Drug Law Regulations Sample Clauses

Drug Law Regulations. 1.1 PFC’s TPCP will under PFC’s responsibility perform obligations under this QA Agreement, as PFC has previously informed NYCOMED that PFC’s TPCP will perform that obligation. Accordingly, PFC’S TPCP will be mentioned as a responsible party under this QA Agreement. However, notwithstanding anything to the contrary, PFC shall not delegate the manufacture and final release of the (bulk) product to any other third party without Nycomed’s prior written consent. 1.2 PFC and PFC’S TPCP are jointly and severally liable towards Nycomed for acts and omissions under the performance of the obligations in the QA Agreement, notwithstanding whether the obligation is contributed to PFC or PFC’S TPCP. 1.3 PFC’S TPCP affirms that it holds the required Manufacturing Authorization (as defined in the Development Agreement) pursuant to the local Drug Law for the manufacture of the product listed in Appendix 1 (herein referred to as the PRODUCT.) 1.4 The parties shall be obliged to immediately advise each other’s Contact Department and Individuals (art. 10) of any changes in the Manufacturing Authorization with regard to the PRODUCT. 1.5 PFC'S TPCP shall be obliged to forward to NYCOMED a copy of PFC'S TPCP's Manufacturing Authorization (art. 1.1) in case of changes or updates. 1.6 The manufacture will take place at: 1.7 PFC’S TPCP and PFC warrant that the PRODUCT is manufactured according to and upon delivery in any respect corresponds to the documents and specifications agreed upon and inserted in the Nycomed Marketing Authorization as specified in Appendix 2. 1.8 PFC’S TPCP and PFC warrant that the PRODUCT will be manufactured, analysed and stored according to the at all time governing US and EU-Guide to Good Manufacturing Practice for Medicinal Products, as well as the agreed directives of NYCOMED. (art.1.1) 1.9 PFC’S TPCP and PFC carries any and all responsibility of faults or damage caused during the manufacture of the PRODUCT in deviation of this Quality agreement.
Sample 1
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Related to Drug Law Regulations

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