Common use of Specific Responsibilities Clause in Contracts

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 in particular: (i) oversee the collaborative activities of the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Product; and (xii) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 2 contracts

Sources: Collaboration and License Agreement (Facet Biotech Corp), Collaboration and License Agreement (Trubion Pharmaceuticals, 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 shall in 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 collaborative activities conduct of the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934Development activities, as amended. Approval forapplicable, Manufacturingunder the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and Commercializing Collaboration Products, in the Field Post-POC Development Plans; (vii) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory; (iiviii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve determine whether the Development Plan(s) (including activities under a Post-POC Development Plan support the Development Budget(s)) filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including whether Drug Approval Filings with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select any Product shall be made in any country or jurisdiction in the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plansTerritory; (ix) review and approve (A) inclusion determine the occurrence of any costs not specifically enumerated in the definitions of Corrector Post-POC Development Costs Failure or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Potentiator Post-POC Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]Failure; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPCinitial Galapagos Territory Development Plan; (xi) discuss periodically (no less often than semi-annually) review and make determinations regarding material safety issues with respect 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 Collaboration Productextent 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 (xiixiv) perform such other functions as appropriate to further are set forth herein or as the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 2 contracts

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

Specific Responsibilities. In addition The Steering Committee shall be responsible for facilitating the exchange of information regarding Licensed Compound and Licensed Product by the Parties as necessary to its overall responsibility for monitoring and providing a forum to discuss and coordinate effect the Parties’ activities under intent of this Agreement. In addition, the JSC Steering Committee shall in particularbe responsible for, among other things: (ia) oversee the collaborative activities of Exchanging information between the Parties under (including information generated by their respective Affiliates and Sublicensees) with regard to clinical *** Certain information on this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, page has been omitted and filed separately with the Securities and Exchange Commission pursuant Commission. Confidential treatment has been requested with respect to Rule 24b-2 the omitted portions. development (including Clinical Development hereunder), conduct of the Securities Exchange Act C1-1310 Study, regulatory submissions and commercialization (including Commercialization hereunder) of 1934, as amended. Approval for, Manufacturing, Licensed Product and Commercializing Collaboration Products, in the Field in the TerritoryLicensed Compound on a worldwide basis; (iib) receive Monitoring activities related to manufacturing of Licensed Product; (c) Approving any Cost-overruns related to the C1-2201 Study, as compared to the budgeted costs agreed as of the Effective Date; (d) Approving the plan(s) for and, if approved, monitoring each Party’s conduct of the ▇▇-▇▇▇▇ ▇▇▇▇▇, Development and discuss reports from Phase IV Trials for Licensed Product, including activities related to the JDCInitial Indication, the JCCTransplant Indication and Additional Indications pursuant to Section 3.3; (e) Reviewing and deciding whether to pursue a Proposal (as defined in Section 3.3(a)) jointly or permit a Developing Party to pursue a Proposal alone or to prevent either Party from pursuing a Proposal if such Proposal is reasonably likely to have a material and adverse effect on the Licensed Product in or outside the Territory (which if such Proposal is pursued thereafter shall be subject to the monitoring of activities (if pursued alone) and approval and monitoring of activities (if pursued jointly) pursuant to Section 2.4(d)); (f) Coordinating the Parties’ trademark and Patent protection for Licensed Product in their respective territories; (g) Approving the plan(s) for and, the JFCif approved, and the JPC, and provide guidance thereto, approve the monitoring Development Plan(sundertaken pursuant to Section 3.4(c) (including the Development Budget(sallocation of Costs associated therewith)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iiih) establish such additional joint subcommittees Reviewing and monitoring the global forecasted demand for Licensed Product and, in connection therewith, approving the Forecasts (as it deems necessary defined in Section 3.1(a) of the Supply Agreement) for Licensed Product pursuant to achieve the objectives and intent of this Agreementprocedures to be mutually agreed; (ivi) attempt Coordinating the timing of the transfer of responsibility under and ownership of all regulatory filings related to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated Licensed Product in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated Territory from Pharming to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration ProductSantarus; and (xiij) perform performing such other functions as appropriate to further mutually agreed by the Parties in furtherance of the purposes of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 2 contracts

Sources: License Agreement (Santarus Inc), License Agreement (Santarus Inc)

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 shall, subject to the terms of this Agreement, in particular: (ia) oversee the collaborative activities of the Parties under this Agreement, create ; (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 overall strategy Development Budget in any Development Plan for Developing a Collaboration Product) and seeking Regulatory [ * ] = Certain confidential information contained 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 this document, marked by brackets, has been omitted any US Commercialization Plan) and filed separately any proposed amendments thereto; (g) with the Securities and Exchange Commission pursuant respect to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in approve pricing of such Products and supply thereof within the Field in the Collaboration Territory; (iih) 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 the JDC, the JCC, the JFC, and the JPC, Subcommittees and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (ivk) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committeeSubcommittee; (vl) review approve strategies for obtaining, maintaining, defending and approve decisions to terminate Development on any enforcing trademark protection for Collaboration Product, including Products within the Collaboration Territory in accordance with respect to specific indicationsthe terms and conditions of Section 13.6.1(a); (vim) discuss 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 Develop Collaboration Products (approve any other than TRU-016) recommendations and for which indicationssubmissions from the JRC, JMC, JDC and JCC; (viio) select establish such additional Subcommittees as it deems necessary to achieve the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, objectives and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion intent of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Productthis Agreement; and (xiip) perform such have any other functions as appropriate to further responsibility expressly designated for the purposes of JSC under this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 2 contracts

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

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 shall in particularJDC shall: (ia) 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 this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ JDC meeting; *** ] = Certain confidential information contained in this document, marked by brackets, agreement has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 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 conduct of Pre Exercise Development Activities; (c) periodically (no less often than annually) review and approve each Post Exercise Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the Securities Exchange Act JDC meeting; (d) serve as a forum for discussing the conduct of 1934the applicable Country-Specific Development Activities; (e) serve as a forum for discussing and oversee the conduct of Additional Licensor Development Activities; (f) serve as a forum for reviewing and approving strategies for obtaining Regulatory Approvals including approving use of consultants, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Field Licensed Products in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iiig) establish secure access methods (such additional joint subcommittees as it deems necessary secure databases) for each Party to achieve the objectives access Regulatory Documentation and intent of other JDC related Information as contemplated under this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Product; and (xiih) perform such other functions as appropriate to further are set forth herein or as the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 2 contracts

Sources: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, 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 shall in particularJDC shall: (i) oversee periodically […***…] review and serve as a forum for discussing the collaborative activities Initial Development Plan and Budget, such review to include oversight of the Parties under this Agreementproject risk and mitigation strategies, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this documentapprove amendments thereto, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territoryincluding any Material Amendment; (ii) receive oversee the conduct of Development activities under the Initial Development Plan and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretoBudget; (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 additional joint subcommittees as it deems necessary secure databases) for each Party to achieve the objectives access Regulatory Documentation and intent of other JDC related Information as contemplated under this Agreement; (ivvi) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; periodically (vno less often than annually) review and approve decisions to terminate Development on any Collaboration Productserve as a forum for discussing and planning the communication, including with respect to specific indications; (vi) discuss publication, abstract or presentation plan and decide whether to Develop Collaboration Products (other than TRU-016) and for which indicationsactivities, if any; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and periodically review and approve any changes theretoserve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) review and approve the manufacturing plan for [ * ] and [ * ] any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion rejection of the applicable Development Budgets or Commercialization Budgets allocated 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 Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDCsubcontractor. Notwithstanding Section 13.9, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Product; and (xii) perform such other functions as appropriate to further the for purposes of this Agreement as allocated to it in writing by the Parties.Section 2.2.2

Appears in 2 contracts

Sources: Exclusive License Agreement (Ablynx NV), Exclusive License Agreement (Ablynx 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 Products in the Licensee Territory and the United States, and shall serve as a forum to discuss for the coordination of Development activities for the Licensed Products for the Licensee Territory and coordinate the Parties’ activities under this AgreementUnited States. In particular, the JSC shall in particularJDC shall: (i) oversee periodically ([***]) review the collaborative activities of the Parties under this AgreementInitial Development Plan, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this documentapprove amendments thereto, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territoryincluding any Material Amendment; (ii) receive serve as a forum for discussing proposed Joint Development Activities and discuss reports from the JDC, the JCC, the JFCProposed Unilateral Activities; (iii) periodically ([***]) review each Development Plan and Budget for Joint Development Activities and Unilateral Activities, and the JPC, review and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it byany disputes regarding whether any Proposed Unilateral Activities, and disputes within, the JDC, the JCC, the JFC, and the JPCproposed Phase IV Studies, or any other committeeproposed regulatory action could have a Material Adverse Effect on a Party; (v) periodically review and serve as a forum for discussing Collaboration Candidate Development Plans and Budgets, and review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indicationsamendments thereto; (vi) discuss periodically review the conduct of Development activities under each Collaboration Candidate Development Plan and decide whether to Develop Collaboration Products (other than TRU-016) and for which indicationsBudget; (vii) select oversee the Lead conduct of Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes theretoactivities under the Initial Development Plan; (viii) review oversee the conduct of Joint Development Activities and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plansUnilateral Activities; (ix) review serve as a forum for discussing and approve (A) inclusion of any costs not specifically enumerated coordinating strategies for obtaining Regulatory Approvals for the Licensed Products in the definitions of Development Costs or Commercialization Costs or any component thereof, Licensee Territory and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]United States; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC;determine whether a Compound Failure has occurred; and (xi) discuss establish secure access methods (such as secure databases) for each Party to access the other Party’s Regulatory Documentation and make determinations regarding material safety issues with respect to the Collaboration Productother Information as contemplated under this Agreement; and (xii) perform such other functions as appropriate to further are set forth herein or as the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 2 contracts

Sources: License Agreement (Reata Pharmaceuticals Inc), License Agreement (Reata Pharmaceuticals Inc)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this AgreementCollaboration, [*], the JSC shall JEC shall, in particular: (i) oversee , be responsible for the collaborative activities of following, in each case with respect to the Parties under this AgreementCollaboration Compounds and/or Products, create and review the overall strategy for Developing and seeking Regulatory [ * as applicable: [*] = Certain Portions of this exhibit have been omitted pursuant to a confidential information contained in treatment request. An unredacted version of this document, marked by brackets, exhibit has been omitted and filed separately with the Securities and Exchange Commission pursuant Commission. (i) approving all key regulatory and Development actions with respect to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field any country in the Territory, including (A) Product labeling for the first and each subsequent indication and any other material changes or supplements thereto in each Region and (B) life cycle management decision or plans for a Product, including whether to seek new formulations, indications, or uses for a Product; (ii) receive approving a range of suggested prices and discuss reports from the JDCdiscount strategies for a Product, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretofor use Territory-wide or in a Region; (iii) establish such additional joint subcommittees as it deems necessary to achieve directing and overseeing the objectives and intent various Committees on all significant strategic issues that fall within the purview of this Agreementthe various Committees; (iv) attempt to resolve issues presented to it byapproving (A) each Territory-wide Long-Term Development Plan, (B) each Territory-wide Annual Development Plan and Budget, (C) each Pre-Launch Commercialization Plan and Budget for each Region, (D) each Territory-wide Long-Term Commercialization Plan, (E) each Annual Commercialization Plan and Budget for each Region, and disputes within, (F) any amendments and modifications to such plans and budgets that involve material changes to funding levels or the JDC, the JCC, the JFC, and the JPC, or any other committeeParties’ resource commitments; (v) review and approve decisions to terminate Development on any Collaboration Productcoordinating the activities of the Parties hereunder, including facilitating communications between the Parties with respect to specific indicationsthe Development and Commercialization of the Collaboration Compounds and Products; (vi) discuss receiving updates and decide whether to Develop Collaboration Products (reports on the activities and achievements of the other than TRU-016) Committees and for which indicationsreviewing and commenting on the progress of the other Committees; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes theretoproviding a forum for dispute resolution as provided in Section 2.10(c); (viii) review subject to Section 5.5, Article 9 and approve Section 13.1(d), with input from the manufacturing plan Intellectual Property Operating Committee, reviewing and approving strategies for [ * ] obtaining Patent and [ * ] or [ * ] with associated budgetProduct Trademark protection for each Product, resource allocation for enforcing such Patents and regulatory plansTrademarks, and for defending Third Party claims relating to Patents and Trademarks in the Territory, subject to the terms and conditions of this Agreement; provided, that in the event of a dispute in the JEC concerning such matters, [*]; (ix) review subject to Section 5.5 and approve (A) inclusion with input from the Intellectual Property Operating Committee, reviewing and approving the terms of any costs not specifically enumerated in Third Party license agreement to be entered into after the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party Execution Date with respect to Third Party intellectual property relating to the relevant Calendar Quarter by more than [ * Development, manufacture, or Commercialization of a Product in the Territory; [*]; (x) review with input from the CFDT, approving patient assistance programs, vendor return policies and approve any changes indigent access programs recommended by the ROCs; [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the specific responsibilities of the JDC, the JCC, the JFC, Securities and the JPC;Exchange Commission. (xi) discuss and make determinations regarding material safety issues with respect reviewing, resolving, and/or approving such matters as are referred to it by the Alliance Managers, JFC, JDC, JCC, CFDT or any ROC; (xii) performing such other duties as are expressly assigned to the Collaboration ProductJEC in this Agreement; and (xiixiii) perform performing such other functions as appropriate to further the purposes of the Collaboration, consistent with this Agreement Agreement, and such other responsibilities as allocated to it in writing may be agreed by the PartiesParties by mutual Party Written Consent.

Appears in 1 contract

Sources: Co Development and Co Promotion Agreement (Bristol Myers Squibb Co)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under collaboration established by this Agreement, the JSC shall in particular: (i) oversee the collaborative activities of the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viiia) review and approve the manufacturing plan initial Core Development Plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plansany Co-Promote Product; (ixb) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, amendments and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect updates to the relevant Calendar Quarter Core Development Plan for any Co-Promote Product presented by more than [ * ]the DWG; (xc) review amendments and updates to the Development for any Co-Promote Product presented by the DWG; (d) upon receipt of notice from either Party identifying any activity or lack of activity that has or would reasonably be likely to have a material adverse impact on the Development of a Co-Promote Product, review any such activity, and discuss such issue and propose potential actions to mitigate such adverse impact that would be commensurate with the harm or potential harm, and form a Sub Group to further discuss and manage potential avenues for the remediation of such issue; (e) review and approve the Regulatory Strategy (and amendments and updates thereto) presented by the DWG; (f) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPCNew Product Proposal; (xig) review and approve the initial Global Strategic Plan and any amendments and updates thereto, in each case presented to the JSC by the CWG; (h) review and approve the initial Core Commercialization Plan, including the initial Core Commercialization Budget, and any amendments and updates to the Core Commercialization Plan, including the Core Commercialization Budget, in each case presented to the JSC by the CWG; (i) review the initial Non-Core Commercialization Plan, and any amendments and updates to the Non-Core Commercialization Plan presented to the JSC by Kite, and approve the same with respect any Co-Promote Product; (j) review the Medical Affairs Plan and any amendments and updates presented to the JSC by the ERG; (k) upon receipt of notice from either Party identifying any activity or lack of activity that has or would reasonably be likely to have a material adverse impact on the Manufacture or Commercialization of a Co-Promote Product, discuss such issue and propose actions to mitigate such adverse impact that would be commensurate with the harm or potential harm, and form a Sub Group to further discuss and make determinations regarding material safety issues with respect to manage the Collaboration Productremediation of such issue if appropriate; (l) review and approve the Global Scientific Publication Strategy (and substantive amendments and updates thereto) presented by the MAC; (m) oversee the DWG, MWG, PSC, CWG; ERG, MAG, and FWG, and establish various sub working groups (each, a “Sub Group”) for particular projects or activities, including at the request of the DWG, MWG, PSC, CWG, ERG, or FWG; and (xiin) perform such other functions as are assigned to it in this Agreement or as appropriate to further the purposes of this Agreement as allocated to it agreed in writing by the Parties, including periodic evaluations of performance against goals.

Appears in 1 contract

Sources: Collaboration and License Agreement (Arcellx, Inc.)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ AZ’s activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the collaborative activities development, Manufacture and Commercialization of the Parties under this Agreement, create and review Products in the overall strategy for Developing and seeking Regulatory Field in the Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for. (ii) review and comment on the Development Plan and amendments thereto, Manufacturing, including reviewing and Commercializing Collaboration Products, commenting on the overall strategy and design of all human clinical trials and other studies conducted under the Development Plan; (iii) approve any change in the Field Development Plan that would [ * ], or [ * ], of the [ * ]; (iv) discuss the requirements for Marketing Approval of Products in the Territory; (iiv) receive and discuss reports from facilitate the JDC, flow of Information between the JCC, Parties with respect to the JFCdevelopment of, and obtaining Marketing Approval for the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretoProducts; (iiivi) review the results of Phase 3 Clinical Trials of Products; (vii) review AZ’s proposed timing for announcing the top line results of each of the Major Three RA Trials following the unblinding of such trial results; for the avoidance of doubt AZ shall notify Rigel either directly or via the JSC of its decision to unblind clinical data in whichever of the Three Major RA Trials shall be the first to report clinical data as further described in Section 15.13; (viii) discuss and agree the reimbursement of any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Product; and (xiixiv) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: License and Collaboration Agreement (Rigel Pharmaceuticals Inc)

Specific Responsibilities. The JSC shall manage the implementation of this Agreement and oversee the Development and Commercialization of Compounds and Products in the Territory and, subject to Section ‎2.4.5 (Joint Committee Decision Making), resolve certain matters that are not unanimously decided by the JDC or JCC. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreementparticular, the JSC shall in particular: (i) oversee the collaborative activities of the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ shall: *** ] = Certain confidential information contained in this document, marked by brackets, agreement has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. (a) coordinate activities and facilitate communication of the Securities Exchange Act Parties in connection with the Development and Commercialization of 1934, as amended. Approval for, Manufacturing, Compounds and Commercializing Collaboration Products, Products included in the Field CNS Program and in the TerritoryPeripheral Program, respectively; (iib) receive review and discuss reports from the progress of activities in connection with the Development and Commercialization of Compounds and Products included in the CNS Program and in the Peripheral Program, respectively; (c) coordinate and oversee the operation of the JDC, JCC and any other joint subcommittee established by JSC, including resolving any disputed matter of the JCCJDC, the JFC, JCC and the JPC, and provide guidance thereto, approve the Development Plan(s) other subcommittees in accordance with Section 2.4.5 (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)Joint Committee Decision Making), and any amendments theretopromote effective member participation in each such Committee’s or subcommittee’s operations; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (xd) review and approve any changes amendment to the specific responsibilities CNS Development Plan; (e) review and approve any Additional CNS Development Proposal in accordance with Section ‎3.2.4 (Additional CNS Program Development Activities); (f) review and comment on the then-current Peripheral Development Plan, including any updates to the Peripheral Development Plan made by Sanofi in accordance with Section 3.2.1(c) (Content of Peripheral Development Plan); (g) review the JDCGlobal Commercialization Plan, the JCC, the JFCincluding updates thereto made by Sanofi in accordance with Section 5.3.3 (Amendments and Updates), and the JPCprogress of activities being conducted under the Global Commercialization Plan; (xih) discuss oversee the execution of the Technology Transfer Plan; (i) form Working Groups as needed to fulfill the obligations of the JSC under this Agreement, including a Finance Working Group unless Denali has exercised the Denali Royalty Option for all CNS Products pursuant to Section ‎7.8 (Denali Royalty Option) with responsibilities as provided in Section ‎7.7.7 (Financial Reporting Activities; Finance Working Group), [***], and make determinations regarding material safety a Manufacture Working Group with responsibility as provided in Section 4.5 (Manufacture Working Group); (j) oversee the Working Groups created by the JSC on all significant strategic issues that fall within the purview of each such Working Group; (k) except with respect to matters within the Collaboration Product; andresponsibility of [***] or as otherwise agreed in writing by the Parties, resolve issues presented to the JSC by any Working Group established by such JSC; (xiil) resolve issues presented to the JSC in accordance with this Agreement (including those matters outlined in Section 2.4.5(b)(ii)); and *** Certain information in this 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. (m) perform such other functions as appropriate to further the purposes of are set forth in this Agreement as allocated to it the function of the JSC or as the Parties may otherwise mutually agree in writing by the Partieswriting.

Appears in 1 contract

Sources: Collaboration and License Agreement (Denali Therapeutics Inc.)

Specific Responsibilities. In addition The JRDC will, subject to its overall responsibility the escalation, final decision-making authority and dispute resolution procedures in Section 9.9: (a) be responsible for monitoring and providing a forum to discuss and coordinate overseeing the Parties’ performance of their respective activities under the 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 AgreementAgreement 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 JSC shall R&D Expert in particular:accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 2.4.4; (i) oversee the collaborative activities of the Parties under this Agreementreview, create discuss and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territorydetermine [***]; (iij) receive 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 from and data provided by Kymera pursuant to Section 2.5.6 within [***] after the JDC, the JCC, the JFCdelivery of each such report, and determine if a relevant Degrader satisfies the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretoSecond Additional Degrader Criteria; (iiio) establish such additional joint 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 AgreementJRDC or the R&D Expert or by Sanofi in accordance with Section 2.5.6; (ivp) attempt review and discuss reports and data provided by Kymera pursuant to resolve issues presented to it bySection 2.6.5 within [***] after the delivery of each such report, and disputes withindetermine 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 JDCJRDC 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, the JCCdiscuss and approve a Research Budget Excession in accordance with Section 2.5.4, the JFCincluding whether any such Research Budget Excession was in Kymera’s reasonable control; (t) review, discuss and the JPC, or 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 other committeerelated overspend as a Series 2 Permitted Overrun; (v) review review, discuss and approve decisions to terminate Development on any Collaboration ProductSeries 2 Research Budget Excession in accordance with Section 2.6.4, including with respect to specific indicationswhether any such Series 2 Research Budget Excession was in Kymera’s reasonable control; (viw) discuss and decide whether approve a transfer of Materials from one Party to Develop Collaboration Products (the other than TRU-016) Party in accordance with Section 2.8 and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred discuss information provided by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]MTA Research Studies; (x) review and approve any changes during the Research Term prior to the specific responsibilities Sanofi’s exercise of the JDCSanofi Participation Election Right with respect to Collaboration Target 2, determine the JCC, first Indication for which the JFC, and the JPCfirst IND will be filed with respect to a Licensed Product; (xiy) discuss and make determinations regarding material safety issues 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 the Collaboration Product; andMTA Development Studies; (xiiz) perform 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 other functions 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 appropriate to further the purposes of this Agreement as allocated to it in writing a Backup Degrader, whether by the Parties.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 not been selected as the 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.)

Specific Responsibilities. In addition The JSC shall have the following responsibilities with respect to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this AgreementProject generally, the JSC shall in particularProject Plan, and to the Assay and the IVD Kit: (i) oversee Oversee the collaborative activities progress of the Activities under the Project and facilitate the exchange of information between the Parties under this Agreement, create and review during the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedTerm; ​ 1. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory;​ ​ (ii) receive Review quarterly progress reports under the Project and discuss reports from the JDCProject Plan, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) as well as quarterly updates on regulatory activities (including the Development Budget(s)) Regulatory Approval process and the Commercialization Plan(s) (including the Commercialization Budget(s)timelines), communications and any amendments theretocoordination. Each Party shall deliver such reports to JSC on a timely manner; (iii) establish such additional joint subcommittees Review and approve any scope changes as it deems necessary described in Section 2.2 to achieve the objectives Project Plan and intent of this Agreementtimelines therefor; (iv) attempt Maintain the list of Target Countries and make modifications thereto upon APR’s notification and upon the appropriate adjustments in the Budget and Pass Through Expenses pursuant to resolve issues presented Section 3.6. For clarity, Target Countries shall be determined by APR and not the JSC, but subject to it by, and disputes within, agreement on the JDC, the JCC, the JFC, and the JPC, or any other committeeamended Budget as provided in Section 3.6; (v) review Align strategy and approve decisions to terminate Development on any Collaboration Producttiming for the Regulatory Approval of the Assay and IVD Kit (including the labeling thereof) with the regulatory strategy and timing for the APR Product (including the labeling thereof); provided that the regulatory strategy for the APR Product (including the labeling thereof) shall be solely determined by APR, including with respect to specific indicationsas set forth in Section 4.1; (vi) discuss Annually review and decide whether to Develop Collaboration Products modify the Project Plan (other than TRU-016including timelines) and Budget (including appropriate adjustments to reflect costs for which indicationsRegulatory Approval of the Assay and/or the IVD Kit arising from newly identified and/or changes to Target Countries); (vii) select Establish, monitor and delegate duties to other committees, subcommittees, or directed teams (each a “Working Group”) on an “as needed” basis to oversee particular projects or activities, including the Lead Joint Development PartyCommittee (the “JDC”), Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes theretowhich is described below; (viii) review Hear and approve resolve disputes of the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budgetWorking Groups, resource allocation and regulatory plansincluding the JDC; (ix) review and approve (A) inclusion Approve all Pass-Through Expenses in excess of any costs not specifically enumerated $[***] in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ];total; and (x) review and approve any changes Taking such other actions as may be specifically allocated to the specific responsibilities JSC by the Parties from time to time; Each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. For the avoidance of doubt, APR shall be solely responsible for the performance of all clinical trials of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration APR Product; and (xii) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: Companion Diagnostics Agreement (Aprea Therapeutics, Inc.)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum strategic oversight with respect to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular: (i) oversee the collaborative activities of the Parties under this Agreement; (ii) review and discuss the Development and Commercialization of Products and any other ongoing activities; (iii) determine whether to initiate a pivotal Clinical Trial with respect to either the [*] Indication or the [*] Indication (but not [*]); (iv) determine whether to select as the formulation for the MDV3100 Product for which approval of the NDA will be sought, create either the formulation used for the Initial MDV3100 Product or a [*] used for a [*] MDV3100 Product (it being understood that the JSC will select the [*] that is in the best interest of the Product with the goal of maintaining the [*] agreed upon in the Joint Development Plan for [*]); (v) review and discuss reports from the JDC, JMC, JMAC and JCC and provide guidance thereto, direct the activities of such committees, and, except in the case of the Initial Joint Development Plan and the initial Joint Manufacturing Plan, approve each Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto; (vi) review and discuss strategies for obtaining, maintaining, defending and enforcing patent and trademark protection for Products within the overall strategy for Developing Territory; (vii) attempt to resolve issues presented to it by, and seeking Regulatory [ * disputes within, the JDC, JMC, JMAC, JCC, or any other subcommittee; (viii) determine whether the conduct and oversight of a Voluntary Phase 4 Clinical Trial should be undertaken by the JDC instead of the JMAC; (ix) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities securities and Exchange Commission exchange commission pursuant to Rule rule 24b-2 of the Securities Exchange Act securities exchange act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ];. (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Product; and (xii) perform such other functions as appropriate appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement Agreement, in each case as allocated to it agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration Agreement (Medivation, Inc.)

Specific Responsibilities. In addition Subject to its overall responsibility the oversight of the JSC, the JDC shall be responsible for monitoring and providing a forum to discuss and coordinate overseeing Development strategy for the Parties’ activities Product globally under this Agreement. The JDC’s responsibilities shall include the following: (a) overseeing the preparation of annual updates and other amendments to the Global Development Plan (including the budget therefor) for approval by the JSC; (b) subject to Section 8.1.6(a), reviewing and approving a form of Core Data Sheet and submitting a draft thereof to the JSC shall for its approval pursuant to Section 2.2.3; (c) monitoring compliance with the then-current budget included in particular: the Global Development Plan; (id) oversee reviewing, coordinating and monitoring the collaborative activities and progress of the Parties under in implementing the Development activities contemplated by the Global Development Plan; (e) monitoring the activities of its Working Groups, including the JMAT, JRT and CDS Working Group in accordance the terms of this AgreementAgreement (provided, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this documentclarity, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from that despite the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including ’s global role with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development PartyDevelopment, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party its role with respect to the relevant Calendar Quarter by more than [ * ]; (x) review JMAT and approve any changes Medical Affairs Activities will be limited to the specific JMAT’s responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues under this Agreement with respect to the Collaboration Major Markets); (f) in consultation with the JRT, recommending to the JSC whether and when to submit a DAA, including a BLA, for the Product anywhere in the Territory; (g) facilitating the flow of information with respect to the Development of the Product and coordinating such information flow with other Committees, as appropriate; (h) overseeing the strategic planning and conduct of Clinical Trials consistent with the allocation of sponsorship and responsibility for Clinical Trials set forth in Section 4.6.2; provided, that the JDC shall coordinate with the JMAT with respect to the JDC’s strategic planning and conduct of Phase III-B Studies and Phase IV Studies; (i) making forecasts of Clinical Supply requirements for Development of the Product and reviewing the supply of Product; and (xiij) perform such other functions as appropriate making recommendations for further Development of the Product, including Development for new indications that are not in the then current Global Development Plan; (k) providing Quarterly updates on the JDC’s activities to further the purposes of JSC; (l) establishing and implementing a responsibility assignment matrix consistent with this Agreement as allocated to it in writing by define the Parties.roles and responsibilities between the Parties with respect to Development activities; and

Appears in 1 contract

Sources: Joint Commercialization Agreement (Seagen 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 shall in particularJCC shall: (i) oversee periodically (no less often than annually) review and serve as a forum for discussing AbbVie’s Commercialization activities in the collaborative activities of AbbVie Territory and AbbVie’s global brand plan for the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territoryincluding marketing and promotional materials, Product messaging, Commercialization budgets and Detailing effort; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and establish a strategy for the Commercialization Plan(s) (including of the Commercialization Budget(s)), and any amendments theretoCo-Promotion Products in the Co-Promotion Territory; (iii) establish such additional joint subcommittees as it deems necessary to achieve review and approve the objectives and intent of this Agreementinitial Co-Promotion Plan; (iv) attempt to resolve issues presented to it by, periodically (no less often than annually) review and disputes within, serve as a forum for discussing the JDC, the JCC, the JFC, Co-Promotion Plan and the JPC, or any other committeereview and approve amendments thereto; (v) review and approve decisions the manner in which the Markings are to terminate Development be presented on any Collaboration Product, including with respect to specific indicationspromotional materials and Product Labeling for the Co-Promotion Products in the Co-Promotion Territory; (vi) discuss review and decide whether to Develop Collaboration 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 than TRU-016) and for which indicationsrequirements of this Agreement; (vii) select oversee at a high level all Commercialization activities in the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, Galapagos Territory with respect to the Products; (viii) periodically (no less often than annually) review and Lead serve as a forum for discussing the Galapagos Territory Commercialization PartyPlan and its implementation, and review and approve any changes amendments thereto; (viii) review and approve ; provided, that AbbVie shall ensure that its representatives on the manufacturing 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 [ * ] or [ * ] with associated budget, resource allocation and regulatory plansthe other requirements of this Agreement; (ix) review and approve (A) inclusion the form and content of any costs not specifically enumerated all marketing and promotional materials and all Product messaging to be used in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party Galapagos Territory with respect to the relevant Calendar Quarter Products; * Confidential information, indicated by more than [ * [...***...];, has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. (x) review and approve any changes the form and content of all training materials to be used in the Galapagos Territory with respect to the specific responsibilities of the JDC, the JCC, the JFC, and the JPCProducts; (xi) discuss the selection of all Distributors and make determinations regarding material safety issues with respect Third Party co-promoters and promoters engaged to support Commercialization activities in the Collaboration ProductGalapagos Territory and review the performance of all such Third Parties; and (xii) perform such other functions as appropriate to further are set forth herein or as the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 1 contract

Sources: Collaboration Agreement (Galapagos Nv)

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 in particular: (i) oversee the collaborative activities of the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee;; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Product; and (xii) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: Collaboration and License Agreement (Facet Biotech Corp)

Specific Responsibilities. In addition to its overall responsibility the JSC’s general discussion, review and coordination regarding the Development and Manufacture of Licensed Compounds, Licensed Products and Licensed Diagnostic Products, the JSC will in particular, discuss the following: (a) review and approve each Basket Program Development Plan and Basket Program Development Budget; provided, that, for monitoring clarity, [...***...]. For clarity, the synopses of Study 1 and providing a forum Study 2 have been attached for informational purposes only to discuss ensure that [...***...]. In regard to Study 1 and coordinate Study 2, [...***...] will use reasonable efforts to incorporate comments from [...***...]’s review into protocol amendments for Study 1 and Study 2, assuming that these amendments do not materially affect the study design or result in material delays to the study timelines; (b) the Parties’ Development activities under this Agreementwith respect to Basket Studies, the JSC shall in particular:including matters related to progress, timelines, status, safety and budget; (ic) oversee high level information regarding the collaborative activities of supply chain for Licensed Compound and Licensed Product including back-up mandatory sites and the Parties under this ability to meet forecasted demand (unless and until provided for in the applicable Supply Agreement); * Confidential Information, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked indicated by brackets[...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission pursuant Commission. (d) Celgene’s Development activities (other than Basket Studies) with respect to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Licensed Products or Licensed Diagnostic Products, in the Field in the Territoryincluding Clinical Trials; ; (iie) receive and discuss reports from Clinical Trials for Licensed Products or Licensed Diagnostic Products to be conducted in the JDCBeiGene Territory, other than in the JCC, Heme Field (provided that safety data relating to Clinical Trials in the JFC, and Heme Field shall be within the JPC, and provide guidance thereto, approve remit of the Development Plan(s) (including the Development Budget(sJSC)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iiif) establish such additional joint subcommittees as it deems necessary Amendments to achieve the objectives Basket Program Development Plan and intent of this AgreementBasket Program Development Budget; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vig) discuss specific requirements to demonstrate [...***...] for each Licensed Product Developed hereunder by or on behalf of Celgene or its Affiliates or Sublicensees (which must be mutually agreed by the Parties and decide whether are not subject to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration ProductJSC approval); and (xiih) perform such other functions the expansion of the responsibilities of the JSC as appropriate to further the purposes of this Agreement as allocated to it in writing mutually agreed by the Parties.

Appears in 1 contract

Sources: Exclusive License and Collaboration Agreement (BeiGene, Ltd.)

Specific Responsibilities. In addition Subject to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreementoversight of the JEC [*], the JSC shall JDC shall, in particular, be responsible for the following, in each case with respect to the Collaboration Compounds and/or Products, as applicable: (i) oversee with input from the collaborative activities CFDT or the Regional Operating Committees, as appropriate, reviewing and recommending, for approval by the JEC, each Long-Term Development Plan, each Annual Development Plan and Budget for the Collaboration Compounds and Products, and all material changes to the Annual Development Plan and Budget recommended by the CFDT or the Regional Operating Committees made during the course of a Year, subject, if applicable, to the requirement of Joint Committee Consent or Party Written Consent to the extent required by Section 3.2(b); (ii) not less often than semi-annually, reviewing the Long-Term Development Plan, which shall be submitted to the JEC for approval if an increase of more than ten percent (10%) in the total budgeted amount is involved or for any non‑financial change that significantly affects the scope, science, timing or likelihood of success of the Parties under this AgreementDevelopment program for a Product, create subject, if applicable, to the requirement of Joint Committee Consent or Party Written Consent to the extent required by Section 3.2(b); (iii) (A) reviewing and review endorsing, for approval by the overall strategy JEC, the decision to file a DAA for Developing the first and seeking Regulatory [ * each subsequent indication (and all amendments and supplements to a DAA and the content of such filings to be made (other than routine reporting obligations, such as non-serious Adverse Event reports, unless there is a dispute [*] = Certain Portions of this exhibit have been omitted pursuant to a confidential information contained in treatment request. An unredacted version of this document, marked by brackets, exhibit has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934Commission. relating thereto)), as amended. Approval for, Manufacturing(B) determining and approving Territory-wide regulatory strategies and guidelines, and Commercializing Collaboration Products, (C) reviewing all key regulatory filings in the Field in Territory for consistency with Territory-wide regulatory strategy/guidelines approved by the TerritoryJEC; [*]; (iiiv) receive monitoring Development activities, reviewing all significant information generated in the course of implementing each Long-Term Development Plan and discuss reports from each Annual Development Plan and Budget and otherwise overseeing the JDC, implementation of each Long-Term Development Plan and each Annual Development Plan and Budget by the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretoCFDT; (iiiv) establish reviewing and approving, with input from the CFDT, the scientific integrity, statistical analysis plans, and protocols (and any investigators’ brochure(s) and revisions thereto) of all Clinical Trials conducted in the Territory (it being understood that the JDC may delegate to a working group established by the JDC (which shall operate by the procedures set forth in Section 2.10) the review and approval of such additional joint subcommittees matters to avoid inappropriate delay); provided, that once such scientific integrity of a Phase IV Clinical Trial is approved, JDC approval shall not be required under this paragraph for a subsequent Phase IV Clinical Trial that uses substantially the same protocol as it deems necessary that previously approved; (vi) determining at each Decision Point, if any, whether the Development activities to achieve which such Decision Point pertains have satisfied the objectives corresponding Success Criteria, if any, and intent advise the JEC and the Parties in writing of such findings no later than thirty (30) days following the applicable Decision Point, which writing shall set forth in detail the basis for such determination; (vii) reviewing and approving any significant agreements, including any agreement with an aggregate expense of more than [*] (or such other amount as may be specified by the JEC from time to time), with Third Parties to be entered into by either or both Parties relating to the Development of a Collaboration Compound or Product, or such other threshold to which the Parties may agree by mutual Party Written Consent or Joint Committee Consent of the JEC; (viii) unless and to the extent delegated to the CFDT, reviewing and approving the content, strategies for, and other aspects (other than level of funding) for (A) Product labeling, (B) early access and compassionate use programs in a country for a given indication (i.e., prior to Launch in such country for such indication), (C) Medical Education Activities, and (D) pediatric exclusivity extension Clinical Trials; (ix) unless and to the extent delegated to the CFDT, approving the content, strategies for, and other aspects (other than level of funding) for investigator sponsored clinical studies; (x) assisting in coordinating scientific interactions and resolving disagreements between BMS and COLLABORATOR during the course of implementing each Long-Term Development Plan and Annual Development Plan and Budget; [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. (xi) approving (A) a regulatory strategy plan for obtaining Approvals and matters relating thereto; (B) publication strategies for data arising out of Clinical Trials; and (C) significant post-Approval filings and submissions to the applicable Regulatory Authorities (including supplements and amendments to Approvals); (xii) reviewing and approving guidelines for the allocation by the CFDT or the Regional Operating Committees of responsibilities for Development activities between BMS and COLLABORATOR, consistent with Section 2.13; (xiii) subject to Section 3.7, with input from the CFDT and the ROCs, making recommendations to the JEC concerning whether to seek new indications, formulations or uses for the Collaboration Compounds and Products, such as for Product life cycle management; (xiv) reviewing and approving a patient risk management strategy and plan for the Products; (xv) overseeing the regulatory functions and actions of the CFDT and the ROCs; (xvi) performing such other duties as are expressly assigned to the JDC in this Agreement; (ivxvii) attempt performing such other functions as the JEC may request from time to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Producttime; and (xiixviii) perform such other functions as appropriate providing Quarterly updates on its activities and achievements to further the purposes of this Agreement as allocated to it in writing by the PartiesJEC.

Appears in 1 contract

Sources: Co Development and Co Promotion Agreement (Bristol Myers Squibb Co)

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 shall: (a) establish a strategy for (i) the Development, Approval, Commercialization and other Exploitation of the Licensed Products in particular:(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) oversee facilitate the collaborative activities exchange of Development Information relating to all Clinical Trials and Post Approval Studies and Commercialization Information for the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Licensed Products, in the Field in the Territory; (iij) receive and discuss reports from the JDCestablish such other committees (each, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)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 Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretoLicensed Products on a worldwide basis; (iiik) establish consider labeling issues and undertake coordination of labeling on a worldwide basis so as to ensure such additional joint subcommittees degree of consistency in labeling as it the JSC deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration Productbe desirable; and (xiil) perform such other functions as appropriate are set forth herein or as the Parties may mutually agree in writing. For clarity, subject to further the purposes terms of this Agreement as allocated to it Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in writing by the Partiesits individual capacity.

Appears in 1 contract

Sources: Collaboration Agreement (Salix Pharmaceuticals LTD)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss particular, the JCC shall: (a) oversee and coordinate the Parties’ activities under on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the JSC shall Commercialization of Licensed Compounds and Products so that each Party may undertake Commercialization of Licensed Compounds and Products in particular:accordance with the Commercialization Plans and this Agreement; (ib) oversee the collaborative activities Manufacturing Working Group to ensure that Manufacturing Plans, and related budget information, are incorporated into the applicable Commercialization Plans; (c) develop and update, on an annual basis, Manufacturing Plans for inclusion in the Commercialization Plans to ensure a reliable commercial supply of the Parties under this Agreement, create Licensed Compound and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field Products in the Territory; (iid) receive coordinate with the JDC with respect to regulatory matters; (e) coordinate with the JDC with respect to pharmacovigilance matters; (f) develop and discuss reports from present to the JDCJSC for approval the Global Branding Strategy and updates to such Global Branding Strategy during the Term as necessary; (g) review and present to the JSC for approval the initial US Commercialization Plan, including the JCC, the JFC, US Commercialization Budget therein and the JPCallocation of Commercialization activities between the Parties, which US Commercialization Plan shall be consistent with the Global Branding Strategy and provide guidance theretoSection 5.3.1, approve in accordance with this Agreement and, as appropriate, present to the Development Plan(s) (JSC for review and approval proposed updates and amendments to such US Commercialization Plan, including the Development Budget(s)US Commercialization Budget included therein; (h) review and comment on the initial or updated (as applicable) Ex-US Commercialization Plan(s) (including the Commercialization Budget(s))Plan, and any material amendments theretoto such Ex-US Commercialization Plans, and submit such plans to the JSC for review and approval; (iiii) establish such additional joint subcommittees as it deems necessary to achieve coordinate the objectives activities of the Parties under the US Commercialization Plan and intent oversee the implementation of this Agreementthe US Commercialization Plan and oversee the implementation of the Ex-US Commercialization Plan; (ivj) attempt to resolve issues presented to it byreview each Party’s Commercialization activities in the US and AbbVie’s Commercialization activities in the Ex-US Territory, and disputes within, the JDC, the JCC, the JFC, and the JPC, including a review of actual financial results versus budget or any other committeeplan; (vk) to the extent necessary, share planning and budgeting information with the JDC and JMAC and coordinate with the JDC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Manufacture and Commercialization of Products and Medical Affairs Activities in the Field in the US, as applicable; (l) review and comment upon amendments and updates to the Global Publication Strategy developed and presented by the JMAC in accordance with Section 9.4.1; (m) oversee the Manufacturing Working Group, Co-Promotion Working Group and any other Working Group that reports to the JCC; (n) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indicationsterms for Co-Promotion of Product in the United States for inclusion in the US Commercialization Plan; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viiio) review and approve the manufacturing plan update, on an annual basis, pricing, discounting and reimbursement decisions for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or US Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration ProductPlan; and (xiip) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as allocated to it the extent agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration and License Agreement (Infinity Pharmaceuticals, Inc.)

Specific Responsibilities. In addition to its overall responsibility The JRC shall develop the strategies for monitoring and providing oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum to discuss and coordinate for the Parties’ activities under this Agreementcoordination of such activities. In particular, the JSC shall in particularJRC shall: (ia) oversee the collaborative activities of serve as a discussion forum in relation to potential Modulator Targets and Antigen Targets for inclusion as potential Collaboration Targets (including respective Substitute Targets, if any) during any period when the Parties under this Agreement, create and review the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant have not elected to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the Territoryappoint a Gatekeeper; (iib) receive periodically (no less often than [***]) review and discuss reports from serve as a forum for discussing the JDC, the JCC, the JFCDiscovery Research Plan for each Collaboration Target, and the JPC, review and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (c) oversee the conduct and progress of the Discovery Research Activities (including the need for potential amendments to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such additional joint subcommittees as it deems necessary secure databases) for each Party to achieve the objectives access research and intent of discovery and other JRC related information and Know-How as contemplated under this Agreement; (ivl) attempt monitor and implement the transfer of CMC materials to resolve issues presented Genentech, whether pursuant to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, Section 5.3 or any other committeeSection 5.4; (vm) review monitor and approve decisions implement the technology transfer to terminate Development on any Collaboration Product, including with respect Genentech pursuant to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plans; (ix) review and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration ProductSection 5.4; and (xiin) perform such other functions as appropriate to further are set forth herein or as the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 1 contract

Sources: Discovery Collaboration and License Agreement (BICYCLE THERAPEUTICS PLC)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreementresponsibilities set forth in Section 4.3(a), the JSC JTT shall in particular: (i) oversee the collaborative execution of the Transition Plan and discuss, monitor, coordinate and provide the necessary support for the Transition activities of the Parties under this Agreement, create the Transition Plan, the Development Plan and review Budget and the overall strategy for Developing Shared Territory Commercialization Plan and seeking Regulatory [ * ] = Certain confidential information contained in this documentBudget (other than […***…], marked by brackets, has been omitted and filed separately with which remain under the Securities and Exchange Commission pursuant to Rule 24b-2 purview of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field in the TerritoryJDC); (ii) receive and discuss reports from the JDCreview, at least […***…], the JCC, Shared Territory Commercialization Plan and Budget and suggest any applicable amendments thereto for review and approval by the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretoJTT; (iii) review and approve any amendments, modifications or changes to the Transition Plan, the Development activities contemplated by the Development Plan and Budget (other than […***…]), the Shared Territory Commercialization Plan and Budget or any other Commercialization plan applicable to […***…]; (iv) discuss and analyze a material breach by any Party (if referred to it by the non-breaching Party), determine and approve any Remedial Measures to be imposed on such breaching Party and oversee timely implementation of such Remedial Measures by the breaching Party; (v) approve or consent to any matters under this Agreement that require the approval or consent of the JTT; (vi) prior to the Initial Transition Date, prepare, review and approve a Joint Development Plan and Budget, if requested by a Party; (vii) attempt to resolve any disputes referred to it by any Country Transition Teams pursuant to Section 4.5(a) or by the Functional Team, or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10; (viii) establish such additional joint subcommittees working groups as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan for [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory plansforegoing objectives; (ix) discuss compliance issues arising under this Agreement or the Transition Ancillary Agreements that would conflict with […***…] on an ad hoc basis as required; provided that, day-to-day discussions will be had by the Transition Compliance Working Group in accordance with Section 4.4(b). When dealing with such compliance issues, the JTT will invite representatives with relevant compliance knowledge and expertise from both Parties to participate in the discussions; and (x) prior to the last MA Transfer Completion Date to occur, review and approve (A) inclusion Galapagos Public Communications, as need be; provided that, in case of any costs Galapagos Public Communication that is required by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed, (1) Galapagos shall not specifically enumerated in be required to delay such Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the definitions of Development Costs or Commercialization Costs or any component thereofJTT, and (B3) Galapagos shall not be required to make any costs incurred disclosure to the JTT that is not permitted by Applicable Law or the rules of a Party that exceed that stock exchange on which the portion securities of Galapagos are listed. For clarity, the applicable Development Budgets JTT shall have no oversight or Commercialization Budgets allocated to such Party decision-making authority with respect to the relevant Calendar Quarter by more than [ * ]; (x) review and approve Commercialization of any changes Licensed Products or Gilead Combination Products in the Gilead Territory, as set forth in Section 9.1(g), except to the specific responsibilities extent such activities materially adversely affect the Exploitation of the JDCLicensed Product or Galapagos Combination Products by Galapagos in the Galapagos Territory, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the Collaboration Product; and contrary herein (xii) perform any issues related to such other functions as appropriate activities not agreed to further the purposes of this Agreement as allocated to it in writing by the PartiesJTT will be resolved in accordance with Section 16.6). Additionally, the JTT shall have no oversight or decision making authority with respect to […***…].

Appears in 1 contract

Sources: Transition & Amendment 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 shall in particularJDC shall: (i) 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 under this Agreement, create Initial Development Plan and review Budget; (iii) serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the overall strategy for Developing and seeking Regulatory [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Approval for, Manufacturing, and Commercializing Collaboration Products, in the Field Licensed Products in the Territory; (iiiv) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments theretodetermine whether a Compound Failure has occurred; (iiiv) establish secure access methods (such additional joint subcommittees as it deems necessary secure databases) for each Party to achieve the objectives access Regulatory Documentation and intent of other JDC related Information as contemplated under this Agreement; (ivvi) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; periodically (vno less often than annually) review and approve decisions to terminate Development on any Collaboration Productserve as a forum for discussing and planning the communication, including with respect to specific indications; (vi) discuss publication, abstract or presentation plan and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications;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) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and periodically review and approve any changes theretoserve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable; (viii) review and 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 manufacturing plan 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 [ * ] and [ * ] or [ * ] with associated budget, resource allocation and regulatory planspurposes of this Section 2.2.2(vii) AbbVie shall be permitted to provide notice via email; (ix) review determine the appropriate timeline for the transfer of Regulatory Documentation, Ablynx Know-How, Joint Know-How and approve (A) inclusion of any costs not specifically enumerated in the definitions of Development Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that exceed that the portion of the applicable Development Budgets or Commercialization Budgets allocated other Information from Ablynx to such Party with respect AbbVie pursuant to the relevant Calendar Quarter by more than [ * ]; (x) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and make determinations regarding material safety issues with respect to the Collaboration ProductSection 3.5.4; and (xiix) perform such other functions as appropriate to further are set forth herein or as the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 1 contract

Sources: Exclusive License Agreement (Ablynx NV)