Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shall: (a) 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 applicable minutes of the JDC meeting; *** 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. (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 JDC meeting; (d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory; (g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and (h) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 2 contracts
Samples: Co Development and Option Agreement (Alector, Inc.), Co Development and Option Agreement (Alector, Inc.)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the TerritoryLicensee Territory and the United States, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the TerritoryLicensee Territory and the United States. In particular, the JDC shall:
(ai) periodically (no less often than annually[***]) review the Initial Development Plan, and review and approve amendments thereto, including any Material Amendment;
(ii) serve as a forum for discussing proposed Joint Development Activities and Proposed Unilateral Activities;
(iii) periodically ([***]) review each Development Plan and Budget for Joint Development Activities and Unilateral Activities, and review and approve amendments thereto;
(iv) resolve any disputes regarding whether any Proposed Unilateral Activities, proposed Phase IV Studies, or proposed regulatory action could have a Material Adverse Effect on a Party;
(v) periodically review and serve as a forum for discussing each Pre Exercise Collaboration Candidate Development Plan Plans and BudgetBudgets, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** 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.;
(bvi) periodically review the conduct of Development activities under each Collaboration Candidate Development Plan and Budget;
(vii) oversee the conduct of Development activities under the Initial Development Plan;
(viii) oversee the conduct of Joint Development Activities and Unilateral Activities;
(ix) 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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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 coordinating strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the TerritoryLicensee Territory and the United States;
(gx) determine whether a Compound Failure has occurred; and
(xi) establish secure access methods (such as secure databases) for each Party to access the other Party’s Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and
(hxii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 2 contracts
Samples: License Agreement (Reata Pharmaceuticals Inc), License Agreement (Reata Pharmaceuticals Inc)
Specific Responsibilities. The JDC Steering Committee shall meet at least semi-annually, or as otherwise agreed to be responsible for facilitating the exchange of information regarding Licensed Compound and Licensed Product by the Parties, and such meetings may be conducted by telephone, video-conference or in person Parties as determined by necessary to effect the JDC members, provided that with respect to in person meetings, unless otherwise agreed the location intent of such meetings shall alternate between locations designated by Licensor and locations designated by AbbVie. The JDC shall develop the strategies for and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territorythis Agreement. In particularaddition, the JDC shallSteering Committee shall be responsible for, among other things:
(a) periodically Exchanging information between the Parties (no less often than annuallyincluding information generated by their respective Affiliates and Sublicensees) 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 applicable minutes of the JDC meeting; with regard to clinical *** Certain information in on this agreement page has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text Confidential treatment has been requested with respect to the omitted portions. development (including Clinical Development hereunder), conduct of the C1-1310 Study, regulatory submissions and is the subject commercialization (including Commercialization hereunder) of Licensed Product and Licensed Compound on a confidential treatment request.worldwide basis;
(b) serve as a forum for discussing and oversee the conduct Monitoring activities related to manufacturing of Pre Exercise Development ActivitiesLicensed Product;
(c) periodically (no less often than annually) review and approve each Post Exercise Development Plan and BudgetApproving any Cost-overruns related to the C1-2201 Study, and review and approve amendments thereto, which approval will be reflected in as compared to the applicable minutes budgeted costs agreed as of the JDC meetingEffective Date;
(d) serve as a forum Approving the plan(s) for discussing the and, if approved, monitoring each Party’s conduct of the applicable CountryX0-Specific 0000 Xxxxx, Development Activitiesand Phase IV Trials for Licensed Product, including activities related to the Initial Indication, the Transplant Indication and Additional Indications pursuant to Section 3.3;
(e) serve Reviewing and deciding whether to pursue a Proposal (as defined in Section 3.3(a)) jointly or permit a forum for discussing 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 oversee adverse effect on the conduct Licensed Product in or outside the Territory (which if such Proposal is pursued thereafter shall be subject to the monitoring of Additional Licensor Development Activitiesactivities (if pursued alone) and approval and monitoring of activities (if pursued jointly) pursuant to Section 2.4(d));
(f) serve as a forum Coordinating the Parties’ trademark and Patent protection for reviewing and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products Product in the Territorytheir respective territories;
(g) establish secure access methods (such as secure databasesApproving the plan(s) for each Party and, if approved, monitoring Development undertaken pursuant to access Regulatory Documentation Section 3.4(c) (including the allocation of Costs associated therewith);
(h) Reviewing and other JDC monitoring the global forecasted demand for Licensed Product and, in connection therewith, approving the Forecasts (as defined in Section 3.1(a) of the Supply Agreement) for Licensed Product pursuant to procedures to be mutually agreed;
(i) Coordinating the timing of the transfer of responsibility under and ownership of all regulatory filings related Information as contemplated under this Agreementto the Licensed Product in the Territory from Pharming to Santarus; and
(hj) perform performing such other functions as are set forth herein or as mutually agreed by the Parties may mutually agree in writing, except where in conflict with any provision furtherance of the purposes of this Agreement.
Appears in 2 contracts
Samples: License Agreement (Santarus Inc), License Agreement (Santarus Inc)
Specific Responsibilities. The JDC shall meet at least semi-annuallymanage, or as otherwise agreed to 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 coordinate and oversee the Parties’ activities under the Potentiator POC Development of Plan, the Licensed Antibodies or Licensed Products in Corrector/Combination Product POC Development Plan, the TerritoryPost-POC Development Plans, and shall serve as a forum for the coordination of Galapagos Territory Development activities for the Licensed Antibodies or Licensed Products for the TerritoryPlan. In particular, the JDC shall:
(ai) as applicable, develop and approve each of the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and each Post-POC Development Plan, in accordance with the terms hereof;
(ii) periodically (no less often than semi-annually) review and serve as a forum for discussing, as applicable, the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans, and review and approve amendments thereto, including any amendments to the POC Budgets and Post-POC Development Budgets;
(iii) consider, review and approve any amendments to the Potentiator POC Success Criteria and the Corrector/Combination Product POC Success Criteria, or the inclusion therein of a new Potentiator Standard or Combination Standard, as applicable;
(iv) determine whether any Potentiator Product satisfies the Potentiator POC Success Criteria;
(v) determine whether any Combination Product satisfies the Corrector/Combination Product POC Success Criteria;
(vi) oversee the conduct of Development activities, as applicable, under the Potentiator POC Development Plan, the Corrector/Combination Product POC Development Plan, and the Post-POC Development Plans;
(vii) serve as a forum for discussing strategies for obtaining Regulatory Approvals for the Products in the Territory;
(viii) determine whether the Development activities under a Post-POC Development Plan support the filing of a Drug Approval Application for the applicable Product in any country or jurisdiction in the Territory and whether Drug Approval Filings with respect to any Product shall be made in any country or jurisdiction in the Territory;
(ix) determine the occurrence of Corrector Post-POC Development Failure or Potentiator Post-POC Development Failure;
(x) review and approve the initial Galapagos Territory Development Plan;
(xi) periodically (no less often than semi-annually) review and serve as a forum for discussing each Pre Exercise the Galapagos Territory Development Plan and BudgetPlan, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** 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.
(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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(gxii) establish secure access methods (such as secure databases) or other processes for each Party to exchange and access Regulatory Documentation and other JDC Development-related Information as contemplated under this Agreement;
(xiii) discuss, and to the extent provided in Section 3.10, approve, the selection of all Third Party Providers engaged to support the Development activities and review the performance of all such Third Party Providers; and
(hxiv) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 2 contracts
Samples: Collaboration Agreement (Galapagos Nv), Collaboration Agreement (Galapagos Nv)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 and oversee the Development of the Licensed Antibodies Compounds or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies Compounds or Licensed Products for the Territory. In particular, the JDC shall:
(ai) periodically (no less often than annually) […***…] review and serve as a forum for discussing each Pre Exercise the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** 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.including any Material Amendment;
(bii) oversee the conduct of Development activities under the Initial Development Plan and Budget;
(iii) 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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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 coordinating strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking 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;
(gv) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and;
(hvi) perform periodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any;
(vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable;
(viii) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such other functions as are set forth herein or as the Parties may mutually agree in writing[…***…] period, except where in conflict with any provision then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes of this Agreement.Section 2.2.2
Appears in 2 contracts
Samples: Exclusive License Agreement (Ablynx NV), Exclusive License Agreement (Ablynx NV)
Specific Responsibilities. The JDC In addition to its general responsibilities, the FSC shall meet at least semi-annuallyhave the following responsibilities. For clarity, or as otherwise agreed certain decisions of the China Committee are subject to approval by the PartiesJSC: • Review, discuss and agree the proposed calculation of Net Profit which for clarity shall be initially prepared by FibroGen WFOE, including the calculation of any amounts to be paid by the Parties hereunder; the FSC shall prepare for the China Committee a mutually agreed calculation of Net Profit for final approval by the JSC, and such meetings may any adjustment proposed to implement equal profit sharing in accordance with this Exhibit D. • Review the Quarterly Statement to be conducted prepared by telephoneFibroGen WFOE. • Recommend minor amendments to implement the profit/loss sharing required by this Exhibit D, video-conference or in person as determined for review by the JDC membersChina Committee and final approval, provided that with respect if any, by the JSC. Such proposed amendments may comprise amendments to the payment methodology described in person meetingsthis Exhibit D, 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territorytaking into account a Party’s then current transfer pricing policies, manufacturing plant locations, and inter-Affiliate licensing practices and policies. Any amendments mutually agreed by the FSC shall serve as a forum be prepared for the coordination of Development activities China Committee for approval, for final approval by the JSC; no such amendments shall be implemented unless and until finally approved by the JSC, without escalation to the Executive Officers. For clarity, no Party shall be required to make any material changes to its internal accounting and reporting systems and standards to implement any such amendments. • Review significant cost and expense reconciliation questions raised between the Parties. • Agree on a process to invoice taking into account Indirect Taxes requirements. • Establish the process for financial detail discussions between the Parties regarding the costs and expenses charged to the profit and loss calculations for the Licensed Antibodies or Licensed Products for the TerritoryFirst Product. In particularaddition, the JDC shall:
(a) 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 FSC will be reflected in the applicable minutes of the JDC meeting; *** 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.
(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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and
(h) perform such other functions as are set forth herein or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement., as directed by the China Committee or the JSC. * * * [*] [Note: To be updated as applicable] [*] [*] [*] [*] [*] [*] [*]
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Fibrogen Inc)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 JRC shall develop the strategies for and oversee the Development of Discovery Research Activities in accordance with the Licensed Antibodies or Licensed Products in the Territoryapplicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territorysuch activities. In particular, the JDC JRC shall:
(a) 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 have not elected to appoint a Gatekeeper;
(b) periodically (no less often than annually[***]) review and serve as a forum for discussing the Discovery Research Plan for each Pre Exercise Development Plan and BudgetCollaboration Target, and review and approve 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), which approval will and discuss and agree upon any activities to be reflected 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 minutes in order to confirm whether all components of the JDC meeting; *** Certain information in this agreement has been omitted LSR Go Data Package and filed separately with the Securities and Exchange Commission. Dev Go Data Package, as applicable, are complete [***] indicates that text has been omitted and is the subject of a confidential treatment request.];
(bf) 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 discussing and oversee discussion of results from the conduct of Pre Exercise Development the Discovery Research Activities;
(cj) 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 extend the Research Term as provided in the applicable minutes of the JDC meetingSection 2.4.2;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(gk) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation research and discovery and other JDC JRC related Information information and Know-How as contemplated under this Agreement;
(l) monitor and implement the transfer of CMC materials to Genentech, whether pursuant to Section 5.3 or Section 5.4;
(m) monitor and implement the technology transfer to Genentech pursuant to Section 5.4; and
(hn) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 1 contract
Samples: Discovery Collaboration and License Agreement (BICYCLE THERAPEUTICS PLC)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed In addition to by the Parties, and such meetings may be conducted by telephone, video-conference or its overall responsibilities set forth 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particularSection 4.3(a), the JDC shallJTT shall in particular:
(ai) periodically oversee the execution of the Transition Plan and discuss, monitor, coordinate and provide the necessary support for the Transition activities of the Parties under this Agreement, the Transition Plan, the Development Plan and Budget and the Shared Territory Commercialization Plan and Budget (no less often other than annually[…***…], which remain under the purview of the JDC);
(ii) review, at least […***…], the Shared Territory Commercialization Plan and Budget and suggest any applicable amendments thereto for review and approval by the JTT;
(iii) review and serve as 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 forum for discussing each Pre Exercise 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, and review and approve amendments theretoif 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, which approval will be reflected in or any disputes that may arise out of Galapagos’ exercise of its General Direction pursuant to Section 4.10;
(viii) establish such additional working groups as it deems necessary to achieve the applicable minutes of foregoing objectives;
(ix) discuss compliance issues arising under this Agreement or the JDC meeting; *** Certain information in this agreement has been omitted and filed separately Transition Ancillary Agreements that would conflict with the Securities and Exchange Commission. […***…] indicates that text has been omitted and is the subject of a confidential treatment request.
(b) serve on an ad hoc basis 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 Budgetrequired; provided that, and review and approve amendments thereto, which approval day-to-day discussions will be reflected 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 applicable minutes of the JDC meeting;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreementdiscussions; and
(hx) perform prior to the last MA Transfer Completion Date to occur, review and approve Galapagos Public Communications, as need be; provided that, in case of any 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 be required to delay such other functions Galapagos Public Communication for such JTT review, (2) such Galapagos Public Communication shall not require any approval of the JTT, and (3) Galapagos shall not be required to make any disclosure to the JTT that is not permitted by Applicable Law or the rules of a stock exchange on which the securities of Galapagos are listed. For clarity, the JTT shall have no oversight or decision-making authority with respect to the Commercialization of any Licensed Products or Gilead Combination Products in the Gilead Territory, as are set forth herein or as the Parties may mutually agree in writingSection 9.1(g), except where to the extent such activities materially adversely affect the Exploitation of the Licensed Product or Galapagos Combination Products by Galapagos in conflict the Galapagos Territory, with respect to which activities neither Party shall have unilateral final decision-making authority notwithstanding anything to the contrary herein (any provision of this Agreementissues related to such activities not agreed to by the JTT 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
Specific Responsibilities. The JDC shall meet at least semi-annuallyIn addition to its overall responsibility for the Collaboration, or as otherwise agreed to by [*], the PartiesJEC shall, and such meetings may in particular, be conducted by telephoneresponsible for the following, video-conference or in person as determined by the JDC members, provided that each case with respect to in person meetingsthe Collaboration Compounds and/or Products, unless otherwise agreed the location as applicable: [*] = Portions of such meetings shall alternate between locations designated by Licensor and locations designated by AbbViethis exhibit have been omitted pursuant to a confidential treatment request. The JDC shall develop the strategies for and oversee the Development An unredacted version of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shall:
(a) 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 applicable minutes of the JDC meeting; *** Certain information in this agreement exhibit 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.
(bi) serve as approving all key regulatory and Development actions with respect to 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 forum Product, including whether to seek new formulations, indications, or uses for discussing and oversee the conduct of Pre Exercise Development Activitiesa Product;
(cii) periodically approving a range of suggested prices and discount strategies for a Product, for use Territory-wide or in a Region;
(no less often than annuallyiii) review directing and approve overseeing the various Committees on all significant strategic issues that fall within the purview of the various Committees;
(iv) approving (A) each Post Exercise Territory-wide Long-Term Development Plan, (B) each Territory-wide Annual Development Plan and Budget, (C) each Pre-Launch Commercialization Plan and review Budget for each Region, (D) each Territory-wide Long-Term Commercialization Plan, (E) each Annual Commercialization Plan and approve Budget for each Region, and (F) any amendments thereto, which approval will be reflected in and modifications to such plans and budgets that involve material changes to funding levels or the applicable minutes of the JDC meetingParties’ resource commitments;
(dv) serve as coordinating the activities of the Parties hereunder, including facilitating communications between the Parties with respect to the Development and Commercialization of the Collaboration Compounds and Products;
(vi) receiving updates and reports on the activities and achievements of the other Committees and reviewing and commenting on the progress of the other Committees;
(vii) providing a forum for discussing the conduct of the applicable Country-Specific Development Activitiesdispute resolution as provided in Section 2.10(c);
(eviii) serve as a forum for discussing subject to Section 5.5, Article 9 and oversee Section 13.1(d), with input from the conduct of Additional Licensor Development Activities;
(f) serve as a forum for Intellectual Property Operating Committee, reviewing and approving strategies for obtaining Regulatory Approvals including approving use of consultantsPatent and Product Trademark protection for each Product, key opinion leaders or any other experts for enforcing such Patents and Trademarks, and for defending Third Party claims relating to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products 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, [*];
(gix) establish secure subject to Section 5.5 and with input from the Intellectual Property Operating Committee, reviewing and approving the terms of any Third Party license agreement to be entered into after the Execution Date with respect to Third Party intellectual property relating to the Development, manufacture, or Commercialization of a Product in the Territory; [*]
(x) with input from the CFDT, approving patient assistance programs, vendor return policies and indigent access methods 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 Securities and Exchange Commission.
(xi) reviewing, resolving, and/or approving such matters as secure databasesare referred to it by the Alliance Managers, JFC, JDC, JCC, CFDT or any ROC;
(xii) for each Party performing such other duties as are expressly assigned to access Regulatory Documentation and other JDC related Information as contemplated under the JEC in this Agreement; and
(hxiii) perform performing such other functions as are set forth herein or appropriate to further the purposes of the Collaboration, consistent with this Agreement, and such other responsibilities as may be agreed by the Parties may mutually agree in writing, except where in conflict with any provision of this Agreementby mutual Party Written Consent.
Appears in 1 contract
Samples: Co Development and Co Promotion Agreement (Bristol Myers Squibb Co)
Specific Responsibilities. The JDC shall meet at least semi-annuallyshall, or as otherwise agreed to by consistent with the Partiesrights and obligations of the Parties set forth in this Agreement, 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 and oversee the Development Development, but not the Manufacturing or Commercialization, of the Licensed Antibodies or Licensed Products Product in the Territory, and shall serve as a forum for the coordination of Development Development, but not Manufacturing or Commercialization, activities for the Licensed Antibodies or Licensed Products Product for the Territory. In particular, the JDC shall:
(a) periodically (no less often than annuallyi) review and serve as a forum provide input regarding the Development of and Regulatory Approvals for discussing each Pre Exercise Development Plan the Product for the Initial Indication and Budget, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted in the United States and is the subject of a confidential treatment request.
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development ActivitiesEuropean Union;
(cii) periodically (no less often than annually) review oversee all Clinical Studies and approve each Post Exercise Development Plan Post-Approval Studies for the Product for the Initial Indication and Budget, and review and approve amendments thereto, which approval will be reflected the [**] in the applicable minutes of United States and the JDC meetingEuropean Union;
(diii) serve as a forum for discussing the conduct of the applicable Country-Specific Development Activities;
(e) serve as a forum for discussing review, provide input and direction regarding, and oversee the conduct of Additional Licensor Development Activities;
(f) serve as a forum for reviewing and approving strategies for obtaining Regulatory Approvals Approvals, including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for Product Labeling for indications in addition to the Licensed Products Initial Indication, for the Product in the TerritoryUnited States and the European Union;
(giv) review, provide input and direction regarding, and oversee strategies for obtaining Regulatory Approvals, including Regulatory Approvals for Product Labeling, for the Product in the Territory outside of the United States and the European Union for any indication;
(v) review the progress reports made by each Party pursuant to Section 6.1.3;
(vi) establish a common secure access methods (such as secure databases) information exchange platform for the purpose of electronically sharing information accessible to each Party to access Regulatory Documentation for the receipt, review, investigation, recording, communication, and exchange (as between the Parties) of Clinical Data and other JDC related Information as contemplated under this Agreementarising from Clinical Studies and regulatory activities; and
(hvii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 1 contract
Samples: Development and Distribution Agreement (Surmodics Inc)
Specific Responsibilities. The JDC JSC shall meet at least semi-annually, or as otherwise agreed to by have the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JDC members, provided that following responsibilities with respect to in person meetingsthe Project generally, 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the TerritoryProject Plan, and shall serve as a forum for to the coordination of Development activities for Assay and the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shallIVD Kit:
(ai) periodically Oversee the progress of the Activities under the Project and facilitate the exchange of information between the Parties during the Term;
1.
(no less often than annuallyii) Review quarterly progress reports under the Project and Project Plan, as well as quarterly updates on regulatory activities (including the Regulatory Approval process and timelines), communications and coordination. Each Party shall deliver such reports to JSC on a timely manner;
(iii) Review and approve any scope changes as described in Section 2.2 to the Project Plan and timelines therefor;
(iv) 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 Section 3.6. For clarity, Target Countries shall be determined by APR and not the JSC, but subject to agreement on the amended Budget as provided in Section 3.6;
(v) Align strategy and timing 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, as set forth in Section 4.1;
(vi) Annually review and serve modify the Project Plan (including timelines) and Budget (including appropriate adjustments to reflect costs for Regulatory Approval of the Assay and/or the IVD Kit arising from newly identified and/or changes to Target Countries);
(vii) Establish, monitor and delegate duties to other committees, subcommittees, or directed teams (each a “Working Group”) on an “as a forum for discussing each Pre Exercise needed” basis to oversee particular projects or activities, including the Joint Development Plan and Budget, and review and approve amendments theretoCommittee (the “JDC”), which approval will be reflected in the applicable minutes is described below;
(viii) Hear and resolve disputes of the JDC meeting; *** Certain information Working Groups, including the JDC;
(ix) Approve all Pass-Through Expenses in this agreement has been omitted and filed separately with the Securities and Exchange Commission. excess of $[***] 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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreementtotal; and
(hx) perform Taking such other functions actions as are set forth herein or as may be specifically allocated to the JSC by the Parties may mutually 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, except where in conflict with any provision APR shall be solely responsible for the performance of this Agreementall clinical trials of the APR Product.
Appears in 1 contract
Samples: Companion Diagnostics Agreement (Aprea Therapeutics, Inc.)
Specific Responsibilities. The JDC JSC shall meet at least semi-annually, or as otherwise agreed to by manage 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 implementation of such meetings shall alternate between locations designated by Licensor and locations designated by AbbVie. The JDC shall develop the strategies for this Agreement and oversee the Development and Commercialization of the Licensed Antibodies or Licensed Compounds and Products in the TerritoryTerritory and, and shall serve as a forum for subject to Section 2.4.5 (Joint Committee Decision Making), resolve certain matters that are not unanimously decided by the coordination of Development activities for the Licensed Antibodies JDC or Licensed Products for the TerritoryJCC. In particular, the JDC JSC shall:
(a) 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 applicable minutes of the JDC meeting; : *** 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.
(a) coordinate activities and facilitate communication of the Parties in connection with the Development and Commercialization of Compounds and Products included in the CNS Program and in the Peripheral Program, respectively;
(b) serve as a forum for discussing review and oversee discuss the conduct progress of Pre Exercise activities in connection with the Development Activitiesand Commercialization of Compounds and Products included in the CNS Program and in the Peripheral Program, respectively;
(c) periodically coordinate and oversee the operation of the JDC, JCC and any other joint subcommittee established by JSC, including resolving any disputed matter of the JDC, JCC and other subcommittees in accordance with Section 2.4.5 (no less often than annually) review and approve each Post Exercise Development Plan and BudgetJoint Committee Decision Making), and review and approve amendments thereto, which approval will be reflected promote effective member participation in the applicable minutes of the JDC meetingeach such Committee’s or subcommittee’s operations;
(d) serve as a forum for discussing review and approve any amendment to the conduct of the applicable Country-Specific CNS Development ActivitiesPlan;
(e) serve as a forum for discussing review and oversee the conduct of approve any Additional Licensor CNS Development Proposal in accordance with Section 3.2.4 (Additional CNS Program Development Activities);
(f) serve as a forum for reviewing review and approving strategies for obtaining Regulatory Approvals comment on the then-current Peripheral Development Plan, including approving use any updates to the Peripheral Development Plan made by Sanofi in accordance with Section 3.2.1(c) (Content of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the TerritoryPeripheral Development Plan);
(g) establish secure access methods review the Global Commercialization Plan, including updates thereto made by Sanofi in accordance with Section 5.3.3 (such Amendments and Updates), and the progress of activities being conducted under the Global Commercialization Plan;
(h) oversee the execution of the Technology Transfer Plan;
(i) form Working Groups as secure databases) for each Party needed to access Regulatory Documentation and other JDC related Information as contemplated 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; andFinance Working Group), [***], and a Manufacture Working Group with responsibility as provided in Section 4.5 (Manufacture Working Group);
(hj) 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 responsibility of [***] or as otherwise agreed in writing by the Parties, resolve issues presented to the JSC by any Working Group established by such JSC;
(l) 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 are set forth herein in this Agreement as the function of the JSC or as the Parties may otherwise mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (Denali Therapeutics Inc.)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed In addition to by its overall responsibility to coordinate and to facilitate information sharing between the Parties, and such meetings may be conducted by telephone, video-conference or in person as determined by the JDC members, provided that Parties with respect to the Exploitation of Compounds or Licensed Products, the JSC will:
(a) review and discuss any Eidos Proposed Studies and Bayer Proposed Studies;
(b) decide on any proposed material changes to Eidos Proposed Studies after exercise of the Eidos Study Data Option by Bayer and to Bayer Proposed Studies after exercise of the Bayer Study Data Option by Xxxxx;
(c) share information with respect to [***];
(d) share information, discuss and coordinate, and decide in person meetingscase of any [***] raised pursuant to Section 3.2, unless otherwise agreed with respect to [***] by Bayer Parties in the location Licensed Territory and by Eidos, its Affiliates and its Sublicensees outside the Licensed Territory;
(e) share information, discuss and coordinate, and decide in case of such meetings shall alternate between locations designated by Licensor and locations designated by AbbVie. The JDC shall develop the any [***] raised pursuant to Section 3.2, with respect to regulatory strategies for Licensed Products, including responses to Request for Information (RfI) from Regulatory Authorities, label optimization for Licensed Products and oversee the Development of any post-approval requirements relating to XXXx for Licensed Products within or outside the Licensed Antibodies or Territory;
(f) share information, discuss and decide a joint approach of entering into an In-License Agreement pursuant to Section 7.9(a);
(g) share information, discuss and coordinate a joint approach with respect to contract manufacturers for Licensed Products in the Territoryor components thereof pursuant to Section 6.1;
(h) review, discuss and shall serve as a forum for the coordination sharing of Development activities information, between the Parties, that is reasonably necessary or useful for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shall:
(a) 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 applicable minutes of the JDC meeting; *** Certain information in JSC to perform its responsibilities under 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.
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development ActivitiesSection 2.2;
(ci) 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 attempt to resolve in the applicable minutes of first instance all matters between the JDC meetingParties that fall within the JSC’s authority and are in dispute, including matters presented to it by any Sub-Committee, in accordance with Section 2.5 and Article 14;
(dj) serve establish Sub-Committees as a forum are required for discussing properly exchanging on, reviewing and coordinating, the conduct matters specified under Section 2.7 and establish any other Sub-Committees as it deems necessary to achieve the objectives and intent of this Agreement, as well as decide on delegating, or withdrawing any former delegation, of responsibilities and decision-making authority that the JSC has under this Section 2.2 to any such Sub-Committee after prior consultation of the applicable CountrySub-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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this AgreementCommittee; and
(hk) perform such other functions as are set forth herein assigned to it in this Agreement or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this AgreementAgreement to the extent agreed in writing by the Parties.
Appears in 1 contract
Samples: Exclusive License Agreement (BridgeBio Pharma, Inc.)
Specific Responsibilities. The Subject to the oversight of the JEC [*], the JDC shall meet at least shall, in particular, be responsible for the following, in each case with respect to the Collaboration Compounds and/or Products, as applicable:
(i) with input from the 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 as otherwise agreed for any non‑financial change that significantly affects the scope, science, timing or likelihood of success of the Development program for a Product, 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 endorsing, for approval by the PartiesJEC, the decision to file a DAA for the first and each subsequent indication (and all amendments and supplements to a DAA and the content of such meetings may filings to be conducted by telephonemade (other than routine reporting obligations, videosuch as non-conference or in person as determined by the JDC members, provided that with respect to in person meetingsserious Adverse Event reports, unless otherwise agreed the location there is a dispute [*] = Portions of such meetings shall alternate between locations designated by Licensor and locations designated by AbbViethis exhibit have been omitted pursuant to a confidential treatment request. The JDC shall develop the strategies for and oversee the Development An unredacted version of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shall:
(a) 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 applicable minutes of the JDC meeting; *** Certain information in this agreement exhibit has been omitted and filed separately with the Securities and Exchange Commission. relating thereto)), (B) determining and approving Territory-wide regulatory strategies and guidelines, and (C) reviewing all key regulatory filings in the Territory for consistency with Territory-wide regulatory strategy/guidelines approved by the JEC; [**];
(iv) monitoring Development activities, reviewing all significant information generated in the course of implementing each Long-Term Development Plan and each Annual Development Plan and Budget and otherwise overseeing the implementation of each Long-Term Development Plan and each Annual Development Plan and Budget by the CFDT;
(v) 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 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 that previously approved;
(vi) determining at each Decision Point, if any, whether the Development activities to which such Decision Point pertains have satisfied the corresponding Success Criteria, if any, and 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 [*] indicates that text has (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 and is the subject of pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission.
(bxi) serve as approving (A) a forum regulatory strategy plan for discussing obtaining Approvals and oversee matters relating thereto; (B) publication strategies for data arising out of Clinical Trials; and (C) significant post-Approval filings and submissions to the conduct of Pre Exercise Development Activitiesapplicable Regulatory Authorities (including supplements and amendments to Approvals);
(cxii) periodically (no less often than annually) review reviewing and approve each Post Exercise approving guidelines for the allocation by the CFDT or the Regional Operating Committees of responsibilities for Development Plan activities between BMS and BudgetCOLLABORATOR, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meetingconsistent with Section 2.13;
(dxiii) serve 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 a forum for discussing the conduct of the applicable Country-Specific Development ActivitiesProduct life cycle management;
(exiv) serve as reviewing and approving a forum patient risk management strategy and plan for discussing and oversee the conduct of Additional Licensor Development ActivitiesProducts;
(fxv) serve as a forum for reviewing overseeing the regulatory functions and approving strategies for obtaining Regulatory Approvals including approving use actions of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in CFDT and the TerritoryROCs;
(gxvi) establish secure access methods (performing such other duties as secure databases) for each Party are expressly assigned to access Regulatory Documentation and other the JDC related Information as contemplated under in this Agreement;
(xvii) performing such other functions as the JEC may request from time to time; and
(hxviii) perform such other functions as are set forth herein or as providing Quarterly updates on its activities and achievements to the Parties may mutually agree in writing, except where in conflict with any provision of this AgreementJEC.
Appears in 1 contract
Samples: Co Development and Co Promotion Agreement (Bristol Myers Squibb Co)
Specific Responsibilities. The JDC shall meet at least semiJRDC will, subject to the escalation, final decision-annually, or as otherwise agreed to by the Parties, making authority and such meetings may be conducted by telephone, video-conference or dispute resolution procedures 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC shallSection 9.9:
(a) periodically be responsible for 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;
(no less often than annuallyb) review and serve as a forum for discussing discuss each Pre Exercise amended Research Plan and Early Development Plan and Budgetapprove updates or material amendments to the Research Plan and the Early Development Plan;
(c) discuss and determine whether a Degrader that is Researched under this Agreement meets the Screening Xxxxxxxx, X0 Xxxxxxxx, Xxxxx 0 Ready Criteria or Phase 2 Ready Criteria;
(d) review, discuss and approve changes to the Screening Xxxxxxxx, X0 Xxxxxxxx, Xxxxx 0 Ready Criteria or Phase 2 Ready Criteria;
(e) discuss and determine whether Successful Completion has been achieved;
(f) review and approve amendments thereto, which approval will be reflected in discuss the applicable minutes list of the JDC meeting; *** Certain information in this agreement has been omitted Degraders provided by Kymera pursuant to Section 2.2.2;
(g) review and filed separately with the Securities discuss reports and Exchange Commission. data provided by Kymera pursuant to Section 2.4.4 within [***] indicates that text has been omitted and is after the subject delivery 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 Budgetsuch report, and review and approve amendments thereto, which approval will be reflected in determine if a relevant Degrader satisfies the applicable minutes of the JDC meetingFirst Additional Degrader Criteria;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement; and
(h) perform cause the minutes of the JRDC to reflect any selection of a Degrader as a First Additional Degrader, whether by the JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 2.4.4;
(i) review, discuss and determine [***];
(j) review, discuss and determine [***];
(k) review, discuss and approve [***];
(l) following [***], discuss and determine [***];
(m) review, discuss and determine whether a Collaboration Candidate or Licensed Product Directed Against Collaboration Target 2 satisfies the Phase 1 Ready Criteria;
(n) review and discuss reports and data provided by Kymera pursuant to Section 2.5.6 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Second Additional Degrader Criteria;
(o) cause the minutes of the JRDC to reflect any selection of a Degrader as a Second Additional Degrader, whether by the JRDC or the R&D Expert or by Sanofi in accordance with Section 2.5.6;
(p) review and discuss reports and data provided by Kymera pursuant to Section 2.6.5 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the X0 Xxxxxxxx;
(q) cause the minutes of the JRDC to reflect any selection of a Collaboration Compound as a Collaboration Candidate, whether by the JRDC or the R&D Expert;
(r) review and discuss information provided by Kymera pursuant to Section 2.5.4 and whether to approve any related overspend as a Permitted Overrun;
(s) review, discuss and approve a Research Budget Excession in accordance with Section 2.5.4, including whether any such Research Budget Excession was in Kymera’s reasonable control;
(t) review, discuss and determine whether Research Activities under Section 2.6.3 should be discontinued;
(u) review and discuss information provided by Kymera pursuant to Section 2.6.4 and whether to approve any related overspend as a Series 2 Permitted Overrun;
(v) review, discuss and approve Series 2 Research Budget Excession in accordance with Section 2.6.4, including whether any such Series 2 Research Budget Excession was in Kymera’s reasonable control;
(w) discuss and approve a transfer of Materials from one Party to the other functions Party in accordance with Section 2.8 and discuss information provided by a Party with respect to MTA Research Studies;
(x) during the Research Term prior to Sanofi’s exercise of the Sanofi Participation Election Right with respect to Collaboration Target 2, determine the first Indication for which the first IND will be filed with respect to a Licensed Product;
(y) discuss and approve a transfer of Materials from one Party to the other Party in accordance with Section 3.5 and discuss information provided by a Party with respect to MTA Development Studies;
(z) review and discuss reports provided by a Party pursuant to Section 2.11, Section 3.7 or Section 5.5;
(aa) to the extent contemplated by Section 5.2.3, review, discussion and approve an extension of time during which Kymera will make its personnel reasonably available;
(bb) review and discuss information provided by Kymera pursuant to Section 5.5.6 and whether to approve any related overspend as are set forth herein a Permitted Backup Research Overrun;
(cc) review, discuss and determine, in accordance with Section 5.5.6, whether any Backup Research Budget Excession was in Kymera’s reasonable control;
(dd) review and discuss reports and data provided by Kymera pursuant to Section 5.5.7 within [***] after the delivery of each such report, and determine if a relevant Degrader satisfies the Backup Degrader Criteria;
(ee) cause the minutes of the JRDC to reflect any selection of a Degrader as a Backup Degrader, whether by the JRDC, the R&D Expert in accordance with Section 9.9.2(b)(iii) or by Sanofi in accordance with Section 5.5.10;
(ff) in coordination with the JPC, review and discuss any requests by Kymera pursuant to Section 5.6.5 regarding a potential reversion of any Collaboration Compounds or Collaboration Candidates Directed Against Collaboration Target 1 that were Researched by or on behalf of Kymera under Section 2.3, 2.4, 2.5 or 5.5 but have not been selected as the Parties may mutually agree First Additional Degraders, Second Additional Degraders or Backup Degraders; (gg) review and discuss reports provided by Sanofi in writing, except where in conflict accordance with any provision of this Agreement.Section 5.9;
Appears in 1 contract
Samples: Collaboration and License Agreement (Kymera Therapeutics, Inc.)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 and oversee the Development of the Licensed Antibodies Compounds or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies Compounds or Licensed Products for the Territory. In particular, the JDC shall:
(ai) periodically (no less often than annually) […***…] review and serve as a forum for discussing each Pre Exercise the Initial Development Plan and Budget, such review to include oversight of project risk and mitigation strategies, and review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** 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.including any Material Amendment;
(bii) oversee the conduct of Development activities under the Initial Development Plan and Budget;
(iii) 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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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 coordinating strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(giv) determine whether a Compound Failure has occurred;
(v) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreement;
(vi) periodically (no less often than annually) review and serve as a forum for discussing and planning the communication, publication, abstract or presentation plan and activities, if any; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[...***...]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(vii) periodically review and serve as a forum for discussing the […***…] Development Plan or RA Phase 3 Development Plan, as applicable;
(viii) approve any subcontractors that Ablynx may utilize in any interactions with a Regulatory Authority; provided, that AbbVie shall provide notice of approval or rejection of the subcontractor within […***…] from the date of request by Ablynx. In the event AbbVie does not provide notice within such […***…] period, then AbbVie will be deemed to have given its consent to such subcontractor. Notwithstanding Section 13.9, for purposes of this Section 2.2.2(vii) AbbVie shall be permitted to provide notice via email;
(ix) determine the appropriate timeline for the transfer of Regulatory Documentation, Ablynx Know-How, Joint Know-How and other Information from Ablynx to AbbVie pursuant to Section 3.5.4; and
(hx) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 1 contract
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 JCC shall develop the strategies for and oversee the Development Commercialization of the Licensed Antibodies or Licensed Co-Promotion Products in the Territory, Co-Promotion Territory and shall serve as oversee at a forum for high level all Commercialization activities in the coordination of Development activities for Galapagos Territory with respect to the Licensed Antibodies or Licensed Products for the TerritoryProducts. In particular, the JDC JCC shall:
(ai) periodically (no less often than annually) review and serve as a forum for discussing each Pre Exercise Development Plan AbbVie’s Commercialization activities in the AbbVie Territory and BudgetAbbVie’s global brand plan for the Products, including marketing and promotional materials, Product messaging, Commercialization budgets and Detailing effort;
(ii) establish a strategy for the Commercialization of the Co-Promotion Products in the Co-Promotion Territory;
(iii) review and approve amendments thereto, which approval will be reflected in the applicable minutes of the JDC meeting; *** 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.
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development Activitiesinitial Co-Promotion Plan;
(civ) 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 JDC meeting;
(d) serve as a forum for discussing the conduct of the applicable CountryCo-Specific Development ActivitiesPromotion Plan and review and approve amendments thereto;
(ev) review and approve the manner in which the Markings are to be presented on promotional materials and Product Labeling for the Co-Promotion Products in the Co-Promotion Territory;
(vi) review and approve the initial Galapagos Territory Commercialization Plan; provided, that AbbVie shall ensure that its representatives on the JCC do not unreasonably withhold such approval so long as the initial Galapagos Territory Commercialization Plan is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of this Agreement;
(vii) oversee at a high level all Commercialization activities in the Galapagos Territory with respect to the Products;
(viii) periodically (no less often than annually) review and serve as a forum for discussing the Galapagos Territory Commercialization Plan and oversee its implementation, and review and approve any amendments thereto; provided, that AbbVie shall ensure that its representatives on the conduct JCC do not unreasonably withhold such approval so long as such amendment is consistent with AbbVie’s then-current global brand plan for the Products and the other requirements of Additional Licensor Development Activitiesthis Agreement;
(fix) serve as a forum for reviewing review and approving strategies for obtaining Regulatory Approvals including approving use approve the form and content of consultants, key opinion leaders or any other experts all marketing and promotional materials and all Product messaging to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products be used in the TerritoryGalapagos Territory with respect to the Products; * Confidential information, indicated by [...***...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission.
(x) review and approve the form and content of all training materials to be used in the Galapagos Territory with respect to the Products;
(gxi) establish secure access methods (discuss the selection of all Distributors and Third Party co-promoters and promoters engaged to support Commercialization activities in the Galapagos Territory and review the performance of all such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this AgreementThird Parties; and
(hxii) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Appears in 1 contract
Specific Responsibilities. The JDC shall meet at least semi-annuallyIn addition to the JSC’s general discussion, or as otherwise agreed to by the Parties, review 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 and oversee coordination regarding the Development and Manufacture of the Licensed Antibodies or Compounds, Licensed Products and Licensed Diagnostic Products, the JSC will in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, discuss the JDC shallfollowing:
(a) periodically (no less often than annually) review and serve as a forum for discussing approve each Pre Exercise Basket Program Development Plan and Basket Program Development Budget; provided, that, for clarity, [...***...]. For clarity, the synopses of Study 1 and Study 2 have been attached for informational purposes only to ensure that [...***...]. In regard to Study 1 and Study 2, [...***...] will use reasonable efforts to incorporate comments from [...***...]’s review into protocol amendments for Study 1 and approve Study 2, assuming that these amendments theretodo not materially affect the study design or result in material delays to the study timelines;
(b) the Parties’ Development activities with respect to Basket Studies, which approval will be reflected including matters related to progress, timelines, status, safety and budget;
(c) high level information regarding the supply chain for Licensed Compound and Licensed Product including back-up mandatory sites and the ability to meet forecasted demand (unless and until provided for in the applicable minutes of the JDC meetingSupply Agreement); * Confidential Information, indicated by [...*** Certain information in this agreement *...], has been omitted from this filing and filed separately with the U.S. Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
(b) serve as a forum for discussing and oversee the 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 JDC meeting;
(d) serve as a forum for discussing the conduct of the applicable Country-Specific Celgene’s Development Activitiesactivities (other than Basket Studies) with respect to Licensed Products or Licensed Diagnostic Products, including Clinical Trials; ;
(e) serve as a forum Clinical Trials for discussing and oversee Licensed Products or Licensed Diagnostic Products to be conducted in the conduct BeiGene Territory, other than in the Heme Field (provided that safety data relating to Clinical Trials in the Heme Field shall be within the remit of Additional Licensor Development Activitiesthe JSC);
(f) serve as a forum for reviewing Amendments to the Basket Program Development Plan and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the TerritoryBasket Program Development Budget;
(g) establish secure access methods (such as secure databases) discuss specific requirements to demonstrate [...***...] for each Party Licensed Product Developed hereunder by or on behalf of Celgene or its Affiliates or Sublicensees (which must be mutually agreed by the Parties and are not subject to access Regulatory Documentation and other JDC related Information as contemplated under this AgreementJSC approval); and
(h) perform such other functions the expansion of the responsibilities of the JSC as are set forth herein or as mutually agreed by the Parties may mutually agree in writing, except where in conflict with any provision of this AgreementParties.
Appears in 1 contract
Samples: Exclusive License and Collaboration Agreement (BeiGene, Ltd.)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed In addition to by 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 Approval for, Manufacturing, and such meetings may be conducted by telephoneCommercializing Collaboration Products, 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 and oversee the Development of the Licensed Antibodies or Licensed Products Field in the Territory;
(ii) receive and discuss reports from the JDC, the JCC, the JFC, and shall serve 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 a forum for it deems necessary to achieve the coordination objectives and intent of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particularthis Agreement;
(iv) attempt to resolve issues presented to it by, and disputes within, the JDC shall:
(a) periodically (no less often than annually) review and serve as a forum for discussing each Pre Exercise Development Plan and BudgetJDC, the JCC, the JFC, and review and approve amendments theretothe JPC, which approval will be reflected in the applicable minutes of the JDC meetingor any other committee; **[ * ] = Certain confidential information contained in this agreement document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is Commission pursuant to Rule 24b-2 of the subject Securities Exchange Act of a confidential treatment request1934, as amended.
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development Activities;
(c) periodically (no less often than annuallyv) review and approve each Post Exercise decisions to terminate Development Plan on any Collaboration Product, including with respect to specific indications;
(vi) discuss and Budgetdecide 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 amendments any changes thereto, which approval will be reflected in the applicable minutes of the JDC meeting;
(dviii) serve as review and approve the manufacturing plan [ * ] 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 forum for discussing Party that exceed that the conduct portion of the applicable Country-Specific Development ActivitiesBudgets or Commercialization Budgets allocated to such Party with respect to the relevant Calendar Quarter by more than [ * ];
(ex) serve as a forum for discussing review and oversee approve any changes to the conduct specific responsibilities of Additional Licensor Development Activitiesthe JDC, the JCC, the JFC, and the JPC;
(fxi) serve as a forum for reviewing discuss and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or any other experts make determinations regarding material safety issues with respect to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(g) establish secure access methods (such as secure databases) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this AgreementCollaboration Product; and
(hxii) perform such other functions as are set forth herein or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this AgreementAgreement as allocated to it in writing by the Parties.
Appears in 1 contract
Samples: Collaboration and License Agreement (Facet Biotech Corp)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed In addition to by its overall responsibility for monitoring and providing a forum to discuss and coordinate 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development ’ activities for the Licensed Antibodies or Licensed Products for the Territory. In particularunder this Agreement, the JDC shallJSC shall in particular:
(ai) periodically (no less often than annually) oversee the collaborative activities of the Parties under this Agreement, create and review the overall strategy for Developing and serve as a forum for discussing each Pre Exercise Development Plan and Budgetseeking Regulatory Approval for, Manufacturing, and review and approve amendments theretoCommercializing Collaboration Products, which approval will be reflected in the applicable minutes of the JDC meeting; *** 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.
(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 JDC meeting;
(d) serve as a forum for discussing the conduct of the 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products Field in the Territory;
(gii) 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 secure access methods (such additional joint subcommittees as secure databases) for each Party it deems necessary to access Regulatory Documentation achieve the objectives and other JDC related Information as contemplated under 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 [*] 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
(hxii) perform such other functions as are set forth herein or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this AgreementAgreement as allocated to it in writing by the Parties.
Appears in 1 contract
Samples: Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed In addition to 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum its overall responsibility for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particularcollaboration established by this Agreement, the JDC shallJSC shall in particular:
(a) periodically (no less often than annually) review and serve as a forum for discussing each Pre Exercise approve the initial Core Development Plan and Budget, and for any Co-Promote Product;
(b) review and approve amendments thereto, which approval will be reflected in and updates to the applicable minutes of Core Development Plan for any Co-Promote Product presented by the JDC meeting; *** 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.
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development ActivitiesDWG;
(c) periodically (no less often than annually) review amendments and approve each Post Exercise updates to the Development Plan and Budget, and review and approve amendments thereto, which approval will be reflected in for any Co-Promote Product presented by the applicable minutes of the JDC meetingDWG;
(d) serve as upon receipt of notice from either Party identifying any activity or lack of activity that has or would reasonably be likely to have a forum 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 discussing the conduct remediation of the applicable Country-Specific Development Activitiessuch issue;
(e) serve as a forum for discussing review and oversee approve the conduct of Additional Licensor Development ActivitiesRegulatory Strategy (and amendments and updates thereto) presented by the DWG;
(f) serve as a forum for reviewing review and approving strategies for obtaining Regulatory Approvals including approving use of consultants, key opinion leaders or approve any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the TerritoryNew Product Proposal;
(g) 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 manage the remediation 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 secure access methods various sub working groups (such as secure databaseseach, a “Sub Group”) for each Party to access Regulatory Documentation and other JDC related Information as contemplated under this Agreementparticular projects or activities, including at the request of the DWG, MWG, PSC, CWG, ERG, or FWG; and
(hn) perform such other functions as are set forth herein assigned to it in this Agreement or as appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this AgreementAgreement as agreed in writing by the Parties, including periodic evaluations of performance against goals.
Appears in 1 contract
Samples: Collaboration and License Agreement (Arcellx, Inc.)
Specific Responsibilities. The JDC shall meet at least semi-annually, or as otherwise agreed to 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 and oversee the Development of the Licensed Antibodies or Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Antibodies or Licensed Products for the Territory. In particular, the JDC JCC shall:
(a) periodically (no less often than annually) review oversee and serve as a forum for discussing each Pre Exercise Development Plan and Budgetcoordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and review from AbbVie to Infinity of AbbVie Know-How, related to the Commercialization of Licensed Compounds and approve amendments thereto, which approval will be reflected Products so that each Party may undertake Commercialization of Licensed Compounds and Products in the applicable minutes of the JDC meeting; *** Certain information in this agreement has been omitted and filed separately accordance with the Securities Commercialization Plans and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.this Agreement;
(b) serve as a forum for discussing and oversee the conduct of Pre Exercise Development ActivitiesManufacturing Working Group to ensure that Manufacturing Plans, and related budget information, are incorporated into the applicable Commercialization Plans;
(c) periodically (no less often than annually) review develop and approve each Post Exercise Development Plan and Budgetupdate, and review and approve amendments theretoon an annual basis, which approval will be reflected Manufacturing Plans for inclusion in the applicable minutes Commercialization Plans to ensure a reliable commercial supply of the JDC meeting;
(d) serve as a forum for discussing the conduct of the applicable Country-Specific Development Activities;
(e) serve as a forum for discussing Licensed Compound 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, key opinion leaders or any other experts to seek advice on strategies for seeking Regulatory Approvals for the Licensed Products in the Territory;
(d) coordinate with the JDC with respect to regulatory matters;
(e) coordinate with the JDC with respect to pharmacovigilance matters;
(f) develop and present to the JSC for approval the Global Branding Strategy and updates to such Global Branding Strategy during the Term as necessary;
(g) establish secure access methods review and present to the JSC for approval the initial US Commercialization Plan, including the US Commercialization Budget therein and the allocation of Commercialization activities between the Parties, which US Commercialization Plan shall be consistent with the Global Branding Strategy and Section 5.3.1, in accordance with this Agreement and, as appropriate, present to the JSC for review and approval proposed updates and amendments to such US Commercialization Plan, including the US Commercialization Budget included therein;
(h) review and comment on the initial or updated (as applicable) Ex-US Commercialization Plan, and any material amendments to such Ex-US Commercialization Plans, and submit such plans to the JSC for review and approval;
(i) coordinate the activities of the Parties under the US Commercialization Plan and oversee the implementation of the US Commercialization Plan and oversee the implementation of the Ex-US Commercialization Plan;
(j) review each Party’s Commercialization activities in the US and AbbVie’s Commercialization activities in the Ex-US Territory, including a review of actual financial results versus budget or plan;
(k) 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 secure databasesapplicable;
(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 terms for each Party to access Regulatory Documentation Co-Promotion of Product in the United States for inclusion in the US Commercialization Plan;
(o) review and other JDC related Information as contemplated under this Agreementupdate, on an annual basis, pricing, discounting and reimbursement decisions for inclusion in the US Commercialization Plan; and
(hp) perform such other functions as are set forth herein assigned to it in this Agreement or as are appropriate to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this AgreementAgreement to the extent agreed in writing by the Parties.
Appears in 1 contract
Samples: Collaboration and License Agreement (Infinity Pharmaceuticals, Inc.)