Commercial Manufacturing and Supply Sample Clauses

Commercial Manufacturing and Supply. Customer shall purchase Product from Lonza during the Term at the Price outlined in Attachment A. Lonza shall manufacture all Product as ordered and accepted per Section 6, under this Agreement at the Facility and pursuant to the terms hereof and the Quality Agreement. Manufacturing of Product may not be relocated from the Facility without Customer’s prior written consent.
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Commercial Manufacturing and Supply. In connection with any Manufacturing and Supply Agreement entered into pursuant to this Agreement, Bayer shall provide Formulated Amikacin for commercial supply of the Product and shall be responsible for final packaging of Formulated Amikacin with the Device. Bayer’s cost for the Device, Formulated Amikacin, and final Product packaging for commercial supply for the Shared Territory shall be included in Allowable Expenses. Nektar shall supply the Device for use in the Manufacture of commercial supplies of the Product to Bayer, at a price for the Shared Territory equal to Nektar’s Fully Burdened Manufacturing Cost therefor, and at a price for the Royalty Territory equal to one hundred thirty (130%) of Nektar’s Fully Burdened Manufacturing Cost therefor. In the event that the amount Bayer pays to Nektar for the Device in the Royalty [***] indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Territory [***] in accordance with the dollar amounts and time schedule to be set forth in the Manufacturing and Supply Agreement, such agreement would specify that Bayer would have the right to [***] for commercial supply of the Device to provide reasonable accommodation for the [***], provided that in no event would the purchase price for the Device be less than [***] of Nektar’s Fully Burdened Manufacturing Cost therefor. All amounts paid by Bayer to Nektar for commercial supply of the Device for the Shared Territory, and Bayer’s Cost of Goods Sold (as defined in Exhibit 1.8) for manufacturing Formulated Amikacin, and performing final packaging and labeling of the Product, for commercial supply in the Shared Territory, will be included in Allowable Expenses.
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Commercial Manufacturing and Supply. [***]. Each Commercial Manufacturing and Supply Plan will be incorporated into, and form part of, the applicable Commercialization Plan and Budget and will be reviewed and approved as part of the applicable Commercialization Plan and Budget in accordance with Section 5.1 and updated in accordance with Section 5.8. Each Commercial Manufacturing and Supply Plan shall include reasonable and customary terms concerning compliance with cGMP, quality assurance, and quality control, taking into account where applicable each Party’s standard operating procedures.
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Commercial Manufacturing and Supply. Licensee is solely responsible for the Manufacture of a Molecule and each Product for commercial purposes in the Field in the Territory.
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Commercial Manufacturing and Supply. In connection with any Manufacturing and Supply Agreement entered into pursuant to this Agreement, Bayer shall provide Formulated Amikacin for commercial supply of the Product and shall be responsible for final packaging of Formulated Amikacin with the Device. Nektar shall supply the Device for use in the Manufacture of commercial supplies of the Product to Bayer, at a price (a) for the United States equal to Nektar’s Fully Burdened Manufacturing Cost without any xxxx-up; and (b) for the Royalty Territory equal to Nektar’s Fully Burdened Manufacturing Cost therefor plus the xxxx-up (the “Xxxx-Up”) set forth in Table 9.1(b) below; provided, however, that, in the United States as well as in the Royalty Territory, the price shall not exceed [***] (the “Cap”) for the remaining time in the calendar year in which the Commercial Launch took place, and in each calendar year thereafter (each a “Calendar Year”). Subject to a potential adjustment pursuant to Section 9.1(b)(e) below, the Cap for the respective Calendar Year is either (i) [***] or (ii) [***], whichever is lower. (For clarity, the Parties recognize and intend that the first Calendar Year may be of short duration, such as only a few days or months, depending on the date of the Commercial Launch.) In the Manufacturing and Supply Agreement, the Parties shall include provisions addressing all of the following:
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Commercial Manufacturing and Supply. Aevi is solely responsible for the Manufacture of the Molecule and each Product for commercial purposes in the Field in the Territory.
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Commercial Manufacturing and Supply. Licensee shall develop a manufacturing and supply strategy for Licensed Product (including API, drug substance and finished dosage form) consistent with the Commercialization Plan. Pursuant to this strategy, Licensee shall be solely responsible for Manufacturing and supplying the API, drug substance and finished dosage form of any Licensed Product for Commercialization in the Territory. In this role, Licensee shall identify and manage Third Party contract manufacturers, as well as lead all supply chain [***]Confidential Information, indicated by [***], has been omitted by this filing and filed separately with the Securities and Exchange Commission. management and quality control activities. Forendo acknowledges that Licensee has the final decision-making authority over Manufacturing activities in the Territory in its discretion.
Sample 1
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Commercial Manufacturing and Supply. As of the Effective Date, the Parties do not intend that commercial-scale Manufacturing be conducted under this Agreement. Notwithstanding the foregoing, in anticipation of the potential negotiation of a commercial-scale manufacturing agreement (a “Commercial Supply Agreement”), the Parties may discuss the possibility of [***] including the possibility of Biogen (i) [***], (ii) [***] and (iii) [***]. Further, neither Party is obliged to negotiate or enter into a Commercial Supply Agreement [***].
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Commercial Manufacturing and Supply. 6.4.1 OnCore shall develop a manufacturing and supply strategy for Licensed Product (including API, drug substance and finished dosage form) consistent with the Commercialization Plan. Pursuant to this strategy, OnCore shall be solely responsible for Manufacturing and supplying the API, drug substance and finished dosage form of any Licensed Product for Commercialization in the Field throughout the Territory. In this role, OnCore shall identify and manage Third Party contract manufacturers, as well as lead all supply chain management and quality control activities.
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Related to Commercial Manufacturing and Supply

  • 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.

  • 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.

  • 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 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 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.

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Commercial Supply Celgene shall Manufacture and supply all Commercial Supplies.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

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