Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.
Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.
Trial Version If the Program is a Trial Version (a “Trial Version”), You may use the Program only for the purpose of evaluating the Program.
How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. How to File an Expedited Appeal Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.
Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.
Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.
Additional Information for Product Development Projects Outcome of product development efforts, such copyrights and license agreements. • Units sold or projected to be sold in California and outside of California. • Total annual sales or projected annual sales (in dollars) of products developed under the Agreement. • Investment dollars/follow-on private funding as a result of Energy Commission funding. • Patent numbers and applications, along with dates and brief descriptions. Additional Information for Product Demonstrations: • Outcome of demonstrations and status of technology. • Number of similar installations. • Jobs created/retained as a result of the Agreement.
