Common use of REJECTED PRODUCT Clause in Contracts

REJECTED PRODUCT. 6.1 NEW ALPHA will inspect pursuant to New Alpha Review and Release, and GENERICO will inspect pursuant to Generico Manufacturing, each batch of Product and Pipeline Product for compliance with the Specifications, cGMPs, the FDCA and any and all other applicable Legal Requirements. If after inspection of Product or Pipeline Product NEW ALPHA notifies GENERICO, or GENERICO notifies NEW ALPHA, that any Product or Pipeline Product is non-compliant, as determined by such Party’s testing and inspection of the Product or Pipeline Product, the Parties will in good faith attempt to mutually determine whether the failure of the Product or Pipeline Product, as applicable, to comply is a result of Generico Manufacturing or New Alpha Manufacturing and the provisions of Section 6.2 will apply; provided, however, that the provisions of Section 6.2 will not apply (and thus GENERICO will Note: Redacted portions have been marked with (***). The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission. have no responsibility or liability relating to any non-compliance) with respect to any Pipeline Products in clause (A) or (B) of such definition unless, in any quarter beginning with the first quarter ending after the Effective Date, (***) of such Pipeline Products are non-compliant; provided further, that Pipeline Products shall only be determined non-compliant if GENERICO fails to perform Generico Manufacturing according to the Specifications for such Pipeline Product provided by NEW ALPHA.

REJECTED PRODUCT. 6.1 NEW ALPHA will inspect pursuant to New Alpha Review and Release, and GENERICO will inspect pursuant to Generico Manufacturing, each batch of Product and Pipeline Product for compliance with the Specifications, cGMPs, the FDCA and any and all other applicable Legal Requirements. If after inspection of Product or Pipeline Product NEW ALPHA notifies GENERICO, or GENERICO notifies NEW ALPHA, that any Product or Pipeline Product is non-compliant, as determined by such Party’s testing and inspection of the Product or Pipeline Product, the Parties will in good faith attempt to mutually determine whether the failure of the Product or Pipeline Product, as applicable, to comply is a result of Generico Manufacturing or New Alpha Manufacturing and the provisions of Section 6.2 will apply; provided, however, that the provisions of Section 6.2 will not apply (and thus GENERICO will Note: Redacted portions have been marked with (***). The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission. provided, however, that the provisions of Section 6.2 will not apply (and thus GENERICO will have no responsibility or liability relating to any non-compliance) with respect to any Pipeline Products in clause (A) or (B) of such definition unless, in any quarter beginning with the first quarter ending after the Effective Date, (***) of such Pipeline Products are non-compliant; provided further, that Pipeline Products shall only be determined non-compliant if GENERICO fails to perform Generico Manufacturing according to the Specifications for such Pipeline Product provided by NEW ALPHA.