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. (b) Cipher and/or its nominee shall have the right to conduct an audit of the facilities and records of Distributor, and/or its SubDistributors relating to the Marketing, Testing, and storage of the Product and of any correspondence between Distributor, its SubDistributors and the Regulatory Authority related to the Product or such facilities, during business hours upon ten (10) Business Days prior written notice to Distributor not more than once per calendar year during the Term of this Agreement, unless any Authority or any Third Party raises any questions about the quality of the Product or the Testing, Marketing or storage thereof which could have a material detrimental effect on the sales or use of the Product, in which case Cipher’s audit right shall not be subject to the foregoing annual limitation until the specific issue or question has been resolved, and Distributor shall promptly supply to Cipher all data and results relating to all Testing performed by Distributor on the Product.

Facility Audits. (a) Distributor American Regent and/or its nominee shall have the right to conduct an audit of any Approved Manufacturing Site(s) manufacturing site 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 Manufactured during business hours upon ten (10) Business Days prior written notice to Cipher but CytoDyn not more than once per calendar year during the Term of this Agreement, unless either Party, any Authority the FDA or any Third Party raises any questions about the quality of a Product which could have a material detrimental effect on the sales or use of a Product, in which case American Regent’s audit right shall not be subject to the foregoing limitation until the specific issue in question has been resolved, and CytoDyn shall promptly supply to American Regent all data and results relating to all Testing performed in connection with the issue in question. CytoDyn shall be responsible for its own costs, and those of its contract manufacturers, for a first audit by American Regent hereunder. American Regent shall bear the fees and costs of any subsequent audit, including the fees and costs payable by CytoDyn to any Third-Party subcontractor that Manufactures the Product. (b) CytoDyn and/or its nominee shall have the right to conduct an audit of the facilities and records of American Regent relating to the Marketing, Testing, and storage of the Product which and of any correspondence between American Regent and the FDA related to the Product or such facilities, during business hours upon reasonable prior written notice to American Regent not more than once per any twenty-four month period during the Term of this Agreement, unless any Official Body reasonably believes that American Regent may be in material breach of its obligations under Article 3 or Section 4.4 or Applicable Laws governing the Marketing of Product that could have a material detrimental effect on the sales or use of the Product, in which case DistributorCytoDyn’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. (b) Cipher and/or its nominee shall have the right to conduct an audit of the facilities and records of Distributor, and/or its SubDistributors relating to the Marketing, Testing, and storage of the Product and of any correspondence between Distributor, its SubDistributors and the Regulatory Authority related to the Product or such facilities, during business hours upon ten (10) Business Days prior written notice to Distributor not more than once per calendar year during the Term of this Agreement, unless any Authority or any Third Party raises any questions about the quality of the Product or the Testing, Marketing or storage thereof which could have a material detrimental effect on the sales or use of the Product, in which case Cipher’s audit right shall not be subject to the foregoing annual limitation until the specific issue or question has been resolved, and Distributor American Regent shall promptly supply to Cipher CytoDyn all data and results relating to all Testing performed by Distributor American Regent on the Product.

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-▇▇▇▇ 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-▇▇▇▇ 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-▇▇▇▇ 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. (b) Cipher Can-▇▇▇▇ and/or its nominee shall have the right to conduct an audit of the facilities and records of Distributor, Distributor and/or its SubDistributors and/or their Affiliates relating to the Marketing, Testing, and storage of the Supplied Product and of any correspondence between Distributor, Distributor and/or its SubDistributors and/or their Affiliates and the Regulatory Authority related to the Supplied Product or such facilities, during business hours upon ten (10) Business Days prior written notice to Distributor not more than once per calendar year Fiscal Year during the Term of this Agreement, unless any Authority or any Third Party raises any questions about the quality of the Supplied Product or the Testing, Testing and Marketing or storage thereof which could have a material detrimental effect on the sales or use of the Supplied Product, in which case Cipher’s Can-▇▇▇▇’▇ audit right shall not be subject to the foregoing annual limitation until the specific issue or question has been resolved, and Distributor shall promptly supply to Cipher Can-▇▇▇▇ all data and results relating to all Testing performed by Distributor on the Supplied Product.