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.
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. 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.”
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.
13.2 Both Parties agree and acknowledge that the manufacturing facilities may be used to manufacture products other than the Products and to manufacture the Products for Third Parties. This right must be exercised within five (5) years or it becomes non-exclusive as to the manufacture. Such manufacturing facility will be in compliance with internationally accepted standards for GMP, FDA, quality control and quality assurance.
13.3 With regard to a decision on making the investment to establish and maintain one or more manufacturing facilities for the manufacture of the Products, both Parties agree that, prior to the Licensee deciding to proceed with the establishment of the manufacturing facilities,
(i) BTI has to provide the Licensee a forecast of its purchase orders of the Products; and
(ii) They should agree on the price of the Products manufactured and supplied by the Licensee to BTI.
13.4 The Licensee shall be responsible for the maintenance and repair of all equipment used in the manufacture of the Products in accordance with applicable laws and consistent with good industry practice.
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. BI RCV 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. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers or its subsidiaries are operated in compliance in all material respects with all applicable statutes, rules, regulations and guidance of the Regulatory Authorities. Any certificate signed by an officer of the Company and delivered to Xxxxx or to counsel for Xxxxx in connection with this Agreement shall be deemed to be a representation and warranty by the Company to Xxxxx as to the matters set forth therein. The Company acknowledges that Xxxxx and, for purposes of the opinions to be delivered pursuant to Section 7 hereof, counsel to the Company and counsel to Xxxxx, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
