Paradigm Technology. Shall mean any materials, know-how, information, discoveries or inventions that are discovered or developed by Paradigm or in-licensed by Paradigm. 3 1.41 Transcription Factor "Transcription Factor" shall mean a protein that associates with or near the promoter region of a gene and thereby regulates transcription of such gene. 1.42 Submitted for Regulatory Approval "Submitted for Regulatory Approval" shall mean a
... submission to the appropriate regulatory agency in any one of the United States, the European Union and Japan of a properly completed application that, if approved by the agency, would permit commercialization of the product without filing any additional applications. Whether or not the agency approves of the product or requires additional information is not relevant in determining the products' status as Submitted for Regulatory Approval. 1.43 Permitted Assignee "Permitted Assignee" shall mean an entity that did not derive significant revenues from the sale of seeds or crop protection products in its most recent fiscal year preceding the date of determination of whether such entity is a Permitted Assignee. 1.44 Nominations "Nominations" shall mean either 1) Arabidopsis sequence-verified constructs in the appropriate binary vectors; or 2) as Arabidopsis sequence information and suggested 5' and 3' primers for PCR-based cloning at Paradigm. 1.45 Reservations "Reservations" shall mean Arabidopsis DNA sequence information which comprises either the full sequence of a gene (including the start and stop codon) or sufficient information to uniquely identify a single gene. 1.46 Drugs and Dietary Supplements "Drugs" and "Dietary Supplements" shall have the meaning as set out in 21 4 U.S.C. ss.ss. 321(g) and (ff) as of January 23, 2000. 1.3 Amended Definitions The Agreement is amended by replacing Articles 1.11 and 1.18 with the following Article. 1.11. Improvements "Improvements" shall mean any improvements to Monsanto Enabling Technology and Monsanto Enabling Assets. Improvements may or may not result in patentable subject matter. 1.18 Net Product Revenues "Net Product Revenues" shall mean the gross invoiced sales of Licensed Products or Paradigm Enabled Products received by Paradigm, its Affiliates or, in the case of Paradigm Enabled Products, its licensee during the applicable period in arm's length transactions after deduction of the following items, provided and to the extent such items are actually incurred and do not exceed reasonable and customary amounts in each market in which such sales occurred: (1) trade and quantity discounts and rebates; (ii) credits or allowances made for rejection or return of previously sold Licensed Products or Paradigm Enabled Products; (iii) any tax or government charge levied on the sale, such as value added tax (but not including income tax); and (iv) any charges for freight or insurance. In the event that the Licensed Product or Paradigm Enabled Product is not sold or is used internally by Paradigm, an Affiliate of Paradigm, or, in the case of Paradigm Enabled Products, its licensee, or is sold or otherwise transferred to a third party for a price lower than if it had been sold to a third party in an arm's length transaction ("fair market value"), then Net Product Revenues shall be the fair market value of the Licensed Product or Paradigm Enabled Product.
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