Common use of Testing and Inspections Clause in Contracts

Testing and Inspections. Insys shall make certain that the Third Party Manufacturer performs quality assurance testing with respect to the Product, including stability testing, so that the Product conforms to the Specifications and applicable Law. Insys shall make certain that the Third Party Manufacturer provides the results thereof to Mylan in the form of a Certificate of Analysis (“COA”) and a Certificate of Conformance (“COC”). Insys will also make certain that the Third Party Manufacturer provides Mylan with Material Safety Data Sheets (“MSDS”) as required for the Product, and updates of the same as necessary. Insys will make certain that the Third Party Manufacturer arranges for Mylan’s personnel, upon reasonable notice, to visit for reasonable durations during regular business hours its facility or any other third party manufacturer facility used for the manufacture, packaging, storage, testing or release of the Product, including to observe the manufacture, testing and release of the Product, and will arrange that such Mylan personnel may review and make copies of any relevant records in connection therewith. Any deficiencies in cGMPs as practiced at any such facility and noted by Mylan during such inspection will be communicated to Insys and Insys will make certain that the Third Party Manufacturer uses reasonable efforts to remediate such deficiencies. In the event that Insys or the Third Party Manufacturer disputes that such deficiencies relate to cGMPs, then Insys may refer the matter to the dispute resolution process provided by Section 12.8 of this Agreement. Mylan’s right to inspect production facilities under this Section 5.1 shall be limited to one (1) inspection per calendar year, unless deficiencies in cGMPs are being remediated pursuant to the immediately preceding sentence, in which case Mylan may conduct additional inspections upon reasonable notice until such deficiencies are remediated. Mylan agrees that it will not, directly or indirectly (through any other persons, entity or otherwise) develop, manufacture, sell, or market, any generic pharmaceutical product which has the same active ingredients and strength as the Drug Product using the information provided in the Insys ANDA or other confidential information provided to Mylan by Insys or by the Third Party Manufacturer pursuant to this paragraph.