Regulatory Files means any IND, NDA or any other filings filed with any Regulatory Authority with respect to the Programs.
Regulatory Files means (a) all adverse event reports and other data, information and materials relating to adverse experiences and other safety issues with respect to the Product; (b) all material correspondence between Sun and any Governmental Authority relating to the Product, including any filings, submissions, safety reports or updates, complaint files and product quality reviews and all clinical or pre-clinical data derived from clinical studies conducted or sponsored by Sun; (c) the NDA; and (d) all other records, data and material held by Sun with respect to its compliance with the FDA Act, CDAPCA, CSA, PPACA and applicable regulations issued by a Regulatory Authority (both with respect to the Product and to Sun’s activities subject to the FDA Act, CDAPCA, CSA, PPACA or the applicable regulations issued by a Regulatory Authority) as set out in Schedule 1(bbb).
Regulatory Files means copies of all U.S. regulatory files with respect to (a) Marketing Authorizations for the Products, (b) all adverse event reports and other data, information and materials relating to adverse experiences and other safety issues submitted to any Governmental Entity with respect to any of the Products and (c) all material correspondence with any Governmental Entity relating to any of the Products, including any safety reports or updates, complaint files and product quality reviews.
Examples of Regulatory Files in a sentence
Without limiting the license rights granted under this ARTICLE 2, the Parties understand and agree that the assignment of such Regulatory Files does not include an assignment of any Licensed Intellectual Property.
The assignment of such Regulatory Files to the Transferee does not include an assignment of any Licensed Intellectual Property.
After such Regulatory Files are assigned to the Symphony Collaboration, Licensor shall have no further rights therein or obligations thereunder; provided, however, that during the [ * ] days following such assignment of Regulatory Files, at the Symphony Collaboration’s reasonable request and expense, Licensor shall use commercially reasonable efforts to provide the Symphony Collaboration or its designee with assistance in respect of such Regulatory Files.
Without limiting the license rights granted under ARTICLE 2, the Parties understand and agree that the assignment of such Regulatory Files does not include an assignment of any Licensed IP.
Symphony shall, at the reasonable request of Licensee and at Licensee’s expense, perform any acts that Licensee may reasonably deem necessary or desirable to evidence or confirm Licensee’s ownership interest in such Regulatory Files, including, but not limited to, making further written assignments in a form reasonably determined by Licensee.
More Definitions of Regulatory Files
Regulatory Files means any Drug Master File, IND, NDA, FDA minutes, Chemistry Manufacturing Controls, or any other filings filed with any Regulatory Authority with respect to a Program or any of XXx-0000, XXx-0000 or SLx-4090.
Regulatory Files means copies of all regulatory files with respect to (a) Marketing Authorizations for the Products, (b) manufacturing processes, batch records and quality assurance records within AMAG’s possession or control, (c) all adverse event reports and other data, information and materials relating to adverse experiences and other safety issues submitted to any Governmental Authority with respect to any of the Products and included in the global safety database for the Product, (d) clinical information related to investigational studies and sponsored studies within AMAG’s possession or control, and (e) all material correspondence with any Governmental Authority relating to any of the Products, including any safety reports or updates, complaint files and product quality reviews.
Regulatory Files means all files of the Seller with respect to (a) all clinical trial and marketing applications including all amendments, supplements, annual reports and all other written and verbal communications with all Regulatory Authorities, (b) all adverse event reports and other material data, information and materials relating to adverse experiences and other safety issues with respect to the Products, (c) all material correspondence between the Seller, on the one hand, and any Governmental Entity, on the other hand, relating to the Products, including any deficiencies or requests for information, safety reports or updates, complaint files and product quality reviews, traceability records, all clinical or pre-clinical data derived from clinical studies conducted or sponsored by or on behalf of Seller, and (d) all other material documents, reports, records and other data, information and materials relevant to compliance with the applicable Law relating to the Products and the Seller’s activities concerning the development, testing (including conducting clinical trials), regulatory approval, manufacture, processing, packaging, distribution, importation, marketing, storage, labeling, promotion, or sale of the Products.
Regulatory Files has the meaning ascribed thereto in the Purchase Agreement.
Regulatory Files with respect to the Product, (a) all documentation comprising the Drug Authorization, (b) correspondence and reports necessary to, or otherwise describing the ability to, commercially distribute, sell or market the Product submitted to or received from Governmental Bodies (including minutes and official contact reports relating to any communications with any Governmental Body) and relevant supporting documents submitted to or received from Governmental Bodies with respect thereto, including all regulatory drug lists, final versions of advertising and promotion documents, adverse event files and complaint files, and including the documents referenced in the complete regulatory chronology for the ANDA for the Product, including all supplements thereto and required regulatory files and data relating thereto in Seller’s possession or control on the date hereof, and (c) all documentation comprising methodology and “reasonable assumption” documentation (including historical methodologies) used to calculate any government price reports pertaining to the Product, and (d) data (including clinical and pre-clinical data) contained in any of the foregoing or otherwise in Seller’s possession or control on the date hereof. Regulatory Files excludes any and all proprietary and confidential information of Third Parties that may be included in any of the foregoing and the Product core data sheet, which shall be retained by Seller.
Regulatory Files means (a) all Product Adverse Drug Event Reports (PADER's) over the life of the Product and other data, information and materials relating to adverse experiences and other safety issues solely with respect to the Product, (b) all material correspondence between the Seller or any of the Seller's Affiliates, on the one hand, and any Governmental Entity, on the other hand, relating to the Product, including any safety reports or updates, complaint files and product quality reviews, all clinical or pre-clinical data derived from clinical studies conducted or sponsored by the Seller or its Affiliates, (c) all other documents, reports, records and other data, information and materials relating to the Product and relevant to compliance with the Act and all other Governmental Rules of the Product and the Seller's activities concerning the development, testing (including conducting clinical trials), manufacture, processing, distribution, importation, marketing, storage, labeling, packaging, promotion, or sale of the Product, (d) the original Product NDA and all supplements and amendments to such NDA over the life of the Product, and (e) all Product NDA Annual Reports (AR's) over the life of the Product.
Regulatory Files or “Regulatory Filings” shall mean:
(a) the technical, medical and scientific licenses, permits, registrations, authorizations and approvals (including applications therefor, supplements and amendments, pre-and post-approvals, and labeling approvals) of any Governmental Authority necessary for the development (including the conduct of clinical trials), manufacture, distribution, marketing, promotion, offer for sale, import, export or sale of a drug product or a drug substance;
(b) all technical, scientific, chemical, biological, pharmacological, and toxicological data as well as all clinical and preclinical reports (together with clinical data sets associated with such reports), and all validation documents and data; and
(c) all correspondence to or from Governmental Authorities.