Common use of Regulatory Inspection or Audit Clause in Contracts

Regulatory Inspection or Audit. (a) If a Regulatory Authority desires to conduct an inspection or audit with regard to the Product of Collaborator's facility or a facility under contract with Collaborator in or for the Licensed Territory, Collaborator shall permit and cooperate with such inspection or audit, and shall cause the contract facility to permit and cooperate with such Regulatory Authority and Affymax during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which Collaborator shall immediately provide to Affymax), Collaborator shall prepare the response to any such observations, and shall provide a copy of such response to Affymax that has been translated into English. Collaborator agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate applicable Laws. If a Regulatory Authority in the Licensed Territory desires to conduct an inspection or audit of Affymax's facility, or a facility under contract with Affymax, with regard to the Product in the Licensed Territory, Affymax shall cooperate and cause the contract facility to cooperate with such Regulatory Authority and Collaborator during such inspection or audit. Collaborator shall have the right to have a representative observe such inspection or audit and Collaborator shall, if requested by Affymax, assist Affymax in preparing for, facilitating and/or enabling such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority, Collaborator shall provide a copy of such observations, Affymax shall prepare a draft response to any such observations in English, in consultation with Collaborator, and Collaborator shall prepare and file the final response with such Regulatory Authority. (b) Audit of Product Manufacturer. Collaborator shall notify Affymax within forty-eight (48) hours of receipt of notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities being used to conduct Finished Manufacture of the Finished Product. Collaborator shall also provide Affymax with copies of any written communications received from Regulatory Authorities with respect to such facilities within seventy-two (72) hours of receipt.

Regulatory Inspection or Audit. (a) If a Regulatory Authority desires to conduct an inspection or audit with regard respect to the Product of Collaborator's Serenity’s facility or a facility under contract with Collaborator in Serenity where a Product is manufactured, packaged, stored, and developed or has been developed, including without limitation Clinical Study sites, central laboratories, data management organization, and/or any vendor Serenity has used for the Licensed TerritoryDevelopment of Products (a “Facility Inspection”), Collaborator Serenity shall permit and cooperate with such inspection or auditFacility Inspection, and shall cause the such contract facility to permit and cooperate with such Regulatory Authority and Affymax Allergan during such Facility Inspection. Upon receipt of notice or any other indication whatsoever of any Regulatory Authority of any Facility Inspection, and in no event more than forty-eight (48) hours after receiving such notice, Serenity will promptly notify Allergan thereof. Serenity will permit a representative of Allergan to be present during applicable portions of the inspection, and Serenity will provide Allergan with all documents and any other relevant information available about the progress of the inspection. Serenity will provide copies of any inspection reports or auditnotifications received during or after the inspection, including any notices of observation the facility receives or other reports of the outcome of such inspection. Serenity shall obtain and reveal to Allergan, all inspection reports for itself, its Affiliates, or for any of its vendors, suppliers, or other Third Parties by any Government Authority arising from a Facility Inspection, and the progress and outcome of any Facility Inspection as it may relate to the Product. Following receipt of the inspection or audit observations of such Regulatory Authority (Authority, Serenity shall provide a copy of which Collaborator shall immediately provide such observations to Affymax)Allergan, Collaborator Serenity shall prepare a draft ***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. response to any such observations, in consultation with Allergan, and Serenity shall provide a copy prepare and file the final response with such Regulatory Authority, subject to Allergan’s prior approval of such response to Affymax that has been translated into Englishfinal response. Collaborator Serenity agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate applicable Laws. If a Regulatory Authority in the Licensed Territory desires to conduct an inspection or audit of Affymax's facility, or a facility under contract with Affymax, with regard to the Product in the Licensed Territory, Affymax shall cooperate and cause the contract facility to cooperate with such Regulatory Authority and Collaborator during such inspection or audit. Collaborator shall have the right to have a representative observe such inspection or audit and Collaborator shall, if requested by Affymax, assist Affymax in preparing for, facilitating and/or enabling such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority, Collaborator shall provide a copy of such observations, Affymax shall prepare a draft response to any such observations in English, in consultation with Collaborator, and Collaborator shall prepare and file the final response with such Regulatory Authoritycommitment violates Applicable Laws. (b) Audit of Product Manufacturer. Collaborator shall notify Affymax within forty-eight (48) hours of receipt of notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities being used to conduct Finished Manufacture of the Finished Product. Collaborator shall also provide Affymax with copies of any written communications received from Regulatory Authorities with respect to such facilities within seventy-two (72) hours of receipt.

Regulatory Inspection or Audit. (a) If a Regulatory Authority desires to conduct an inspection or audit with regard to the Product of Collaborator's ’s facility or a facility under contract with Collaborator in or for the Licensed Territory, Collaborator shall permit and cooperate with such inspection or audit, and shall cause the contract facility to permit and cooperate with such Regulatory Authority and Affymax during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which Collaborator shall immediately provide to Affymax), Collaborator shall prepare the response to any such observations, and shall provide a copy of such response to Affymax that has been translated into English. Collaborator agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate applicable Laws. If a Regulatory Authority in the Licensed Territory desires to conduct an inspection or audit of Affymax's ’s facility, or a facility under contract with Affymax, with regard to the Product in the Licensed Territory, Affymax shall cooperate and cause the contract facility to cooperate with such Regulatory Authority and Collaborator during such inspection or audit. Collaborator [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. shall have the right to have a representative observe such inspection or audit and Collaborator shall, if requested by Affymax, assist Affymax in preparing for, facilitating and/or enabling such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority, Collaborator shall provide a copy of such observations, Affymax shall prepare a draft response to any such observations in English, in consultation with Collaborator, and Collaborator shall prepare and file the final response with such Regulatory Authority. (b) Audit of Product Manufacturer. Collaborator shall notify Affymax within forty-eight (48) hours of receipt of notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities being used to conduct Finished Manufacture of the Finished Product. Collaborator shall also provide Affymax with copies of any written communications received from Regulatory Authorities with respect to such facilities within seventy-two (72) hours of receipt.