Responsibilities of BMS Sample Clauses

Responsibilities of BMS. Subject to the activities performed by FivePrime in support of the Research Program, BMS shall have the sole right and responsibility for the development, regulatory approval, manufacturing and commercialization of Licensed Compound(s) and Product(s) in the Field and the Territory, including decision-making authority and all funding for such activities. Without limiting the foregoing, BMS shall be responsible, at its sole cost and expense, for (i) all GMP manufacturing activities for clinical and commercial supply, with FivePrime providing technical support relating to the FivePrime Know-How as agreed in the Research Plan, (ii) all necessary IND-enabling studies for the Licensed Compounds and Products; and (iii) all clinical development and commercialization of Licensed Compounds and Products.
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Responsibilities of BMS. (a) Except as may be provided for in Section 6 of this Agreement, BMS shall be solely responsible for the costs and expenses of its sales force and conducting its other activities under this Agreement. (b) BMS shall have the sole authority to determine the price of the Product sold by BMS or ASCENT, including price increases or decreases and the timing thereof as determined by BMS. (c) BMS shall have the sole responsibility, at its cost and expense, for Product manufacture, shipping, distribution and warehousing, for the invoicing and billing of purchasers of the Product, for order confirmation (if any) in accordance with BMS customary practices, and for the collection of receivables resulting from Net Sales. BMS will book all sales of the Product. All sales will be deemed made pursuant to contract between BMS and the customer. (d) BMS shall use ** , including maintaining reasonable levels of inventory in light of customary industry practice, to ensure that sufficient stock of the Product will be available in its inventory to fill orders from the trade in accordance with normal industry practices. BMS agrees that in the event that there is not sufficient stock of the Product, it will allocate supply of the Product on an equitable basis between the pediatric and non-pediatric markets. (e) BMS shall use ** to maintain all necessary authorizations with the FDA to market the Product in the Territory in commercial quantities. (f) Promptly following the execution of this Agreement, BMS shall furnish ASCENT with the names of Pediatricians prescribing the Product, if any, called on by BMS in the Territory during the immediately preceding 12-month period, that were not previously disclosed to ASCENT.
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Responsibilities of BMS. BMS shall be responsible for: (i) manufacturing and supplying sufficient GMP-grade quantities of BMS Compound, as further described in Article 4 above, and, where required, providing for the release by a Qualified Person (as such term will be defined in the Supply and Quality Documentation), or providing the necessary documentation in support of quality release, of the BMS Compound if such release is required for the Combined Therapy Study; (ii) cooperating with Checkmate to obtain all necessary approvals and clearances, including IRB approvals and customs clearances and to compile all necessary Combined Therapy Study Regulatory Documentation to be filed with Regulatory Authority(ies) for the Combined Therapy Study; (iii) reviewing the Protocol and Statistical Analysis Plan, and any amendments thereto, in accordance with Section 2.1(b) (with the Protocol and Statistical Analysis Plan, and any amendments thereto, to be approved in accordance with Section 2.1(b)); (iv) drafting and updating the Combined Therapy investigator’s brochure in accordance with Section 2.1(f), in the event that a new Combined Therapy investigator’s brochure is required by a Regulatory Authority for the Combined Therapy Study; (v) reviewing the template ICF and template Site Agreement, and any amendments thereto, in accordance with Section 2.1(d) (with the template ICF and template Site Agreement, and any amendments thereto, to be approved in accordance with Section 2.1(d)); (vi) providing feedback to Checkmate on the CRO/Study Site List in accordance with Section 2.1(c) (with such CRO/Study Site List to be approved by the JDC in accordance with Section 2.4(p)); (vii) to the extent necessary for the conduct of each particular Combined Therapy Study, providing a Right of Cross-Reference to the relevant Regulatory Documentation for the BMS Compound, provided that, except as provided in Section 3.2, such Right of Cross-Reference shall terminate upon the earlier of (A) the completion or termination of such Combined Therapy Study and (B) the expiration or termination of this Agreement, except that in the case of termination for a Material Safety Issue pursuant to Section 12.4(a), such Right of Cross-Reference shall remain in effect solely (1) to the extent necessary to permit Checkmate to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (2) as necessary to permit Checkmate to continue to dose subjects enrolled in the Combined Therapy Stud...
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Responsibilities of BMS. Subject to Section 10.1 and JDC direction and oversight as provided in Section 3.3(b), BMS shall be responsible for the following activities: (i) (A) Manufacturing the BMS Assets for use in the Collaboration Studies and Independent Studies, and, if applicable, providing for the release by a Qualified Person (as such term will be defined in the applicable Quality Agreement) or providing the necessary documentation in support of quality release, of the BMS Assets if such release is required for the Collaboration Studies and Independent Studies, (B) if applicable, packaging and Labelling Bulk Form Nektar Compound provided by Nektar to BMS for use in the Collaboration Studies and Independent Studies, and (C) for each Collaboration Study for which BMS is the Lead Party, providing the JDC (or a working team designated by the JDC) [***] with a clinical drug supply forecast for Nektar Assets, the BMS Assets and any Third Party Asset (such forecasts to include strategies for drug supply overages, drug supply quantities and required delivery dates); (ii) for each Collaboration Study for which BMS is the Lead Party, providing Nektar with reasonable advance notice of scheduled meetings or other material non-written communications with a Regulatory Authority and the opportunity to participate in each such meeting or other non-written communication, to the extent that it relates to the Monotherapy, Combined Therapy or a Nektar Asset and providing Nektar with the opportunity to review, provide comments to BMS within [***] on, and, if inconsistent with the applicable Protocol(s) or JDC guidance, approve all submissions and written correspondence with a Regulatory Authority that relates to the Monotherapy, Combined Therapy or Nektar Asset; provided, however, in no event shall BMS or any Affiliate of BMS initiate communications with or respond to any communications initiated by any Regulatory Authority solely with respect to a Nektar Asset without the prior written consent of the Nektar and provided further that Nektar, if requested, shall step out of any portions of such meetings or other non-written communications with a Regulatory Authority that relate solely to the use of a BMS Asset as a monotherapy; (iii) for each Collaboration Study for which BMS is the Lead Party, providing Nektar a written summary of meetings or a summary of other non-written communications with a Regulatory Authority within [***] of such meeting or communication, and copies of any official corresp...
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