Information for Regulatory Applications. The information furnished or to be furnished by Seller to Purchaser for the purpose of enabling Purchaser to complete and file applications with any regulatory body is or will be true and complete in all material respects as of the date so furnished.
Information for Regulatory Applications. Upon Equillium’s written request, Biocon shall provide to Equillium copies of the complete Master Batch Records and specific Manufacturing SOPs and updates as defined in the Quality Agreement, copies of the relevant documents identifying any Biocon technology used in the Manufacture of Clinical Material under the Manufacturing SOPs, and all CMC Data. Equillium has the right to review and copy the executed, completed Batch Records for each Batch, as needed for Equillium to prepare the Chemistry, Manufacturing and Controls (CMC) sections for any Regulatory Filing that Equillium (or its Affiliate or Sublicensee) intends to file or for any other appropriate regulatory purpose relating to ITO or Product. All such Information shall be provided in English. Biocon shall prepare and maintain the Batch Records for each Batch of Clinical Material Manufactured hereunder, and shall provide Equillium access to such Batch Records for review and inspection, and shall provide copies thereof to Equillium, at Equillium’s expense for actual out-of-pocket copying costs, if so requested by Equillium.
Information for Regulatory Applications. (a) To the extent permitted by applicable Law, WTSB shall prepare and furnish SPFI with all information concerning WTSB (including information relating to its directors, officers and Shareholders as may be reasonably requested) that is required for inclusion in any application, statement or document to be made or filed by SPFI with any Governmental Authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. WTSB shall fully cooperate with SPFI in the filing of any applications, statements or other documents necessary to complete the transactions contemplated by this Agreement. WTSB shall have the right to review in advance, and to the extent practicable consult with SPFI, in each case subject to applicable Laws relating to the exchange of information, with respect to all written information submitted to any Governmental Authority in connection with the transactions contemplated by this Agreement, but SPFI shall not be required to provide WTSB with confidential portions of any filing with a Governmental Authority. In exercising the foregoing right, WTSB agrees to act reasonably and as promptly as practicable.
(b) As soon as practicable following the Execution Date, WTSB will prepare and file all necessary applications for which it is responsible with and provide all necessary notices to any appropriate Governmental Authorities having jurisdiction over WTSB with respect to the transactions contemplated by this Agreement. WTSB shall pay all requisite filing fees and other expenses associated with such applications and notices to such Governmental Authorities. WTSB shall promptly furnish SPFI and its counsel with copies of all such regulatory filings and all correspondence for which confidential treatment has not been requested. WTSB shall use its Commercially Reasonable Efforts to obtain all Required Approvals and any other approvals from third parties, including those listed on Schedule 4.13 of the Disclosure Schedules, at the earliest practicable time.
(c) WTSB agrees that none of the information supplied or to be supplied by WTSB for inclusion or incorporation by reference in (i) the Proxy Statement and any amendment or supplement thereto, at the date(s) of mailing to Shareholders and at the time of the WTSB Meeting, and (ii) any other filings made under applicable federal or Texas banking or securities Laws, shall contain any untrue statement of a material fact or omit to state any material fact requ...
Information for Regulatory Applications. FFFC shall prepare and maintain a DMF in the Territory for the API manufactured hereunder, and update such DMF as required by Applicable Law, with such DMF to contain reasonably appropriate information concerning Master Batch Records (and API Manufacturing Procedures) as necessary and appropriate for all Regulatory Submissions in the Territory and for the development, manufacture, commercialization, and use of Drug Product in the Territory. Except as may be agreed in writing by the Parties in any agreement for the supply of Drug Product for use or sale outside the Territory pursuant to any agreement negotiated in accordance with Section 2.11, FFFC shall not file any DMF for the API or any other form of Solithromycin outside of the Territory, nor enable or permit any Affiliate of FFFC or any Third Party to file a DMF concerning the API or any other form of Solithromycin or reference any such DMF filed or maintained by or on behalf of FFFC (provided that the foregoing shall not limit Cempra’s rights, including its rights to sublicense, under Section 6.3(b)), and FFFC shall ensure that no Affiliate of FFFC files any DMF for API or any other form of Solithromycin except to the extent otherwise agreed to in writing by Cempra. Upon Cempra’s written request, FFFC shall provide to Cempra, in English, the complete Master Batch Records, Batch Records, and any other API production records, and specific API Manufacturing Procedures and updates, and copies of the relevant documents containing any other FFFC technology used in manufacturing API, to the extent such technology and API Manufacturing Procedures are not maintained as confidential in the DMF maintained by FFFC. Cempra has the right to review and copy the executed, completed Batch Records for each Batch, as needed for Cempra, its Affiliates, and its or its Affiliate’s licensees to prepare the CMC sections for any particular Regulatory Submissions that Cempra (or its Affiliate or its or its Affiliate’s licensee) intends to file or for any other appropriate regulatory purpose relating to API or any Drug Product to the extent such technology and API Manufacturing Procedures are not maintained as confidential in the DMF maintained by FFFC. FFFC shall prepare and maintain the Batch Records for each Batch of API manufactured hereunder, and shall provide Cempra, its Affiliates, and its and its Affiliates’ licensees access to such Batch Records for review and inspection, and shall provide copies thereof to Cempra upon...
Information for Regulatory Applications. Seller and OKFC shall expeditiously provide Buyer with all information concerning Seller, OKFC and the Bank necessary for Buyer to complete its regulatory application required for consummation of the transaction provided for herein, and Seller and OKFC jointly and severally represent and warrant to Buyer that all such information shall be true and complete in all material respects. Such representation and warranty shall be true on the date hereof, on the Pre-Closing Date and on the Closing Date as if remade on such dates and shall survive the Closing as provided in Subsection 16.3. 16 17 8.
Information for Regulatory Applications. To the extent permitted by law, State Bank will furnish Bancshares with all information concerning State Bank required for inclusion in any application, filing, statement or document to be made or filed by Bancshares or State Bank with any federal or state regulatory or supervisory authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. State Bank represents and warrants that all information so furnished for such applications and filings shall, to the best of its knowledge, be true and correct in all material respects without omission of any material fact required to be stated to make the information not misleading. State Bank agrees at any time, upon the request of Bancshares, to furnish to Bancshares a written letter or statement confirming the accuracy of the information with respect to State Bank contained in any report or other application or statement referred to in this Agreement, and confirming that the information with respect to State Bank contained in such document or draft was furnished by State Bank expressly for use therein or, if such is not the case, indicating the inaccuracies contained in such document or indicating the information not furnished by State Bank expressly for use therein.
Information for Regulatory Applications. To the extent permitted by law, Union will furnish Bancshares with all information concerning Union required for inclusion in any application, filing, statement or document to be made or filed by Bancshares or Union with any federal or state regulatory or supervisory authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. Union represents and warrants that all information so furnished for such applications and filings shall, to the best of its knowledge, be true and correct in all material respects without omission of any material fact required to be stated to make the information not misleading. Union agrees at any time, upon the request of Bancshares, to furnish to Bancshares a written letter or statement confirming the accuracy of the information with respect to Union contained in any report or other application or statement referred to in Sections 4.1 or 4.4 of this Agreement, and confirming that the information with respect to Union contained in such document or draft was furnished by Union expressly for use therein or, if such is not the case, indicating the inaccuracies contained in such document or indicating the information not furnished by Union expressly for use therein.
Information for Regulatory Applications. Upon Altus's written request, Lonza shall provide to Altus the complete Master Batch Records and specific Manufacturing and Analytical SOP's and updates as defined in the Quality Agreement, and copies of the relevant documents containing any other Lonza Technology used in manufacturing each Bulk Product Component. Altus has the right to review and copy the executed, completed Batch Records for each Batch, all as needed for Altus to prepare the CMC Sections for any particular Regulatory Application that Altus (or its Affiliate or licensee) intends to file or for any other appropriate regulatory purpose relating to a Bulk Product Component or the Final Product. All such Information shall be provided in English. Lonza shall prepare and maintain the Batch Records for each Batch of Bulk Product Component manufactured hereunder, and shall provide Altus access to such Batch Records for review and inspection, and shall provide copies thereof to Altus, at Altus' expense for actual out-of-pocket copying costs and the costs (at an agreed FTE rate) for Lonza's internal employee time required for such copying, if so requested by Altus.
Information for Regulatory Applications. To the extent permitted by law, Cadence will furnish CBC with all information concerning Cadence required for inclusion in any application, filing, registration statement or document to be made or filed by CBC or Cadence with any federal or state regulatory or supervisory authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. Cadence represents and warrants that all information so furnished for such applications and filings shall, to the best of its Knowledge, be true and correct in all material respects without omission of any material fact required to be stated therein to make the information not misleading. Cadence agrees at any time, upon the request of CBC, to furnish to CBC a written letter or statement confirming the accuracy of the information with respect to Cadence contained in any report or other application or statement referred to in this Agreement, and confirming that the information with respect to Cadence contained in such document or draft was furnished by Cadence expressly for use therein or, if such is not the case, indicating the inaccuracies contained in such document or indicating the information not furnished by Cadence expressly for use therein.
Information for Regulatory Applications. Each of Bancorp and PSB shall promptly respond, and use its best efforts to cause its directors, officers, accountants and affiliates to promptly respond, to requests by the other party and its counsel for information for inclusion in the various applications for regulatory approvals. Each of Bancorp and PSB hereby covenants with the other that none of such information provided will contain any untrue statement of a material fact or omit any material fact required to be stated therein or necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading; and, at all times up to and including the Effective Time, none of such information as it may be amended or supplemented, will contain any untrue statement of a material fact or omit any material fact required to be stated therein or necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading.
