1.29 Know-How means all present and future scientific, technical, or commercial information, results and data of any type whatsoever developed or generated in relation to the Compound or the Product in the Field, in any tangible or intangible form, whether patentable or not, including, without limitation, all (i) biological, toxicological, chemical, and biochemical information, (ii) metabolic, non-clinical, pre-clinical, clinical, pharmacological, and pharmacokinetic data, (iii) physico-chemical properties, assays, formulations, quality controls, processes, synthesis processes, manufacturing methods and data, specifications, discoveries, formulae, protocols, practices, reagents, inventions, Improvement, databases (iv) toxicological, clinical and analytical information, trial and stability data, case reports forms, data analyses, reports, studies and procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), summaries and information contained in submissions to and information from ethical committees, the FDA or other Regulatory Authorities, and manufacturing process and development information, results and data, whether or not patentable, (v) regulatory filing (IND, NDA and updates), meeting minutes and correspondences with regulatory agencies, and (vi) any other information relating thereto.
1.30 Knowledge means, with respect to a Party, the actual knowledge of the Executive Officer or any officer of such Party.
1.31 Manufacture or Manufacturing means all activities related to the conversion of Compounds into finished Product.
1.32 Marketing Authorization means, with respect to a Product, the regulatory approval (including the approval by an applicable Governmental Authority in certain countries or territories of the price at which a Product is sold, where such approval is necessary to market such Product), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary to sell such Product for use in the Field in any country or jurisdiction.
1.33 Net Sales means with respect to the Product, the gross amounts invoiced by Tyligand, or its Affiliates or Sublicensees, to Third Party customers for sales or other transfers or disposition of the Product, less the sum of the following (i) through (v):
(i) customary trade, quantity, and cash discounts or rebates actually allowed on Product;
(ii) credits or allowances given to customers for rejections or returns of Product or on account of retroactive price reductions affecting such Product;
(iii) sales taxes, excise taxes, use taxes and import/export duties levied on or measured by the billing amount for Product, as adjusted for rebates and refunds, or other governmental charges, in each case actually due or incurred with respect to the production, importation, use or sale of a Product to third parties;
(iv) transportation charges, including handling charges and costs of insurance, to the extent that they are included in the price of the Product; and
(v) Product rebates and Product charge backs including those actually granted to managed care entities and government agencies.
Sales or transfers of Products among Tyligand and its Affiliates would be excluded from the computation of Net Sales if not for end use, and no royalties would be payable on such sales, unless and until such Products are sold to a third party. Further, sales of a Product by Tyligand or its Affiliates that are for compassionate use or on a named patient/named hospital basis shall be excluded from the computation of Net Sales and no payment shall be payable on such sales.