Manufacture and Supply by OPKO Sample Clauses

Manufacture and Supply by OPKO. Within [***] days following the Effective Date, OPKO and Licensee shall negotiate in good faith the terms of a supply agreement (the “Supply Agreement”) and related quality agreement (the “Quality Agreement”) pursuant to which OPKO shall supply to Licensee, directly or through a Third Party, Product in either, at Licensee’s option, finished and packaged form (“Finished Product”), or unlabeled, bulk capsule form (“Bulk Product”) to support the development, sale and commercialization of the Product in the Licensee Territory. The Supply Agreement shall provide that the clinical supply of Finished Product, along with placebo, will be supplied to Licensee at [***] and the commercial supply of Finished Product or Bulk Product (at Licensee’s option) will be supplied to Licensee at [***], with the understanding that the estimated supply price after the [***] for Finished Product as of the Effective Date is [***] and Bulk Product [***].
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Manufacture and Supply by OPKO. Upon Licensee’s request, OPKO and Licensee shall negotiate in good faith the terms of a supply agreement (the “Supply Agreement”) and related quality agreement (the “Quality Agreement”) pursuant to which OPKO shall supply to Licensee, directly or through a Third Party, Product in bulk capsule form (“Bulk Product”) to support the development, sale and commercialization of the Product in the Field in the License Territory. For clarity, Licensee shall be responsible for packaging the Product to meet any requirements under Applicable Law in the License Territory. In addition, OPKO shall supply reasonable quantities of Compound required by Licensee for [***] and pre-clinical or non-clinical development of the Product permitted under this Agreement. Notwithstanding the foregoing to the contrary, OPKO shall have no obligation to enter into a Supply Agreement with Licensee with respect to the supply of Product in a dosage form or formulation that is different than the dosage form or formulation that OPKO is manufacturing or has manufactured for the use of OPKO, its Affiliates and Sublicensees in the OPKO Territory; provided, however that, upon Licensee’s request, OPKO and Licensee shall discuss in good faith OPKO or its Affiliates providing the Product with modifications necessary or useful for the development and commercialization of the Product in the Field in the License Territory. The clinical supply of Bulk Product and Compound for Research, pre-clinical or non-clinical work will be supplied to Licensee at [***] and the commercial supply of Bulk Product will be supplied to Licensee at [***]. Certain terms to be included in the Supply Agreement are set forth in Schedule 10.2 attached hereto and the Supply Agreement shall contain such other terms customary and reasonable for an agreement of such type.

Related to Manufacture and Supply by OPKO

  • 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.

  • Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • 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 TheraSense shall be responsible for the ------------------ manufacture of FreeStyle Products for sale to Nipro.

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • 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.

  • License Agreement The Trust shall have the non-exclusive right to use the name "Invesco" to designate any current or future series of shares only so long as Invesco Advisers, Inc. serves as investment manager or adviser to the Trust with respect to such series of shares.

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