Commercial Manufacturing and Supply Sample Clauses

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 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. 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. [***]. 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. 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. 6.4.2 Following OnCore’s establishment of its commercial supply of API, NeuroVive may purchase API from OnCore’s then-current contract manufacturer at the same price as OnCore obtains from such manufacturer, and OnCore shall be responsible to ensure that such manufacturer extends the same price to NeuroVive as it does to OnCore for manufacture at that scale or batch size. On a Calendar Quarterly basis, NeuroVive will communicate to OnCore its estimated requirement for API.
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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.
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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. 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: (a) the Device cost in the United States shall be equal to (i) Nektar’s Fully Burdened Manufacturing Costs or (ii) the applicable [***] for the respective Calendar Year, whichever is lower; (b) in the Royalty Territory, if the Fully Burdened Manufacturing Costs are lower than the High COGs set out in the table attached hereto as Exhibit 9.1(b), the Xxxx-up to be payable by Bayer to Nektar in addition to the Fully Burdened Manufacturing Costs shall be [***] dependent on [***] (the “Device Xxxx-Up Thresholds”). If the Fully Burdened Manufacturing Costs are higher than [***], the Xxxx-up to be payable by Bayer to Nektar in the Royalty Territory in addition to the Fully Burdened Manufacturing Costs shall be limited [***]. If the Fully Burdened Manufacturing Costs exceed [***] for the respective Calendar Year, [***] applies. For the avoidance of doubt, it is set forth herein that in no event shall the price per Device including Fully Burdened Manufacturing Costs and Xxxx-up exceed the applicable [***] for the respective Calendar Year. (c) commencing with the first Calendar Year and any Calendar Year therea...
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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. 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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Related to Commercial Manufacturing and Supply

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • 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 Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Technology Research Analyst Job# 1810 General Characteristics

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • 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.

  • Commercial Supply After the Option Termination Date: (a) if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

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