For clarity, each Near Term Milestone Payment is payable only once, regardless of the number of Combination Products that achieve the relevant Near Term Milestone Event or the number of times a Combination Product achieves such Near Term Milestone Event, and in no event will aggregate Near Term Milestone Payments exceed $2,500,000.
Notwithstanding anything to the contrary, in the event that any Primary Royalty Product includes, in addition to one or more CDCs, one or more other active pharmaceutical ingredients (a Primary Combination Product), the Primary Net Sales of such Primary Combination Product in a particular country, for the purposes of determining royalty payments due to Legacy hereunder, shall be determined by multiplying the Primary Net Sales of the Primary Combination Product in such country by the fraction, A / (A+B), where A is the weighted average sale price of the Primary Royalty Product including the CDC(s) (and not any of the other active pharmaceutical ingredients included in the Primary Combination Product) (the Primary Basic Product) when sold separately in finished form in such country, and B is the weighted average sale price(s) of product(s) including the other active pharmaceutical ingredient(s) (and not any CDC(s)) (such products, Other Primary Royalty Products ) sold separately in finished form in such country (if there is more than one Primary Other Product, B shall equal the sum of all such Other Primary Royalty Products weighted average sale prices in such country).
Modifications and Combinations In Manner Other Than Ordinary Course. No license or immunity is granted under this Agreement by Enzo, either directly or by implication, estoppel, or otherwise, to any Person acquiring Products for the modification or combination by such Person of Products with other items other than # in the ordinary and intended manner in the ordinary course of use of Products, # as specified by Sections 2.2 and 2.3, or # as otherwise permitted by the law of patent exhaustion.
Subdivision or Combination of Common Shares. If the Company at any time on or after the issuance date of this Warrant (“Issuance Date”), subdivides (by any stock split, stock dividend, recapitalization or otherwise) one or more classes of its outstanding Common Shares into a greater number of shares, the Exercise Price in effect immediately prior to such subdivision will be proportionately reduced and the number of Warrant Shares will be proportionately increased. Any adjustment under this section shall become effective at the close of business on the date the subdivision or combination becomes effective. Each such adjustment of the Exercise Price shall be calculated to the nearest one-hundredth of a cent. Such adjustment shall be made successively whenever any event covered by this section shall occur.
As used in this definition of “Net Sales,” “Combination Product” means a Licensed Product that is sold for a single price with one or more additional active ingredients (whether co-formulated or co-packaged) that are not Licensed Products.
“ Products” means any past, current and future products and services, product lines, devices, systems, assays, components, subassemblies, kits, hardware, software, or any combination of the foregoing which are made, used, sold, offered for sale, distributed, imported, or otherwise commercialized by or for or its Affiliates, and Natural Evolutions thereof, that, but for the license granted in this Agreement, infringe (actually or allegedly) a Valid Claim of the Licensed Enzo Patent Rights. For the avoidance of doubt, all accused products, manufactured articles, services, processes, systems, or methods that are the subject of the Litigation are included in and constitute Products.
Combination Product means # a finished dosage form of a Licensed Product containing the Antibody and one or more pharmaceutically active ingredients other than such Antibody or # a Licensed Product sold as one of a bundle of products without a separate price.
As used above, the term Combination Product means any Licensed Product sold in a single finished dosage or co-packaged form that contains # a Product Candidate and # one or more active ingredients that are not Product Candidates or Licensed Products.
Covenant Not to Market Competing Products. Except as expressly contemplated by the terms of this Agreement, the Parties and their respective Subsidiaries shall not, and shall not negotiate to or agree to, # develop, file for Regulatory Approval, acquire, license, manufacture anywhere for use in the Territory, or # Market or otherwise commercialize in or for the Territory, any pharmaceutical product that is # a Generic Equivalent to a Product, # an AG Product with respect to a Product, or # any extended release or delayed release prescription cough/cold medicine containing codeine, either alone or with a Third Party (each, a “Competing Product”) during the Term of a Product. Notwithstanding the foregoing, clause (C) shall not prevent either Party from developing, manufacturing and Marketing, a Generic Equivalent (whose approval is or will be based on an ANDA) of a Third Party extended release or delayed release prescription cough/cold medicine containing codeine product which Third Party product was approved pursuant an NDA and such product shall not be deemed a Competing Product. If TRIS engages any Third Party to use TRIS’ modified release technology for liquid suspension products to manufacture Product, it shall enter into an agreement with such Third Party whereby such Third Party agrees not to Market a Generic Equivalent to such Product during the Term of such Product.
Royalties for Valid Claim Company Products. In consideration for the rights granted hereunder, in each calendar quarter during the Term and in each applicable country in which Denali records Net Sales of a Valid Claim Product that incorporates a Company Compound (each a Valid Claim Company Product) in such country, and subject to and in accordance with the terms and conditions of this Agreement, Denali shall pay to on a Licensed Product-by-Licensed Product and country-by-country basis an amount equal to of annual Net Sales of such Valid Claim Company Product sold in such countries.
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