Regulatory Correspondence definition
Regulatory Correspondence means all applications, submissions, filings, reports or other documents, submitted or required to be submitted to any Governmental Authority, including the FDA, including amendments or supplements to any such documents and correspondence and other submissions related thereto (including minutes and official contact reports relating to any communications with any Governmental Authority), annual reports, safety reports, including Adverse Event reports, other periodic reports, and electronic establishment registration and drug listing files, as well as all correspondence received from such Governmental Authority and regulatory and clinical files and data pertaining to the foregoing in possession of Sellers or their respective Affiliates, whether in paper or electronic form.
Regulatory Correspondence means any and all of the following: all applications, registrations, approvals, concurrences, and filings with, and other submissions and correspondence relating to any Acquired Asset, including to or from a United States or foreign patent office, any state counterpart, and any other Governmental Authority (in each case together with all supporting and background documentation).
Regulatory Correspondence shall have the meaning set forth in Section 1.1(c).
Examples of Regulatory Correspondence in a sentence
SUPPLIER shall have the opportunity to provide comments and advice in connection with such Regulatory Correspondence and DISTRIBUTOR shall, on request from SUPPLIER, provide SUPPLIER with details of such Regulatory Correspondence.
DISTRIBUTOR shall provide SUPPLIER with prior written notice of its contacts, liaisons, discussions, meetings, and correspondence with, and submissions to, any Government Authority to the extent relating to, or otherwise affecting, the Market Authorization of each Product (“Regulatory Correspondence”) and shall provide details of what will be, and what was, covered in such Regulatory Correspondence.
The Company shall promptly deliver to Parent copies of all Regulatory Correspondence received or reduced to written form from the date hereof through the Closing.
Sonus shall promptly deliver to OncoGenex copies of all Sonus Regulatory Correspondence received or reduced to written form between the date of this Agreement and the Effective Date.
OncoGenex shall promptly deliver to Sonus copies of all OncoGenex Regulatory Correspondence received or reduced to written form between the date of this Agreement and the Effective Date.
More Definitions of Regulatory Correspondence
Regulatory Correspondence means all applications, submissions, reports or other documents, submitted or required to submitted to the FDA, including but not limited to BLAs, amendments or supplements to any such applications, annual reports, safety reports, including adverse event reports, other periodic reports, and electronic establishment registration and drug listing files, as well as all correspondence received from the FDA, whether in paper or electronic form, and reports of telephone contacts with the FDA.
Regulatory Correspondence means all applications, submissions, filings, reports or other documents, submitted or required to be submitted to any Governmental Authority, including the FDA, including amendments or supplements to any such documents and correspondence and other submissions related thereto (including minutes and official contact reports relating to any communications with any Governmental Authority), annual reports, safety reports, including Adverse Event reports, other periodic reports, and electronic establishment registration and drug listing files, as well as all correspondence received from such Governmental Authority and regulatory and clinical files and data pertaining to the foregoing in possession or control of Sellers or their respective Affiliates, whether in paper or electronic form.
Regulatory Correspondence means all correspondence including but not limited to letters with Health Regulatory Authorities.
Regulatory Correspondence means any and all of the following: (i) all Regulatory Applications and all other applications, registrations, approvals, concurrences and filings with any Governmental Authority concerning or related to any Regulated Product or Device Regulation; and (ii) any other submissions, correspondence, or other communications relating to any Regulated Product or any Device Regulation, including any correspondence or communication to or from the FDA, any state counterpart, any Notified Body, or any other Governmental Authority (in each case together with all supporting and background documentation, and, with respect to FDA filings and submissions, identifying the type of the filing or submission (whether under a Regulatory Application procedure or otherwise)), including all warning letters, all vigilance reports, all MDRs, all correspondence relating to clinical activities, all responses to FDA audits, all CE technical or CE ▇▇▇▇ files, all facilities registration documentation and all device listing documentation.
Regulatory Correspondence has the meaning set forth in Section 4.17(g).
Regulatory Correspondence means any and all of the following to the extent that they relate to any Product or the Exploitation of any Product and are in the possession of GENAERA as of the Effective Date: all applications, registrations, approvals, concurrences and filings with, and other submissions and correspondence relating to, any Products to or from the FDA, any state counterpart, any European notified body and any other foreign Governmental Authority with similar authority, and, with respect to FDA filings and submissions, identifying the type of the filing or submission (whether under an IND or NDA or otherwise), including all warning letters, all vigilance reports, all adverse event reports, all correspondence relating to clinical activities, all responses to FDA audits, all European notified body audits, all responses to European notified bodies, all CE technical or CE Marking files, all facilities registration documentation and all device listing documentation.
Regulatory Correspondence means all applications, submissions, filings, reports or other documents, submitted or required to be submitted to any Governmental Authority, including the FDA, including amendments or supplements to any such documents and correspondence and other submissions related thereto (including minutes and official contact reports relating to any communications with any Governmental Authority), annual reports, safety reports, including adverse event reports, other periodic reports, and electronic establishment registration and drug listing files, as well as all correspondence received from such Governmental Authority and regulatory and clinical files and data pertaining to the foregoing in possession of Seller, whether in paper or electronic form.