Common use of Facility Audits Clause in Contracts

Facility Audits. (a) Distributor and/or its nominee shall have the right to conduct an audit of any Approved Manufacturing Site(s) at which the Product is being Manufactured, of Manufacturing records (including batch records) relating to the production of such Product, if applicable, of the Contract Finisher(s)’ facility where Product is Packaged and of any correspondence between Cipher and the Regulatory Authority related to such Product or such facilities, in each case during business hours upon ten (10) Business Days prior written notice to Cipher but not more than once per calendar year during the Term of this Agreement, unless either Party, any Authority or any Third Party raises any questions about the quality of the Product which could have a material detrimental effect on the sales or use of the Product, in which case Distributor’s audit right shall not be subject to the foregoing annual limitation until the specific issue in question has been resolved, and Cipher shall promptly supply or cause its Approved Manufacturer to supply to Distributor all data and results relating to all Testing performed in connection with the issue in question.

Facility Audits. (a) Distributor and/or its nominee shall have the right to conduct an audit of any Approved Manufacturing Site(s) at which the Supplied Product is being Manufactured, of Manufacturing records (including batch records) relating to the production of such Product, if applicable, of the Contract Finisher(s)’ facility where Supplied Product is Packaged and of any correspondence between Cipher Can-Xxxx and the Regulatory Authority related to such Supplied Product or such facilities, in each case during business hours upon ten (10) Business Days prior written notice to Cipher but Can-Xxxx not more than once per calendar year Fiscal Year during the Term of this Agreement, unless either Party, any Authority or any Third Party raises any questions about the quality of the Supplied Product which could have a material detrimental effect on the sales or use of the Supplied Product, in which case Distributor’s audit right shall not be subject to the foregoing annual limitation until the specific issue in question has been resolved, and Cipher Can-Xxxx shall promptly supply or cause its Approved Manufacturer to supply to Distributor all data and results relating to all Testing performed in connection with the issue in question.