MANUFACTURE AND SUPPLY OF CAPTISOL Sample Clauses

MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement and any related quality agreement shall govern the manufacture and supply of Captisol for use in the formulation of the Licensed Product.
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MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement and any related quality agreement shall govern the manufacture and supply of Captisol for use in the formulation of the Licensed Product or Probe Study Product, and nothing in the Supply Agreement (including Section 2.2 thereof) shall limit Sage’s right to use Probe Study Product in accordance with the terms of this Agreement.
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MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement and any related quality agreement shall govern the manufacture and supply of Captisol for use in the formulation of the Licensed Product. LICENSE AGREEMENT PAGE 6 *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
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MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement and any related Quality Agreement shall govern the manufacture and supply of Captisol® sulfobutylether ß(beta) cyclodextrin, sodium salt for use in the preparation, formulation and production of the Licensed Products. Company acknowledges and agrees that CyDex is the exclusive manufacturer of Captisol for Company and its Affiliates and Sublicensees and nothing set forth herein shall be deemed to grant Company or its Affiliates or Sublicensees the right to manufacture Captisol nor the right to contract the manufacture of Captisol to a Third Party. It is understood that it shall be Company’s responsibility to obtain, at Company’s sole expense and from sources other than CyDex, all materials (including all quantities of the Compound, but excluding Captisol) needed by Company for its activities in connection with this Agreement and in connection with manufacturing Licensed Products - it being further understood, of course, that Company is to obtain at Company’s sole expense and solely from CyDex (pursuant to the Supply Agreement) all Captisol needed by Company in connection with developing and manufacturing Licensed Products.
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MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement and any related Quality Agreement shall govern the manufacture and supply of Captisol for use in the formulation of the Licensed Product. Company acknowledges and agrees that, pursuant to the Supply Agreement, CyDex is the exclusive manufacturer of Captisol for Company and its Affiliates and Sublicensees and nothing set forth herein shall be deemed to grant Company or its Affiliates or Sublicensees the right to manufacture Captisol nor the right to contract the manufacture of Captisol to a third party [***]. CyDex shall have the right to change the Specifications from time to time during the Term; [***]. CyDex shall provide Company with [***] prior written notice of any proposed change to the Specifications and provide Company with an opportunity to evaluate whether [***]. Lilly shall have the right to discontinue using/purchasing CyDex’s Captisol at any time for any reason at its sole discretion [***].
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MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement shall govern the manufacture and supply of Captisol® sulfobutylether b (beta) cyclodextrin, sodium salt for use in Company’s (and its Affiliates’ and their Sublicensees’) preparation, formulation and production of the Licensed Products, both before and after Marketing Approval (the “Licensed Products Related Uses”). Company acknowledges and agrees that CyDex is, during the term of the Supply Agreement, the exclusive manufacturer of sulfobutylether b (beta) cyclodextrin, sodium salt for Company and its Affiliates and Sublicensees for the aforementioned Licensed Products Related Uses. Nothing set forth herein shall be deemed to grant Company or its Affiliates or Sublicensees the right to manufacture Captisol nor the right to contract the manufacture of Captisol to a Third Party, except pursuant to any express provisions of the Supply Agreement. It is understood that it shall be Company’s and its Affiliates’ responsibility to obtain, at Company’s and its Affiliates’ sole expense and from sources other than CyDex, all materials (including all quantities of the Compound, but excluding sulfobutylether b (beta) cyclodextrin, sodium salt) needed by Company and its Affiliates for the Licensed Products Related Uses — it being further understood, of course, that Company is to obtain at Company’s sole expense and solely from CyDex (pursuant to the Supply Agreement) all sulfobutylether b (beta) cyclodextrin, sodium salt needed by Company and its Affiliates and Sublicensees for the Licensed Products Related Uses. It is of the essence that the only Captisol used in or for any Licensed Product shall be Captisol supplied by CyDex under the Supply Agreement or previously supplied by CyDex under the July 2014 Agreement, and Company hereby covenants and agrees that Company and its Affiliates and Sublicensees shall not use in or for any Licensed Product any other Captisol other than Captisol® and further covenants and agrees that Company and its Affiliates and Sublicensees shall not use in or for any Licensed Product any Captisol® obtained other than directly from CyDex under the Supply Agreement or previously under the July 2014 Agreement.
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MANUFACTURE AND SUPPLY OF CAPTISOL. The provisions of the Supply Agreement and any related Quality Agreement shall govern the manufacture and supply of Captisol for use in the formulation of the Licensed Products. Company acknowledges and agrees that, pursuant to the Supply Agreement, CyDex is the exclusive manufacturer of Captisol for Company and its Affiliates and Sublicensees and nothing set forth herein shall be deemed to grant Company or its Affiliates or Sublicensees the right to manufacture Captisol nor the right to contract the manufacture of Captisol to a Third Party except as provided in Section 3.8(d) of the Supply Agreement.
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MANUFACTURE AND SUPPLY OF CAPTISOL 
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Related to MANUFACTURE AND SUPPLY OF CAPTISOL

  • Manufacture and Supply BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, *CONFIDENTIAL TREATMENT REQUESTED. supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, 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 Study Drug in connection with this Agreement.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements.

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Supply of Products During the term of this Agreement and any extension hereof, the Seller shall sell and supply the products as set out in Schedule 1 hereto (“Products”) to SiPM and SiPM shall buy from the Seller such Products on a non-exclusive basis. The specifications of the Products are set out in Schedule 2 hereto. SUPPLY AGREEMENT - SiPM A Supply Agreement is a document between two parties, a Supplier and a Purchaser. The Supplier can be an individual or business and is the party that " supplies," or sells, the goods to the Purchaser. The Purchaser can also be an individual or a business and is the party that purchases for its use the goods that the Supplier provides.

  • Supply of Product 3.1 In accordance with the terms of this Agreement, GENSIA SICOR (through SICOR) shall supply all of PURCHASER'S ordered requirements for Product in bulk form for use by PURCHASER in the Territories in accordance with the provisions of this Agreement. The right and license of PURCHASER to obtain, use and distribute Product (including, without limitation, the right to make or have made Product) from GENSIA SICOR and SICOR shall be (i) non-exclusive in the Non-exclusive Territory, and (ii exclusive in the Exclusive Territory; provided, however, that the rights and licenses set forth in clause (ii) above shall be co-exclusive in each jurisdiction in which GENSIA SICOR (or ALCO or SICOR, as the case may be) has binding written agreements, or binding written commitments that will lead to binding written agreements, to sell Product on the Restatement Date (which is limited to only those [ * ] and the [ * ] with whom GENSIA SICOR has commitments that are in existence on the Restatement Date), but only with respect to such third parties and only until the earlier of expiration or termination of such agreements; and provided, further that GENSIA SICOR shall use all diligent efforts (without any obligation to violate or alter the terms of such agreements existing on the Restatement Date) to provide PURCHASER with exclusive rights and licenses to sell the Products in the Territory as soon as possible. All Product hereunder shall be manufactured at SICOR's GMP facilities at Rho, Italy, the facility identified in Exhibit 9 hereto, the Santxx Xxxility and additional (as necessary and as provided in Section 6 below) GMP qualified facilities that are approved in advance by PURCHASER (which approval will not be unreasonably withheld). In addition, all Product shall be manufactured (A) in accordance with drug substance manufacturing and quality control procedures existing on the Effective Date, which drug substance manufacturing and quality control procedures have been included in manufacturer's Abbreviated Antibiotic Drug Application ("AADA") submitted to the FDA in 1996, and that will be submitted to other Regulatory Authorities in the Territory (which AADA shall include at least the elements set forth in the Drug Master File) in accordance with U.S. FDA current Good Manufacturing Practices, and (B) to the Q/C Specifications. GENSIA SICOR shall cause SICOR to use its diligent efforts to [ * ] in order to produce and supply all Product ordered by Purchaser hereunder and to meet the Product [ * ] that will be set forth in Schedule 1 hereto within [ * ] after the Restatement Date. In addition, GENSIA SICOR agrees to the following (and GENSIA SICOR agrees to cause SICOR to undertake):

  • 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.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Manufacturing Rights (a) If Tesla fails to supply Product ordered by ViewRay in accordance with the Section 3.3, in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then Tesla shall use Commercially Reasonable Efforts to remedy the problem or secure an alternative source of supply within [***] at no cost to ViewRay, and any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If Tesla is unable to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then Tesla shall consult with ViewRay and the parties shall work together to remedy the problem. If Tesla is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to Tesla, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b).

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

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