Generic Product

Generic Product. On a country-by-country basis, a product (i) having the same composition of matter as Licensed Product or which has a marketing approval as a generic product by the regulatory authorities and which could not have been sold or with respect to which a license would have been required to be obtained from Cell Cure, if patent or other exclusivity rights covering such Licensed Product would have been in full force and effect, and [*Certain information has been omitted under a request for... confidential treatment, and the omitted information has been filed with the Commission]. However, a product shall not be considered a Generic Product if Teva or anyone on its behalf was involved in its approval or commercialization. View More

Generic Product. On a country-by-country basis, and a Licensed Product by Licensed Product basis, a product independently developed by a third party (i) having the same composition of matter as the Licensed Product or which has a marketing approval as a generic product by the regulatory authorities, (ii) can reasonably be or is reasonably used for the same indication or indications for which the Licensed Product is approved and which could not have been sold or with respect to which a license would have been... required to be obtained from Rexahn, if patent or other exclusivity rights covering the Licensed Product would have been in full force and effect, and (iii) that (a) following the First Commercial Sale of such Generic Product the annual Net Sales of the Licensed Product has declined in that year by greater than *** percent (***%) compared to the average annual Net Sales of the Licensed Product during the *** (***) *** preceding the First Commercial Sale of such Generic Product, or (b) within *** *** following the First Commercial Sale of such Generic Product, it attains a market share of more than *** percent (***%) of the relevant market for the Licensed Product, as determined by reference to IMS or a similar source commonly recognized in the industry. However, a product shall not be considered as a Generic Product if Teva or anyone on its behalf was involved in its approval or commercialization. View More

Generic Product. With respect to any product, a different product that is marketed pursuant to an Abbreviated New Drug Application (that is not the same Abbreviated New Drug Application as the product, if applicable) and is listed as therapeutically equivalent to the product in the FDA Orange Book

Generic Product. Means, with respect to a given Product in a given country, any pharmaceutical product that: (a) is marketed for sale in such country by a Third Party other than an authorized licensee; (b) contains the same active pharmaceutical ingredient as contained in such Product, [ * ]; and (c) is approved or registered for use in such country (pursuant to 21 U.S.C. 355(b)(2), a separate DAA, other drug approval application or comparable process). With respect to a Product that is sold as a combination... with another active pharmaceutical ingredient (collectively, the "Combined Active Pharmaceutical Ingredients"), a Generic Product shall, for View More

Generic Product. Means, with respect to a Product in a particular country, another pharmaceutical product that: [**Confidential Treatment Requested**]

Generic Product. Means—regardless of whether a product is considered generic, branded, private-labeled or otherwise—a product for which FDA approval is sought as, or that has been deemed by FDA to be, bioequivalent to one of the Fanapt Products and has the same strength and dosage form as one of the Fanapt Products, including any Authorized Generic. For the avoidance of doubt, "Generic Product" does not include the Fanapt Products themselves.