Regulatory Notification Sample Clauses

Regulatory Notification. County shall promptly notify Optum Rx of all inquiries from federal or state governmental departments, attorneys, Members, or other persons alleging a complaint with Price Edge for Non-Covered Drugs and provide any applicable documentation of such.
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Regulatory Notification. Without limiting any specific notices required elsewhere herein or pursuant to any Ancillary Agreement, each Party shall notify the other Party promptly (i.e. without delay and with reasonable time to prepare any possible required action) upon: (a) receiving any regulatory communication from the FDA, including without limitation any communication with respect to any: (i) safety or efficacy issue with respect to a Product; or (ii) advertising or promotional claims with respect to a Product; or (b) receiving information concerning the initiation of any investigation, review or inquiry regarding a Product by the FDA including but not limited to: (i) the need for a remedial action related to one or more batches of a Product (including a recall or withdrawal); (ii) possible detention, seizure of or injunction against distribution of a Product; (ii) the facilities used in conjunction with the manufacturing or distribution of a Product; (iv) the receipt of a report concerning any bacteriological contamination, significant chemical, physical, or other change or deterioration in distributed Product such that it fails to meet the Product Specifications; or (v) the receipt of any complaint concerning suspected or actual Product tampering or the contamination or mix-up with or in the ingredients in any batch, package, or container of a Product; or (c) the initiation of any investigation, review or inquiry by the FDA or any other Governmental Authority within or outside the Territory regarding the manufacture and supply of LAS 34273. If either Party decides that it must communicate with the FDA regarding a Product, then it shall so advise the other Party immediately and, unless prohibited by applicable Laws, provide the other Party in advance with a copy of any proposed written communication with the FDA. For purposes of clarity it is acknowledged that nothing herein shall be construed as limiting a Party's right to communicate with any Governmental Authority or take such other immediate action related to a Product as is it reasonably deems necessary in order to comply with applicable Laws; provided that notification to the other Party is provided as soon as practicable thereafter.
Regulatory Notification. IFF shall be responsible, at its own expense, for preparing and filing Regulatory Submissions and seeking and achieving Regulatory Notifications for Reb C in the Territory, including generating any data and other information, preparing all reports, and assembling panels of qualified scientific experts necessary or desirable as part of a Regulatory Submission. All such Regulatory Submissions shall be filed in the name of IFF or its designees. IFF shall permit Redpoint access to and grant Redpoint the right to reference and use all data, regulatory filings and regulatory communications associated with Reb C.
Regulatory Notification. Participating Group shall promptly notify PBM of all inquiries from federal or state governmental departments, attorneys, Members, or other persons alleging a complaint with this Enhanced Savings Program and provide any applicable documentation of such.
Regulatory Notification. Solely to the extent that, and for so long as, AVEO has an active IND or Regulatory Approval Application with respect to any Product, the following will apply: (a) Each Party will report to the other Party all Adverse Events or Serious Adverse Events with respect to any Product, as the case may be, in its respective territory, within timeframes consistent with its reporting obligations under applicable Laws and in any event no later than [**] hours following receipt of notification by the clinical site of a Serious Adverse Event, which report will, in each case, include the circumstances and nature of such Serious Adverse Event. In addition, to the extent requested by a Party, the other Party will promptly provide to such Party any other information or materials that such Party may require to provide to any Regulatory Authority with respect to any such Serious Adverse Event. (b) Each Party will promptly notify the other Party upon its determination that any event, incident or circumstance has occurred that may result in the need for a Recall, market withdrawal or stock recovery of a Product (but in no event later than [**] hours and in all cases prior to the execution of such Recall, market withdrawal or stock recovery). For all Recalls, the Parties will reasonably consult with each other with respect to the actions to be taken to address such Recall. Subject to the foregoing, (i) for all Recalls, market withdrawals and stock recoveries that are taken in the Licensed Territory, CANbridge will be responsible for execution, and AVEO will reasonably cooperate in all such efforts and (ii) for all Recalls, market withdrawals and stock recoveries that are taken in the North America Territory, AVEO will be responsible for execution, and CANbridge will reasonably cooperate in all such efforts. All expenses incurred in connection with any Recall (including expenses for notification, destruction and return of the affected Product and any refund to customers of amounts paid for such Product) in the Licensed Territory will be the sole responsibility of CANbridge, and, subject to any allocation of responsibility to CANbridge as a manufacturer of Product that is set forth in the Supply Agreement, all expenses incurred in connection with any Recall in the North America Territory will be the sole responsibility of AVEO. (c) The Parties will enter into a pharmacovigilance agreement on reasonable and customary terms that sets forth, among other things, guidelines and proced...

Related to Regulatory Notification

  • Customer Notification By executing this Agreement, the Advisor acknowledges that as required by the Advisers Act the Sub-Advisor has supplied to the Advisor and the Trust copies of the Sub-Advisor’s Form ADV with all exhibits and attachments (including the Sub-Advisor’s statement of financial condition) and will promptly supply to the Advisor copies of all amendments or restatements of such document. Otherwise, the Advisor’s rights under federal law allow termination of this contract without penalty within five business days after entering into this contract. U.S. law also requires the Sub-Advisor to obtain, verify, and record information that identifies each person or entity that opens an account. The Sub-Advisor will ask for the Trust’s legal name, principal place of business address, and Taxpayer Identification or other identification number, and may ask for other identifying information.

  • Antitrust Notification If the Holder determines, in its sole judgment upon the advice of counsel, that the issuance of any Warrant Shares pursuant to the terms hereof would be subject to the provisions of the Hxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended (the “HSR Act”), the Company shall file as soon as practicable after the date on which the Company receives notice from the Holder of the applicability of the HSR Act and a request to so file with the United States Federal Trade Commission and the United States Department of Justice the notification and report form required to be filed by it pursuant to the HSR Act in connection with such issuance.

  • REPORTING - NOTIFICATION A. Quarterly Reports In addition to any reports required pursuant to §19 or pursuant to any exhibit, for any contract having a term longer than 3 months, Local Agency shall submit, on a quarterly basis, a written report specifying progress made for each specified performance measure and standard in this Agreement. Such progress report shall be in accordance with the procedures developed and prescribed by the State. Progress reports shall be submitted to the State not later than five (5) Business Days following the end of each calendar quarter or at such time as otherwise specified by the State.

  • Privacy Notification (1) The authority to request the above personal information from a seller of goods or services or a lessor of real or personal property, and the authority to maintain such information, is found in Section 5 of the State Tax Law. Disclosure of this information by the seller or lessor to the State is mandatory. The principal purpose for which the information is collected is to enable the State to identify individuals, businesses and others who have been delinquent in filing tax returns or may have understated their tax liabilities and to generally identify persons affected by the taxes administered by the Commissioner of Taxation and Finance. The information will be used for tax administration purposes and for any other purpose authorized by law. (2) The personal information is requested by the purchasing unit of the agency contracting to purchase the goods or services or lease the real or personal property covered by this contract or lease. The information is maintained in the Statewide Financial System by the Vendor Management Unit within the Bureau of State Expenditures, Office of the State Comptroller, 000 Xxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000.

  • Required Notifications Each Grantor shall promptly notify the Administrative Agent, in writing, of: (i) any Lien (other than Permitted Liens) on any of the Collateral which would adversely affect the ability of the Administrative Agent to exercise any of its remedies hereunder and (ii) the occurrence of any other event which could reasonably be expected to have a material impairment on the aggregate value of the Collateral or on the security interests created hereby.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Recall Notification Notice of recall shall be sent to the bargaining unit member by certified mail. The City shall be deemed to have fulfilled its obligation by mailing the recall notice by certified mail, return receipt requested, to the last address provided by the bargaining unit member.

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

  • FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

  • Regulatory Consents The waiting period applicable to the consummation of the Merger under the HSR Act shall have expired or been earlier terminated.

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