Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. The JRC shall develop the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particular, the 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 [***]) review and serve as a forum for discussing the Discovery Research Plan for each Collaboration 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), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research and discovery and other JRC related 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 (n) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

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

Specific Responsibilities. The JRC shall develop the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particular, the JRC shallJDC shall be responsible for the following activities with respect to the Product: (a) serve as a discussion forum in relation to potential Modulator Targets overseeing the development of, and Antigen Targets for inclusion as potential Collaboration Targets (including respective Substitute Targetsreviewing and revising, if anyapplicable, the GT Operational Plan (and related GT Operational Budget) during and Territory Development Plan (and any period when updates to any of the Parties have not elected to appoint a Gatekeeperforegoing) for the Product in the Field in the Territory for final approval by the JSC; (b) periodically (no less often than [***]) review reviewing and serve as a forum overseeing activities under the Development Plans for discussing the Discovery Research Plan for each Collaboration Target, and review and approve any amendments theretoProduct in the Field in the Territory; (c) oversee overseeing clinical and regulatory matters relating to the conduct and progress of Product in the Discovery Research Activities Field in the Territory arising from the Development Plans (including the need for potential amendments to the LSR Go and Dev Go Criteriainteractions with Regulatory Authorities), and discuss reviewing and agree upon any activities to be allocated approving protocols (including amendments thereto), statistical analysis plans, clinical trial plans (in terms of designs, endpoints, scales, sample sizes, study cohorts, doses and duration), clinical methodology and monitoring requirements for performance by Genentech (if any)all clinical trials, including post-marketing non-approval trials, of the Product in the Field in the Territory as contemplated under the Development Plans; (d) monitor reviewing and approving ZLAB’s support of any investigator initiated study for the achievement of (i) Product in the Hit Success Criteria determining POP Achievement, (ii) Field in the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm CriteriaTerritory; (e) monitor reviewing the completion of progress of, and results and data from, ongoing clinical trials under the activities Development Plans, including ongoing enrollment and budgetary issues and ongoing safety, both protocol-specific and across the generation of the data Development Plans; provided that Regeneron shall not be required to be included in provide any Proprietary Manufacturing Information to the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]JDC or ZLAB; (f) prior reviewing the progress of, and results and data from, Global Trials conducted by or on behalf of Regeneron in the Territory or ROW; provided that with respect to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package any such Global Trial […***…]; (g) prior with respect to any Global Trial conducted by or on behalf of ZLAB in the commencement Territory, reviewing and discussing Regeneron’s protocol for such Global Trial (including patient eligibility, sample analysis, and centralized imaging reads), site qualification requirements and any other policies and procedures regarding the conduct of such Global Trial globally (as well as any updates thereto provided by Regeneron) (the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]“Global Trial Requirements”); (h) discuss the scope of any modifications or improvements requested by Genentech with respect to any Discovery Construct Global Trial conducted by or Development Candidate pursuant to Section 5.2on behalf of Regeneron (other than by or on behalf of ZLAB) in the Territory, reviewing and discussing Regeneron’s protocol for such Global Trial; (i) serve as a forum for discussion of results from reviewing and discussing the conduct of the Discovery Research ActivitiesGTC Budgets provided by Regeneron pursuant to Section 5.3.2(b); (j) extend the Research Term as provided in Section 2.4.2[…***…]; (k) establish secure access methods (such as secure databases) for each Party to access research and discovery and other JRC related information and Know-How as contemplated under this Agreement[…***…]; (l) monitor evaluating for Development, Manufacturing and implement Commercialization in the transfer of CMC materials Field in or for the Territory (i) any new doses, forms, formulations, presentations and delivery systems (including Territory Product Changes), (ii) any new proposed Approved Indications and (iii) all other changes or improvements with respect to Genentechthe Approved Product, whether pursuant in each case ((i), (ii) and (iii)), that a Party may propose from time to Section 5.3 or Section 5.4time and presenting the same to the JSC; (m) monitor overseeing, monitoring and implement coordinating the technology transfer submission of Registration Filings in the Field in the Territory, including reviewing and coordinating material communications, filings and correspondence with Regulatory Authorities in the Territory in connection with the Product in the Field; provided that […***…] or […***…] or […***…]; (n) developing and proposing to Genentech pursuant the JSC, in consultation with the JCC, the Target Labeling for the Product in the Field (which shall comply with the Global Marketing Guidelines); (o) reviewing ZLAB’s forecasts for quantities of Product required for ZLAB’s Development […***…] in the Territory; (p) with respect to Section 5.4Regeneron’s Development of the Product in the Territory, discussing the timing and nature of Regeneron’s and ZLAB’s communications with Regulatory Authorities and key opinion leaders in the Territory regarding the Product; and (nq) perform considering and acting on such other functions matters as are set forth herein specifically assigned to the JDC under this Agreement or as by the Parties may mutually agree in writing, except where in conflict with any provision of this AgreementJSC.

Appears in 1 contract

Sources: Collaboration Agreement (Zai Lab LTD)

Specific Responsibilities. The JRC shall develop the strategies In addition to its overall responsibility for monitoring and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as providing a forum for the coordination of such activities. In particularto discuss AZ’s activities under this Agreement, the JRC shallJSC shall in particular: (ai) serve as a discussion forum oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the development, Manufacture and Commercialization of the Products 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 GatekeeperField in the Territory; (b) periodically (no less often than [***]ii) review and serve comment on the Development Plan and amendments thereto, including reviewing and commenting on the overall strategy and design of all human clinical trials and other studies conducted under the Development Plan; (iii) approve any change in the Development Plan that would [ * ], or [ * ], of (iv) discuss the requirements for Marketing Approval of Products in the (v) facilitate the flow of Information between the Parties with respect to the development of, and obtaining Marketing Approval for the Products; (vi) review the results of Phase 3 Clinical Trials of Products; (vii) review AZ’s proposed timing for announcing the top line results of each of the Major Three RA Trials following the unblinding of such trial results; for the avoidance of doubt AZ shall notify Rigel either directly or via the JSC of its decision to unblind clinical data in whichever of the Three Major RA Trials shall be the first to report clinical data as a forum further described in Section 15.13; (viii) discuss and agree the reimbursement of any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for discussing obtaining, maintaining and enforcing patent protection for the Discovery Research Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan for each Collaboration Targetto be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and approve facilitate discussion of any amendments theretorequests in relation to Publications pursuant to Section 12.4; (c) oversee the conduct and progress of the Discovery Research Activities (including the need for potential amendments to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (kxiii) establish secure access methods (such additional joint subcommittees as secure databases) for each Party it deems necessary to access research achieve the objectives and discovery and other JRC related information and Know-How as contemplated under intent of 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 (nxiv) 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

Sources: License and Collaboration Agreement

Specific Responsibilities. The JRC shall develop the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particular, the JRC JDC shall: (a) serve as a discussion forum oversee and coordinate the on-going transfer, in relation accordance with the terms of this Agreement, from Infinity to potential Modulator Targets AbbVie of Infinity Know-How, and Antigen Targets for inclusion as potential Collaboration Targets (including respective Substitute Targetsfrom AbbVie to Infinity of AbbVie Know-How, if any) during any period when related to the Parties have not elected to appoint a GatekeeperDevelopment of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP and this Agreement; (b) periodically (no less often than [***]) review coordinate the activities of the Parties under the GDP and serve as a forum for discussing oversee the Discovery Research Plan for each Collaboration Target, and review and approve any amendments theretoimplementation of the GDP; (c) oversee the conduct and progress of the Discovery Research Activities (including the need for potential amendments to the LSR Go extent necessary, share planning and Dev Go Criteria)budgeting information with the JCC and the JMAC and coordinate with the JCC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Commercialization, Manufacturing and discuss and agree upon any activities to be allocated for performance by Genentech (if any)Medical Affairs Activities of Products in the Field, as applicable; (d) monitor develop and update, on an annual basis, the achievement of (i) proposed global regulatory strategy for the Hit Success Criteria determining POP Achievement, (ii) Products in the LSR Go Criteria, (iii) Field in the Dev Go CriteriaTerritory, and (iv) include such proposed strategy in the Targeting Arm CriteriaGDP, for approval by the JSC in accordance with this Agreement; (e) monitor on an annual basis, update the completion of GDP, including the activities Development Budget and the generation allocation of Development responsibilities between the data required Parties and present to be included the JSC for approval proposed amendments to the GDP, including the Development Budget, in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]accordance with Section 4.1.5; (f) prior to develop and update, on an annual basis, for inclusion in the commencement GDP, the CMC Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Lead Generation Phase for a Collaboration Program, discuss Licensed Compound and agree upon Products in the contents of the LSR Go Data Package [***]Territory; (g) prior review and comment on Regulatory Filings relating to the commencement of Products in the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]Field in accordance with Section 4.4; (h) discuss review and comment on the scope of any modifications or improvements requested initial Global Publication Strategy and amendments thereto prepared and presented by Genentech the JMAC from time to any Discovery Construct or Development Candidate pursuant to time in accordance with Section 5.29.4.1; (i) serve as a forum for discussion of results from oversee the conduct of Regulatory Working Group, the Discovery Research ActivitiesPharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDC; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research monitor progress and discovery and other JRC related information and Know-How as contemplated performance of Development activities under this Agreement; (l) monitor and implement the transfer , including a review of CMC materials to Genentech, whether pursuant to Section 5.3 actual financial results versus budget or Section 5.4; (m) monitor and implement the technology transfer to Genentech pursuant to Section 5.4plan; and (nk) 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 as agreed in writing by the Parties.

Appears in 1 contract

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

Specific Responsibilities. The JRC shall develop In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particularParties’ activities under this Agreement, the JRC shallJSC shall in particular: (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 [***]) review and serve as a forum for discussing the Discovery Research Plan for each Collaboration 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), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from oversee the conduct collaborative activities of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research and discovery and other JRC related information and Know-How as contemplated Parties under this Agreement; (lii) monitor review and implement discuss the transfer Development and Commercialization of CMC materials to Genentech, whether pursuant to Section 5.3 or Section 5.4Products and any other ongoing activities; (miii) monitor determine whether to initiate a pivotal Clinical Trial with respect to either the [*] Indication or the [*] Indication (but not [*]); (iv) determine whether to select as the formulation for the MDV3100 Product for which approval of the NDA will be sought, either the formulation used for the Initial MDV3100 Product or a [*] used for a [*] MDV3100 Product (it being understood that the JSC will select the [*] that is in the best interest of the Product with the goal of maintaining the [*] agreed upon in the Joint Development Plan for [*]); (v) review and implement discuss reports from the technology transfer JDC, JMC, JMAC and JCC and provide guidance thereto, direct the activities of such committees, and, except in the case of the Initial Joint Development Plan and the initial Joint Manufacturing Plan, approve each Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto; (vi) review and discuss strategies for obtaining, maintaining, defending and enforcing patent and trademark protection for Products within the Territory; (vii) attempt to Genentech resolve issues presented to it by, and disputes within, the JDC, JMC, JMAC, JCC, or any other subcommittee; (viii) determine whether the conduct and oversight of a Voluntary Phase 4 Clinical Trial should be undertaken by the JDC instead of the JMAC; (ix) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the securities and exchange commission pursuant to Section 5.4; andrule 24b-2 of the securities exchange act of 1934, as amended. (nx) perform such other functions as are set forth herein or appropriate, and direct each other Committee to perform such other functions as appropriate, to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement, in each case as agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration Agreement (Medivation, Inc.)

Specific Responsibilities. The JRC Subject to the oversight of the JSC, the JDC shall develop the strategies be responsible for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum overseeing Development strategy for the coordination of such activitiesProduct globally under this Agreement. In particular, The JDC’s responsibilities shall include the JRC shall: following: (a) serve as a discussion forum in relation overseeing the preparation of annual updates and other amendments to potential Modulator Targets and Antigen Targets for inclusion as potential Collaboration Targets the Global Development Plan (including respective Substitute Targets, if anythe budget therefor) during any period when for approval by the Parties have not elected to appoint a Gatekeeper; JSC; (b) periodically (no less often than [***]) review subject to Section 8.1.6(a), reviewing and serve as approving a forum form of Core Data Sheet and submitting a draft thereof to the JSC for discussing the Discovery Research Plan for each Collaboration Target, and review and approve any amendments thereto; its approval pursuant to Section 2.2.3; (c) oversee monitoring compliance with the conduct then-current budget included in the Global Development Plan; (d) reviewing, coordinating and monitoring the activities and progress of the Discovery Research Activities Parties in implementing the Development activities contemplated by the Global Development Plan; (e) monitoring the activities of its Working Groups, including the need JMAT, JRT and CDS Working Group in accordance the terms of this Agreement (provided, for potential amendments clarity, that despite the JDC’s global role with respect to Development, its role with respect to the LSR Go JMAT and Dev Go CriteriaMedical Affairs Activities will be limited to the JMAT’s responsibilities under this Agreement with respect to the Major Markets); (f) in consultation with the JRT, recommending to the JSC whether and discuss when to submit a DAA, including a BLA, for the Product anywhere in the Territory; (g) facilitating the flow of information with respect to the Development of the Product and agree upon any activities coordinating such information flow with other Committees, as appropriate; (h) overseeing the strategic planning and conduct of Clinical Trials consistent with the allocation of sponsorship and responsibility for Clinical Trials set forth in Section 4.6.2; provided, that the JDC shall coordinate with the JMAT with respect to be allocated for performance by Genentech (if any); (d) monitor the achievement JDC’s strategic planning and conduct of Phase III-B Studies and Phase IV Studies; (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 making forecasts of Clinical Supply requirements for Development of the activities Product and reviewing the generation supply of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; Product; (j) extend making recommendations for further Development of the Research Term as provided Product, including Development for new indications that are not in Section 2.4.2; the then current Global Development Plan; (k) establish secure access methods (such as secure databases) for each Party providing Quarterly updates on the JDC’s activities to access research and discovery and other JRC related information and Know-How as contemplated under this Agreement; the JSC; (l) monitor establishing and implement implementing a responsibility assignment matrix consistent with this Agreement to define the transfer of CMC materials roles and responsibilities between the Parties with respect to Genentech, whether pursuant to Section 5.3 or Section 5.4; (m) monitor and implement the technology transfer to Genentech pursuant to Section 5.4Development activities; and (n) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

Sources: Joint Commercialization Agreement (Seagen Inc.)

Specific Responsibilities. The JRC JCC shall develop oversee and coordinate the strategies for Commercialization of CNS Compounds and oversee CNS Products in the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activitiesTerritory. In particular, the JRC JCC shall: (a) serve as a discussion forum review and finalize the Co-Commercialization Plan and Co‑Commercialization Budget, and material amendments thereto, including any updates to such plan or budget in relation to potential Modulator Targets accordance with Section ‎5.3.3 (Amendments 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 GatekeeperUpdates); (b) periodically (no less often than discuss, review and finalize reasonably in advance of the first Regulatory Approval for the first CNS Product, and annually thereafter, a non-binding [***]) review and serve as a forum ] estimated sales forecast for discussing the Discovery Research Plan for each Collaboration Target, and review and approve any amendments theretoCNS Products; (c) oversee with respect to any CNS Product(s) and countries within the conduct Co‑Commercialization Territory with respect to which Denali has exercised the Co‑Commercialization Option, prepare and progress of approve, the Discovery Research Activities (including the need Parties’ strategies related to field-based medical education activities by either Party and grant-based medical education programs for potential amendments to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any)such CNS Product(s) in each such country; (d) monitor the achievement of (i) competitive landscape for CNS Products in the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm CriteriaTerritory; (e) monitor discuss, review and finalize the completion Parties’ strategies related to any marketing studies, epidemiological studies, modeling and pharmaco-economic studies, investigator-initiated clinical trials or post-marketing surveillance studies with respect to CNS Products in each country of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]Co-Commercialization Territory; (f) prior to the commencement discuss pricing of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]CNS Products; (g) prior to review and approve the commencement Detail position for CNS Products in the conduct of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]Co-Commercialization Activities; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; implement a process for reviewing and approving (i) serve as a forum Promotional Materials and (ii) training materials and programs for discussion of results from sales representatives, in each case (i) and (ii), that are intended for use with Co-Commercialization Products in applicable Co-Commercialization Countries to the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party extent to access research and discovery and other JRC related 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 5.4which Denali has exercised its Co‑Commercialization Option; and (ni) perform such other functions as are set forth herein in this Agreement as the function of the JCC or as the Parties may otherwise mutually agree in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

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

Specific Responsibilities. The JRC shall develop the strategies In addition to its overall responsibility for monitoring and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as providing a forum for the coordination of such activities. In particularto discuss AZ’s activities under this Agreement, the JRC shallJSC shall in particular: (ai) serve oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the development, Manufacture and Commercialization of the Products in the Field in the Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as a discussion forum in relation to potential Modulator Targets amended. (ii) review and Antigen Targets for inclusion as potential Collaboration Targets (comment on the Development Plan and amendments thereto, including respective Substitute Targets, if any) during any period when reviewing and commenting on the Parties have not elected to appoint a Gatekeeperoverall strategy and design of all human clinical trials and other studies conducted under the Development Plan; (biii) periodically approve any change in the Development Plan that would [ * ], or [ * ], of the [ * ]; (no less often than [***]iv) discuss the requirements for Marketing Approval of Products in the Territory; (v) facilitate the flow of Information between the Parties with respect to the development of, and obtaining Marketing Approval for the Products; (vi) review the results of Phase 3 Clinical Trials of Products; (vii) review AZ’s proposed timing for announcing the top line results of each of the Major Three RA Trials following the unblinding of such trial results; for the avoidance of doubt AZ shall notify Rigel either directly or via the JSC of its decision to unblind clinical data in whichever of the Three Major RA Trials shall be the first to report clinical data as further described in Section 15.13; (viii) discuss and agree the reimbursement of any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and serve as a forum for discussing discuss AZ’s scientific presentation and publication strategy relating to the Discovery Research Plan for each Collaboration TargetProducts in the Territory, and review and approve facilitate discussion of any amendments theretorequests in relation to Publications pursuant to Section 12.4; (c) oversee the conduct and progress of the Discovery Research Activities (including the need for potential amendments to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (kxiii) establish secure access methods (such additional joint subcommittees as secure databases) for each Party it deems necessary to access research achieve the objectives and discovery and other JRC related information and Know-How as contemplated under intent of 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 (nxiv) 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

Sources: License and Collaboration Agreement (Rigel Pharmaceuticals Inc)

Specific Responsibilities. The JRC shall develop In addition to its overall responsibility for Development, Regulatory Approval and Manufacturing, the strategies JSC shall, in particular, be responsible in both the Territory and the Retained Territory for: (i) reviewing on-going Development activities including those referred to in Section 2.1(d); (ii) reviewing cost sharing in accordance with Section 2.1(d) and making recommendations thereon to the Parties for their approval; (iii) reviewing and oversee making recommendations to the Discovery Research Activities Parties for their approval regarding the Manufacturing plans and supply chain strategy in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination provisions of such activities. In particular, the 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 GatekeeperArticle 7; (biv) periodically (no less often than reviewing and making recommendations to the Parties for their approval regarding the regulatory strategy for obtaining Regulatory Approvals; [***]] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO 17 C.F.R. SECTIONS 200.80(B)(4) review AND 240.24B-2. (v) reviewing and serve as a forum making recommendations to the Parties for discussing their approval regarding the Discovery Research Plan for each Collaboration Target, Patent and review Product Trademark filing and approve any amendments theretoprosecution strategy; (cvi) oversee the conduct reviewing and progress of the Discovery Research Activities (including the need for potential amendments making recommendations to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated Parties for performance by Genentech (if any); (d) monitor their approval regarding 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 publication strategy in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to line with Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research and discovery and other JRC related 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 5.411.3; and (nvii) 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 writingwriting from time to time; in the case of each subparagraph (i)-(vii), except where consistent with the activities and Clinical Plan Development Costs set out in conflict the Clinical Development Plan and with any provision of this Agreementthe activities and Manufacturing Costs set out in the Manufacturing Plan; and (viii) reviewing, sharing and discussing (with each Party taking into consideration the other’s reasonable points and comments) Commercialization strategies, Commercialization plans, branding, including global brand strategies, Product positioning, advertising and promotional material, Product claims, Investigator Initiated Trials, communication, life cycle management (Phase 3b/4 trials) and other Commercialization matters.

Appears in 1 contract

Sources: License and Co Development Agreement (Basilea Pharmaceutica Ltd.)

Specific Responsibilities. The JRC shall develop the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particular, the JRC DWG shall: (a) serve as a discussion forum oversee and coordinate the on-going sharing and transfer of Know-How generated in relation or related 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 GatekeeperDevelopment of Licensed Products; (b) periodically (no less often than [***]) review and serve as a forum for discussing oversee the Discovery Research Plan implementation of the GDP for each Collaboration Target, and review and approve any amendments theretoLicensed Product for the Development of such Licensed Product; (c) oversee review and update the conduct Core Development Plan for each Co-Promote Product and progress of Core Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, present to the Discovery Research Activities (including the need JSC for potential review and approval proposed substantive amendments to the LSR Go and Dev Go Criteria)Core Development Plan, and discuss and agree upon any activities to be allocated for performance by Genentech (if any)including the Core Development Budget, in accordance with Section 4.2.5; (d) monitor on a Licensed Product-by-Licensed Product basis, develop and propose to the achievement of JSC for review and approval a regulatory and clinical strategy for such Licensed Product (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria“Regulatory Strategy”); (e) monitor oversee the completion implementation of the activities and Regulatory Strategy for the generation Regulatory Approval of each Co-Promote Product once it has been approved by the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]JSC; (f) prior to the commencement of the Lead Generation Phase in connection with each Co-Promote Option for a Collaboration ProgramLicensed Product, discuss any Phase 1 Clinical Study Report and agree upon the contents of the LSR Go Data Package [***]any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) prior provide a forum for the Parties to the commencement of the Lead Validation Phase for a Collaboration Program, review and discuss and agree upon the contents of the Dev Go Data Package [***]regulatory matters as provided in Section 4.4; (h) discuss review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the scope of same with respect the Existing Product or any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2Co-Promote Product; (i) serve as review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a forum for discussion of results from Licensed Product, and approve the conduct of same with respect the Discovery Research ActivitiesExisting Product or any Co-Promote Product; (j) extend review the Research Term as provided design and protocol of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products in Section 2.4.2the Field, and approve the same with respect the Existing Product or any Co-Promote Product; (k) establish secure access methods discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (such as secure databasesor their Affiliates’) respective regulatory responsibilities and which may be necessary for each Party to access research and discovery and other JRC related information and Know-How as contemplated under this Agreementcompliance with the applicable regulatory pharmacovigilance requirements; (l) monitor review and implement submit to 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 5.4JSC for approval any New Product Proposal; and (nm) 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 as agreed in writing by the Parties.

Appears in 1 contract

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

Specific Responsibilities. The JRC shall develop In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particularParties’ activities under this Agreement, the JRC shallJSC shall in particular: (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 [***]) review and serve as a forum for discussing the Discovery Research Plan for each Collaboration 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), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, and (iv) the Targeting Arm Criteria; (e) monitor the completion of the activities and the generation of the data required to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior to the commencement of the Lead Generation Phase for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from oversee the conduct collaborative activities of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research and discovery and other JRC related information and Know-How as contemplated Parties under this Agreement; (lii) monitor review and implement discuss the transfer Development and Commercialization of CMC materials to Genentech, whether pursuant to Section 5.3 or Section 5.4Products and any other ongoing activities; (miii) monitor determine whether to initiate a pivotal Clinical Trial with respect to either the [*] Indication or the [*] Indication (but not [*]); (iv) determine whether to select as the formulation for the MDV3100 Product for which approval of the NDA will be sought, either the formulation used for the Initial MDV3100 Product or a [*] used for a [*] MDV3100 Product (it being understood that the JSC will select the [*] that is in the best interest of the Product with the goal of maintaining the [*] agreed upon in the Joint Development Plan for [*]); (v) review and implement discuss reports from the technology transfer to Genentech JDC, JMC, JMAC and JCC and provide guidance thereto, direct the activities of such committees, and, except in the case of the Initial Joint Development Plan and the initial Joint Manufacturing Plan, approve each Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Section 5.4Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (vi) review and discuss strategies for obtaining, maintaining, defending and enforcing patent and trademark protection for Products within the Territory; (vii) attempt to resolve issues presented to it by, and disputes within, the JDC, JMC, JMAC, JCC, or any other subcommittee; (viii) determine whether the conduct and oversight of a Voluntary Phase 4 Clinical Trial should be undertaken by the JDC instead of the JMAC; (ix) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (nx) perform such other functions as are set forth herein or appropriate, and direct each other Committee to perform such other functions as appropriate, to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement, in each case as agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration Agreement (Medivation, Inc.)

Specific Responsibilities. The JRC shall develop In particular, the strategies for and JDC will: (i) oversee the Discovery Research Activities initial transfer of the Nogra Know-How and designated Development activities related to the Licensed Compounds and Licensed Products from Nogra to Licensee in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination terms of such activities. In particular, the 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 Gatekeeperthis Agreement; (bii) periodically oversee the implementation of the Global Development Plan within the JSC-approved Development Budget for the Development of the Licensed Compounds and Licensed Products once they have been approved by the JSC; (no less often than [***]iii) review and serve as a forum update the Global Development Plan, including the Development Budget set forth therein, on an annual basis and, from time to time, present to the JSC for discussing the Discovery Research Plan for each Collaboration Target, and review and approve any amendments thereto; (c) oversee the conduct and progress of the Discovery Research Activities (including the need for potential approval proposed substantive amendments to the LSR Go and Dev Go Criteria)Global Development Plan, and discuss and agree upon any activities to be allocated for performance by Genentech (if anyincluding the Development Budget, in accordance with Section 5.2(c); (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) develop and propose to the Targeting Arm Criteria; (e) monitor the completion JSC a global regulatory strategy with respect to seeking and obtaining Regulatory Approval of the activities and the generation Licensed Products in each of the data required Indications in the Field to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]Global Development Plan; (fv) prior to oversee the commencement implementation of the Lead Generation Phase global regulatory strategy for a Collaboration Program, discuss and agree upon the contents Regulatory Approval of the LSR Go Data Package [***]Licensed Products in each of the Indications in the Field once it has been approved by the JSC; (gvi) prior to the commencement review, approve and oversee performance of non-clinical research or development of the Lead Validation Phase for a Collaboration Program, discuss Licensed Compounds and agree upon Licensed Products in the contents of the Dev Go Data Package [***]Field; (hvii) discuss review and approve clinical study design, including clinical study endpoints, clinical methodology and monitoring requirements for the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Clinical Studies included in the Global Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research and discovery and other JRC related 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 5.4Plan; and (nviii) 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 as agreed in writing by the Parties.

Appears in 1 contract

Sources: License Agreement (Celgene Corp /De/)

Specific Responsibilities. The JRC shall develop In addition to its overall responsibility for monitoring and providing strategic oversight with respect to the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particularParties’ activities under this Agreement, the JRC shallJSC will in particular: (a) serve as a discussion forum in relation review, discuss, and determine whether to potential Modulator Targets and Antigen Targets for inclusion as potential Collaboration Targets (including respective Substitute Targets, if any) during any period when approve the Parties have not elected to appoint a Gatekeeperupdated Transition Plan; (b) periodically (no less often than [***]) review and serve as a forum for discussing the Discovery Research Plan for each Collaboration Targetreview, discuss, and review determine whether to approve the Development Plan, the planned PMF network, and approve any the Commercialization Plan, and all amendments theretothereto (but, for clarity, not including the terms of the Co-promotion Agreement); (c) oversee the conduct review and progress of the Discovery Research Activities (including the need for potential amendments discuss any material revisions to the LSR Go and Dev Go CriteriaDevelopment Milestone Achievement Dates proposed by GEHC in accordance with Section 4.2.2 (Amendments to the Development Plan), and discuss and agree upon any activities to be allocated for measure performance by Genentech (if any)against the then-current Development Milestone Achievement Dates; (d) monitor the achievement of (i) the Hit Success Criteria determining POP Achievement, (ii) the LSR Go Criteria, (iii) the Dev Go Criteria, discuss and (iv) the Targeting Arm Criteriaprovide input regarding when to initiate or discontinue any Clinical Trial under each Development Plan; provided that nothing is intended to limit a Party’s ability to comply with Applicable Law or manage subject safety; (e) monitor discuss the completion of the activities and the generation of the data required to be included requirements for Regulatory Approval and, where applicable, Pricing Approval, in the LSR Go Data Package Core Markets and review and determine overall regulatory strategy with respect to the Dev Go Data Package, as applicable Licensed Product in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]Field; (f) prior to review and discuss the commencement Development, Manufacture, and Commercialization of the Lead Generation Phase for a Collaboration ProgramLicensed Product in the Field, discuss including measuring performance against, and agree upon compliance with, the contents of the LSR Go Data Package [***]then-current Development Plan and Commercialization Plan; (g) prior facilitate the flow of information between the Parties with respect to the commencement Development and Commercialization of the Lead Validation Phase for a Collaboration Program, discuss and agree upon Licensed Product in the contents of the Dev Go Data Package [***]Field; (h) discuss discuss, on *** basis, any *** (as applicable) during the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2previous ***; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activitiesattempt to resolve issues presented to it by either Party relating to this Agreement, and disputes within any other subcommittee; (j) extend establish additional Committees and restructure existing Committees as it deems necessary to achieve the Research Term as provided in Section 2.4.2; (k) establish secure access methods (such as secure databases) for each Party to access research objectives and discovery and other JRC related information and Know-How as contemplated under intent of 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 (nk) perform such other functions as are set forth herein or appropriate, and direct each other Committee to perform such other functions as appropriate, to further the Parties may mutually agree in writing, except where in conflict with any provision purposes of this Agreement, in each case, as agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration and License Agreement (Lantheus Holdings, Inc.)

Specific Responsibilities. The JRC Subject to the oversight of the JSC, the JDC shall develop the strategies be responsible for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum overseeing Development strategy for the coordination of such activities. In particularProduct globally under the Collaboration Agreement and this Agreement, including the JRC shallfollowing: (a) serve as a discussion forum in relation to potential Modulator Targets overseeing the development of goals and Antigen Targets strategy for inclusion as potential Collaboration Targets the Development of the Product (including respective Substitute Targets, if anyregulatory strategies and prioritization of Clinical Trials and indications for the Product) during any period when for review and approval by the Parties have not elected to appoint a GatekeeperJSC; (b) periodically overseeing the preparation of annual updates to, and other amendments of, the Global Development Plan for approval by the JSC; (no less often than [***]c) overseeing the development of goals and strategy for Drug Regulatory Approval Applications for review and serve approval by the JSC; (d) preparing the Core Data Sheet pursuant to Section 7.1.6(b) and submitting draft to the JSC for approval; (e) monitoring compliance with the then-current budget included in the Global Development Plan on a continuing basis; (f) reviewing, coordinating and monitoring the activities and progress of the Parties in implementing the Development activities in the Global Development Plan; (g) facilitating the flow of information with respect to the Development of the Product and coordinate with other Committees, as a forum appropriate; (h) overseeing the preparation of recommendations to the JSC for discussing further Development of the Discovery Research Plan Product, including Development for each Collaboration Targetnew indications that are not in the then current Global Development Plan; (i) overseeing the conduct of Clinical Trials (including Required Phase IV Studies), including approval of the final version of all Clinical Trial protocols and review and approve any material amendments thereto; (cj) oversee the conduct and progress of the Discovery Research Activities (including the need for potential amendments subject to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any); (d) monitor the achievement terms 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 this Agreement and the generation Approved Plans, recommending allocation of the data required to be included in the LSR Go Data Package responsibilities for Development activities between Agensys and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]; (f) prior SGI to the commencement of the Lead Generation Phase JSC for a Collaboration Program, discuss and agree upon the contents of the LSR Go Data Package [***]; (g) prior to the commencement of the Lead Validation Phase for a Collaboration Program, discuss and agree upon the contents of the Dev Go Data Package [***]; (h) discuss the scope of any modifications or improvements requested by Genentech to any Discovery Construct or Development Candidate pursuant to Section 5.2; (i) serve as a forum for discussion of results from the conduct of the Discovery Research Activities; (j) extend the Research Term as provided in Section 2.4.2approval; (k) establish secure access methods (such as secure databases) overseeing the forecasting of quantities of Product required for each Party to access research and discovery and other JRC related information and Know-How as contemplated under this AgreementClinical Trials for incorporation into the Global Manufacturing Plan; (l) monitor providing Quarterly updates on the JDC’s activities and implement achievements to the transfer of CMC materials to Genentech, whether pursuant to Section 5.3 or Section 5.4;JSC; and (m) monitor and implement the technology transfer to Genentech pursuant to Section 5.4; and (n) perform performing such other functions as the JSC may request from time to time or are set forth herein or as expressly assigned to the Parties may mutually agree JDC in writing, except where in conflict with any provision of this Agreement.

Appears in 1 contract

Sources: Joint Commercialization Agreement (Seattle Genetics Inc /Wa)

Specific Responsibilities. The JRC shall develop the strategies for and oversee the Discovery Research Activities in accordance with the applicable Discovery Research Plan for each Collaboration Program, and shall serve as a forum for the coordination of such activities. In particular, the JRC JCC shall: (a) serve as a discussion forum oversee and coordinate the on-going transfer, in relation accordance with the terms of this Agreement, from Infinity to potential Modulator Targets AbbVie of Infinity Know-How, and Antigen Targets for inclusion as potential Collaboration Targets (including respective Substitute Targetsfrom AbbVie to Infinity of AbbVie Know-How, if any) during any period when related to the Parties have not elected to appoint a GatekeeperCommercialization of Licensed Compounds and Products so that each Party may undertake Commercialization of Licensed Compounds and Products in accordance with the Commercialization Plans and this Agreement; (b) periodically (no less often than [***]) review and serve as a forum for discussing oversee the Discovery Research Plan for each Collaboration TargetManufacturing Working Group to ensure that Manufacturing Plans, and review and approve any amendments theretorelated budget information, are incorporated into the applicable Commercialization Plans; (c) oversee develop and update, on an annual basis, Manufacturing Plans for inclusion in the conduct and progress Commercialization Plans to ensure a reliable commercial supply of the Discovery Research Activities (including Licensed Compound and Products in the need for potential amendments to the LSR Go and Dev Go Criteria), and discuss and agree upon any activities to be allocated for performance by Genentech (if any)Territory; (d) monitor coordinate with 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 CriteriaJDC with respect to regulatory matters; (e) monitor coordinate with the completion of the activities and the generation of the data required JDC with respect to be included in the LSR Go Data Package and the Dev Go Data Package, as applicable in order to confirm whether all components of the LSR Go Data Package and the Dev Go Data Package, as applicable, are complete [***]pharmacovigilance matters; (f) prior develop and present to the commencement of JSC for approval the Lead Generation Phase for a Collaboration Program, discuss Global Branding Strategy and agree upon updates to such Global Branding Strategy during the contents of the LSR Go Data Package [***]Term as necessary; (g) prior review and present to the commencement JSC for approval the initial US Commercialization Plan, including the US Commercialization Budget therein and the allocation of Commercialization activities between the Lead Validation Phase 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 a Collaboration Programreview and approval proposed updates and amendments to such US Commercialization Plan, discuss and agree upon including the contents of the Dev Go Data Package [***]US Commercialization Budget included therein; (h) discuss review and comment on the scope of initial or updated (as applicable) Ex-US Commercialization Plan, and any modifications or improvements requested by Genentech material amendments to any Discovery Construct or Development Candidate pursuant such Ex-US Commercialization Plans, and submit such plans to Section 5.2the JSC for review and approval; (i) serve as a forum for discussion of results from coordinate the conduct activities of the Discovery Research ActivitiesParties 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) extend review each Party’s Commercialization activities in the Research Term as provided US and AbbVie’s Commercialization activities in Section 2.4.2the Ex-US Territory, including a review of actual financial results versus budget or plan; (k) establish secure access methods (such 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 databases) for each Party to access research and discovery and other JRC related information and Know-How as contemplated under this Agreementapplicable; (l) monitor review and implement comment upon amendments and updates to the transfer of CMC materials to Genentech, whether pursuant to Global Publication Strategy developed and presented by the JMAC in accordance with Section 5.3 or Section 5.49.4.1; (m) monitor oversee the Manufacturing Working Group, Co-Promotion Working Group and implement any other Working Group that reports to the technology transfer to Genentech pursuant to Section 5.4JCC; (n) review and approve terms for Co-Promotion of Product in the United States for inclusion in the US Commercialization Plan; (o) review and update, on an annual basis, pricing, discounting and reimbursement decisions for inclusion in the US Commercialization Plan; and (np) 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

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