Common use of Regulatory Services Clause in Contracts

Regulatory Services. 2.7.1 In the event Seller, in the course of performing the Services, is required to submit any Regulatory Documentation to a Governmental Entity, Seller shall provide the Company a draft of such Regulatory Documentation as far in advance of the intended date of submission as reasonably possible and shall incorporate any comments thereto provided by the Company. Seller shall promptly notify the Company of any other Regulatory Documentation received from or to be submitted to any Governmental Entity, including correspondence, meeting minutes and summaries received by Seller from, or to be submitted by Seller to, any Governmental Entities, and shall provide the Company with copies thereof within five (5) Business Days after receipt thereof or, if such documents are prepared by Seller for submission to Governmental Entities, sufficiently in advance of such submission so as to allow the Company to review and finalize the content of such submission with Seller. Notwithstanding the foregoing, Seller shall not be required to delay a regulatory submission to any Governmental Entity or incorporate any comments of the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. For clarity, the terms of this Section 2.7.1 do not apply to correspondence with or reporting to Governmental Entities regarding adverse events or other safety information pertaining to the Compound or Products, which correspondence and reporting are governed by the terms of Section 2.8. 2.7.2 Seller shall provide the Company with reasonable advance notice of all meetings, conferences and discussions scheduled with any Governmental Entity concerning the Compound or Product, and shall incorporate any input from the Company in preparing for such meetings, conferences or discussions; provided, that Seller shall not be required to incorporate any input from the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. One or more representatives of the Company shall have the right to attend and participate in all such meetings, conferences, and discussions to the extent not prohibited by Applicable Law or the applicable Governmental Entity, and Seller shall facilitate such participation. If the Company elects not to participate in such meetings, conferences or discussions, Seller shall provide the Company with written summaries of such meetings, conferences or discussions as soon as reasonably practicable after the conclusion thereof.

Regulatory Services. 2.7.1 3.7.1 In the event Seller, in the course of performing the Services, is required to submit any Regulatory Documentation to a Governmental Entity, Seller shall provide the Company a draft of such Regulatory Documentation as far in advance of the intended date of submission as reasonably possible and shall incorporate any comments thereto provided by the Company. Seller shall promptly notify the Company of any other Regulatory Documentation received from or to be submitted to any Governmental Entity, including correspondence, meeting minutes and summaries received by Seller from, or to be submitted by Seller to, any Governmental Entities, and shall provide the Company with copies thereof within five (5) Business Days after receipt thereof or, if such documents are prepared by Seller for submission to Governmental Entities, sufficiently in advance of such submission so as to allow the Company to review and finalize the content of such submission with Seller. Notwithstanding the foregoing, Seller shall not be required to delay a regulatory submission to any Governmental Entity or incorporate any comments of the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. For clarity, the terms of this Section 2.7.1 do not shall apply to correspondence with with, inquiries or requests from, or reporting to Governmental Entities regarding adverse events drug reactions/experiences, safety data and other information concerning the safety of Product or other safety information pertaining to the Compound or Products, which correspondence and reporting are governed by the terms of Section 2.8(“Safety Information”). 2.7.2 3.7.2 Seller shall provide the Company with reasonable advance notice of all meetings, conferences and discussions scheduled with any Governmental Entity concerning the Compound or Product, and shall incorporate any input from the Company in preparing for such meetings, conferences or discussions; provided, that Seller shall not be required to incorporate any input from the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. One or more representatives of the Company shall have the right to attend and participate in all such meetings, conferences, and discussions to the extent not prohibited by Applicable Law or the applicable Governmental Entity, and Seller shall facilitate such participation. If the Company elects not to participate in such meetings, conferences or discussions, Seller shall provide the Company with written summaries of such meetings, conferences or discussions as soon as reasonably practicable after the conclusion thereof. 3.7.3 During the Initial Service Period, Seller shall be responsible for submitting the DSUR involving the Product (the “Product DSUR”) or the Executive Summary of the Product DSUR to applicable regulatory authorities, ethics committees, institutional review boards and investigative sites. Before submitting the final version of the Product DSUR, Seller shall send a draft to the Company for review and comment as far in advance of the intended date of submission as reasonably possible and Seller shall incorporate any comments thereto provided by the Company. Notwithstanding the foregoing, Seller shall not be required to incorporate any of the Company’s comments to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. Seller shall provide the final version of the Product DSUR to the Company at the same time that Seller submits the Product DSUR to any regulatory authorities. For purposes hereof, “Development Safety Update Report” or “DSUR” shall mean a periodic summary of safety information for regulatory authorities, including benefit-risk considerations, for a drug, biologic or vaccine under development or study, prepared by the sponsor of the clinical study(ies).