Regulatory Communications and Filings Sample Clauses

Regulatory Communications and Filings. Pfizer shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Regulatory Approvals (“Marketing Authorization Applications”) and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in USA and, subject to Section 9.2.1, the ROW. BionTech shall prepare, file in BioNTech’s name, diligently prosecute to grant, and maintain all applications for Marketing Authorization Applications and all Regulatory Approvals obtained therefrom in respect of any Candidates or Products in EU. The JSC may vary from the foregoing allocations by mutual consent. In accordance with Section 9.2.1, each Party shall cooperate with the other Party with respect to any and all regulatory matters for which the other Party is responsible pursuant to this Agreement or the Research and Development Plan. Unless exigent action is required with respect to a given filing before a Regulatory Authority concerning a Candidate or Product, or a material communication with a Regulatory Authority concerning the same, the Party submitting such Marketing Authorization Application shall provide the other Party with copies of all filings relating to such Marketing Authorization Application prior to submission within a reasonable amount of time (but not less than [***] Business Days) to allow such Party to review and comment on such filings, and the Party submitting such Marketing Authorization Application shall consider all comments and proposed revisions from the other Party in good faith prior to submission. The Party responsible for filing such Regulatory Approvals shall consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Marketing Authorization Applications and the prosecution thereof, including any material communications that it receives with respect to the same. Upon request of the other Party, the Lead Development Party responsible for filing applications for such Regulatory Approvals shall provide to the other Party copies of all final Marketing Authorization Applications and filings relating thereto that it submits. The foregoing provisions of this Section 9.2.2 shall also apply to material and substantive communications with Regulatory Authorities.
AutoNDA by SimpleDocs
Regulatory Communications and Filings. The Designated Regulatory Party will prepare, submit and maintain all Regulatory Filings and obtain all Regulatory Approvals for which it is responsible in accordance with the applicable Development Plan. The other Party will cooperate with the Designated Regulatory Party, at its reasonable request, with respect to any regulatory matters for which the Designated Regulatory Party is responsible. Unless exigent action is required with respect to such Regulatory Filing or material communication, the Designated Regulatory Party will provide the other Party with copies of Key Regulatory Filings prior to submission within a reasonable amount of time (but not less than five (5) business days) to allow such Party to review and comment on such Key Regulatory Filings, and the Designated Regulatory Party will consider all comments and proposed revisions from the other Party in good faith prior to submission (but in the event of a disagreement between the Parties with respect to such comments and proposed revisions, (i) if the Development Lead’s determination is consistent with the then-current Development Plan, then the Development Lead’s determination shall prevail, and (ii) if the Development Lead’s determination is not consistent with the then-current Development Plan, then such matter shall be escalated to the JSC for review (and if a Critical Matter, further escalated to the CRC)). The Designated Regulatory Party will consult with the other Party regarding, and keep the other Party informed of, the status of the preparation of all Regulatory Filings it submits, Governmental Authority review of any such Regulatory Filings, and all Regulatory Approvals that it obtains with respect to a Product. Upon request of the other Party, the Designated Regulatory Party will provide to the other Party copies of all final Regulatory Filings it submits.
Regulatory Communications and Filings. (a) BeiGene will prepare, submit and maintain Regulatory Filings, leveraging where appropriate global documentation that Amgen has provided, and obtain all Regulatory Approvals for Products in the Collaboration Territory in accordance with the applicable Global Development Plan and Commercialization Plan, and Applicable Law in the Collaboration Territory. The Parties will cooperate with each other with respect to any regulatory matters with respect to Products in a manner sufficient to enable the Parties to satisfy any reporting obligations to Governmental Authorities or other reasonable business purpose related to the Products. All development, review and compilation of Regulatory Filings by BeiGene shall be performed within the Amgen systems. (b) With respect to Products and the Collaboration Territory, unless exigent action is required with respect to any Key Regulatory Filings and Material Communications, the Regulatory Lead will provide the Non-Regulatory Lead with copies of all Key Regulatory Filings and Material Communications prior to submission within a reasonable amount of time (but not less than […***…]) to allow the Non-Regulatory Lead to review and comment on such Key Regulatory Filings and Material Communications, and the Regulatory Lead will ensure inclusion of all substantive comments and proposed revisions from the Non-Regulatory Lead in good faith prior to submission. In the event of a disagreement between the Parties with respect to such comments and proposed revisions, if the Regulatory Lead’s determination: (i) is consistent with […***…], and the applicable regulations in the Collaboration Territory, (ii) […***…] and (iii) […***…] , then the Regulatory Lead’s determination shall prevail; otherwise such disagreement shall be escalated to the JAC. (c) In the case of an exigent action, the Regulatory Lead shall use reasonable efforts to notify the Non-Regulatory Lead prior to making any such Key Regulatory Filing and Material Communications for the Products in the Collaboration Territory and, thereafter, the Regulatory Lead shall use reasonable efforts to provide the Non-Regulatory Lead with a copy (and if applicable an English translation) of such Key Regulatory Filings and Material Communications within […***…] after making such Key Regulatory Filings and Material Communications. For the purpose of this Section 3.2.3, “exigent action” shall mean an action that, in the good faith determination of the Regulatory Lead, requires attention o...
Regulatory Communications and Filings. Each Party shall send to the other Party drafts of all material Regulatory Materials intended to be submitted to the Competent Authorities, with respect to Pfizer, in the Pfizer Territory, and with respect to Servier, those countries in the Servier Territory to be agreed to by the Parties throughout the Term, in draft form and give the other Party at least [***] days, or in the event of urgent filings, any shorter reasonable period of time, to comment on such drafts of Regulatory Materials, such comments to be considered in good faith and included by the Party receiving these comments in its sole discretion. Each Party shall notify the other Party of any material Regulatory Materials submitted to or received from the Competent Authorities, with respect to Pfizer, in the Pfizer Territory, and with respect to Servier, in the those countries in the Servier Territory to be agreed to by the Parties throughout the Term, and shall provide the other Party with copies thereof.

Related to Regulatory Communications and Filings

  • APPROVAL OF GENERAL COMMUNICATIONS Competitive Supplier shall cooperate with and assist the Town in the drafting and sending of messages and information to Eligible Consumers concerning the Program or any matter arising under or related to this Agreement or the Program. Competitive Supplier shall, prior to sending any direct mail, advertising, solicitation, bill insert, electronic mail, or other similar written or electronic communication (collectively, “General Communications”) to Participating Consumers (but excluding individually drafted or tailored communications responding to a specific complaint or communication of an individual consumer), provide a copy of such General Communication to the Town for its review (for consistency with the Town’s purposes and goals) and approval. The Town shall have the right to disapprove such General Communications and suggest revisions if it finds the communication inconsistent with the purposes and goals of the Town, factually inaccurate, or likely to mislead provided, however, that: (i) the communication shall be deemed approved if the Town fails to respond within ten (10) Business Days, and (ii) no approval shall be necessary for any communication (a) regarding any emergency situation involving any risk to the public health, safety or welfare; (b) that has been approved by the Department, the DOER; or (c) in the nature of routine monthly or periodic bills, or collection notices, except that any bill insert or message included at the bottom of such bill not within the scope of (a) or (b) above shall require advanced review and approval by the Town; and (iii) no approval or lack of approval shall relieve the Competitive Supplier of its obligations and responsibility for its actions and omissions under this Agreement, or other than as set forth in sub-clause ‘i’ of this Section 7.6, result in a waiver of any rights, remedies or defenses of the Town. The Town may reject or exclude any proposed General Communication that, in its reasonable judgment, is contrary to the interests and objectives of the Program or the Town.

  • Offering Communications (a) Other than the Preliminary Prospectus, the Prospectus and the Ratings Issuer Free Writing Prospectus, each Underwriter severally represents, warrants and agrees with the Company, the Issuer and the Seller that it has not made, used, prepared, authorized, approved or referred to and will not prepare, make, use, authorize, approve or refer to any “written communication” (as defined in Rule 405 under the Act) that constitutes an offer to sell or solicitation of an offer to buy the Notes, including, but not limited to any “ABS informational and computational materials” as defined in Item 1101(a) of Regulation AB under the Act unless such Underwriter has obtained the prior written approval of the Company, the Issuer and the Seller; provided, however, each Underwriter may prepare and convey to one or more of its potential investors one or more “written communications” (as defined in Rule 405 under the Act) containing no more than the following: (i) information contemplated by Rule 134 under the Act and included or to be included in the Preliminary Prospectus or the Prospectus, (ii) information relating to the CUSIPs, yield, benchmark, and trade date of the Notes and (iii) a column or other entry showing the status of the subscriptions for the Notes and/or expected pricing parameters of the Notes (each such written communication, an “Underwriter Free Writing Prospectus”); provided, that no such Underwriter Free Writing Prospectus would be required to be filed with the Commission. (b) Each Underwriter severally represents, warrants and agrees with the Company, the Issuer and the Seller that: (i) each Underwriter Free Writing Prospectus prepared by it will not, as of the date such Underwriter Free Writing Prospectus was conveyed or delivered to any prospective purchaser of Notes, include any untrue statement of a material fact or omit any material fact necessary to make the statements contained therein, in light of the circumstances under which they were made, not misleading; provided, however, that no Underwriter makes such representation, warranty or agreement to the extent such misstatements or omissions were (i) made in reliance upon and in conformity with any written information furnished to the related Underwriter by the Company, the Issuer or the Seller expressly for use therein or (ii) as a result of any inaccurate information (including as a result of any omission therein) in the Preliminary Prospectus, the Prospectus or the Ratings Issuer Free Writing Prospectus (solely when taken together with the Preliminary Prospectus or the Prospectus, as applicable), which information was not corrected by information subsequently provided by the Company, the Issuer or the Seller to the related Underwriter prior to the time of use of such Underwriter Free Writing Prospectus; (ii) each Underwriter Free Writing Prospectus prepared by it shall contain a legend substantially in the form of and in compliance with Rule 433(c)(2)(i) of the Act, and shall otherwise conform to any requirements for “free writing prospectuses” under the Act; and (iii) each Underwriter Free Writing Prospectus prepared by it shall be delivered to the Company, the Issuer and the Seller no later than the Business Day prior to the required filing date. (c) Each Underwriter severally represents and agrees that (a) it has not entered, and will not enter, into any contract of sale for the Notes (subject to the proviso to clause (ii) below) until at least the later of (i) three business days after the original Preliminary Prospectus for the Notes has been initially filed by the Company with the Commission (as determined by reference to the “Filing Date” according to the “Filing Detail” webpage for the Company related to such filing, as made available on the Commission’s website) and (ii) 48 hours after any supplement to the Preliminary Prospectus that reflects a material change from the information contained in the Preliminary Prospectus has been filed by the Company with the Commission (as determined by reference to the time such filing was “Accepted” according to the “Filing Detail” webpage for the Company related to such filing, as made available on the Commission’s website); provided, however, that in the case of any such contract of sale entered into before the filing of a supplement as referred to in this clause (ii), it will not consummate such transaction without entering into a new contract of sale in accordance with this clause (ii); (b) that it did not enter into any contract of sale for any Notes prior to the Time of Sale; and (c) that it will, at any time that such Underwriter is acting as an “underwriter” (as defined in Section 2(a)(11) of the Act) with respect to the Notes, (A) convey to each investor to whom Notes are sold by it during the period prior to the filing of the final Prospectus (as notified to the Underwriters by the Company), at or prior to the applicable time of any such contract of sale with respect to such investor, the Preliminary Prospectus and (B) comply with Rule 173 of the Act, including, but not limited to (I) by delivering to each investor to whom Notes are sold by it no later than two Business Days following the completion of such sale (i.e., the date of settlement), a copy of the final Prospectus or a notice to the effect that such sale was made pursuant to the Registration Statement and (II) if only a notice has been sent pursuant to the foregoing clause (I), by delivering to any investor to whom Notes are sold by it, upon request of such investor, a copy of the final Prospectus.

  • Information and communication The Parties shall support the development of modern methods of information handling, including the media, and stimulate the effective mutual exchange of information. Priority shall be given to programmes aimed at providing the general public with basic information about the Community and the Republic of Azerbaijan, including, where possible, access to databases, in full respect of intellectual property rights.

  • Public Communications (1) Subject to compliance with applicable Securities Laws, immediately after the execution of this Agreement, or such later time prior to the next opening of markets in Toronto or New York as is agreed to by the Company and the Purchaser, the Company and the Purchaser shall issue a news release announcing the entering into of this Agreement, which news release shall be satisfactory in form and substance to each of the Company and the Purchaser, each acting reasonably, and, thereafter, file such news release, a corresponding material change report in prescribed form and this Agreement in accordance with applicable Securities Laws. (2) No Party shall issue any press release or make any other public statement or disclosure with respect to this Agreement or the Arrangement without the consent of the other Party (which consent shall not be unreasonably withheld, conditioned or delayed), and the Company must not make any filing with any Governmental Entity (except as contemplated by this Article 4) with respect to this Agreement or the Arrangement without the consent of the Purchaser (which consent shall not be unreasonably withheld, conditioned or delayed); provided that any Party that is required to make disclosure by Law shall use its commercially reasonable efforts to give the other Party prior oral or written notice (and if such prior notice is not possible, to give notice immediately following the making of any such disclosure or filing) and a reasonable opportunity to review or comment on the disclosure or filing (other than with respect to confidential information contained in such disclosure or filing). The Party making such disclosure shall give reasonable consideration to any comments made by the other Party or its counsel, and if such prior notice is not possible, shall give such notice immediately following the making of such disclosure or filing. (3) The Company and the Purchaser agree to cooperate in the preparation of formal presentations, if any, to any Company Shareholders or other securityholders of the Company or the analyst community regarding the Arrangement, and the Company agrees to consult with the Purchaser in connection with any formal meeting with analysts that it may have, provided, however, that the foregoing shall be subject to the Company’s overriding obligation to make any disclosure or filing required by applicable Laws or stock exchange rules and if the Company is required to make any such disclosure, it shall use its commercially reasonable efforts to give the Purchaser a reasonable opportunity to review and comment thereon prior to its dissemination.

  • Regulatory Reports Since January 1, 2018, Company and its Subsidiaries have duly filed with the FRB, the FDIC, the OCC and any other applicable Governmental Authority, in correct form, the reports and other documents required to be filed under applicable Laws and regulations and have paid all fees and assessments due and payable in connection therewith, and such reports were, in all material respects, complete and accurate and in compliance with the requirements of applicable Laws and regulations. No report, including any report filed with the OCC, the FDIC, the Federal Reserve Board, the Securities Exchange Commission or any other federal or state regulatory agency, and no report, proxy statement, registration statement or offering materials made or given to shareholders of Company or the Bank, in each case, since December 31, 2017, as of the respective dates thereof, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. The call reports of the Bank and accompanying schedules as filed with the OCC, for each calendar quarter beginning with the quarter ended December 31, 2017, through the Closing Date have been and will be prepared in accordance with applicable regulatory requirements, including applicable regulatory accounting principles and practices through periods covered by such reports. Other than normal examinations conducted by a Governmental Authority in the Ordinary Course of Business of Company and its Subsidiaries, no Governmental Authority has notified Company or any of its Subsidiaries that it has initiated or has pending any proceeding or, to Company’s Knowledge, threatened an investigation into the business or operations of Company or any of its Subsidiaries since January 1, 2018 that would reasonably be expected to result in a Material Adverse Effect on Company. There is no material unresolved violation, criticism, or exception by any Governmental Authority with respect to any report or statement relating to any examinations or inspections of Company or any of its Subsidiaries. There have been no formal or informal inquiries by, or disagreements or disputes with, any Governmental Authority with respect to the business, operations, policies or procedures of Company or any of its Subsidiaries since January 1, 2018. Notwithstanding the foregoing, nothing in this Section 3.09 shall require Company or Bank to provide Buyer with any confidential regulatory supervisory information of Company or Bank.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • General Communications The type of communications described and defined in Article

  • Routine Communications All routine communications related to the Contract shall be sent to the Department’s Contract Manager. If any of the Contractor’s contract information changes during the life of the Contract, the Contractor shall notify the Department’s Contract Manager; such updates do not necessitate a formal amendment to the Contract. Communications relating to a Customer contract or purchase order should be addressed to the contact person identified in the contract or purchase order. Routine communications may be my email, regular mail, or telephone.

  • Posting of Communications (a) The Borrower agrees that the Administrative Agent may, but shall not be obligated to, make any Communications available to the Lenders and the Fronting Banks by posting the Communications on IntraLinks™, DebtDomain, SyndTrak, ClearPar or any other electronic platform chosen by the Administrative Agent to be its electronic transmission system (the “Approved Electronic Platform”). (b) Although the Approved Electronic Platform and its primary web portal are secured with generally-applicable security procedures and policies implemented or modified by the Administrative Agent from time to time (including, as of the Closing Date, a user ID/password authorization system) and the Approved Electronic Platform is secured through a per-deal authorization method whereby each user may access the Approved Electronic Platform only on a deal-by-deal basis, each of the Lenders, each of the Fronting Banks and each of the Borrowers acknowledges and agrees that the distribution of material through an electronic medium is not necessarily secure, that the Administrative Agent is not responsible for approving or vetting the representatives or contacts of any Lender that are added to the Approved Electronic Platform, and that there may be confidentiality and other risks associated with such distribution. Each of the Lenders, each of the Fronting Banks and each of the Borrowers hereby approves distribution of the Communications through the Approved Electronic Platform and understands and assumes the risks of such distribution. (c) THE APPROVED ELECTRONIC PLATFORM AND THE COMMUNICATIONS ARE PROVIDED “AS IS” AND “AS AVAILABLE”. THE APPLICABLE PARTIES (AS DEFINED BELOW) DO NOT WARRANT THE ACCURACY OR COMPLETENESS OF THE COMMUNICATIONS, OR THE ADEQUACY OF THE APPROVED ELECTRONIC PLATFORM AND EXPRESSLY DISCLAIM LIABILITY FOR ERRORS OR OMISSIONS IN THE APPROVED ELECTRONIC PLATFORM AND THE COMMUNICATIONS. NO WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS OR FREEDOM FROM VIRUSES OR OTHER CODE DEFECTS, IS MADE BY THE APPLICABLE PARTIES IN CONNECTION WITH THE COMMUNICATIONS OR THE APPROVED ELECTRONIC PLATFORM. IN NO EVENT SHALL THE ADMINISTRATIVE AGENT, ANY JOINT LEAD ARRANGER OR ANY OF THEIR RESPECTIVE RELATED PARTIES (COLLECTIVELY, “APPLICABLE PARTIES”) HAVE ANY LIABILITY TO ANY BORROWER, ANY LENDER, ANY FRONTING BANK OR ANY OTHER PERSON OR ENTITY FOR DAMAGES OF ANY KIND, INCLUDING DIRECT OR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, LOSSES OR EXPENSES (WHETHER IN TORT, CONTRACT OR OTHERWISE) ARISING OUT OF ANY BORROWER’S OR THE ADMINISTRATIVE AGENT’S TRANSMISSION OF COMMUNICATIONS THROUGH THE INTERNET OR THE APPROVED ELECTRONIC PLATFORM. (d) Each Lender and each Fronting Bank agrees that notice to it (as provided in the next sentence) specifying that Communications have been posted to the Approved Electronic Platform shall constitute effective delivery of the Communications to such Lender for purposes of the Loan Documents. Each Lender and Fronting Bank agrees (i) to notify the Administrative Agent in writing (which could be in the form of electronic communication) from time to time of such Lender’s or Fronting Bank’s (as applicable) email address to which the foregoing notice may be sent by electronic transmission and (ii) that the foregoing notice may be sent to such email address. (e) Each of the Lenders, each of the Fronting Banks and each of the Borrowers agrees that the Administrative Agent may, but (except as may be required by applicable law) shall not be obligated to, store the Communications on the Approved Electronic Platform in accordance with the Administrative Agent’s generally applicable document retention procedures and policies. (f) Nothing herein shall prejudice the right of the Administrative Agent, any Lender or any Fronting Bank to give any notice or other communication pursuant to any Loan Document in any other manner specified in such Loan Document.

  • COPIES OF REGULATORY REPORTS AND FILINGS Upon reasonable request, Competitive Supplier shall provide to the Town a copy of each public periodic or incident-related report or record relating to this ESA which it files with any Massachusetts or federal agency regulating rates, service, compliance with environmental laws, or compliance with affirmative action and equal opportunity requirements, unless the Competitive Supplier is required by law or regulation to keep such reports confidential. The Town shall treat any reports and/or filings received from Competitive Supplier as confidential information subject to the terms of Article 16. Competitive Supplier shall be reimbursed its reasonable costs of providing such copies.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!