We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

Common use of Role Clause in Contracts

Role. The SCC shall have the responsibility of coordinating and overseeing the conduct of each Study (and other related activities set forth in the applicable Study Plan, including regulatory activities) and shall enable the exchange of information between the Parties. In particular, the SCC is empowered to: (i) serve as a forum for discussing Study activities; (ii) review and approve the initial Study Plan for each Study and any amendments to the applicable Study Plan; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iii) review and approve the applicable Protocol for each Study and any amendments thereto; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iv) serve as a forum for discussing strategies to obtain Regulatory Approvals necessary to conduct the applicable Study and for coordinating all regulatory activities (including communications with Regulatory Authorities) for the applicable Study; (v) serve as a forum for discussing strategies for any diagnostic product to be included in the applicable Study (including the selection of any Third Party to develop or provide any such diagnostic product for the applicable Study); (vi) serve as a forum for discussing matters relating to supply and Manufacturing, including Forecasts, specifications, Delivery and Non-Conformances; (vii) establish and oversee joint sub-teams agreed by the Parties to oversee particular projects or activities within the purview of the SCC; and (viii) perform such other functions as are set forth herein, or as the Parties may mutually agree in writing.

Appears in 3 contracts

Samples: Supply and Non Exclusive License Agreement (MAIA Biotechnology, Inc.), Supply and Non Exclusive License Agreement (MAIA Biotechnology, Inc.), Supply and Non Exclusive License Agreement (MAIA Biotechnology, Inc.)

Role. The SCC JSC shall have the responsibility of coordinating and overseeing the conduct of each Study (and other related activities set forth in the applicable Study Plan, including regulatory activities) and shall enable the exchange of information between the Parties. In particular, the SCC is empowered to: (i) serve as provide a forum for discussing Study activities; the discussion of the Parties’ activities under this Agreement; (ii) review and approve discuss the initial Study Plan overall strategy for each Study the Development and any amendments to Commercialization of Licensed Products in the applicable Study PlanField in the Territory; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iii) review and discuss the initial Territory Development Plan and review, discuss, and approve the applicable Protocol for each Study and any amendments theretothereto in accordance with Section 5.4; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iv) serve as a forum for discussing strategies review and discuss any material amendments to obtain Regulatory Approvals necessary the Global Development Plan that are related to conduct the applicable Study and for coordinating all regulatory activities (including communications Territory in accordance with Regulatory Authorities) for the applicable Study; Section 5.3(c); (v) serve as a forum review, discuss, and approve the Commercialization Plan and amendments thereto including the reimbursement price for discussing strategies for any diagnostic product to be included the Licensed Product in the applicable Study (including the selection of any Third Party to develop or provide any such diagnostic product for the applicable Study); Territory; (vi) serve as a forum for discussing matters relating to supply and Manufacturing, including Forecasts, specifications, Delivery and Non-Conformances; (vii) establish and oversee joint sub-teams agreed by the Parties JDC as necessary or advisable to oversee particular projects further the purpose of this Agreement; (vii) discuss potential implications of Zai’s decision to file and hold Regulatory Submissions, Regulatory Approvals and any pricing or activities within reimbursement approvals, as applicable, for Licensed Products in the purview of the SCCTerritory in its own name; and (viii) discuss and approve clinical supply arrangements; (ix) review and discuss annually a charitable care THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 15 strategy (covering compassionate sales or use, or an indigent program) for the Licensed Products in the Field in the Territory; and (x) perform such other functions as are expressly set forth herein, in this Agreement or as allocated to the Parties may mutually agree in writingJSC by the Parties’ written agreement.

Appears in 1 contract

Samples: License and Collaboration Agreement (Zai Lab LTD)

Role. The SCC JSC shall have the responsibility of coordinating and overseeing the conduct of each Study (and other related activities set forth in the applicable Study Plan, including regulatory activities) and shall enable the exchange of information between the Parties. In particular, the SCC is empowered to: (i) serve as provide a forum for discussing Study activities; the discussion of the Parties’ activities under this Agreement; (ii) review and approve discuss the initial Study Plan overall strategy for each Study the Development and any amendments to Commercialization of Licensed Products in the applicable Study PlanField in the Territory; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iii) review and discuss the initial Territory Development Plan and review, discuss, and approve the applicable Protocol for each Study and any amendments theretothereto in accordance with Section 5.4; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iv) serve as a forum for discussing strategies review and discuss any material amendments to obtain Regulatory Approvals necessary the Global Development Plan that are related to conduct the applicable Study and for coordinating all regulatory activities (including communications Territory in accordance with Regulatory Authorities) for the applicable Study; Section 5.3(c); (v) serve as a forum review, discuss, and approve the Commercialization Plan and amendments thereto including the reimbursement price for discussing strategies for any diagnostic product to be included the Licensed Product in the applicable Study (including the selection of any Third Party to develop or provide any such diagnostic product for the applicable Study); Territory; (vi) serve as a forum for discussing matters relating to supply and Manufacturing, including Forecasts, specifications, Delivery and Non-Conformances; (vii) establish and oversee joint sub-teams agreed by the Parties JDC as necessary or advisable to oversee particular projects further the purpose of this Agreement; (vii) discuss potential implications of Zai’s decision to file and hold Regulatory Submissions, Regulatory Approvals and any pricing or activities within reimbursement approvals, as applicable, for Licensed Products in the purview of the SCCTerritory in its own name; and (viii) discuss and approve clinical supply arrangements; (ix) review and discuss annually a charitable care CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. 15 strategy (covering compassionate sales or use, or an indigent program) for the Licensed Products in the Field in the Territory; and (x) perform such other functions as are expressly set forth herein, in this Agreement or as allocated to the Parties may mutually agree in writingJSC by the Parties’ written agreement.

Appears in 1 contract

Samples: License and Collaboration Agreement (Zai Lab LTD)

Role. The SCC JSC shall have the responsibility of coordinating and overseeing the conduct of each Study (and other related activities set forth in the applicable Study Plan, including regulatory activities) and shall enable the exchange of information between the Parties. In particular, the SCC is empowered to: (i) serve as provide a forum for discussing Study activities; the discussion of the Parties’ activities under this Agreement; (ii) review and approve discuss the initial Study Plan overall strategy for each Study the Development and any amendments to Commercialization of Licensed Products in the applicable Study PlanField in the Territory; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iii) review and discuss the initial Territory Development Plan and review, discuss, and approve the applicable Protocol for each Study and any amendments theretothereto in accordance with Section 5.4; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iv) serve as a forum for discussing strategies review and discuss any material amendments to obtain Regulatory Approvals necessary the Global Development Plan that are related to conduct the applicable Study and for coordinating all regulatory activities (including communications Territory in accordance with Regulatory Authorities) for the applicable Study; Section 5.3(c); (v) serve as a forum review, discuss, and approve the Commercialization Plan and amendments thereto including the reimbursement price for discussing strategies for any diagnostic product to be included the Licensed Product in the applicable Study (including the selection of any Third Party to develop or provide any such diagnostic product for the applicable Study); Territory; (vi) serve as a forum for discussing matters relating to supply and Manufacturing, including Forecasts, specifications, Delivery and Non-Conformances; (vii) establish and oversee joint sub-teams agreed by the Parties JDC as necessary or advisable to oversee particular projects further the purpose of this Agreement; (vii) discuss potential implications of Zai’s decision to file and hold Regulatory Submissions, Regulatory Approvals and any pricing or activities within reimbursement approvals, as applicable, for Licensed Products in the purview of the SCCTerritory in its own name; and (viii) discuss and approve clinical supply arrangements; (ix) review and discuss annually a charitable care strategy (covering compassionate sales or use, or an indigent program) for the Licensed Products in the Field in the Territory; and (x) perform such other functions as are expressly set forth herein, in this Agreement or as allocated to the Parties may mutually agree in writingJSC by the Parties’ written agreement.

Appears in 1 contract

Samples: License and Collaboration Agreement (NovoCure LTD)

Role. The SCC JSC shall have the responsibility of coordinating and overseeing the conduct of each Study (and other related activities set forth in the applicable Study Plan, including regulatory activities) and shall enable the exchange of information between the Parties. In particular, the SCC is empowered to: (i) serve as provide a forum for discussing Study activities; the discussion of the Parties’ activities under this Agreement; (ii) review and discuss the overall strategy for the Development and Commercialization of the Licensed Product in the Field in the Territory; (iii) review, discuss and approve the initial Study Development Plan for each Study and amendments thereto; (iv) review and discuss the Commercialization Plan and amendments thereto; (v) consider information provided by Licensor with respect to any amendments to the applicable Study Plan; for clarity, Regeneron’s approval shall only be required for decisions issue relating to the Combination or Manufacturing and supply to Licensee of the Regeneron Product; (iii) review and approve the applicable Protocol for each Study and any amendments thereto; for clarity, Regeneron’s approval shall only be required for decisions relating to the Combination or the Regeneron Product; (iv) serve as a forum for discussing strategies to obtain Regulatory Approvals necessary to conduct the applicable Study and for coordinating all regulatory activities (including communications with Regulatory Authorities) Licensed Compound and/or Licensed Product for the applicable Study; (v) serve as a forum for discussing strategies for any diagnostic product to be included in the applicable Study (including the selection of any Third Party to develop or provide any such diagnostic product for the applicable Study); Territory; (vi) serve as a forum for discussing matters discuss any issue relating to Manufacturing of the Licensed Compound and/or Licensed Product that may impact the ability of Licensor to Manufacture or supply and Manufacturing, including Forecasts, specifications, Delivery and Non-Conformances; the Licensed Compound and/or Licensed Product for the Territory in accordance with the Supply Agreement; (vii) establish on at least an annual basis, discuss the proposed Development activities that each Party is considering undertaking during the next year; (viii) discuss and oversee joint sub-teams agreed by consider any clinical study that either Party may be considering undertaking or that they are undertaking and that may occur both inside and outside the Parties to oversee particular projects or activities within the purview Territory, including, but not limited to, considering which Party will be responsible for such clinical study and appropriate sharing of the SCCcosts of such study; and (viiiix) consider regulatory issues and medical affairs that relate to the Licensed Product both inside and outside the Territory; (x) establish joint subcommittees (such as Development subcommittee and Commercialization subcommittee) as necessary or advisable to further the purpose of this Agreement; (xi) consider any request from Licensee to undertake Improvements as further set out in Section 3.3; and (xii) perform such other functions as are expressly set forth herein, in this Agreement or as allocated to it by the Parties may mutually agree in writingParties’ written agreement.

Appears in 1 contract

Samples: License Agreement (PhaseBio Pharmaceuticals Inc)