Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.
Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Royalty-Bearing Product means (a) any Product that is not a Co-Developed Product and (b) any Co-Developed Product to the extent sold outside of the Co-Development Territory.
Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.
Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.
Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.
Other Product means Product which an End User acquired from sources other than Integrator.
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.
Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.
Hemp product means the same as that term is defined in § 3.2-4112.
Vapor product means any:
Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.
Drug Product means a specific drug in dosage form from a known source of manufacture, whether
New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.
Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.
Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.
Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;
Licensed Compound means [***].
Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.
medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
Additional Indication means any indication other than the Initial Indication.
Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."
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
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.