Regulatory Documents. (a) Since January 1, 1998, the Company, its Subsidiaries, the Non-Registered Funds and, to the Knowledge of the Symphony Parties, the Funds, 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, including the SEC and the NASD, and have timely paid in full all fees and assessments due and payable in connection therewith other than such failures to timely file or pay that would not reasonably be expected to result in a Company Material Adverse Effect. Each of the Company and its Subsidiaries is, and has been since the later of its inception and January 1, 1995, duly registered as an investment adviser under the Advisers Act and under all applicable state statutes (if required to be so registered under Applicable Law) and duly registered and licensed under all Applicable Laws or exempt therefrom, except as would not reasonably be expected to have a Company Material Adverse Effect. Section 2.6 of the Company Disclosure Schedule lists the jurisdictions in which the Company and its Subsidiaries are registered as investment advisers or are required to give notice that they are acting as investment advisers and in which they are required to be registered or licensed in any other capacity pursuant to any of the Securities Laws. Each such registration or license is, and when required by Applicable Law has been, in full force and effect.
(b) As of their respective dates, the Regulatory Documents of the Company, its Subsidiaries, the Non-Registered Funds and, to the Knowledge of the Symphony Parties, the Funds, complied in all material respects with Applicable Laws, and none of such Regulatory Documents (other than those relating to the Funds), as of their respective dates or as of such other dates as so required under Applicable Law, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. The Company has previously delivered to Buyer a true, correct and complete copy of each such Regulatory Document filed with the SEC by the Company, its Subsidiaries and the Non-Registered Funds after January 1, 1998 and prior to the date hereof.
Regulatory Documents. 20 Section 4.8 Financial Statements......................................21 Section 4.9
Regulatory Documents. 3.01 SUPPLIER is responsible for maintaining the appropriate registration documents for the PRODUCT (i.e. dossier for CEP, DMF or equivalent) in countries where these documents have been submitted already. ☐ ☒ ☐
3.02 Upon mutual agreement with CUSTOMER, SUPPLIER will prepare and submit registration documents in countries where SUPPLIER has not yet registered the product. ☐ ☒ ☐
3.03 SUPPLIER is responsible for all regulatory contacts with the relevant regulatory authority with jurisdiction over the PRODUCT. ☐ ☒ ☐
3.04 SUPPLIER will provide current information to CUSTOMER Affiliates reasonably requested for submission of any regulatory dossier by CUSTOMER Affiliates for finished drug products made from PRODUCT. Such information will include either access to CEP (including the appropriate stability data for the respective PRODUCT, if no retest date is defined in the CEP), or applicants’ part to DMF, or equivalent. ☐ ☒ ☐
3.05 CUSTOMER Affiliates are responsible for submitting the regulatory dossier for the Marketing Authorization Application associated with any finished drug product made from the respective PRODUCT. Such regulatory dossier, as it pertains to SUPPLIER, will refer to SUPPLIER’s CEP, DMF or equivalent, where applicable. ☒ ☐ ☐
Regulatory Documents. Gilead represents and warrants to EyeTech that:
(a) Gilead has furnished EyeTech with access to a complete copy of the United States Regulatory Documents for the Product, including all material amendments and supplements thereto;
(b) the Regulatory Documents have been accepted by, and Gilead has received no notice that the Regulatory Documents are not in good standing with, the relevant Regulatory Authorities;
(c) to its knowledge, Gilead has filed with the relevant Regulatory Authorities all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to the Regulatory Documents which are material;
(d) Gilead has received no written notice of any regulatory action by the relevant Regulatory Authorities which may reasonably be expected to have a material adverse effect on the ability of a Party to obtain Regulatory Approval for Products based upon the Regulatory Documents.
Regulatory Documents. Lilly represents and warrants to Versicor that: (a) Lilly has furnished Versicor 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) to the best of Lilly's knowledge, 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 approved 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 relevant regulatory authorities; (e) Lilly has filed with the relevant regulatory authorities all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to the Regulatory Documents which are material; and (f) there is no pending or overtly threatened action by relevant regulatory authorities which will have a material adverse effect on the Regulatory Documents. Except for the representations contained in this Section 5.7, upon which Versicor is relying (which Lilly hereby acknowledges), Versicor has had a reasonable opportunity to review and evaluate the Regulatory Documents and Versicor is relying solely upon its own judgment and experience in connection therewith.
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. 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. 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. (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.
(b) As of their respective dates, the Regulatory Documents of the Price Entities complied in all material respects with Applicable Law, and none of such Regulatory Documents, as of their respective dates or as of such other dates so required under Applicable Law, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading, except as would not, individually or in the aggregate, have a Price Material Adverse Effect.
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.
