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 3.5.9 Discuss [**; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees]; and (k) Have 3.5.10 Having such other responsibilities as may be assigned to the Joint Steering Committee 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 ; provided that the Commission. Confidential treatment has been requested JCC shall not have responsibility for (a) any aspect of the marketing, sale or promotion of CONCERTA®, or (b) with respect to the omitted portionsProduct, 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

Sources: Co Promotion Agreement (Cephalon Inc)

Responsibilities. The Joint Steering Committee shall ---------------- perform the following functionsJMC will: (a) Manage consistent with the provisions of Section 6.2, designate the team leader and oversee the Development and Commercialization other members of the Collaboration Products in Manufacturing Working Group, which team leader and members shall be chosen from among the United States pursuant to personnel of the terms of this AgreementParties having relevant experience, and allocate the respective roles on the Manufacturing Working Group among such members; (b) Review review on a periodic basis and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and make any material amendments necessary changes to the U.S. Development Plans team leader and U.S. Marketing Plansother members of the Manufacturing Working Group, or the allocation of roles among such members; (c) Coordinate Development and Commercialization oversee the Manufacturing Working Group, in consultation with the JDC, with respect to matters relating to the pre-clinical or clinical Manufacture 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 CommitteeProducts; (d) At each meeting oversee the Manufacturing Working Group, in consultation with the JCC, with respect to matters relating to the commercial Manufacture of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 meetingProducts; (e) Review and approve oversee the progress of Manufacturing Working Group, in consultation with the other committees; (f) Review and approve JDC, with respect to Manufacturing quality matters for 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. ** ] = 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 review of the results of regulatory and environmental, health and safety inspections and audits related to the Manufacture of the Products and the review and discussion of steps taken by CRISPR to address any deficiencies noted; (g) oversee the Manufacture of the Products in the Field 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 (p) perform such other duties as are specifically assigned to the JMC under this Agreement or as may be delegated to the JMC by the JSC. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted portions.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

Appears in 1 contract

Sources: Joint Development and Commercialization Agreement (CRISPR Therapeutics AG)

Responsibilities. The Joint Steering 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 Development and preparation by the Parties of, each Co-Commercialization of the Collaboration Plan for Co-Commercialized Products in the United States pursuant to Co-Commercialization Territory, including the terms of this Agreementbudgets with respect thereto; (b) Review and approve preparing or directing the U.S. Development Plans and preparation by the U.S. Marketing Plans Parties of each amendment to any Co-Commercialization Plan for Collaboration Co-Commercialized Products and any material amendments to in the U.S. Development Plans and U.S. Marketing PlansCo-Commercialization Territory or the related budget with respect thereto; (c) Coordinate Development determining style guidelines and Commercialization the appearance of the Collaboration Co-Commercialized Products in the ROW with the Development Co-Commercialization Territory, including packaging and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing Committeepromotional materials; (d) At each meeting of determining managed health care strategy and tactics, including Pricing, rebates, discounts and charge-backs for Co-Commercialized Products in the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for the United States to the budgeted Development Expenses and Marketing Expenses for the United States for the yearCo-to-date, as current as practicable to a date immediately prior to the date of the meetingCommercialization Territory; (e) Review and approve determining the progress appropriate use of medical science liaisons in support of the other committeesCo-Commercialized Products; (f) Review determining the format and approve quantities of promotional sales, marketing and educational materials for the trademarks selected under Section 2.4Co-Commercialized Products; (g) Review reviewing and approve "go/noapproving any proposals for modifications of existing Co-go" decisions and other matters referred to the Joint Steering CommitteeCommercialized Products, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Productsnew formulations after First Commercial Sale and line extensions; (h) Life cycle management of, agreeing upon the design and intellectual property protection for, the Collaboration Products in the United Statesimplementation of all Co-Commercialized Product launch activities; (i) Approve any and all ** policies and ** monitoring the progress of Commercialization of Co-Commercialized Products in the ** for Collaboration Products, including **Co-Commercialization Territory under each Co-Commercialization Plan and of each Party’s activities thereunder; (j) In accordance reviewing and circulating to the Parties data, reports or other information submitted by either Party with respect to the procedures established Commercialization of Co-Commercialized Products in Section 3.1.4the Co-Commercialization Territory; (k) determining appropriate targets for sales force staffing and territory mapping purposes, resolve disputesdetermining 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, disagreements market withdrawals and deadlocks unresolved 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 other committeesminutes of the USJMC; and (ko) Have making such other responsibilities decisions as may be assigned delegated to the Joint Steering 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 time. ** = Certain information on this page has been omitted and filed separately with during the Commission. Confidential treatment has been requested with respect to the omitted portionsTerm.

Appears in 1 contract

Sources: License, Co Development and Co Commercialization Agreement (Arqule Inc)

Responsibilities. The Joint Steering Committee shall ---------------- perform RYCOM Responsibilities ----------------------- In addition to the following functions: (a) Manage and oversee the Development and Commercialization structure of the Collaboration relationship outlined above RYCOM will architect, develop and operate a fully managed signature verification authentication, and other solutions offering using SNaulrs platform and proprietary IP for the Canadian market. RYCOM will provide all necessary hardware, secure facility and engineering, sales, marketing support to deliver the service. This solution will be co-developed and revenue shared with SiVault however, RYCOM wig operate and manage the solution in its entirety signature verification and other solutions wig be marketed to End Users, and white labeled for Channel Markets requiring speed to market. A. End User Market Development RYCAM shag use its best commercial efforts to engage End-Users, sell Products in the United States and license software contained within or delivered with such Products. Company Technology shall be licensed by End-Users pursuant to the End-User License Agreement ("E▇▇▇") contained In the Product. E-132 B. Distribution and Channel Market Development: RYCOM may sell to third parties ('Sub-Reseller & Integrators') to market and sell the Products and license the Software Products under the terns of this Agreement applicable to RYCOM. Each Sub-Reseller shall execute a written agreement (a 'Sub-Reseller Agreement") with RYCOM binding the Sub-Reseller to provisions substantially similar to (and no less advantageous to Company than) those contained In this Agreement, and all associated Addenda. Each obligation of RYCOM under each such provision shall also be applicable to each Sub-Reseller. Each Sub-Reseller Agreement shall also contain any other provisions necessary for RYCOM to satisfy its commitments under this Agreement. RYCOM shag keep executed Sub-Reseller Agreements and records pertaining to each Sub-Reseller, and shall provide copies of such information on a monthly basis. RYCOM agrees to enforce the terms of this Agreement;its Sub-Reseller Agreements so as to affect a timely cure of any Sub-Reseller breach of the SutrReseller Agreement and to notify Company of any known breach of such terms. SiVault Responsibilities and Consideration (a) SiVault will provide RYCOM at no charge with an unlimited capacity signature verification software solution license to architect and develop a fully managed service offering for the Canadian market RYCOM will be responsible for purchasing all necessary hardware components required. Revenue generated from the signature verification serv'f- wig be shared between RYCOM and SiVault as outlined in the attached Addendum RYCOM and StVVault Pricing and Revenue Share Arrangement b) Review SiVault will provide at no charge RYCOM and approve its Engineering and Sales, Marketing personnel with the U.S. Development Plans necessary product training and support to successfully develop, market and sell the U.S. Marketing Plans for Collaboration Products signature verification, authentication and any material amendments to the U.S. Development Plans other solution's. Such training wig include literature, collateral, presentations, CD's, web based training and U.S. Marketing Plans;on-site training. (c) Coordinate Development SIVault will at no charge provide technical assistance fix software support 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;configuration support to RYCOM engineering personnel. (d) At each meeting of SiVault will at no charge provide to RYCOM all necessary signature verification solution product updates, features, changes, revisions etc as and when they become available to deliver the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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;signature verification service. (e) Review SiVault will furnish RYCOM with all third party product market evaluation 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 ** testing reports for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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 portionssignature verification solution.

Appears in 1 contract

Sources: Strategic Alliance and Exclusive Management Agreement (SiVault Systems, Inc.)

Responsibilities. The Joint Steering 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 and oversee establishing the Development and strategy for the Commercialization of the Collaboration Licensed Products in the United States pursuant to the terms of this Agreement; Field in North America; (b) Review developing and approve approving the U.S. Development Plans Commercialization Plan/Budget in accordance with Section 2.5, as well as updating the Commercialization Plan/Budget and amending the U.S. Marketing Plans for Collaboration Products and any material amendments Commercialization Plan/Budget from time to the U.S. Development Plans and U.S. Marketing Plans; time as appropriate; (c) Coordinate Development 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 Collaboration strategy for Commercializing the Licensed Products in the ROW with the Development Field in North America (including strategies related to regulatory approvals, reimbursement, advertising and Commercialization of the Collaboration Products promotion, brand integrity, sales, and launch sequence as set forth in the United States with appropriate liaison with Commercialization Plan/Budget); (e) providing input to the Joint Development Committee regarding the target product profile for the Licensed Products and making recommendations regarding changes to the Joint Marketing Committee; same; (df) At each meeting 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 and that the Parties mutually agree shall be the responsibility of the Joint Steering Commercialization Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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.

Appears in 1 contract

Sources: Collaboration, License and Option Agreement

Responsibilities. The Joint Steering 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 the Development and discussing each Co-Commercialization of the Collaboration Plan for Co-Commercialized Licensed Products in the United States pursuant to the terms of this AgreementCo-Commercialization Territory, including amendments thereto; (b) Review and approve the U.S. Development Plans determining style guidelines and the U.S. Marketing Plans for Collaboration appearance of Co-Commercialized Licensed Products and any material amendments to in the U.S. Development Plans and U.S. Marketing PlansCo-Commercialization Territory, including packaging; (c) Coordinate Development determining managed health care strategy and Commercialization of the Collaboration tactics, including Pricing, rebates, discounts and charge-backs for Co-Commercialized Licensed Products in the ROW with the Development and Co-Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteeTerritory; (d) At each meeting determining the appropriate use of medical science liaisons in support of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for the United States to the budgeted Development Expenses and Marketing Expenses for the United States for the yearCo-to-date, as current as practicable to a date immediately prior to the date of the meetingCommercialized Licensed Products; (e) Review determining the format and approve quantities of promotional sales, marketing and educational materials for the progress of the other committeesCo-Commercialized Licensed Products; (f) Review reviewing and approve the trademarks selected under Section 2.4; (g) Review and approve "go/noapproving any proposals for modifications of existing Co-go" decisions and other matters referred to the Joint Steering CommitteeCommercialized Licensed Products, including, without limitation, new formulations after First Commercial Sale and line extensions; (g) agreeing upon the continued Development design and implementation of a particular Collaboration all Co-Commercialized Licensed Product or the inclusion of Additional Productslaunch activities; (h) Life cycle management of, and intellectual property protection for, monitoring the Collaboration progress of Co-Commercialization of Co-Commercialized Licensed Products in the United StatesCo-Commercialization Territory under the Co-Commercialization Plan and each Party’s activities thereunder; (i) Approve any reviewing and all ** policies 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 ** for Collaboration Products, including **Co-Commercialization Territory; (j) In accordance 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 procedures established 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 Section 3.1.4, resolve disputes, disagreements the minutes of the USJCC; (n) reviewing and deadlocks unresolved by the other committeesapproving Product Promotional Materials related to Co-Commercialized Licensed Products; and (ko) Have making such other responsibilities decisions as may be assigned delegated to the Joint Steering Committee USJCC pursuant to this Agreement or as may be mutually agreed upon by mutual written agreement of the Parties from time to time. ** = Certain information on this page has been omitted and filed separately with during the Commission. Confidential treatment has been requested with respect to the omitted portionsTerm.

Appears in 1 contract

Sources: License and Co Commercialization Agreement (Arqule Inc)

Responsibilities. The Joint Steering Committee a. Heads of agencies shall: (1) Cooperate with the Secretary of the Budget and the Secretary of General Services to implement the Contractor Responsibility Program, including the amendment of existing regulations, when appropriate. (2) Have primary responsibility for reporting instances of contractor nonresponsibility, deficient contractor performance, including performance on requirements contracts (commonly (3) Designate a senior manager to carry out the agency’s responsibilities under this directive and report to the Department Security Coordinator (DSC) the name of the individual. This person shall ---------------- perform the following functionsbe responsible for: (a) Manage and oversee the Development and Commercialization of the Collaboration Products in the United States pursuant authorizing updates to the terms of this AgreementCentral Contractor Responsibility File and designating who has the update capability and who is authorized to access the file; (b) Review and approve ensuring that the U.S. Development Plans and overall security of the U.S. Marketing Plans Central Contractor responsibility File is maintained for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing Plans;his agency; and (c) Coordinate Development making a written determination that the agency has followed the procedures in section 7a, in determining the contractor to be responsible. (4) Consult with the Office of General Counsel and Commercialization the Office of State Inspector General in the implementation and operation of this program and in investigating complaints of contractor nonresponsibility. (5) Incorporate design and/or per- formance standards in contracts, where applicable, so that contract monitoring can be accomplished. (6) Ensure that Invitations for Bids contain language stating that if a contractor has been suspended or debarred, its bids will not be accepted or considered. (7) Ensure that all solicitations include a provision that the prospective contractor and subcontractor certify that they have not been suspended/debarred from any other state or federal government. (8) Ensure that all contracts include a provision permitting the termination of any subcontracts with contractors who have been suspended or debarred by the Commonwealth consistent with the provision of section 5d (5). (9) Ensure that the policies and proce- dures prescribed through the Directive Manage- ment System are implemented within the agency. (10) Require that contractors and pro- posed subcontractors provide their name and federal identification number in response to solicitations for bids. b. Secretary of the Collaboration Products in the ROW Budget shall: (1) Develop jointly with the Development Secretary of General Services a Contractor Responsibility Program. (2) Direct the development and Commercialization mainte- ▇▇▇▇▇ with cooperation from the Department of General Services of a centralized system to collect and disseminate reports of contractor nonresponsi- bility and deficient performance as well as sanctions imposed against contractors. (3) Assist the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee Department of General Services and the Joint Marketing Committee;Office of State Inspector General in developing and maintaining policies, procedures, and guidelines for agencies to investigate and report contractor nonresponsibility and deficient perform- ance. (d4) At each meeting Exempt specific grant and loan programs from this directive and notify the Secretary of the Joint Steering Committee, review a comparison General Services of actual Development Expenses and Marketing Expenses for 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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 portionsthese exemptions.

Appears in 1 contract

Sources: Memorandum of Understanding

Responsibilities. The During the term of the Agreement, the Commercialization Team Leaders shall meet to discuss the progress of the Commercialization Program and other activities as the Joint Steering Committee shall ---------------- perform the following functions: may approve at least bi-weekly by phone or video conference, and in person at least once every calendar month (a) Manage and oversee the Development and Commercialization of the Collaboration Products in the United States pursuant to the terms of this Agreement; (b) Review and approve the U.S. Development Plans and 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 location alternating between the facilities of ACLARA and TWT unless otherwise agreed). The Commercialization of Team Leader for each Party shall act as the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing Committee; (d) At each meeting chairperson of the Joint Steering CommitteeCommittee for such Party and shall keep the Joint Steering Committee reasonably informed regarding such Party's progress under the Commercialization Program. Additionally, review a comparison of actual Development Expenses each Project Leader shall be responsible for (i) monitoring the schedules and Marketing Expenses for 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 Commercialization Program against the Commercialization Plan and Budget; (ii) discussing remedial measures if the Commercialization Team Leaders determine that the progress with respect to a particular Sales Goal or a particular task under the Commercialization Plan and Budget is unsatisfactory; (iii) receiving and submitting requests for information, materials and/or assistance between the Parties, including coordinating sales calls and information sharing; (iv) preparing and providing quarterly written reports to the other committees; Party in accordance with Section 6.7.5(ii); (fv) Review coordinating the preparation and approve providing each proposed Commercialization Plan and Budget to the trademarks selected under Section 2.4; other Joint Steering Committee members by October 1 of each calendar year; (gvi) Review overseeing and approve "go/no-go" decisions coordinating orders of ACLARA Components and Approved Products, including the forecasts therefor; and (vii) performing such other matters referred activities as approved by the Joint Steering Committee. Approximately [ * ] hours of each Commercialization Team Leader's time during each calendar month hereunder shall be dedicated to such activities to the extent necessary to perform the activities; it being understood that each Commercialization Team Leader shall devote greater time to such activities during the plan and budget establishment process as is reasonably necessary in order to coordinate and prepare a draft Commercialization Plan and Budget to the Joint Steering Committee, including, without limitation, . Such time commitment of 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as Commercialization Team Leaders may be assigned to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon adjusted by written agreement of 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.

Appears in 1 contract

Sources: Development and Commercialization Agreement (Aclara Biosciences Inc)

Responsibilities. The Joint Steering Committee shall ---------------- perform purpose of the following functionsJSC 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 Plan and to oversee the Collaboration. 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 Territory Specific Development Plan; (ii) review, discuss and approve proposals to add any Additional Program to the Collaboration, which approval shall also subsequently require the approval of the Parties themselves; (iii) review the results of the QTPP Testing and determine if the QTPP Testing results achieve the specifications that are set forth in the Territory Specific Development Plan; (iv) coordinate the supply of Materials (including Vector Supply) between the Parties for use under the Territory Specific Development Plan; (v) 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 Collaboration; (vi) review and discuss (but for clarity, not approve) the Development of the Product by JW in the JW Territory after Completion of the Phase I Trial; (vii) review and discuss (but for clarity, not approve) the Commercialization Plan for the Product by JW; (viii) establish such subcommittees and working groups as it may deem appropriate to carry out the goals of the Collaboration; and (ix) 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 to review and approve any Development and Commercialization of the Collaboration Products in the United States pursuant JW Product by JW, provided that such revision shall be subject to the terms of this Agreement; (b) Review Parties’ mutual agreement and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments not subject 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 the United States to the budgeted Development Expenses and Marketing Expenses for the United States for the year▇▇▇▇’s final decision-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 making authority 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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 portions2.3(d).

Appears in 1 contract

Sources: Collaboration Agreement

Responsibilities. The Joint Steering Supply Committee shall perform ---------------- perform the following functions: (a) Manage and oversee the activities in relation to manufacture and supply of API Compound and Collaboration Products for use in Development and Commercialization of the and establish procedures and protocols for testing API Compound and Collaboration Products in to ensure that such API Compound and Collaboration Products comply with the United States pursuant specifications (the "Testing ------- Protocol"). The Parties will utilize such Testing Protocol with respect to the terms of this AgreementAPI -------- Compound and Collaboration Product that they may receive from Product Suppliers to ensure that such API Compound or Collaboration Product meets specifications; (b) Review Recommend and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments coordinate necessary adjustments to the U.S. Development Plans and U.S. Marketing Plansmanufacturing schedule to ensure it is meeting the needs for all Collaboration Products; (c) Coordinate Development and Commercialization allocation of the Collaboration Products API Compound in the ROW with the Development and Commercialization event of the Collaboration Products in a shortage between the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteeROW, it being understood that, in the event of a shortage, allocation of API Compound shall be as follows:**; (d) At each meeting Review the quality of the Joint Steering Committeemanufacture of the Collaboration Products, review a comparison reviewing as appropriate reports of actual Development Expenses the manufacturers of API Compound and Marketing Expenses for the United States Collaboration Products and reports as to the budgeted Development Expenses and Marketing Expenses for quality of any packaging that bears the United States for relevant trademarks or housemarks of the year-to-date, Parties (as current as practicable to a date immediately prior owned by or licensed to the date of the meetingrelevant Party under Section 2.4) as prescribed by this Agreement; (e) Review Recommend and approve the progress of the other committeesimplement optimal inventory levels and safety stock targets; (f) Review Set improvement targets and approve the trademarks selected under Section 2.4monitor performance against these targets for cost, yield, delivery and other appropriate measures; (g) Review Establish guidelines to facilitate improved efficiencies and approve "go/no-go" decisions compliance with current Good Manufacturing Practices by Product Suppliers; 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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. (h) Have such other responsibilities as may be assigned to the Joint Supply Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

Appears in 1 contract

Sources: Collaboration Agreement (Adolor Corp)

Responsibilities. The Joint Steering 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 JSC, [*] — in every case subject to consistency with the Basic Development Plan and 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 JSC for approval [*], including but not limited to [*] (subject to consistency with the Basic Commercial Plan); (iii) On an annual rolling basis beginning within six (6) months of the Effective Date, update and amend the Medical Marketing Plan for the following Calendar Year so that it can immediately thereafter submit to the JSC such proposed Medical Marketing Plan for review and approval; (iv) Recommend to the JSC any material amendments or modifications to the Medical Marketing Plan during the Calendar Year with respect to the US; (v) Provide reports to the JSC regarding the state of the markets for Licensed Product and opportunities and issues concerning the Commercialization of the Collaboration Products in the United States pursuant to the terms Licensed Product, including consideration of this Agreement[*]; (bvi) Review and approve the U.S. Development Plans and 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 the United States to the budgeted Development Expenses and Marketing Expenses for the United States 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; (evii) Review and approve the Regularly review ASTELLAS’ 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 States that is consistent with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved Medical Marketing Plan. Such [*] will be undertaken by the other committeesASTELLAS; and (kviii) Have such other responsibilities as may be assigned to the Joint Steering 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. ** = 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.

Appears in 1 contract

Sources: License, Development and Commercialization Agreement (Theravance Inc)

Responsibilities. The Joint Steering Committee JSC will be responsible for directing and overseeing the Research Collaboration during the Research Term. The responsibilities and authority of the JSC shall ---------------- perform the following functionsbe as follows: (a1) Manage Establishing, determining the content of, reviewing, and oversee approving each Program of Work for each Collaboration Target selected and designated by GSK for prosecution under the Development Research Collaboration, and Commercialization of the Collaboration Products in the United States pursuant reviewing and approving changes or further refinements to the terms of this Agreementsame or to the Lead Criteria or Lead Compound Criteria for any Collaboration Target; (b2) Review Monitoring all of the activities under the Research Collaboration. The JSC will monitor the progress of research activities under each Program of Work within the Research Plan and approve may at any time request reports describing it with as much specificity as the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing PlansJSC may determine; (c3) Coordinate Development and Commercialization Declaration of when a relevant Collaboration Compound has become a Lead by achievement 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 CommitteeLead Criteria for selection by GSK as a relevant Target Compound; (d4) At each meeting Declaration of when a Lead within the relevant Target Compounds has become a Lead Compound (or a Backup Compounds) by achievement of the Joint Steering CommitteeLead Compound Criteria; [***]*. (5) Identification, review implementation and oversight of a comparison of actual Development Expenses and Marketing Expenses strategy to generate Backup Compounds for 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 meetingeach Collaboration Target; (e6) Review and approve the progress Recommendation to GSK of the other committeesLead Compounds or Backup Compounds for progression by GSK, at GSK’s sole discretion, for Development by GSK hereunder; (f7) Review Determination that a Collaboration Target is no longer suitable for further research and approve development under the trademarks selected collaboration under the relevant Program, subject to GSK’s rights under Section 2.46 regarding termination of a Program; (g) Review and approve "go/no-go" decisions and other matters referred 8) Facilitating transfer of information as provided by GSK with respect to the Joint Steering Committeeany Licensed Products or Lead Compounds in Development, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Productsdevelopment thereof by Sirna pursuant to Section 3.5; (h9) Life cycle management of, Establish a process by which GSK can submit task orders to Sirna for FTE-based research in support of Development; 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time. ** = Certain Indicates that certain information on this page contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (10) Establishment of an IP Subcommittee to develop, monitor and oversee a mutually-agreed strategy with respect to filing, prosecution and enforcement of all Sirna Patents, Sirna Know-How, GSK Patents, GSK Know-How, Joint Patents and Joint Know-How pertaining to any Collaboration Target, Lead, Target Compound, Lead Compound, Backup Compounds or Licensed Product, subject to GSK’s rights under Article 9 after Development has been initiated by GSK.

Appears in 1 contract

Sources: Strategic Alliance Agreement (Sirna Therapeutics Inc)

Responsibilities. The Joint Steering duties of the Alternate Dispute Resolution Committee shall ---------------- perform include but are not limited to the following functionsfollowing: (ai) Manage Maintain a list of persons qualified by temperament and oversee experience, and with technical or legal expertise in matters likely to be the Development subject of disputes, to serve as mediators or arbitrators under these PJM Dispute Resolution Procedures; ii) Determine the rates and Commercialization other costs and charges that shall be paid to mediators, advisors and arbitrators for or in connection with their services; iii) Determine whether mediation is not warranted in a particular dispute; iv) Provide to disputing parties lists of mediators, advisors or arbitrators to resolve particular disputes; v) Compile and make available to parties to disputes, arbitrators, and other interested persons suggested procedures for the arbitration of disputes in accordance with Section 4.5; vi) Maintain and make available to parties to disputes, mediators, advisors, arbitrators, and other interested persons the written decisions required by Section 4.12; vii) Establish such procedures and schedules, in addition to those specified herein, as it shall deem appropriate to further the prompt, efficient, fair and equitable resolution of disputes; and viii) Provide such oversight and supervision of the Collaboration Products in the United States dispute resolution processes and procedures instituted pursuant to the terms of this Agreement; (b) Review and approve the U.S. Development Plans and 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 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities Related PJM Agreements as may be assigned appropriate to facilitate the Joint Steering Committee pursuant prompt, efficient, fair and equitable resolution of disputes. SCHEDULE 6 ---------- Revision No. 1 REGIONAL TRANSMISSION EXPANSION PLANNING PROTOCOL ------------------------------------------------- Issued: June 2, 1997 Effective: January 1, 1998 1. REGIONAL TRANSMISSION EXPANSION PLANNING PROTOCOL Purpose and Objectives This Regional Transmission Expansion Planning Protocol shall govern the process by which the Members shall rely upon the Office of the Interconnection to this Agreement or as may prepare a plan for the enhancement and expansion of the Transmission Facilities in order to meet the demands for firm transmission service in the PJM Control Area. The Regional Transmission Expansion Plan to be mutually agreed upon by developed shall enable the Parties from time transmission needs in the PJM Control Area to time. ** = Certain information be met on this page has been omitted a reliable, economic and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsenvironmentally acceptable basis.

Appears in 1 contract

Sources: Operating Agreement (PPL Electric Utilities Corp)

Responsibilities. The Joint Steering 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 Development and preparation by the Parties of, each Product Co-Commercialization of the Collaboration Plan for Co-Commercialized Products in the United States pursuant to Co-Commercialization Territory, including the terms of this Agreementbudgets with respect thereto; (b) Review and approve preparing, or directing the U.S. Development Plans and preparation by the U.S. Marketing Plans Parties of, each amendment to any Product Co-Commercialization Plan for Collaboration Co-Commercialized Products and any material amendments to in the U.S. Development Plans and U.S. Marketing PlansCo-Commercialization Territory or the related budget with respect thereto; (c) Coordinate Development reviewing and Commercialization of the Collaboration approving [***] matters for Co-Commercialized Products in the ROW with the Development and Co-Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteeTerritory; (d) At each meeting of reviewing and approving [***] matters for Co-Commercialized Products in the Joint Steering CommitteeCo-Commercialization Territory, review a comparison of actual Development Expenses and Marketing Expenses for the United States to the budgeted Development Expenses and Marketing Expenses for the United States for the yearincluding Co-to-date, as current as practicable to a date immediately prior to the date of the meetingCommercialization Trademarks; (e) Review reviewing and approve approving [***] of Co-Commercialized Products in the progress Co-Commercialization Territory, including [***]; Portions of this Exhibit were omitted and have been filed separately with the Secretary of the other committees;Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. (f) Review reviewing and approve approving [***], including [***] for Co-Commercialized Products in the trademarks selected under Section 2.4Co-Commercialization Territory; (g) Review determining the appropriate use of [***] in support of the Co-Commercialized Products; (h) determining the format and approve "go/noquantities of promotional sales, marketing and educational materials for the Co-go" decisions Commercialized Products; (i) in conjunction with the JDC, reviewing and other matters referred to the Joint Steering Committeeapproving any proposals for [***] of existing Co-Commercialized Products, 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 [***] after First Commercial Sale and [***]; (j) In accordance with agreeing upon the procedures established in Section 3.1.4, resolve disputes, disagreements design and deadlocks unresolved by the other committees; andimplementation of all Co-Commercialized Product [***] activities; (k) Have 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 Steering 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 to time. ** = Certain information on this page has been omitted and filed separately with during the Commission. Confidential treatment has been requested with respect Term; (v) establishing any subcommittees or teams as deemed necessary; and (w) resolving any other disputes raised to the omitted portionsJCC.

Appears in 1 contract

Sources: Collaborative Development, Commercialization and License Agreement (Synta Pharmaceuticals Corp)

Responsibilities. The Joint Steering Committee JCC shall ---------------- perform the following functions: (ai) Manage review and approve the annual Marketing Plan developed by Endo; (ii) oversee the Development implementation of the Marketing Plans and approve modifications to the Marketing Plan throughout the year; (iii) discuss the state of the markets for the Product in the Territory and opportunities and issues concerning the Commercialization of the Collaboration Products in the United States pursuant to the terms Product, including consideration of this Agreementmarketing and promotional strategy, marketing research plans, labeling, Product positioning and Product profile issues; (biv) Review if applicable under Sections 5.5 and 5.8, oversee and coordinate the sales efforts of Endo and DURECT; (v) review and approve the U.S. Development Plans 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 U.S. Marketing Plans context of the overall marketing and promotional strategy for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing PlansProduct; (cvi) Coordinate Development review and direct all indigent care use of the Product; (vii) review and approve Sales Projections in accordance with Section 6.3; (viii) 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 Collaboration Products in Product, Finished Product and Implanter, including the ROW with the Development Marketing Plan, Marketing Budgets, market research studies, and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee Product, Finished Product and the Joint Marketing CommitteeImplanter sales and prescription trends and sales forecasts; (dx) At at each meeting of the Joint Steering CommitteeJCC, review a comparison of actual Development Expenses sales and Marketing Expenses for the United States marketing expenses to the budgeted Development Expenses and expenses in the relevant Marketing Expenses for the United States Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting; (exi) Review at least once each calendar year by a date no later than [* * *], review and approve the progress of the other committeesMarketing Plan as updated by Endo; (fxii) Review review and approve the trademarks selected under Section 2.4general guidelines applicable to the 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); (gxiii) Review evaluate and approve "go/no-go" decisions and other matters referred to the Joint Steering Committee, including, without limitation, the continued Development use of a particular Collaboration Product or the inclusion of Additional Productsany technical support representatives; (hxiv) Life cycle management ofreview and direct the publication strategy, and intellectual property protection for, in consultation with the Collaboration Products in the United StatesPDC; (ixv) Approve any in consultation with the PDC, review and all ** policies and ** in approve the ** Specifications for Collaboration Productsthe Finished Product, including **the packaging and related materials, prior to Commercial use; (jxvi) In accordance develop3 appropriate procedures, pursuant to Section 8.13 and in consultation with the procedures established in JMC, regarding the manufacture and sale of Implanters; (xvii) review and, if appropriate, approve the supplemental call plan, if any, submitted by DURECT pursuant to Section 3.1.4, resolve disputes, disagreements 5.8; (xviii) evaluate and deadlocks unresolved by the other committeesdetermine whether to market and sell an Implant Kit; and (kxix) Have have such other responsibilities as may be assigned to the Joint Steering Committee JCC 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.

Appears in 1 contract

Sources: License Agreement (Durect Corp)

Responsibilities. The Joint Steering 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 Development and Commercialization Steering Committee, as may be reasonably required to meet the goals of the Collaboration Products Research Plan and the Collaboration, and in the United States pursuant to event of Monsanto’s exercise of the terms of this AgreementResearch Extension Option; (b) Review To recommend to the Steering Committee changes in assays and approve the U.S. Development Plans and the U.S. Marketing Plans validation processes for Collaboration Products Hit Homologs, Special Collaboration Hits and any material amendments Preferred Mode of Use; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the U.S. Development Plans confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and U.S. Marketing Plans;Exchange Commission. (c) Coordinate Development To recommend to the Steering Committee amendments, modifications and Commercialization supplements to the Research Plan, and changes to validation criteria of the Collaboration Products in the ROW with the Development Hit Homologs Special Collaboration Hits and Commercialization Preferred Modes of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteeUse; (d) At least sixty (60) days prior to the commencement of each meeting of Collaboration Year, to review and approve, subject to final approval by the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses detailed research plan for the United States subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the budgeted Development Expenses Discovery Programs to be conducted and Marketing Expenses for the United States for Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the year-to-date, as current as practicable Steering Committee shall automatically constitute an amendment to a date immediately prior to the date and part of the meetingResearch Plan; (e) Review To discuss ways for Monsanto to assist the gene discovery and approve the progress identification of the other committeesPreferred Modes of Use processes, such as by providing Evogene with certain know-how and Monsanto Data; (f) Review To monitor the parties’ performance of their respective Diligence Obligations (based on the reports to be provided by each party as set forth in Sections 2.8.1 and approve 2.8.2) and to review and amend the trademarks selected under Section 2.4format of the parties’ reports, as may be reasonably required in order to enable the Research Committee to monitor the parties’ performance of their respective Diligence Obligations; (g) Review To discuss, at a general level, information provided on Collaboration Hit Homologs and approve "go/no-go" decisions and other matters referred to Special Collaboration Hits, such as the Joint Steering Committee, including, without limitationCollaboration Hit Data Backpacks, the continued Development of a particular Collaboration Product or the inclusion of Additional Products; (h) Life cycle management ofDiscovery Validation Data Backpacks, and intellectual property protection for, the Collaboration Products Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to the validation of the Collaboration Hit Homologs, Special Collaboration Hits and Preferred Modes of Use in the United States; (i) Approve any and all Monsanto Pipeline; *** policies and ** in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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 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.

Appears in 1 contract

Sources: Collaboration and License Agreement (Evogene Ltd.)

Responsibilities. The Joint Steering Committee JCC shall ---------------- perform be responsible for overseeing the conduct and progress of the Commercialization of each Product in the U.S. Territory and the Co-Promotion of each Co-Promoted Product in the U.S. Territory. Without limiting the generality of the foregoing, the JCC shall have the following functionsresponsibilities: (a) Manage and oversee preparing or directing the Development and preparation by the Parties of, each Product Commercialization of Plan, including the Collaboration Products in the United States pursuant to the terms of this Agreementbudget; (b) Review and approve preparing or directing the U.S. Development Plans and preparation by the U.S. Marketing Plans for Collaboration Products and Parties of, each amendment to any material amendments to Product Commercialization Plan or the U.S. Development Plans and U.S. Marketing Plansrelated budget; (c) Coordinate Development deciding Pricing and Commercialization of the Collaboration Products Branding matters 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 CommitteeU.S. Territory; (d) At each meeting deciding appearance of the Joint Steering CommitteeProduct, review a comparison of actual Development Expenses packaging and Marketing Expenses for 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 meetingpromotional materials; (e) Review determining managed health care strategy and approve the progress of the other committeestactics, including pricing, rebates, discounts and charge-backs; (f) Review agreeing upon the market definition against which the Product will be measured for internal and approve the trademarks selected under Section 2.4external reporting purposes; (g) Review determining the appropriate use of medical science liaisons in support of the Product; (h) determining the format and approve "go/no-go" decisions quantities of promotional sales, marketing and other matters referred to educational materials for the Joint Steering CommitteeProduct; (i) reviewing and approving any proposals for development of additional Product or modifications of existing Products, including, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Products; (h) Life cycle management of, new formulations after First Commercial Sale 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 **line extensions; (j) In accordance with agreeing upon the procedures established in Section 3.1.4, resolve disputes, disagreements design and deadlocks unresolved by the other committees; andimplementation of all Product launch activities; (k) Have monitoring the progress of Commercialization of Products under each Annual Product 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 Products; (m) reconciling issues between, the Parties with respect to the Parties’ respective share of Operating Income (Loss) with respect to Co-Promoted Products; (n) preparing or directing the preparation by the Parties of short-term and long-term sales forecasts for Products; (o) determining appropriate targets for sales force staffing and territory mapping purposes, determining the Co-Promotion Percentage of each Party, provided that the Co-Promotion percentage of neither Party shall be [***], and coordinating the Detailing efforts of both Parties with respect to Co-Promoted Products; (p) overseeing all recalls, market withdrawals and any other corrective actions related to Products; (q) receiving and providing to the Parties sales reports pertaining to Collaboration Products; (r) subject to the requirement in the Co-Promotion Agreement that Third Parties shall only be used to Co-Promote if the other Party has been given the option to conduct the extra Details and be reimbursed on the basis set forth in the Co-Promotion Agreement and turned down the option, approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Collaboration Products, any such approval to be reflected in the minutes of the JCC; (s) monitoring compliance of marketing activities throughout the Territory with Applicable Laws and the corporate governance codes and policies of the Parties; (t) making such other responsibilities decisions as may be assigned delegated to the Joint Steering 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 to time. ** = Certain information on this page has been omitted during the Term; (u) reviewing the MERCK ROW Product Commercialization Plan as set forth in Section 3.5.2 and filed separately with the Commission. Confidential treatment has been requested providing a forum for discussion with respect to the omitted portionsCommercialization of Products in the ROW Territory.

Appears in 1 contract

Sources: Collaboration Agreement (Ariad Pharmaceuticals Inc)

Responsibilities. The Joint Steering 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 JMC’s performance of its responsibilities; (b) reviewing data, reports or other information submitted to it by the JDC, JMC and JFC from time to time; (c) resolving all JDC, JMC or JFC matters that are referred to the JSC for resolution; (d) making such other decisions as may be delegated to the JSC pursuant to this Agreement or by mutual written agreement of the Parties 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 update 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 the Collaboration Products each Licensed Product in the United States pursuant Field to the terms extent applicable. In the event ImmunoGen exercises a Co-Development Option, the members of this Agreement; Biotest and ImmunoGen on the JSC shall provide (bi) Review and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments an update as to the U.S. Development Plans and U.S. Marketing Plans; (c) Coordinate Development and Commercialization of the Collaboration Products in the ROW with Co-Promotion strategy for the Development and Commercialization of the Collaboration Products each Co-Developed Product in the United States 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 appropriate liaison with respect thereto in the Joint Development Committee 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 Joint Marketing Committee; (d) At each 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 Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee 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 portionsJSC.

Appears in 1 contract

Sources: Collaborative Development and License Agreement (Immunogen Inc)

Responsibilities. The Joint Steering Committee shall ---------------- perform the following functions: (a) Manage and oversee the Development and Commercialization of the Collaboration Products in the United States pursuant Subject to the terms of this Agreement; (b) Review and approve the U.S. Development Plans and 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 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 limitation3.1.1(a), 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; JDC’s responsibilities will be: (i) Approve reviewing and approving the Development Plan no less than once per Year and any amendments thereto; (ii) reviewing and all ** policies approving the Development Budget no less than once per Year and ** any amendments thereto; (iii) approving (or establishing procedures to approve) protocols for non-clinical or clinical studies (including Post-Approval Research) conducted for purposes of seeking Regulatory Approval for the Product in the ** Territory; (iv) making modifications to and performing quarterly monitoring of progress of such non-clinical and clinical studies and proposing additional studies for Collaboration Products, including the Product in the [**; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees; and (k) Have such other responsibilities as may be assigned to the Joint Steering Committee ] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this Agreement or as may be mutually agreed upon by the Parties from time to time. ** = Certain information on this page exhibit has been omitted and filed separately with the Commission. Confidential treatment has been requested Territory; (v) reviewing and commenting on Regulatory Submissions relating to the Product in the Territory and approving such Regulatory Submissions as specified in Exhibit D; (vi) subject to Section 3.8, developing and coordinating a strategy for publications relating to the Product in the Territory to be made by the Parties and their respective Affiliates, licensees and Sublicensees; (vii) subject to Sections 3.2.2, 3.2.3 and 3.2.4 and any other applicable terms of this Agreement, facilitating the exchange of all data, information, material or results relating to the Development of the Product in the Territory; (viii) facilitating the exchange of Ironwood Know-How that is necessary or useful for AstraZeneca to conduct Development activities; and (ix) developing procedures for monitoring Third Party submissions to Regulatory Authorities in the Territory with respect to the omitted portionsProducts. The JDC may appoint additional committees as desired. Without limiting the foregoing, AstraZeneca acknowledges and agrees that any Development Plan approved by the JDC will be subject to review by the Joint Development Committee constituted under the Forest Agreement, and that no clinical Development of the Product may be conducted in the Forest Territory which Forest reasonably believes may adversely affect the timely development of any Product in the Forest Territory; provided that the foregoing provisions of this sentence apply solely to the extent and for so long as Forest has such rights under the Forest Agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Ironwood Pharmaceuticals Inc)

Responsibilities. The Joint Steering Committee shall ---------------- perform the following functionsJMC will: (a) Manage consistent with the provisions of Section 6.2, designate the team leader and oversee the Development and Commercialization other members of the Collaboration Products in Manufacturing Working Group, which team leader and members shall be chosen from among the United States pursuant to personnel of the terms of this AgreementParties having relevant experience, and allocate the respective roles on the Manufacturing Working Group among such members; (b) Review review on a periodic basis and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and make any material amendments necessary changes to the U.S. Development Plans team leader and U.S. Marketing Plansother members of the Manufacturing Working Group, or the allocation of roles among such members; (c) Coordinate Development and Commercialization oversee the Manufacturing Working Group, in consultation with the JDC, with respect to matters relating to the pre-clinical or clinical Manufacture 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 CommitteeProducts; (d) At each meeting oversee the Manufacturing Working Group, in consultation with the JCC, with respect to matters relating to the commercial Manufacture of the Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 meetingProducts; (e) Review and approve oversee the progress of Manufacturing Working Group, in consultation with the other committeesJDC, with respect to Manufacturing quality matters for the Products; (f) Review oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the review of the results of regulatory and approve environmental, health and safety inspections and audits related to the trademarks selected under Section 2.4Manufacture of the Products and the review and discussion of steps taken by CRISPR to address any deficiencies noted; (g) Review and approve "go/no-go" decisions and other matters referred to oversee the Joint Steering CommitteeManufacture of the Products in the Field in the Territory, includingin consultation with the JDC or JCC, without limitation, the continued Development of a particular Collaboration Product or the inclusion of Additional Productsas applicable; (h) Life cycle management of, and intellectual property protection for, allocate responsibilities for Manufacturing activities with respect to the Collaboration Products in the United StatesField in the Territory between the Parties; (i) Approve any review, discuss and all ** policies and ** approve, in consultation with the ** for Collaboration ProductsJDC 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) In accordance 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 procedures established 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 Section 3.1.4excess of $[***], resolve disputes, disagreements and deadlocks unresolved by the other committeesas set forth in ARTICLE 9; and (kp) Have perform such other responsibilities duties as may be are specifically assigned to the Joint Steering Committee pursuant to JMC under this Agreement or as may be mutually agreed upon delegated to the JMC 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 portionsJSC.

Appears in 1 contract

Sources: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)

Responsibilities. The Joint Steering Committee JCC shall ---------------- perform the following functions: (ai) Manage and oversee the Development preparation and Commercialization implementation of the Collaboration Products in the United States pursuant to the terms of this Agreement; (b) Review and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments to the U.S. Development Plans and U.S. Marketing Plans; (cii) Coordinate Development oversee and Commercialization coordinate the sales efforts of ERS and the Company; (iii) review and approve Marketing Plans; (iv) discuss the state of the Collaboration markets for Products in the ROW 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 Development and Commercialization of the Collaboration Products in the United States with appropriate liaison with the Joint Development Committee and the Joint Marketing CommitteePlans; (dv) 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 Steering CommitteeJCC, review a comparison of actual Development Expenses sales and Marketing Expenses for the United States marketing expenses to the budgeted Development Expenses and expenses in the relevant Marketing Expenses for the United States Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting; (exiii) Review review and approve the progress 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 other committeesCompany in the promotion of such Products (such guidelines to be consistent with the then-current Marketing Plan applicable to such Products); (fxiv) Review 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 trademarks selected under Section 2.4joint publication strategy together with the PDC; (gxvi) Review evaluate and approve "go/nodetermine the existence or non-go" decisions and other matters existence of a Co-Promotion Problem 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 JCC in the United States; (i) Approve any and all ** policies and ** in the ** for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committees5.6(e); and (kxvii) Have have such other responsibilities as may be assigned to the Joint Steering Committee JCC 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 ." (f) Section 2.4(d) is hereby deleted in its entirety and filed separately replaced with the Commission. Confidential treatment has been requested with respect to the omitted portions.following:

Appears in 1 contract

Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc)

Responsibilities. The Joint Steering Committee JPC shall ---------------- perform the following functions: (ai) Manage and oversee Consult with THERAVANCE in the case of the Development 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 (providing any comments within thirty (30) days of the submission thereof by the applicable Party) and submit them to the JSC for review and approval; (ii) At an appropriate and regular frequency, review the Development strategy (and, when appropriate, the Commercialization strategy) for the Licensed Product in the Field; (iii) Review and discuss whether or not to recommend to the JSC any material amendments or modifications to the Development Plan or the Commercialization Plan; (iv) Coordinate and monitor regulatory strategy and activities for the Licensed Product in accordance with Article 7; (v) 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 Collaboration Products in the United States pursuant to the terms Licensed Product, including consideration of this Agreementmarketing and promotional strategy, marketing research plans, and labeling; (bvii) Review At an appropriate and approve regular frequency, review the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products status of all studies conducted on Licensed Product and any material amendments to the U.S. Development Plans and U.S. Marketing Plansresults therefrom; (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; (dviii) At each meeting of the Joint Steering Committeean appropriate and regular frequency, review a comparison Net Sales of actual Development Expenses and Marketing Expenses for the United States to the budgeted Development Expenses and Marketing Expenses for the United States 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; (eix) Review Plan and review all publications described in Section 9.03, and 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 ** publications policy for Collaboration Products, including **; (j) In accordance with the procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committeessuch publications; and (kx) Have such other responsibilities as may be assigned to the Joint Steering 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 on this page has been omitted and filed separately with the Commission**CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Confidential treatment has been requested with respect to the omitted portionsCONFIDENTIAL 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 Steering Commercialization Committee shall ---------------- perform be responsible for the following functionswith respect to all Joint DDCs and Joint Products: (a) Manage and oversee the Development and Commercialization maintaining global oversight of the Collaboration Commercialization process for all Joint DDCs and Joint Products; (b) appointing a global new product pre-launch team at or prior to the commencement of Phase IIIA Studies for such Joint DDC (a "Global New Product Pre-Launch Team"), which shall be responsible for the preparation of the Global Commercialization Framework, pursuant to Section 7.2.1, for such Joint DDC and the transition of such Global Commercialization Framework to the U.S. Joint Commercialization Product Team and the ROW Commercialization Product Team; (c) reviewing and approving the Global Commercialization Framework for each Joint DDC and Joint Product; (d) appointing a joint commercialization product team comprised of an equal number of representatives designated by each of ▇▇▇▇▇▇ and Millennium to prepare and implement the U.S. Commercialization 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) approving the appointment by ▇▇▇▇▇▇ of a commercialization product team comprised of representatives designated by ▇▇▇▇▇▇ to prepare and implement the ROW Commercialization Plan and prepare the ROW Commercialization Budget for each Joint DDC and/or Joint Product in ROW (each a "ROW Commercialization Product Team") and reviewing recommendations from and advising all ROW Commercialization Product Teams; (f) reviewing and approving the U.S. Commercialization Plan and the ROW Commercialization Plan for each Joint DDC and Joint Product; (g) reviewing and 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 budget, and determining the geographic breakdown for the ROW Commercialization Budget; (h) overseeing the implementation of 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 States pursuant to ensure that such allocation is consistent with the terms provisions of this AgreementSections 7.3 and 7.4; (bk) Review and approve the U.S. Development Plans and the U.S. Marketing Plans for Collaboration Products and any material amendments establishing Co-Promotion Guidelines, if applicable, pursuant to the U.S. Development Plans and U.S. Marketing PlansSection 7.6; (cl) 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 developing recommendations with the Joint Development Manufacturing Committee regarding the manufacturing and the supply chain strategy for a Joint Marketing Committee; (d) At each meeting of the DDC and Joint Steering Committee, review a comparison of actual Development Expenses and Marketing Expenses for 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 CommitteeProduct, including, without limitation, which Party (or Third Party) shall be responsible for specific activities within the continued Development of a particular Collaboration Product or the inclusion of Additional Productssupply chain; (hm) Life cycle management 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 intellectual property protection approving, protocols for, and otherwise overseeing and monitoring Phase IV Studies under 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 procedures established in Section 3.1.4, resolve disputes, disagreements and deadlocks unresolved by the other committeesCommercialization Program; and (kq) Have performing such other tasks and undertaking such other responsibilities as may be assigned to the Joint Steering Committee pursuant to set forth in 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 portionsAgreement.

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Sources: Collaboration and License Agreement (Millennium Pharmaceuticals Inc)