DRUG FORMULARIES Sample Clauses

DRUG FORMULARIES. If CONTRACTOR utilizes a prescription drug formulary for Members, CONTRACTOR must fully disclose its use of the formulary in its marketing materials. During the term of the Agreement, CONTRACTOR cannot create a new formulary or significantly revise an existing formulary; however, minor revisions to include new drugs, or to remove drugs in compliance with FDA directives are allowed. HHSC will determine if a revision is significant. CONTRACTOR may revise the formulary on a annual basis, subject to HHSC review and approval.
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DRUG FORMULARIES. If CONTRACTOR utilizes a prescription drug formulary for Members, CONTRACTOR must fully disclose its use of the formulary in its marketing materials. During the term of the Agreement, CONTRACTOR cannot create a new formulary or significantly revise an existing formulary; however, minor revisions to include new drugs, or to remove drugs are allowed. Other revisions to the formulary may be approved by HHSC, including the CHIP Medical Director and other program clinical staff, in consultation with CONTRACTOR's Quality Improvement Committee (or other committee composed of physicians, pharmacists, and other professionals). HHSC will determine if a revision is significant. Revisions to the formulary in compliance with FDA directives are allowed without HHSC prior approval. CONTRACTOR may revise the formulary on an annual basis, subject to HHSC review and approval. CONTRACTOR will allow a Member to continue receiving a drug that has been removed from the formulary at the contracted benefit level until the end of the Member's eligibility year. This does not preclude a physician or other health professional from prescribing another drug on CONTRACTOR's formulary that is medically appropriate. CONTRACTOR must have a process for consideration of drugs outside the formulary when medically necessary. If CONTRACTOR refuses to provide benefits to a Member for a drug that is not included in a drug formulary, and that Member's physician has determined that the drug is medically necessary, such refusal constitutes an adverse determination for purposes of section 2, article 21.58A, Texas Insurance Code, and the Member may appeal the adverse determination under Texas Insurance Code, article 21.58A, sections 6 and 6A.
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DRUG FORMULARIES. The MCO can implement restrictions on prescribed drugs; however, before a Hoosier Healthwise MCO implements a drug formulary, the MCO must submit the formulary to OMPP at least 35 days before the MCO intends to implement the formulary. OMPP will forward the formulary to the DUR Board for review and recommendation. Based on the recommendation of the DUR Board, OMPP will either approve, disapprove or require modifications to the MCO's proposed formulary. IC 00-00-00-00 provides that if a Hoosier Healthwise MCO removes one or more drugs from the formulary or places new restrictions on one or more drugs on the formulary, the MCO must submit the changes to OMPP for review and recommendation by the DUR Board. More information regarding the DUR Board is available at xxx.xxxxxxxxxxxxxxx.xxx.
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Related to DRUG FORMULARIES

  • Product The term “

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Product Quality (a) Tesoro warrants that all Products delivered under this Agreement or any Purchaser Order shall meet the latest applicable pipeline specifications for that Product upon receipt at the applicable Terminal and contain no deleterious substances or concentrations of any contaminants that may make it or its components commercially unacceptable in general industry application. Tesoro shall not deliver to any of the Terminals any Products which: (a) would in any way be injurious to any of the Terminals; (b) would render any of the Terminals unfit for the proper storage of similar Products; (c) would contaminate or otherwise downgrade the quality of the Products stored in commingled storage; (d) may not be lawfully stored at the Terminals; or (e) otherwise do not meet applicable Product specifications for such Product that are customary in the location of the Terminal. If, however, there are Products that do not have such applicable specifications, the specifications shall be mutually agreed upon by the Parties. Should Tesoro's commingled Products not meet or exceed the minimum quality standards set forth in this Agreement or any applicable Purchase Order, Tesoro shall be liable for all loss, damage and cost incurred thereby, including damage to Products of third parties commingled with Tesoro's unfit Products.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Product Development SB shall have responsibility for, and control of, the development and commercialization of each Product arising from this Agreement, including process development, delivery system and formulation development, preclinical studies, clinical studies, sales and marketing.

  • 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.

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • Labeling Upon request, Lessee will xxxx the Equipment indicating Lessor's interest with labels provided by Lessor. Lessee will keep all Equipment free from any other marking or labeling which might be interpreted as a claim of ownership.

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