Manufacturing Requirements Clause Samples
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Manufacturing Requirements. 5.5.1 SMI has and will manufacture the Modified Starch in accordance with the (i) Modified Starch Product Specifications, (ii) applicable Regulatory Laws including United States Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Modified Starch. In addition, during the Term, SMI will maintain, or cause to be maintained, the Modified Starch manufacturing facility’s (ies’) registrations as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, QSR and CMDCAS requirements. SMI shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, CryoLife’s standard requirements for approval as a vendor as described in CryoLife’s quality system review policy, and SMI’s standard quality assurance policies, copies of which have been provided to the other Party contemporaneously with the execution of this Agreement.
5.5.2 Once it obtains United States Regulatory Approval, CryoLife will Manufacture Products in accordance with the (i) Products Specifications, (ii) applicable Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, QSR requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Products manufactured by CryoLife. Once it commences Commercial Manufacturing of the Products for a country in the Territory for which it can Manufacture pursuant to appropriate Regulatory Approval, CryoLife will maintain, or cause to be maintained, the Products manufacturing facility’s (ies’) registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, FDA GMP compliance, CMDCAS requirements, as applicable for such country. CryoLife shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement.
5.5.3 Upon the request of either Party, the other Part...
Manufacturing Requirements. Manufacturing requirements shall be in accordance with paragraph 8.3. above except that the over-wrap shall also include helically wound filaments.
Manufacturing Requirements. Manufacturing requirements shall be in accordance with paragraph 8.3. above except that the curing temperature for thermosetting resins shall be at least 10 °C below the softening temperature of the plastic liner.
Manufacturing Requirements. Admedus shall manufacture the Product in accordance with (i) the Specifications, (ii) applicable regulations relating to current Good Manufacturing Practices and similar protocols (“GMP”), quality system regulations of the FDA (“QSR”), including master device and lot history records, ISO [***] requirements (including appropriate certification), (iii) other applicable rules and regulations of the FDA and the MDD/MDR, and (iv) Admedus’s standard quality assurance policies. Admedus shall become compliant, and maintain compliance, with ISO [***], ISO [***] and ISO [***] as soon as reasonably practicable. Admedus shall maintain its certification under the Medical Device Single Audit Program (“MDSAP”). Upon the request of L▇▇▇▇▇▇▇, Admedus shall, as soon as practicable after such request but in any event within three (3) business days, provide LeMaitre with written evidence of compliance with the criteria set forth in the preceding sentences of this Section 6(e). During the term hereof, Admedus will maintain or cause to be maintained the Product manufacturing facility’s registration with the FDA and other regulatory agencies, as applicable, as a medical device manufacturing facility and will maintain such facility registration with all applicable regulatory authorities or cause such facility to be maintained such that the facility would pass a FDA or MDSAP audit for compliance with GMP and QSR. During the term hereof, Admedus shall maintain all ongoing quality assurance and testing procedures required to comply with applicable regulatory requirements. For a period of the longer of five (5) years after delivery to LeMaitre of each Product, or such longer period as may be required by GMP and other applicable rules and regulations of any regulatory authority, Admedus shall (x) maintain traceability for each Product including the manufacturing date and lot number of each unit of Product and each component and material comprising each Product, (y) provide to LeMaitre a copy of such records without charge upon LeMaitre’s request and (z) maintain records subject to 21 CFR 820 Subpart M, such as the Device Master Record, quality system record, and complaint files. Admedus shall include in each shipment of Product to LeMaitre copies of the manufacturing and quality records corresponding to the Product in such shipment.
Manufacturing Requirements. SMI has and will manufacture Products in accordance with the (i) Product Specifications, (ii) applicable Regulatory Laws, including master device and lot history records, and ISO 13485 requirements (including appropriate certification), MDD Requirements, CMDCAS Requirements (when such CMDCAS Requirements are necessary for CryoLife to obtain Canadian registration), and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Products. Upon the request of CryoLife, SMI shall provide CryoLife with written evidence of compliance with the criteria set forth in the preceding sentence. Upon CryoLife’s request, SMI shall provide CryoLife with written evidence of compliance with the criteria set forth herein. During the Term, SMI will maintain, or cause to be maintained, the Products manufacturing facility’s registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD Requirements, and CMDCAS Requirements (when such CMDCAS Requirements are necessary for CryoLife to obtain Canadian registration). SMI shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, CryoLife’s standard requirements for approval as a vendor as described in CryoLife’s quality system review policy, and SMI’s standard quality assurance policies, copies of which are attached hereto.
Manufacturing Requirements. Andrx shall manufacture, package, label, store, test and ship the Products in accordance with: (a) all applicable Laws, (b) the Specifications, including requirements for Product dating, (c) the requirements of the approved NDAs and any Other Country Application and (d) the Quality Assurance Agreement. Andrx’s responsibilities and obligations described in the foregoing sentence are hereinafter referred to as the “Manufacturing Requirements”. Andrx shall perform such quality control and quality assurance testing as is required (but in no event less than as generally practiced in the pharmaceutical manufacturing industry) to ensure that the Products comply with all of the Manufacturing Requirements. If the Products as manufactured by Andrx fail to meet the Manufacturing Requirements, Andrx shall, at its sole cost and expense, manufacture additional Products to replace such defective Products. Replacement of such non-conforming Products shall be Purchaser’s sole remedy for such failure, except to the extent provided elsewhere in this Agreement. In such circumstances, Purchaser will have no obligation to purchase or pay for any rejected Products, but shall pay for the replacement product. * filed under application for confidential treatment
Manufacturing Requirements. Coty covenants that all Products manufactured and/or supplied under this Agreement:
(a) will meet the Specifications;
(b) will be manufactured in accordance with Coty Standard Practices and Applicable Law;
(c) will not be adulterated, misbranded or otherwise in violation of any Applicable Law as of the delivery to Ascendia;
(d) will be of merchantable quality and safe for the purposes for which intended to be used;
(e) will meet any claims made about them in the applicable packaging; and
(f) will comply with applicable labeling guidelines and standards of the Cosmetics, Toiletry and Fragrance Association.
Manufacturing Requirements. All manufactured items and/or fabricated assemblies subject to operation under pressure, operation by connection to an electric source, or operation involving a connection toa manufactured, natural; or LP gas source shall be constructed and approved in a manner acceptable to the appropriate state inspector which customarily requires the label or re-examination listing or identification marking of appropriate safety standard organization; such as the American Society of Mechanical Engineers for pressure vessels; the Underwriters Laboratories and/or National Electrical Manufacturers' Association for electrically operated assemblies; or the American Gas Association for gas operated assemblies, where such approvals of listings have been established for the type of device offered and furnished. Further, all items furnished shall meet all requirements of the Occupational Safety and Health Act (OSHA), and state and federal requirements relating to clean air and water pollution. Energy Star Compliance. All Products constituting electronic office equipment, including but not limited to, computers, monitors, printers, scanners, photocopy machines, and facsimile machines, shall be Energy Star compliant. If any of the Products do not satisfy Energy Star requirements, Vendor shall provide a justification statement explaining why the Products are not Energy Star compliant.
Manufacturing Requirements. Licensee shall establish or contract with cGMP-compliant manufacturing facilities that meet all requirements of the FDA, EMA, and other regulatory agencies where Licensed Products are to be manufactured and/or sold, and the Technology shall only be applied to Licensed Products manufactured in such cGMP-compliant facilities.
Manufacturing Requirements. Each DVD Disc Replicator must manufacture and distribute CSS Recordable DVDs in a manner to ensure that at least five hundred (500) unique Secured Disc Key Sets are applied randomly across all CSS Recordable DVDs distributed by such Replicator.