Pharmaceutical Contract Manufacturing Agreement Pdf

1.9 “chemical testing,” the process test of the chemical properties of the product or piping product during the manufacturing process or a plumbing product. 6.2 If the parties are unable to determine each other, within 60 days of the success of a notice of refusal by one of the parties, whether the non-compliance with the pipeline product or products is due to convulation or new alpha production, this dispute is designated by an independent audit organization accredited by the FDA or by an advisor appointed by the contracting parties. , whose designation is not unduly accepted or delayed by any of the parties. To the extent that the parties are unable to agree on a trial organization or advisor, each party will designate such an entity and both entities agree to a mutually acceptable control body. The product control body determines the source of non-compliance (i.e. Generico Manufacturing or New Alpha Manufacturing). Both parties will provide the truth with the information reasonably necessary for the truth to adopt such a provision; provided, however, that each party may, to the extent it deems necessary, deprive the independent third-party service of protected information. Any provision of the independent third party body is final and binding on the parties. If the independent third-party agency indicates that it is unable to determine whether it is unable to provide proprietary information due to the decision of NEW ALPHA or GENERICOs not to disclose proprietary information, it is considered that non-compliance with the denied applicable product (A) New Alpha Manufacturing in the event that NEW ALPHA is the undisclosed party or (B) Generico Manufacturing , if GENERICO is not the undisclosed party. If the independent third party determination is inconclusive, it is considered that 50% of the non-compliance with this rejected product is due to new alpha manufacturing and 50% to Generico Manufacturing. NEW ALPHA must have the final provision for the disposal of a pipe product or product; provided that no pipeline product or product can be released if one of the parties has found that this product or pipeline is not compliant.