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.
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.
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.
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 [***]. [***].
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.
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 

Related to MANUFACTURE AND SUPPLY OF CAPTISOL

  • Manufacture and Supply Subject to the terms and conditions of this Agreement, Collaboration Products shall be manufactured and supplied for preclinical and clinical testing and for commercial sale upon the following terms and conditions:

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  • 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.

  • 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.

  • Supply of Product Salix shall use reasonable efforts to supply the Product during the Co-Promotion Period in sufficient quantities to satisfy the levels of Product sales forecasted in the then current Marketing Plan. Salix shall maintain reasonable inventory levels of the Product in order to ensure their ability to fulfill this obligation. Salix shall have the sole responsibility and right to fill orders with respect to the Product. Altana shall not solicit orders for the Product but, if for any reason, Altana shall receive an order for the Product, Altana shall promptly forward to Salix any such orders. All orders for Product shall be subject to acceptance by Salix, in its sole discretion, which acceptance shall not be unreasonably withheld. Salix may cancel any order for Product at any time after acceptance without incurring any liability to Altana. Salix shall be solely responsible for responding to requests from Target Physicians for individual patients who need the Product but are unable to afford it. Any such request shall be forwarded by Altana to Salix for processing. Salix shall have the sole right and responsibility for establishing and modifying the terms and conditions of the sale of the Product, including (a) the price at which the Product will be sold, (b) whether the Product will be subject to trade or quantity discounts, (c) whether any discount will be provided for payments on accounts receivable, (d) whether the Product will be subject to rebates, returns and allowances or retroactive price reductions, (e) the channels of distribution of the Product, and (f) whether credit [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. is to be granted or refused in connection with any sale of Product. In the event that Salix fails to supply the Product as required pursuant to this Agreement for any reason other than a Force Majeure, which such failure results in lost sales for Altana, the Parties shall meet and attempt to negotiate a mutually agreeable and commercially reasonable solution. If the Parties cannot reach such an agreement within a reasonable period of time, the issue will be dealt with as contemplated under Section 4.4 of this Agreement.

  • 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 Manufacturing Rights will be governed by Attachment 6.

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