Clinical Programs. The preclinical and clinical trials conducted by or on behalf of the Company that are described in the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with procedures and controls pursuant to accepted professional scientific standards and all applicable local, state and federal and foreign laws, rules, regulations and published guidance, including, but not limited to, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. The descriptions of the results of such studies, tests and trials contained in the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects. Other than as described in the Pricing Disclosure Package, the Company is not aware of any studies, tests or trials the results of which reasonably call into question the clinical trial results described or referred to in the Prospectus when viewed in the context in which such results are described and the clinical state of development. Other than as described in the Pricing Disclosure Package, in the past five years, the Company has not received any written notices or correspondence from the U.S. Food and Drug Administration or any foreign, state or local governmental body exercising comparable authority, including the European Medicines Agency (collectively, the “Regulatory Authorities”) requiring the termination or suspension of any preclinical or clinical trials conducted by or on behalf of the Company. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the Regulatory Authorities or that additional studies, tests or preclinical or clinical trials will reach similar results or conclusions.
Clinical Programs. If Client participates in a Clinical Program(s), Client shall:
a. Ensure each pharmacy, participating pharmacist(s), and pharmacy staff:
i. meets all licensing and other requirements to provide program services, and are in good standing with all applicable regulatory boards and licensing agencies, such as a state board of pharmacy; and
ii. are not excluded by the Office of Inspector General (OIG) or General Services Administration (GSA) from providing services for government sponsored health plans; and
iii. complete any required training for such Clinical Program(s) provided by Outcomes.
b. Maintain reasonable general and professional liability insurance appropriate to cover the Clinical Program. Client agrees that Client has made an independent determination of each patient’s need for and the appropriateness of a specific treatment under the Clinical Program and that Client is providing the services based such independent judgment. Client agrees that it is solely liable for the services it provides in a Clinical Program, and waives and releases Outcomes from all claims, liabilities, losses, damages, and injuries incurred by a patient or third-party arising out of a Clinical Program.
Clinical Programs. As of the Effective Date of this Contract, Contractor shall provide all of the Clinical Programs listed in Exhibit S, Standard Programs, and all of the programs listed in this Section 3.3.3 and are hereby made available to HCA, Members, and the Members’ providers, as appropriate. Such programs will be reviewed by the parties and updated on an annual basis.
Clinical Programs. (i) Establish and implement clinical and special programs, services, practices and procedures deemed appropriate by Manager, and establish and maintain internal policies and procedures and plans of organization for each program;
(ii) Establish and maintain standards and quality control of programs; and
(iii) Prepare written evaluations of each program in relation to its operation, goals and objectives and implement any required changes in policies or programs of the Facility.
Clinical Programs. All clinical programs operated by Seller at the Hospital.
Clinical Programs. As consideration for the clinical Services selected by County in accordance with the Agreement, County will pay to Contractor the fees set forth below:
A. Base Clinical Services (included in base administrative fee)
Clinical Programs. As consideration for the clinical Services selected by County in accordance with the Agreement, County will pay to Contractor the fees set forth below: Concurrent DUR No Charge Inform Prescribing Program No Charge Quantity level limit (QLL) system edits & support No Charge Prior authorization (PA) system edits & support No Charge Duration of therapy edits & support No Charge Therapeutic interchange (as required) No Charge Quarterly clinical program reporting No Charge
Clinical Programs. BIOGEN will, at its sole expense, be responsible for the worldwide design and conduct of all pre-clinical, clinical, development and regulatory work under this Agreement for PRODUCTS being developed for sale hereunder and under the BML AGREEMENT, with input from CVT through its representation on the OPERATING COMMITTEE and the Strategy Committee. Notwithstanding the foregoing, CVT shall lead the protocol design and selection of key investigators for the following clinical studies which are in the planning stages as of the Effective Date, subject to BIOGEN's guidance and right of final approval:
(i) Phase II clinical trial of intravenous CVT-124 for [ * ]
(ii) Phase II clinical trial of intravenous CVT-124 for protection against [ * ] at BIOGEN's option; and -------------------------- * Confidential treatment requested.
(iii) Phase I [ * ] study. Protocols for the above clinical trials shall be approved by the OPERATING COMMITTEE, as defined below, as soon as possible after the Effective Date.
Clinical Programs. Subject to applicable Law, Member Pharmacy must provide to MedImpact any and all reasonably available information that MedImpact needs to perform clinical programs and services and conduct drug utilization review. Member Pharmacy must support all such clinical programs and services.
Clinical Programs. WellPoint shall develop such clinical/disease management programs as are mutually agreed upon in writing by the Parties, and the revenues from which shall be shared as mutually agreed upon by the Parties in writing. [Confidential Treatment — Intentionally Left Blank]
