Prescription Drug User Fee Act Sample Clauses

Prescription Drug User Fee Act. Following the Effective Date, Buyer shall assume and have responsibility for fees or charges associated with the Product due and payable to the FDA after the Effective Date pursuant to the Prescription Drug User Fee Act, and any reauthorization thereto. Seller shall retain full responsibility and liability for all fees or charges due and payable to the FDA on or prior to the Effective Date.
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Prescription Drug User Fee Act. Following the Effective Date, Buyer shall assume and have responsibility for fees or charges associated with the Product due and payable to the FDA after the Effective Date pursuant to the Prescription Drug User Fee, and any reauthorization thereto ("PDUFA Fees"). Seller shall retain full responsibility and liability for the PDUFA Fees due and payable on or prior to the Effective Date. In the event the Seller makes payment of any PDUFA Fees after the Effective Date, the Buyer shall reimburse the PDUFA Fees to the Seller within thirty (30) Business Days from the date of receipt of invoice raised by the Seller."

Related to Prescription Drug User Fee Act

  • Prescription Drug Plan Retail and mail order prescription drug copays for bargaining unit employees shall be as follows:

  • Prescription Drugs The agreement may impose a variety of limits affecting the scope or duration of benefits that are not expressed numerically. An example of these types of treatments limit is preauthorization. Preauthorization is applied to behavioral health services in the same way as medical benefits. The only exception is except where clinically appropriate standards of care may permit a difference. Mental disorders are covered under Section A. Mental Health Services. Substance abuse disorders are covered under

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • OMNIBUS PROCUREMENT ACT OF 1992 It is the policy of New York State to maximize opportunities for the participation of New York State business enterprises, including minority and women-owned business enterprises as bidders, subcontractors and suppliers on its procurement contracts. Information on the availability of New York State subcontractors and suppliers is available from: NYS Department of Economic Development Division for Xxxxx Xxxxxxxx Xxxxxx, Xxx Xxxx 00000 Telephone: 000-000-0000 Fax: 000-000-0000 email: xxx@xxx.xx.xxx A directory of certified minority and women-owned business enterprises is available from: NYS Department of Economic Development Division of Minority and Women's Business Development 000 Xxxxx Xxxxxx Xxx Xxxx, XX 00000 212-803-2414 email: xxxxxxxxxxxxxxxxx@xxx.xx.xxx xxxxx://xx.xxxxxxxxxxxxxx.xxx/FrontEnd/VendorSearchPu blic.asp The Omnibus Procurement Act of 1992 requires that by signing this bid proposal or contract, as applicable, Contractors certify that whenever the total bid amount is greater than $1 million: (a) The Contractor has made reasonable efforts to encourage the participation of New York State Business Enterprises as suppliers and subcontractors, including certified minority and women-owned business enterprises, on this project, and has retained the documentation of these efforts to be provided upon request to the State; (b) The Contractor has complied with the Federal Equal Opportunity Act of 1972 (P.L. 92-261), as amended; (c) The Contractor agrees to make reasonable efforts to provide notification to New York State residents of employment opportunities on this project through listing any such positions with the Job Service Division of the New York State Department of Labor, or providing such notification in such manner as is consistent with existing collective bargaining contracts or agreements. The Contractor agrees to document these efforts and to provide said documentation to the State upon request; and (d) The Contractor acknowledges notice that the State may seek to obtain offset credits from foreign countries as a result of this contract and agrees to cooperate with the State in these efforts.

  • Fraud, Waste, and Abuse Contractor understands that HHS does not tolerate any type of fraud, waste, or abuse. Violations of law, agency policies, or standards of ethical conduct will be investigated, and appropriate actions will be taken. Pursuant to Texas Government Code, Section 321.022, if the administrative head of a department or entity that is subject to audit by the state auditor has reasonable cause to believe that money received from the state by the department or entity or by a client or contractor of the department or entity may have been lost, misappropriated, or misused, or that other fraudulent or unlawful conduct has occurred in relation to the operation of the department or entity, the administrative head shall report the reason and basis for the belief to the Texas State Auditor’s Office (SAO). All employees or contractors who have reasonable cause to believe that fraud, waste, or abuse has occurred (including misconduct by any HHS employee, Grantee officer, agent, employee, or subcontractor that would constitute fraud, waste, or abuse) are required to immediately report the questioned activity to the Health and Human Services Commission's Office of Inspector General. Contractor agrees to comply with all applicable laws, rules, regulations, and System Agency policies regarding fraud, waste, and abuse including, but not limited to, HHS Circular C-027. A report to the SAO must be made through one of the following avenues: ● SAO Toll Free Hotline: 1-800-TX-AUDIT ● SAO website: xxxx://xxx.xxxxx.xxxxx.xx.xx/ All reports made to the OIG must be made through one of the following avenues: ● OIG Toll Free Hotline 0-000-000-0000 ● OIG Website: XxxxxxXxxxxXxxxx.xxx ● Internal Affairs Email: XxxxxxxxXxxxxxxXxxxxxxx@xxxx.xxxxx.xx.xx ● OIG Hotline Email: XXXXxxxxXxxxxxx@xxxx.xxxxx.xx.xx. ● OIG Mailing Address: Office of Inspector General Attn: Fraud Hotline MC 1300 P.O. Box 85200 Austin, Texas 78708-5200

  • Prescription Safety Glasses Prescription safety glasses will be furnished by the employer. The employer retains the authority to establish reasonable rules and procedures regarding frequency of issue, replacement of damaged glasses, limits on reimbursement costs and coordination with the employer's vision plan.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Health Insurance Portability and Accountability Act of 1996 This paragraph was intentionally left blank.

  • DRUG/ALCOHOL TESTING Section 33.1 Drug testing may be conducted on employees during their duty hours upon reasonable suspicion or randomly by computer selection. Alcohol testing will be conducted only upon reasonable suspicion. Reasonable suspicion that an employee used or is using a controlled substance or alcohol in an unlawful or abusive manner may be based upon, but not limited to: A. Observable phenomena, such as direct observation of drug or alcohol use or possession and/or the physical symptoms of being under the influence of a drug or alcohol; B. A pattern or abnormal conduct or erratic behavior, including abnormal leave patterns; C. Arrest or conviction for a drug or alcohol-related offense, or the identification of an employee as the focus of a criminal investigation into illegal drug or alcohol possession, use, or trafficking; D. Information provided either by reliable and credible sources or independently corroborated; E. Evidence that an employee has tampered with a previous drug test; F. Facts or circumstances developed in the course of an authorized investigation of an accident or unsafe working practices. Section 33.2 Drug/alcohol testing shall be conducted solely for administrative purposes and the results obtained shall not be used in criminal proceedings. Under no circumstances may the results of drug/alcohol screening or testing be released to a third party for use in a criminal prosecution against the affected employee. The following procedure shall not preclude the Employer from other administrative action but such actions shall not be based solely upon the initial reagent testing results alone. Section 33.3 All drug screening tests shall be conducted by laboratories meeting the standards of the Substance Abuse and Mental Health Service Administration. No test shall be considered positive until it has been confirmed by a Gas Chromatography/Mass Spectrometry. The procedures utilized by the Employer and testing laboratory shall include an evidentiary chain of custody control and split sample testing. All procedures shall be outlined in writing and this outline shall be followed in all situations arising under this article. Section 33.4 Alcohol testing shall be done in accordance with the law of the State of Ohio to detect drivers operating a motor vehicle under the influence. A positive result shall entitle the Employer to proceed with sanctions as set forth in this Article. Section 33.5 The results of the testing shall be delivered to a specified employee of the Employer with command responsibility and the employee tested. An employee whose confirmatory test result is positive shall have the right to request a certified copy of the testing results in which the vendor shall affirm that the test results were obtained using the approved protocol methods. The employee shall provide a signed release for disclosure of the testing results to the Employer. A representative for the bargaining unit shall have a right of access to the results upon request to the Employer, with the employee’s written consent. Refusal to submit to the testing provided for under this Agreement may be grounds for discipline. A. If a drug screening test is positive, a confirmatory test shall be conducted utilizing the fluid from the primary sample. B. In the event that any confirmation drug test results are positive, the employee is entitled to have the split sample tested by another DHHS-certified lab in the manner prescribed above at the employee’s expense. The employee must request the split sample test within seventy-two (72) hours of being notified of a positive result. The results of this test, whether positive or negative, shall be determinative. Section 33.7 A list of three (3) testing laboratories shall be maintained by the Employer. These laboratories shall conduct any testing directed by the Employer. The Employer shall obtain the approval of the bargaining unit representative as to any laboratories put on this list, which approval shall not be unreasonably withheld. Section 33.8 If after the testing required above has produced a positive result the Employer may require the employee to participate in any rehabilitation or detoxification program that is covered by the employee’s health insurance. Discipline allowed by the positive findings provided for above shall be deferred pending rehabilitation of the employee within a reasonable period. An employee who participates in a rehabilitation or detoxification program shall be allowed to use sick time and vacation leave for the period of the rehabilitation or detoxification program. If no such leave credits are available, the employee shall be placed on medical leave of absence without pay for the period of the rehabilitation or detoxification program. Upon completion of such program and upon receiving results from a retest demonstrating that the employee is no longer abusing a controlled substance/alcohol, the employee shall be returned to his/her former position. Such employee may be subject to periodic retesting upon his/her return to his/her position for a period of one (1) year from the date of his/her return to work. Any employee in a rehabilitation or detoxification program in accordance with this Article will not lose any seniority or benefits, should it be necessary for the employee to be placed on medical leave of absence without pay, for a period not to exceed ninety (90) days. Section 33.9 If the employee refuses to undergo rehabilitation or detoxification, or if he/she tests positive during a retesting within one (1) year after his/her return to work from such a program, the employee shall be subject to disciplinary action, including removal from his/her position and termination of his/her employment. Section 33.10 Costs of all drug screening tests and confirmatory tests shall be borne by the Employer except that any test initiated at the request of the employee shall be at the employee’s expense. Section 33.11 The Employer may conduct four (4) tests of an employee during the one (1) year period after the employee has completed a rehabilitation or detoxification program as provided above. Section 33.12 The provisions of this Article shall not require the Employer to offer a rehabilitation/detoxification program to any employee more than once.

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