Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. The JDC shall manage, coordinate and oversee the Parties’ activities under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and the Galapagos Territory Development Plan. In particular, the JDC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) review and serve as a forum for discussing, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans, and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development Budgets; (iii) consider, review and approve any amendments to the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicable; (iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteria; (v) determine whether any Combination Product satisfies the Corrector/Combination Product POC Success Criteria; (vi) oversee the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans; (vii) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Plan; (xi) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto; (xii) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other Development-related Information as contemplated under this Agreement; (xiii) discuss, and to the extent provided in Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providers; and (xiv) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 2 contracts

Sources: Collaboration Agreement (Galapagos Nv), Collaboration Agreement (Galapagos Nv)

Specific Responsibilities. The JDC shall manage, coordinate develop the strategies for and oversee the Parties’ activities under Development of the Potentiator POC Development Plan, Licensed Compounds or Licensed Products in the Corrector/Combination Product POC Development Plan, the Post-POC Development PlansTerritory, and shall serve as a forum for the Galapagos Territory coordination of Development Planactivities for the Licensed Compounds or Licensed Products for the Territory. In particular, the JDC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) […***…] review and serve as a forum for discussingdiscussing the Initial Development Plan and Budget, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, such review to include oversight of project risk and the Post-POC Development Plansmitigation strategies, and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development BudgetsMaterial Amendment; (iii) consider, review and approve any amendments to the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicable; (iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteria; (v) determine whether any Combination Product satisfies the Corrector/Combination Product POC Success Criteria; (viii) oversee the conduct of Development activities, as applicable, activities under the Potentiator POC Initial Development Plan, the Corrector/Combination Product POC Development Plan, Plan and the Post-POC Development PlansBudget; (viiiii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (iv) determine whether a Compound Failure has occurred; (viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Plan; (xi) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto; (xiiv) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other Development-JDC related Information as contemplated under this Agreement; (xiiivi) discussperiodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and to the extent provided in Section 3.10activities, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providers; andif any; (xivvii) perform periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such other functions as are set forth herein or as the Parties may mutually agree in writing[…***…] period, except where in conflict with any provision then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes of this Agreement.Section 2.2.2

Appears in 2 contracts

Sources: Exclusive License Agreement (Ablynx NV), Exclusive License Agreement (Ablynx NV)

Specific Responsibilities. The JDC JCC shall manage, coordinate develop the strategies for and oversee the Parties’ Commercialization of the Co-Promotion Products in the Co-Promotion Territory and oversee at a high level all Commercialization activities under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and in the Galapagos Territory Development Planwith respect to the Products. In particular, the JDC JCC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) review and serve as a forum for discussingdiscussing AbbVie’s Commercialization activities in the AbbVie Territory and AbbVie’s global brand plan for the Products, including marketing and promotional materials, Product messaging, Commercialization budgets and Detailing effort; (ii) establish a strategy for the Commercialization of the Co-Promotion Products in the Co-Promotion Territory; (iii) review and approve the initial Co-Promotion Plan; (iv) periodically (no less often than annually) review and serve as applicable, a forum for discussing the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the PostCo-POC Development Plans, Promotion Plan and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development Budgets; (iii) consider, review and approve any amendments to the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicable; (iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteria; (v) determine whether any Combination review and approve the manner in which the Markings are to be presented on promotional materials and Product satisfies Labeling for the Corrector/Combination Product POC Success CriteriaCo-Promotion Products in the Co-Promotion Territory; (vi) oversee the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans; (vii) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Commercialization Plan; provided, that AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval so long as the initial Galapagos Territory Commercialization Plan is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of this Agreement; (xivii) oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the Products; (viii) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development PlanCommercialization Plan and its implementation, and review and approve any amendments thereto; (xii) establish secure access methods (; provided, that AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval so long as secure databases) or such amendment is consistent with AbbVie’s then-current global brand plan for the Products and the other processes for each Party to exchange and access Regulatory Documentation and other Development-related Information as contemplated under requirements of this Agreement; (xiiiix) discuss, review and approve the form and content of all marketing and promotional materials and all Product messaging to be used in the Galapagos Territory with respect to the extent provided Products; (x) review and approve the form and content of all training materials to be used in Section 3.10, approve, the Galapagos Territory with respect to the Products; (xi) discuss the selection of all Distributors and Third Party Providers co-promoters and promoters engaged to support Commercialization activities in the Development activities Galapagos Territory and review the performance of all such Third Party ProvidersParties; and (xivxii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 2 contracts

Sources: Collaboration Agreement (Galapagos Nv), Collaboration Agreement (Galapagos Nv)

Specific Responsibilities. The JDC shall manageJRDC will, coordinate subject to the escalation, final decision-making authority and oversee dispute resolution procedures in Section 9.9: (a) be responsible for overseeing the Parties’ performance of their respective activities under the Potentiator POC Research Plan and Early Development Plan and provide support to each Party with respect to such Party’s activities thereunder; (b) review and discuss each amended Research Plan and Early Development Plan and approve updates or material amendments to the Research Plan and the Early Development Plan; (c) discuss and determine whether a Degrader that is Researched under this Agreement meets the Screening ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Ready Criteria or Phase 2 Ready Criteria; (d) review, discuss and approve changes to the Screening ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Ready Criteria or Phase 2 Ready Criteria; (e) discuss and determine whether Successful Completion has been achieved; (f) review and discuss the list of Degraders provided by Kymera pursuant to Section 2.2.2; (g) review and discuss reports and data provided by Kymera pursuant to Section 2.4.4 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the First Additional Degrader Criteria; (h) cause the minutes of the JRDC to reflect any selection of a Degrader as a First Additional Degrader, whether by the JRDC, the Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and the Galapagos Territory Development Plan. In particular, the JDC shall:R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 2.4.4; (i) as applicablereview, develop discuss and determine [***]; (j) review, discuss and determine [***]; (k) review, discuss and approve [***]; (l) following [***], discuss and determine [***]; (m) review, discuss and determine whether a Collaboration Candidate or Licensed Product Directed Against Collaboration Target 2 satisfies the Phase 1 Ready Criteria; (n) review and discuss reports and data provided by Kymera pursuant to Section 2.5.6 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Second Additional Degrader Criteria; (o) cause the minutes of the Potentiator POC Development PlanJRDC to reflect any selection of a Degrader as a Second Additional Degrader, whether by the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, JRDC or the R&D Expert or by Sanofi in accordance with the terms hereofSection 2.5.6; (ii) periodically (no less often than semi-annuallyp) review and serve as a forum for discussing, as applicable, discuss reports and data provided by Kymera pursuant to Section 2.6.5 within [***] after the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plandelivery of each such report, and determine if a relevant Degrader satisfies the Post-POC Development Plans, and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development Budgets▇▇ ▇▇▇▇▇▇▇▇; (iiiq) considercause the minutes of the JRDC to reflect any selection of a Collaboration Compound as a Collaboration Candidate, review and approve any amendments to whether by the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, JRDC or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicableR&D Expert; (ivr) review and discuss information provided by Kymera pursuant to Section 2.5.4 and whether to approve any related overspend as a Permitted Overrun; (s) review, discuss and approve a Research Budget Excession in accordance with Section 2.5.4, including whether any such Research Budget Excession was in Kymera’s reasonable control; (t) review, discuss and determine whether Research Activities under Section 2.6.3 should be discontinued; (u) review and discuss information provided by Kymera pursuant to Section 2.6.4 and whether to approve any Potentiator Product satisfies the Potentiator POC Success Criteriarelated overspend as a Series 2 Permitted Overrun; (v) determine review, discuss and approve Series 2 Research Budget Excession in accordance with Section 2.6.4, including whether any Combination Product satisfies the Corrector/Combination Product POC Success Criteriasuch Series 2 Research Budget Excession was in Kymera’s reasonable control; (viw) oversee discuss and approve a transfer of Materials from one Party to the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, other Party in accordance with Section 2.8 and the Post-POC Development Plans; (vii) serve as discuss information provided by a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings Party with respect to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development FailureMTA Research Studies; (x) review and approve during the initial Galapagos Territory Development PlanResearch Term prior to Sanofi’s exercise of the Sanofi Participation Election Right with respect to Collaboration Target 2, determine the first Indication for which the first IND will be filed with respect to a Licensed Product; (xiy) periodically discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 3.5 and discuss information provided by a Party with respect to MTA Development Studies; (no less often than semi-annuallyz) review and serve as discuss reports provided by a forum for discussing the Galapagos Territory Development PlanParty pursuant to Section 2.11, and review and approve amendments theretoSection 3.7 or Section 5.5; (xiiaa) establish secure access methods (such as secure databases) or other processes for each Party to exchange the extent contemplated by Section 5.2.3, review, discussion and access Regulatory Documentation and other Development-related Information as contemplated under this Agreementapprove an extension of time during which Kymera will make its personnel reasonably available; (xiiibb) discussreview and discuss information provided by Kymera pursuant to Section 5.5.6 and whether to approve any related overspend as a Permitted Backup Research Overrun; (cc) review, discuss and determine, in accordance with Section 5.5.6, whether any Backup Research Budget Excession was in Kymera’s reasonable control; (dd) review and discuss reports and data provided by Kymera pursuant to Section 5.5.7 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Backup Degrader Criteria; (ee) cause the minutes of the JRDC to reflect any selection of a Degrader as a Backup Degrader, whether by the extent provided in Section 3.10, approveJRDC, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providers; andR&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 5.5.10; (xivff) perform such other functions as are set forth herein in coordination with the JPC, review and discuss any requests by Kymera pursuant to Section 5.6.5 regarding a potential reversion of any Collaboration Compounds or Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by or on behalf of Kymera under Section 2.3, 2.4, 2.5 or 5.5 but have not been selected as the Parties may mutually agree First Additional Degraders, Second Additional Degraders or Backup Degraders; (gg) review and discuss reports provided by Sanofi in writing, except where in conflict accordance with any provision of this Agreement.Section 5.9;

Appears in 1 contract

Sources: Collaboration and License Agreement (Kymera Therapeutics, Inc.)

Specific Responsibilities. The JDC shall manage, coordinate develop the strategies for and oversee the Parties’ activities under Development of the Potentiator POC Development Plan, Licensed Compounds or Licensed Products in the Corrector/Combination Product POC Development Plan, the Post-POC Development PlansTerritory, and shall serve as a forum for the Galapagos Territory coordination of Development Planactivities for the Licensed Compounds or Licensed Products for the Territory. In particular, the JDC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) […***…] review and serve as a forum for discussingdiscussing the Initial Development Plan and Budget, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, such review to include oversight of project risk and the Post-POC Development Plansmitigation strategies, and review and approve amendments thereto, including any amendments to Material Amendment; (ii) oversee the POC Budgets conduct of Development activities under the Initial Development Plan and Post-POC Development BudgetsBudget; (iii) consider, review serve as a forum for discussing and approve any amendments to coordinating strategies for obtaining Regulatory Approvals for the Potentiator POC Success Criteria and Licensed Products in the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicableTerritory; (iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteriaa Compound Failure has occurred; (v) determine whether any Combination Product satisfies the Corrector/Combination Product POC Success Criteria; (vi) oversee the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans; (vii) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Plan; (xi) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto; (xii) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other Development-JDC related Information as contemplated under this Agreement; (xiiivi) discussperiodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes of this Section 2.2.2(vii) AbbVie shall be permitted to provide notice via email; (ix) determine the extent provided in appropriate timeline for the transfer of Regulatory Documentation, Ablynx Know-How, Joint Know-How and other Information from Ablynx to AbbVie pursuant to Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providers3.5.4; and (xivx) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

Sources: Exclusive License Agreement (Ablynx NV)

Specific Responsibilities. The JDC JCC shall manage, coordinate develop the strategies for and oversee the Parties’ Commercialization of the Co-Promotion Products in the Co-Promotion Territory and oversee at a high level all Commercialization activities under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and in the Galapagos Territory Development Planwith respect to the Products. In particular, the JDC JCC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) review and serve as a forum for discussingdiscussing AbbVie’s Commercialization activities in the AbbVie Territory and AbbVie’s global brand plan for the Products, including marketing and promotional materials, Product messaging, Commercialization budgets and Detailing effort; (ii) establish a strategy for the Commercialization of the Co-Promotion Products in the Co-Promotion Territory; (iii) review and approve the initial Co-Promotion Plan; (iv) periodically (no less often than annually) review and serve as applicable, a forum for discussing the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the PostCo-POC Development Plans, Promotion Plan and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development Budgets; (iii) consider, review and approve any amendments to the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicable; (iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteria; (v) determine whether any Combination review and approve the manner in which the Markings are to be presented on promotional materials and Product satisfies Labeling for the Corrector/Combination Product POC Success CriteriaCo-Promotion Products in the Co-Promotion Territory; (vi) oversee the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans; (vii) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Commercialization Plan; provided, that AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval so long as the initial Galapagos Territory Commercialization Plan is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of this Agreement; (xivii) oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the Products; (viii) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development PlanCommercialization Plan and its implementation, and review and approve any amendments thereto; (xii) establish secure access methods (; provided, that AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval so long as secure databases) or such amendment is consistent with AbbVie’s then-current global brand plan for the Products and the other processes for each Party to exchange and access Regulatory Documentation and other Development-related Information as contemplated under requirements of this Agreement; (xiiiix) discuss, review and approve the form and content of all marketing and promotional materials and all Product messaging to be used in the Galapagos Territory with respect to the extent provided Products; * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. (x) review and approve the form and content of all training materials to be used in Section 3.10, approve, the Galapagos Territory with respect to the Products; (xi) discuss the selection of all Distributors and Third Party Providers co-promoters and promoters engaged to support Commercialization activities in the Development activities Galapagos Territory and review the performance of all such Third Party ProvidersParties; and (xivxii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Galapagos Nv)

Specific Responsibilities. The JDC shall manage, coordinate and oversee the Parties’ activities under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and the Galapagos Territory Development Plan. In particular, the JDC shallwill: (i) as applicable, develop facilitate the flow of information between the Parties with respect to the Development and approve each Commercialization of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, Licensed Antibodies and each Post-POC Development Plan, in accordance with the terms hereofLicensed Products; (ii) periodically (no less often than semi-annually) review and serve as a forum for discussingreview, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plandiscuss, and the Post-POC determine whether to approve updates to any Ongoing JS001 Development Plans, Plan or Ongoing JS001 Development Budget pursuant to Section 4.2(a) (Plans and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development Budgets); (iii) consider, review and approve any amendments discuss Development Proposals presented by either Party pursuant to the Potentiator POC Success Criteria Section 4.3(a) (Proposals and the Corrector/Combination Product POC Success CriteriaJDC Review), or the inclusion therein of a new Potentiator Standard or Combination Standardand, as applicable;subject to Section 3.2(b)(iv), Independent Trials, Independent Development Plans, and Independent ​ ​ ​ Development Budgets presented by either Party pursuant to Section 4.5 (Independent Development); ​ (iv) review, discuss, and determine whether to approve each Joint Development Plan and Joint Development Budget, and each update thereto, pursuant to Section 4.4 (Joint Development), which will include any Potentiator Product satisfies the Potentiator POC Success Criteria;Independent Development Plan or Independent Development Budget that becomes a Joint Development Plan or Joint Development Budget following a Party’s opt-in pursuant to Section 4.5 (Independent Development), and any updates thereto; ​ (v) after the Option Exercise with respect to an Option Program, review, discuss, and determine whether to approve all updates or amendments to any Combination applicable Optioned Licensed Product satisfies the Corrector/Combination Trials, Optioned Licensed Product POC Success CriteriaDevelopment Plan, and Optioned Licensed Product Development Budget pursuant to Section 4.6 (Development of Optioned Licensed Products) or Section 2.8 (Coherus License Options); (vi) oversee the conduct of review and discuss any Development activities, as applicable, under the Potentiator POC reports provided by either Party pursuant to Section 4.10 (Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development PlansReports); (vii) serve as a forum for discussing strategies for obtaining review, discuss, and determine whether to approve the Transition Plan pursuant to Section 5.1 (Regulatory Approvals for the Products in the TerritoryResponsibilities); (viii) determine whether review, discuss, and approve (A) the Development date by which the Parties will complete all transition activities under a Post-POC Development Plan support the filing of a Drug Approval Application to enable Coherus to assume regulatory responsibilities for the applicable Product in any country or jurisdiction Licensed Antibodies and Licensed Products in the Coherus Territory (other than those related to the Junshi Clinical Trials), and (B) whether Drug Approval Filings with respect Coherus will assume responsibility for further regulatory activities for the Licensed Antibodies and Licensed Products throughout the Coherus Territory for the Ongoing JS001 Trial following transfer of the applicable Regulatory Approvals and Regulatory Materials for the Ongoing JS001 Trial to any Product shall be made Coherus, in any country or jurisdiction in the Territoryeach case ((A) – (B)) pursuant to Section 5.2 (Assignment of Regulatory Materials); (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failurereview and discuss any Commercialization updates provided by Coherus pursuant to Section 7.3 (Commercialization Report); (x) review and approve to the initial Galapagos Territory extent not specified in a Joint Development Plan; (xi) periodically (no less often than semi-annually) review and serve as a forum for discussing Plan approved by the Galapagos Territory Development PlanJDC, and review and approve amendments thereto; (xii) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other Development-related Information as contemplated under this Agreement; (xiii) review, discuss, and determine which Party will have control and decision-making authority with respect to preparing and submitting regulatory filings and conducting communications with Regulatory Authorities, in each case related to the extent provided in Section 3.10Licensed Antibodies and Licensed Products that is the subject of the Joint Development Plan approved by the JDC, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providersas applicable; and (xivxi) perform such other functions as are set forth herein or as appropriate, to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement, in each case as agreed in writing by the Parties.

Appears in 1 contract

Sources: Exclusive License and Commercialization Agreement (Coherus BioSciences, Inc.)

Specific Responsibilities. The JDC JSC shall manage, coordinate continuously monitor the progress of the Development Plan and oversee Budget and provide status reports to the senior management of each of the Parties as appropriate. The Parties contemplate that the responsibilities of the Joint Steering Committee shall evolve during the course of the Parties’ activities relationship under this Agreement. In support of its responsibility for overseeing and coordinating the Potentiator POC Development Planand Exploitation of the Licensed Products, the Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and the Galapagos Territory Development Plan. In particular, the JDC JSC shall: (a) establish a strategy for (i) as applicablethe Development, develop Approval, Commercialization and approve each other Exploitation of the Potentiator POC Development PlanLicensed Products in (A) the Human Excluding HIV/AIDS/ID/Pediatric Field in the Salix Human Excluding HIV/AIDS/ID/Pediatric Territory; (B) the HIV/AIDS/Pediatric Field in the Salix HIV/AIDS/Pediatric Territory; and (C) the ID Field in the Salix ID Territory and (ii) the coordination of the Development, Approval, Commercialization and other Exploitation of the Corrector/Combination Product POC Development PlanLicensed Products in fields and countries other than those specified in the preceding clause (i) to the extent such Development, Approval, Commercialization and each Post-POC Development Planother Exploitation impacts or affects the Development, Approval, Commercialization and other Exploitation of the Licensed Products in accordance with the terms hereoffields and countries specified in clause (i); (ii) periodically (no less often than semi-annuallyb) review and serve as a forum monitor the Development Plan and Budget and the implementation thereof and make recommendations to the Parties regarding updates, amendments and modifications to the Development Plan and Budget; (c) consider the allocation of responsibilities between the Parties for discussingDevelopment pursuant to the Development Plan and Budget; (d) consider the allocation of responsibilities between the Parties for Commercialization and other Exploitation activities pursuant to one or more written plans covering the Commercialization and other Exploitation of each Licensed Product; (e) review and make recommendations to the Parties regarding the conduct of Clinical Trials for additional indications for Licensed Products, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development PlanPost Approval Studies for Licensed Products, and the Post-POC Development Plans, and review and approve amendments thereto, including any amendments to the POC Budgets Development Plan and Post-POC Development BudgetsBudget in respect thereof; (iiif) considerreview statistical analysis plans and protocols for, review and approve any amendments to monitor the Potentiator POC Success Criteria progress of, all Clinical Trials and Post Approval Studies for the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicableLicensed Products; (ivg) determine whether any Potentiator Product satisfies review and make recommendations to the Potentiator POC Success CriteriaParties on all proposed product labeling, Drug Approval Applications and other filings with the Regulatory Authorities with respect to Approvals for the Licensed Products; (vh) determine whether any Combination review and make recommendations to the Parties on advertising and promotional materials and strategies, packaging designs and Product satisfies the Corrector/Combination Product POC Success CriteriaTrademarks for each Licensed Product; (vii) oversee facilitate the conduct exchange of Development activities, as applicable, under Information relating to all Clinical Trials and Post Approval Studies and Commercialization Information for the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development PlansLicensed Products; (viij) serve establish such other committees (each, including the JSC, a “Committee”) as deemed appropriate by the JSC, including such Committees as the JSC deems appropriate to coordinate the Development, Approval, Commercialization and other Exploitation of the Licensed Products on a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territoryworldwide basis; (viiik) determine whether consider labeling issues and undertake coordination of labeling on a worldwide basis so as to ensure such degree of consistency in labeling as the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect JSC deems to any Product shall be made in any country or jurisdiction in the Territory; (ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure; (x) review and approve the initial Galapagos Territory Development Plan; (xi) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto; (xii) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other Development-related Information as contemplated under this Agreement; (xiii) discuss, and to the extent provided in Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providersdesirable; and (xivl) perform such other functions as are set forth herein or as the Parties may mutually agree in writing. For clarity, except where in conflict with any provision subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.

Appears in 1 contract

Sources: Collaboration Agreement (Salix Pharmaceuticals LTD)

Specific Responsibilities. The JDC shall manage, coordinate and oversee the Parties’ activities under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, the Combination Product Post-POC Development PlansPlan, the CMC Plan, the Potentiator Post-POC Development Plan and the Galapagos Territory Development Plan. In particular, the JDC shall: (i) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, Plan in accordance with the terms hereof; (ii) periodically (no less often than semi-annually) review and serve as a forum for discussing, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Combination Product Post-POC Development PlansPlan, and the Potentiator Product Post-POC Development Plan and review and approve amendments thereto, including any amendments to the Combination Product POC Budgets and Budget, Combination Product Post-POC Development BudgetsBudget and the Potentiator Post-POC Development Budget; (iii) considerdetermine the Corrector Molecules, review Potentiator Molecules, Dual Combination Products and approve any amendments Triple Combination Products to be Developed in Phase 1s and Phase 2s under the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicableDevelopment Plan; (iv) determine whether to discontinue (A) any Potentiator Phase 1 or Phase 2 under the Combination Product satisfies POC Development Plan with respect to any particular Molecule or any particular Molecule(s) contained in a Combination Product or to select for Development in a Phase 1 or Phase 2 under the Combination Product POC Development Plan a new Molecule or a Combination Product containing one (1) or more new Molecules or (B) any Phase 2 under the Potentiator Post-POC Success Criteria;Development Plan; * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. (v) periodically (no less often than semi-annually) review and serve as a forum for discussing the CMC Plan and review and approve CMC Amendments; (vi) determine whether any P+C1 Dual Combination Product satisfies the Corrector/P+C1 Dual Combination Product POC Success Criteria; (vivii) determine whether any Triple Combination Product satisfies the Triple Combination End of Phase 1 Success Criteria, Triple Combination Heterozygous Success Criteria, or Triple Combination Homozygous Success Criteria, as applicable; (viii) oversee the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Combination Product Post-POC Development PlansPlan, the Potentiator Post-POC Development Plan and the CMC Plan; (viiix) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (viiix) determine whether the Development activities under a the Combination Product Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Combination Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Combination Product shall be made in any country or jurisdiction in the Territory; (ixxi) determine the occurrence of Corrector Post-POC Development Failure or Potentiator a Combination Post-POC Development Failure; (xxii) determine whether the Development activities under the Potentiator Post-POC Development Plan support the filing of a Drug Approval Application for the Potentiator Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Potentiator Product shall be made in any country or jurisdiction in the Territory; (xiii) review and approve the initial Galapagos Territory Development Plan; (xixiv) periodically (no less often than semi-annually) review and serve as a forum for discussing the Galapagos Territory Development Plan, and review and approve amendments thereto; (xiixv) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other Development-related Information as contemplated under this Agreement; (xiiixvi) discuss, and to the extent provided in Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providers; and (xivxvii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

Sources: Collaboration Agreement (Galapagos Nv)