Safety and Efficacy Claims Sample Clauses

Safety and Efficacy Claims. CPL shall promptly notify Helix of any information or notice of which it becomes aware concerning the safety or efficacy claims of the Product, including, without limitation, any threatened or pending action by any Regulatory Authority. Helix shall be responsible for handling all complaints and communications from Regulatory Authorities with respect to the Product. CPL shall cooperate in resolving such complaints and responding to such communications to the extent they pertain to Product and are reasonably requested by Helix in connection therewith. Helix shall pay CPL for all Actual & Reasonable costs and expenses incurred by CPL in connection with the performance of CPL's obligations under this Section 6.12 except in the event and to the extent that such complaints or communications are directly attributable to CPL's breach of the warranties set forth in Sections 11.1 and 11.2.
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Safety and Efficacy Claims. BioVectra shall promptly notify Helix of any information or notice of which it becomes aware concerning the safety or efficacy claims of the Product, including, without limitation, any threatened or pending action by any Regulatory Authority regarding the Product. Helix shall be responsible for handling all complaints and communications from Regulatory Authorities with respect to the Product. BioVectra shall cooperate in resolving such complaints and responding to such communications to the extent they pertain to Product and are reasonably requested by Helix in connection therewith. Helix shall pay BioVectra for all Actual & Reasonable Costs and Expenses incurred by BioVectra in connection with the performance of BioVectra's obligations under this Section 6.12 except in the event and to the extent that such complaints or communications are directly attributable to BioVectra's breach of the warranties set forth in Sections 11.1 and 11.2.
Safety and Efficacy Claims. Each Party shall promptly notify the other of any information or notice that they become aware of concerning the safety or efficacy claims of the Product, including, without limitation, any threatened or pending action by any Regulatory Authority. Tercica shall be responsible for handling all complaints and communications from Regulatory Authorities with respect to the Product. CBSB shall cooperate in resolving such complaints and responding to such communications to the extent they pertain to Drug Substance and are reasonably requested by Tercica in connection therewith. Tercica shall reimburse CBSB for all reasonable costs and expenses incurred by CBSB in connection with the performance of CBSB’s obligations under this Section 11.11.2, except in the event that such complaints or communications are traced to or directly attributable to CBSB’s breach of the warranties set forth in Sections 17.1 and 17.2.
Safety and Efficacy Claims. Each Party shall promptly notify the other of any information or notice it is or becomes aware of concerning the safety or efficacy claims of any Genta Product, including, without limitation, any threatened or pending action by any Regulatory Authority. Genta or the Genta Partner(s) shall be responsible for handling all complaints and communications from Regulatory Authorities with respect to the Genta Product. Avecia shall cooperate in resolving such complaints and responding to such communications to the extent they pertain to API and are reasonably requested by Genta in connection therewith.
Safety and Efficacy Claims. Each Party shall promptly notify the other of any information or notice it is or becomes aware of concerning the safety or efficacy claims of any HemoSense Product, including, without limitation, any threatened or pending action by any regulatory authority. HemoSense shall be responsible for handling all complaints and communications from regulatory authorities with respect to the HemoSense Product. HTI shall cooperate in resolving such complaints and responding to such communications to the extent *** Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. they pertain to Coagulation Cocktail 2 and are reasonably requested by HemoSense in connection therewith.

Related to Safety and Efficacy Claims

  • HEALTH, SAFETY AND ENVIRONMENT In the performance of this Contract, Contractor and Operator shall conduct Petroleum Operations with due regard to health, safety and the protection of the environment (“HSE”) and the conservation of natural resources, and shall in particular:

  • Safety and Security Procedures Contractor shall maintain and enforce, at the Contractor Work Locations, industry-standard safety and physical security policies and procedures. While at each Court Work Location, Contractor shall comply with the safety and security policies and procedures in effect at such Court Work Location.

  • COMPLIANCE WITH HEALTH, SAFETY, AND ENVIRONMENTAL REGULATIONS The Contractor, it’s Subcontractors, and their respective employees, shall comply fully with all applicable federal, state, and local health, safety, and environmental laws, ordinances, rules and regulations in the performance of the services, including but not limited to those promulgated by the City and by the Occupational Safety and Health Administration (OSHA). In case of conflict, the most stringent safety requirement shall govern. The Contractor shall indemnify and hold the City harmless from and against all claims, demands, suits, actions, judgments, fines, penalties and liability of every kind arising from the breach of the Contractor’s obligations under this paragraph.

  • Accident Prevention Health and Safety Committee (a) The Employer and the Union agree that they mutually desire to maintain standards of safety and health in the workplace in order to prevent accidents, injury and illness. (b) Recognizing its responsibilities under the applicable legislation, the Employer agrees to accept as a member of its Accident Prevention – Health & Safety Committee at least three (3) representatives, one from each base, selected or appointed by the Union from amongst bargaining unit employees. At any time where a vote is required, an equal number of representatives from each side shall be entitled to vote. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs and recommend actions to be taken to improve conditions related to safety and health. (d) The Employee agrees to co-operate reasonably in providing necessary information to enable the Committee to fulfill its functions. (e) Meetings shall be held quarterly or more frequently at the call of the Chair if required. The Committee shall maintain minutes of all meetings and make the same available for review. (f) Any representative appointed or select in accordance with (b) hereof shall serve a term of one (1) calendar year from the date of appointment which may be renewed for further periods of one (1) year. The Union will encourage its representative(s) to serve at least one (1) year. Time off for such representative(s) to attend meetings of the Accident Prevention – Health & Safety Committee in accordance with the foregoing shall be granted and time so spent attending such meetings shall be deemed to be work time for which the representative(s) shall be paid by the Employer at his regular or premium rate as may be applicable. (g) The Union agrees to endeavour to obtain the full co-operation of its membership in the observation of all safety rules and practices. (h) Pregnant employees may request to be transferred from their current duties if, in the professional opinion of the employee’s physician, the pregnancy may be at risk. If such a transfer is not feasible, the pregnant employee, if she so requests, will be granted an unpaid leave of absence before commencement of the maternity leave referred to in Article 16.04

  • SAFETY AND HEALTH A. The Employer agrees to provide a safe, clean wholesome surrounding in all places of employment. B. Each Department head shall issue instructions to all supervisory personnel to carry out the provisions of this Article. C. When an employee reports any condition which he/she believes to be injurious to his/her health to the administrative head of a work location, the administrative head shall correct the situation if within his/her authority, or shall report said complaint to his/her supervisor. D. A copy of the provisions of this Article shall be conspicuously posted in each work location. E. In all new places of employment, where the Union alleges that the air quality is inferior, the person in charge of the location will make reasonable efforts to have air quality checked. If the air quality is found to be sub-standard, the person in charge of the location shall make reasonable efforts to improve it. F. Whenever temperature inside any work location is unusually hot or cold, the person in charge of such work location shall immediately contact the person responsible for the building to determine the cause and probable length of time necessary to correct the problem. G. The Employer will make every reasonable effort to xxxxx asbestos containing materials as recommended by the Division of Occupational Hygiene. Where such cleanup is not possible, the Employer will make every effort to avoid making work assignments, which will unduly expose employees to known hazardous materials. H. Pregnant employees who work in conditions/situations deemed hazardous or dangerous to the pregnancy by the attending physician may request a temporary reassignment within their job description or a comparable position, and may be reassigned within two (2) weeks of notification for the duration of the pregnancy. Upon request by management, the employee will provide medical evidence. Such work assignments shall be determined by the appointing authority or his/her designee. This request must be made in writing to the Appointing Authority. I. Grievances involving the interpretation or application of the provisions of this Article may be processed through Step III of the grievance procedure set forth in Article 23, but may not be the subject of arbitration. Section 19.2 The Parties agree to establish a program to monitor air quality at new and existing worksites. The parties agree to negotiate over the specific provisions of such a protocol within 60 days. Section 19.3 The parties agree to establish a safety and security committee to study all state buildings and leased property where state employees work. The mission of the study will be to establish more consistent safety and security policies to ensure the safety and security of all state employees at their work site and citizens of the Commonwealth that visit state agencies. In addition, the parties agree to establish a training program to promote the safety and security of all state employees that may include, but shall not be limited to active shooter training, front line security, and reception practices and protocol for 911 emergencies.

  • SAFETY PRACTICES (a) i Employees requiring glasses must wear glasses, preferably with safety lenses instead of contact lenses while on the job site. ii W.C.B. approved safety footwear must be worn at all times while on the job site. iii Employee attire will be in conformance with W.C.B. Regulation and the Employer’s policy.

  • Environmental, Health and Safety Matters (a) Comply in all material respects with all applicable Environmental Laws, including, without limitation, obtaining and complying with and maintaining any and all licenses, approvals, notifications, registrations or permits required by applicable Environmental Laws. For purposes of this Section 5.12(a), material noncompliance by the Company, any of its Subsidiaries or any tenant or subtenant, with any applicable Environmental Law shall be deemed not to constitute a breach of this covenant provided that, upon learning of any actual or suspected material noncompliance, the Company and the relevant Subsidiaries shall promptly undertake all reasonable efforts to achieve material compliance (or contest in good faith by appropriate proceedings the alleged violation or applicable Environmental Law at issue and (to the extent required by GAAP) provide on the books of the Company or any of its Subsidiaries, as the case may be, reserves in accordance with GAAP with respect thereto), and provided further that, in any case, such noncompliance, and any other noncompliance with applicable Environmental Law, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect. (b) Promptly comply in all material respects with all lawful orders and directives of all Governmental Authorities regarding applicable Environmental Laws, except to the extent that the validity thereof is currently being contested in good faith by appropriate proceedings and (to the extent required by GAAP) reserves in accordance with GAAP with respect thereto have been provided on the books of the Company or any of its Subsidiaries, as the case may be. (c) Defend, indemnify and hold harmless the Administrative Agent and the Lenders, and their respective parents, subsidiaries, affiliates, employees, agents, officers and directors, from and against any claims, demands, penalties, fines, liabilities, settlements, damages, costs and expenses of whatever kind or nature, known or unknown, contingent or otherwise, arising out of, or in any way relating to the violation of, noncompliance with or liability under any Environmental Laws applicable to the Company or any of its Subsidiaries or any of their respective operations or properties, or any orders, requirements or demands of Governmental Authorities related thereto, including, without limitation, attorney’s and consultant’s fees, investigation and laboratory fees, response costs, court costs and litigation expenses, except to the extent that any of the foregoing arise out of the gross negligence or willful misconduct of (or, as determined pursuant to a claim initiated by the Company, breach in bad faith of its express obligations under the applicable Loan Documents by) the party seeking indemnification therefor, in each case, as determined by a final non-appealable judgment by a court of competent jurisdiction. This indemnity shall continue in full force and effect regardless of the termination of this Agreement.

  • Joint Health and Safety Committee (a) The Employer and the Union agree that they mutually desire to maintain standards of occupational health and safety in the organization, in order to prevent accidents, injury and illness. The parties agree to promote health and safety throughout the organization. The employer shall provide orientation and training in health and safety to new and current employees on an ongoing basis, and employees shall attend required health and safety training sessions. (b) Recognizing its responsibilities under the applicable legislation, the Employer agrees to accept as a member of its Joint Health and Safety Committee, at least one representative from the bargaining unit. The number of committee members will be no less than that determined by legislation and the bargaining unit will be entitled to the same membership as any other employee group on the committees. The Union shall notify the employer of their representatives. (c) Such Committee shall identify potential dangers and hazards, institute means of improving health and safety programs, and recommend actions to be taken to improve conditions related to occupational health and safety. (d) The Employer agrees to cooperate reasonably in providing necessary information to enable the Committee to fulfill its functions. The Committee shall respect the confidentiality of the information. (e) The Union agrees to endeavour to obtain the full cooperation of its membership in the observation of all safety rules and practices. (f) Meetings shall be held every third month or more frequently at the call of either co-chair, if required. The Committee shall keep Minutes of all meetings and make the Minutes available for review. (g) All time spent by a member of the Joint Health and Safety Committee attending meetings of the Committee and carrying out the members duties, shall be deemed to be time worked for which the member shall be paid by the Employer at the member's applicable rate of pay, and the member shall be entitled to such time from the member's work as necessary for those duties. (h) The employer shall take every precaution reasonable in the circumstances for the protection of a worker. [Occupational Health and Safety Act, s. 25

  • Health and Safety Plan Consultant shall prepare and submit a Health and Safety Plan (“HASP”) for the portion of Consultant’s work that will involve field work, assessments, or investigations of certain Project elements. The HASP shall describe how Consultant plans to complete field work, assessments, and/or investigations at the RWF. Consultant’s HASP must comply with the CIP HASP and shall be updated as new conditions are encountered.

  • Occupational Health and Safety Committee ‌ (a) The parties agree that a joint occupational health and safety committee will be established. The Committee shall govern itself in accordance with the provisions of the Occupational Health and Safety Regulations made pursuant to the Workers Compensation Act. The Committee shall be between the Employer and the Union, with equal representation, and with each party appointing its own representatives. The Union agrees to actively pursue with the other Health Care unions, where more than one union is certified with the Employer, a joint union/employer committee for the purposes of the Occupational Health and Safety Regulations. (b) Employees who are members of the Committee shall be granted leave without loss of pay or receive straight-time regular wages while attending meetings of the Joint Committee. Employees who are members of the Committee shall be granted leave without loss of pay or receive straight-time regular wages to participate in joint workplace inspections and joint accident investigations at the request of the Committee pursuant to the WCB Occupational Health and Safety Regulations. Committee meetings, workplace inspections and accident investigations shall be scheduled during normal working hours whenever practicable. (c) The Occupational Health and Safety Committee shall have as part of its mandate the jurisdiction to receive complaints or concerns regarding workload problems which are safety-related, the right to investigate such complaints, the right to define the problem and the right to make recommendations for a solution. Where the Committee determines that a safety-related workload problem exists, it shall inform the Employer. Within 21 days thereafter, the Employer shall advise the Committee what steps it has taken or proposes to take to rectify the safety-related workload problem identified by the Committee. If the Union is not satisfied with the Employer's response, it may refer the matter to the Industry Trouble shooter for a written recommendation. (d) No employee shall be disciplined for refusal to work when excused by the provisions of the

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