Supply for Development Sample Clauses

Supply for Development. If requested by Licensee by written notice, Ipsen shall manufacture and supply, or cause to be manufactured and supplied, [ ]* in sufficient quantities to satisfy the reasonable requirements of Licensee and its Sublicensees and Contractors for use of such [ ]* in Development activities with respect to such Licensed Product until the end of [ ]* for such Licensed Product. Xxxxx’x supply of [ ]* to Licensee under this Section 8.1 shall be provided at Xxxxx’x Manufacturing Cost. Promptly following Licensee’s notice, the Parties shall enter into a clinical supply agreement and a technical agreement with respect to such clinical supplies (the “Clinical Supply Agreements”)(1). Xxxxx’x Manufacturing Cost will be agreed upon in the Clinical Supply Agreements (to reflect Xxxxx’x actual costs for manufacturing the [ ]* as well as a mechanism for adjusting such Manufacturing Cost in case of increase or decrease of any component of such Manufacturing Cost. The Clinical Supply Agreements will provide for the terms and conditions of the transfer of Xxxxx’x manufacturing technology at the end of [ ]*, provided, however, that the Parties agree that such transfer will be made at Licensee’s cost and expense, less an amount equal to the Xxxxx Manufacturing Transfer Cost, to be estimated and agreed by the parties in good faith. For the avoidance of doubt, in the event Licensee does not notify Ipsen with its request for the manufacturing by Ipsen of [ ]* pursuant to this Section 8.1, the transfer of manufacturing technology shall be made under the terms and conditions of Section 8.1. Ipsen shall not be obligated to manufacture any quantities of [ ]* pursuant to this Section 8.1 if and to the extent that such quantities will be used by Licensee or any of its Sublicensees or Contractors to make finished Licensed Product for use in [ ]*.
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Supply for Development. Amylin shall supply ACTII, without cost to ACTII, with sufficient quantities of Field Products for ACTII to conduct all the activities described in the Product Development Plan.
Supply for Development. As and to the extent requested by Xxxxxx, Xxxx shall manufacture and supply to Xxxxxx, in accordance with Section 3.1, Xxxx Products for purposes of developing and/or obtaining regulatory approval of the Xxxx Products or End Products (including for non-clinical and clinical studies) and other similar and related purposes at the Development Transfer Price, but not for commercial sale. Xxxxxx shall keep Xxxx reasonably informed of its anticipated requirements of Xxxx Products for such purposes, whether through the Project Manager meetings pursuant to Section 2.3 (if applicable), or otherwise. Xxxxxx may order Xxxx Products for the development-related purposes described above under this Section 3.2 from Xxxx by providing Xxxx with a binding purchase order indicating: (i) the quantities of Xxxx Product ordered (provided such quantities are consistent with the terms of this Agreement), (ii) the requested delivery date [****], and (iii) a delivery location. Upon receipt of any such conforming purchase order, Xxxx shall manufacture and supply Xxxx Product in accordance therewith. Any term in such purchase order that is inconsistent with this Agreement shall not be binding upon Xxxx; otherwise Xxxx shall send a confirmation to Xxxxxx within [****] of receiving any such conforming purchase order. “Development Transfer Price” means [****].
Supply for Development. If requested by Licensee by written notice, Ipsen shall manufacture and supply, or cause to be manufactured and supplied, [ ]* in sufficient quantities to satisfy the reasonable requirements of Licensee and its Sublicensees and Contractors for use of such [ ]* in Development activities with respect to such Licensed Product until the end of [ ]*. Xxxxx’x supply of [ ]* to Licensee under this Section 8.1 shall be provided at Xxxxx’x Manufacturing Cost. Promptly following Licensee’s notice, the Parties shall enter into a clinical supply agreement and a technical agreement with respect to such clinical supplies (the “Clinical Supply Agreements”)(1). Xxxxx’x Manufacturing Cost will
Supply for Development. At Adolor’s sole option, EpiCept shall be responsible to supply, or to obtain supply, for Adolor’s requirements in the Territory of Licensed Product for clinical and other development activities in accordance with Adolor’s obligations under this Agreement. Alternatively, Adolor, in its sole discretion, shall be entitled to supply and manufacture clinical supplies of Licensed Product in the Territory. The Parties acknowledge that Third Party subcontractors may be engaged by Adolor to carry out such manufacture and supply on Adolor’s behalf. Within sixty (60) days after the Effective Date, in the amounts and at a price per patch set forth on Schedule 3.10(a), EpiCept shall deliver to a location designated by Adolor LidoPAIN® SP Product 9.5% patches and LidoPAIN® SP Product placebo 0.0% patches that are stored at PharmaForm.
Supply for Development. CancerVax shall use Commercially Reasonable Efforts to supply the Parties with Product for use in the Development of the Product, as specified in the Development Plan, and for use in Phase IV Clinical Trials, and shall deliver Product requested by Serono as directed from time to time. The costs of such Product shall be calculated as the Cost of Goods. Serono shall pay CancerVax for all amounts of Product required by Serono pursuant to this Section 8.1, and CancerVax shall accrue the Cost of Goods of all amounts of Product required by CancerVax pursuant to this Section 8.1, and such payments and accruals shall be deemed a Development Expense or a Commercial Expense, as applicable.
Supply for Development. The Lead Development Party is entitled to either engage a Third Party to manufacture and supply such quantities of Collaboration Product as may be required for Development, or to manufacture and supply itself all or a portion of the Collaboration Product required for Development, but in any event shall do one of the foregoing so that the Collaboration Product is supplied. If Nuvelo manufactures, the Collaboration Product shall be supplied at [*] of Manufacturing Costs. If a Third Party manufactures, then the Collaboration Product shall be supplied at [*] of the price charged by the Third Party, and the time spent by Nuvelo FTEs to manage the Third Party supplier shall be excluded from the calculation of Manufacturing Costs, Development Costs and Allowable Commercialization Expenses. Manufacturing Costs for Development (with the [*]) are incorporated into Development Costs to the full extent provided in the Financial Appendix.
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Related to Supply for Development

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • 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.

  • Joint Development All inventions, know-how, trade secrets, data or information which result from joint development by the Parties hereto shall be jointly owned by the Parties. The Parties hereby agree to cooperate in good faith in the filing of any and all patent applications in all jurisdictions.

  • 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.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

  • Product Development SB shall have responsibility for, and control of, the development and commercialization of each Product arising from this Agreement, including process development, delivery system and formulation development, preclinical studies, clinical studies, sales and marketing.

  • Research and Development (i) Advice and assistance in relation to research and development of Party B;

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