Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall, subject to the terms of this Agreement, in particular: (a) oversee the collaborative activities of the Parties under this Agreement; (b) oversee the activities of Verve and Beam with respect to each Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s); (c) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments thereto; (d) oversee activities under the Technology Transfer Plan; (e) review and decide whether to approve any amendments to the Research Plan submitted by the JRC; (f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto; (g) with respect to Collaboration Products, approve pricing of such Products and supply thereof within the Collaboration Territory; (h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products; (i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs; (j) receive and discuss reports from Subcommittees and provide guidance thereto; (k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee; (l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a); (m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a); (n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC; (o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (p) have any other responsibility expressly designated for the JSC under this Agreement.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Verve Therapeutics, Inc.), Collaboration and License Agreement (Verve Therapeutics, Inc.)
Specific Responsibilities. In addition to its overall responsibility for monitoring The JDC shall manage, coordinate and providing a forum to discuss and coordinate oversee the Parties’ activities under this Agreementthe Potentiator POC Development Plan, the JSC Corrector/Combination Product POC Development Plan, the Post-POC Development Plans, and the Galapagos Territory Development Plan. In particular, the JDC shall, subject to the terms of this Agreement, in particular:
(ai) 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 collaborative 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 Parties 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;
(bxiii) oversee discuss, and to the activities extent provided in Section 3.10, approve, the selection of Verve and Beam with respect all Third Party Providers engaged to each Development Plan for Opt-In Products and Collaboration Products (including support the Development Budget in any Development Plan for a Collaboration Product) activities and review the Commercialization performance of Collaboration Product(s);
(c) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments thereto;
(d) oversee activities under the Technology Transfer Plan;
(e) review and decide whether to approve any amendments to the Research Plan submitted by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto;
(g) with respect to Collaboration Products, approve pricing of all such Products and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of this AgreementThird Party Providers; and
(pxiv) have perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any other responsibility expressly designated for the JSC under provision of this Agreement.
Appears in 2 contracts
Sources: Collaboration Agreement (Galapagos Nv), Collaboration Agreement (Galapagos Nv)
Specific Responsibilities. In addition to its overall responsibility The JDC shall develop the strategies for monitoring and providing oversee the Development of the Licensed Compounds or Licensed Products in the Territory, and shall serve as a forum to discuss and coordinate for the Parties’ coordination of Development activities under this Agreementfor the Licensed Compounds or Licensed Products for the Territory. In particular, the JSC JDC shall, subject to the terms of this Agreement, in particular:
(ai) periodically […***…] review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment;
(ii) oversee the collaborative conduct of Development activities of under the Parties Initial Development Plan and Budget;
(iii) 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;
(v) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement;
(bvi) oversee periodically (no less often than annually) review and serve as a forum for discussing and planning the activities of Verve communication, publication, abstract or presentation plan and Beam with respect to each Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s)activities, if any;
(cvii) periodically review and decide whether to approve any proposed serve as a forum for discussing the […***…] Development Plan for Opt-In Products and Collaboration Products (including the or RA Phase 3 Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments theretoPlan, as applicable;
(dviii) oversee activities under the Technology Transfer Plan;
(e) review and decide whether to approve any amendments to the Research Plan submitted by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget subcontractors that Ablynx may utilize in any US Commercialization Plan) and any proposed amendments thereto;
(g) interactions with respect to Collaboration Productsa Regulatory Authority; provided, approve pricing that AbbVie shall provide notice of such Products and supply thereof approval or rejection of the subcontractor within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions […***…] from the JRCdate of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, JMCthen AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent for purposes of this Agreement; and
(p) have any other responsibility expressly designated for the JSC under this Agreement.Section 2.2.2
Appears in 2 contracts
Sources: Exclusive License Agreement (Ablynx NV), Exclusive License Agreement (Ablynx NV)
Specific Responsibilities. In addition The JDC shall meet at least semi-annually, or as otherwise agreed to its overall responsibility by the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JDC members, provided that with respect to in person meetings, unless otherwise agreed the location of such meetings shall alternate between locations designated by Licensor and locations designated by AbbVie. The JDC shall develop the strategies for monitoring and providing oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum to discuss and coordinate for the Parties’ coordination of Development activities under this Agreementfor the Licensed Antibodies or Licensed Products for the Territory. In particular, the JSC JDC shall, subject to the terms of this Agreement, in particular:
(a) oversee periodically (no less often than annually) review and serve as a forum for discussing each Pre Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the collaborative activities applicable minutes of the Parties under JDC meeting; *** Certain information in this Agreement;agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(b) serve as a forum for discussing and oversee the activities conduct of Verve and Beam with respect to each Pre Exercise Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s)Activities;
(c) periodically (no less often than annually) review and decide whether to approve any proposed each Post Exercise Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) Budget, and any proposed review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting;
(d) oversee activities under serve as a forum for discussing the Technology Transfer Planconduct of the applicable Country-Specific Development Activities;
(e) review serve as a forum for discussing and decide whether to approve any amendments to oversee the Research Plan submitted by the JRCconduct of Additional Licensor Development Activities;
(f) review serve as a forum for reviewing and decide whether approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to approve each proposed US Commercialization Plan (including seek advice on strategies for seeking Regulatory Approvals for the Commercialization Budget Licensed Products in any US Commercialization Plan) and any proposed amendments theretothe Territory;
(g) with respect establish secure access methods (such as secure databases) for each Party to Collaboration Products, approve pricing of such Products access Regulatory Documentation and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses other JDC related Information as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of contemplated under this Agreement; and
(ph) have perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any other responsibility expressly designated for the JSC under provision of this Agreement.
Appears in 2 contracts
Sources: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, Inc.)
Specific Responsibilities. The JCC shall develop the strategies for and oversee the Commercialization of the Co-Promotion Products in the Co-Promotion Territory and oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the Products. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreementparticular, the JSC JCC shall, subject to the terms of this Agreement, in particular:
(ai) oversee periodically (no less often than annually) review and serve as a forum for discussing AbbVie’s Commercialization activities in the collaborative activities 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 Parties under 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 a forum for discussing the Co-Promotion Plan and review and approve amendments thereto;
(v) review and approve the manner in which the Markings are to be presented on promotional materials and Product Labeling for the Co-Promotion Products in the Co-Promotion Territory;
(vi) review and approve the initial Galapagos Territory 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;
(bvii) oversee at a high level all Commercialization activities in the activities of Verve and Beam Galapagos Territory with respect to each Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s);
(c) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments thereto;
(d) oversee activities under the Technology Transfer Plan;
(e) review and decide whether to approve any amendments to the Research Plan submitted by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto;
(g) with respect to Collaboration Products, approve pricing of such Products and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(iviii) periodically (no less often than annually) review and decide whether to serve as a forum for discussing the Galapagos Territory Commercialization Plan and its implementation, and review and approve any amendments thereto; provided, that AbbVie shall ensure that its representatives on the designation JCC do not unreasonably withhold such approval so long as such amendment is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Coststhis Agreement;
(jix) receive review and discuss reports 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 Products; * Confidential information, indicated by [...***...], has been omitted from Subcommittees this filing and provide guidance theretofiled 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 the Galapagos Territory with respect to the Products;
(kxi) attempt discuss the selection of all Distributors and Third Party co-promoters and promoters engaged to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case support Commercialization activities in the Collaboration Galapagos Territory in accordance with and review the terms and conditions performance of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish all such additional Subcommittees as it deems necessary to achieve the objectives and intent of this AgreementThird Parties; and
(pxii) have perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any other responsibility expressly designated for the JSC under provision of this Agreement.
Appears in 1 contract
Specific Responsibilities. In addition to its overall responsibility for monitoring The JDC shall manage, coordinate and providing a forum to discuss and coordinate oversee the Parties’ activities under this Agreementthe Combination Product POC Development Plan, the JSC Combination Product Post-POC Development Plan, the CMC Plan, the Potentiator Post-POC Development Plan and the Galapagos Territory Development Plan. In particular, the JDC shall, subject to the terms of this Agreement, in particular:
(ai) develop and approve the Potentiator 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 Combination Product POC Development Plan, the Combination Product Post-POC Development Plan, and the Potentiator Product Post-POC Development Plan and review and approve amendments thereto, including any amendments to the Combination Product POC Budget, Combination Product Post-POC Development Budget and the Potentiator Post-POC Development Budget;
(iii) determine the Corrector Molecules, Potentiator Molecules, Dual Combination Products and Triple Combination Products to be Developed in Phase 1s and Phase 2s under the Combination Product POC Development Plan;
(iv) determine whether to discontinue (A) any Phase 1 or Phase 2 under the Combination Product 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 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 P+C1 Dual Combination Product POC Success Criteria;
(vii) 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 collaborative conduct of Development activities, as applicable, under the Combination Product POC Development Plan, the Combination Product Post-POC Development Plan, the Potentiator Post-POC Development Plan and the CMC Plan;
(ix) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory;
(x) determine whether the Development activities under the Combination Product Post-POC Development Plan support the filing of a Drug Approval Application for the Parties 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;
(xi) determine the occurrence of a Combination Post-POC Development Failure;
(xii) 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;
(xiv) 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;
(xv) 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;
(bxvi) oversee discuss, and to the activities extent provided in Section 3.10, approve, the selection of Verve and Beam with respect all Third Party Providers engaged to each Development Plan for Opt-In Products and Collaboration Products (including support the Development Budget in any Development Plan for a Collaboration Product) activities and review the Commercialization performance of Collaboration Product(s);
(c) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments thereto;
(d) oversee activities under the Technology Transfer Plan;
(e) review and decide whether to approve any amendments to the Research Plan submitted by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto;
(g) with respect to Collaboration Products, approve pricing of all such Products and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of this AgreementThird Party Providers; and
(pxvii) have perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any other responsibility expressly designated for the JSC under provision of this Agreement.
Appears in 1 contract
Specific Responsibilities. In addition The JSC shall continuously monitor the progress of the Development Plan and Budget and provide status reports to its overall responsibility for monitoring and providing a forum to discuss and coordinate 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 Development and Exploitation of the Licensed Products, the JSC shall:
(a) establish a strategy for (i) the Development, Approval, Commercialization and other Exploitation of the Licensed 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 Licensed Products in fields and countries other than those specified in the preceding clause (i) to the extent such Development, Approval, Commercialization and other Exploitation impacts or affects the Development, Approval, Commercialization and other Exploitation of the Licensed Products in the fields and countries specified in clause (i);
(b) review and 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 Development 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, Post Approval Studies for Licensed Products, and amendments to the Development Plan and Budget in respect thereof;
(f) review statistical analysis plans and protocols for, and monitor the progress of, all Clinical Trials and Post Approval Studies for the Licensed Products;
(g) review and make recommendations to the Parties on all proposed product labeling, Drug Approval Applications and other filings with the Regulatory Authorities with respect to Approvals for the Licensed Products;
(h) review and make recommendations to the Parties on advertising and promotional materials and strategies, packaging designs and Product Trademarks for each Licensed Product;
(i) facilitate the exchange of Development Information relating to all Clinical Trials and Post Approval Studies and Commercialization Information for the Licensed Products;
(j) 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 worldwide basis;
(k) consider labeling issues and undertake coordination of labeling on a worldwide basis so as to ensure such degree of consistency in labeling as the JSC deems to be desirable; and
(l) perform such other functions as are set forth herein or as the Parties may mutually agree in writing. For clarity, subject to the terms of this Agreement, in particular:
(a) oversee the collaborative activities of the Parties under this Agreement;
(b) oversee the activities and resources of Verve each Party shall be managed by such Party, acting independently and Beam with respect to each Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s);
(c) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments thereto;
(d) oversee activities under the Technology Transfer Plan;
(e) review and decide whether to approve any amendments to the Research Plan submitted by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto;
(g) with respect to Collaboration Products, approve pricing of such Products and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and
(p) have any other responsibility expressly designated for the JSC under this Agreementits individual capacity.
Appears in 1 contract
Sources: Collaboration Agreement (Salix Pharmaceuticals LTD)
Specific Responsibilities. In addition The JDC will:
(i) facilitate the flow of information between the Parties with respect to its overall responsibility for monitoring the Development and providing a forum Commercialization of the Licensed Antibodies and Licensed Products;
(ii) review, discuss, and determine whether to approve updates to any Ongoing JS001 Development Plan or Ongoing JS001 Development Budget pursuant to Section 4.2(a) (Plans and Budgets);
(iii) review and discuss Development Proposals presented by either Party pursuant to Section 4.3(a) (Proposals and coordinate the Parties’ activities under this AgreementJDC Review), the JSC shalland, 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 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 terms Option Exercise with respect to an Option Program, review, discuss, and determine whether to approve all updates or amendments to any applicable Optioned Licensed Product Trials, Optioned Licensed Product Development 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) review and discuss any Development reports provided by either Party pursuant to Section 4.10 (Development Reports);
(vii) review, discuss, and determine whether to approve the Transition Plan pursuant to Section 5.1 (Regulatory Responsibilities);
(viii) review, discuss, and approve (A) the date by which the Parties will complete all transition activities to enable Coherus to assume regulatory responsibilities for the Licensed Antibodies and Licensed Products in the Coherus Territory (other than those related to the Junshi Clinical Trials), and (B) whether 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 Coherus, in each case ((A) – (B)) pursuant to Section 5.2 (Assignment of Regulatory Materials);
(ix) review and discuss any Commercialization updates provided by Coherus pursuant to Section 7.3 (Commercialization Report);
(x) to the extent not specified in a Joint Development Plan approved by the JDC, 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 Licensed Antibodies and Licensed Products that is the subject of the Joint Development Plan approved by the JDC, as applicable; and
(xi) perform such other functions as appropriate, to further the purposes of this Agreement, in particular:
(a) oversee the collaborative activities of the Parties under this Agreement;
(b) oversee the activities of Verve and Beam with respect to each Development Plan for Opt-In Products and Collaboration Products (including the Development Budget case as agreed in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s);
(c) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments thereto;
(d) oversee activities under the Technology Transfer Plan;
(e) review and decide whether to approve any amendments to the Research Plan submitted writing by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto;
(g) with respect to Collaboration Products, approve pricing of such Products and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and
(p) have any other responsibility expressly designated for the JSC under this AgreementParties.
Appears in 1 contract
Sources: Exclusive License and Commercialization Agreement (Coherus BioSciences, Inc.)
Specific Responsibilities. In addition to its overall responsibility The JDC shall develop the strategies for monitoring and providing oversee the Development of the Licensed Compounds or Licensed Products in the Territory, and shall serve as a forum to discuss and coordinate for the Parties’ coordination of Development activities under this Agreementfor the Licensed Compounds or Licensed Products for the Territory. In particular, the JSC JDC shall, subject to the terms of this Agreement, in particular:
(ai) periodically […***…] review and serve as a forum for discussing the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, including any Material Amendment;
(ii) oversee the collaborative conduct of Development activities of under the Parties Initial Development Plan and Budget;
(iii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the Territory;
(iv) determine whether a Compound Failure has occurred;
(v) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement;
(bvi) oversee periodically (no less often than annually) review and serve as a forum for discussing and planning the activities of Verve communication, publication, abstract or presentation plan and Beam with respect to each 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 for Opt-In Products and Collaboration Products (including the or RA Phase 3 Development Budget in any Development Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s)Plan, as applicable;
(cviii) review and decide whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including the Development Budget subcontractors that Ablynx may utilize in any Development Plan 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 a Collaboration Productpurposes of this Section 2.2.2(vii) and any proposed amendments theretoAbbVie shall be permitted to provide notice via email;
(dix) oversee activities under determine the Technology Transfer Plan;
(e) review appropriate timeline for the transfer of Regulatory Documentation, Ablynx Know-How, Joint Know-How and decide whether other Information from Ablynx to approve any amendments AbbVie pursuant to the Research Plan submitted by the JRC;
(f) review and decide whether to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments thereto;
(g) with respect to Collaboration Products, approve pricing of such Products and supply thereof within the Collaboration Territory;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Products;
(i) review and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costs;
(j) receive and discuss reports from Subcommittees and provide guidance thereto;
(k) attempt to resolve issues presented to it by, and disputes within, any Subcommittee;
(l) approve strategies for obtaining, maintaining, defending and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(m) approve all trademarks selected to be used to identify Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin for use in connection with the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a);
(n) review and decide whether to approve any other recommendations and submissions from the JRC, JMC, JDC and JCC;
(o) establish such additional Subcommittees as it deems necessary to achieve the objectives and intent of this Agreement3.5.4; and
(px) have perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any other responsibility expressly designated for the JSC under provision of this Agreement.
Appears in 1 contract
Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shallThe JRDC will, subject to the terms of this Agreementescalation, final decision-making authority and dispute resolution procedures in particularSection 9.9:
(a) oversee be responsible for overseeing the collaborative Parties’ performance of their respective activities of under the Parties under this AgreementResearch Plan and Early Development Plan and provide support to each Party with respect to such Party’s activities thereunder;
(b) oversee the activities of Verve review and Beam with respect to discuss each amended Research Plan and Early Development Plan for Opt-In Products and Collaboration Products (including approve updates or material amendments to the Development Budget in any Development Research Plan for a Collaboration Product) and the Commercialization of Collaboration Product(s)Early Development Plan;
(c) review discuss and decide determine whether to approve any proposed Development Plan for Opt-In Products and Collaboration Products (including a Degrader that is Researched under this Agreement meets the Development Budget in any Development Plan for a Collaboration Product) and any proposed amendments theretoScreening ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Ready Criteria or Phase 2 Ready Criteria;
(d) oversee activities under review, discuss and approve changes to the Technology Transfer PlanScreening ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇ Ready Criteria or Phase 2 Ready Criteria;
(e) review discuss and decide determine whether to approve any amendments to the Research Plan submitted by the JRCSuccessful Completion has been achieved;
(f) review and decide whether discuss the list of Degraders provided by Kymera pursuant to approve each proposed US Commercialization Plan (including the Commercialization Budget in any US Commercialization Plan) and any proposed amendments theretoSection 2.2.2;
(g) with respect review and discuss reports and data provided by Kymera pursuant to Collaboration ProductsSection 2.4.4 within [***] after the delivery of each such report, approve pricing of such Products and supply thereof within determine if a relevant Degrader satisfies the Collaboration TerritoryFirst Additional Degrader Criteria;
(h) approve clinical supply plans for Opt-In Products and Collaboration Products and commercial supply plans for Collaboration Productscause the minutes of the JRDC to reflect any selection of a Degrader as a First Additional Degrader, whether by the JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 2.4.4;
(i) review review, discuss and decide whether to approve the designation of any costs or expenses as Post-Approval Shared Development Costs or Post-Approval Shared Regulatory Costsdetermine [***];
(j) receive review, discuss and discuss reports from Subcommittees and provide guidance theretodetermine [***];
(k) attempt to resolve issues presented to it byreview, discuss and disputes within, any Subcommitteeapprove [***];
(l) approve strategies for obtainingfollowing [***], maintaining, defending discuss and enforcing trademark protection for Collaboration Products within the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a)determine [***];
(m) approve all trademarks selected to be used to identify review, discuss and determine whether a Collaboration Products and all trademarks, logos, taglines, trade dress, packaging configuration, domain names Candidate or indicia of origin for use in connection with Licensed Product Directed Against Collaboration Target 2 satisfies the sale or marketing of Collaboration Products, in each case in the Collaboration Territory in accordance with the terms and conditions of Section 13.6.1(a)Phase 1 Ready Criteria;
(n) review and decide whether discuss reports and data provided by Kymera pursuant to approve any other recommendations Section 2.5.6 within [***] after the delivery of each such report, and submissions from determine if a relevant Degrader satisfies the JRC, JMC, JDC and JCCSecond Additional Degrader Criteria;
(o) establish such additional Subcommittees cause the minutes of the JRDC to reflect any selection of a Degrader as it deems necessary to achieve a Second Additional Degrader, whether by the objectives and intent of this Agreement; andJRDC or the R&D Expert or by Sanofi in accordance with Section 2.5.6;
(p) review and discuss reports and data provided by Kymera pursuant to Section 2.6.5 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the ▇▇ ▇▇▇▇▇▇▇▇;
(q) cause the minutes of the JRDC to reflect any selection of a Collaboration Compound as a Collaboration Candidate, whether by the JRDC or the R&D Expert;
(r) 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 related overspend as a Series 2 Permitted Overrun;
(v) review, discuss and approve Series 2 Research Budget Excession in accordance with Section 2.6.4, including whether any such Series 2 Research Budget Excession was in Kymera’s reasonable control;
(w) discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 2.8 and discuss information provided by a Party with respect to MTA Research Studies;
(x) during the Research 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;
(y) 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;
(z) review and discuss reports provided by a Party pursuant to Section 2.11, Section 3.7 or Section 5.5;
(aa) to the extent contemplated by Section 5.2.3, review, discussion and approve an extension of time during which Kymera will make its personnel reasonably available;
(bb) review 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 JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 5.5.10;
(ff) 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 any other responsibility expressly designated for not been selected as the JSC under this Agreement.First Additional Degraders, Second Additional Degraders or Backup Degraders; (gg) review and discuss reports provided by Sanofi in accordance with Section 5.9;
Appears in 1 contract
Sources: Collaboration and License Agreement (Kymera Therapeutics, Inc.)