Medical Device Establishment Registration Sample Clauses

Medical Device Establishment Registration. GBI shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and Specifications developer for the Products, as is required.
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Medical Device Establishment Registration. HJL shall maintain a Medical Device Establishment Registration (as defined under the Act) as Manufacturer of Record and Specifications developer for the Products, as is required.
Medical Device Establishment Registration. Novare shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and specifications developer for the Products, as is required.
Medical Device Establishment Registration. Ivivi shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and Specifications developer for the Product, as required by law, including without limitation those defined by 21 CFR Part 807. If Ivivi is not the manufacturer of the Product and is using a third party to manufacture the Product, then such third-party manufacturer shall maintain the Medical Device Establishment Registration as required by law and the foregoing sentence and Ivivi shall ensure compliance with such requirement. In any event, Ivivi shall keep Allergan informed of, and obtain Allergan's prior written approval (which shall not be unreasonably withheld) prior to, any modifications to the manufacturing process and/or the specifications for the Product.
Medical Device Establishment Registration. During the term of this Supply Agreement or as required by law, which ever date is later, HJL shall continue to maintain a Medical Device Establishment Registration and Listing (as defined under the United States Food, Drug and Cosmetic Act and the regulations promulgated thereunder, as amended from time to time (the “Act”)) as the contract manufacturer.

Related to Medical Device Establishment Registration

  • LICENSING, ACCREDITATION AND REGISTRATION The Contractor shall comply with all applicable local, state, and federal licensing, accreditation and registration requirements or standards necessary for the performance of this Contract.

  • Account Registration (a) Custodian shall open and maintain one or more custody accounts in the name of Customer and shall act pursuant to the terms of this Agreement. Each such account opened and maintained by Custodian shall be referred to herein as a “Custody Account”. Each deposit account in the name of Customer shall be referred to herein as a “Cash Account”. Custody Accounts and Cash Accounts are collectively referred to herein as “Accounts” and may be individually referred to herein as an “Account”. Custody Accounts are also referred to herein as “Securities Accounts” and may be individually referred to herein as a “Securities Account”.

  • NERC Registration The NTO shall register or enter into agreement with a NERC registered entity for all required NERC functions applicable to the NTO, that may include, without limitation, those functions designated by NERC to be: “Transmission Owner” and “Transmission Planner” and “Transmission Operator.” The Parties agree to negotiate in good faith the compliance obligations for the NERC functions applicable to, and to be performed by, each Party with respect to the NTO’s facilities. Notwithstanding the foregoing, the ISO shall register for the “Transmission Operator” function for all NTO Transmission Facilities under ISO Operational Control identified in Appendix A-1 of this Agreement.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Ship’s name and registration Each Borrower shall keep the Ship owned by it registered in its name under an Approved Flag; shall not do, omit to do or allow to be done anything as a result of which such registration might be cancelled or imperilled; and shall not change the name or port of registry of the Ship owned by it.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Bulk Registration Data Access to Icann Periodic Access to Thin Registration Data. In order to verify and ensure the operational stability of Registry Services as well as to facilitate compliance checks on accredited registrars, Registry Operator will provide ICANN on a weekly basis (the day to be designated by ICANN) with up-to-date Registration Data as specified below. Data will include data committed as of 00:00:00 UTC on the day previous to the one designated for retrieval by ICANN.

  • Initial Registration The Company shall file a Registration Statement under the Securities Act promptly, but in any event within thirty (30) days following the Closing, to permit the public resale of all the Registrable Securities held by the Holders from time to time as permitted by Rule 415 under the Securities Act (or any successor or similar provision adopted by the Commission then in effect) (“Rule 415”) on the terms and conditions specified in this subsection 2.1.1 and shall use its commercially reasonable efforts to cause such Registration Statement to be declared effective as soon as practicable after the filing thereof, but in no event later than sixty (60) days following the filing deadline (the “Effectiveness Deadline”); provided, that the Effectiveness Deadline shall be extended to ninety (90) days after the filing deadline if the Registration Statement is reviewed by, and receives comments from, the Commission. The Registration Statement filed with the Commission pursuant to this subsection 2.1.1 shall be a shelf registration statement on Form S-1 (a “Form S-1”) or such other form of registration statement as is then available to effect a registration for resale of such Registrable Securities, covering such Registrable Securities, and shall contain a Prospectus in such form as to permit any Holder to sell such Registrable Securities pursuant to Rule 415 at any time beginning on the effective date for such Registration Statement. A Registration Statement filed pursuant to this subsection 2.1.1 shall provide for the resale pursuant to any method or combination of methods legally available to, and requested by, the Holders. The Company shall use its commercially reasonable efforts to cause a Registration Statement filed pursuant to this subsection 2.1.1 to remain effective, and to be supplemented and amended to the extent necessary to ensure that such Registration Statement is available or, if not available, that another Registration Statement is available, for the resale of all the Registrable Securities held by the Holders until all such Registrable Securities have ceased to be Registrable Securities. As soon as practicable following the effective date of a Registration Statement filed pursuant to this subsection 2.1.1, but in any event within two (2) business days of such date, the Company shall notify the Holders of the effectiveness of such Registration Statement. When effective, a Registration Statement filed pursuant to this subsection 2.1.1 (including the documents incorporated therein by reference) will comply as to form in all material respects with all applicable requirements of the Securities Act and the Exchange Act and will not contain a Misstatement.

  • AGREED FACTS Registration History 7. Since June 2006, the Respondent has been registered in Ontario as a mutual fund salesperson (now known as a dealing representative)1 with WFG Securities Inc. (the “Member”), a Member of the MFDA. 8. At all material times, the Respondent conducted business in the Vaughan, Ontario area. 9. At all material times, the Member’s policies and procedures prohibited Approved Persons from signing a client’s name to a document. 10. Between January 2018 and September 2018, while the Respondent was an Approved Person of the Member, the Respondent signed the initials of clients on 8 trade tickets next to alterations he made to information on the trade tickets, and submitted them to the Member for processing. 11. The alterations made by the Respondent on the trade tickets included alterations to: trade instructions, client signature dates and special instructions. 12. At all material times, the Member’s policies and procedures prohibited Approved Persons from altering information on a signed document without the client initialing the document to show that the changes were approved. 13. In May 2018, while the Respondent was an Approved Person of the Member, he altered 1 account form in respect of 1 client by altering information on a trade ticket without having the client initial the alterations, and used this altered form to process a transaction. 1 In September 2009, the registration category mutual fund salesperson was changed to “dealing representative” when National Instrument 31-103 came into force. 14. The Respondent altered the trading instructions, special instructions and representative commission percentage on the trade ticket without having the client initial these alterations. 15. At all material times, the Member’s policies and procedures prohibited Approved Persons from holding an account form which was signed by a client and was blank or only partially completed. 16. Between January 2015 and October 2018, while the Respondent was an Approved Person of the Member, he obtained, possessed and used to process transactions, 30 pre-signed account forms in respect of 21 clients. 17. The pre-signed account forms consisted of: 25 Trade Tickets, 3 New Account Application Forms and 2 Non Financial Information Update Forms.

  • Registration Compliance; No Stop Order No order suspending the effectiveness of the Registration Statement shall be in effect, and no proceeding for such purpose, pursuant to Rule 401(g)(2) or pursuant to Section 8A under the Securities Act shall be pending before or threatened by the Commission; the Prospectus and each Issuer Free Writing Prospectus shall have been timely filed with the Commission under the Securities Act (in the case of an Issuer Free Writing Prospectus, to the extent required by Rule 433 under the Securities Act) and in accordance with Section 4(a) hereof; and all requests by the Commission for additional information shall have been complied with to the reasonable satisfaction of the Representatives.

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