Regulatory Documents. 20 Section 4.8 Financial Statements......................................21 Section 4.9
Regulatory Documents. Gilead represents and warrants to EyeTech that:
Regulatory Documents. Each party will advise the other party hereto of its intention to change any Drug Product regulatory documents prior to submission of the document to any regulatory body. If the change affects the rights and obligations of a party hereto under this Agreement, such party may seek to review or alter any part of the document at any time within ten (10) business days after receipt of notification thereof; provided that if no alterations are submitted to the other party within such ten-day period, each party will be deemed to have consented to the documents, as amended.
Regulatory Documents. Lilly represents and warrants to Tularik that: -------------------- (a) Lilly has furnished Tularik with access to a complete copy of the United States Regulatory Documents for the Product, including all material amendments and supplements thereto; (b) Lilly is and was, at all times prior to the Effective Date, the lawful holder of all rights under the Regulatory Documents; (c) [ * ], Lilly has complied in all material respects with all applicable laws and regulations in connection with the preparation and submission to the relevant Regulatory Authorities of the Regulatory Documents; (d) the Regulatory Documents have been accepted by, and nothing has come to the attention of Lilly which has, or reasonably should have, led Lilly to believe that the Regulatory Documents are not in good standing with, the relevant Regulatory [ * ]=Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Regulatory Documents. Upon request by, and in mutual consultation with Client, Supplier shall be responsible for preparation of documentation on Manufacture of any products manufactured for Client as required for the Regulatory Submissions of Client, limited to Supplier’s activities under this agreement. Client shall provide portions of Regulatory Submissions, related to any products manufactured by Supplier for Client and Supplier’s, activities performed under this agreement, to Supplier for review and written consent, prior to submission to any Regulatory Authority. Client shall, upon submission to any Regulatory Authority, provide Supplier with current copies of portions of Regulatory Submissions. including amendments and supplements thereto, related to any products manufactured by Supplier for Client and Supplier’s activities performed under this agreement. Supplier will provide, in mutually agreed timelines, all other information related to any products manufactured by Supplier for Client that Client may reasonably request for its Regulatory Submissions, including any data for annual reports (e.g. annual stability reports). When a change is known to require, or has the potential to require a Regulatory Submission, Supplier with Client will develop a joint strategy to secure the appropriate regulatory approval prior to implementation of the change at Supplier and Client. For Change Control see section 3. Supplier shall be responsible for preparation of the Drug Master File related to any products manufactured for Client and submission of such documents to any Regulatory Authority, including maintaining such submissions (hereafter altogether called ‘DMF’).
Regulatory Documents. Each party will advise the other party hereto of its intention to change any Drug Product regulatory documents prior to submission of the document to any regulatory body. If the change affects the rights and obligations of a party hereto under this Agreement, such party may seek to review or alter any part of the document at any time within ten (10) business days after receipt of notification thereof; provided that if no alterations are submitted to the other party within such ten-day period, each party will be deemed to have consented to the alteration. CUMBERLAND shall reimburse FAULDING for all out-of-pocket expenses and reasonable internal costs of changes to Drug Product regulatory documents, subject to CUMBERLAND’s prior consent pursuant to Paragraph 5.5.
Regulatory Documents. (a) Since January 1, 1998, the Price Entities have timely filed all forms, reports, registration statements, schedules and other documents, together with any amendments required to be made with respect thereto, that were required to be filed with any Governmental Authority and have timely paid in full all fees and assessments due and payable in connection therewith, except in each case with respect to matters contested in good faith by the appropriate proceedings or for such failures to file or pay such amounts that would not, individually or in the aggregate, have a Price Material Adverse Effect.
Regulatory Documents. No later than [***] after the Effective Date, Amgen shall notify relevant Regulatory Authorities in the Territory of, and take all actions reasonably necessary to effect, the transfer of the Regulatory Documents to Anthera. Amgen and Anthera shall share equally in the out-of-pocket costs of such transfer. Following the completion of such transfer, Anthera shall be responsible for the filing of all further regulatory documents for the Licensed Product in the Field in the Territory, and for all contacts with Regulatory Authorities with respect to Licensed Products in the Territory within the Field. At Anthera’s request, Amgen may, at its sole discretion and election, provide reasonable support (including participation in regulatory discussions relating to the Licensed Products) to Anthera, at Anthera’s sole expense. If Amgen agrees to provide support/participation, Anthera shall pay Amgen for such support/participation at a rate of [***]/hour and Anthera shall also pay all of Amgen’s reasonable, documented external expenses, including travel, per diem and lodging with respect to such support or participation. Amgen shall invoice Anthera on a quarterly basis for such support and participation and expenses, and Anthera shall pay each such invoice within [***] of receipt.
Regulatory Documents. (a) Since April 30, 1993, Opgroup, the Opgroup Subsidiaries and the Identified Funds (other than the SBAM Funds) and, to the Knowledge of Opgroup, the SBAM Funds, have filed all Regulatory Documents, together with any amendments required to be made with respect thereto, that were required to be filed by them with any Governmental Authority, including the SEC, with respect to the Money Management Business.
Regulatory Documents. (a) Since November 15, 1994, PIMCO Advisors and each PIMCO Advisors Subsidiary has timely filed all Regulatory Documents, together with any amendments required to be made with respect thereto, that were required to be filed by them with any Governmental Authority, including the SEC.
