NDA Filing. Means a completed new drug application filed with the FDA. [ * ] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission. -5- 1.27 "Net Sales" means: --------- (a) With respect to an Extracellular Product containing a Research Compound as its sole, independently active pharmaceutical ingredient, the gross amount invoiced for the sale or other disposition of such Extracellular
... Product by a party, its Affiliates and its sublicensees to unrelated third parties, less the following deductions related to the sale or other disposition: (i) discounts, credits, rebates, allowances and adjustments for rejections, recalls or returns; (ii) retroactive price reductions imposed by governmental authorities (including, but not limited to, any statutory or contractual discounts or rebates mandated by governmental authorities, such as rebates provided for under 42 U.S.C. (S) 1396); (iii) sales, excise, value-added and similar taxes or duties imposed on the sale and included in the invoiced amount; (iv) transportation, insurance and other handling expenses directly chargeable to the sale and separately shown on the invoice; and (v) [ * ] (b) With respect to an Extracellular Product containing a Research Compound and one or more other independently active pharmaceutical ingredients which are not Research Compounds, the gross amount invoiced for a sale or other disposition of such Extracellular Product in a particular country by a party, its Affiliates and its sublicensees to unrelated third parties, less the deductions set forth in (a)(i) through (v) above, shall be multiplied by a fraction: (i) [ * ]. (c) With respect to an Extracellular Product for [ * ] containing a Research Compound as its sole, independently active pharmaceutical ingredient, which Extracellular Product is sold in Premium Delivery Systems, an amount calculated by multiplying (i) [ * ]. (d) Any Extracellular Product sold or otherwise disposed of in other than an arm's-length transaction or for other property (e.g., barter) shall be deemed invoiced at its fair market value in the country of sale or disposition. [ * ] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission. -6- 1.28 "Phase III Clinical Trial" means one or a series of pivotal clinical ------------------------ trials normally performed, which, if successful, would provide sufficient data to allow the preparation and filing of a Regulatory Filing in a Major Market Country.
View More
