Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the 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 amended. (ii) review and 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 the [ * ]; (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 discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (xiv) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: License and Collaboration Agreement (Rigel Pharmaceuticals Inc)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum strategic oversight with respect to discuss AZ’s the Parties’ activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s the collaborative activities of the Parties under this Agreement relating to Products comprising Rigel Compounds, including Agreement; (ii) review and discuss the development, Manufacture Development and Commercialization of Products and any other ongoing activities; (iii) determine whether to initiate a pivotal Clinical Trial with respect to either the Products [*] 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 Field best interest of the Product with the goal of maintaining the [*] agreed upon in the TerritoryJoint Development Plan for [*]); (v) review and discuss reports from the JDC, JMC, JMAC and JCC and provide guidance thereto, direct the activities of such committees, and, except in the case of the Initial Joint Development Plan and the initial Joint Manufacturing Plan, approve each Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto; [ * [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (iivi) review and comment on the Development Plan discuss strategies for obtaining, maintaining, defending and amendments thereto, including reviewing enforcing patent 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 the [ * ]; (iv) discuss the requirements trademark protection for Marketing Approval of Products in within the Territory; (vvii) facilitate the flow of Information between the Parties with respect attempt to the development ofresolve issues presented to it by, and obtaining Marketing Approval for disputes within, 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 JDC, JMC, JMAC, JCC, 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 15.13any other subcommittee; (viii) discuss determine whether the conduct and agree oversight of a Voluntary Phase 4 Clinical Trial should be undertaken by the reimbursement JDC instead of any costs and expenses between the Parties at the FTE Rate as further described in hereinJMAC; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (xivx) perform such other functions as appropriate appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement Agreement, in each case as allocated to it agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration Agreement (Medivation, Inc.)

Specific Responsibilities. In addition particular, the DWG shall: (a) oversee and coordinate the on-going sharing and transfer of Know-How generated in or related to its overall responsibility the Development of Licensed Products; (b) oversee the implementation of the GDP for monitoring each Licensed Product for the Development of such Licensed Product; (c) review and providing update the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and 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) provide a forum for the Parties to review and discuss AZ’s activities under this Agreementregulatory matters as provided in Section 4.4; (h) 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 JSC shall in particular:same with respect the Existing Product or any Co-Promote Product; (i) review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (j) review the design and protocol of and oversee AZ’s activities under this Agreement relating performance of GLP toxicology studies or other studies to Products comprising Rigel Compounds, including the development, Manufacture and Commercialization support IND filing of the Licensed Products in the Field in Field, and approve the Territory; [ * ] = Certain confidential same with respect the Existing Product or any Co-Promote Product; (k) discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information contained in this document, marked by brackets, has been omitted needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and filed separately which may be necessary for compliance with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.applicable regulatory pharmacovigilance requirements; (iil) review and 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 the [ * ]; (iv) discuss the requirements for Marketing Approval of Products in the Territory; (v) facilitate the flow of Information between the Parties with respect submit to the development of, and obtaining Marketing Approval JSC 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 approval any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this AgreementNew Product Proposal; and (xivm) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as allocated to it agreed in writing by the Parties.

Appears in 1 contract

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

Specific Responsibilities. In addition to its overall responsibility for monitoring particular, the JDC shall: (a) oversee and providing a forum to discuss AZ’s activities under coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the JSC shall Development of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in particular:accordance with the GDP and this Agreement; (ib) coordinate the activities of the Parties under the GDP and oversee AZ’s activities under this Agreement relating the implementation of the GDP; (c) to the extent necessary, share planning and 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 Medical Affairs Activities of Products comprising Rigel Compoundsin the Field, including as applicable; (d) develop and update, on an annual basis, the development, Manufacture and Commercialization of proposed global regulatory strategy for the Products in the Field in the Territory; [ * ] = Certain confidential information contained , and include such proposed strategy in the GDP, for approval by the JSC in accordance with this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (ii) review and 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 PlanAgreement; (iiie) approve any change in on an annual basis, update the GDP, including the Development Plan that would [ * ]Budget and the allocation of Development responsibilities between the Parties and present to the JSC for approval proposed amendments to the GDP, or [ * ]including the Development Budget, of the [ * ]in accordance with Section 4.1.5; (ivf) discuss develop and update, on an annual basis, for inclusion in the requirements GDP, the CMC Development plans and the Manufacturing Plans for Marketing Approval the pre-clinical and clinical supply of the Licensed Compound and 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; (xiig) review and discuss AZ’s scientific presentation and publication strategy comment on Regulatory Filings relating to the Products in the Territory, and review and facilitate discussion of any requests Field in relation to Publications pursuant to accordance with Section 12.44.4; (xiiih) establish such additional joint subcommittees as it deems necessary review and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to achieve time in accordance with Section 9.4.1; (i) oversee the objectives Regulatory Working Group, the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and intent any other Working Groups that reports to the JDC; (j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or plan; and (xivk) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as allocated to it agreed in writing by the Parties.

Appears in 1 contract

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

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the 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 amended.; (ii) review and 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 the [ * ];of (iv) discuss the requirements for Marketing Approval of Products in the Territory;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 further described in Section 15.13; (viii) discuss and agree the reimbursement of any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (xiv) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: License and Collaboration Agreement

Specific Responsibilities. In addition to its overall responsibility for monitoring particular, the JMAC shall: (a) oversee and providing a forum to discuss AZ’s activities under coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the Medical Affairs Activities with respect to the Licensed Compounds and Products so that each Party may undertake Medical Affairs Activities of Licensed Compounds and Products in accordance with the Medical Affairs Plan and this Agreement; (b) prepare and present to the JSC shall for approval the initial Medical Affairs Plan (with input from the JDC and JCC), including the Medical Affairs Budget therein, and the allocation of responsibilities between the Parties and, as appropriate, prepare and present to the JSC for review and approval proposed interim and annual updates and amendments to such Medical Affairs Plan, including the Medical Affairs Budget; (c) review, approve and manage all Investigator Sponsored Clinical Studies and ensure adherence to the Parties’ corporate policies and all federal/state regulations; (d) coordinate the activities of the Parties under the Medical Affairs Plan and oversee the implementation of the Medical Affairs Plan; (e) prepare and approve the Global Publication Strategy (with input from the JDC and JCC) and any amendments thereto; (f) prepare a MSL Deployment Plan for each of the United States, each Major Market Country and certain other territories or regions in particular:the Territory in accordance with the Medical Affairs Plan; (g) coordinate Congresses, scientific symposia, and scientific advisory boards; (h) develop scientific and medical education communication platforms; (i) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the development, Manufacture provide a forum for 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 amended. (ii) review and 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 the [ * ]; (iv) discuss the requirements for Marketing Approval of Products in the Territory; (v) facilitate the flow of Information communications between the Parties with respect to the development of, and obtaining Marketing Approval Medical Affairs Activities for the Licensed Compound and Products; (vij) review meet promptly following its formation to discuss Infinity’s ongoing Medical Affairs Activities with respect to the results of Phase 3 Clinical Trials of Products; (vii) review AZ’s proposed timing for announcing Product and the top line results of each of the Major Three RA Trials following the unblinding continuation of such trial results; for activities until such time as the avoidance of doubt AZ shall notify Rigel either directly or via JMAC establishes 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 initial Medical Affairs Plan; (xk) review strategies for obtaining, maintaining oversee the IST/IIS Working Group and enforcing patent protection for any other Working Group that reports to the Products within the Territory consistent with Article 9 hereinJMAC; (xil) review each Party’s Medical Affairs Activities under the Commercialization Medical Affairs Plan to be prepared by AZ; (xii) including review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreementactual financial results versus budget or plan; and (xivm) perform such other functions as may be appropriate to further the purposes of this Agreement as allocated with respect to it in writing by the PartiesMedical Affairs activities for the Licensed Compound and Products.

Appears in 1 contract

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

Specific Responsibilities. In addition Subject to its overall responsibility the oversight of the JSC, the JDC shall be responsible for monitoring overseeing Development strategy for the Product globally under the Collaboration Agreement and providing a forum to discuss AZ’s activities under this Agreement, including the JSC shall in particularfollowing: (ia) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including overseeing the development, Manufacture development of goals and Commercialization strategy for the Development of the Products Product (including regulatory strategies and prioritization of Clinical Trials and indications for the Product) for review and approval by the JSC; (b) overseeing the preparation of annual updates to, and other amendments of, the Global Development Plan for approval by the JSC; (c) overseeing the development of goals and strategy for Drug Regulatory Approval Applications for review and 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 Field 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 Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (ii) review and 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 Global Development Plan; (iiig) approve any change in the Development Plan that would [ * ], or [ * ], of the [ * ]; (iv) discuss the requirements for Marketing Approval of Products in the Territory; (v) facilitate facilitating the flow of Information between the Parties information with respect to the development ofDevelopment of the Product and coordinate with other Committees, and obtaining Marketing Approval for the Productsas appropriate; (vih) review overseeing the results preparation of Phase 3 Clinical Trials of Products; (vii) review AZ’s proposed timing recommendations to the JSC for announcing the top line results of each further Development of the Major Three RA Trials following Product, including Development for new indications that are not in 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 then current Global Development Plan; (xi) review strategies for obtainingoverseeing the conduct of Clinical Trials (including Required Phase IV Studies), maintaining including approval of the final version of all Clinical Trial protocols and enforcing patent protection for the Products within the Territory consistent with Article 9 hereinany material amendments thereto; (xij) review subject to the Commercialization Plan terms of this Agreement and the Approved Plans, recommending allocation of responsibilities for Development activities between Agensys and SGI to be prepared by AZthe JSC for approval; (xiik) review and discuss AZ’s scientific presentation and publication strategy relating to overseeing the Products in forecasting of quantities of Product required for Clinical Trials for incorporation into the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4Global Manufacturing Plan; (xiiil) establish such additional joint subcommittees as it deems necessary providing Quarterly updates on the JDC’s activities and achievements to achieve the objectives and intent of this AgreementJSC; and (xivm) perform performing such other functions as appropriate the JSC may request from time to further time or are expressly assigned to the purposes of JDC in this Agreement as allocated to it in writing by the PartiesAgreement.

Appears in 1 contract

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

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum strategic oversight with respect to discuss AZ’s the Parties’ activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s the collaborative activities of the Parties under this Agreement relating to Products comprising Rigel Compounds, including Agreement; (ii) review and discuss the development, Manufacture Development and Commercialization of Products and any other ongoing activities; (iii) determine whether to initiate a pivotal Clinical Trial with respect to either the Products [*] 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 Field best interest of the Product with the goal of maintaining the [*] agreed upon in the Joint Development Plan for [*]); (v) review and discuss reports from the JDC, JMC, JMAC and JCC and provide guidance thereto, direct the activities of such committees, and, except in the case of the Initial Joint Development Plan and the initial Joint Manufacturing Plan, approve each Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan and Joint Commercialization Plan and, in the case of all plans, amendments thereto; (vi) review and discuss strategies for obtaining, maintaining, defending and enforcing patent and trademark protection for Products within the 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 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities securities and Exchange Commission exchange commission pursuant to Rule rule 24b-2 of the Securities Exchange Act securities exchange act of 1934, as amended. (ii) review and 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 the [ * ]; (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 discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (xiv) perform such other functions as appropriate appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement Agreement, in each case as allocated to it agreed in writing by the Parties.

Appears in 1 contract

Sources: Collaboration Agreement (Medivation, Inc.)

Specific Responsibilities. In addition Subject to its overall responsibility the oversight of the JSC, the JDC shall be responsible for monitoring and providing a forum to discuss AZ’s activities overseeing Development strategy for the Product globally under this Agreement. The JDC’s responsibilities shall include the following: (a) overseeing the preparation of annual updates and other amendments to the Global Development Plan (including the budget therefor) for approval by the JSC; (b) subject to Section 8.1.6(a), reviewing and approving a form of Core Data Sheet and submitting a draft thereof to the JSC shall for its approval pursuant to Section 2.2.3; (c) monitoring compliance with the then-current budget included in particular: the Global Development Plan; (id) oversee AZreviewing, coordinating and monitoring the activities and progress of the Parties in implementing the Development activities contemplated by the Global Development Plan; (e) monitoring the activities of its Working Groups, including the JMAT, JRT and CDS Working Group in accordance the terms of this Agreement (provided, for clarity, that despite the JDC’s activities global role with respect to Development, its role with respect to the JMAT and Medical Affairs Activities will be limited to the JMAT’s responsibilities under this Agreement relating with respect to Products comprising Rigel Compoundsthe Major Markets); (f) in consultation with the JRT, recommending to the JSC whether and when to submit a DAA, including a BLA, for the development, Manufacture and Commercialization of the Products in the Field Product anywhere in the Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (iig) review and 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 the [ * ]; (iv) discuss the requirements for Marketing Approval of Products in the Territory; (v) facilitate facilitating the flow of Information information with respect to the Development of the Product and coordinating such information flow with other Committees, as appropriate; (h) overseeing the strategic planning and conduct of Clinical Trials consistent with the allocation of sponsorship and responsibility for Clinical Trials set forth in Section 4.6.2; provided, that the JDC shall coordinate with the JMAT with respect to the JDC’s strategic planning and conduct of Phase III-B Studies and Phase IV Studies; (i) making forecasts of Clinical Supply requirements for Development of the Product and reviewing the supply of Product; (j) making recommendations for further Development of the Product, including Development for new indications that are not in the then current Global Development Plan; (k) providing Quarterly updates on the JDC’s activities to the JSC; (l) establishing and implementing a responsibility assignment matrix consistent with this Agreement to define the roles and responsibilities 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 discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this AgreementDevelopment activities; and (xiv) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: Joint Commercialization Agreement (Seagen Inc.)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s and coordinate the Parties’ activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s the collaborative activities of the Parties under this Agreement relating to Products comprising Rigel CompoundsAgreement, including create and review the developmentoverall strategy for Developing and seeking Regulatory Approval for, Manufacture Manufacturing, and Commercialization of the Products Commercializing Collaboration 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 amended.; (ii) review receive and comment on discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any 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 the [ * ]; (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 discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to specific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the manufacturing plan [*] 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 (xivxii) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

Specific Responsibilities. In addition Subject to its overall responsibility for monitoring and providing a forum to discuss AZ’s activities under this Agreementthe oversight of the JEC [*], the JSC shall JCC shall, in particular, be responsible for the following, in each case with respect to the Collaboration Compounds and/or Products, as applicable: (i) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including reviewing and recommending for approval by the development, Manufacture and Commercialization of the Products in the Field in JEC the Territory-wide Commercial strategy for the Collaboration Compounds and Products; [ * [*] = Certain Portions of this exhibit have been omitted pursuant to a confidential information contained in treatment request. An unredacted version of this document, marked by brackets, exhibit has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amendedCommission. (ii) review reviewing, with input from the CFDT and comment on the Development Plan Regional Operating Committees, as appropriate, and amendments theretoapproving Territory-wide Product positioning, including reviewing messaging, branding and commenting on the overall strategy and design of all human clinical trials and other studies conducted under the Development Planreimbursement strategies; (iii) approve any change in with input from the Development Plan that would [ * ]CFDT or the Regional Operating Committees, as appropriate, reviewing and recommending (under guidelines developed by the Parties’ counsel), for approval by the JEC, a range of suggested prices and discount strategies for a Product, for use Territory-wide, or [ * ]where appropriate, of the [ * ]; (iv) discuss the requirements for Marketing Approval of Products in a Region and/or in country in the Territory; (iv) subject to Section 3.7, with input from the CFDT, and in consultation with the JDC, making recommendations to the JEC concerning whether to seek new indications, formulations or uses for the Collaboration Compounds and Products in the Territory, such as for Product life cycle management; (v) facilitate reviewing and recommending for approval by the flow of Information between the Parties with respect to the development of, and obtaining Marketing Approval for the ProductsJEC Territory-wide marketing budgets; (vi) review approving, following consideration of the results recommendations of Phase 3 Clinical Trials of Productsthe CFDT and after consultation with the SCC, packaging designs and Product Trademarks for use in the Territory; (vii) review AZ’s proposed timing to the extent referred to the JCC by the CFDT or the applicable ROC, reviewing each Long-Term Commercialization Plan and each Annual Commercialization Plan and Budget for announcing consistency with strategies and guidance adopted in clauses (i), (ii), (iii) and (vi) of this Section 2.4(b) and presenting to the top line results of each of JEC for resolution any inconsistencies noted that cannot be resolved by discussion with 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 15.13applicable ROC; (viii) discuss and agree performing such other duties as are expressly assigned to the reimbursement of any costs and expenses between the Parties at the FTE Rate as further described JCC in hereinthis Agreement; (ix) discuss and agree any amendments performing such other functions as the JEC may request from time to the Transition Plan;time; and (x) review strategies for obtaining, maintaining providing Quarterly updates on the JCC’s activities and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating achievements to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; and (xiv) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the PartiesJEC.

Appears in 1 contract

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

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s activities under this Agreementparticular, the JSC JDC shall in particularbe responsible for the following activities with respect to the Product: (ia) oversee AZ’s overseeing the development of, and reviewing and revising, if applicable, the GT Operational Plan (and related GT Operational Budget) and Territory Development Plan (and any updates to any of the foregoing) for the Product in the Field in the Territory for final approval by the JSC; (b) reviewing and overseeing activities under this Agreement relating to Products comprising Rigel Compounds, including the development, Manufacture and Commercialization of Development Plans for the Products Product in the Field in the Territory; [ * ] = Certain confidential information contained ; (c) overseeing clinical and regulatory matters relating to the Product in this documentthe Field in the Territory arising from the Development Plans (including interactions with Regulatory Authorities), marked by bracketsand reviewing and approving protocols (including amendments thereto), has been omitted statistical analysis plans, clinical trial plans (in terms of designs, endpoints, scales, sample sizes, study cohorts, doses and filed separately with the Securities duration), clinical methodology and Exchange Commission pursuant to Rule 24b-2 monitoring requirements for all clinical trials, including post-marketing non-approval trials, of the Securities Exchange Act of 1934, Product in the Field in the Territory as amended. (ii) review and 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 contemplated under the Development PlanPlans; (iiid) approve reviewing and approving ZLAB’s support of any change investigator initiated study for the Product in the Development Plan that would [ * ], or [ * ], of the [ * ]; (iv) discuss the requirements for Marketing Approval of Products Field in the Territory; (ve) facilitate reviewing the flow progress of, and results and data from, ongoing clinical trials under the Development Plans, including ongoing enrollment and budgetary issues and ongoing safety, both protocol-specific and across the Development Plans; provided that Regeneron shall not be required to provide any Proprietary Manufacturing Information to the JDC or ZLAB; (f) reviewing the progress of, and results and data from, Global Trials conducted by or on behalf of Information between Regeneron in the Parties Territory or ROW; provided that with respect to any such Global Trial […***…]; (g) with respect to any Global Trial conducted by or on behalf of ZLAB in the 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 “Global Trial Requirements”); (h) with respect to any Global Trial conducted by or on 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) reviewing and discussing the GTC Budgets provided by Regeneron pursuant to Section 5.3.2(b); (j) […***…]; (k) […***…]; (l) evaluating for Development, Manufacturing and Commercialization in the 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 the development ofApproved Product, in each case ((i), (ii) and obtaining Marketing Approval for (iii)), that a Party may propose from time to time and presenting the Productssame to the JSC; (vim) review overseeing, monitoring and coordinating the results submission of Phase 3 Clinical Trials of Products; (vii) review AZ’s proposed timing for announcing Registration Filings in the top line results of each of the Major Three RA Trials following the unblinding of such trial results; for the avoidance of doubt AZ shall notify Rigel either directly or via the JSC of its decision to unblind clinical data in whichever of the Three Major RA Trials shall be the first to report clinical data as further described in Section 15.13; (viii) discuss and agree the reimbursement of any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products Field in the Territory, including reviewing and review coordinating material communications, filings and facilitate discussion of any requests correspondence with Regulatory Authorities in relation to Publications pursuant to Section 12.4the Territory in connection with the Product in the Field; provided that […***…] or […***…] or […***…]; (xiiin) establish such additional joint subcommittees as it deems necessary developing and proposing to achieve the objectives 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 Regeneron’s Development of the Product in the Territory, discussing the timing and intent nature of this AgreementRegeneron’s and ZLAB’s communications with Regulatory Authorities and key opinion leaders in the Territory regarding the Product; and (xivq) perform considering and acting on such other functions matters as appropriate specifically assigned to further the purposes of JDC under this Agreement as allocated to it in writing or by the PartiesJSC.

Appears in 1 contract

Sources: Collaboration Agreement (Zai Lab LTD)

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s and coordinate the Parties’ activities under this Agreement, the JSC shall in particular: (i) oversee AZ’s the collaborative activities of the Parties under this Agreement relating to Products comprising Rigel CompoundsAgreement, including create and review the developmentoverall strategy for Developing and seeking Regulatory Approval for, Manufacture Manufacturing, and Commercialization of the Products Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (iiv) review and comment approve decisions to terminate Development on the Development Plan and amendments theretoany Collaboration Product, including reviewing and commenting on the overall strategy and design of all human clinical trials and other studies conducted under the Development Planwith respect to specific indications; (iiivi) 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 change 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 Plan Costs or Commercialization Costs or any component thereof, and (B) any costs incurred by a Party that would [ * ], or [ * ], 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 [ * ]; (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 obtainingand approve any changes to the specific responsibilities of the JDC, maintaining the JCC, the JFC, and enforcing patent protection for the Products within the Territory consistent with Article 9 hereinJPC; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review discuss and discuss AZ’s scientific presentation and publication strategy relating make determinations regarding material safety issues with respect to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this AgreementCollaboration Product; and (xivxii) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties.

Appears in 1 contract

Sources: Collaboration and License Agreement (Facet Biotech Corp)

Specific Responsibilities. The JCC shall oversee and coordinate the Commercialization of CNS Compounds and CNS Products in the Territory. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s activities under this Agreementparticular, the JSC shall in particularJCC shall: (i) 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 amended. (iia) review and comment on finalize the Development Co-Commercialization Plan and Co‑Commercialization Budget, and material amendments thereto, including reviewing any updates to such plan or budget in accordance with Section ‎5.3.3 (Amendments and commenting on the overall strategy and design of all human clinical trials and other studies conducted under the Development PlanUpdates); (iiib) approve any change discuss, review and finalize reasonably in the Development Plan that would [ * ], or [ * ], advance of the [ * ]first Regulatory Approval for the first CNS Product, and annually thereafter, a non-binding [***] estimated sales forecast for the CNS Products; (ivc) discuss with respect to any CNS Product(s) and countries within the requirements Co‑Commercialization Territory with respect to which Denali has exercised the Co‑Commercialization Option, prepare and approve, the Parties’ strategies related to field-based medical education activities by either Party and grant-based medical education programs for Marketing Approval of such CNS Product(s) in each such country; (d) monitor the competitive landscape for CNS Products in the Territory; (ve) facilitate discuss, review and finalize the flow of Information between the Parties 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 development of, and obtaining Marketing Approval for the Co-Commercialization Territory; (f) discuss pricing of CNS Products; (vig) review and approve the results Detail position for CNS Products in the conduct of Phase 3 Clinical Trials of ProductsCo-Commercialization Activities; (viih) review AZ’s proposed timing implement a process for announcing the top line results of reviewing and approving (i) Promotional Materials and (ii) training materials and programs for sales representatives, in each of the Major Three RA Trials following the unblinding of such trial results; case (i) and (ii), that are intended for the avoidance of doubt AZ shall notify Rigel either directly or via the JSC of its decision to unblind clinical data use with Co-Commercialization Products 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 applicable Co-Commercialization Countries 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 extent to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreementwhich Denali has exercised its Co‑Commercialization Option; and (xivi) perform such other functions as appropriate to further the purposes of are set forth in this Agreement as allocated to it the function of the JCC or as the Parties may otherwise mutually agree in writing by the Partieswriting.

Appears in 1 contract

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

Specific Responsibilities. In addition to its overall responsibility for monitoring and providing a forum to discuss AZ’s the activities under this Agreement, the JSC shall in particular: (ia) oversee AZ’s activities under this Agreement relating review and approve annual updates and amendments to Products comprising Rigel Compoundsthe GDP, including the development, Manufacture global regulatory strategy (and Commercialization of the Products amendments and updates thereto) included in the Field in GDP and presented by the Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.JDC; (iib) review and comment on discuss, as necessary, the Development performance of each Party, or a Party’s Affiliate or Sublicensee, as applicable, in performing the activities under the GDP, the Medical Affairs Plan and amendments theretoor the Commercialization Plans, including reviewing actual financial results versus budget or plan, compliance with applicable Laws and commenting on any agreed-upon standards for conduct of such activities and progress of the overall strategy and design of all human clinical trials and other studies conducted under the Development PlanClinical Studies then on-going; (iiic) review and approve the initial US Commercialization Plan, including the initial US Commercialization Budget, and any change amendments and updates to such US Commercialization Plan and US Commercialization Budget, in each case presented to the Development Plan that would [ * ], or [ * ], of JSC by the [ * ]JCC; (ivd) discuss review and approve the requirements for Marketing Approval of Products initial Ex-US Commercialization Plan and any amendments and updates thereto, in each case presented to the TerritoryJSC by the JCC; (ve) facilitate review and approve the flow of Information between initial Medical Affairs Plan, including the Parties with respect initial Medical Affairs Budget, and any amendments and updates thereto, in each case presented to the development of, and obtaining Marketing Approval for JSC by the ProductsJMAC; (vif) review and approve the results of Phase 3 Clinical Trials of ProductsGlobal Branding Strategy, and any amendments and updates thereto, presented by the JCC; (viig) review AZ’s proposed timing for announcing oversee the top line results of each of Finance Working Group and any other Working Groups that reports into 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 15.13JSC; (viiih) discuss and agree attempt to resolve disputes within the reimbursement of JDC, the JCC, the JMAC, the Finance Working Group or any costs and expenses between the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments other Working Group that reports to the Transition Plan; (x) review strategies for obtaining, maintaining and enforcing patent protection for the Products within the Territory consistent with Article 9 herein; (xi) review the Commercialization Plan to be prepared by AZ; (xii) review and discuss AZ’s scientific presentation and publication strategy relating to the Products in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this AgreementJSC; and (xivi) perform such other functions as are assigned to it in this Agreement or as appropriate to further the purposes of this Agreement as allocated to it the extent agreed to in writing by the Parties.

Appears in 1 contract

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

Specific Responsibilities. In addition to its overall responsibility for monitoring particular, the JCC shall: (a) oversee and providing a forum to discuss AZ’s activities under coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the JSC shall in particular: (i) oversee AZ’s activities under this Agreement relating to Products comprising Rigel Compounds, including the development, Manufacture and Commercialization of the Licensed Compounds and Products so that each Party may undertake Commercialization of Licensed Compounds and Products in the Field in the Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately accordance with the Securities Commercialization Plans and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (ii) review and 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 Planthis Agreement; (iiib) approve any change in oversee the Development Plan Manufacturing Working Group to ensure that would [ * ]Manufacturing Plans, or [ * ]and related budget information, of are incorporated into the [ * ]applicable Commercialization Plans; (ivc) discuss develop and update, on an annual basis, Manufacturing Plans for inclusion in the requirements for Marketing Approval Commercialization Plans to ensure a reliable commercial supply of the Licensed Compound and Products in the Territory; (vd) facilitate coordinate with the flow 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) review and present to the JSC for approval the initial US Commercialization Plan, including the US Commercialization Budget therein and the allocation of Information 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 ofDevelopment, Manufacture and obtaining Marketing Approval for Commercialization of Products and Medical Affairs Activities in the ProductsField in the US, as applicable; (vil) review and comment upon amendments and updates to the results of Phase 3 Clinical Trials of ProductsGlobal Publication Strategy developed and presented by the JMAC in accordance with Section 9.4.1; (viim) review AZ’s proposed timing for announcing oversee the top line results of each of Manufacturing Working Group, Co-Promotion Working Group and any other Working Group that reports to 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 15.13JCC; (viiin) discuss review and agree approve terms for Co-Promotion of Product in the reimbursement of any costs and expenses between United States for inclusion in the Parties at the FTE Rate as further described in herein; (ix) discuss and agree any amendments to the Transition US Commercialization 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; (xiio) review and discuss AZ’s scientific presentation update, on an annual basis, pricing, discounting and publication strategy relating to the Products reimbursement decisions for inclusion in the Territory, and review and facilitate discussion of any requests in relation to Publications pursuant to Section 12.4; (xiii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this AgreementUS Commercialization Plan; and (xivp) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as allocated to it the extent agreed in writing by the Parties.

Appears in 1 contract

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