Pharmaceutical Products. Outpatient
Pharmaceutical Products. If a Party requires, as a condition for approving the marketing of a pharmaceutical product that utilizes a new chemical entity, the submission of undisclosed test or other data necessary to determine whether the use of such products is safe and effective, the Party shall protect against disclosure of the data of persons making such submissions, where the origination of such data involves considerable effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.
Pharmaceutical Products. Emergent shall perform the 3PL Services for the Products that are defined in ARTICLE I of the Agreement (for purposes of this Schedule E, Vials of the Products shall be referred to as the “3PL Vials”).
Pharmaceutical Products. A change to 30.01-30.05 heading totalled 30.01 to 30.05 from any other heading; or It does not require a change in tariff classification heading to totalled 30.01 to 30.05, complying with a regional value content requirement according to Article 4.2. A change to 3006.10-3006.40 subheading 3006.10 to 3006.40 from any other heading; or there is a change in tariff classification at the subheading 3006.10 to 3006.40, complying with a regional value content requirement according to Article 4.2. 3006.50 provided that qualifies as originating in accordance with article 4.11. a change to 3006.60-3006.91 subheading 3006.60 to 3006.70 from any other heading; or there is a change in tariff classification at the subheading 3006.60 to 3006.91, complying with a regional value content requirement according to Article 4.2. It does not require 3006.92 tariff classification change to subheading 3006.80 provided that waste and scrap are wholly obtained or produced entirely in the territory of a Party as defined in article 4.26. 31.01-31.05 heading to a change to 31.02 31.05 from any other heading; or It does not require a change in tariff classification heading to 31.02 to 31.05, complying with a regional value content requirement according to Article 4.2.
Pharmaceutical Products. A change to heading 30.01 from any other heading.
Pharmaceutical Products. Schedule 3.38.1 lists each product distributed or sold by PSI or Phoenix during the five-year period ending on January 31, 2005 (collectively, the “Products”). Each Product manufactured by PSI or Phoenix has been manufactured substantially in accordance with (a) the product certificate or other product registration applicable to such Product, (b) the specifications under which the Product is normally and has normally been manufactured and (c) the provisions of all applicable Laws, including, without limitation, the requirements of the Food, Drug and Cosmetic Act of 1938, as amended, and the Food and Drug Administration and any other Agency with jurisdiction over PSI, Phoenix or any of the Products (including, without limitation, with regard to investigational use, premarket clearance, good manufacturing practices, labeling, advertising, record keeping, requisite filings and security). The formulation, development, manufacturing, licensing, packaging, distribution, storage, labeling, promotion, advertising and sale of the Products are in substantial compliance with all applicable Laws, including, without limitation, the requirements of the Food, Drug and Cosmetic Act of 1938, as amended, and the Food and Drug Administration and any other Agency with jurisdiction over PSI, Phoenix or any of the Products (including, without limitation, with regard to investigational use, premarket clearance, good manufacturing practices, labeling, advertising, record keeping, requisite filings and security).
Pharmaceutical Products. The Maximum Reimbursement Allowances for pharmaceutical products shall be as set forth above in 3.1, except the applicable percentage shall be one hundred percent (100%).
Pharmaceutical Products. (a) King and King-Nevada represent and warrant that they have delivered to Mallinckrodt certain information or given Mallinckrodt access to all existing information regarding each of the Current Products (along with a description of its container/closure system) currently manufactured, marketed, sold or licensed by King, King-Nevada or their affiliates. The Current Products and all other products currently manufactured, sold or licensed by King, King-Nevada or their affiliates are referred to collectively as the "Pharmaceutical Products".
(b) Except as set forth on Schedule 5.13 there have been no (i) Pharmaceutical Products which have been recalled, withdrawn or suspended by King, King-Nevada or their affiliates in the United States and/or outside of the United States (whether voluntarily or otherwise) during the period commencing January 1, 1995 and ending on the date hereof, or (ii) proceedings in the United States and/or outside of the United States pending against King, King-Nevada or their affiliates at any time during the period commencing January 1, 1995 and ending on the date hereof (whether such proceedings have since been completed or remain pending) seeking the recall, withdrawal, suspension or seizure of any Pharmaceutical Product or seeking to enjoin King or its affiliates from engaging in any activities pertaining to such Pharmaceutical Products or to affirmatively perform activities pertaining to such Pharmaceutical Products prior to shipping such products.
(c) To the knowledge of King and King-Nevada. except as set forth in Schedule 5.13:
(i) there exists no set of facts which could reasonably be expected to furnish a basis for the recall or withdrawal of any Pharmaceutical Product or the suspension of any product registration, product license, manufacturing license, wholesale dealers license, export license or other governmental license, approval or consent of any governmental regulatory agency with respect to any of the Pharmaceutical Products or the Bristol Facility;
(ii) there exists no set of facts which could reasonably be expected to furnish a basis for the recall, withdrawal, suspension or seizure by order of any state, federal or foreign agency or court of law of any Pharmaceutical Product or which could reasonably be expected to form the basis for the issuance of an injunction pertaining to such Pharmaceutical Products, including, without limitation, the procedures used to manufacture and test such products;
(iii) there exists no...
Pharmaceutical Products. Prescription drug products according to a DSHS approved formulary, which includes both legend and over-the-counter (OTC) products. The Contractor’s formulary shall include all therapeutic classes in DSHS’ fee-for-service drug file and a sufficient variety of drugs in each therapeutic class to meet enrollees’ medically necessary health care needs. The Contractor shall provide participating pharmacies and participating providers with its formulary and information about how to request non-formulary drugs. The Contractor shall have policies and procedures for the administration of the pharmacy benefit including formulary exceptions. The Contractor shall approve or deny all requests for non-formulary drugs by the business day following the day of request. Covered drug products shall include:
11.13.12.1 Oral, enteral and parenteral nutritional supplements and supplies, including prescribed infant formulas;
11.13.12.2 All Food and Drug Administration (FDA) approved contraceptive drugs, devices, and supplies; including but not limited to Depo-Provera, Norplant, and OTC products;
11.13.12.3 Antigens and allergens; and
11.13.12.4 Therapeutic vitamins and iron prescribed for prenatal and postnatal care.
Pharmaceutical Products. Pharmaceutical products and supplies shall be reimbursed based on National Drug Codes (“NDC codes”), excluding the noted exceptions. The Plan will update The Plan’s NDC fee schedule monthly with the price that is in effect at the time of the update. If ASP is unavailable, pharmaceutical products categorized as Exception will be reimbursed as Single Source or Multi Source. When ASP, WAC, MAC and AWP are unavailable, pharmaceutical products categorized as: Exception, Vaccines and Immunizations, Single Source and/or Multi Source will be reimbursed in accordance with The Plan’s NDC fee schedule in effect as of the date of service.
