FDA and Other Regulatory Correspondence Sample Clauses

FDA and Other Regulatory Correspondence. Collegium shall be responsible for fulfilling all applicable notice requirements with FDA regarding the Marketing of the Products and the appointment of Hikma as distributor of the Products. Each Party shall promptly inform the other of any correspondence from the FDA or other regulatory authority, or the results of any inspections by the FDA or other regulatory authority, that would reasonably be expected to materially affect its ability to meet its obligations under this Agreement. Additionally, to the extent required by Applicable Law and requested by Hikma, Collegium agrees to file all advertising and marketing collateral and other documentation requested to be utilized by Hikma in connection with and regarding the Products, with the FDA Office of Prescription Drug Promotion within [***] business days from the date of receipt of such request from Hikma.
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Related to FDA and Other Regulatory Correspondence

  • Reports The Depositary shall make available for inspection by Owners at its Office any reports and communications, including any proxy solicitation material, received from the Company which are both (a) received by the Depositary as the holder of the Deposited Securities and (b) made generally available to the holders of those Deposited Securities by the Company. The Company shall furnish reports and communications, including any proxy soliciting material to which this Section applies, to the Depositary in English, to the extent those materials are required to be translated into English pursuant to any regulations of the Commission.

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  • Environmental Matters Except as, in the aggregate, could not reasonably be expected to have a Material Adverse Effect:

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