Regulatory Communication Clause Samples

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Regulatory Communication. Supplier shall promptly provide HUMACYTE with copies of any requests, directives and other correspondence between Supplier and a Regulatory Authority relating to (i) Supplier’s manufacture, processing or sale of any Product, or (ii) any facility at which a Product is manufactured or processed to the extent pertinent to any Product and shall, in each case (i) and (ii), provide HUMACYTE the right to review and comment on Supplier’s draft communication to any Regulatory Authority with respect prior to Supplier’s submission of such communication and Supplier shall consider in good faith any comments or suggestions from HUMACYTE that are received prior to the time Supplier is required to submit such communication to the applicable Regulatory Authority.
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Regulatory Communication. In the event of any Manufacturing Change pursuant to this Section 2.9 (Changes to Manufacturing), Amgen shall cooperate with Purchaser to provide to the applicable Governmental Authority in the Territory documentation required by Law to be provided with respect to such change (through Purchaser or directly to the relevant Governmental Agency). In no event will Amgen be obligated under this Agreement to (i) conduct any studies (pre-clinical, clinical or other) to support Purchaser’s regulatory filings or (ii) transfer to Purchaser any technology, know-how, cell lines or other materials in connection with any Manufacturing Change implemented by Amgen. Should Purchaser request that Amgen agree to conduct additional work for the purpose of supplementing Purchaser’s regulatory filing in the Territory, the Parties shall discuss in good faith the terms and conditions (including economic terms) upon which Amgen in its discretion may agree to conduct such work and any agreement of the Parties with respect thereto shall be reflected in writing and signed by each of the Parties. Purchaser shall provide to Amgen copies of all regulatory filings and correspondence submitted or received by Purchaser or its agents in connection with any Manufacturing Changes, and any other documentation reasonably requested by Amgen related thereto.
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Regulatory Communication. With respect to the Remediation Activities, Seller shall serve as the liaison with any governmental entity involved in or otherwise overseeing or having jurisdiction of the Remediation Activities. Should Buyer or Seller receive or otherwise come to have any communication, written or oral, with any governmental entity regarding the Remediation Activities or conditions relating to the Remediation Activities, Buyer or Seller shall promptly share such communication with the other.
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Regulatory Communication. Except as may otherwise be provided in any pharmacovigilance agreement or quality agreement entered into between the Parties or any of their Affiliates in connection with this Agreement, Distributor shall not communicate with any Governmental Authority regarding Product or this Agreement without the prior written consent of Prestwick (such consent not to be unreasonably withheld, delayed, or conditioned) unless such communication is required by a Governmental Authority or by applicable Law, subpoena or other legal process. In the event that Prestwick consents and/or Distributor is required by a Governmental Authority or by applicable Law, subpoena or other legal process to communicate with such Governmental Authority, then Distributor shall, to the extent practicable, provide Prestwick with reasonable advance notice of any meeting or other communication with any Governmental Authority relating to Product, and Prestwick shall have the right, if legally permissible, to participate in any such meeting or other communications as well as have the right to participate in all preparations, internal caucuses, and debriefing sessions related to such meetings or other communications, in each case solely to the extent related to Product. Distributor shall promptly, but in no event more than two (2) Business Days after receipt, furnish Prestwick with copies of all documents or correspondence Distributor has had with or receives from any Governmental Authority, and contact reports conversations or meetings with any Governmental Authority, in each case relating to Product (including without limitation any minutes from a meeting with respect thereto).
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Regulatory Communication. 11.1 If either Party receives criticism in a report of examination or in a related document or specific oral communication from, or is subject to formal or informal supervisory action by, or enters an agreement with, any Regulatory Authority with respect to a matter relating to (including omissions therefrom) the Program, including: (a) non-compliance with Applicable Law, or the presence or absence of any aspect of the Program which may lead to re-characterization of Bank’s provision of Bank funds as other than extensions of credit by Bank as the true lender under such Loans; or (b) otherwise could substantially interfere with Bank’s rights as true lender, (any such event a “Criticism”), each Party shall (i) advise the other Party promptly in writing of the Criticism received and share the relevant portions of any written documentation, or for oral communications, provide a detailed summary in writing, received from the relevant Regulatory Authority to the extent not specifically prohibited by Applicable Law and (ii) take all reasonable actions deemed necessary by the Parties to address the Criticism in the manner and time determined by the Parties or specified by the relevant Regulatory Authority. 11.2 Each Party shall, to the extent permitted by Applicable Law, provide the other Party with notice and copies of any written communications from any Regulatory Authority (“Regulatory Communications”), with respect to either the Program or the Party, received by such Party concerning any aspect of the Program within two (2) Banking Days of receipt of such Regulatory Communication. For any Regulatory Communication related to the Program for which a response from a Party is required, or in a Party’s reasonable judgment is prudent, the Parties shall use their commercially reasonable efforts to coordinate and cooperate on the response. If the Parties are unable to agree on a response to a Regulatory Communication, the Party that received such Regulatory Communication shall have the final authority to approve the actual response to such Regulatory Communication; provided that unless otherwise instructed or permitted by the other Party, no Party shall respond to a Regulatory Communication with respect to issues related to the other Party’s participation in the Program except as required by such Regulatory Authority or Applicable Law.
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Regulatory Communication. Supplier shall promptly provide Humacyte with copies of any requests, directives and other correspondence between Supplier and a Regulatory Authority relating to (i) Supplier’s manufacture, testing, processing, marketing, sale, or other exploitation of any Product, or (ii) any facility at which a Product is manufactured or processed to the extent pertinent to any Product and shall, in each case (i) and (ii), provide Humacyte with a reasonable opportunity to review and comment on Supplier’s draft communication to any Regulatory Authority to the extent related to the Product, prior to Supplier’s submission of such communication and Supplier shall consider in good faith any comments or suggestions from Humacyte that are received prior to the time Supplier is required to submit such communication to the applicable Regulatory Authority.
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Related to Regulatory Communication

  • 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.

  • Fund Communications The Service Provider shall, upon request by the Fund, on each business day, report the number of shares on which the transfer agency fee is to be paid pursuant to this Agreement. The Service Provider shall also provide the Fund with a monthly invoice.

  • 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.

  • 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.

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