Product Delivery Device definition

Product Delivery Device means any device for delivery or administration of a Pharmaceutical Product.
Sample 1Sample 2Sample 3
Product Delivery Device means a device or delivery system that is used for administering or delivering a Product (such as a syringe, inhaler or specialized drug delivery system) and is sold accompanying such Product, such as in a sterile kit, but will not include packaging items such as bottles used to hold Product in tablet form; Gross invoice price of Product sold and the deductions allowed in Sections 1.67(a)-(f) shall be calculated in accordance with Merck’s internal accounting procedures, consistently applied.
Sample 1
Product Delivery Device means a device or delivery system that is used for administering or delivering a Royalty Product (such as a syringe or specialized drug delivery system) and is packaged and sold with such Royalty Product, such as in a sterile kit. With respect to sales of Combination Products, Net Sales for the purpose of determining royalties owed for sales of such Combination Product shall be calculated by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average gross invoice price in the applicable country in the Territory of the Royalty Product sold separately in the same formulation and dosage, and B is the sum of the average gross invoice prices in the applicable country in the Territory of all other therapeutically active ingredients in the Combination Product sold separately in the same formulation and dosage, during the applicable royalty period, provided that such sales are in arms-length transactions and such gross invoice prices are available. In the event that such gross invoice prices are not available in such period, then Net Sales of the Royalty Product shall be calculated on the basis of the gross invoice price of the Combination Product multiplied by a fraction, the numerator of which shall be [ * ] and the denominator of which shall be [ * ]. The deductions set forth in paragraphs (a) through (e) above will be applied in calculating Net Sales for a Combination Product. In the event that either Party reasonably believes that the calculation carried out with respect to the Combination Product does not fairly reflect the value of the Royalty Compound in the Combination Product relative to the other clinically active components in the Combination Product, the Parties shall negotiate in good faith and agree on another, commercially reasonable means of calculating Net Sales with respect to such Combination Product that fairly reflects the relative contribution, to the total market value of such Combination Product, of the Royalty Compound in the Product.
Sample 1

Examples of Product Delivery Device in a sentence

  • MedImmune shall not, before, on or after the Effective Date, have any obligation to contribute to any remuneration of any inventor employed or previously employed by Inovio or any of its Affiliates or make any other payment save as provided in the License Agreement in respect of the Product, Delivery Device IP or Enabling Technology Patents or Know-How.

  • To the best of Inovio’s and its Affiliates’ knowledge as of the Effective Date, no actual or threatened breach of confidentiality has been committed by any Third Party in relation to the Product, Delivery Device, Enabling Technology or the Know-How.

  • MedImmune shall not, before, on or after the Effective Date, have any obligation to contribute to any remuneration of any inventor employed or previously employed by Inovio or any of its Affiliates or make any other payment save as provided in the License Agreement in respect of the Product, Delivery Device Patents, Enabling Technology Patents or Know-How.

  • Palatin hereby grants to AMAG a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any analogous Law recognized outside of the United States), to all Data Controlled by Palatin or its Affiliates that relate to any Compound, Product, Pharmaceutical Product or Product Delivery Device, and Palatin shall provide a signed statement to this effect, if requested by AMAG, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Law outside of the United States).

  • Compound, Product, Pharmaceutical Product or Product Delivery Device, (b) prepared in accordance with Regulation S-X and U.S. GAAP and (c) in the case of the Audited Financial Statements, accompanied by an opinion (the “Audit Opinion”) of KPMG LLP (the “Independent Auditor”), which opinion complies with Regulation S-X.

  • In addition, AMAG may assign its rights and obligations under this Agreement to a Third Party where AMAG or its Affiliate is required, or makes a good faith determination based on advice of counsel, to divest a Compound, Product, Pharmaceutical Product or Product Delivery Device in order to comply with Law or the order of any Governmental Authority as a result of a merger or acquisition, provided that the assignee shall expressly agree to be bound by AMAG’s obligations under this Agreement.

  • Pharmaceutical Product or Product Delivery Device or relating to the transactions contemplated by this Agreement.

  • On the Effective Date, Palatin will assign, and will cause its Affiliates to assign, to AMAG or its designee all contracts to which Palatin or any of its Affiliates are a party that relate to the manufacture or supply of any Compound, Product, Pharmaceutical Product or Product Delivery Device, including those contracts listed in Schedule 2.11.

Related to Product Delivery Device

  • House dust mite product means a product whose label, packaging, or accompanying literature states that the product is suitable for use against house dust mites, but does not indicate that the product is suitable for use against ants, cockroaches, or other household crawling arthropods.

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • Alternative nicotine product means any noncombustible product containing nicotine that is intended for human consumption, whether chewed, absorbed, dissolved, or ingested by any other means. "Alternative nicotine product" does not include any nicotine vapor product, tobacco product, or product regulated as a drug or device by the U.S. Food and Drug Administration (FDA) under Chapter V (21

  • Vapor product means any:

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

  • Special food product means a food product that is all of the following:

  • Defective Product has the meaning set forth in Section 5.2.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Other Product means Product which an End User acquired from sources other than Integrator.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • Household product means any consumer product that is primarily designed to be used inside or outside of living quarters or residences that are occupied or intended for occupation by individuals, including the immediate surroundings.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • Basket Componenti means the respective share as specified in § 1 of the Product and Underlying Data.

  • Manufactured dwelling means a residential trailer, a mobile home or a manufactured

  • Cost of materials means the cost of components, parts or materials which are intended for the production, manufacturing or assembling of the goods bid for and which are not produced, manufactured or assembled in the factory where the production, manufacture or assembly of such goods occurs, including freight, landing costs, port charges, import duties and other import costs of such components, parts or materials and all costs in connection with the handling and transport thereof prior to delivery at that factory;

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.