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 *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 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.
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:
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:
Manufacturing Option. (a) Q-Med hereby grants to Medicis an option (the "OPTION") to obtain a license commencing on the date that is * * * from the expiration date of the Term without giving effect to any extensions thereof, to make and have made, develop and improve by itself or on its behalf in the Territory, the Licensed Products. Such license (the "MANUFACTURING LICENSE") shall be granted by Q-Med within * * * of the date of Q-Med's receipt from Medicis of an exercise notice (the "EXERCISE NOTICE"), and shall include the terms set forth on Schedule D hereto and any other terms and conditions negotiated in good faith and agreed to by the Parties during such * * * period. The Parties hereby agree that this Section 10.1 imposes an enforceable obligation to grant the Manufacturing License based on the terms set forth in Schedule D and to negotiate in good faith such additional terms as may be agreed to by the Parties. Medicis shall deliver the Exercise Notice no less than * * * prior to the date on which Medicis intends to commence to make or to have made, develop and improve the Licensed Products pursuant to the Option; provided that Medicis shall not deliver the Exercise Notice earlier than the later to occur of * * *. Medicis may deliver the Exercise Notice at any time from and after the date referred to in the immediately preceding sentence and before the expiration of the Term without giving effect to any extensions thereof. Medicis and Q-Med will fully cooperate in obtaining all required Regulatory Approvals in connection with Medicis' lawful manufacture of the Licensed Products for Commercial Distribution and Investigational Distribution; provided that Medicis will pay the cost and expenses of obtaining such approvals.
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.
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.
Manufacturing Option. 6.18.1 Licensor grants to Licensee an exclusive option under Licensor IP Rights to make and have made bulk active and/or finished dosage form of the Initial Product (the “Manufacturing Option”), as the case may be. Licensee shall have the right to exercise the Manufacturing Option, without prejudice to other remedies (except in case of Force Majeure events), only in the case of failure of Licensor to implement the mechanisms for curing the Default in accordance with Section 6.17(c).
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.
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.
Manufacturing Option. (a) ALFASIGMA will have the option exercisable at any time during the Term, without any fee or consideration to IPI, to Manufacture (or have Manufactured) the Compound for Development and/or Commercialization of the Product in the ALFASIGMA Territory with a right to sub-license in multiple tiers (the “Manufacturing Option”) (i) without IPI’s approval, in the event that IPI is unable to provide the Compound to ALFASIGMA pursuant to Article V, Exhibit D and Exhibit F and (ii) upon IPI’s approval (such approval to not be unreasonably withheld), in the event that ALFASIGMA is able to Manufacture and/or have Manufactured the Compound of similar quality at cost more favorable than that then currently applied or offered (as the case may be) by IPI to ALFASIGMA, provided, however, that, (x) ALFASIGMA offers to IPI the same Manufacturing terms, and (y) the approval by IPI under paragraph (ii) above shall not be denied in case IPI is not able to match any such Manufacturing terms.
