Initial Products definition

Initial Products means DynaCirc and DynaCirc CR manufactured using bulk amounts of the Active Ingredient supplied by ASL.

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Initial Products means any wafers and components (finished or unfinished) owned by Provider as of the Supply Commencement Date that are located as of such date outside Japan.

Initial Products means the [*****].

Examples of Initial Products in a sentence

• To the extent Cerecor elects in writing to support any such Direct Costs in excess of $1,000,000 for any such activity(ies) for any Initial Product(s), (i) Avadel shall promptly perform such activity(ies) for such Initial Product(s) and (ii) Cerecor shall reimburse Avadel for such Direct Costs within thirty (30) days of its receipt of a written invoice with respect thereto.

• Avadel shall use reasonable diligent efforts to complete the Avadel Development Program for the Initial Products within eighteen (18) months from the Effective Date.

• The purchase price (“Purchase Price”) for the Active Ingredient purchased from ASL for a period of three (3) years from the date of Regulatory Approval for either of the Initial Products (the “Initial Pricing Period”) shall be as set forth on Exhibit B hereto.

• Proprius wishes to obtain, and ORGENTEC is willing to grant to Proprius, a license to develop and commercialize Initial Products (as defined below), subject to the terms and conditions set forth herein.

• The parties agree, however, to negotiate in good faith a Purchase Price and royalty rate for New Products which (a) reflect the cost of manufacture of such New Product relative to the projected commercial selling price and (b) reasonably approximate the relative margins contemplated for the, Initial Products.

More Definitions of Initial Products

Initial Products means those pharmaceutical products listed on Exhibit B attached hereto and incorporated herein by reference and only in those dosage forms and presentations listed on Exhibit B.

Initial Products means (a) the Orbactiv Product for which, as of the Effective Date, the EC has approved an MAA to Commercialize such Product in the Field in the EU (such approval, the “Orbactiv EU MA”); and (b) the Vabomere Product for which, as of the Effective Date, Rempex London Ltd, an Affiliate of Company, has filed an MAA to Commercialize such Product in the Field in the EU (the approval of such MAA, if granted, the “Vabomere EU MA”).

Initial Products means up to 1500 USP units per vial of recombinant human PH20 hyaluronidase as the active pharmaceutical ingredient in (i) any liquid injectable formulation, and/or (ii) any lyophilized formulation, which shall include the Initial Drug, in each case for the DESI Review indication of "enhancing the dispersion and absorption of other injected drugs" (cf. Federal Register, supra). Initial Product(s) shall also encompass any of the following improvements to the Initial Drug: line extensions, packaging, labeling, change of excipient, minor alterations of the Initial Drug itself (such as variations in the structure of the active compound that do not substantially alter its properties (i.e. as would not require a new IND and/or a Supplemental New Drug Application (NDA)), and Initial Drug produced by newly developed manufacturing methods.

Initial Products means the 125 mg and 250 mg oral capsule dosage forms the Branded Products in finished final packaging form as contemplated by this Agreement.

Initial Products means PA32540 (immediate release omeprazole 40mg and delayed release and/or enteric coated aspirin 325mg) and PA8140 (immediate release omeprazole 40mg and delayed release and/or enteric coated aspirin 81mg).

Initial Products means, collectively, the Initial Bi-Directional Product and the Initial(1) Product.

Initial Products means (a) bempedoic acid tablet for LDL-C lowering indications, and (b) bempedoic acid/ezetimibe combination tablet for LDL-C lowering indications.