Manufacturing and Technical Assistance Sample Clauses

Manufacturing and Technical Assistance. (a) Provided that Roche uses good faith efforts in order to assist BioCryst in fulfilling its obligations hereunder, BioCryst shall: (1) during the first twenty-four (24) months after the Effective Date supply (in accordance with the guidelines set forth on Exhibit 6.3(a)(1)) at its own cost all Compound required to be used for Development of Licensed Product in the Field; provided, however, that notwithstanding anything to the contrary contained in Exhibit 6.3(a)(1), BioCryst shall not be obligated to provide Roche more than *** of Compound, and (2) within sixty (60) days of the Effective Date, commence a Know-How transfer (in accordance with the guidelines set forth on Exhibit 6.3(a)(2)), to Roche that will enable Roche to manufacture Licensed Product. The clinical supply of Compound shall meet current good manufacturing practices of the FDA (as set forth in 21 C.F.R. Parts 210 and 211) and the ICH guidelines of the European Union and all other applicable rules, regulations, guides and guidances. Promptly after the Closing Date, BioCryst shall deliver to Roche: (i) *** of all intermediates pure enough to calibrate analytical instruments, (ii) analytical methods, (iii) batch records of the whole chemical synthesis, to the extent they exist, (iv) safety investigation reports for all chemical steps, and (v) a list of key suppliers including agreements (if any) and all respective lead times. After transition of manufacturing to Roche as contemplated in this paragraph, Roche shall be responsible to supply, at its own cost, all clinical supply of Compound required for Development of Licensed Product in the Field, as approved by the JSC. In consideration for BioCryst’s agreement to supply Roche with Compound as set forth herein, Roche agrees to prepay BioCryst’s costs and expenses incurred in manufacturing such Compound in the amount of five million dollars ($5,000,000) (the “Contract Manufacturing and Manufacturing Transfer Fee”), which shall be due within *** (***) days of (i) the Closing Date of this Agreement and (ii) receipt by Roche of an invoice (in BioCryst’s standard invoice format) for such sum.
Sample 1
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Related to Manufacturing and Technical Assistance

  • Technical Assistance Except as expressly set forth elsewhere in this Agreement (including in the Exhibits), in the CONTRIBUTION AGREEMENT, in the SEPARATION AGREEMENT, or any other mutually executed agreement between the parties, no party shall be required to provide the other party with any technical assistance or to furnish any other party with, or obtain on their behalf, any documents, materials or other information or Technology.

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

  • 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.

  • TECHNICAL SUPPORT SERVICES 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").

  • 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.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • 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.

  • Assistance and Cooperation After the Closing Date, each of Seller and Purchaser shall:

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

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