FDA Regulation. The Company is and has been in compliance with all applicable laws administered or issued by the FDA or any similar governmental entity, including the Federal Food, Drug, and Cosmetic Act and all other laws regarding developing, testing, manufacturing, marketing, distributing or promoting the products of the Company, or complaint handling or adverse event reporting.
FDA Regulation. As to each product or product candidate 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”) and/or the jurisdiction of the non-U.S. counterparts thereof that is currently being tested, sold and/or marketed by the Company (each such product, a “Product”), such Product is being tested, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and/or 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, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company currently has no products that have been approved by the FDA or any non-U.S. counterparts thereof to be manufactured, packaged, labeled, distributed, sold and/or marketed. 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 and the Company has not received any notice, warning letter or other communication from the FDA or any other governmental entity or any non-U.S. counterparts thereof, 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 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 Product, (iii) imposes a clinical hold on any clinical investigation by the Company, (iv) enjoins production at any facility of the Company, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company, 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...
FDA Regulation. (i) Neither the Company nor any of its subsidiaries has made any knowingly false statements on, or, to the best knowledge of the Company, uncorrected or uncompleted material omissions from, any applications, approvals, reports or other submissions to any applicable regulatory authority, or in or from any other records and documentation prepared or maintained to comply with the requirements of the United States Food and Drug Administration (the “FDA”) or any comparable regulatory authority relating to the Company’s product candidates.
FDA Regulation. Parent is and has been in compliance in all material respects with all applicable Laws administered or issued by the FDA or any similar Governmental Authority, including the Federal Food, Drug, and Cosmetic Act and all other Laws regarding developing, testing, manufacturing, marketing, distributing or promoting the products of Parent, or complaint handling or adverse event reporting.
FDA Regulation. The Company is and since January 1, 2017 has been in compliance in all material respects with all applicable laws administered or issued by the FDA or, to the Company’s Knowledge, any similar Governmental Entity, including the Federal Food, Drug, and Cosmetic Act regarding developing, testing, manufacturing, marketing, distributing or promoting the products of the Company and its Subsidiaries, or complaint handling or adverse event reporting.
FDA Regulation. (a) Since January 1, 2003, the Xxxxxx Entities have been in compliance in all material respects with all applicable provisions of the Federal Food, Drug and Cosmetic Act 21 U.S.C. 301 et seq. (“FFDCA”), the Public Health Service Act and all applicable implementing U.S. Food and Drug Administration (“FDA”) rules, regulations and policies, and all corresponding applicable foreign, state and local laws, rules and regulations relative to the conduct or operation of the Xxxxxx Business, the products manufactured or sold by any of the Xxxxxx Entities (the “Products”) or the ownership or use of any of their assets or properties (including, without limitation, the good manufacturing practice requirements under the Quality System Regulation, 21 C.F.R. 820, and the electronic records and the electronic signatures regulation at C.F.R. Part 11). Since January 1, 2003, none of the Products is or has been adulterated or misbranded as defined under FFDCA. Since January 1, 2003, no Xxxxxx Entity has received any written notification from the FDA or any other applicable governmental authority indicating that any of the Products is misbranded or adulterated. Since January 1, 2003, none of the employees, agents or independent contractors of the Xxxxxx Entities has been disbarred, subject to disbarment under 21 U.S.C. 335, or otherwise disqualified or suspended from performing services or otherwise subject to any restrictions or sanctions by the FDA or any other governmental authority or professional body.
FDA Regulation. Inhibrx is and has been in compliance with all applicable laws administered or issued by the FDA or any similar governmental entity, including the Federal Food, Drug, and Cosmetic Act and all other laws regarding developing, testing, manufacturing, marketing, distributing or promoting the products of Inhibrx, or complaint handling or adverse event reporting.
FDA Regulation. Except as described in the Prospectus, to the Company's knowledge, there are no rulemaking or similar proceedings before the United States Food and Drug Administration (the "FDA") or comparable Federal, state, local or foreign government bodies which involve or affect the Company, which, if the subject of an action unfavorable to the Company, could reasonably be expected to involve a prospective material adverse change in or effect on the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company.
FDA Regulation. The Food and Drug Administration, or FDA, generally has the authority to regulate medical devices, including computer applications, when devices are indicated, labeled or intended to be used in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, or are intended to affect the structure or function of the body. We do not believe that any of our current applications or services are subject to FDA regulation as medical devices, however, expansion of our application and service offerings could subject us to FDA regulation. However, there can be no assurance that the FDA will not assert jurisdiction over certain aspects of our business. FDA jurisdiction over our business, including our applications and services, could materially impact our ability to introduce new applications and services in a timely manner because of the FDA approval process. In addition, compliance with FDA regulations could be expensive. REGULATION OF THE INTERNET Laws and regulations applicable to communications or commerce over the Internet may be adopted covering user privacy, pricing, content, copyright, distribution and characteristics and quality of products and services. In addition, some states or foreign countries could apply existing laws concerning issues such as property ownership, sales tax, libel and personal privacy to transactions conducted over the Internet. Additional laws or regulations or application of laws to transactions over the Internet could require us to change our operations or increase our cost of doing business.
FDA Regulation. Except as described in Section 4.28 of the Disclosure Schedule, each Seller possesses and has performed its obligations with respect to all Approvals required by the United States Food and Drug Administration (the “FDA”) and any other federal, state or foreign agencies or bodies engaged in the regulation of the Business. No Seller has received notification of any proceeding relating to revocation or modification of any such Approval or has any reason to believe that any such Approval will not be renewed or that it is not in compliance with the Federal Food, Drug and Cosmetic Act, related Regulations and guidance documents issued by the FDA or the Laws and guidance documents issued by similar Governmental Authorities.
