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.
Manufacturing Requirements. (a) LICENSEE will have manufactured on its behalf only by those manufacturers authorized by HONEYWELL pursuant to HONEYWELL’S Direct Ship Authority (“APPROVED MANUFACTURERS”) any LICENSED PRODUCTS in accordance with the then-current guidelines of HONEYWELL’S Direct Ship Authority and other pertinent laws, rules and regulations of any REGULATORY AUTHORITIES in all applicable jurisdictions. In the event that LICENSEE fails to comply with the guidelines of HONEYWELL’S Direct Ship Authority set forth in this Article 13, HONEYWELL may, at its option, have manufactured, sell, have sold, import and distribute the LICENSED PRODUCTS through (a) one of the licensees to the PRE-EXISTING AGREEMENTS, or (b) a manufacturer of the LICENSED PRODUCTS to have manufactured and/or procure those LICENSED PRODUCTS in respect of which LICENSEE is failing to comply with HONEYWELL’S Direct Ship Authority, until HONEYWELL determines in its reasonable discretion that LICENSEE has cured such failure. The exercise of such right by HONEYWELL shall not be deemed to be a breach of LICENSEE’S exclusive rights under this AGREEMENT or the SUPPLY AGREEMENT, provided that HONEYWELL does not grant to any third party during such period, a license or sublicense to the TECHNOLOGY to have manufactured, sell, have sold, import or distribute the LICENSED PRODUCTS. In the event that LICENSEE fails to comply with the guidelines of HONEYWELL’S Direct Ship Authority, HONEYWELL shall, at LICENSEE’s request and expense, use reasonable efforts to assist LICENSEE in regaining compliance as soon as possible.
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. Coty covenants that all Products manufactured and/or supplied under this Agreement:
Manufacturing Requirements. (a) Unless otherwise approved by Medifocus, JV shall have all Products manufactured by manufacturers who are currently manufacturing Products for Medifocus on such terms and conditions acceptable to both JV and Medifocus, including that (i) notwithstanding any prior inspection or payments, all Products shall be subject to final inspection and acceptance at JV’s designated destination point within sixty (60) days after delivery, (ii) without prejudice to any other right or remedy of JV, in case any item is defective in material or workmanship, or otherwise not in conformity with the Product Specifications, Product Approvals or the requirements of JV’s order, JV shall have the right to reject it, (iii) any item that has been rejected must be replaced by and at the expense of manufacturer promptly after notice, (iv) JV shall not be required to pay for any rejected item, or its shipping costs or any other costs related thereto, and (v) that JV shall return all rejected Products to manufacturer at manufacturer’s expense.
Manufacturing Requirements. 4.1 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
