Manufacturing Facilities Clause Samples
POPULAR SAMPLE Copied 5 times
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. 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. 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. All manufacturing of the Manufactured Products shall be done in the Licensee's own facilities or qualified contract manufacturing facilities.
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. Without limiting PiSA’s obligations under the Technical Agreement, PiSA shall be responsible for obtaining and maintaining manufacturing facilities in Guadalajara, Mexico or at other PiSA manufacturing facilities subject to NxStage’s prior written consent, which shall not be unreasonably withheld, and other equipment, supplies and staff necessary to perform its obligations hereunder in accordance with this Agreement and the Technical Agreement. PiSA will manufacture the Product at such facilities and shall not change the location of such manufacture without NxStage’s prior written consent, not to be unreasonably withheld (it being understood that, without limiting the foregoing, NxStage shall have no obligation to consent to a request to change the location of manufacture which would increase NxStage’s Product shipping costs). PiSA undertakes that the facility where PiSA will manufacture the Product, and all the procedures used in manufacturing and processing, shall enable PiSA to maintain manufacturing of Product according to the Specifications. PiSA acknowledges that the manufacturing facilities for the Product must be registered with the FDA under the requirements of the current GMP and shall comply with the requirements of FDA 21 CFR Part 820 Quality System Regulation.
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 ▇▇▇▇▇ or to counsel for ▇▇▇▇▇ in connection with this Agreement shall be deemed to be a representation and warranty by the Company to ▇▇▇▇▇ as to the matters set forth therein. The Company acknowledges that ▇▇▇▇▇ and, for purposes of the opinions to be delivered pursuant to Section 7 hereof, counsel to the Company and counsel to ▇▇▇▇▇, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.