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. (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. 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.
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. 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. As of the Effective Date, to AMAG’s Best Knowledge, neither AMAG nor any officer, employee or agent of AMAG has knowingly made an untrue statement of a material fact to any Regulatory Authority in or outside the Licensed Territory with respect to the Product or knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority in or outside the Licensed Territory with respect to the Product; and
Regulatory Authority Communications. As between the Parties, Xxxxxxxxx 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. Genevant shall use Commercially Reasonable Efforts to provide assistance reasonably requested by Xxxxxxxxx in connection with the foregoing activities, subject to compensation from Gritstone at the FTE Rate.
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. In addition to its obligations under this Agreement, each Party shall disclose to the other Party (and each Party shall have the right to subsequently disclose to its Affiliates and subcontractors and licensees, specifically those licensees of the Product in the case of Aimmune, who are bound by obligations of confidentiality substantially consistent with those in ARTICLE 12) the following regulatory information: All material information pertaining to material adverse or potentially material adverse actions taken or that may be taken by Regulatory Authorities, in connection with the Product or Antibody, including any notice, audit notice, notice of initiation by Regulatory Authorities of investigations, detentions, seizures or injunctions concerning the Product or Antibody, notice of violation letter (i.e., an untitled letter), warning letter, service of process or other equivalent communication or action. Without limiting the generality of the foregoing, each Party shall promptly, but in any event within [***] ([***]) Business Days, inform the other Party of any material adverse or potentially material adverse actions taken or that may be taken by Regulatory Authorities in connection with the Product or Antibody, including any notice, audit notice, notice of initiation by Regulatory Authorities of investigations, detentions, seizures or injunctions concerning the Product or Antibody, notice of violation letter (i.e., an untitled letter), warning letter, service of process or other equivalent communication or action.
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.
