Communication With Agencies. Until the Registrations are transferred to Buyer, Seller shall have responsibility for all communications with the FDA relating to the CV Products, and Seller will promptly provide Buyer with copies of all communications from the FDA with respect to the CV Products and/or the manufacture thereof, and Seller shall consult with Buyer and reflect the Buyer’s reasonable requests regarding all communications to the FDA with respect to the CV Products and/or the manufacture thereof, prior to making such communication with the FDA. After such transfer has been completed, Buyer shall have responsibility for all such communication it sends to or receives from any Governmental Entity in the applicable Territory concerning the CV Products.
Communication With Agencies. Until the Registrations are transferred to Buyer, Seller shall have responsibility for all communications with the FDA relating to the Product, and Seller will promptly provide Buyer with copies of all communications from the FDA with respect to the Product and/or the manufacture thereof, and Seller shall consult with Buyer and reflect the Buyer’s reasonable requests regarding all communications to the FDA with respect to the Product and/or the manufacture thereof, prior to making such communication with the FDA. After such transfer has been completed, Buyer shall have responsibility for all such communication it sends to or receives from any Governmental Entity in the Territory concerning the Product.
Communication With Agencies. Until the Registrations are transferred to Buyer, Buyer, as the Regulatory Agent, shall have responsibility for all communications with FDA and corresponding foreign bodies relating to the Products, and Company shall, and shall cause each of the Sellers to, promptly provide Buyer with copies of all communications to or from the FDA with respect to each Product and/or the manufacture thereof. After such transfer has been completed, Buyer shall have responsibility for all such communication and each party shall promptly provide the other with copies of any communications or contacts it sends to or receives from any other governmental agency in the Territory concerning the Products, other than communications by Buyer concerning promotional materials, with respect to which Buyer shall not be required to provide copies to Company.
Communication With Agencies. Centocor, as the party responsible for obtaining and maintaining Regulatory Approvals, will have the primary responsibility for communications with various regulatory agencies but will do so in collaboration with Schering-Plough. Schering-Plough will have the right to have representatives present at all meetings with regulatory agencies in the Territory concerning the Product. The foregoing notwithstanding, to the extent that Schering-Plough holds the market authorizations and Marketing Approvals in a country in the Territory, Schering-Plough shall have primary responsibility for such communications, and will do so in collaboration with Centocor, with Centocor having the right to have representatives present at any meetings with regulatory agencies in such countries concerning the Product. Each party will provide the other with copies of any significant communications (which are known to the party to exist and which the party can obtain copies of) with any regulatory agency throughout the world concerning the Product, including but not limited to reports of Adverse Events, but excluding communications pertaining to or included in the manufacturing master file.
Communication With Agencies. Until the Regulatory Materials are transferred to Purchaser following the Closing, Seller shall have responsibility for all communications with the FDA relating to the Products. After such transfer has been completed, Purchaser shall have responsibility for all such communications. Following the Closing, Seller shall promptly provide Purchaser with copies of any communications or contacts it sends to or receives from any other Governmental Entity concerning the Products.
Communication With Agencies. Until the Registrations are transferred to Buyer (a) Seller shall have responsibility for all communications with the FDA relating to the Product, (b) Seller will promptly provide Buyer with copies of all communications from the FDA with respect to the Product and/or the manufacture thereof, (c) Seller shall consult with Buyer and reflect the Buyer’s reasonable requests regarding all communications to the FDA with respect to the Product and/or the manufacture thereof, prior to making such communication with the FDA and (d) Buyer shall have the right to attend all meetings between Seller and the FDA with respect to the Product. After such transfer has been completed, Buyer shall have responsibility for all such communication it sends to or receives from any Governmental Entity in the applicable Territory concerning the Product.
Communication With Agencies. During the TERM, each party shall promptly provide the other party with copies of any significant communications to or from the FDA with respect to the PRODUCTS. From and after the date on which MEDICIS assumes responsibility for FDA regulatory matters for all PRODUCTS except the Loprox Cream and the LOPROX LOTION pursuant to Section 7.1 hereof, MEDICIS shall have responsibility for all communication with the FDA relating to the PRODUCTS other than the Loprox Cream and the LOPROX LOTION. From and after such date, the parties shall also cooperate at their own expense to ensure that (i) MEDICIS obtains, in a timely manner, all information concerning the PRODUCTS outside the TERRITORY necessary to meet its regulatory obligations in the TERRITORY, and (ii) that HMRI receives, in a timely manner, all information concerning the PRODUCTS inside the TERRITORY necessary to meet the regulatory obligations of HMR and their AFFILIATES outside the TERRITORY. Upon the earlier of (i) the PURCHASE DATE; or (ii) achievement of the LOPROX CREAM REGULATORY GOALS, MEDICIS and HMRI shall each send a letter to the FDA informing the FDA that MEDICIS is assuming all responsibility for FDA regulatory matters as to the Loprox Cream and MEDICIS shall thereafter do so. Upon the earlier of (i) the PURCHASE DATE; or (ii) achievement of the LOPROX LOTION REGULATORY GOALS, MEDICIS and HMRI shall each send a letter to the FDA informing the FDA that MEDICIS is assuming all responsibility for FDA regulatory matters as to the LOPROX LOTION and MEDICIS shall thereafter do so.
Communication With Agencies. As between the parties, CLIENT shall have the sole right to communicate with the appropriate Agencies relating to Product, and PROVIDER shall have no right to do so. PROVIDER shall provide CLIENT or its Affiliate, promptly, all information in PROVIDER’S (or its Affiliates’ or subcontractors’) possession or control concerning Product which is reasonably requested by CLIENT (or its Affiliates) and which is reasonably necessary to meet CLIENT’S (and its Affiliates’) regulatory obligations. PROVIDER shall, to the extent such notice is not prohibited by applicable Law, notify CLIENT within [***] of any Agency request for samples of Product or Manufacturing Batch records or any other information related to Product and will not provide such material, records or information until such notification is made to CLIENT.
Communication With Agencies. After the transfer of the Eton Registrations to BXXX has been completed, BXXX shall have responsibility for all such communications, and, until such time as the FDA approves the first Product, BXXX shall use commercially reasonable efforts to obtain approval by the FDA of a Product, including responding in a timely manner to any communications or requests from the FDA, provided that the application by BXXX (or its Affiliate) for any labelling changes to or for such Product, and any delays caused thereby, shall not constitute a failure by BXXX to use such commercially reasonable efforts. Until such time as the FDA approves the first Product, BXXX shall (i) promptly provide Eton with copies of any communications BXXX receives from the FDA concerning the Products, (ii) provide Eton with draft copies of all proposed communications from BXXX to the FDA with respect to the Products and (iii) permit Eton with a reasonable period of time (not to exceed [* * *]) to review and comment on such communications.
Communication With Agencies. In the Applicable Markets, Qualigen shall have responsibility for communications with the Regulatory Authorities concerning any required Regulatory Approvals, approval of Product related marketing and advertising materials, and Product quality matters.
