FDA Approval Matters Clause Samples
The FDA Approval Matters clause establishes requirements related to obtaining and maintaining approval from the U.S. Food and Drug Administration (FDA) for a product or service. Typically, this clause outlines the obligations of a party to secure all necessary FDA clearances before commercializing a product, and may require ongoing compliance with FDA regulations throughout the term of the agreement. Its core function is to ensure that all products or services subject to FDA oversight are legally authorized for use or sale, thereby mitigating regulatory risk and protecting both parties from potential legal or financial consequences of non-compliance.
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FDA Approval Matters. (a) The Sellers shall notify the Buyers in writing of any communications with the FDA or any similar Governmental Authority in any other jurisdiction, related to, concerning, or associated with the Products, any Acquired Asset or the CIED Business, whether written or oral, as soon as reasonably practicable, but in no event later than three (3) Business Days after the receipt of such communication, and within such same time period, the Sellers shall provide the Buyers with copies of any such written communications and written summaries of any such oral communications.
(b) From time to time and at the reasonable request of any Buyer, the Sellers shall provide such Buyer(s) with updates concerning the progress of regulatory filings made or to be made by or on behalf of any Seller or any of its Affiliates or Representatives and the strategy for obtaining necessary regulatory authorizations, clearances or approvals to develop, research, manufacture, market and sell the Products.
FDA Approval Matters. The Company shall notify Purchaser of any substantive communications with the FDA or any corollary entity in any other jurisdiction, including outside of the United States of America, or any other Governmental Authority, whether written or oral, as soon as reasonably practicable, but in no event later than ten (10) days after the receipt of such substantive communication, and within such same time period, the Company shall provide the Purchaser with copies of any such written communications and written summaries of any such substantive oral communications. The Company shall immediately, and in any event within three (3) business days of the FDA Approval Date notify Purchaser, in writing and with reasonable specificity, of such FDA Approval, and shall provide copies of all relevant correspondence regarding receipt of FDA Approval.
FDA Approval Matters. (a) The Company shall notify Purchaser of any material communications with the FDA or any corollary entity in any other jurisdiction, including outside of the United States of America, or any other Governmental Body, whether written or oral, as soon as reasonably practicable, but in no event later than five (5) Business Days after the receipt of such communication, and within such same time period, the Company shall provide Purchaser with copies of any such written communications and written summaries of any such oral communications.
(b) From time to time and at the reasonable request of Purchaser, the Company shall provide Purchaser with updates concerning the progress of the Company’s regulatory filings and strategy for obtaining necessary regulatory approvals to market and sell the products of the Company. The Company shall furnish to Purchaser for its review and comment, and shall consult with Purchaser regarding, any material regulatory filing prior to finalizing such filings and delivering them to the relevant regulatory authorities.
FDA Approval Matters. (a) The Company shall notify Parent of any communications with the FDA or any corollary entity in any other jurisdiction, including outside of the United States, or any other Governmental Authority, whether written or oral, as soon as reasonably practicable, but in no event later than two (2) Business Days after the receipt of such communication, and within such same time period, the Company shall provide Parent with copies of any such written communications and written summaries of any such oral communications.
(b) From time to time and at the reasonable request of Parent, the Company shall provide Parent with updates concerning the progress of the Company’s regulatory filings and strategy for obtaining necessary regulatory Approvals to market and sell the LipoSonix Product. The Company shall reasonably consult with Parent regarding any material regulatory filing prior to finalizing such filings and delivering them to the relevant regulatory authorities.
FDA Approval Matters. (a) Prior to the Closing, Seller shall notify Buyer of any communications with the FDA or any Governmental Authority in any other jurisdiction, including outside of the United States, or any other Governmental Authority, whether written or oral, as soon as reasonably practicable, but in no event later than three (3) Business Days after the receipt of such communication, and within such same time period, Seller shall provide Buyer with copies of any such written communications and written summaries of any such oral communications.
(b) Prior to the Closing, from time to time and at the reasonable request of Buyer, Seller shall provide Buyer with updates concerning the progress of the Company’s regulatory filings and strategy for obtaining necessary regulatory Approvals to market and sell the LipoSonix Product. Seller shall reasonably consult with Buyer regarding any regulatory filing prior to finalizing such filings and delivering them to the relevant Governmental Authorities.
FDA Approval Matters. (a) During the Interim Period and except as prohibited by applicable Law, the Company shall provide Parent with an accurate and complete copy (or summary in the case of oral communications) of any communications with the FDA or any corollary entity in any other jurisdiction, including outside of the United States of America, whether written or oral, as soon as reasonably practicable, but in no event later than three (3) business days after the receipt of such communication.
(b) During the Interim Period and except as prohibited by applicable Law, (i) from time to time and at the reasonable request of Parent, the Company shall discuss with Parent the progress of regulatory filings made or to be made by the Company relating to the Company Products and any changes since the date hereof to the strategy for obtaining necessary Regulatory Approvals to manufacture, market and sell the Company Products, and (ii) the Company shall furnish to Parent for its review and comment, and shall consult with Parent regarding, any material regulatory filing relating to the Company Products prior to finalizing such filings and delivering them to the relevant Regulatory Authorities.
FDA Approval Matters. (a) The Company shall notify Parent of any material communications with the FDA or any corollary entity in any other jurisdiction, including outside of the United States of America, or any other Governmental Authority, whether written or oral, as soon as reasonably practicable, but in no event later than five (5) business days after the receipt of such communication, and within such same time period, the Company shall provide Parent with copies of any such written communications and written summaries of any such oral communications. For purposes of this Section 5.3(a), “material communications” with the FDA shall include any communications in which the FDA or any corollary entity provides feedback, comments, questions or other information to the Company which addresses, or is reasonably likely to impact, the development by the Company of the products to which such communication pertains or the timeline and prospects for approval of such products by the FDA or such corollary entity, as the case may be, whether positive or adverse.
(b) From time to time and at the reasonable request of Parent, the Company shall provide Parent with updates concerning the progress of the Company’s regulatory filings and strategy for obtaining necessary regulatory approvals to market and sell the products of the Company. The Company shall furnish such updates to Parent for its review and comment, and Parent shall provide such comments, if any, as soon as reasonably practicable but, in no event, later than thirty (30) business days after the receipt of such request for comment. The Company shall consult with Parent regarding any material regulatory filing prior to finalizing such filings and delivering them to the relevant regulatory authorities.