Pharmaceutical Products Sample Clauses

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. 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. 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. 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 change to heading 30.01 from any other heading.

Pharmaceutical Products. Prescription drug products according to a Department 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.

Pharmaceutical Products. (a) Schedule 4.25(a) lists each product currently developed, manufactured, licensed, distributed or sold by the Company or any Company Subsidiary (collectively, the "Products"). Each Product manufactured by the Company or any Company Subsidiary has been manufactured in accordance with (i) the product registration applicable to such Product, and (ii) the specifications under which the Product is normally and has normally been manufactured. (b) Schedule 4.25(b) lists all product registrations which are pending or maintained by the Company or any Company Subsidiary, and with respect to pending product registrations, the phase of clinical development of the Products which are the subject thereof. A true and complete copy of each such product registration has been previously delivered to Buyer. (c) Schedule 4.25(c) lists all (i) Products which at any time have been recalled, withdrawn or suspended by the Company or any Company Subsidiary, since January 1, 1998, whether voluntarily or otherwise, (ii) without limiting the generality of Section 4.12, completed or pending proceedings, since January 1, 1998, seeking the recall, withdrawal, suspension or seizure of any Product, and (iii) regulatory letters, warning letters, and letters of adverse findings from governmental authorities received, since January 1, 1998, by the Company, any Company Subsidiary or, to the Seller's Knowledge, their respective attorneys, copies of which have previously been delivered to Buyer. (d) Except as set forth on Schedule 4.25(d), to Seller's Knowledge, there exist no set of facts, as the business of the Company or the Company Subsidiaries is currently conducted: (i) which could reasonably be expected to furnish a basis for the recall, withdrawal or suspension of any Product registration, Product license, manufacturing license, wholesale dealers license, export license or other license, approval or consent of any currently applicable domestic or foreign governmental or regulatory authority with respect to the Company, any Company Subsidiary, or any of the Products; (ii) which could reasonably be expected to furnish a basis for the recall, withdrawal or suspension of any Product from the market, the termination or suspension of any clinical testing of any Product, or the change in marketing classification of any Product; or (iii) which could reasonably be expected to have a Company Material Adverse Effect in connection with the continued operation of any facility of the Company or any ...