| (f) | any particular Bispecific construct, but excluding any antibody framework common in Adimab’s antibody library(ies). |
1.34“Field” means all diagnostic, therapeutic or prophylactic uses for human and/or animals.
1.42“Know-How” means all technical information and know-how, including (i) inventions, discoveries, trade secrets, data, specifications, instructions, processes, formulae, materials (including cell lines, vectors, plasmids, nucleic acids and the like), methods, protocols, expertise and any other technology, including the applicability of any of the foregoing to formulations, compositions or products or to their manufacture, development, registration, use or marketing or to methods of assaying or testing them or processes for their manufacture, formulations containing them or compositions incorporating or comprising them, and (ii) all data, instructions, processes, formula, strategies, and expertise, whether biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, analytical, clinical or otherwise and whether related to safety, quality control, manufacturing or other disciplines.
1.43“Lead Product” has the meaning set forth in Section 4.4 (Milestone Payments).
1.44“Licensee” means a Third Party to whom BLACK BELT has granted, directly or indirectly, rights to research, develop, manufacture, and/or commercialize Program-Benefited Antibodies; provided however, that Licensees shall exclude fee-for-service contract research organizations or contract manufacturing organizations acting in such capacity. For clarity, sublicensees of the license granted by Adimab to BLACK BELT pursuant to Section 3.2 (Commercial Rights) shall be Licensees.
1.46“Marketing Approval” each means, with in any given country, approval to market a Product legally as a drug or biologic, including approval of a Biologic License Application (as defined in the U.S. Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder (21 C.F.R. §§ 600-680)) in the United States, or approval of a comparable filing in the United States or any other jurisdiction. Pricing approval need not be obtained in order for Marketing Approval to be achieved.
1.47“Milestone Event” has the meaning set forth in Section 4.4 (Milestone Payments).
1.48“Milestone Payment” has the meaning set forth in Section 4.4 (Milestone Payments).
1.50“Net Sales” means the gross amounts invoiced for a Program Antibody or Product by BLACK BELT, its Affiliates and Licensees for sales or other commercial disposition of such Program Antibody or Product to a Third Party purchaser, less the following:
| (a) | trade and quantity discounts (other than early pay cash discounts) actually allowed with respect to such sales which effectively reduce the selling price and are appropriately deducted from sales under appropriate accounting principles, consistently applied; |
| (b) | returns, rebates, chargebacks and other allowances actually allowed with respect to such sales; |
(c)retroactive price reductions that are actually allowed or granted;
| (d) | deductions to the gross invoice price of Program Antibody or Product imposed by regulatory authorities or other governmental entities; |
| (e) | sales (such as VAT or its equivalent) and excise taxes, other consumption taxes, and customs duties (excluding any taxes paid on the income from such sales) to the extent the selling person is not otherwise entitled to a credit or a refund for such taxes or duties; and |