Generic Product(s) definition
Generic Product(s) means any pharmaceutical product that (i) is sold by a Third Party that is not a licensee or Sublicensee of Abbott or its Affiliates, or any of their licensees or Sublicensees under a marketing authorization granted by a Regulatory Authority to such Third Party, and (ii) contains the same Compound as an active pharmaceutical ingredient as the relevant Product and (x) for purposes of the United States, is approved in reliance on the prior approval of a Product as determined by the FDA, or (y) for purposes of a country outside the United States, is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority. On a country by country basis, a Product licensed or produced by Abbott (e.g. an authorized generic product) will not constitute a Generic Product.
Generic Product(s) means a Third Party’s product(s) or Third Parties’ product(s) that has the same or substantially the same active pharmaceutical ingredient as a Product and receives Approval through a regulatory approval process in which either: (i) the applicant for, or sponsor of such Approval; or (ii) the Regulatory Authority that granted such Approval, relied, in whole or in part, upon […***…] submitted by, or on behalf of, Sanofi (or its Affiliate or sublicensee), to any Regulatory Authority, to support the Approval of a Product.
Generic Product(s) means, with respect to a particular Product commercialized by BI in a particular country, any product (other than Products commercialized by BI, its Affiliates or Sublicensees pursuant to this Agreement) that either (a) is a “follow-on biologic” (FOB) or biosimilar or equivalent version to a Product, as defined by the competent Regulatory Authority, and administered in an equivalent dosage form as such Product or (b) for which a Third Party has received Regulatory Approval (based upon then-current applicable Laws governing approval of biological products) whose application for approval relies to a large extent (but not exclusively) on data generated by BI, including Regulatory Approval under section 505(b)(2) of the Federal Food Drug, and Cosmetic Act.
Examples of Generic Product(s) in a sentence
The Contractor must maintain prices for Brand Name and Generic Products for the first year of the Contract as proposed in the Products List.
Where no Generic Market Data is available for a particular geographical region, the Parties will determine the level of sales of Generic Products in such region in good faith based on the totality of the information then available for global sales of Licensed Products and Generic Products.
Respondents shall provide a Price Proposal for statewide coverage and provide a discount off MSRP for all Product Categories, including Brand Name and Generic Products, for the initial and renewal terms.
The term of this Agreement, as to a particular Licensed Product in a particular country, shall expire (on a country-by-country basis) upon the earlier of: (i) the expiration of the Royalty Term for such Licensed Product in such country, or (ii) the end of calendar quarter in which sales in such country of Generic Products exceed [***]% (on a “per unit” basis) of the sales of the Licensed Product in such country.
Product Group specific to this RFP (Brand Name or Generic Products).
More Definitions of Generic Product(s)
Generic Product(s) means a product or products containing an active ingredient having the same or substantially the same chemical structure as the applicable Compound contained in the applicable Product, whether approved under an NDA, ANDA, an application under 505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority within the Territory.
Generic Product(s) means with respect to a particular Licensed Product in a country, a pharmaceutical product that (a) contains the same or substantially the same active ingredient(s) as such Licensed Product, (b) is approved for use in such country by the applicable Regulatory Authority, whether approved under an NDA, ANDA, an application under 505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority and (c) is sold in the same country as such Licensed Product by any Third Party that is not a Sublicensee of Company or its Affiliates and did not purchase such product in a chain of distribution that included any of Company or any of its Affiliates or its Sublicensees.
Generic Product(s) means a commercial product the use, sale or distribution of which utilizes Licensed Technology that is not covered in whole or in part by a Valid Claim of the Licensed Patents. A product that is sold, distributed or used for testing, development, or clinical trial purposes shall not be considered a commercial product.
Generic Product(s) means any pharmaceutical products (other than the Product commercialized by Organon and Pfizer pursuant to this Agreement) that contain the Compound and can reasonably be or are reasonably used for the same indication or indications as the Product.
Generic Product(s) means a product or products containing an active ingredient having the same or substantially the same chemical structure as the applicable ASO targeting Clusterin that is the active ingredient contained in the applicable Product, whether approved under an NDA, ANDA, an application under 505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority within the applicable country. [***] means [***], a biotech company with head office in [***]. [***] [***] means those patents listed in Appendix B.
Generic Product(s) means collectively the Group A Generic Products, the Group B Generic Products and the Group C Generic Products.
Generic Product(s) means, with respect to a Product that has received Regulatory Approval granted by a Governmental Authority in a country in the Territory, a pharmaceutical product which contains any phentolamine salt which is highly similar, or similar enough to the one contained in a reference Product, notwithstanding minor differences in clinically inactive components, to permit an applicant for Governmental Authority to refer to and rely on clinical and other scientific information regarding the safety, purity, potency and/or efficacy of the reference Product in order to allow such pharmaceutical product to receive Regulatory Approval in any jurisdiction within the Territory through an abbreviated, expedited, or other similar regulatory pathway, that is marketed for sale in such country by a Third Party other than pursuant to any rights granted by Licensee or their Affiliates.