Back-Up Supply. For a period equal to the term of the Amended and Restated Distribution Agreement, MacroPore shall (upon orders placed by Medtronic) manufacture and supply Medtronic with any requirements for Field of Use Bioabsorbable Implants and those Accessories that are manufactured (in whole or in part) by MacroPore. The back-up supply of Field of Use Bioabsorbable Implants and Accessories shall be provided pursuant to the terms of the Amended and Restated Distribution Agreement, provided that after the transfer of the Specified Assets pursuant to Section 2.1, Medtronic shall supply, at Medtronic's cost and expense, the tooling and any other Specified Assets reasonably necessary for MacroPore to manufacture and supply these requirements.
Back-Up Supply. With respect to Maxipime-Registered Trademark-, BMS agrees to commercially reasonable efforts to qualify a back-up facility or supplier for the finishing of packaged Maxipime-Registered Trademark- Product, but not bulk compound, as promptly as reasonably practicable after the Effective Date; PROVIDED, however, that BMS shall not be obligated to qualify a back-up supplier or facility to finish or package any of the Piggyback or ADD-Vantage-Registered Trademark- formulations for Maxipime-Registered Trademark- or any back-up supplier of the frozen, premixed formulation of Azactam-Registered Trademark- supplied by Xxxxxx. BMS estimates that, unless unanticipated regulatory problems are encountered, BMS will be able to qualify a back-up BMS finishing facility with one year after the Effective Date. With respect to Azactam-Registered Trademark- (other than the frozen, premixed presentation prepared by Xxxxxx), BMS has already qualified a Third Party (Ben Venue) as of the Effective Date to provide finished Product (but not bulk compound) for the lyophilized Aztreonam product. If and when BMS switches to a crystalline, sterile dry powder fill Aztreonam product and has transferred the finishing and packaging for this Product to its Anagni, Italy facility, BMS will use commercially reasonable efforts to qualify a back-up BMS facility or supplier of said finished, packaged Product (but not the bulk compound) within one-year after BMS has so transferred its finishing facility to Anagni, Italy to make the finished, packaged, sterile dry powder Aztreonam Product. BMS will use commercially reasonable efforts to maintain, once established, a back-up supplier or back-up BMS finishing facility for packaging and finishing each Product during the applicable Term for such Product. BMS shall be entitled to change in its discretion its back-up supplier or back-up supply facility once all necessary approvals have been obtained and shall give DURA prompt written notice of any such change. It is understood that BMS is under no obligation to qualify a back-up supplier or facility to make bulk cefepime hydrochloride or bulk aztreonam.
Back-Up Supply. El Dorado will supply nitric acid to BMS in accordance with the Back-up Supply Plan set forth in Exhibit B hereof.
Back-Up Supply. For a period from the closing date up to and including December 1, 2004 MacroPore shall act as a back-up supplier to Medicis supplying its requirements (not otherwise provided for or self-manufactured) for Field of Use Bioabsorbable Implants (“Products”) as manufactured by MacroPore in the Field of Use Business as follows:
Back-Up Supply. For a period from the Closing Date up to and including the first anniversary of the Closing Date, MacroPore shall act as a back-up supplier to MAST supplying its requirements (not otherwise provided for or self-manufactured) for Field of Use Bioabsorbable Implants which had been marketed by MacroPore as of the Closing Date (“Products”):
Back-Up Supply. (a) Licensee shall be entitled to manufacture either Compound or Products for the Territory, if: (i) Angionetics is unable to supply all of Licensee’s demand for either Ad5FGF-4 or finished Generx Product as agreed; (ii) Angionetics’ third party manufacturer has a regulatory issue; (iii) at Licensee’s reasonable request, provided that Licensee has sold at least 50,000 units of Product, within the ExclusiveTerritory, for at least two out of three previous calendar years, or (iv) at Licensee’s request if the selling price of Generx in the Exclusive Territory materially decreases as a result of (x) competition in the Exclusive Territory or (y) pricing adjustment to maintain Licensee’s market share.
(b) Angionetics agrees, upon Licensee’s request, to transfer to Licensee all Angionetics Know-How related to manufacturing the Compound and Product to Licensee, and to use Commercially Reasonable Efforts to cause its third party contract manufacturer(s), including SAFC®, located in Carlsbad, California, to do the same.
Back-Up Supply. The Parties acknowledge that the Praluent Substance Supply Agreement will address the Parties’ rights and obligations in respect of back-up supply of Formulated Drug Substance by Regeneron to Sanofi during the term of the Praluent Substance Supply Agreement. If after the term of the Praluent Substance Supply Agreement, (a) Sanofi experiences [* * *], (b) Sanofi is [* * *] and (c) Regeneron is [* * *], then, upon Sanofi’s reasonable request (which request shall include Sanofi’s requested quantities of, and delivery dates for, Formulated Drug Substance manufactured [* * *], “Back-Up Request”), Regeneron shall consider Sanofi’s Back-Up Request and within [* * *] Business Days of receiving such request, Regeneron shall [* * *], and (x) if Regeneron [* * *] and (y) if Regeneron [* * *].
Back-Up Supply. Manufacturer recognizes, acknowledges and agrees that during the Term, Buyer and its Affiliates may share the Specifications, Intellectual Property Rights, process specifications, technical information as well as any other data or information, exclusive of *** and any other financial information pertaining directly to Manufacturer, that may be useful or necessary in connection with manufacturing, packaging, producing and storing the Products with another party (which may be a competitor of Manufacturer) for such other party to qualify its facility so that such party may manufacture and produce Product that meets the Specifications if so requested by Buyer. Manufacturer further recognizes, acknowledges and agrees that during the Term Buyer may so request that such party manufacture, package, validate, produce and store such qualified Product and perform stability testing and any other tests on such Product that Buyer deems necessary or appropriate to ensure that such party is able to manufacture validated and qualified Product that complies with the Specifications. Buyer agrees that during the Term it will not purchase any Product from such manufacturer for sale to a third party in the Territory (e.g., Failure to Supply), except as otherwise permitted in accordance with the terms herein or if the Agreement is terminated or expires.
Back-Up Supply. The Lead Manufacturing Party shall be responsible for developing, under the review of the JMC, commercially reasonable arrangements, where appropriate, for back-up sources of supply of Products that appropriately and reasonably minimize the risk of supply shortfalls and that take into account expected inventory levels under Section 7.7, provided that notwithstanding Section 2.5.2(k), the Lead Manufacturing Party shall be solely responsible for using Diligent Efforts to ensure that there are adequate supplies of each Product and MDX-1379 to meet the demand for same throughout the Territory at all times.
Back-Up Supply. To avoid out-of-stock situations the Joint Manufacturing Committee shall determine whether and under what circumstances back-up suppliers are necessary and/or when such suppliers shall be engaged.
