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 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.

Examples of ANDA Product in a sentence

• On information and belief, the administration of the Natco ANDA Product will occur with Natco’s specific intent and encouragement, and will be conduct that Natco knows or should know will occur.

• On information and belief, the administration of the Teva ANDA Product will occur with Teva’s specific intent and encouragement, and will be conduct that Teva knows or should know will occur.

• Impax shall use Diligent Efforts to obtain Regulatory Approval in the Territory for each ANDA Product.

• If Natco’s marketing and sale of the Natco ANDA Product prior to expiration of the ’342 patent and all other relevant exclusivities are not enjoined, Gilead will suffer substantial and irreparable harm for which there is no remedy at law.

• 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.

More Definitions of ANDA Product

ANDA Product means the products to be supplied by HMRI to Rugby pursuant to the Contract Manufacturing Agreement.

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).

ANDA Product shall have the meaning set forth in the OEM Agreement.

ANDA Product means a Drug Product manufactured under an ANDA.

ANDA Product means a drug product sold, offered for sale or distributed pursuant to Abbreviated New Drug Application No. 208417 (and defined in greater detail in the Settlement Agreement); the term

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 a Product for which Regulatory Approval has been granted on the basis of an ANDA.