Efficacy and Safety Sample Clauses

Efficacy and Safety. Sanofi and each Sanofi Affiliate that is or will be a party to any Alliance Agreement, to their best knowledge and belief, have not made any statement to BMS or any BMS Affiliate that is or will be a party to any Alliance Agreement regarding the efficacy or safety of any Product or any process for manufacturing, processing or finishing such Product that is in any material respect untrue or misleading, nor has Sanofi or such Sanofi Affiliate omitted to disclose to BMS or such BMS Affiliates any material fact or information regarding the efficacy or safety of any such process or Product.
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Efficacy and Safety. BMS and each BMS Affiliate that is or will be a party to any Alliance Agreement, to their best knowledge and belief, have not made any statement to Sanofi or any Sanofi Affiliate that is or will be a party to any Alliance Agreement regarding the efficacy or safety of any Product or any process for manufacturing, processing or finishing such Product that is in any material respect untrue or misleading, nor has BMS or such BMS Affiliate omitted to disclose to SS_NYL2/121582 19 (PA_79523 2) * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION Sanofi or such Sanofi Affiliates any material fact or information regarding the efficacy or safety of any such process or Product.
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Efficacy and Safety. Results From a Completed Phase 2b Study in Patients With Active Systemic Lupus Erythematosus 24
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Efficacy and Safety. Results from a Completed Phase 2b Study with trehalose formulation in patients with Active Systemic Lupus Erythematosus 26
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Efficacy and Safety. Results from a Completed Phase 2b Study with trehalose formulation in patients with Active Systemic Lupus Erythematosus One clinical study have been completed in the CEP 33457 clinical program developed by TEVA former Cephalon. TEVA, former Cephalon has sponsored an US Phase 2b (Study C33457/2047), randomized, double- blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of a 200 mcg dose of IPP-201101 given every 4 weeks compared with placebo in patients with active SLE. The study consists of a 2-week screening period (visit 1), a 44-week treatment period beginning with a baseline visit in which randomization is completed and study drug treatment starts (visits 2 through 13), and a final assessment 4 weeks after the last dose of study drug (visit 14 [week 48]). A trehalose formulation of IPP-201101 (P140, foregiremod) has been used. The clinical outcome was negative. IPP-201101 was ineffective with even a trend to be less effective than placebo (D = - 6 %).
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Related to Efficacy and Safety

  • Health and Safety C8.1 The Contractor shall promptly notify the Authority of any health and safety hazards which may arise in connection with the performance of the Contract. The Authority shall promptly notify the Contractor of any health and safety hazards which may exist or arise at the Authority’s Premises and which may affect the Contractor in the performance of the Contract.

  • Environmental, Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

  • Environment, Health, and Safety 24.4.1. The Supplier and its staff (and/or any sub-supplier and/or subcontractor) shall comply with the laws and regulations in force related to protection of the environment, the health and safety instructions applicable to the Goods and Services performed pursuant to the Contract and especially, if appropriate, to the Goodsand Services performedon any Site by a third company.

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • SAFETY AND HEALTH 20.1 The Employer, employee and Union have a significant responsibility for workplace safety and health.

  • Environmental and Safety Laws To its knowledge, the Company is not in violation of any applicable statute, law or regulation relating to the environment or occupational health and safety, and to its knowledge, no material expenditures are or will be required in order to comply with any such existing statute, law or regulation.

  • Environmental and Safety Matters Except as disclosed in Schedule 4.13:

  • 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.

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

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