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. 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. To the extent permitted by law, South Texas will furnish Bancshares with all information concerning South Texas, CNB Delaware and CNB required for inclusion in any application, filing, statement or document to be made or filed by Bancshares, South Texas, CNB Delaware or CNB with any federal or state regulatory or supervisory authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. South Texas 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. South Texas will indemnify and hold harmless Bancshares from and against any and all losses, claims, damages, expenses or liabilities to which Bancshares may become subject under applicable laws, rules and regulations and will reimburse Bancshares for any legal or other expenses reasonably incurred by Bancshares in connection with investigating or defending any actions whether or not resulting in liability, insofar as such losses, claims, damages, expenses, liabilities or actions arise out of or are based on any untrue statement or alleged untrue statement of a material fact contained in any such application or proxy materials or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein, or necessary in order to make the statements therein not misleading, but only insofar as such statement or omission was made in reliance upon and in conformity with information expressly furnished by South Texas expressly for use therein. South Texas 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 South Texas, CNB Delaware and CNB 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 South Texas, CNB Delaware and CNB contained in such document or draft was furnished by South Texas 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 South Texas expressly for use therein.
Information for Regulatory Applications. Each of Bankshares and BHS 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 Bankshares and BHS 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.
Information for Regulatory Applications. Bank of York shall promptly, but not later than five (5) Business Days after receipt of a written request by Investar, furnish Investar with all information, data and documents concerning Bank of York required for inclusion in (a) any application, filing, statement or document to be made or filed by Investar with any Governmental Body in connection with the transactions contemplated by this Agreement during the pendency of this Agreement or (b) any other filings with federal or state securities authorities.
Information for Regulatory Applications. To the extent permitted by law, Prosperity will furnish SNB with all information concerning Prosperity required for inclusion in any application, filing, statement or document to be made or filed by SNB with any federal or state regulatory or supervisory authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. Prosperity agrees, upon the request of SNB, to furnish to SNB a written letter or statement confirming to the best of its knowledge the accuracy of the information with respect to Prosperity contained in any report or other application or statement referred to in Sections 6.1 or 6.3 of this Agreement, and confirming that the information with respect to Prosperity contained in such document or draft was furnished 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 Prosperity expressly for use therein.
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 8.2.7
Information for Regulatory Applications. To the extent --------------------------------------- permitted by law, the Seller shall, and shall cause the Bank to, furnish Purchaser with all information concerning the Seller and the Bank required for inclusion in any application, filing, statement or document to be made or filed by Purchaser, with any federal or state regulatory or supervisory authority in connection with the transactions contemplated by this Agreement during the pendency of this Agreement. The Seller represents and warrants to the Purchaser that all information furnished by the Seller or the Bank 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. The Seller agrees at any time, upon the request of Purchaser, to furnish, or to cause the Bank to furnish, to Purchaser a written letter or statement confirming the accuracy of the information with respect to Seller and the Bank, contained in any report or other application or statement referred to in this Agreement, and confirming that the information with respect to Seller and the Bank, contained in such document or draft was furnished by the Seller or the 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 the Seller or the Bank 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.
