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. 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. 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. Supplier will manufacture Company Product in accordance with the then-current (a) Product Specifications, (b) applicable regulations relating to current Good Manufacturing Practices and similar protocols required by the Act (“CGMP”), quality system regulations of the FDA (“QSR”), including master device and lot history records, and ISO 13485 requirements (including appropriate certification), MDD requirements, CMDCAS requirements, and (c) other pertinent rules and regulations of Regulatory Authorities that have approved sale of the Company Product. Upon the request of BioForm, Supplier shall provide BioForm with written evidence of compliance with the criteria set forth in the preceding sentence. During the Term, Supplier will maintain, or cause to be maintained, the Company **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Product manufacturing facility’s registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities or cause such facility to be maintained such that the facility would pass an audit for compliance with CGMP and QSR. Supplier shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, BioForm’s standard requirements for approval as a vendor as described in BioForm’s supplier quality system review policy, and Supplier’s standard quality assurance policies, copies of which are attached hereto. For seven years after delivery to BioForm of each Company Product unit, or such longer period as may be required by CGMP and other applicable rules and regulations of any Regulatory Authority, Supplier shall (i) maintain traceability for each Company Product unit including the manufacturing date and lot number of each Company Product unit and each component and material comprising each Company Product and (ii) provide BioForm a copy of such records upon BioForm’s written request.
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. 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. Compliance 4.2 Master Batch Record (MBR) (Manufacturing and Packaging Log Sheets 4.3 Product Formulation 4.5 Manufacturing Process Summary 4.6 Reports 4.7 Records Retention 4.8 Technical Support 4.9 Reprocessing 4.10 Reconciliation 4.11 Product Specifications 4.12 Storage Conditions Bulk API 4.13 Storage Conditions for Drug Product 4.14 Packaging 4.15 Labeling 4.16 Label Destruction 4.17 Lot Numbering and Expiration Dating DRUG PRODUCT MANUFACTURER LIGAND PHARMACEUTICALS INCORPORATED Contractor/Quality Manual for Drug Product Revision Date Section Number February 2004 Table of Contents
