IN FEDERAL MARKETING ORDERS Sample Clauses

IN FEDERAL MARKETING ORDERS. On completion and publication of the study described in this section, the Secretary shall)
Sample 1Sample 2Sample 3See All (6)
AutoNDA by SimpleDocs

Related to IN FEDERAL MARKETING ORDERS

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, the Company and its subsidiaries: (i) are in compliance in all material respects with all statutes, rules, regulations, ordinances, orders and decrees applicable to the ownership, testing, in humans or laboratory models, development, manufacture, formulation, packaging, processing, recordkeeping, use, distribution, marketing, labeling, promotion, sale, price reporting, reimbursement, storage, import, export or disposal of any product manufactured or distributed by or for the Company or any of its subsidiaries (“Applicable Laws”), except where the failure to so comply would not, individually or in the aggregate, result in a Material Adverse Effect; (ii) to the knowledge of Company and its subsidiaries, have not, either voluntarily or involuntarily, disclosed to any governmental authority any violations of Applicable Laws, except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iii) have not received any Food and Drug Administration (“FDA”) Form 483 or any foreign counterpart thereof, warning letter, clinical hold notice or untitled letter from the FDA, any Institutional Review Board (as defined by federal regulation at 21 CFR Section 56.102(g)) or any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any licenses, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”), except such as would not, individually or in the aggregate, result in a Material Adverse Effect; (iv) have not received notification of nor have reason to believe that any audits by a governmental authority have resulted in a determination that any of their respective products have been improperly reimbursed, except such audits and determinations as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (v) possess all Authorizations (including, without limitation, exemptions under any Investigational Device Exemption or Investigational New Drug Application, as described at 21 CFR Sections 312 and 812, and approvals of any Institutional Review Board), which are in full force and effect, required for the conduct of their respective businesses (and such Authorizations are valid and in full force and effect) and are not in violation of any term of any such Authorizations, except where the failure to possess such Authorization or the violation of such Authorization would not, individually or in the aggregate, result in a Material Adverse Effect; (vi) have not received written notice of any pending or threatened claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion from any governmental authority or Institutional Review Board alleging that any of their respective operations or activities is in violation of any Applicable Laws or Authorizations and the Company has no knowledge or reason to believe that any such governmental authority, Institutional Review Board or other non-governmental authority is considering any such claim, suit, proceeding, clinical hold, hearing, enforcement, audit, investigation, arbitration, suspension, debarment or exclusion except for any such claims, suits, proceedings, clinical holds, hearings, enforcements, audits, investigations, arbitrations, suspensions, debarments or exclusions that would not, individually or in the aggregate, result in a Material Adverse Effect; (vii) have not received written notice that any governmental authority or Institutional Review Board has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and the Company has no knowledge or reason to believe that any such governmental authority is considering such action, except for any such actions that would not, individually or in the aggregate, result in a Material Adverse Effect; (viii) have, or have had on their behalf, filed, declared, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as are required by any Applicable Laws or Authorizations, except where the failure to so file, declare, obtain, maintain or submit would not, individually or in the aggregate, result in a Material Adverse Effect and 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); and (ix) have not, either voluntarily or involuntarily, initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter or investigator notice relating to an alleged lack of safety or efficacy of any product or product candidate, any alleged product defect, or violation of any material Applicable Laws or Authorizations and the Company is not aware of any facts that would cause the Company or any of its subsidiaries to initiate any such notice or action and the Company has no knowledge or reason to believe that any governmental authority, Institutional Review Board or other non-governmental authority intends to initiate any such notice or action, except for any such notices or actions that would not, individually or in the aggregate, result in a Material Adverse Effect. Any clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are described in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable federal, state, local and foreign laws, rules and regulations, including, but not limited to, the Federal Food, Drug, and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Any descriptions of studies, tests and preclinical and clinical trials, including any related results and regulatory status, contained in the Registration Statement, the General Disclosure Package or the Prospectus are, and will be, accurate and complete in all material respects. The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus. Neither the Company nor any of its subsidiaries has received any written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or any of its subsidiaries or in which the Company or any of its subsidiaries has participated.

  • 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.

  • References to Statutes, Public Acts, Regulations, Codes and Executive Orders All references in this Contract to any statute, public act, regulation, code or executive order shall mean such statute, public act, regulation, code or executive order, respectively, as it has been amended, replaced or superseded at any time. Notwithstanding any language in this Contract that relates to such statute, public act, regulation, code or executive order, and notwithstanding a lack of a formal amendment to this Contract, this Contract shall always be read and interpreted as if it contained the most current and applicable wording and requirements of such statute, public act, regulation, code or executive order as if their most current language had been used in and requirements incorporated into this Contract at the time of its execution.

  • Regulatory Agencies Nothing herein contained shall grant, or be construed to grant, PDC the right or authority to waive or release any rights, privileges, or obligations which Partnership may have federal or state laws or under rules, regulations or orders promulgated under such laws in reference to oil, gas and mineral operations, including the location, operation, or production of xxxxx, on tracts offsetting or adjacent to the Contract Area. With respect to operations hereunder, the Partnership agrees to release PDC from any and all losses, damages, injuries, claims and causes of action arising out of, incident to or resulting directly or indirectly from Operator's interpretation or application of rules, rulings, regulations, or orders of the Department of Energy or predecessor or successor agencies to the extent such interpretation or application was made in good faith. The Partnership further agrees to reimburse PDC for any amounts applicable to Partnerships share of production that PDC may be required to refund, rebate or pay as a result of such an incorrect interpretation or application.

  • Grievance Commissioner System This is to confirm the discussion of the parties during collective bargaining that they are committed to encouraging early discussion and resolution of labour relations issues at the local level and seek to resolve grievances in a timely and cost efficient manner. To that end, this is to confirm that pursuant to Article 8, the parties agree that the Employer and Union at individual nursing homes may agree to utilize the following process in order to resolve a particular grievance through the utilization of a joint mediation-arbitration procedure:

  • Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.

  • COMPTROLLER'S APPROVAL In accordance with Section 112 of the State Finance Law (or, if this contract is with the State University or City University of New York, Section 355 or Section 6218 of the Education Law), if this contract exceeds $50,000 (or the minimum thresholds agreed to by the Office of the State Comptroller for certain S.U.N.Y. and C.U.N.Y. contracts), or if this is an amendment for any amount to a contract which, as so amended, exceeds said statutory amount, or if, by this contract, the State agrees to give something other than money when the value or reasonably estimated value of such consideration exceeds $10,000, it shall not be valid, effective or binding upon the State until it has been approved by the State Comptroller and filed in his office. Comptroller's approval of contracts let by the Office of General Services is required when such contracts exceed $85,000 (State Finance Law Section 163.6-a). However, such pre-approval shall not be required for any contract established as a centralized contract through the Office of General Services or for a purchase order or other transaction issued under such centralized contract.

  • Statutory Authority Connecticut General Statute §§ 10a-104, 10a-108, 4a-52a, and 10a-151b provide the University with authority to enter into contracts in the pursuit of its mission.

  • Executive Orders This Contract is subject to the provisions of Executive Order No. Three of Governor Xxxxxx X. Xxxxxxx, promulgated June 16, 1971, concerning labor employment practices, Executive Order No. Seventeen of Governor Xxxxxx X. Xxxxxxx, promulgated February 15, 1973, concerning the listing of employment openings and Executive Order No. Sixteen of Governor Xxxx X. Xxxxxxx promulgated August 4, 1999, concerning violence in the workplace, all of which are incorporated into and are made a part of the Contract as if they had been fully set forth in it. The Contract may also be subject to Executive Order No. 14 of Governor M. Xxxx Xxxx, promulgated April 17, 2006, concerning procurement of cleaning products and services, Executive Order No. 61 of Governor Xxxxxx X. Xxxxxx promulgated December 13, 2017 concerning the Policy for the Management of State Information Technology Projects, as issued by the Office of Policy and Management, Policy ID IT-SDLC-17-04, and Executive Order No. 49 of Governor Xxxxxx X. Xxxxxx, promulgated May 22, 2015, mandating disclosure of certain gifts to public employees and contributions to certain candidates for office in accordance with their respective terms and conditions. If Executive Orders 14, 61 or 49 are applicable, it is deemed to be incorporated into and are made a part of the Contract as if it had been fully set forth in it. At the Contractor’s request, the State shall provide a copy of these orders to the Contractor.

  • FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Applicants The Commission gives notice that the following applicants have filed an application for an Ocean Transportation Intermediary (OTI) license as a Non- Vessel-Operating Common Carrier (NVO) and/or Ocean Freight Forwarder (OFF) pursuant to section 19 of the telephone at (202) 523–5843 or by email at XXX@xxx.xxx. 5G Logistics Solutions LLC (NVO & OFF), 0000 XX 000xx Xxxxx, Xxxxx, XX 00000. Officers: Xxxxxxxx Xxxxxx, President (QI), Xxxxxxx X. Xxxxx, Vice President. Application Type: New NVO & OFF License. American Cargo International, Inc. (NVO & OFF), 0000 XX 00xx Xxxxxx, Miami, FL 33128. Officers: Xxxxx Xx Xxx, Vice President (QI), Xxxxx Xxxxxxxx, Member. Application Type: License Transfer to American Cargo International, LLC. Atlanta Customs Brokers & Intl Freight Forwarders Inc dba ACB Ocean Services (NVO & OFF), 000 Xxxxxxx Xxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx, XX 00000. Officers: Xxxxx Xxxxxxxx, Vice President Exports (QI), Xxxxxx Xxxxxx, President. Application Type: New NVO & OFF License. Xxxxxxx International Transport, L.L.C. (NVO & OFF), 0000 Xxxxxxxxxx Xxxxxxx, XxXxxxxxx, XX 00000. Officers: Xxxxxx X. Xxxxxxxx, Vice President (QI), Xxxxxx X. Xxxxxx, Managing Member. Application Type: QI Change. CMS Shipping Agency, Inc. dba Atlantic Pacific Lines (NVO & OFF), 0000 Xxxxxxxx, Xxxxx 000, Xxxx Xxxx Xxxxxx, XX 00000. Officer: Xxxxxx Xxxxxxx, President (QI). Application Type: Name Change to Atlantic Pacific Lines, Inc, dba Atlantic Pacific Lines. DBN Carrier, Inc. (NVO), 000 X. Xxxxxxxx Avenue, Suite 5B, Los Angeles, CA 90036. Officers: Xxxxxxxxxx Xxxxxxxxxx, President (QI), Xxxxxxx Xxxxxxxxxx, Secretary. Application Type: New NVO License. Xxxxxx Xxxxxxxxx dba Galaxy Enterprises LA (NVO), 00000 Xxxxxxx Xxxx., Xxxxx 00, Xxxxxxx Xxxx, CA 91403. Officer: Xxxxxx Xxxxxxxxx, Sole Proprietor (QI). Application Type: New NVO License. Forward Systems Group, Inc. (NVO & OFF), 1915 NW 00xx Xxxxxx, Xxxxx, XX 00000. Officers: Xxxxxxx Xxxxxxx, President (QI), Xxxxx X. Xxxxxxx, COO. Application Type: New NVO & OFF License. Xxxxx X. Xxxxx & Co. dba JJB Global Logistics Co., Ltd. dba JJB Inland Logistics JJB Link Logistics Company 0000 Xxxxxxxxxx Xxxx, Xxxxx 000, Xxxxxxx, XX 00000. Officers: Xxxxxx Xxxxxx, President (QI), Xxxxxx Xxxxx, Secretary. Application Type: New NVO & OFF License. NMC Logistics Solutions, Inc. (NVO & OFF), 0000 XX 00xx Xxxxxx, Xxxxx, XX 00000. Officers: Xxxxxxx Xxxxxxx, President (QI), Xxxxx Xxxxxx, Secretary. Application Type: New NVO & OFF License. Platinum Cargo Logistics, Inc. (NVO & OFF), 00000 X. Xxx Xxxx Avenue, Torrance, CA 90501. Officers: Xxxxxx

Time is Money Join Law Insider Premium to draft better contracts faster.