Supply of Bulk Drug Substance Clause Samples

Supply of Bulk Drug Substance. Until such time as Servier may establish a second source of Bulk Drug Substance as contemplated in Section 6.7, Servier, its Affiliates and sublicensees shall purchase exclusively from XOMA, and XOMA shall Manufacture and supply exclusively to Servier or its Affiliates or sublicensees, subject to the terms of this Article 6, and to the terms of the Supply Agreement (as defined below), all Bulk Drug Substance required by Servier, its Affiliates and sublicensees for Development use and for Commercial use.
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Supply of Bulk Drug Substance. ▇▇▇▇▇▇▇ shall, and shall require its Affiliates and Sublicensees to, purchase from Biogen Idec their respective requirements for Bulk Drug Substance in connection with the development and commercialization of Existing Product, unless and until a Trigger Event has occurred.
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Supply of Bulk Drug Substance. (a) The Parties acknowledge that they have entered into the Supply Agreement, pursuant to which Solvay agrees to supply to Cadence, and Cadence agrees to purchase from Solvay, Bulk Drug Substance pursuant to the terms and conditions set forth therein. (b) The Parties agree that, in consideration for the development of the Licensed Process, the associated expenses borne, and investments made by Solvay, Cadence recognizes Solvay as its primary supplier for Bulk Drug Substance and, except as otherwise provided in Section 5.1 of the Supply Agreement or in Clause 9.3(d) of this Agreement, Cadence shall order from Solvay a minimum of ##### (#####) of the Aggregate Annual Requirement. For the avoidance of doubt, the Parties hereto agree that nothing in this Agreement or in the Supply Agreement is intended to limit or restrict, in any manner, the rights of Cadence, its Affiliates and Sublicensees, to make, have made, purchase, use, import, export, market or sell any quantity of Omiganan Drug Substance that is made by any means other than by the Licensed Process.
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Supply of Bulk Drug Substance. (a) Mitsubishi agrees to supply Triangle with those quantities of Bulk Drug Substance necessary for Triangle to perform the Development Program free of charge, not to exceed ***. Such obligation shall include all preclinical studies and Phase I, II and III clinical trials under the Development Program. In the event *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Triangle requires quantities of Bulk Drug Substance in excess of the quantity specified above in order to perform the Development Program and demonstrates the need for such additional quantities to the reasonable satisfaction of Mitsubishi, Mitsubishi agrees to give due consideration to Triangle's request for such additional quantities; provided, however, that the cost of such additional quantities shall be divided equally between Mitsubishi and Triangle. (b) The delivery schedule for all Bulk Drug Substance shall be determined from time to time by mutual agreement of the parties. All Bulk Drug Substance supplied pursuant to this Section 2.6 shall (i) be manufactured in accordance with Current Good Manufacturing Practices as promulgated by the FDA, (ii) be suitable for use in formulating Finished Drug Product, and (iii) meet specifications, determined in accordance with applicable analytical methodology, to be mutually agreed upon in good faith by the parties hereto as promptly as practicable after the Effective Date. In the event of any failure by Mitsubishi in supplying the Bulk Drug Substance conforming to such requirements, Mitsubishi's sole obligation to Triangle shall be promptly to replace the defective quantities with conforming Bulk Drug Substance. In no event will Mitsubishi be liable to Triangle for any damage or losses on account of such failure. (c) During the Development Program, Mitsubishi shall also provide Triangle, free of charge, with those quantities of (i) analytical reference materials and (ii) all impurities and degradation products to the extent they are available to Mitsubishi which are measured when performing the analytical methodology for the Bulk Drug Substance and the Licensed Product and which are required by Triangle to conduct the analytical work necessary to obtain Registration of the Licensed Product in each country of the Territory. (d) Mitsubishi shall allow, and shall cause its subcontractors to allow, Triangle employees and/or consultants and FDA and other regulatory personn...
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Supply of Bulk Drug Substance. MGI agrees to supply, upon and subject to the terms and conditions set forth in this Agreement and during the term hereof, all requirements of Dainippon for Bulk Drug Substance for sale in the Territory.
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Supply of Bulk Drug Substance. Immunex shall supply Bulk Drug Substance to Wyeth from the RI Site, and Wyeth shall supply Bulk Drug Substance to Immunex from the BIOS Site, subject to the terms and conditions of this Agreement and the Quality Agreement. All Bulk Drug Substance supplied by Immunex or Wyeth hereunder shall conform to the provisions of the Quality Agreement, including, without limitation, the Specifications for such Bulk Drug Substance set forth in the Quality Agreement.
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Related to Supply of Bulk Drug Substance

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • 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.

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service ▇▇▇▇, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

  • 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.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.