Regulatory Authority Communications. (a) In the event CMO receives any correspondence from any Regulatory Authority relating to a Biologic, or any notice of inspection or any inspection visit by any Regulatory Authority relating to a Biologic, CMO shall notify Client thereof in writing as promptly as practicable but in no event later than within the time frames agreed in the Quality Agreement (if applicable). CMO shall keep Client timely informed of any written observations (or any other written communication) by such Regulatory Authority that relate to a Biologic and of CMO’s response to any such observation. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 406 of the Securities Exchange Act of 1933, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
Regulatory Authority Communications. Gritstone shall be solely responsible for initiating and responding to any communications related to any Product from any Regulatory Authority, including meetings with any Regulatory Authorities, at its sole cost and expense. Arbutus shall provide any assistance reasonably requested by Gritstone in connection with the foregoing activities. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Regulatory Authority Communications. Alexion shall be solely responsible for initiating and responding to any communications related to any Product from any Regulatory Authority, including meetings with any Regulatory Authorities.
Regulatory Authority Communications. Client shall be responsible for handling all complaints and communications from Regulatory Authorities with respect to the Product(s). Paragon shall maintain a system for investigating complaints related to the manufacture of the Product(s) by Paragon and shall investigate all such complaints and will cooperate in resolving and responding to such communications to the extent they pertain to the Product’s manufacture and such cooperation is reasonably requested by Client. Client shall reimburse Paragon for all reasonable costs and expenses incurred by Paragon in connection with the performance of Paragon’s obligations under this Section 7.8.2., but only to the extent that (a) the relevant documentation is not specified or contemplated in the Project Plan or produced by Paragon in the ordinary course of business, and (b) Paragon has not made any errors in the manufacture of the Product or in the preparation of the relevant documentation, which errors were the cause for the Regulatory Authority complaint or communication.
Regulatory Authority Communications. (a) The Company shall be solely responsible for initiating and responding to any communications related to any Product from any Regulatory Authority, including meetings with any Regulatory Authorities, at its sole cost and expense. Arbutus shall provide any assistance reasonably requested by the Company in connection with the foregoing activities.
Regulatory Authority Communications. Photocure has not received from any Regulatory Authority any written notice regarding the approvability or approval of any Lumacan Product. No Lumacan Product has been withdrawn, suspended or discontinued by Photocure as a result of any action by any Regulatory Authority, either within or outside the United States (whether voluntarily or otherwise). With respect to Lumacan Products, no officer, employee or, to the knowledge of Photocure and its Affiliates, agent of Photocure has made any untrue statement of a material fact or a fraudulent statement to any Regulatory Authority, failed to disclose any material fact required to be disclosed to any Regulatory Authority, or committed an act, made a statement or failed to make a statement that, at the time such act, statement or omission was made, could reasonably be expected to provide a basis for the FDA to invoke the FDA’s policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy of any Regulatory Authority, nor has any director, officer, employee or, to the knowledge of Photocure and its Affiliates, agent of Photocure or its Affiliates been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a(a) (or any similar law or regulation) or authorized by 21 U.S.C. Section 335a(b) (or any similar law or regulation).
Regulatory Authority Communications. Sarepta shall be primarily responsible for communicating with any Regulatory Authority having jurisdiction anywhere in the world regarding the Lead DMD Product; provided, that Sarepta shall keep the JSC reasonably and timely informed of all such relevant communications regarding the Lead DMD Product or its components; and Catalent shall, where requested by Sarepta to do so, assist Sarepta in communications as they pertain to the Manufacture of Bulk Drug Substance and/or Drug Product, including but not limited to provision of documentation and other evidence, preparation for and participation in any inspection and conduct of any other activities necessary to facilitate the communications between Sarepta and the Regulatory Authority. Catalent shall be responsible for communicating with any Regulatory Authority having jurisdiction over the Catalent Facility regarding matters specifically related to the Catalent Facility; provided, that Catalent shall, as promptly as practicable but in no event later than the time frames agreed in the Quality Agreement, notify Sarepta in the event that Catalent communicates, or intends to communicate, either on its own initiative in accordance with this Agreement or as a result of such a Regulatory Authority initiating contact with Catalent that may affect or involve operations or other activities associated therewith.
Regulatory Authority Communications. As between the Parties, Passage Bio shall be solely responsible for communicating with any Regulatory Authority having jurisdiction anywhere in the world regarding the Passage Bio Products; provided, that [*]; and Catalent shall, where requested by Passage Bio to do so, assist Passage Bio in communications as they pertain to the Manufacture of Bulk Drug Substance and/or Drug Product, including but not limited to provision of documentation and other evidence, preparation for and participation in any inspection and conduct of any other activities necessary to facilitate the communications between Passage Bio and the Regulatory Authority. Catalent shall be responsible for communicating with any Regulatory Authority having jurisdiction over the BWI Facility regarding matters related to the BWI Facility; provided, that Catalent shall, as promptly as practicable but in no event later than the timeframes agreed in the Quality Agreement, notify Passage Bio (and reasonably consult with Passage Bio in advance of any such communications) in the event that Catalent communicates, or intends to communicate, with a Regulatory Authority either on its own initiative in accordance with this Agreement or as a result of such Regulatory Authority initiating contact with Catalent, regarding matters that may affect or involve operations or other activities associated Passage Bio Products.
Regulatory Authority Communications. Baylor will provide Cell Medica with copies of all written communications received by Baylor from any Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Licensed Future Product (if any) or Future Technology (if any) promptly upon Baylor’s receipt thereof and, for verbal communications, shall provide Cell Medica with a written summary thereof promptly after such verbal communication. Baylor shall contemporaneously provide Cell Medica with a copy of any written communication from Baylor to a Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Future Product or Future Technology. Where Baylor is required or intends to respond to any communication from a Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Future Product or Future Technology, to the extent practicable, Baylor shall provide Cell Medica with a copy of such communication and the proposed response sufficiently in advance of the date that such response is to be submitted, in order to permit Cell Medica to review and comment upon such response. To the extent permitted by Applicable Laws, Baylor may, in its reasonable judgment, incorporate such Cell Medica comments into such response prior to submission.
Regulatory Authority Communications. Baylor will provide Kuur with copies of all written communications received by Baylor from any Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Licensed Future Product (if any) or Future Technology (if any) promptly upon Baylor's receipt thereof and, for verbal communications, shall provide Kuur with a written summary thereof promptly after such verbal communication. Baylor shall contemporaneously provide Kuur with a copy of any written communication from Baylor to a Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Future Product or Future Technology. Where Baylor is required or intends to respond to any communication from a Regulatory Authority relating to the Development Plan or to any Licensed Product, Licensed Technology, Future Product or Future Technology, to the extent practicable, Baylor shall provide Kuur with a draft copy of such communication and the proposed response sufficiently in advance of the date that such response is to be submitted, in order to permit Kuur to review and comment upon such response. To the extent permitted by Applicable Laws, Baylor may, in its reasonable judgment, incorporate such Kuur comments into such response prior to submission. Kuur may review any adverse event data or reports for pharmacovigilance as part of its GCP and regulatory compliance.
