Office of Justice Programs The Provider must report suspected fraud, waste and abuse to the OAG’s Office of the Inspector General at 000-000-0000.
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.
Competent Authorities The Parties shall inform each other about the structure, organisation and division of competences of their competent authorities during the first meeting of the Sanitary and Phytosanitary Sub-Committee referred to in Article 65 of this Agreement ("SPS Sub-Committee"). The Parties shall inform each other of any change of the structure, organisation and division of competences, including of the contact points, concerning such competent authorities.
Legal Protection 7.14.1 The University shall provide legal representation to any Member of the Bargaining Unit who is named a defendant in a civil action based on performance of the Member’s duties within the scope of employment. Legal representation will be at the Member’s request, subject to the approval of the Ohio Attorney General and in accordance with Ohio law. Pursuant to Ohio Revised Code Section 9.87 the University shall seek indemnification from the state for liability or judgment of any Member of the Bargaining Unit resulting from the performance of his or her duties for the University. Nothing in this Section is intended to expand or conflict with current Ohio law.
7.14.2 As long as the University continues to provide liability insurance coverage pursuant to ORC 3345.202 for any member of the University Board of Trustees or any University officer, the University shall continue to provide that level of liability insurance coverage for each Bargaining Unit Faculty 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.
Alcohol and Drugs Service Provider agrees that the presence of alcohol and drugs are prohibited on the Work Site and while performing their Services. If the Service Provider or any of their agents, employees, or subcontractors are determined to be present or with alcohol or drugs in their possession, this Agreement shall terminate immediately.
Department of Agriculture United States Department of Agriculture at 0-000-000-0000, 000-000-0000, or xxxx://xxx.xxxxx.xxx/plantind/ to determine those specific project sites located in the quarantined area or for any regulated article used on this project originating in a quarantined county.
Department Heads Department heads shall normally be tenured and hold the rank of Associate Professor or Professor in one of the departments to be served, unless mutually agreed to by the departmental faculty and administration.
3.1.2.1 When it becomes known that a department head position will become vacant, or if the department head position has already become vacant, or if a new department is created, the xxxx of the college shall meet with the department faculty within two (2) weeks to discuss qualifications and expectations for the position. Specific guidelines will be formulated which may include:
a. Whether internal and/or external candidates shall be considered
b. Desired qualifications, including rank
c. Budgetary considerations
d. The target number of recommended candidates that will be submitted to the xxxx for consideration
3.1.2.1.1 Following the discussion described in 3.1.2.1, the department faculty shall communicate their recommendations within two (2) weeks to the xxxx. The xxxx shall promptly confirm or modify the department faculty’s recommendations and communicate the guidelines and procedures in choosing the new department head.
3.1.2.2 The department faculty will formulate its recommendation(s) among all candidates and forward same to the xxxx, with supporting rationale. When the department faculty is able to find more than one (1) acceptable candidate, the department may rank order its list of acceptable candidates and give reasons for its ranking. If the department is able to find only one (1) acceptable candidate, it shall recommend that candidate. If the department faculty does not find an acceptable candidate, the search will be ended. The xxxx will review the departmental recommendation(s) with the PVPAA. If the department’s recommendation(s) is approved by the PVPAA, the PVPAA shall recommend the appointment of the candidate to the President of the University. If the University does not accept the recommended candidate(s), the University has the right to declare the search process has ended.
3.1.2.3 In the event a department head position is not filled in a timely fashion through the preceding procedures, the Board may appoint a department head for a period not to exceed one (1) year. During this year the procedures specified in sections 3.1.2.1 and 3.
Medicines To be filled in if your child requires medication as part of an individual health plan, for example for an on-going condition such as asthma or eczema etc and is for the use of that child only. For staff: Individual health plan sighted and a copy taken: Tick One: Yes No Name of medicine: Method and dose of medicine: When does the medicine need to be taken: (State time or specific symptoms) Parent/Guardian Signature: Date: / / Enrolment Details: Date of Enrolment: / / Date of Entry: / / Date of Exit: / / Please Note: 20 Hours ECE is for up to six hours per day, up to 20 hours per week and there must be no compulsory fees when a child is receiving 20 Hours ECE funding. Days Enrolled: Monday Tuesday Wednesday Thursday Friday Times Enrolled: Total hours: 20 Hours ECE at this service Total hours: 20 Hours ECE at another service Total hours: Parent/Guardian Signature: Date: / /
INTERNATIONAL BOYCOTT PROHIBITION In accordance with Section 220-f of the Labor Law and Section 139-h of the State Finance Law, if this contract exceeds $5,000, the Contractor agrees, as a material condition of the contract, that neither the Contractor nor any substantially owned or affiliated person, firm, partnership or corporation has participated, is participating, or shall participate in an international boycott in violation of the federal Export Administration Act of 1979 (50 USC App. Sections 2401 et seq.) or regulations thereunder. If such Contractor, or any of the aforesaid affiliates of Contractor, is convicted or is otherwise found to have violated said laws or regulations upon the final determination of the United States Commerce Department or any other appropriate agency of the United States subsequent to the contract's execution, such contract, amendment or modification thereto shall be rendered forfeit and void. The Contractor shall so notify the State Comptroller within five (5) business days of such conviction, determination or disposition of appeal (2NYCRR 105.4).