ANDA Product definition
ANDA Product means each of the following products (including any future packaging changes or pack sizes): (a) the XXXXX Products; (b) the XXXXX Products; (c) the XXXXX Products; and (d) the XXXXX Products.
ANDA Product means the product to be manufactured under the ANDA that is the subject of the Patent Infringement Claim.
ANDA Product means a Generic OMIDRIA Product sold, offered for sale or distributed pursuant to ANDA No. 210183, including supplements or amendments to ANDA No. 210183, but excluding any such supplements or amendments after the original filing date of ANDA No. 210183 that change the mode of administration or active ingredient(s).
Examples of ANDA Product in a sentence
Medicis’ right to receive a share of the Gross Profit under this Section 6.3 with respect to an ANDA Product shall expire, on an ANDA Product-by-ANDA Product basis, ten (10) years after the first commercial sale by Impax of such ANDA Product in the Territory after the applicable ANDA has been approved by the FDA.
Impax shall use Diligent Efforts to obtain Regulatory Approval in the Territory for each ANDA Product.
Impax shall comply with all applicable laws and regulations in connection with its research, development and commercialization activities for each ANDA Product in the Territory.
Impax shall, to the extent it has not already done so prior to the Effective Date, conduct an in vivo bioequivalence study for each such ANDA Product.
If such study demonstrates bioequivalence, then Impax shall file an ANDA for such ANDA Product.
More Definitions of ANDA Product
ANDA Product means a drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 210183 (and defined in greater detail in the Settlement Agreement); the term “OMIDRIA Patents” shall mean United States Patent Numbers 8,173,707, 8,586,633, 9,066,856, 9,278,101, 9,399,040, 9,486,406, and 9,855,246 and (iii) the term “Affiliate” shall mean any entity or person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with Lupin; for purposes of this definition, “control” means (a) ownership, directly or through one or more intermediaries, of (1) more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or (2) more than fifty percent (50%) of the equity interests in the case of any other type of legal entity or status as a general partner in any partnership, or (b) any other arrangement whereby an entity or person has the right to elect a majority of the Board of Directors or equivalent governing body of a corporation or other entity or the right to direct the management and policies of a corporation or other entity.
ANDA Product means the products to be supplied by HMRI to Rugby pursuant to the Contract Manufacturing Agreement.
ANDA Product means a generic drug active pharmaceutical ingredient in finished dosage form, (injectable, lyophilized, powder fill, soft gel capsule or tablet), approved by the FDA for sale in the United States pursuant to an ANDA, but excluding specifically Patent Challenging Products.
ANDA Product means a phaimaceutical product that (a)(i) is a bendamustine hydi·ochloride solution, and (ii) is therapeutically equivalent to the Bendeka®
ANDA Product means each Product designated as an ANDA Product on Section 4(u)(vii) of the Disclosure Schedule.
ANDA Product means a pharmaceutical product that (a)(i) is a bendamustine hydrochloride solution, and (ii) is therapeutically equivalent to the Bendeka® NDA Product, as manufactured or sold for use in the Territory in a 100 mg/4 mL (25 mg/mL) dosage strength in a multiple-dose vial, and (iii) has an FDA approved label [***] and (b) is sold, offered for sale or distributed under an ANDA that references the Bendeka® NDA Product as the reference-listed drug, and is filed or otherwise controlled by a person or entity other than Plaintiffs or their Affiliates. For the avoidance of doubt, the Dr. Reddy’s Product is not an ANDA Product, and ANDA Product does not include (1) [***], or (2) [***].
ANDA Product means a product that is the subject of an Abbreviated New Drug Application, as defined under 21 U.S.C. § 355(j), filed by a Third Party with the FDA, for which the Licensed Product is the reference listed drug.