Responsibilities. The JDCC shall 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 responsibilities: (a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities; (b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory; (c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5. (d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory; (e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory; (f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products; (h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory; (i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory; (j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory; (k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and (l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 5 contracts
Sources: Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc), Collaborative Development and License Agreement (Enanta Pharmaceuticals Inc)
Responsibilities. The JDCC JSC shall be responsible for overseeing the Development serve as a forum to share Know-How and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality learnings from each of the foregoingInhaled Collaboration and Vaccines Collaboration. Specifically, the JDCC shall have the following responsibilitiesJSC shall:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving provide oversight over the Collaboration Program and providing facilitate communication and discussion between the Committee Parties with respect to the Parties sales reports pertaining Collaboration Program; Confidential treatment has been requested with respect to Coportions 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.
(ii) ensure that each of the JVRC and JIRC be kept informed of data and Know-Developed Products in How generated under each of the Co-Developed TerritoryInhaled Plan and Vaccines Plan, respectively, that may have broad applicability or usefulness to both the Vaccines Plan and Inhaled Plan;
(jiii) approving review and approve amendments to the Inhaled Plan and Vaccines Plan and all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territoryassociated budgets;
(kiv) reviewing discuss and approving resolve any ingredients 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 are therapeutically 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 biologically active that are proposed by either Party for inclusion with a Co-Developed Product Delivery Vaccine Field, as well as outside the Liquidia Respiratory Field, the Inhaled Field or Co-Delivery Vaccine Field that is expected to create 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 Combination Productparty) 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
(lx) performing perform such activities other functions as may be delegated to the JDCC pursuant to this Agreement, or agreed by mutual written agreement of the Parties after the Approval Datein 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 JDCC shall be responsible for overseeing JSC will oversee and supervise the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality overall performance of the foregoing, the JDCC shall have the following responsibilitiesCollaboration Plan and within such scope will:
(ai) Periodically review the development Parties’ efforts and discussion of strategies for progress under the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesCollaboration Plan;
(bii) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in Review the Co-Development TerritoryCollaboration Program;
(ciii) coordinating Review any proposed modifications or amendments to the Collaboration Plan and the Collaboration Program;
(iv) Prioritize and oversee execution of specific activities to be performed under the Collaboration Plan and the Collaboration Program;
(v) Review Patent Committee advice with regard to scientific activities to be performed under the Collaboration Plan and the Collaboration Program;
(vi) Review Collaboration Program Advisory Committee advice with regard to scientific activities to be performed under the Collaboration Plan and the Collaboration Program;
(vii) Review and select Product Candidates for additional work as part of the Collaboration Program; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(viii) Review and evaluate Product Candidates for which Development work should be performed as part of the Collaboration Program;
(ix) Review and Commercialization efforts approve of both Parties in the Co-Development Territory regulatory plans and strategies for Product Candidates;
(x) Review all Regulatory Filings with respect to CoProduct Candidates;
(xi) Form such other committees (“Sub-Developed ProductsCommittees”) as the JSC may deem appropriate. For purposes of clarityAs soon as practicable (but not later than sixty (60) days) after the Effective Date, the JDCC shall not be responsible for coordinating communications with Regulatory AuthoritiesParties will establish a Sub-Committee comprised of three (3) representatives of Celgene, which is the sole responsibility three (3) representatives of Bluebird, and ▇▇. ▇▇▇▇▇▇, however, ▇ ▇▇▇▇▇▇ . Brenner (the “Collaboration Program Advisory Committee”). The Collaboration Program Advisory Committee will work directly with a regulatory liaison monitor and advise the Parties on the conduct and progress of the Collaboration Program. Each Party may replace its representatives on the Collaboration Program Advisory Committee at any time upon written notice to the other Party. Any such Sub-Committee (including the Collaboration Program Advisory Committee) may make recommendations to the JSC but may not be designated by Enanta on coordinating key regulatory FDA communications on Codelegated JSC decision-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territorymaking authority;
(exii) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory Address such other matters relating to the JSC as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts activities of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by under this Agreement as either Party to provide Representatives to Co-Promote Co-Developed Products in may bring before the Co-Developed Territory;
(k) reviewing and approving JSC, including any ingredients matters that are therapeutically or biologically active that are proposed by either Party expressly for inclusion with a Co-Developed Product the JSC to create a Combination Productdecide as provided in this Agreement; and
(lxiii) performing such activities as may be delegated Attempt to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Dateresolve any disputes on an informal basis.
Appears in 3 contracts
Sources: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Responsibilities. The JDCC shall (a) Pursuant to the RLP Development Plan for a Regional Licensed Product and, except as otherwise provided in such RLP Development Plan, or set forth in Section 7.2.1.1(b) below, each Party will be solely responsible for overseeing all regulatory matters relating to such Regional Licensed Product in its Territory and will own all INDs, NDAs, Regulatory Materials and related regulatory documents 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. in its Territory with respect to such Regional Licensed Product, including any drug master files maintained by or on behalf of such Party solely with respect thereto in such Territory, which will be and remain such Party’s sole responsibility. At Novartis’s request, [***] for a Regional Licensed Product, Surface will promptly assign and transfer to Novartis all INDs, Regulatory Materials and other regulatory documentation in the Development Novartis Territory with respect to such Regional Licensed Product that is in the possession and control of Surface, and each Party will submit to the applicable Regulatory Authority all filings, letters and other documentation necessary to effect such assignment and transfer as soon as practicable and no later than [***] after such request for such Regional Licensed Product, in each case, including any drug master files maintained by or on behalf of Surface solely with respect thereto. For clarity, Surface will not be required to transfer any drug master files maintained by or on behalf of any Third Party, including any contract manufacturer; provided that Novartis has access to or rights to cross-reference those drug master files pursuant to Section 7.2.3 to permit Novartis to comply with its regulatory obligation in connection with the Research, Development, Manufacture, and Commercialization of Co-Developed Products in the Co-Development TerritoryRegional Licensed Products. Without limiting the generality of the foregoing, the JDCC shall Each Party will have the following responsibilities:
sole right to (ai) the development oversee, monitor and discussion of strategies for the Development coordinate all regulatory actions, communications and Commercialization of filings with, and submissions to, each Co-Developed Product Regulatory Authority in the Co-Development Territoryits Territory with respect to such Regional Licensed Product; (ii) interface, including allocation of responsibilities for correspond and meet with each Regulatory Authority in its Territory with respect to such Development Regional Licensed Product, and Commercialization activities;(iii) seek and maintain all regulatory filings in its Territory with respect to such Regional Licensed Product.
(b) reviewing Notwithstanding the foregoing, and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory solely with respect to Co-Developed Productsthe first Phase 1 Safety Study conducted under a RLP Development Plan, Surface will have the right, but not the obligation, to draft the protocol, develop the IND strategy, and file INDs globally, including in the Novartis Territory, after input and review by Novartis, and, if Surface exercises such right, Surface will use reasonable efforts to address any concerns raised by Novartis in connection with such activities. For purposes of clarityIf Surface files INDs in the Novartis Territory as set forth above, then, unless otherwise agreed by the JDCC shall not Parties, promptly following [***] Surface will assign the INDs in the Novartis Territory to Novartis and from that point forward, Novartis will be primarily responsible for coordinating communications the related regulatory activities 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 respect thereto in the Co-Developed Novartis Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance Novartis will reimburse Surface for its portion of Development Costs incurred by Surface in accordance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory 5.2.3.2 with respect to Co-Developed Products;
(h) overseeing all recallsthe performance of activities described in this Section 7.2.1.1, market withdrawals including drafting protocols, developing IND strategies and any other corrective actions related preparing and submitting INDs. If Surface does not exercise such right to Co-Developed Products file INDs in the Co-Development Novartis Territory;
(i) receiving , then Novartis will draft the protocol, develop the IND strategy, and providing to file the Parties sales reports pertaining to Co-Developed Products INDs in the Co-Developed Novartis Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement. 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, or by mutual written agreement of the Parties after the Approval DateAS AMENDED.
Appears in 3 contracts
Sources: Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.), Collaboration Agreement (Surface Oncology, Inc.)
Responsibilities. The JDCC JSC shall 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 responsibilitiesfor:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving reviewing and providing approving the initial Global Development Plan prepared by the JDC, including all budgets relating to development activities to be conducted by MERRIMACK hereunder;
(ii) periodically reviewing the Global Development Plan and suggesting or approving such updates or amendments to the Parties sales reports pertaining to Global Development Plan as the JSC deems appropriate, including all budget amendments;
(iii) as long as MERRIMACK does not opt out of Co-Developed Products in Promotion, reviewing and approving the initial Commercialization Plan for the Co-Developed TerritoryPromoted Product(s) prepared by the JCC, including all budgets;
(jiv) approving all Third Parties to be engaged by either Party to provide Representatives to as long as MERRIMACK does not terminate Co-Promote Co-Developed Products in Promotion, periodically reviewing the Commercialization Plan for the Co-Developed TerritoryPromoted Product(s) and suggesting or approving such updates or amendments to such Commercialization Plan as the JSC deems appropriate, including all budget amendments;
(kv) reviewing providing overall strategic direction with respect to research, development, regulatory and approving 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 Global Development Plan and the Commercialization Plan (if any) hereunder;
(vii) establishing a projected Marketing Authorization application filing date for the United States (“US Filing Date”) for each Licensed Product, which planned US Filing Date may be periodically updated by the JSC based on its reasonable assessment of the clinical progress of such Licensed Product;
(viii) keeping MERRIMACK apprised, through MERRIMACK’s representatives on the JSC, of the planned US Filing Date for each Licensed Product, including any ingredients updates thereto;
(ix) attempting to resolve disputes arising under this Agreement that are therapeutically referred to the JSC by the JDC, JCC or biologically active that are proposed by either of the Parties (for clarity, the JSC shall not have the authority to resolve disputes between the Parties regarding whether a Party for inclusion with a Co-Developed Product to create a Combination Producthas fulfilled or breached any obligation under this Agreement); and
(lx) performing such activities other tasks and undertaking such other responsibilities as may be delegated to the JDCC pursuant to set forth in this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Merrimack Pharmaceuticals Inc), License and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Responsibilities. The JDCC JPT shall be responsible for (a) overseeing the conduct and progress of the Research Program, the recommendation of Optimized Lead Compounds and the recommendation of Development Candidates for which ARCHEMIX is responsible for performing ARCHEMIX Development Activities; provided, that, any ARCHEMIX Development Activities with respect to Co-Developed Collaboration Aptamers shall fall in the scope of responsibility of the Joint Development Committee described in Section 2.3 below; and (b) overseeing the Development of Optimized Lead Compounds and Commercialization Development Candidates for which, and the conduct and progress of each Development Program under which, ARCHEMIX is responsible for performing ARCHEMIX Development Activities, 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. provided, that, any ARCHEMIX Development Activities with respect to Co-Developed Products Collaboration Aptamers shall fall in the Co-scope of responsibility of the Joint Development TerritoryCommittee described in Section 2.3 below. Without limiting the generality of the foregoing, the JDCC JPT shall have the following responsibilities:
(a) preparing or directing the development preparation of, approving, and discussion of strategies recommending to the JSC for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesits approval all Annual Research Plans;
(b) reviewing preparing or directing the preparation of and discussing a Marketing and Sales Plan for each Coapproving amendments to JSC-Developed Product approved Annual Research Plans as it deems appropriate in furtherance of the objectives of the Research Program as set forth in the CoResearch Plan and, if any member of the JPT asserts that any such JPT-Development Territoryapproved amendment would change the objectives of such Annual Research Plan, submitting such amendment to the JSC for its consideration;
(c) coordinating monitoring the Development progress of each Annual Research Plan and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enantaeach Party’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.activities thereunder;
(d) reviewing and providing input in a forum for consensual decision making with respect to the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryResearch Program;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products data, reports or other information submitted by either Party with respect to work conducted in the Co-Developed TerritoryResearch Program;
(f) presenting sales forecasts preparing for the JSC on at least a semi-annual basis a progress report for the Research Program in reasonable detail and the results of all efforts in the Co-Development Territory providing to the JSC such additional information as needed, but no less often than two (2) times per Calendar Yearit may request;
(g) coordinating recommending amendments to the Detailing efforts OLSC and/or DCSC as it deems appropriate in furtherance of both Parties the objectives of the Research Program or Development Program, as applicable, as set forth in the Co-Research Plan or Development Territory with respect to Co-Developed ProductsPlan, as applicable;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in nominating Lead Compounds as Optimized Lead Compounds for acceptance by the Co-Development TerritoryJSC;
(i) receiving and providing to nominating Optimized Lead Compounds for which ARCHEMIX is responsible for performing ARCHEMIX Development Activities as Development Candidates for acceptance by the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryJSC;
(j) approving preparing or directing the preparation of, approving, and recommending to the JSC for its approval all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed TerritoryAnnual Development Plans under which ARCHEMIX is responsible for performing Development activities;
(k) reviewing preparing or directing the preparation of and approving amendments to JSC-approved Annual Development Plans under which ARCHEMIX is responsible for performing ARCHEMIX Development Activities, as it deems appropriate in furtherance of the Development of Development Candidates and, if any ingredients member of the JPT asserts 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. that are therapeutically any such JPT-approved amendment would change the objectives of that Annual Development Plan, submitting such amendment to the JSC for its consideration;
(l) monitoring the progress of the Development of each Development Candidate for which ARCHEMIX is performing ARCHEMIX Development Activities, in accordance with, and of each Party’s activities under, the applicable Annual Development Plan;
(m) providing a forum for consensual decision making with respect to the Development Program under which ARCHEMIX is responsible for performing ARCHEMIX Development Activities;
(n) reviewing data, reports or biologically active that are proposed other information submitted by either Party with respect to work conducted in the Development Program under which ARCHEMIX is responsible for inclusion with performing ARCHEMIX Development Activities;
(o) preparing for the JSC on at least a Cosemi-Developed Product annual basis a progress report for the Development Program under which ARCHEMIX is responsible for performing ARCHEMIX Development Activities, in reasonable detail and providing to create a Combination Productthe JSC such additional information as it may request; and
(lp) making any other decisions as may be delegated to the JPT pursuant to this Agreement or by mutual written agreement of the Parties after the Effective Date and performing such activities as may be delegated to the JDCC JPT pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The JDCC JPT shall be responsible for (i) overseeing the Development conduct and Commercialization progress of Co-Developed Products in the Co-Development TerritoryResearch Program and (ii) recommending Program Aptamers to the JMC for nomination as Lead Compounds and Clinical Candidates. Without limiting the generality of the foregoing, the JDCC JPT shall have the following responsibilities:
(a) preparing or directing the development preparation of, and discussion of strategies recommending to the JMC for the Development its approval, all Annual Research Plans and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesbudgets therefor;
(b) preparing or directing the preparation of all amendments to JMC-approved Annual Research Plans as it deems appropriate in furtherance of the objectives of the Research Program as set forth in the Annual Research Plan and submitting such amendments to the JMC for its consideration;
(c) monitoring the progress of each Annual Research Plan and of each Party’s activities thereunder;
(d) providing a forum for consensual decision making with respect to the Research Program;
(e) reviewing data, reports or other information submitted by either Party with respect to work conducted in the Research Program; 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 406 of the Securities Act.
(f) preparing for the JMC on at least a semi-annual basis a progress report for the Research Program in reasonable detail and providing to the JMC such additional information as it may request;
(g) recommending amendments to the Lead Selection Criteria and Clinical Candidate Selection Criteria as it deems appropriate, in furtherance of the objectives of the Research Program as set forth in the Research Plan;
(h) considering the need for, and recommending as appropriate, the identification and research of Back-Up Collaboration Compounds;
(i) nominating Collaboration Compounds or IL-23 Aptamers as Lead Compounds for acceptance by the JMC;
(j) nominating Lead Compounds as Clinical Candidates for acceptance by the JMC;
(k) discussing all Annual Development Plans for Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation;
(l) discussing all amendments to the Annual Development Plans described in Section 2.2.4(k), above and submitting such amendments to the JMC for its consideration;
(m) reviewing data, reports or other information submitted by either Party with respect to work conducted in the Development of Clinical Candidates that are, or are eligible for designation as, Co-Developed Products;
(n) preparing for the JMC on at least an annual basis a Marketing reasonably detailed progress report regarding the Development of Development Leads and Sales Clinical Candidates that are, or are eligible for designation as, Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation and providing to the JMC such additional information as it may reasonably request on this subject; 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 406 of the Securities Act.
(o) implementing a mutually acceptable mechanism for reporting Adverse Events between the Parties for each Development Lead, Clinical Candidate and Product;
(p) discussing strategies for the promotion and marketing of all Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation if ELAN alone (rather than with or through a Sublicensee) is or will be promoting and marketing a Co-Developed Product; provided, that, ELAN agrees to use Commercially Reasonable Efforts to include the JPT rights set forth in this Section 2.2.4(p) in each Sublicense Agreement;
(q) discussing the Product Commercialization Plan for each Co-Developed Product in the applicable Co-Development TerritoryTerritory(ies), Indication and formulation, if ELAN alone (rather than with or through a Sublicensee) is or will be Commercializing a Co-Developed Product; provided, that, ELAN agrees to use Commercially Reasonable Efforts to include the JPT rights set forth in this Section 2.2.4(q) in each Sublicense Agreement;
(cr) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on discussing the short-term and long-term sales forecasts for Co-Developed Products in the applicable Co-Development Territory(ies), Indication and formulation if ELAN alone (rather than with or through a Sublicensee) is or will be Commercializing a Co-Developed TerritoryProduct; provided, that, ELAN agrees to use Commercially Reasonable Efforts to include the JPT rights set forth in this Section 2.2.4(r) in each Sublicense Agreement;
(fs) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing discussing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the applicable Co-Development Territory;
(i) receiving Territory(ies), Indication and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productformulation; and
(lt) making any other decisions and performing such activities as may reasonably be delegated to the JDCC JPT pursuant to this Agreement, Agreement or by mutual written agreement of the Parties after the Approval Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The JDCC shall be responsible for overseeing POC Committee will discuss the Development Parties’ performance of Collaboration Activities under the Internal SAV Program Plans and Commercialization of CoPOC Plans. The POC Committee may form project teams to oversee any day-Developed Products in to-day activities necessary to execute the Co-Development TerritoryPOC Plans. Without limiting the generality of the foregoing, within such scope, the JDCC shall POC Committee will have the following responsibilities:
(ai) discuss an ISP Party’s performance of any Internal SAV Program under an Internal SAV Program Plan;
(ii) review each Party’s performance of Collaboration Activities under the development POC Plans;
(iii) review any proposed modifications or amendments to a given POC Plan (including the Data Sharing and discussion Sample Testing Schedule included therein);
(iv) review and discuss any Additional Moderna PCV POC Term Studies conducted in accordance with Section 3.3(d);
(v) resolve any disputes related to the Additional Moderna PCV POC Term Study contemplated in Section 3.3(d); Plan;
(vi) prioritize and oversee execution of strategies specific activities to be performed under each POC
(vii) review and discuss amendments to the KRAS Transition Plan (provided that any amendments to the KRAS Transition Plan must be mutually agreed to by the Parties in writing) and oversee the activities to be performed for the Development transition of the KRAS Program (including transfer of the IND) under the POC Plan and Commercialization KRAS Transition Plan for the KRAS Program;
(viii) review data, reports or other information submitted by either Party with respect to Collaboration Activities under each Internal SAV Program Plan or POC Plan;
(ix) review and discuss any actual or potential Safety Issue or Technical Failure;
(x) review and discuss any Pre-GLP Tox Data Package for a given Internal SAV Program;
(xi) review and discuss any SAV IND Data Package for a given Joint SAV Program;
(xii) form such other subcommittees or project teams as the POC Committee may deem appropriate (including any project teams to oversee the day-to-day activities necessary to execute the POC Plans) and oversee the activities of each Coany subcommittees or project teams formed by the POC Committee, including by receiving and reviewing reports and other information submitted by those subcommittees or project teams (if applicable); provided, that any such subcommittee or project team may make recommendations to the POC Committee but may not be delegated POC Committee decision-Developed Product making authority;
(xiii) [***];
(xiv) coordinate and oversee the Manufacturing activities under a POC Plan with respect to PCVs (including Collaboration PCV Products) under the applicable Programs in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesCMC matters;
(bxv) reviewing review and discussing discuss Manufacturing activities under a Marketing and Sales POC Plan for each Co-Developed Product with respect to SAVs (including Collaboration SAV Products) under the applicable Joint SAV Program in the Co-Development Territory, including CMC matters;
(cxvi) coordinating discuss and resolve all disputes referred to the Development and Commercialization efforts of both Parties in POC Committee by any subcommittee or project teams established by the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryPOC Committee;
(exvii) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and review proposed publications regarding the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties Collaboration Activities proposed to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products published 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 accordance with a Co-Developed Product to create a Combination ProductSection 12.2; and
(lxviii) performing such activities as may be delegated attempt to the JDCC pursuant resolve any disputes relating to this Agreement, or by mutual written agreement of the Parties after the Approval DateAgreement on an informal basis.
Appears in 2 contracts
Sources: Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement
Responsibilities. The JDCC Research Committee shall be responsible for overseeing supervise the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality execution of the foregoingResearch Plan and administer the Funded Project, the JDCC and its responsibilities shall have the following responsibilitiesinclude, without limitation:
(a) To periodically review whether there is need to amend or supplement the development Research Plan and discussion to recommend changes thereto to the Steering Committee, as may be reasonably required to meet the goals of strategies the Research Plan and the Collaboration; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the Development information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;Exchange Commission.
(b) reviewing To recommend to the Steering Committee changes in assays and discussing a Marketing validation processes for Collaboration Hit Homologs, Special Collaboration Hits and Sales Plan for each Co-Developed Product in the Co-Development TerritoryPreferred Mode of Use;
(c) coordinating To recommend to the Development Steering Committee amendments, modifications and Commercialization efforts supplements to the Research Plan, and changes to validation criteria of both Parties Collaboration Hit Homologs Special Collaboration Hits and Preferred Modes of Use;
(d) At least sixty (60) days prior to the commencement of each Collaboration Year, to review and approve, subject to final approval by the Steering Committee, a detailed research plan for the subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the Discovery Programs to be conducted and the Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the Steering Committee shall automatically constitute an amendment to and part of the Research Plan;
(e) To discuss ways for Monsanto to assist the gene discovery and 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 [* * *] set forth in [* * *] ([* * *]) and to [* * *] to the Co-Development Territory Steering Committee, as may be reasonably required to meet the goals of the Research Plan and the Collaboration;
(f) 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 2.8.2) and to review and amend the format 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) To discuss, at a general level, information provided on Collaboration Hit Homologs and Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks,, the Collaboration Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to Cothe validation of the Collaboration Hit Homologs, Special Collaboration Hits and Preferred Modes of Use in the Monsanto Pipeline;
(h) To receive from Evogene information on possible Independent Discovery Rounds, in accordance with Section 4.2.1, and to discuss information provided by Evogene on Internal Non-Developed ProductsField Hits which underwent the Core Validation and met the Validated Hit criteria as set forth in Section 4.2.2; *** Confidential treatment has been requested for redacted portions of this exhibit. For purposes This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of claritythis exhibit has been provided separately to the Securities and Exchange Commission.
(i) To review issues relating to Publications resulting from the activities conducted under the Collaboration, in accordance with Section 2.10;
(j) To keep a record of the JDCC shall not be responsible for coordinating communications with Regulatory AuthoritiesCollaboration Hit Sets, which is the sole responsibility of Special Collaboration Hits, PlaNet Genes, PlaNet ▇▇▇▇ ▇▇▇▇▇▇, howeverRePack Recommendations and GeneDex Recommendations licensed to Monsanto hereunder, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products termination of any such license in accordance with the Co-Development Territory;
terms of this Agreement (i) receiving and providing to For the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving avoidance of doubt, all Third Parties to GeneSpec Genes, including those that are Homologs of Collaboration Hits, shall be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territoryrecorded as such);
(k) reviewing 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 approving 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 ingredients that are therapeutically or biologically active that are proposed other decisions expressly assigned to the Research Committee by either Party for inclusion with a Co-Developed Product to create a Combination Productthis Agreement; and
(lq) performing To exercise such activities additional responsibilities as may be delegated to the JDCC pursuant to this Agreement, or Research Committee by mutual written agreement of the Parties after the Approval DateSteering Committee.
Appears in 2 contracts
Sources: Collaboration Agreement (Evogene Ltd.), Collaboration Agreement (Evogene Ltd.)
Responsibilities. The JDCC JSC shall be responsible for overseeing perform the Development and Commercialization of Cofollowing functions, subject to the final decision-Developed Products in the Co-Development Territory. Without limiting the generality making authority of the foregoing, the JDCC shall have the following responsibilitiesrespective Parties as set forth in Section 4.1.5:
(a) review and monitor progress of the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesCollaboration;
(b) reviewing and discussing a Marketing and Sales Plan for determine whether Target Validation has been achieved with respect to each Co-Developed Product in the Co-Development TerritorySelected Target;
(c) coordinating review and approve changes to the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible Tractable Hit Criteria for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.each Selected Target;
(d) reviewing and providing input in determine whether the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territoryapplicable Tractable Hit Criteria have been achieved with respect to any Compound;
(e) reviewing review and providing input on approve changes to the short-term and long-term sales forecasts Lead Candidate Criteria for Co-Developed Products in the Co-Developed Territoryeach Selected Target;
(f) presenting sales forecasts and determine whether the results of all efforts in the Co-Development Territory applicable Lead Candidate Criteria have been achieved with respect to the JSC as needed, but no less often than two (2) times per Calendar Yearany Compound;
(g) coordinating review and approve changes to the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed ProductsCandidate Selection Criteria for each Selected Target;
(h) overseeing all recalls, market withdrawals and determine whether the applicable Development Candidate Selection Criteria have been achieved with respect to any other corrective actions related to Co-Developed Products in the Co-Development TerritoryCompound;
(i) receiving serve as a forum for exchange of information and providing to facilitate discussions regarding the Parties sales reports pertaining to Co-Developed conduct of the Collaboration and the Development of Licensed Compounds, Licensed Products in the Co-Developed Territoryand Diagnostic Products hereunder;
(j) approving all Third Parties discuss and attempt to be engaged by either Party resolve any deadlocked issues submitted to provide Representatives to Co-Promote Co-Developed Products it in accordance with the Co-Developed Territoryprocedures established in Section 4.1.5;
(k) reviewing review and approving any ingredients that are therapeutically approve Research Plans submitted by the JPT;
(l) review and discuss ROFO Packages;
(m) such other responsibilities as may be assigned to the JSC pursuant to this Agreement or biologically active that are proposed as may be mutually agreed by either Party for inclusion with a Co-Developed Product the Parties from time to create a Combination Producttime; and
(ln) performing 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 activities as may be delegated matter within [**] days after the matter is first brought to the JDCC pursuant to this AgreementJSC’s attention, or by mutual written agreement of or, if earlier, at the Parties after the Approval Datenext regularly-scheduled JSC meeting.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement (Epizyme, Inc.)
Responsibilities. The JDCC JSC shall be responsible for overseeing the conduct and progress of the Research Program, the Development of Optimized Lead Compounds, the Development and Commercialization of Co-Developed Products in Collaboration Aptamers and the Co-Development Territoryof other Aptamers for which ARCHEMIX is performing Development activities. Without limiting the generality of the foregoing, the JDCC JSC shall have the following responsibilities:: Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act.
(a) overseeing the development JPT’s, JDC’s and discussion JCC’s performance of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesits respective responsibilities;
(b) reviewing and discussing approving each Annual Research Plan and each Annual Development Plan under which ARCHEMIX is responsible for performing ARCHEMIX Development Activities for a Marketing and Sales Plan for each Collaboration Aptamer, including, without limitation, a Co-Developed Product in the Co-Development TerritoryCandidate;
(c) coordinating determining, in accordance with Section 4.10.6(b), the Development and Commercialization efforts of both Parties in the ARCHEMIX Co-Development Territory Participation Level with respect to a Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Development Candidate;
(d) reviewing determining whether to file an IND and providing input in the preparation of whether to Initiate any Clinical Trial, with respect to a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryCollaboration Agreement;
(e) reviewing and providing input on approving any amendment to each Annual Research Plan approved by the short-term JPT and long-term sales forecasts submitted to it for Co-Developed Products in the Co-Developed Territoryits approval;
(f) presenting sales forecasts reviewing and the results of all efforts in the approving any amendment to an Annual Development Plan that covers a Co-Developed Development Territory Candidate and/or under which ARCHEMIX is responsible for performing Development activities approved by the JPT and submitted to the JSC as needed, but no less often than two (2) times per Calendar Yearit for its approval;
(g) coordinating reviewing data, reports or other information submitted to it by the Detailing efforts of both Parties in the Co-Development Territory with respect JPT from time to Co-Developed Productstime;
(h) overseeing resolving all recallsJPT, market withdrawals JDC and any other corrective actions related to Co-Developed Products JCC matters that are in the Co-Development Territorydispute;
(i) receiving reviewing and providing either approving or rejecting any decision of the JPT to nominate any Lead Compound as an Optimized Lead Compound or any decision of the Parties sales reports pertaining JPT to Co-Developed Products in the Co-Developed Territorynominate any Optimized Lead Compound as a Development Candidate;
(j) approving all Third Parties resolving any dispute as to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;whether a milestone event under this Agreement has occurred; and
(k) reviewing implementing a mutually acceptable mechanism for reporting Adverse Events between the Parties for each Development Candidate and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing making such activities other decisions as may be delegated to the JDCC JSC pursuant to this Agreement, Agreement or by mutual written agreement of the Parties after the Approval Effective Date.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Responsibilities. The JDCC 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) discuss material issues and provide input to each other regarding the Prosecution and Maintenance of Jounce Patents, Celgene Patents, Collaboration Patents and Joint Collaboration Patents, including recommending whether or not to file a Collaboration Patent in all Core Countries; (b) serve as a forum for exchanging information and facilitating discussions regarding patentability and freedom to operate assessments; and (c) perform such other responsibilities 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 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 overseeing coordinating the Development and Commercialization implementation of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilities:
(a) the development and discussion 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 Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Diagnostic 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, the Patent Committee shall not have any authority beyond the specific matters set forth in this would Section 4.3.4, and in particular shall not apply have any power to routine regulatory submissions amend, modify, interpret or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep waive the JDCC informed terms of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-this Agreement or any Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this & Commercialization Agreement, or to alter, increase, expand or waive compliance by mutual written agreement of a Party with, a Party’s obligations under this Agreement or any Development & Commercialization Agreement. In any case where a matter within the Parties Patent Committee’s authority arises, the Patent Committee shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] after the Approval Datematter is first brought to the Patent Committee’s attention (or, if earlier, at the next regularly scheduled Patent Committee meeting).
Appears in 2 contracts
Sources: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)
Responsibilities. The JDCC shall be responsible for overseeing POC Committee will discuss the Development Parties’ performance of Collaboration Activities under the Internal SAV Program Plans and Commercialization of CoPOC Plans. The POC Committee may form project teams to oversee any day-Developed Products in to-day activities necessary to execute the Co-Development TerritoryPOC Plans. Without limiting the generality of the foregoing, within such scope, the JDCC shall POC Committee will have the following responsibilities:
(ai) discuss an ISP Party’s performance of any Internal SAV Program under an Internal SAV Program Plan;
(ii) review each Party’s performance of Collaboration Activities under the development POC Plans;
(iii) review any proposed modifications or amendments to a given POC Plan (including the Data Sharing and discussion Sample Testing Schedule included therein);
(iv) review and discuss any Additional Moderna PCV POC Term Studies conducted in accordance with Section 3.3(d);
(v) resolve any disputes related to the Additional Moderna PCV POC Term Study contemplated in Section 3.3(d);
(vi) prioritize and oversee execution of strategies specific activities to be performed under each POC Plan;
(vii) review and discuss amendments to the KRAS Transition Plan (provided that any amendments to the KRAS Transition Plan must be mutually agreed to by the Parties in writing) and oversee the activities to be performed for the Development transition of the KRAS Program (including transfer of the IND) under the POC Plan and Commercialization KRAS Transition Plan for the KRAS Program;
(viii) review data, reports or other information submitted by either Party with respect to Collaboration Activities under each Internal SAV Program Plan or POC Plan;
(ix) review and discuss any actual or potential Safety Issue or Technical Failure;
(x) review and discuss any Pre-GLP Tox Data Package for a given Internal SAV Program;
(xi) review and discuss any SAV IND Data Package for a given Joint SAV Program;
(xii) form such other subcommittees or project teams as the POC Committee may deem appropriate (including any project teams to oversee the day-to-day activities necessary to execute the POC Plans) and oversee the activities of each Coany subcommittees or project teams formed by the POC Committee, including by receiving and reviewing reports and other information submitted by those subcommittees or project teams (if applicable); provided, that any such subcommittee or project team may make recommendations to the POC Committee but may not be delegated POC Committee decision-Developed Product making authority;
(xiii) [***];
(xiv) coordinate and oversee the Manufacturing activities under a POC Plan with respect to PCVs (including Collaboration PCV Products) under the applicable Programs in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesCMC matters;
(bxv) reviewing review and discussing discuss Manufacturing activities under a Marketing and Sales POC Plan for each Co-Developed Product with respect to SAVs (including Collaboration SAV Products) under the applicable Joint SAV Program in the Co-Development Territory, including CMC matters;
(cxvi) coordinating discuss and resolve all disputes referred to the Development and Commercialization efforts of both Parties in POC Committee by any subcommittee or project teams established by the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryPOC Committee;
(exvii) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and review proposed publications regarding the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties Collaboration Activities proposed to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products published 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 accordance with a Co-Developed Product to create a Combination ProductSection 12.2; and
(lxviii) performing such activities as may be delegated attempt to the JDCC pursuant resolve any disputes relating to this Agreement, or by mutual written agreement of the Parties after the Approval DateAgreement on an informal basis.
Appears in 2 contracts
Sources: Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.), Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.)
Responsibilities. The JDCC PDC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality not oversee, review, approve or evaluate any of the foregoing, the JDCC DURECT Activities. The PDC shall have perform the following responsibilitiesfunctions:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving approve and providing to oversee the Parties sales reports pertaining to Co-Developed Products in implementation of the Co-Developed TerritoryDevelopment Plan;
(jii) approving all Third Parties to be engaged at least once each calendar year by either Party to provide Representatives to Co-Promote Co-Developed Products in a date not later than [* * *], review and approve any amendments or modifications of the Co-Developed TerritoryDevelopment Plan;
(kiii) reviewing at least twice annually, review the Development Budget;
(iv) at each meeting of the PDC, review a comparison of actual development and approving regulatory expenses to the budgeted expenses in the Development Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(v) review and evaluate progress of the development activities; provided that the PDC shall not have authority to make any ingredients determination that are therapeutically any Party is in breach of this Agreement;
(vi) review and approve all compassionate use of the Product, Finished Product and Implanter;
(vii) review the publication strategy together with the JCC;
(viii) review and recommend to the JEC “go/no-go” decisions;
(ix) in connection with clinical trials, approve protocols, trial budget and trial design;
(x) review Regulatory Data and Regulatory Documentation to be provided by DURECT regarding all Product and Implanter development activities outside the Territory (to the extent DURECT is permitted by Third Parties, if applicable, to do so);
(xi) review and, if appropriate, approve development plans, utilizing an approach similar to the Development Plan, with respect to line extensions of the Product or biologically active Related Products; provided that are proposed by either the PDC shall not approve plans to develop at any one time more than [* * *] such products without the written authorization of DURECT and Endo;
(xii) in good faith consider potential additional line extensions of the Product and Related Products in addition to those considered pursuant to the foregoing clause (x);
(xiii) coordinate the allocation of responsibilities among the Parties with respect to development of the Product, Finished Product and Implanter based on the Development Plan;
(xiv) consult with the JMC regarding adoption of a Third Party for inclusion Manufacturing Plan pursuant to Section 8.15;
(xv) determine which portions of protocols, regulatory filings, correspondence to or from regulatory authorities etc., should be redacted before being shared with a Co-Developed Product to create a Combination ProductALZA; and
(lxvi) performing have such activities other responsibilities as may be delegated assigned to the JDCC PDC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 1 contract
Sources: License Agreement (Durect Corp)
Responsibilities. The JDCC Research Committee shall be responsible for overseeing supervise the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality execution of the foregoingResearch Plan and administer the Funded Project, the JDCC and its responsibilities shall have the following responsibilitiesinclude, without limitation:
(a) To periodically review whether there is need to amend or supplement the development Research Plan and discussion to recommend changes thereto to the Steering Committee, as may be reasonably required to meet the goals of strategies for the Development Research Plan and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesCollaboration;
(b) reviewing To recommend to the Steering Committee changes in assays and discussing a Marketing validation processes for Collaboration Hit Homologs, Special Collaboration Hits and Sales Plan for each Co-Developed Product in the Co-Development TerritoryPreferred Mode of Use;
(c) coordinating To recommend to the Development Steering Committee amendments, modifications and Commercialization efforts supplements to the Research Plan, and changes to validation criteria of both Parties 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 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.
(d) At least sixty (60) days prior to the commencement of each Collaboration Year, to review and approve, subject to final approval by the Steering Committee, a detailed research plan for the subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the Discovery Programs to be conducted and the Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of which, upon approval by the Steering Committee shall automatically constitute an amendment to and part of the Research Plan;
(e) To discuss ways for Monsanto to assist the gene discovery and 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 [* * *] set forth in [* * *] ([* * *]) and to [* * *] to the Co-Development Territory Steering Committee, as may be reasonably required to meet the goals of the Research Plan and the Collaboration;
(f) 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 2.8.2) and to review and amend the format 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) To discuss, at a general level, information provided on Collaboration Hit Homologs and Special Collaboration Hits, such as the Collaboration Hit Data Backpacks, the Discovery Validation Data Backpacks,, the Collaboration Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to Cothe validation of the Collaboration Hit Homologs, Special Collaboration Hits and Preferred Modes of Use in the Monsanto Pipeline;
(h) To receive from Evogene information on possible Independent Discovery Rounds, in accordance with Section 4.2.1, and to discuss information provided by Evogene on Internal Non-Developed Products. For purposes Field Hits which underwent the Core Validation and met the Validated Hit criteria as set forth in Section 4.2.2;
(i) To review issues relating to Publications resulting from the activities conducted under the Collaboration, in accordance with Section 2.10;
(j) To keep a record of claritythe Collaboration Hit Sets, the JDCC shall not be responsible for coordinating communications with Regulatory AuthoritiesSpecial Collaboration Hits, which is the sole responsibility of PlaNet Genes, PlaNet ▇▇▇▇ ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison RePack Recommendations and GeneDex Recommendations licensed 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 Monsanto *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory information subject to the JSC confidentiality request. Omissions are designated as needed[***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission. hereunder, but no less often than two (2) times per Calendar Year;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products termination of any such license in accordance with the Co-Development Territory;
terms of this Agreement (i) receiving and providing to For the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving avoidance of doubt, all Third Parties to GeneSpec Genes, including those that are Homologs of Collaboration Hits, shall be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territoryrecorded as such);
(k) reviewing 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 approving 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 ingredients that are therapeutically or biologically active that are proposed other decisions expressly assigned to the Research Committee by either Party for inclusion with a Co-Developed Product to create a Combination Productthis Agreement; and
(lq) performing To exercise such activities additional responsibilities as may be delegated to the JDCC pursuant to this Agreement, or Research Committee by mutual written agreement of the Parties after the Approval DateSteering Committee.
Appears in 1 contract
Responsibilities. The JDCC shall be responsible for overseeing During the Development Term, Feehan’s duties and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality responsibilities will primarily consist of the foregoing, the JDCC shall have the following responsibilitiesfollowing:
(ai) Serve as Chairman of the Board and serve as primary liaison between the Board and management;
(ii) Advise and mentor the New CEO;
(iii) Interact with key shareholders as requested;
(iv) Interact with governmental officials (legislators and regulators) as requested;
(v) Assist management, as requested by the New CEO, with the development and discussion execution of strategies for the Development enacting favorable pawn legislation in both existing and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesnew states;
(bvi) reviewing Advise management with the development of Cash America’s annual business plan and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territorybudget;
(cvii) coordinating Monitor monthly performance reports and alert the Development and Commercialization efforts Board of both Parties any unexpected trends in operational or financial performance;
(viii) Advise management in the Co-Development Territory development of capital allocation strategies;
(ix) Evaluate management’s recommendations for any significant capital investment prior to submission to the Board for approval;
(x) Assist management, as requested by the New CEO, in the assessment and negotiation of any significant transactions;
(xi) Assist management, as requested, with respect the recruitment of senior leadership talent;
(xii) Visit operating locations, as requested, to Co-Developed Productsprovide the Board and management with an independent perspective on operating conditions in the visited locations;
(xiii) Participate, as requested by the New CEO, in periodic management presentations to lenders and analysts; and
(xiv) Perform such other duties as may from time to time be requested by the New CEO or be assigned by the Board or any duly authorized committee thereof. For purposes of clarityOn and after the Effective Date, the JDCC shall not be responsible for coordinating communications Board may adjust the foregoing responsibilities as the Board, in its sole discretion, deems reasonable and appropriate in connection with Regulatory Authorities, which is the sole responsibility of transitioning ▇▇▇▇▇▇, 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. ▇▇▇▇▇▇ from the Executive Chairman of the Board to a non-executive chairman of the Board. In performing his responsibilities hereunder, Feehan will keep obey the JDCC informed lawful directions of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals Board and any other corrective actions related duly authorized committee thereof, and will use his best efforts to Co-Developed Products in promote the Co-Development Territory;
interests of Cash America and to maintain and to promote the reputation thereof. In his role as Chairman during the Term, Feehan (i) receiving will be an employee of CAM but will not be an officer of CAI, CAM or any of their affiliates or subsidiaries, (ii) will not have any authority to individually approve expenditures or transactions; or to commit Cash America to any liability or to sign any binding contracts on behalf of Cash America, (iii) will not have the authority to directly hire or fire any officer or other employee of Cash America, and providing (iv) will not have any direct reports and the New CEO will report directly to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Dateentire Board.
Appears in 1 contract
Sources: Employment Agreement (Cash America International Inc)
Responsibilities. The JDCC During the JRC Term the JRC shall perform the following functions, some or all of which may be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality addressed directly at each meeting of the foregoing, the JDCC shall have the following responsibilitiesJRC:
(a) review and coordinate all activities under the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesProgram;
(b) reviewing review the progress of the Program against the Research Plan and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territoryrelated budget;
(c) coordinating recommend revisions of the Development and Commercialization efforts of both Parties Candidate Selection Criteria or PoC Compound Criteria based on developments in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals Field or product labeling in the Co-Developed Territory. For clarityProgram (including after any failure of a Candidate Selection Compound to achieve the PoC Compound Criteria), this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep provided that any such revisions must be agreed in writing by the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Parties before taking effect;
(d) reviewing prepare, review, modify, update and providing input approve the PoC Trial design consistent with the synopses in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryExhibit 5;
(e) reviewing review, comment on, approve and providing input on update the short-term Research Plan and long-term sales forecasts for Co-Developed Products in the Co-Developed Territoryrelated budget;
(f) presenting sales forecasts and advise whether particular Anacor Compounds or Medicis Compounds should be introduced into, progressed within or prioritized (in relation other Collaboration Compounds) within the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar YearProgram;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Productsadvise whether a new target be evaluated or selected as an Additional Target;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in confirm that a Collaboration Compound has satisfied the Co-Development TerritoryCandidate Selection Criteria or PoC Compound Criteria;
(i) receiving discuss and providing attempt to the Parties sales reports pertaining resolve any deadlock issues submitted to Co-Developed Products in the Co-Developed Territory;it by any Subcommittee; and
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities other responsibilities as may be delegated assigned to the JDCC JRC pursuant to this Agreement or as may be mutually agreed upon in writing by the Parties from time to time. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. For clarity, the JRC shall not have any authority beyond the specific matters set forth above in this Section 3.1.4, and in particular shall not have any power to amend or modify the terms or provisions of this Agreement. In addition, Medicis (and not Anacor or the JRC) shall have the sole right to make decisions in its sole discretion with respect to (i) whether to exercise the PoC Option; and (ii) the Development and commercialization of Medicis Development Compounds (and resultant Products) after exercise by mutual written agreement Medicis of the Parties after the Approval DatePoC Option with respect thereto.
Appears in 1 contract
Sources: Research and Development Option and License Agreement (Anacor Pharmaceuticals Inc)
Responsibilities. The JDCC shall be responsible for overseeing As part of the Development Parties’ implementation and Commercialization performance of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoingPromotion Activities and Medical Affairs Activities hereunder, the JDCC shall have Parties further agree to undertake the following responsibilitiestasks under the oversight of JCC, and to manage such tasks through the MAWG or the MLRWG, as applicable:
(a) the development and discussion of strategies for the Development and Commercialization By [***] of each Co-Developed Product in Calendar Year, review and update the Co-Development TerritoryPromotion Activities and Medical Affairs Activities (which Medical Affairs Activities shall be through the MAWG) and their associated budgets (as applicable) in the U.S. Territory Commercialization Plan and Budget for the next Calendar Year, including allocation of responsibilities and timely submit the preliminary updated U.S. Territory Commercialization Plan and Budget for such Development the next Calendar Year to the JCC for its review, discussion and Commercialization activitiesapproval for submission to the JSC by [***];
(b) reviewing [***] or more frequently, review and discussing a Marketing recommend to the JCC (including through the MAWG, as applicable) any amendments, modifications or updates to the U.S. Territory Commercialization Plan and Sales Plan for each Co-Developed Product in the Co-Development TerritoryBudget, including [***];
(c) coordinating Review, discuss and recommend to the Development JCC any update to the sales projections and Commercialization efforts of both Parties Sales Force Expenses in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling Commercial Budget contained in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings U.S. Territory Commercialization Plan and milestone meetings as specified in Section 4.5.5.Budget;
(d) reviewing [***], review and providing input in recommend to the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed JCC the Target Prescribers to be identified by the Parties with respect to the Ziftomenib Product in the Co-Development TerritoryU.S. Territory in a manner consistent with the U.S. Territory Commercialization Plan and Budget;
(e) reviewing Review, discuss and providing input on recommend to the short-term and long-term sales forecasts for Co-Developed Products JCC the Detailing Need with respect to the Ziftomenib Product in the Co-Developed U.S. Territory, including any revisions thereto under Section 4.3;
(f) presenting sales forecasts Develop and the results of all efforts in the Co-Development Territory recommend to the JSC JCC the Successful Detailing Metrics, as needed, but no less often than two (2) times per Calendar Yeardescribed in Section 4.5;
(g) coordinating Conduct reviews each [***] on the progress of the Parties to meet the annual Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed ProductsNeed;
(h) overseeing all recalls[***] or more frequently, market withdrawals discuss and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing recommend to the Parties sales reports pertaining JCC (through the MAWG) the Medical Affairs Activities, including without limitation educational grants and HCP consulting and payor engagement, with respect to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Ziftomenib Product; and
(li) performing Perform such activities other functions as may be delegated appropriate to further the JDCC pursuant to purposes of this Agreement, or Agreement as determined by mutual written agreement of the Parties after the Approval DateJCC.
Appears in 1 contract
Sources: Co Promotion and Medical Affairs Agreement (Kura Oncology, Inc.)
Responsibilities. The JDCC PDC shall perform the following functions: • (i) review and recommend, pursuant to Section 4.3(f), to the JEC for consideration and approval each Clinical Development Plan, including the related Clinical Budget for each Approved Study and Contingent Approved Study included in such Clinical Development Plan; • (ii) review and recommend, pursuant to Section 4.3(f) or 4.3(i), as applicable, to the JEC for consideration and approval each Proposed Study and each Emergency Study proposed to be responsible added as an Approved Study or a Contingent Approved Study to the then-current Clinical Development Plan pursuant to Section 4.3(e) or 4.3(i), as applicable, including the proposed Clinical Budget for overseeing such Proposed Study or Emergency Study; • (iii) (A) review and recommend, pursuant to Section 4.3(h), to the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality JEC that either (1) each of the foregoingContingencies applicable to a Contingent Approved Study has been satisfied and such Contingent Approved Study should become an Approved Study or (2) that at least one of the Contingencies related to a Contingent Approved Study has failed to be satisfied and such Contingent Approved Study should be removed from the Clinical Development Plan; and (B) review and recommend, pursuant to Section 4.3(h), the JDCC protocol and updated Clinical Budget for each Contingent Approved Study that shall have the following responsibilities:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesbecome an Approved Study;
(biv) reviewing oversee the implementation of the Clinical Development Plans and discussing a Marketing and Sales Plan for each Coany Sole-Developed Product in the Co-Development TerritoryFunded SFI Registrational Studies;
(cv) coordinating the Development review and Commercialization efforts of both Parties approve or, in the Co-case of any Material Modification, recommend to the JEC for approval any amendment or modification to the Clinical Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryPlan;
(evi) reviewing at each meeting of the PDC review a comparison of the actual Development Costs incurred to the budgeted Development Costs for the year-to-date for each Approved Study and providing input on each Contingent Approved Study, as current as practicable to a date immediately prior to the short-term and long-term sales forecasts for Co-Developed Products in date of the Co-Developed Territorymeeting;
(fvii) presenting sales forecasts review and evaluate progress of each Approved Study or Contingent Approved Study and any Sole-Funded SFI Registrational Studies, provided that the results PDC shall not have authority to make any determination that any Party is in breach of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;this Agreement; •
(gviii) coordinating the Detailing efforts review and approve all compassionate use of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(hix) overseeing all recallsreview and approve the joint publication strategy together with the JCC, market withdrawals and any other corrective actions related to Co-Developed Products take the lead in the Co-Development Territory;
(i) receiving coordinating such joint review and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productapproval; and
(lx) performing have such activities other responsibilities as may be delegated assigned to the JDCC PDC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time."
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement
Responsibilities. The JDCC Research Committee shall be responsible for overseeing supervise the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality execution of the foregoingResearch Plan and administer the Funded Project, the JDCC and its responsibilities shall have the following responsibilitiesinclude, without limitation:
(a) To periodically review whether there is need to amend or supplement the development Research Plan and discussion to recommend changes thereto to the Steering Committee, as may be reasonably required to meet the goals of strategies for the Development Research Plan and Commercialization of each Co-Developed Product the Collaboration, and in the Co-Development Territory, including allocation event of responsibilities for such Development and Commercialization activitiesMonsanto’s exercise of the Research Extension Option;
(b) reviewing To recommend to the Steering Committee changes in assays and discussing a Marketing validation processes for Collaboration Hit Homologs, Special Collaboration Hits and Sales Plan Preferred Mode of Use; *** Confidential treatment has been requested for each Co-Developed Product in redacted portions of this exhibit. This copy omits the Co-Development Territory;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.
(c) coordinating To recommend to the Development Steering Committee amendments, modifications and Commercialization efforts supplements to the Research Plan, and changes to validation criteria of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes Collaboration Hit Homologs Special Collaboration Hits and Preferred Modes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Use;
(d) reviewing At least sixty (60) days prior to the commencement of each Collaboration Year, to review and providing input in approve, subject to final approval by the preparation Steering Committee, a detailed research plan for the subsequent Collaboration Year to be prepared and proposed by Evogene (including determining the Discovery Programs to be conducted and the Monsanto-Funded Evogene Data to be generated) (each an “Annual Research Plan”), each of a Marketing which, upon approval by the Steering Committee shall automatically constitute an amendment to and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in part of the Co-Development TerritoryResearch Plan;
(e) reviewing To discuss ways for Monsanto to assist the gene discovery and identification of Preferred Modes of Use processes, such as by providing input on the shortEvogene with certain know-term how and long-term sales forecasts for Co-Developed Products in the Co-Developed TerritoryMonsanto Data;
(f) presenting sales forecasts 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 2.8.2) and to review and amend the results format of all efforts the parties’ reports, as may be reasonably required in order to enable the Co-Development Territory Research Committee to monitor the JSC as needed, but no less often than two (2) times per Calendar Yearparties’ performance of their respective Diligence Obligations;
(g) coordinating To discuss, at a general level, information provided on Collaboration Hit Homologs and Special Collaboration Hits, such as the Detailing efforts of both Parties in Collaboration Hit Data Backpacks, the Co-Development Territory Discovery Validation Data Backpacks, , the Collaboration Hit G2P Data Backpacks, and the Project G2P Validation Data Backpacks and to make recommendations with respect to Co-Developed Products;
(h) overseeing all recallsthe validation of the Collaboration Hit Homologs, market withdrawals Special Collaboration Hits and any other corrective actions related to Co-Developed Products Preferred Modes of Use in the Co-Development Territory;
(i) receiving and providing Monsanto Pipeline; *** Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that confidentiality request. Omissions are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities designated as may be delegated [***]. A complete version of this exhibit has been provided separately to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval DateSecurities and Exchange Commission.
Appears in 1 contract
Responsibilities. The JDCC shall 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 responsibilitiesSteering Committee shall:
(a) the development identify, review, select and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesoversee all Research Projects;
(b) reviewing evaluate and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territorydetermine scientific criteria to be implemented under all Research Projects;
(c) coordinating establish a mechanism by which the Development Parties will exchange deCODE Know-How and Commercialization efforts Roche Know-How, including Program Know-How, and oversee the exchange of both Parties in the Cosuch Know-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.How;
(d) reviewing commencing on the Effective Date, discuss and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion prepare an Annual Research Plan for each Co-Developed Product in Research Project for the Co-Development TerritoryFirst Contract Year of the Research Term, including determining the priorities among the various Research Projects and the appropriate number of FTEs to be used to support each Research Project, and, prior to ninety (90) days after the Effective Date, finalize an Annual Research Plan for each Research Project for the First Contract Year of the Research Term and have each such Annual Research Plan signed and dated by a representative of each Party on the Steering Committee;
(e) reviewing not less than three (3) months prior to the commencement of each subsequent Contract Year during the Research Term, discuss and providing input prepare an Annual Research Plan for each ongoing Research Project, including determining the priorities among the various Research Projects and the appropriate number of FTEs to be used to support each Research Project, and, prior to the commencement of each subsequent Contract Year during the Research Term, finalize an Annual Research Plan for each Research Project for the such Contract Year of the Research Term and have each such Annual Research Plan signed and dated by a representative of each Party on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed TerritorySteering Committee;
(f) presenting sales forecasts and the results decide upon approval of all efforts in the Co-Development Territory proposed amendments or modifications to the JSC as needed, but no less often than two (2) times per Calendar Yearany Annual Research Plan;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Productsevaluate data from all Research Projects;
(h) overseeing all recallscoordinate the activities of the Parties, market withdrawals and review and evaluate progress, under the Research Projects, provided that the Steering Committee shall not have authority to make any other corrective actions related to Co-Developed Products determination that either Party is in breach of its obligations under the Co-Development TerritoryResearch Projects;
(i) receiving discuss, prepare and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territoryfinalize an Annual Research Plan for any new Research Project;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products determine the research milestones and decide when a research milestone established for any Research Project is achieved in the Co-Developed Territorysuch Research Project;
(k) reviewing determine the development milestones, development milestone payments and approving any ingredients that are therapeutically the royalty rates applicable to each Diagnostic Product or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; andIP Trade, consistent with, and taking into account the criteria described in, Sections 5.3(f), (g), (h) and (i);
(l) performing such activities as may be delegated to the JDCC pursuant determine contribution of added value and commensurate eighteen (18) month period for each Elected Project;
(m) prepare and approve each Addendum to this Agreement, or by mutual written agreement of ;
(n) perform any other activities related to the Research Projects as the Parties after the Approval Datemay request from time to time, other than deciding that a Party is in breach of an obligation under this Agreement.
Appears in 1 contract
Sources: Collaboration and Cross License Agreement (Decode Genetics Inc)
Responsibilities. The JDCC JEC shall 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 perform the following responsibilitiesfunctions:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving oversee the development and providing commercialization of the Compounds and Products pursuant to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territoryterms of this Agreement;
(jii) approving all Third Parties review and approve, pursuant to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products Section 4.3(f), each Clinical Development Plan, including the Clinical Budget for each Approved Study and Contingent Approved Study included in the Co-Developed Territorysuch Clinical Development Plan;
(kiii) reviewing review and approving approve, pursuant to Section 4.3(f) or 4.3(i), as applicable, each Proposed Study and each Emergency Study proposed to be added as an Approved Study or a Contingent Approved Study to the then-current Clinical Development Plan pursuant to Section 4.3(e) or 4.3(i), as applicable, including the related Clinical Budget for such Proposed Study or Emergency Study;
(iv) (A) review and approve, pursuant to Section 4.3(h), the determination that either (1) each of the Contingencies applicable to a Contingent Approved Study has been satisfied and such Contingent Approved Study shall become an Approved Study or (2) at least one of the Contingencies related to a Contingent Approved Study has failed to be satisfied and such Contingent Approved Study shall be removed from the Clinical Development Plan; and (B) review and approve, pursuant to Section 4.3(h), the protocol and updated Clinical Budget for each Contingent Approved Study that shall become an Approved Study;
(v) review and approve (A) any ingredients amendments or modifications to any Approved Study or Contingent Approved Study included in the then-current Clinical Development Plan that would reasonably be expected to result in an increase in the aggregate Clinical Budget through the completion of such Approved Study or Contingent Approved Study, as applicable, of [*] or more or (B) any other material modification or amendment to any Approved Study or Contingent Approved Study, including (1) any delay in the expected start date of such Approved Study or Contingent Approved Study by more than [*], (2) any change of [*] or more in the number of patients enrolled or to be enrolled in such approved Study or Contingent Approved Study, (3) a change in the primary or secondary endpoints or any other key provisions of the study protocol design (including study power), publication strategy or data analysis relating to such Approved Study or Contingent Approved Study, (4) any modification or amendment to the Contingencies required to be satisfied for any Contingent Approved Study to become an Approved Study or (5) the early termination of an Approved Study or Contingent Approved Study (any such amendment or modification in clause (A) or (B) of this Section 2.1(b)(v), a "Material Modification"), provided that this Section 2.1(b)(v) shall not apply to the termination of a Contingent Approved Study as a result of failure to satisfy the Contingencies applicable to such Contingent Approved Study (which is the subject of Section 2.1(b)(iv)), provided further that, pending the JEC approval of early termination under this Section 2.1(b)(v)(B)(5), the Responsible Party for an Approved Study or Contingent Approved Study may suspend such Approved Study or Contingent Approved Study, as the case may be, if it believes that failure to do so would jeopardize the welfare or safety of patients;
(vi) at each meeting of the JEC review a comparison of the actual expenses to the budgeted expenses for the year-to-date (including Development Costs for each Approved * Omitted and filed separately pursuant to a request for confidential treatment submitted to the Securities and Exchange Commission. Study and each Contingent Approved Study), as current as practicable to a date immediately prior to the date of the meeting;
(vii) review and evaluate the progress of the other Committees;
(viii) review and take action on any other matters within the scope of the authority of another Committee that are therapeutically or biologically active that are proposed referred to the JEC by either Party such other Committee;
(ix) review and, if unanimously agreed, reallocate spending from the Marketing Budget to the Clinical Budget;
(x) establish and empower a finance committee, which shall consist of an equal number of representatives from each of the Company and BMS (the "Finance Committee") to advise the JEC and make recommendations to the JEC for inclusion the areas it has responsibility as provided in Section 2.2;
(xi) at least once each year, meet with a Co-Developed Product each of the other Committees (which meetings do not need to create a Combination Productinclude all of the other Committees at the same meeting);
(xii) in accordance with the procedures established in Section 2.1(d), resolve disputes, disagreements and deadlocks unresolved by the other Committees; and
(lxiii) performing have such activities other responsibilities as may be delegated assigned to the JDCC JEC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time."
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc)
Responsibilities. The JDCC shall be responsible for overseeing Subject to Section 3.1.1(a), the JDC’s responsibilities will be: (i) reviewing and approving the Development Plan no less than once per Year and Commercialization any amendments thereto; (ii) reviewing and 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 Co-Developed Products seeking Regulatory Approval for the Product in the CoTerritory; (iv) making modifications to and performing quarterly monitoring of progress of such non-clinical and clinical studies and proposing additional studies for the Product in the [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 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 Products. The JDC may appoint additional committees as desired. Without limiting the generality 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 foregoing, Product may be conducted in the JDCC shall have Forest Territory which Forest reasonably believes may adversely affect the following responsibilities:
(a) the timely development and discussion of strategies for the Development and Commercialization of each Co-Developed any Product in the Co-Development Forest Territory, including allocation ; provided that the foregoing provisions of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not sentence apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory solely to the JSC extent and for so long as needed, but no less often than two (2) times per Calendar Year;
(g) coordinating Forest has such rights under the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Forest Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: Collaboration Agreement (Ironwood Pharmaceuticals Inc)
Responsibilities. The JDCC shall 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 responsibilitiesJCC will:
(a) oversee the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product the Shared Products by the Parties in the Co-Development Field in the Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing develop and discussing approve a Marketing and Sales Global Commercialization Plan for each Co-Developed Shared Product in and submit such Global Commercialization Plan to the Co-Development TerritoryJSC for review and discussion;
(c) coordinating amend the Development Global Commercialization Plan for each Shared Product on an annual basis (or more frequently as needed), approve such amendments and submit such updated Global Commercialization efforts of both Parties in Plans to the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible JSC 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 review and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.discussion;
(d) reviewing review, discuss and providing input in approve the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan initial Regional Commercialization Plans for each Co-Developed Shared Product in the Co-Development Territoryand any amendments or updates thereto submitted by Parties;
(e) reviewing and providing input on select product Trademarks for each Shared Product throughout the short-term and long-term sales forecasts for Co-Developed Products in world consistent with the Co-Developed TerritoryGlobal Brand Strategy;
(f) presenting sales forecasts and advise the results JMC in connection with its oversight of all efforts the Manufacturing Working Group with respect to matters relating to the commercial Manufacture of the Shared Products;
(g) advise the JMC in connection with its oversight of the commercial Manufacture of the Shared Products in the Co-Development Territory Field in the Territory;
(h) advise the JMC in connection with its review and discussion of any updates to the Global Manufacturing Plan, including the Manufacturing Budget, proposed by the Manufacturing Working Group;
(i) submit the approved updated Global Commercialization Budget for the subsequent Calendar Year to the JSC as needed, but for inclusion in the Integrated Budget no less often later than two (2) times per [***] of each Calendar Year;
(gj) coordinating advise the Detailing efforts JMC in connection with its review, discussion and approval of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recallsManufacturing process, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territorychanges thereto, for each Shared Product;
(k) reviewing review, discuss and approving approve any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with use of a Co-Developed Product Subcontractor to create conduct a Combination ProductParty’s activities under a Global Commercialization Plan, where the applicable Subcontract is anticipated to entail payments in excess of $[***], as set forth in ARTICLE 9; and
(l) performing perform such activities other duties as are specifically assigned to the JCC under this Agreement or as may be delegated to the JDCC JCC by the JSC. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to this Agreement, or by mutual written agreement Rule 24b-2 of the Parties after the Approval Date.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 JDCC MDT shall 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 responsibilitiesensure that:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving all Approved Persons with access to ADC Highly Confidential Information have been trained by MDT on the procedures for protecting such ADC Highly Confidential Information, including, but not limited to, the requirements set forth in Section 13.1 and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territorythis Section 3.6(b);
(jii) approving all the ADC Highly Confidential Information is never checked into any source code management system such as Github, provided that the foregoing shall not preclude MDT’s use of a private source control system which is dedicated for MDT’s exclusive use and not accessible by Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed TerritoryParties;
(kiii) reviewing MDT or MDT Affiliate personnel do not use the ADC Highly Confidential Information for any purpose other than as permitted under Section 3.6 (a) nor modify or bybass the FreeStyle Libre Technology and/ or ADC MDT Glucose Sensor communication interface or encryption;
(iv) all filenames relating to the ADC Highly Confidential Information are added to .gitignore of any source management system (other than a private source control system allowed under foregoing clause (i)) as soon as they are known;
(v) the ADC Highly Confidential Information shall never be shared via e-mail, Google Drive, Dropbox, or stored on any insecure cloud storage/sharing system provided that, MDT shall be permitted to store the ADC Highly Confidential Information in the same secured cloud storage system where MDT stores its most highly Confidential Information related to building versions of the ADC-MDT System);
(vi) every computer with the ADC Highly Confidential Information on the disk drive has drive encryption and approving any ingredients that are therapeutically password-protection enabled;
(vii) the ADC Highly Confidential Information is never copied onto a USB or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productother external hard drive; and
(lviii) performing it writes an abstraction layer around the FreeStyle Libre Documentation to minimize use of the libraries during developing and testing activities and incorporate such activities other safeguards with respect to the ADC Highly Confidential Information as may be delegated to set forth in the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval DateIntegration Plan.
Appears in 1 contract
Sources: Integration, Supply and Distribution Agreement (MiniMed Group, Inc.)
Responsibilities. The JDCC PDC shall 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 perform the following responsibilitiesfunctions:
(ai) review and recommend, pursuant to Section 4.3(f), to the development JEC for consideration and discussion of strategies for the approval each Clinical Development and Commercialization of each Co-Developed Product in the Co-Development TerritoryPlan, including allocation of responsibilities the related Clinical Budget for each Approved Study and Contingent Approved Study included in such Clinical Development and Commercialization activitiesPlan;
(bii) reviewing review and discussing recommend, pursuant to Section 4.3(f) or 4.3(i), as applicable, to the JEC for consideration and approval each Proposed Study and each Emergency Study proposed to be added as an Approved Study or a Marketing and Sales Contingent Approved Study to the then-current Clinical Development Plan pursuant to Section 4.3(e) or 4.3(i), as applicable, including the proposed Clinical Budget for each Co-Developed Product in the Co-Development Territorysuch Proposed Study or Emergency Study;
(ciii) coordinating (A) review and recommend, pursuant to Section 4.3(h), to the JEC that either (1) each of the Contingencies applicable to a Contingent Approved Study has been satisfied and such Contingent Approved Study should become an Approved Study or (2) that at least one of the Contingencies related to a Contingent Approved Study has failed to be satisfied and such Contingent Approved Study should be removed from the Clinical Development Plan; and Commercialization efforts (B) review and recommend, pursuant to Section 4.3(h), the protocol and updated Clinical Budget for each Contingent Approved Study that shall become an Approved Study;
(iv) oversee the implementation of both Parties the Clinical Development Plans and any Sole-Funded SFI Registrational Studies;
(v) review and approve or, in the Cocase of any Material Modification, recommend to the JEC for approval any amendment or modification to the Clinical Development Plan;
(vi) at each meeting of the PDC review a comparison of the actual Development Costs incurred to the budgeted Development Costs for the year-Development Territory with respect to-date for each Approved Study and each Contingent Approved Study, as current as practicable to Coa date immediately prior to the date of the meeting;
(vii) review and evaluate progress of each Approved Study or Contingent Approved Study and any Sole-Developed Products. For purposes of clarityFunded SFI Registrational Studies, provided that the JDCC PDC shall not have authority to make any determination that any Party is in breach of this Agreement;
(viii) review and approve all compassionate use of Products;
(ix) review and approve the joint publication strategy together with the JCC, and take the lead in coordinating such joint review and approval; and
(x) have such other responsibilities as may be responsible for coordinating communications with Regulatory Authorities, which is assigned to the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison PDC pursuant to this Agreement or as may be designated mutually agreed upon by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as the Parties from time to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5time."
(d) reviewing Section 2.3(d) is hereby deleted in its entirety and providing input in replaced with the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities as may be delegated to the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval Date.following:
Appears in 1 contract
Sources: Development, Promotion, Distribution and Supply Agreement (Imclone Systems Inc)
Responsibilities. The JDCC PDC shall be responsible for overseeing the Development and Commercialization of Co-Developed Products in the Co-Development Territory. Without limiting the generality not oversee, review, approve or evaluate any of the foregoing, the JDCC DURECT Activities. The PDC shall have perform the following responsibilitiesfunctions:
(a) the development and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activities;
(b) reviewing and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development Territory;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;
(e) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving approve and providing to oversee the Parties sales reports pertaining to Co-Developed Products in implementation of the Co-Developed TerritoryDevelopment Plan;
(jii) approving all Third Parties to be engaged at least once each calendar year by either Party to provide Representatives to Co-Promote Co-Developed Products in a date not later than ***, review and approve any amendments or modifications of the Co-Developed TerritoryDevelopment Plan;
(kiii) reviewing at least twice annually, review the Development Budget;
(iv) at each meeting of the PDC, review a comparison of actual development and approving regulatory expenses to the budgeted expenses in the Development Budget for the year-to-date, as current as practicable to a date immediately prior to the date of the meeting;
(v) review and evaluate progress of the development activities; provided that the PDC shall not have authority to make any ingredients determination that are therapeutically any Party is in breach of this Agreement;
(vi) review and approve all compassionate use of the Product, Finished Product and Implanter;
(vii) review the publication strategy together with the JCC;
(viii) review and recommend to the JEC "go/no-go" decisions;
(ix) in connection with clinical trials, approve protocols, trial budget and trial design;
(x) review Regulatory Data and Regulatory Documentation to be provided by DURECT regarding all Product and Implanter development activities outside the Territory (to the extent DURECT is permitted by Third Parties, if applicable, to do so);
(xi) review and, if appropriate, approve development plans, utilizing an approach similar to the Development Plan, with respect to line extensions of the Product or biologically active Related Products; provided that are proposed by either the PDC shall not approve plans to develop at any one time more than *** such products without the written authorization of DURECT and Endo;
(xii) in good faith consider potential additional line extensions of the Product and Related Products in addition to those considered pursuant to the foregoing clause (x);
(xiii) coordinate the allocation of responsibilities among the Parties with respect to development of the Product, Finished Product and Implanter based on the Development Plan;
(xiv) consult with the JMC regarding adoption of a Third Party for inclusion Manufacturing Plan pursuant to Section 8.15;
(xv) determine which portions of protocols, regulatory filings, correspondence to or from regulatory authorities etc., should be redacted before being shared with a Co-Developed Product to create a Combination ProductALZA; and
(lxvi) performing have such activities other responsibilities as may be delegated assigned to the JDCC PDC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datefrom time to time.
Appears in 1 contract
Sources: License Agreement (Endo Pharmaceuticals Holdings Inc)
Responsibilities. The JDCC JPC shall 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 perform the following responsibilitiesfunctions:
(ai) Consult with THERAVANCE in the development case of the Development Plan and discussion with MYLAN in the case of strategies 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 and Commercialization of each Co-Developed Licensed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesField;
(bvi) reviewing Discuss the state of the markets for Licensed Product and discussing a Marketing opportunities and Sales Plan for each Co-Developed Product in issues concerning the Co-Development TerritoryCommercialization of the Licensed Product, including consideration of marketing and promotional strategy, marketing research plans, and labeling;
(cvii) coordinating At an appropriate and regular frequency, review the Development status of all studies conducted on Licensed Product and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territoryany results therefrom;
(eviii) reviewing At an appropriate and providing input on regular frequency, review Net Sales of Licensed Product for the shortyear-term to-date, and longa current outlook for Net Sales for the remainder of the then-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per current Calendar Year;
(gix) coordinating the Detailing efforts of both Parties Plan and review all publications described in the Co-Development Territory with respect to Co-Developed Products;
(h) overseeing all recallsSection 9.03, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving review and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party approve a publications policy for inclusion with a Co-Developed Product to create a Combination Productsuch publications; and
(lx) performing Have such activities other responsibilities as may be delegated assigned to the JDCC JPC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after through the Approval Date.JSC from time to time. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Sources: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Responsibilities. The JDCC JSC shall be responsible for overseeing each Program performed pursuant to this Agreement unless and until GSK exercises one of its Options to a given Program, or unless and until Pharmacopeia acquires the Development right hereunder to independently progress and Commercialization commercialize Products under a given Program. For avoidance of Co-Developed Products doubt, whenever any matter is presented to the JSC or to either Party for decision under Articles 2, 3 or 4 of this Agreement, such decision shall be communicated through the JSC within no more than thirty (30) days, unless a different time period is specifically stated in this Agreement or is otherwise mutually agreed in writing by the Co-Development TerritoryParties with respect to such matter. Failure by either Party to communicate any such decision within the applicable thirty (30) day or other specific time period shall be deemed a positive decision and thus an approval by such Party with respect to such matter. Without limiting the generality of the foregoing, the JDCC JSC shall have perform the following responsibilities:functions, some or all of which may be addressed directly at any given meeting of the JSC
(a) determine the development and discussion of strategies for ** (other than the Development and Commercialization of each Co-Developed Product in **, which shall be determined prior to the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesEffective Date pursuant to Section 3.2.1) which shall be pursued via Programs pursuant to this Agreement;
(b) reviewing and discussing establish a Marketing and Sales Plan Screening Program for each Co-Developed Product in the Co-Development TerritoryInitial Target;
(c) coordinating establish the Development schedule under which GSK shall provide Pharmacopeia reagents and Commercialization efforts of both Parties in the Co-Development Territory with respect assays for each Initial Target, subject to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.3.2.3;
(d) reviewing approve all Programs under this Agreement and providing input in establish the preparation of a Marketing Tractable Hit Criteria, the Lead Declaration Criteria and Sales Plan containing a Co-Promotion Plan the Candidate Selection Criteria (collectively “Criteria”) applicable for each Co-Developed Product in Program with respect to a given Target before the Co-Development Territoryapplicable Program is commenced by Pharmacopeia, it being understood that all such Criteria may be amended by the JSC;
(e) reviewing determine when the Tractable Hit Criteria, the Lead Declaration Criteria, the Candidate Selection Criteria and providing input on the shortProof-term and longof-term sales forecasts Concept Compound Criteria have been met for Co-Developed Products in the Co-Developed Territorya Target;
(f) presenting sales forecasts and the results of all efforts in the Co-Development Territory to the JSC establish Subcommittees as needed, but no less often than two (2) times per Calendar Yearappropriate;
(g) coordinating review and coordinate all of the Detailing efforts of both Parties Parties’ activities under this Agreement, including establishing an annual “Work Plan” for the Parties’ activities in each Program. The Work Plan shall describe the Co-Development Territory with respect activities to Co-Developed Productsbe carried out by each Party; provided, however, that (i) the ** and (ii) each Party shall have the right to determine and implement, in its sole discretion, **. It is further understood that if **;
(h) overseeing all recalls, market withdrawals and any other corrective actions related assign relative priorities to Co-Developed Products in the Co-Development Territory;Programs; and
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities other responsibilities as may be delegated assigned to the JDCC JSC pursuant to this Agreement, Agreement or as may be mutually agreed upon by mutual written agreement of the Parties after the Approval Datein writing from time to time.
Appears in 1 contract
Sources: Product Development and Commercialization Agreement (Pharmacopeia Drug Discovery Inc)
Responsibilities. The JDCC shall 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 responsibilitiesJMC will:
(a) consistent with the development provisions of Section 6.2, designate the team leader and discussion other members of strategies for the Development Manufacturing Working Group, which team leader and Commercialization members shall be chosen from among the personnel of each Co-Developed Product in the Co-Development TerritoryParties having relevant experience, including allocation of responsibilities for and allocate the respective roles on the Manufacturing Working Group among such Development and Commercialization activitiesmembers;
(b) reviewing review on a periodic basis and discussing a Marketing make any necessary changes to the team leader and Sales Plan for each Co-Developed Product in other members of the Co-Development TerritoryManufacturing Working Group, or the allocation of roles among such members;
(c) coordinating oversee the Development and Commercialization efforts of both Parties Manufacturing Working Group, in consultation with the Co-Development Territory JDC, with respect to Comatters relating to the pre-Developed clinical or clinical Manufacture of the Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.;
(d) reviewing and providing input oversee the Manufacturing Working Group, in consultation with the preparation JCC, with respect to matters relating to the commercial Manufacture of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryProducts;
(e) reviewing and providing input on oversee the short-term and long-term sales forecasts Manufacturing Working Group, in consultation with the JDC, with respect to Manufacturing quality matters for Co-Developed Products in the Co-Developed TerritoryProducts;
(f) presenting sales forecasts and oversee the Manufacturing Working Group, in consultation with the JDC, with respect to the review of the results of all efforts 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 Co-Development 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 as neededfor review and discussion; [***] = Certain confidential information contained in this document, but marked by brackets, has been omitted because it is both (i) not material and (ii) would cause competitive harm if publicly disclosed.
(j) submit the approved updated Manufacturing Budget for the subsequent Calendar Year to the JSC for inclusion in the Integrated Budget no less often later than two (2) times per [***] of each Calendar Year;
(gk) coordinating review, discuss and approve the Detailing efforts 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 both Parties in the Co-Development Territory with respect to Co-Developed Manufacturing Working Group regarding capacity planning, supply plans and supply continuity planning for the Products;
(hm) overseeing all recalls, market withdrawals select and approve each CMO and contract testing facility to be engaged with respect to each phase of the Manufacture of any other corrective actions related to Co-Developed Products in the Co-Development TerritoryProduct [***];
(in) receiving and providing to determine whether any Manufacturing technology transfer between the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territoryis necessary;
(jo) approving all Third Parties review, discuss and approve any proposed use of a Subcontractor to be engaged by either Party conduct a Party’s activities under the Global Manufacturing Plan, where the applicable Subcontract is anticipated to provide Representatives to Co-Promote Co-Developed Products entail payments in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productexcess of $[***], as set forth in ARTICLE 9; and
(lp) performing perform such activities other duties as are specifically assigned to the JMC under this Agreement or as may be delegated to the JDCC pursuant to this Agreement, or JMC by mutual written agreement of the Parties after the Approval DateJSC.
Appears in 1 contract
Sources: Joint Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Responsibilities. The JDCC Subject to oversight by the JSC, the Joint Development Committee shall be responsible for overseeing oversee and supervise the Development of the Named Compounds and Commercialization of Co-Developed corresponding Licensed Products in the Co-Development Territory. Without limiting the generality of the foregoingU.S. In addition, the JDCC it shall have perform the following responsibilitiesfunctions:
(a) Manage and oversee the development preparation and discussion implementation of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesPlans;
(b) reviewing Review and discussing a Marketing approve updates and Sales Plan for each Co-Developed Product in amendments to the Co-Development TerritoryPlans;
(c) coordinating Approve the Development strategy, regulatory strategy, formulation and Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of claritymanufacturing process development strategy, the JDCC shall not be responsible and protocols for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated Clinical Studies as such strategies and protocols are proposed by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.Pfizer;
(d) reviewing Review and providing input coordinate regulatory activities to be undertaken by the Parties in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development Territory;accordance with ARTICLE 8.
(e) reviewing and providing input on If the short-term and long-term sales forecasts for Co-Developed Products Parties are sharing Net Profit/Net Loss, at each meeting of the Joint Development Committee, review a comparison of actual Development Costs to the budgeted Development Costs in the CoDevelopment Plan for the Calendar Year-Developed Territoryto-date, as current as practicable to a date immediately prior to the date of the meeting;
(f) presenting sales forecasts Review and the results of all efforts in the Co-Development Territory recommend to the JSC as needed, but no less often than two (2) times per Calendar YearJoint Steering Committee “go/no-go” decisions for Development of the Licensed Products;
(g) coordinating the Detailing efforts of both Parties in the Co-Development Territory Review activities conducted, if any, by a Party with respect to Co-Developed Productsadditional indications for Named Compounds and activities conducted, if any, related to Unnamed Compounds;
(h) overseeing all recalls, market withdrawals Manage and any other corrective actions related to Co-Developed Products in oversee the Co-Development Territory;execution of the Manufacturing Transfer; and
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing Have such activities other responsibilities as may be delegated assigned to the JDCC Joint Development Committee pursuant to this AgreementAgreement or as may be mutually agreed upon by the Parties from time to time. For clarity, and without limiting the foregoing, the JDC shall not have decision-making authority regarding the exercise of a New Collaboration Compound Option, Additional Indication Proposal, or by mutual written agreement of any development plans for Unnamed Compounds. Rather, the Parties after JDC shall only provide the Approval Datenon-developing Party a forum at which to review and comment upon research and development plans and results for Unnamed Compounds and to review Additional Indication Proposals.
Appears in 1 contract
Responsibilities. The JDCC JDC’s overall responsibility shall be responsible for overseeing to facilitate information sharing and coordination between the Development and Commercialization of Co-Developed Products parties in the Co-Development development, registration and commercialization of Product in the Field in each the ANTHERA Territory and the ZENYAKU Territory. Without limiting the generality The specific responsibilities of the foregoing, the JDCC JDC shall have the following responsibilitiesbe:
(ai) to serve as the primary means by which: (1) the parties review and discuss the Joint Development Plan (including the Shared Cost Budget and SLE Cost Budget), as amended from time to time in accordance with Article 4; (2) ZENYAKU consults with ANTHERA and considers in good faith ANTHERA’s comments and suggestions regarding Product development and discussion of strategies for the Development and Commercialization of each Co-Developed Product activities to be conducted in the Co-ZENYAKU Territory; and (3) ANTHERA provides ZENYAKU with updates regarding Product development activities to be conducted in the ANTHERA Territory outside the Joint Development Plan as well as any planned Compound or Product development in the ZENYAKU Territory, including allocation and ANTHERA consults with ZENYAKU and considers in good faith any concerns relating to any of responsibilities for such the foregoing that ZENYAKU may have;
(ii) to serve as the primary means by which: (1) the parties review and discuss the ZENYAKU Development Plan, as amended by ZENYAKU from time to time in accordance with Article 4; and Commercialization (2) ZENYAKU consults with ANTHERA and considers in good faith ANTHERA’s comments and suggestions regarding ZENYAKU Development Plan activities;
(biii) reviewing to facilitate the exchange of ANTHERA Know-How (excluding manufacturing Know-How, the disclosure of which shall be governed by the Product Supply Agreement, except as provided for in this Agreement, including in Articles 4 and discussing a Marketing 6) and Sales Plan for each CoZENYAKU Know-Developed How;
(iv) to serve as the principal means by which ANTHERA keeps ZENYAKU informed regarding ANTHERA’s development, registration and commercialization plans, efforts and results with respect to Compound and Product in the Co-Development Field in the ANTHERA Territory, and by which ZENYAKU keeps ANTHERA informed regarding ZENYAKU’s development, registration and commercialization plans, efforts and results with respect to Compound and Product in the Field in the ZENYAKU Territory;
(cv) coordinating the Development to seek harmonization in global development, regulatory approval, marketing, promotion and Commercialization commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products Compound and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.
(d) reviewing and providing input in the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan for each Co-Developed Product in the Co-Development TerritoryField;
(evi) reviewing and providing input on the short-term and long-term sales forecasts for Co-Developed Products in the Co-Developed Territory;
(f) presenting sales forecasts and the results 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) coordinating the Detailing efforts of both Parties in the Co-Development Territory with respect informally resolve disputes where possible to Co-Developed Products;
(h) overseeing all recalls, market withdrawals and any other corrective actions related to Co-Developed Products in the Co-Development Territory;
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged resolve by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Productconsensus; and
(lvii) performing to carry out such activities other obligations as may be are expressly delegated to the JDCC pursuant to it under this Agreement, or by mutual written agreement of the Parties after the Approval Date. The JDC’s responsibilities and authority shall be limited to those matters expressly delegated to it in this Agreement.
Appears in 1 contract
Sources: Collaboration and License Agreement (Anthera Pharmaceuticals Inc)
Responsibilities. The JDCC Joint Manufacturing Committee shall 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 responsibilitieswith respect to each Joint DDC and/or Joint Product:
(a) determining the development best Manufacturing procedures and discussion processes to be used to produce necessary volumes of strategies for such Joint DDC and/or Joint Product with reproducible high quality and at a competitive cost (including whether or not to authorize the Development and Commercialization use of each Co-Developed Product in a proprietary manufacturing technology of a Party that such Party would be unwilling to transfer to the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiesother Party pursuant to Section 4.9.5);
(b) reviewing and discussing a Marketing and Sales Plan determining the Lead Manufacturing Party for each Co-Developed such Joint DDC and/or Joint Product in accordance with the Co-Development Territoryprovisions of Section 6.3;
(c) coordinating the Development and Commercialization efforts of both Parties in the Co-Development Territory with respect maintaining global oversight over all Manufacturing activities relating to Co-Developed Products. For purposes of clarity, the JDCC shall not be responsible for coordinating communications with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.such Joint DDC and/or Joint Product;
(d) reviewing and providing input in overseeing the preparation of a Marketing and Sales Plan containing a Co-Promotion Plan all Manufacturing Plans for each Co-Developed Product in such Joint DDC and/or Joint Product, subject to review by the Co-Development TerritoryJoint Executive Committee;
(e) reviewing and providing input on monitoring the short-term and long-term sales forecasts for Co-Developed Products in Parties' compliance with their respective obligations under the Co-Developed TerritoryManufacturing Plans;
(f) presenting sales forecasts overseeing regulatory compliance with respect to Manufacturing activities; Confidential Materials omitted and filed separately with the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Year;Securities and Exchange Commission. Asterisks denote omissions.
(g) coordinating reviewing a detailed breakdown of the Detailing efforts components of both Parties in the Co-Development Territory with respect to Co-Developed ProductsStandard Cost of Goods Sold for such Joint DDC and/or Joint Product;
(h) overseeing all recallsdetermining (i) whether the Manufacturing of such Joint DDC and/or Joint Product requires any Special Purpose Equipment; (ii) the budgeted capital costs for the acquisition of such Special Purpose Equipment and the manner in which such capital costs shall be financed (e.g., market withdrawals whether the Parties will share the costs up-front or whether the Lead Manufacturing Party shall incur such costs and recover such costs over the Capital Recovery Period); (iii) the period over which the capital costs relating to such Special Purpose Equipment shall be recovered and reflected in Standard Cost of Goods Sold (the "Capital Recovery Period"); and (iv) the manner in which the Lead Manufacturing Party (or the Parties if the capital costs are shared up-front) shall recover any other corrective actions related to Co-Developed Products unrecovered capital costs in the Co-Development Territory;event that the Joint Manufacturing Committee terminates the Manufacturing rights of the Lead Manufacturing Party prior to the expiration of the Capital Recovery Period; and
(i) receiving and providing to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed Territory;
(j) approving all Third Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territory;
(k) reviewing and approving any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion with a Co-Developed Product to create a Combination Product; and
(l) performing such activities other tasks and undertaking such other responsibilities as may be delegated to the JDCC pursuant to set forth in this Agreement, or by mutual written agreement of the Parties after the Approval Date.
Appears in 1 contract
Sources: Collaboration and License Agreement (Millennium Pharmaceuticals Inc)
Responsibilities. The JDCC shall be responsible Committee for overseeing Manufacturing matters will, subject to the Development and Commercialization other provisions of Co-Developed Products in the Co-Development Territory. Without limiting the generality of the foregoing, the JDCC shall have the following responsibilitiesthis Agreement:
(a) in consultation with any Committee responsible for Development matters, oversee matters relating to the development pre-clinical or clinical Manufacture of the Collaboration Product Candidates and Collaboration Products, including quality matters, review of the results of regulatory and environmental, health and safety inspections and Manufacturing audits and the review and discussion of strategies for the Development and Commercialization of each Co-Developed Product in the Co-Development Territory, including allocation of responsibilities for such Development and Commercialization activitiessteps to address any deficiencies noted;
(b) reviewing in consultation with any Committee responsible for Commercialization matters, as applicable, oversee matters relating to the commercial Manufacture of the Collaboration Product Candidates and discussing a Marketing and Sales Plan for each Co-Developed Product in the Co-Development TerritoryCollaboration Products, as applicable;
(c) coordinating the review, discuss and approve, in consultation with any Committee responsible for Development and or Commercialization efforts of both Parties in the Co-Development Territory with respect to Co-Developed Products. For purposes of claritymatters, as applicable, the JDCC shall not be responsible initial Global Manufacturing Plan (including the Manufacturing Budget) for coordinating communications each Collaboration Product Candidate and Collaboration Product, and any updates or amendments thereto, and submit such Global Manufacturing Plan, updates or amendments to the JSC for review and discussion and, if unable to reach consensus, submit to the JSC, as necessary, for resolution in accordance with Regulatory Authorities, which is the sole responsibility of ▇▇▇▇▇▇, however, ▇▇▇▇▇▇ will work directly with a regulatory liaison to be designated by Enanta on coordinating key regulatory FDA communications on Co-Developed Products and will keep Enanta’s liaison informed as to other regulatory proceedings on Co-Developed Products that will materially affect approvals or product labeling in the Co-Developed Territory. For clarity, this would not apply to routine regulatory submissions or communications necessary to ensure regulatory compliance with FDA guidelines. ▇▇▇▇▇▇ will keep the JDCC informed of key regulatory communications involving key regulatory filings and milestone meetings as specified in Section 4.5.5.2.8;
(d) reviewing review, discuss and providing input approve the Global Manufacturing Transfer Plan for Collaboration Product Candidates or Collaboration Products in the preparation of a Marketing Territory and Sales Plan containing a Co-Promotion Plan any updates or amendments thereto (expected to be made on an annual basis or more frequently as needed), and submit such Global Manufacturing Transfer Plan, updates or amendments to the JSC for each Co-Developed Product review and discussion, and, if unable to reach consensus, submit to the JSC, as necessary, for resolution in the Co-Development Territoryaccordance with Section 2.8;
(e) reviewing subject to and providing input on in accordance with Section 3.4 and Section 10.3, review, discuss and approve which Partnership Party shall be responsible for the short-term Manufacture of Collaboration Product Candidates and long-term sales forecasts for Co-Developed Products in the Co-Developed TerritoryCollaboration Products;
(f) presenting sales forecasts and submit the results of all efforts in the Co-Development Territory to the JSC as needed, but no less often than two (2) times per Calendar Yearupdated Manufacturing Budget for [***];
(g) coordinating the Detailing efforts of both Parties establish, in the Co-Development Territory accordance with respect Applicable Law, standards applicable to Co-Developed Productseach Partnership Party’s Manufacturing activities under this Agreement, reviewing each Partnership Party’s (or a Third Party’s on such Partnership Party’s behalf) performance against such standards and conducting technical reviews;
(h) overseeing all recallsreview and approve templates of agreements for use with CMOs and contract testing facilities for the Manufacture of any Collaboration Product Candidate and Collaboration Product, market withdrawals and as well as any other corrective actions related to Co-Developed Products material modifications or updates thereto, as set forth in the Co-Development TerritorySection 3.4.5;
(i) receiving review, discuss and providing approve any recommendations of the Partnership Parties regarding capacity planning, supply plans and supply continuity planning for the Collaboration Product Candidates and Collaboration Products and make recommendations to the Parties sales reports pertaining to Co-Developed Products in the Co-Developed TerritoryJSC as appropriate;
(j) approving all Third review and discuss whether any Manufacturing technology transfer between the Partnership Parties to be engaged by either Party to provide Representatives to Co-Promote Co-Developed Products in the Co-Developed Territoryis necessary;
(k) reviewing review, discuss and approving approve any ingredients that are therapeutically or biologically active that are proposed by either Party for inclusion use of a Subcontractor to conduct a Partnership Party’s activities under the Global Manufacturing Plan, as set forth in Section 6.1;
(l) review and share the results of regulatory and environmental, health and safety inspections and audits related to the Manufacture of any Collaboration Product Candidates and Collaboration Products with a Co-Developed Product to create a Combination Productthe JSC, as necessary; and
(lm) performing perform such activities other duties as are specifically assigned to it under this Agreement or as may be delegated to it by the JDCC pursuant to this Agreement, or by mutual written agreement of the Parties after the Approval DateJSC.
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (CRISPR Therapeutics AG)