BMS Compound Sample Clauses

BMS Compound. (a) Manufacture and Supply. BMS shall use Commercially Reasonable Efforts to Manufacture or have Manufactured the BMS Compound in drug substance and/or drug product form (as necessary) in reasonable quantities, within minimum lead times and at the points in time as agreed by the JDC for each Combined Therapy Trial, and shall supply such BMS Compound in unmarked vials to Nektar or its designee for use in the Combined Therapy Trials. All BMS Compound supplied to Nektar shall have sufficient expiration dates to complete the Combined Therapy Trial. Nektar or a Third Party conducting activities on behalf of Nektar will package, label and distribute the BMS Compound for use in the Combined Therapy Trials, with associated costs and expenses (and any related taxes) of such activities to be split between the Parties in accordance with Sections 7.2 and 7.3. The cost of Manufacture, supply and distribution (including shipping, taxes and duty, if applicable) of the BMS Compound to Nektar shall be borne solely by BMS, and BMS shall bear the risk of loss for the BMS Compound at all times during the Term; except that Nektar shall bear the risk of loss of the BMS Compound to the extent that the loss arises or results from the gross negligence or intentional misconduct of Nektar or of any Third Party conducting packaging, labeling or distribution activities on behalf of Nektar. BMS shall also be responsible for the payment of any Third Party License Payments that may be due to Ono or to others exclusively on the supply of BMS Compound hereunder for the Combined Therapy Trials. The BMS Compound shall be Manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Compound used by BMS for its other clinical trials of the BMS Compound. BMS shall deliver to Nektar certificates of analysis, and any other documents specified in the Quality Agreement, including such documentation as is necessary to allow Nektar to compare the BMS Compound certificate of analysis to the BMS Compound specifications. The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Compound in connection with this Agreement. BMS will provide Nektar with country-specific customs valuations for the BMS Compound, which Nektar must use for deliveries to each country. Nektar must request these valuations at least [***] prior to each shipment...
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BMS Compound. (a) Manufacture and Supply. BMS shall Manufacture or have Manufactured the BMS Compound and supply, or cause to be supplied, the BMS Compound for the conduct of the Combined Therapy Study. The cost of Manufacture and supply of the BMS Compound shall be borne solely by BMS. BMS shall bear the risk of loss for the BMS Compound, except that in the case where the Company is the Sponsoring Party, BMS shall bear the risk of loss for the BMS Compound until delivery to the Company, or its designee, in accordance with the delivery terms set forth in the applicable Supply and Quality Documentation, and risk of loss for such BMS Compound shall then transfer from BMS to the Company upon such delivery. The BMS Compound shall be Manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Compound used by BMS for its other clinical trials of the BMS Compound. BMS shall deliver to the Company certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Company to compare the BMS Compound certificate of analysis to the BMS Compound specifications. The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Compound in connection with this Agreement, provided that in any event BMS may utilize its established supply chain for the supply of BMS Compound.
BMS Compound. (a) Manufacture and Supply. BMS shall use Commercially Reasonable Efforts to Manufacture or have Manufactured the BMS Compound in drug substance and/or drug product form (as necessary) in reasonable quantities and at the points in time as agreed by the JDC for the performance of the Development Plan or as necessary for Permitted Clinical/Preclinical Research conducted by Five Prime, and shall supply such BMS Compound in unmarked vials to Five Prime or its designee for use in the Combined Therapy Trials or such Permitted Clinical/Preclinical Research. Five Prime will package and label the BMS Compound for use in the Combined Therapy Trials or such Permitted Clinical/Preclinical Research, subject to Section 4.2(b). The cost of Manufacture and supply (including shipping, insurance, taxes and duty, if applicable) of the BMS Compound shall be borne solely by BMS. BMS shall bear the risk of loss for the BMS Compound until delivery of the BMS Compound to Five Prime or its designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due to Ono or to others exclusively on the supply of BMS Compound hereunder for the performance of the Development Plan or Five Prime’s performance of Permitted Clinical/Preclinical Research. The BMS Compound shall be Manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Compound used by BMS for its other clinical trials of the BMS Compound. BMS shall deliver certificates of analysis, and any other documents specified in the Quality Agreement, including such documentation as is necessary to allow Five Prime to compare the BMS Compound certificate of analysis to the BMS Compound specifications. The Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Compound in connection with this Agreement. BMS will provide Five Prime with country-specific customs valuations for the BMS Compound, which Five Prime must use for deliveries to each country. Five Prime must request these valuations at least *** prior to each shipment through the BMS’s clinical supply organization.
BMS Compound 

Related to BMS Compound

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Combination Product The term “

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Product The term “

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

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