Common use of Audit of facilities by Regulatory Authority Clause in Contracts

Audit of facilities by Regulatory Authority. If Regulatory Authority requests an inspection or audit of Sublicensor’s or its Third Party Manufacturer's facility and Sublicensee with regard to the intermediates, Compound or Product (including a manufacturing, storage or testing facility for each) anywhere in the world, Sublicensor shall use good faith efforts to cooperate with Sublicensee and Regulatory Authority in fulfilling such request (and, if applicable, shall use good faith efforts to cause its Third Party Manufacturer to cooperate with Regulatory Authority and Sublicensee in fulfilling such requested inspection or audit). Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which Sublicensor shall promptly provide to Sublicensee), Sublicensor shall use good faith and reasonable efforts to consult with Sublicensee and prepare the response to any such observations, in English.

Appears in 2 contracts

Samples: Sublicense Agreement (Keryx Biopharmaceuticals Inc), Sublicense Agreement (Keryx Biopharmaceuticals Inc)

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Audit of facilities by Regulatory Authority. If Regulatory Authority requests an inspection or audit of Sublicensor’s or its Third Party Manufacturer's ’s facility and Sublicensee with regard to the intermediates, Compound or Product (including a manufacturing, storage or testing facility for each) anywhere in the world, Sublicensor shall use good faith efforts to cooperate with Sublicensee and Regulatory Authority in fulfilling such request (and, if applicable, shall use good faith efforts to cause its Third Party Manufacturer to cooperate with Regulatory Authority and Sublicensee in fulfilling such requested inspection or audit). Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which Sublicensor shall promptly provide to Sublicensee), Sublicensor shall use good faith and reasonable efforts to consult with Sublicensee and prepare the response to any such observations, in English.

Appears in 2 contracts

Samples: Sublicense Agreement (Keryx Biopharmaceuticals Inc), Sublicense Agreement (Keryx Biopharmaceuticals Inc)

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