Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of a Party with regard to a Licensed Product in the Field, each Party agrees to cooperate with the other and the Regulatory Authority during such inspection or audit, including by allowing, to the extent practicable, a representative of the other Party to be present during the applicable portions of such inspection or audit to the extent it relates to the Development, Manufacture or Commercialization of a Licensed Product for use in the Field under this Agreement. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the receiving Party will promptly provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses; provided that the other Party, to the extent practicable, shall have the right to review and comment on such responses to the extent they cover or may be reasonably expected to adversely impact the Licensed Products in the Field in the Territory, and the Party that received the observations shall consider in good faith the comments made by such other Party. In the event the Parties disagree concerning the form or content of a response, the Party that received the observations will decide the appropriate form and content of the response. Without limiting the foregoing, each Party (and its Third Party subcontractors) shall notify the other Party within forty-eight (48) hours of receipt of a notification from a Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities used or proposed to be used for the Manufacture of Licensed Products for use in the Field under this Agreement; provided that such notification shall be given no later than twenty-four (24) hours prior to any such Regulatory Authority audit or inspection.
Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of either Party’s facility or a facility under contract with either Party with regard to the Product in the U.S. Territory, such Party shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which such Party will immediately provide to the other Party), such Party will prepare the response to any such observations. Such Party 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.
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. If a Regulatory Authority desires to conduct an inspection or audit of a Party with regard to a VEGF Product, each Party agrees to cooperate with the other and the Regulatory Authority during such inspection or audit, including by allowing, to the extent practicable, a representative of the other Party to be present during the applicable portions of such inspection or audit. Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of which the receiving Party will immediately provide to the other Party), the Party in receipt of the observations will prepare any appropriate responses that concern a VEGF Product, provided that the other Party shall have the right to review and comment on such responses, and such other Party shall consider in good faith the comments made by such Party. In the event the Parties disagree concerning the form or content of a response, the Party that received the observations will decide the appropriate form and content of the
Regulatory Inspection or Audit. The Parties agree that they will conduct all audits required under PDMA and, additionally, if a Regulatory Authority desires to conduct an inspection or audit of either Party’s facility or a facility under contract with either Party with regard to the Product in the Field in the Territory, such Party shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which such Party will promptly provide to the other Party), such Party will prepare the response to any such observations. Such Party 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.
Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit with regard to the Gen 1 Product or the Gen 2 Product of a Party’s facility or a facility under contract with a Party, such Party shall promptly notify the other Party. In such case, the audited Party shall permit and cooperate with such inspection or audit, and shall cause the contract facility to permit and cooperate with such Regulatory Authority during such inspection or audit. The other Party shall have the right to have a representative observe such inspection or audit and shall, if requested by the audited Party, assist the audited Party in preparing for, facilitating or enabling such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which the audited Party shall immediately provide to the other Party), the audited Party shall prepare a draft response to any such observations, in consultation with the other Party, and the Party that holds the Regulatory Materials in the applicable country or territory shall prepare and file the final response with such Regulatory Authority. Notwithstanding the above, Xxxxxxx obligations to DexCom under this Section 4.7 shall only apply with respect to United States Regulatory Authorities and then only so long as DexCom continues to own the United States Regulatory Approvals for Gen 1 Product. The obligations of DexCom under this Section 4.7 are in addition to any obligations of DexCom under the Supply Agreement.
Regulatory Inspection or Audit. If a Regulatory Authority in the Licensed Territory desires to conduct an inspection or audit with regard to the Product of Taiho’s facility or a facility under contract with Taiho in or for the Licensed Territory, Taiho shall permit and cooperate with such inspection or audit, and shall cause the contract facility to permit and cooperate with such Regulatory Authority during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority and Taiho shall promptly provide to Lung Tx a brief summary of such observations in English, or shall, upon Lung Tx’s written request and at Lung Tx’s expense, provide Lung Tx with an English translation of such observations, Taiho shall prepare the response to any such observations, and shall provide to Lung Tx an English summary of such response or shall, upon Lung Tx’s written request and at Lung Tx’s expenses, provide an English translation of such responses. Xxxxx 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 with regard to the Product of Lung Tx’s facility or a facility under contract with Lung Tx for the Licensed Territory, Lung Tx shall permit and cooperate with such inspection or audit, and shall cause the contract facility to permit and cooperate with such Regulatory Authority and Taiho during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority, Lung Tx shall prepare the response to any such observations, and shall provide a copy of such response to Taiho.
Regulatory Inspection or Audit. If a Regulatory Authority notifies the Company that it plans to conduct an inspection or audit of the Company’s facility or a facility of any Affiliate or Third Party subcontractor with regard to any Product, the Company shall notify Horizon as soon as practicable after receipt of such notification of such audit or inspection and provide Horizon with copies of any materials provided to it by the applicable Regulatory Authority. In addition, if a Regulatory Authority conducts an unannounced inspection or audit of the Company’s facility or a facility of any Affiliate or Third Party subcontractor with regard to any Product, the Company shall notify Horizon as promptly as practicable of such audit or inspection. The Company shall cooperate, and shall cause the Affiliate or Third Party subcontractor to cooperate, with such Regulatory Authority during such inspection or audit. Following any such inspection or audit, (i) the Company will provide Horizon with a copy of any inspection or audit observations of such Regulatory Authority and copies of any other written communications received from Regulatory Authorities with respect to such facilities in a timely manner after its receipt thereof, and (ii) the Company will provide Horizon with a copy of any proposed written response to any such observations or communications with reasonably sufficient time for Horizon’s review and comment, will consider in good faith any reasonable comments timely made by Horizon with respect to such proposed response, and will implement such timely comments to the extent commercially reasonable.
Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of 3SBio’s facility or a facility under contract with 3SBio with regard to the Product in the Licensed Territory, then 3SBio shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit, and 3SBio shall be solely responsible for all costs associated with any such inspection or audit. 3SBio shall provide advance notice of any such inspection or audit to AMAG, and AMAG shall have the right to be present at such inspection or audit at AMAG’s sole cost and expense. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which 3SBio will immediately provide to AMAG), 3SBio will provide a proposed response to any such observations to AMAG for review and comment, and shall consider AMAG’s comments in good faith. 3SBio 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.
Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of Lilly or Amylin with regard to Product or this Agreement, Lilly and Amylin each agrees to cooperate with the
