Safety or Efficacy Sample Clauses

Safety or Efficacy. If at any time during the Term: (i) the Party with responsibility for filing an application for Regulatory Approval hereunder ("Filing Party") decides not to file an application for Regulatory Approval in any Major Subterritory or decides to withdraw such application due to documented adverse reactions or other safety issues with the Product or the Product's lack of efficacy or limited efficacy (collectively, "Safety or Efficacy Issues"); (ii) the Filing Party's application(s) for Regulatory Approval in any Major Subterritory is rejected due to Safety or Efficacy Issues; (iii) the Filing Party's application(s) for Regulatory Approval in any Major Subterritory is subsequently withdrawn because of Safety or Efficacy Issues; (iv) the Product is withdrawn or recalled from the market in any Major Subterritory because of Safety or Efficacy Issues; or (v) at any time during the period from the Effective Date to the effective date of API's assignment of the U.S. NDA for the Product to Abboxx, Xxboxx xxxsonably believes documented Safety or Efficacy Issues exist and Abbott has so notified API in writing, then Abbott may, at its option, terminate this Agreement upon thirty (30) days prior written notice to API. Abbott may, at its option, exercise its right of termination under this Section 16.4(a) on a country-by-country basis, and, if Abbott does so, Abboxx'x xxxmination notice shall specify the country or countries of the Territory affected.
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Safety or Efficacy. If at any time during the Term: (i) GTX decides not to file an application for Regulatory Approval in any country or decides to withdraw such application due to documented adverse reactions or other safety issues with the Product or the Product’s lack of efficacy or limited efficacy (collectively, “Safety or Efficacy Issues”); (ii) GTX’s application(s) for Regulatory Approval in any country is rejected due to Safety or Efficacy Issues; (iii) GTX’s application(s) for Regulatory Approval in any country is subsequently withdrawn because of Safety or Efficacy Issues; or (iv) the Product is withdrawn or recalled from the market in any country because of Safety or Efficacy Issues, then GTX may, at its option, terminate this Agreement with respect to such country upon thirty (30) days prior written notice to Orion. GTX must exercise this right of termination within the later of [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Safety or Efficacy. Except as provided in Schedule 4.2(o), NGL is not aware of any material nonpublic information relating to the safety or efficacy of the (R)-isomer of nicotine for use in a method as claimed in US Patent No. 10,610,526.
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Safety or Efficacy. If at any time during the Term: (i) GTX decides not to file an application for Regulatory Approval in any country or decides to withdraw such application due to documented adverse reactions or other safety issues with the Product or the Product's lack of efficacy or limited efficacy (collectively, "Safety or Efficacy Issues"); (ii) GTX's application(s) for Regulatory Approval in any country is rejected due to Safety or Efficacy Issues; (iii) GTX's application(s) for Regulatory Approval in any country is subsequently withdrawn because of Safety or Efficacy Issues; or (iv) the Product is withdrawn or recalled from the market in any country because of Safety or Efficacy Issues, then GTX may, at its option, terminate this Agreement with respect to such country upon thirty (30) days prior written notice to Orion. GTX must exercise this right of termination within the later of (a) sixty (60) days of the occurrence of the event giving rise to such right or (b) thirty (30) days of GTX's last meeting, if any, with the relevant regulatory authorities, provided that GTX uses reasonable diligence to schedule such meeting and that Orion is providing reasonable co-operation to GTX in connection with such meeting. GTX may, at its option, exercise its right of termination under this Section 20.5.2 on a country-by-country basis, and, if GTX does so, GTX's termination notice shall specify the country or countries of the GTX Territory affected.
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Related to Safety or Efficacy

  • Safety Boots Each employee, after 3 months’ continuous service, will be reimbursed (on production of a receipt), the cost of one pair of safety boots (approved by the employer), in each year, to a maximum of $110.00. Wet Weather All protective clothing such as wet weather jackets, safety helmets, welding jackets, welding xxxxxxx, welding gauntlets, rubber boots, etc, (which remain the property of the Company), will be supplied on all occasions deemed necessary.

  • Safety Glasses 10.3.1 Where a teacher is considered to be working in an “eye danger” area, the teacher shall receive a personal issue of standard neutral safety glasses which shall remain the property of the employer.

  • SAFETY & HEALTH The Employer and the IBTCoalition agree that the safety of employees and the general public is of utmost importance. Therefore, the Employer shall provide a safe work environment that is free of recognized hazards that could cause death, injury or illness.

  • Safety Where an employee is prevented from working at the employee’s particular function as a result of unsafe conditions caused by the inclement weather, the employee may be transferred to other work in the employee’s classification on site, until the unsafe conditions are rectified. Where such alternative is not available and until the unsafe conditions are rectified, the employee shall remain on site. The employee shall be paid for such time without reduction of the employees’ inclement weather entitlement.

  • Joint Occupational Health and Safety Committee The Employer and the Union recognize the role of the joint Occupational Health and Safety Committee in promoting a safe and healthful workplace. The parties agree that a Joint Occupational Health and Safety Committee shall be established for each Employer covered by this Collective Agreement. The Committee shall govern itself in accordance with the provisions of the Industrial Health and Safety Regulations made pursuant to the Workers’ Compensation Act. The Committee shall be as between the Employer and the Union, with equal representation, and with each party appointing its own representatives. Representatives of the Union shall be chosen by the Union membership or appointed by the Union. All minutes of the meetings of the Joint Occupational Health & Safety Committee will be recorded in a mutually agreeable format and will be sent to the Union. The Union further agrees to actively pursue with the other Health Care Unions a Joint Union Committee for the purposes of this Article. The Employer agrees to provide or cause to be provided to Employer members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. The Union agrees to provide or cause to be provided to Union members of the Joint Occupational Health and Safety Committee adequate training and orientation to the duties and responsibilities of committee members to allow the incumbents to fulfil those duties competently. Such training and orientation shall take place within six (6) months of taking office.

  • Occupational Health and Safety Committee The Employer and the Union agree to cooperate in the promotion of safe working conditions, the prevention of accidents, the prevention of workplace injuries and the promotion of safe workplace practices.

  • 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.

  • Safety Data Sheets If specified by City in the solicitation or otherwise required by this Contract, Contractor must send with each shipment one (1) copy of the Safety Data Sheet (SDS) for each item shipped. Failure to comply with this procedure will be cause for immediate termination of the Contract for violation of safety procedures.

  • Safety Footwear 1. The State will provide employees in the classifications listed in Section 7 below, and employees who are currently required to wear safety footwear by Department Work Rules, an allowance of one hundred twenty dollars ($120.00) for replacement of safety footwear.

  • Safety Program The Contractor shall design a specific safety program for the Work for the site(s). The Contractor shall establish and require all Subcontractors to establish reasonable safety programs. The Contractor shall also submit its standard monthly safety reports to the Owner and Design Professional. No imposition of responsibility on the Contractor for safety under this Contract shall relieve any subcontractor of its responsibility for safety of persons or property on or near the Project Site. The Contractor shall include in his plant he names of the person in charge of Safety.

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