1.31. “Know-How” means any and all technical, scientific, and other information, information architecture, drawings, diagrams, processes, knowledge, methods, processes, practices, formulae, assays, instructions, skills, techniques, procedures, technical assistance, designs, drawings, specifications, related to Software, the Licensed Patents, or Licensed Products in all cases, whether or not confidential, developed in the Principal Investigators’ laboratory, or by the Principal Investigator(s), prior to the Effective Date.
1.32. “Laws” means all active governmental constitutions, laws, statutes, ordinances, treaties, rules, common laws, rulings, regulations, orders, charges, directives, determinations, executive orders, writs, judgments, injunctions, decrees, restrictions or similar legally effective pronouncements of any Governmental Authority.
1.33. “Licensed Patents” means the Patents owned or Controlled by Licensor prior to the Effective Date and listed in Exhibit A hereto, which is hereby incorporated into and made part of this Agreement. Notwithstanding the preceding definition, Licensed Patents shall not include any Patent based on research conducted after the Effective Date, except as otherwise agreed in a separate legally enforceable writing executed by the Parties.
1.34. “Licensed Product” will mean any product or service, including but not limited to hardware or software, Exploited by Licensee, any Sublicensee, or any of their respective Affiliates or agents as permitted hereunder (a) the Development, Manufacturing, Commercialization, use, rental or lease of which would, in the absence of the licenses granted to Licensee hereunder, infringe at least one Valid Claim or (b) that is based on, derived from, incorporates, arises from or otherwise makes use of the Software, any Derivative Work, any Licensee Modified Product, or any Know-How, whether in whole or in part.
1.35. “Licensed Product Data” means data (including clinical data) that is possessed, owned or Controlled by Licensee, its Affiliate, or Sublicensee directly relating to any Licensed Product and generated after the Effective Date.
1.36. “Licensee Modified Product” means computer software created by or for Licensee that is not a Derivative Work, but that incorporates, is based on, interoperates with, or shares functionality with the Software or any Derivative Work, in whole or in part.
1.37. “Manufacturing” means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.
1.38. “Net Sales” means all Gross Sales of Licensed Product less the total of the following deductions to the extent they are included in the gross invoiced sale price of the Licensed Product or otherwise directly paid or incurred by Licensee, its Affiliates or its Sublicensees with respect to such sale of the Licensed Product:
(a) trade, cash and/or quantity discounts, retroactive price reductions, chargeback payments and rebates actually allowed to and/or taken by purchasers of a Licensed Product or Third Party payors, including discounts and rebates to governmental payors or managed care organizations, their agencies, purchasers and reimbursers, and allowances or credits to Third Parties for rejections or returns that do not exceed the original invoice amount;