FDA Submission Sample Clauses

FDA Submission. BIONICHE represents and warrants that it has submitted to the FDA information about the Facility and the operating procedures, and personnel at such site in the form required by the FDA. BIONICHE shall keep and maintain the equipment necessary for the Manufacture of any Drug Product in a manufacture-ready state and in good repair. During the term hereof and until the fifth anniversary of termination or expiration, BIONICHE shall maintain written documentation of all use, repair, service, and maintenance of such equipment and shall provide CUMBERLAND copies of such documentation; provided that in the event that a Person acquires substantially all of the assets and business of BIONICHE, BIONICHE may send all such documentation to CUMBERLAND promptly after such acquisition.
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FDA Submission. FAULDING represents and warrants that it has submitted to the FDA information about the manufacturing site to be used for the Drug Product and the facilities, operating procedures, and personnel at such site.
FDA Submission. AL shall take all reasonably necessary actions to support submission and approval of an NDA or ANDA for Product by performing such development and obtaining such data and information as reasonably necessary therefor at its own expense; provided, however, that AL shall not be responsible for engaging the CMO or the performance of the obligations of the CMO that are necessary to support the submission and approval of the NDA or ANDA for Product, including the manufacture of exhibit batches and the payment of transfer costs, which costs shall be paid by Eton. ***Text has been omitted pursuant to Registrant’s confidential treatment request filed with the Securities and Exchange Commission (“Commission”) pursuant to Rule 406 under the Securities Act of 1933. The omitted text has been filed separately with the Commission.
FDA Submission. Sublicensor will provide AbbVie with prompt written notice of any patent information submitted to the FDA for listing in association with the Product upon its receipt of notice from Merck.

Related to FDA Submission

  • BID SUBMISSION All Bids are to be packaged, sealed and submitted to the location stated in the Bid Specifications. Bidders are solely responsible for timely delivery of their Bids to the location set forth in the Bid Specifications prior to the stated Bid opening date/time. A Bid return envelope, if provided with the Bid Specifications, should be used with the Bid sealed inside. If the Bid response does not fit into the envelope, the Bid envelope should be attached to the outside of the sealed box or package with the Bid inside. If using a commercial delivery company that requires use of their shipping package or envelope, Bidder’s sealed Bid, labeled as detailed below, should be placed within the shipper’s sealed envelope to ensure that the Bid is not prematurely opened. All Bids must have a label on the outside of the package or shipping container outlining the following information: “BID ENCLOSED (bold print, all capitals) • Group Number • IFB or RFP Number • Bid Submission date and time” In the event that a Bidder fails to provide such information on the return Bid envelope or shipping material, the receiving entity reserves the right to open the shipping package or envelope to determine the proper Bid number or Product group, and the date and time of Bid opening. Bidder shall have no claim against the receiving entity arising from such opening and such opening shall not affect the validity of the Bid or the procurement. Notwithstanding the receiving agency’s right to open a Bid to ascertain the foregoing information, Bidder assumes all risk of late delivery associated with the Bid not being identified, packaged or labeled in accordance with the foregoing requirements. All Bids must be signed by a person authorized to commit the Bidder to the terms of the Bid Documents and the content of the Bid (offer).

  • Claims Submission We will submit your claims and assist you in any way we reasonably can to help get your claims paid. Your insurance company may need you to supply certain information directly. It is your responsibility to comply with their request. Please be aware that the balance of your claim is your responsibility whether or not your insurance company pays your claim. Your insurance benefit is a contract between you and your insurance company; we are not party to that contract.

  • REPORT SUBMISSION 1. Copies of reporting packages for audits conducted in accordance with 2 CFR Part 200, Subpart F-Audit Requirements, and required by PART I of this form shall be submitted, when required by 2 CFR 200.512, by or on behalf of the recipient directly to the Federal Audit Clearinghouse (FAC) as provided in 2 CFR 200.36 and 200.512

  • Application Submission Submissions of a rental application does not guarantee approval or acceptance. It does not bind us to accept the application or to sign a Lease contact. APPLICANT SCREENING CRITERIA Fair Housing Statement. Xxxxx Management is an equal housing opportunity & fair housing provider. We do not discriminate against persons on the basis of race, color, religion, national origin, sex, familial status, disability, creed, marital status, public assistance, ancestry, and sexual or affectional orientation. Identification and Application Process. Every person over 18 must give consent to be screened and provide a government issued photo ID. Social Security Number verification may be required for specific housing programs. Application Requirements. Applications must be filled out completely and accurately. Any misstatements or omissions made on your application, whether or not discovered before you move into the building, is grounds for denial of an application or termination of an existing lease. Information must be legible and verifiable. If information given on the application cannot be verified, this is a reason for rejection. Omission of information, such as an address or employer, may be grounds for rejection. Occupancy. The initial maximum number of residents in a unit is equal to two persons per bedroom unless otherwise stated in the property’s Resident Selection Plan, where applicable. Each unit is limited to no more than two (2) unrelated or four (4) related adult persons per unit. Xxxxx Management defines a related adult person as either a child, dependent, or parent of the head of household. General occupancy standards and any federal, state, or local housing ordinances will supersede this policy. Housing History. We require the name and last known telephone number of each landlord/property manager for each address you have had for the last three years. Roommate references are not acceptable. The refusal of a prior landlord to give a reference, or a negative reference, may be grounds for rejection. In the case of first-time renters, or applicants without prior rental history, this requirement may be varied subject to additional requirements of management. Eviction Filings. Unlawful detainers or evictions within the past five (5) years is a basis for denial of an application.

  • SUBMISSIONS You acknowledge and agree that any questions, comments, suggestions, ideas, feedback, or other information regarding the Site ("Submissions") provided by you to us are non-confidential and shall become our sole property. We shall own exclusive rights, including all intellectual property rights, and shall be entitled to the unrestricted use and dissemination of these Submissions for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you. You hereby waive all moral rights to any such Submissions, and you hereby warrant that any such Submissions are original with you or that you have the right to submit such Submissions. You agree there shall be no recourse against us for any alleged or actual infringement or misappropriation of any proprietary right in your Submissions.

  • Invoice Submission The Contractor shall accept payment of invoices via EFT. Invoice submission information shall be contained in each individual Order. Payment of invoices will be made by the payment office designated in each individual Order.

  • Resubmission If terminated, resolved or withdrawn, a grievance cannot be resubmitted.

  • 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.

  • Preparation and Submission The Recipient will:

  • Submitting Investigator An investigator who submitted a genomic dataset to an NIH designated data repository (e.g., dbGaP). Study specific DUC addendum phs000178 : The Cancer Genome Atlas (TCGA) Public Posting of Genomic Summary Results - Not Allowed. NIH Data Access Committee (DAC) : NCI DAC Important Contacts : XXXXXX@xxxx.xxx.xxx; XXX@xxxx.xxx.xxx In the event of a data management incident, within 24 hours, please contact emails above.

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