Specific Safety Measures Sample Clauses

Specific Safety Measures. The Parties shall advise each other of any actions, relating to safety of the Product, that were taken by either the ANDA Holder, Distributor or by regulatory health authority (eg, restriction in distribution) as soon as possible but in no event later than one (1) business day. If a specific safety action is needed, WYETH and XXXXXXXXX shall coordinate to address any action taken. The Parties agree to meet after the effective date to establish a detailed Safety Agreement outlining the responsibilities of each Party in connection with collecting and reporting adverse events as well as Literature Reports, Follow-up Reports, Reconciliation, US Periodic Reports, Periodic Safety Update Reports, Product Labeling Activities, and Pharmacovigilance related to the Products which will supersede this Exhibit I. EXHIBIT J Price Per Unit For Manufacture Under WYETH's NDA Unit Volumes per Contract Year 15ml Complete 15ml Refill
AutoNDA by SimpleDocs
Specific Safety Measures. The Parties shall advise each other, within […***…], of any actions relating to safety of the Study Drug taken either by the Party or by a designated Regulatory Authority for their respective studies (such as, for example, a restriction on distribution or clinical holds). If specific safety actions are needed, each Party shall advise and coordinate the implementation of such actions.
Specific Safety Measures. Because of the possible toxicity of the reagents and NM and the possible presence of unknown contaminants, it is highly recommended to wear gloves during this procedure. • All waste materials generated during this procedure should be disposed in the suitable container for chemical waste.
Specific Safety Measures. The Sponsor shall notify the Company within five (5) business days, of any actions relating to safety of the IMP taken either by the Sponsor or by a designated regulatory authority for their respective studies (such as, for example, changes to a Study conduct, a restriction on distribution or clinical holds). If specific safety actions are needed, each party shall advise and coordinate the implementation of such actions. The Company shall notify the Sponsor upon completion of a specific safety measure, as appropriate.
Specific Safety Measures a. The District believes in a best in class approach to ensure the health and safety of its employees and therefore commits to the following:

Related to Specific Safety Measures

  • 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.

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

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Access Controls a. Authorized Access - DST shall have controls that are designed to maintain the logical separation such that access to systems hosting Fund Data and/or being used to provide services to Fund will uniquely identify each individual requiring access, grant access only to authorized personnel based on the principle of least privileges, and prevent unauthorized access to Fund Data.

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • 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.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • Network Access Control The VISION Web Site and the Distribution Support Services Web Site (the “DST Web Sites”) are protected through multiple levels of network controls. The first defense is a border router which exists at the boundary between the DST Web Sites and the Internet Service Provider. The border router provides basic protections including anti-spoofing controls. Next is a highly available pair of stateful firewalls that allow only HTTPS traffic destined to the DST Web Sites. The third network control is a highly available pair of load balancers that terminate the HTTPS connections and then forward the traffic on to one of several available web servers. In addition, a second highly available pair of stateful firewalls enforce network controls between the web servers and any back-end application servers. No Internet traffic is allowed directly to the back-end application servers. The DST Web Sites equipment is located and administered at DST’s Winchester data center. Changes to the systems residing on this computer are submitted through the DST change control process. All services and functions within the DST Web Sites are deactivated with the exception of services and functions which support the transfer of files. All ports on the DST Web Sites are disabled, except those ports required to transfer files. All “listeners,” other than listeners required for inbound connections from the load balancers, are deactivated. Directory structures are “hidden” from the user. Services which provide directory information are also deactivated.

  • 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.

Time is Money Join Law Insider Premium to draft better contracts faster.