Manufacturing Facility Clause Samples
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Manufacturing Facility. In manufacturing any Products, Supplier shall maintain an organization and facilities, including, without limitation, suitable equipment and tools, in accordance with standards generally accepted in the industry, and employ adequately trained and competent personnel in all functions. Supplier will keep complete and accurate records in all material respects with respect to Products it manufactures pursuant to this Agreement. Supplier shall, upon S&W’s request from time to time by providing at least 7 days prior notice, allow S&W or its representatives access to Supplier’s facilities to inspect the manufacture and assembly of the Products during reasonable hours, and provide S&W with such records in the possession of Supplier, as S&W may reasonably request, relating to the manufacture of Products and the source of any raw materials and components used in the Products; provided, however, in no event shall such inspection interfere with the business of Supplier.
Manufacturing Facility. Patheon will manufacture Finished Product at the Facility. Patheon shall not manufacture any Finished Product in any other facility without first obtaining Santarus' prior written consent, such consent not to be unreasonably withheld.
Manufacturing Facility. Prior to the manufacture of any Enzyme, on an Enzyme-by-Enzyme basis, the Parties shall agree upon the Manufacturing Facility for manufacture of such Enzyme. All such Enzyme shall be manufactured at such agreed upon Manufacturing Facility, and Company shall not, without Codexis’ prior written consent, not to be unreasonably withheld, manufacture such Enzyme at any facility other than such Manufacturing Facility. Prior to the delivery of any Batch of such Enzyme to Codexis or its Third Party designee, all such Batches shall be stored in accordance with the Quality Agreement and the applicable Specification, or as otherwise instructed in writing by Codexis, and at such Manufacturing Facility. Codexis and/or its Third Party designee shall have the right to inspect the Manufacturing Facilities and/or documentation related to the manufacture of Enzyme as set forth in the Quality Agreement.
Manufacturing Facility. (a) At all times during the Term, Capricorn shall maintain the Manufacturing Facility, equipment and processes used in producing the Product in strict compliance with all Applicable Laws and cGMP.
(b) Primus and its representatives shall have the right from time to time during normal business hours, and upon reasonable notice, to enter, inspect and evaluate the Manufacturing. Such inspection visits shall be scheduled and organized in such a manner as to comply with cGMP and to minimize to the extent reasonably practicable any disruption to plant and warehouse operations.
(c) Capricorn shall notify Primus within ten (10) Business Days following receipt of any notice of inspection by the FDA or other Regulatory Authority related to any aspect of the Manufacturing Facility and shall provide Primus with a copy of the results of any such inspection promptly after receipt. In the event that the inspection report identifies any deficiencies with respect to the Manufacturing Facility or with any processes or procedures, Capricorn shall promptly furnish to Primus a written statement setting forth the remediation measures that Capricorn intends to implement, the anticipated deadline for the completion of such measures, and the effect, if any, upon Capricorn’s ability to comply with its obligations under this Agreement.
Manufacturing Facility. Capricorn shall manufacture the Product for Primus at the Manufacturing Facility, provided, however, that Capricorn may manufacture and package, or contract with a third party to manufacture and package, the Product at an alternative facility upon not less than thirty (30) days written notice to Primus, specifying the owner and location of the facility. Capricorn shall be responsible for ensuring that such other facility, and any manufacturing of the Product therein, complies in all respects with the representations, warranties, covenants and agreements contained herein that are applicable to the Manufacturing Facility and the manufacture and packaging of the Product by Capricorn (except for representations that relate to the ownership of the Manufacturing Facility by Capricorn).
Manufacturing Facility. The Project will be a manufacturing facility as defined in Section 144 (a) (12) of the Code. The Project may include ancillary facilities which are directly related and ancillary to the Project but any such ancillary facilities will be located on the same site as the Project and not more than 25% of the net proceeds of the Bonds will be used to provide such ancillary facilities.
Manufacturing Facility. As of the Effective Date, the Manufacturing Facility is deemed to be Catalent [*]. As of the Effective Date, the Manufacturing Facility has any and all Regulatory Approvals required for the Manufacture, Labeling, packaging, and exportation of the Product in accordance with the Specifications, cGMP and Applicable Laws, and thereafter the Company will use [*] to ensure that the Manufacturing Facility shall maintains any and all such Regulatory Approvals.
Manufacturing Facility. (a) Subject to the parties pre-existing commitments, each party shall dedicate as much of their facility's capacity as is necessary to carry out this Agreement. Cheminor and Schein shall notify the other in writing of any pending * redacted pursuant to confidential treatment request. inspection, reports and/or legal action by the FDA or other Regulatory Authority and each party shall have the right, if practicable, to have representatives present for such inspection of the other party. Each party shall provide the other with a copy of each FDA or other Regulatory Authority inspection report (and/or associated notices, correspondence and telephone contact reports) (redacted as to information as to products not covered by the other party's distribution rights) within three (3) business days of receipt and a copy of their reply prior to submittal to the FDA or other Regulatory Authority for the other party's review and comment thereon.
(b) Cheminor shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at the Facility to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDAs and non-U.S. equivalents).
(c) Schein shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at its facilities to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance...
Manufacturing Facility. Notwithstanding anything contained herein to the contrary, Lucent reserves the right to manufacture the Device in any Lucent-qualified facility. Lucent also reserves the right to transfer production from one qualified facility to another or to manufacture at multiple qualified facilities.
Manufacturing Facility. Buyer acknowledges that HSC will be expanding its manufacturing facilities (the “Expanded Manufacturing Facility”) in order to produce the Products to be supplied under this Agreement. The estimated completion date for 50% of the manufacturing facility capacity is January 1, 2010, with estimated capacity of 75% completed on January 1, 2011, and 100% of estimated capacity completed on January 1, 2012. Buyer acknowledges the possibility of delays in completing the manufacturing facility and expressly agrees that, so long as 50% of the manufacturing capacity commences production by June 30, 2010, HSC SHALL HAVE NO LIABILITY TO BUYER FOR ANY SUCH DELAY. The parties further agree to the following liquidated damages formula as Buyer’s sole and exclusive remedy and damages for delays beyond June 30, 2010: Liquidated Damages Calculation: $*** multiplied by the number of months delayed beyond June 30, 2010 (pro-rated for partial months). The total liquidated damages shall not exceed the amount of Buyer’s Advance Payment. HSC agrees that the Expanded Manufacturing Facility shall be subject to bi-annual inspections by Buyer. Said inspections shall be subject to HSC’s confidentiality and security policies for site visits. Any fees and costs associated with such inspection shall be borne by Buyer.