Formation and Role. Within [* * *] days after the Effective Date, the Parties shall appoint a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate and oversee the Parties’ activities under this Agreement through the completion of Development Transition. Following the Development Transition, the JSC shall serve solely in an advisory and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the Territory. The role of the JSC shall be to manage, review and discuss Virobay’s activities with respect to the Development and Manufacture of Licensed Products and the transfer of Development responsibilities from Virobay to XXX. For that purpose and to the extent reasonably necessary, the JSC will: (i) coordinate the activities of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of Compounds and Licensed Products under the Development Plan; (ii) review, discuss and approve any proposed amendments or revisions to the Development Plan; (iii) discuss and oversee Virobay’s negotiations and relationships with Third Party manufacturers of Compounds and Licensed Products; (iv) oversee the transfer of Development responsibility and Information from Virobay to XXX; (v) coordinate the Licensed Product Manufacturing and supply activities of the Parties, including the transfer of Manufacturing Information and transition of Manufacturing responsibilities from Virobay to XXX pursuant to Section 7.4; (vi) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Compounds and Licensed Products; (vii) review and facilitate discussion of any requests in relation to publications pursuant to Section 12.3; (viii) confirm completion of Development Transition; and (ix) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and shall have no power (A) to amend, modify, or waive compliance with this Agreement; (B) to determine whether or not a breach of this Agreement has occurred; or (C) to otherwise interpret this Agreement.
Appears in 2 contracts
Samples: Development and License Agreement (Virobay Inc), Development and License Agreement (Virobay Inc)
Formation and Role. Within [* * *] Promptly, and in any event within thirty (30) days after the Effective Date, the Parties shall appoint establish a joint steering development committee (the “Joint Steering Development Committee” or “JSCJDC”) to coordinate and oversee the Parties’ activities under this Agreement through the completion of Development Transition. Following the Development Transition, the JSC shall serve solely in an advisory and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the Territory. The role of the JSC shall be to manage, review and discuss Virobay’s activities with respect to the Development and Manufacture of Licensed Products and the transfer of Development responsibilities from Virobay to XXX. For that purpose and to the extent reasonably necessary, the JSC such JDC will:
(i) coordinate the activities of the Parties under the Development PlanPlans, including facilitating communications information exchange and discussions between the Parties with respect to the Development of Compounds Products, the progress and Licensed Products results (whether preliminary or final) under the Development PlanPlans and ROFN Products;
(ii) review, review and discuss and approve any proposed amendments or revisions to the Development PlanPlans;
(iii) review and discuss any cost to be shared by the Parties; [***] Certain information in this document has been omitted and oversee Virobay’s negotiations filed separately with the Securities and relationships Exchange Commission. Confidential treatment has been requested with Third Party manufacturers of Compounds and Licensed Products;respect to the omitted portions.
(iv) oversee all activities relating to the transfer of Development responsibility manufacturing-related activities, including Product supply, process development/optimization and Information from Virobay to XXXany related procedures;
(v) coordinate the Licensed Product Manufacturing and supply activities of the Partiesoversee technology transfer from Pfenex to Jazz’s Third Party manufacturer, including the transfer of Manufacturing Information and transition of Manufacturing responsibilities from Virobay to XXX pursuant to Section 7.4if applicable;
(vi) review, discuss establish such Working Groups as it deems necessary to achieve the objectives and coordinate the Parties’ scientific presentation and publication strategy relating to the Compounds and Licensed Productsintent of this Agreement;
(vii) discuss the mitigation of potential delays related to the Development Plan and review and facilitate discussion of any requests in relation actual delays related to publications pursuant to Section 12.3the Development Plan;
(viii) confirm completion of Development Transition; and
(ix) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined agreed by the Parties in writing. It is the expectation of the Parties that the JDC will set forth the general principles and strategies upon which the Parties will perform their activities under the Development Plans. The JSC JDC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and all other matters are expressly excluded. In no event shall the JDC have no power (A) the right to amend, modify, or waive compliance with this Agreement; (B) to determine whether or not a breach of this Agreement has occurred; or (C) to otherwise interpret this Agreement.
Appears in 2 contracts
Samples: License Agreement (Pfenex Inc.), License Agreement (Pfenex Inc.)
Formation and Role. Within [* * ***] days ([***]) [***] after the Effective Date, the Parties shall appoint establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate for the overall coordination and oversee oversight of the Parties’ activities under this Agreement through the completion of Development Transition. Following the Development Transition, the JSC shall serve solely in an advisory and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the TerritoryAgreement. The role of the JSC shall be to managehigh-level, review strategic oversight and discuss Virobay’s activities discussion of the Parties’ activities, in particular with respect to the Development and Manufacture co-promotion of Licensed Products for and in the transfer U.S. and, to the extent related to Development of Products for the U.S., Development responsibilities from Virobay of Products for that part of the EU subject to XXXthe jurisdiction of EMA (it being understood that such Development for the EU is anticipated to be closely tied to Development for the U.S.). For that purpose and to the extent reasonably necessary, the JSC will:
(i) coordinate the activities of the Parties under the Development Planthis Agreement, including facilitating communications and discussions discussion between the Parties with respect to the research under the Research Program, Development of Compounds Products for the U.S. and Licensed EU, and Commercialization of Products for the U.S. if ITI exercises a Co-Promotion Option under the Development PlanSection 6.4;
(ii) review, discuss and approve the Development Plan and any proposed amendments or revisions to the Development Plansuch plan;
(iii) review and fully discuss the research of Back-Up Compounds, the Development of Products for the U.S. and oversee Virobay’s negotiations EU, and relationships with Third Party manufacturers the Commercialization of Compounds Products in such regions, and Licensed Productsany other ongoing activities;
(iv) oversee select Back-Up Compounds for further Development; Portions of this Exhibit, indicated by the transfer xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of Development responsibility and Information from Virobay to XXX;the Securities Exchange Act of 1934, as amended.
(v) coordinate the Licensed Product Manufacturing manufacturing and supply activities of the Parties, including the transfer of Manufacturing Information and transition of Manufacturing manufacturing responsibilities from Virobay ITI to XXX Takeda pursuant to Section 7.4;
(vi) review and discuss the draft Commercialization Plan for each Co-Promotion Product;
(vii) review, discuss and coordinate the Commercialization activities of ITI and Takeda with respect to Co-Promotion Products, including pre-launch and post-launch activities and any co-promotion activities by the Parties’ scientific presentation and publication strategy relating to the Compounds and Licensed Products;
(vii) review and facilitate discussion of any requests in relation to publications pursuant to Section 12.3;
(viii) confirm completion of Development Transitionresolve disputes arising from the JRC or JPC; and
(ix) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 3.2 and elsewhere in this Agreement, and shall have no power (A) to amend, modify, or waive compliance with this Agreement; (B) . For clarity, the JSC shall not have the power to determine whether make any tactical or not a breach day-to-day operational decisions with respect to either Party’s activities under this Agreement, and each Party shall have the right to make such decisions with respect to its own activities, reasonably and subject to the terms and conditions of this Agreement has occurred; or (C) to otherwise interpret this Agreement.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Intra-Cellular Therapies, Inc.), License and Collaboration Agreement (Intra-Cellular Therapies, Inc.)
Formation and Role. Within [* * *] thirty (30) days after upon the Effective Dateearlier of the Trigger Date or the date of Development of any TNF-α Development Candidate other than AST-005 pursuant to Section 2.10, the Parties shall appoint will establish a joint steering research committee (the “Joint Steering Committee” or “JSCJRC”) to coordinate govern the pre-clinical stages of the research and oversee collaboration by the Parties’ activities under this Agreement through Parties on the completion of Collaboration Development Transition. Following the Development Transition, the JSC shall serve solely in an advisory Candidates and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the TerritoryCollaboration Products. The role of the JSC shall be to manage, review and discuss Virobay’s activities with respect to the Development and Manufacture of Licensed Products and the transfer of Development responsibilities from Virobay to XXX. For that purpose and to the extent reasonably necessary, the JSC will:
JRC is: (i) coordinate the activities of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of Compounds and Licensed Products under the Development Plan;
(ii) i)to review, discuss and approve any proposed amendments or revisions the overall strategy for the research and collaboration by the Parties on the Collaboration Development Candidates and Collaboration Products in the Field in the Territory; (ii)to review and discuss the overall performance of the research and collaboration by the Parties on the Collaboration Development Candidates and Collaboration Products and to compare such performance to the Development Plan;
objectives outlined in the Collaboration Research Plan and to the diligence obligations set forth in Section 2.5; (iii) discuss and oversee Virobay’s negotiations and relationships with Third Party manufacturers of Compounds and Licensed Products;
(iv) oversee the transfer of Development responsibility and Information from Virobay to XXX;
(v) coordinate the Licensed Product Manufacturing and supply activities of the Partiesiii)to develop, including the transfer of Manufacturing Information and transition of Manufacturing responsibilities from Virobay to XXX pursuant to Section 7.4;
(vi) review, discuss and coordinate approve the Parties’ scientific presentation Collaboration Research Plan and publication strategy relating to the Compounds any amendments thereto; and Licensed Products;
(vii) review and facilitate discussion of any requests in relation to publications pursuant to Section 12.3;
(viii) confirm completion of Development Transition; and
(ix) iv)to perform such other functions as appropriate to further the purposes of this Agreement, Agreement as expressly set forth in this Agreement (including as set forth in Section 2.10) or as mutually determined by the Parties in writing. The JSC shall have JRC has only the powers expressly assigned to it in this Section 3.1 5.1 and elsewhere in this Agreement. For the avoidance of doubt, and shall the JRC will not have input into Development after Stage 5. The JRC has no power (A) to interpret, amend, modify, or waive compliance with this Agreement; . 28 THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (BTHE “COMMISSION”) to determine whether or not a breach of this Agreement has occurred; or (C) to otherwise interpret this AgreementPURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
Appears in 1 contract
Samples: Research Collaboration, Option and License Agreement
Formation and Role. Within [* * *] days after The Parties hereby establish, for the Effective Dateterm of this Agreement, the Parties shall appoint a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate for the overall coordination, oversight and oversee direction of the Parties’ activities under this Agreement through the completion of Development Transition. Following the Development Transition, the JSC shall serve solely in an advisory and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the TerritoryResearch. The role of the JSC shall be to manage, review and discuss Virobay’s activities with respect to the Development and Manufacture of Licensed Products and the transfer of Development responsibilities from Virobay to XXX. For that purpose and to the extent reasonably necessary, the JSC willbe:
(i) coordinate to review and discuss the activities of overall strategy for the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect to the Development of Compounds and Licensed Products under the Development PlanResearch;
(ii) review, to review and discuss and approve any proposed amendments or revisions to updates received from Anacor on the Development Planprogress of each Objective;
(iii) discuss to establish the goals and oversee Virobay’s negotiations resource allocations for each Objective, and relationships with Third Party manufacturers of Compounds to modify such goals and Licensed Productsallocations based on feedback and recommendations from the SAB, Program Leader, and the Foundation;
(iv) oversee to review and propose amendments to the transfer of Development responsibility and Information from Virobay to XXXWork Plan, including its Budget, as necessary based on the Results (provided always that any such amendment shall be made in a signed writing between the Parties);
(v) coordinate the Licensed Product Manufacturing upon request, to have access to and supply activities copies of the Parties, including the transfer of Manufacturing Information and transition of Manufacturing responsibilities from Virobay to XXX pursuant to Section 7.4any Results;
(vi) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to review any Information Controlled by Anacor which is reasonably material to the Compounds and Licensed Productsfurther development of any proposed Project Compound;
(vii) to review and facilitate discussion of any approve requests in relation to publications pursuant to Section 12.3from potential Library Parties for studies with the New Library or New Library Compounds;
(viii) confirm completion to determine whether a potential Project Compound should be nominated as a potential Project Compound as satisfying the requirements of Development Transitionthe applicable TPP and meeting the applicable Objective; and
(ix) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 3.1(a) and elsewhere in this Agreement, and . The JSC shall have no power (A) to interpret, amend, modify, or waive compliance with this Agreement; (B) to determine whether or . For clarity, day-to-day decisions within the scope of the Work Plan and the Library Plan will be made by the personnel conducting and managing such activities and not a breach by the JSC, provided that such day-to-day management is consistent with the Work Plan and the Library Plan, the goals established by the JSC and the terms of this Agreement has occurred; Agreement. Following the completion of the Work Plan, the role of the JSC will be limited to the specific JSC responsibilities outlined in Section 2.8. The JSC shall terminate upon expiration or (C) to otherwise interpret termination of this Agreement.
Appears in 1 contract
Formation and Role. Within [* * *] days after the Effective Date, the The Parties shall appoint agree to establish and convene a joint steering committee (the “Joint Steering Committee” Committee (or “JSC”) to coordinate for the overall coordination and oversee oversight of the Parties’ activities under this Agreement through Agreement, promptly after the completion Effective Date. Each Party shall have an equal number of Development Transitionrepresentatives on the JSC. Following The JSC shall operate by the Development Transitionprocedures set forth in Section 3.4. Except as otherwise provided in Section 14.3(b) and subject to Section 14.2(b), the JSC shall serve solely in an advisory and information-sharing capacity, and the JSC shall disband upon the first Regulatory Approval of a Licensed Product anywhere in the Territory. The role of the JSC Joint Steering Committee shall be to manage, review and discuss Virobay’s activities with respect to the Development and Manufacture of Licensed Products and the transfer of Development responsibilities from Virobay to XXX. For that purpose and to the extent reasonably necessary, the JSC willbe:
(i) coordinate For the activities Shared Territory, (1) to review, coordinate, discuss and approve the overall strategy for the Development, Manufacture, and Regulatory Approval (including the initial approval and any supplements and expansions thereof) of Product and (2) to review and discuss the overall strategy for the Commercialization of the Parties under the Development Plan, including facilitating communications and discussions between the Parties with respect Product subject to the Development of Compounds and Licensed Products under the Development Plansubsection (iv) below;
(ii) For the ROW Territory, to review and discuss the overall strategy for the Development, Manufacture, Regulatory Approval (including the initial approval and any supplements and expansions thereof) and Commercialization of Product;
(iii) to review, discuss and approve the Shared Territory Development Plan on or before December 1 of each calendar year, and any proposed amendments or revisions to the Development Plan;
(iii) discuss and oversee Virobay’s negotiations and relationships with Third Party manufacturers of Compounds and Licensed Productssuch plan;
(iv) oversee to review, discuss and approve the transfer of Development responsibility Commercialization Plan, and Information from Virobay any proposed amendments or revisions to XXXsuch plan provided Cell Genesys has exercised the Co-Promotion Option;
(v) coordinate to resolve any disputes arising within the Licensed Product Manufacturing JDC and supply activities of the Parties, including the transfer of Manufacturing Information and transition of Manufacturing responsibilities from Virobay to XXX pursuant to Section 7.4;JCC; and
(vi) reviewto establish such subcommittees, discuss including without limitation the regulatory working group as provided in Section 5.3 and coordinate the Parties’ scientific presentation Publication Team as provided in Section 6.11, and publication strategy relating to the Compounds and Licensed Products;
(vii) review and facilitate discussion of any requests in relation to publications pursuant to Section 12.3;
(viii) confirm completion of Development Transition; and
(ix) perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined mutually agreed by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement, and shall have no power (A) to amend, modify, or waive compliance with this Agreement; (B) to determine whether or not a breach of this Agreement has occurred; or (C) to otherwise interpret this Agreement.
Appears in 1 contract
Samples: Development and Commercialization Collaboration Agreement (Cell Genesys Inc)