Manufacturing Option Sample Clauses

Manufacturing Option. 5.3.1 Auxilium grants to Ipsen an option under Auxilium IP Rights to make and have ** 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. made the Product (the “Manufacturing Option”). Ipsen shall have the right to exercise the Manufacturing Option, without prejudice to other remedies (except in case of force majeure events), upon occurrence of any of the following events: (a) in case of failure of Auxilium to supply Products at the Supply Price provided in Section 9.10 of this Agreement; or (b) in case of failure of Auxilium to supply Ipsen with duly and timely forecasted and ordered requirements for the Product as provided in Section 9.8 of this Agreement. 5.3.2 Upon Xxxxx’x exercise of the Manufacturing Option, Auxilium shall: (a) without the need for any further agreement, grant a license to Ipsen under all Auxilium IP Rights to make and have made the Product, and promptly transfer at Auxilium’s costs all technical information necessary for Ipsen to make or have made the Product ; and (b) Auxilium shall continue to supply Ipsen with the Product at then prevailing Supply Price as long as Ipsen is not in a position to make or have made the Product. 5.3.3 In the event Ipsen exercises the Manufacturing Option: (a) Ipsen undertakes to make or have made the Product in accordance with Product Specifications, validated manufacturing processes approved by Auxilium, cGMP, and all applicable laws and regulations in the Territory. (b) at Auxilium’s request, Ipsen will supply Auxilium with the Product to the North American market at price reflecting the reduced manufacturing cost under a supply agreement to be negotiated in good faith between the Parties.
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Manufacturing Option. Syndax grants to KHK the option to elect to receive from Syndax a non-exclusive license to Manufacture the Product or the Compound inside or outside the Territory for Commercialization in the Territory, which option may be exercised by KHK solely in the event that Syndax and its designee is unable or unwilling to supply such Product to KHK in a timely manner and in compliance with quality standards (a “Supply Failure”). The Supply Agreements shall include objective criteria for determining whether a Supply Failure has occurred. In the event that KHK exercises such option, KHK shall have the right to Manufacture, or have Manufactured, such Product or Compound in whole or part in or outside the Territory (excluding ***, which are the subject of an exclusive manufacturing license to a Third Party), subject to KHK’s compliance with reasonable manufacturing and clinical safety standards and applicable regulatory requirements. In the event that KHK elects to have one or more of Syndax’s existing contract manufacturers Manufacture the Product or the Compound, Syndax shall reasonably cooperate to allow KHK to enter into a direct contract manufacturing agreement with such contract manufacturers. Any Product Manufactured by KHK pursuant to the foregoing rights shall be exclusively sold in the Territory. Any regulatory activities that are necessary for KHK to perform the foregoing Manufacture of the Product or the Compound shall be performed by the Parties in accordance with Section 4.3. The Commercial Supply Agreement shall include mutually agreed royalty payments to Syndax that, upon transfer of Manufacturing responsibility to KHK, will replace the Transfer Price payments in Section 8.5 so as to provide equitable compensation to Syndax for the licenses granted by Syndax to KHK.
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Manufacturing Option. (a) At any time during Development or Commercialisation and subject to any commitments already made to any Third Party supplier either Party may seek to manufacture and supply Antibody Raw Material by providing written notice to the other Party and the Collaboration Committee that it wishes to assume manufacture and supply of the Antibody Raw Material for the Territory or its Lead Territory. Within [*] after receipt of such request, the other Party shall have the right to provide reciprocal notice of its desire to manufacture and supply Antibody Raw Material. Thereafter, the Collaboration Committee shall promptly meet to consider any and all requests and determine ([*]) whether one or both of the Parties should have the right and obligation to manufacture and supply Antibody Raw Material, applying the following criteria: (i) the FAMC resulting from the requesting Party’s manufacturing is likely to be less than the actual or probable FAMC as invoiced by the Third Party manufacturer or, if both Parties desire to assume such responsibility, the probable FAMC as between the Parties; (ii) other benefits, such as stability of supply or quality of product, are like to accrue to both Parties as a result of manufacture of Antibody Raw Material by the requesting Party or Parties; (iii) a Third Party manufacturer for Development or Commercialisation supplies has not been identified or such Third Party manufacturer is unable or unwilling to enter into a Supply Agreement on terms reasonably satisfactory to both Parties; (iv) the desirability of a second (or further) source of supply of Antibody Raw Material; (v) that the Third Party manufacturer is in material breach of its supplier obligations and that as a result of such breach, the requesting Party or Parties should assume manufacture and supply of Antibody Raw Material; or (vi) the cost and difficulty of enforcing the relevant Supply Agreement to enable one or both Parties to manufacture and supply Antibody Product. (b) If the Collaboration Committee determines that, after applying the foregoing criteria, in total it would be beneficial to the interests of both Parties that the requesting Party or Parties manufacture and supply Antibody Raw Material, the selected Party or Parties shall have the right and obligation to manufacture and supply Antibody Raw Material for either the Territory or its Lead Territory as determined by the Collaboration Committee. Upon selection of a Party, then (i) If Amgen is the selected P...
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Manufacturing Option. (a) MEI hereby grants KHK an option under MEI Technology to Manufacture and to have Manufactured the Compound and/or the Product in the Territory or outside of the Territory exclusively for Development and Commercialization in the Territory, which can be exercised by written notice from KHK to MEI (i) in the event that MEI experiences a “supply failure” with respect to supplying the Compound or Product to KHK under the Commercial Supply Agreement as “supply failure” is defined in the Commercial Supply Agreement and/or Commercial Quality Agreement; (ii) if MEI’s cost of Manufacturing under the Commercial Supply Agreement increases by more than [*CONFIDENTIAL*] from one Calendar Year to the next for reasons other than raw material costs; or (iii) for a period of [*CONFIDENTIAL*] starting [*CONFIDENTIAL*] prior to the anticipated expiration of the Term (the “Manufacturing Option”); provided, that, the Manufacturing Option shall expire [*CONFIDENTIAL*] prior to the anticipated expiration of the Agreement. (b) If the Manufacturing Option is exercised, then: (i) for a transition period of not less than [*CONFIDENTIAL*] (but only longer if the Parties mutually agree) MEI shall continue to supply the Compound and/or the Product to KHK for Development and Commercialization (in accordance with, as applicable, this Agreement or one or more separate supply agreement(s) between the Parties) (the “Transition Period”). MEI shall have no obligation to supply KHK with the Compound and/or Product after the Transition Period. (ii) during Transition Period, MEI shall make available and transfer to KHK, copies of existing embodiments of the MEI Know-How in MEI’s possession that are necessary or reasonably useful in, and as of such date are being used by MEI to, Manufacture of the Compound and Products solely for KHK to Manufacturer or have Manufactured (to the extent permitted by this Agreement) the Compound and Products in accordance with the terms and conditions of this Agreement with no additional consideration during Transition Period. Subject to the proviso in the foregoing sentence, MEI shall use Commercially Reasonable Efforts to provide KHK with reasonable assistance to facilitate the practice of such Manufacturing rights by KHK, its Affiliate or its Sublicensee. In the event that KHK elects to have one or more of MEI’s existing contract manufacturers to Manufacture the Product and/or Compound for the Territory, MEI shall reasonably cooperate to allow KHK to enter into...
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Manufacturing Option. Notwithstanding any other provisions of this Article 8, and upon the expiry of the exclusive right of BLI under paragraph 7.14, Polymer may manufacture, or obtain all but not less than all of its manufacturing requirements of any Product Licensed to Polymer in the Territory from another Person on terms which are more advantageous to Polymer than the terms upon which BLI is willing to provide such manufacturing, as provided for herein, subject to the terms and conditions of paragraphs 8.19 and 8.21.
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Manufacturing Option. In the event of a Supply Failure under the Clinical Supply Agreement or Commercial Supply Agreement, Astellas shall have the option to assume responsibility for the manufacturing of Xork or the Xork Products for use in an Astellas Combination Product (“Manufacturing Option”). Immediately following a Supply Failure under the Clinical Supply Agreement or Commercial Supply Agreement, Astellas may exercise the Manufacturing Option by providing written notice to Selecta. For clarity, if a Supply Failure occurs, Astellas may exercise the Manufacturing Option even if Selecta was not in breach of its obligation to use Commercially Reasonable Efforts to Manufacture and supply Xork or the Xork Products.
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Manufacturing Option. Notwithstanding anything to the contrary set forth herein, KHK shall have the right to exercise its option to assume responsibility for the manufacture of the Lead Licensed Compound (“Manufacturing Option”) in the event that: (i) [***]; (ii) [***]; or (iii) [***]. In the event that KHK exercises the Manufacturing Option, Ardelyx shall continue to supply, and KHK shall continue to purchase, all of KHK’s requirement for the Commercialization of Lead Licensed Product for a period of [***] ([***]) years. Thereafter, Ardelyx shall no longer be obligated to supply Lead Licensed Compound to KHK and KHK shall no longer be obligated to purchase Lead Licensed Compound from Ardelyx.
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Manufacturing Option. Alexza hereby grants Xxxxxx an option to obtain the rights to manufacture the Product, and to manufacture, develop and commercialize Staccato Products, as described in this Section 2 (the “Manufacturing Option”). Xxxxxx may exercise the Manufacturing Option by written notice to Alexza delivered between the Fourth Amendment Effective Date and December 31, 2015 (the “Option Period”). During the Option Period, Xxxxxx shall evaluate the technical requirements, technology transfer and investments necessary to enable Xxxxxx to manufacture the Product at Xxxxxx’x facilities. Alexza shall provide all reasonable cooperation requested by Xxxxxx in connection with such evaluation.
Sample 1

Related to Manufacturing Option

  • Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

  • 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.

  • 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.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • 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 [***].

  • 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.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Recipient Products Updated Project Schedule (if applicable) • Updated List of Match Funds (if applicable) • Updated List of Permits (if applicable) • Kick-off Meeting Agenda

  • Third Party Components The Products and Services may contain third party components (including open source software) subject to separate license agreements. To the limited extent a third party license expressly supersedes this XXXX, such third party license governs Customer’s use of that third party component.

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