Manufacturing Facilities Sample Clauses

Manufacturing Facilities. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Applicable Regulatory Authorities.
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Manufacturing Facilities. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statues, rules, regulations and policies of the Regulatory Authorities. Any certificate signed by or on behalf of the Company and delivered to the Representatives or to counsel for the Underwriters shall be deemed to be a representation and warranty by the Company to each Underwriter as to the matters covered thereby.
Manufacturing Facilities. All manufacturing of the Manufactured Products shall be done in the Licensee's own facilities or qualified contract manufacturing facilities.
Manufacturing Facilities. BI Austria represents and warrants that it and BI Pharma KG shall obtain all relevant APPROVALS required by the relevant HEALTH AUTHORITIES for each of their respective manufacturing facilities and that each of their respective manufacturing facilities conform, and will during the term of this Agreement conform, to the cGMP.
Manufacturing Facilities. 13.1 The Licensee shall purchase or establish and maintain one or more manufacturing facilities for the manufacture of the Products at its own expense.
Manufacturing Facilities. Section 6.2(a) is hereby amended by deleting it in its entirety and replacing it with the following:
Manufacturing Facilities. Bloom Energy and SK shall commence development and expansion of the existing manufacturing facility of the JV Company or development of a new manufacturing facility (“Manufacturing Facilities”). The commencement of Full Assembly activities at the Manufacturing Facilities shall be targeted for January 2023. In case of 2024, sales, marketing, distribution and deployment of the System in Korea and Other Territory shall be fulfilled from the Manufacturing Facilities. It is the understanding of the Parties that the JV Company must receive Fuel Cell Stack or the Fuel Cell Stack integration components of the Hot Box in a volume equivalent to the Original Quarterly Quantity (as defined in the PDA) in 2022, 2023 and 2024.”
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Manufacturing Facilities. To Precision’s Knowledge, all facilities used by Precision in connection with the Manufacture of the Licensed Product, including batch number PBCAR0191-2023-0006, are in good operating condition and repair, were designed to be capable to and were utilized by Precision to Manufacture the Licensed Product [***]. To Precision’s Knowledge, no inspection of such facilities has resulted in any warning letter, notice of violation letter or other notice, response or commitment made to or with the FDA or any other Governmental Authority.
Manufacturing Facilities. XOMA shall ensure that (a) prior to the first filing of an MAA for the Product with the EMA, there is at least one facility qualified to manufacture Bulk Drug Substance for MAA submission to the EMA and (b) prior to the filing of an MAA for the first Major Cardiometabolic Indication for the Product with the EMA, there is a second facility qualified to manufacture Bulk Drug Substance for MAA submission to the EMA; provided that, where upon timely request by Servier, such second Bulk Drug Substance manufacturing facility is to be located in the EU and owned by Servier or by a Third Party contract manufacturer selected by Servier (the “Servier Facility”), the costs and expenses of qualifying and constructing such Servier Facility shall be borne by Servier; and provided further, that where Servier does not so request, XOMA shall establish such second facility outside the EU, at its own expense. In connection with such request by Servier regarding the Servier Facility, the Parties shall discuss in good faith and cooperate with respect to the transfer of XOMA Know-How related to the Manufacture of Bulk Drug Substance and Product to the Servier Facility pursuant to Section 6.8.
Manufacturing Facilities. Upon satisfaction of all Conditions Precedent, Bloom Energy and SK shall commence development of the manufacturing facility of the JV Company, at a location with the capacity to expand (the “Manufacturing Facilities”). Provided that all Conditions Precedent are satisfied or waived in writing by all Parties, the commencement JV Scope activities at the Manufacturing Facilities shall be targeted for April, 2020 and the initial production capacity of the Manufacturing Facilities shall be determined based on the number of Systems that are or are expected to be Delivered (as such term is defined in the PDA) in 2019 and 2020 for deployment in Korea and fulfilled from the facilities of Bloom Energy located in Delaware, USA (the “Delaware Facilities”) and/or the JV Company. It is the understanding of the Parties that for the Manufacturing Facilities to be operational, the JV Company must receive a minimum Delivery volume of 50 MW each calendar year.
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