Generic Competition. If a Licensed Product is sold in a country where a product that is an AB Rated Product with respect to such Licensed Product is sold or marketed by a Third Party pursuant to a regulatory approval for the commercial sale and marketing thereof for human therapeutic or prophylactic use in such country, then the royalty rate applicable under Section 5.2(f)(i) to Net Sales of such Licensed Product in such country shall be reduced to [*] percent ([*]%) of the rate originally stated therein (i.e., reduced to [*]% or [*]%, depending on worldwide Net Sales), effective with respect to all Net Sales of such Licensed Product in such country occurring on or after the first day of the first calendar month following the month during which such AB Rated Product is first sold in such country.
Generic Competition. If, during a given calendar year, there is sale of a generic Sphingosomal Vincristine or sale of an approved equivalent to Sphingosomal Vincristine (collectively, “Approved Sphingosomal Vincristine Equivalents”) in any country in the Territory, then, for such country, the total amount of royalties payable to INEX for the Net Sales of Sphingosomal Vincristine in such country during such calendar year will be reduced to [*] of the royalties payable to INEX pursuant to Section 3.1.2 for such calendar year, in such country.
Generic Competition. Notwithstanding the foregoing, if either Party (a) reasonably believes that a Third Party may be filing or preparing or seeking to file a generic or abridged Drug Approval Application in the Licensee Territory that refers to or relies on Regulatory Documentation submitted by either Party to any Regulatory Authority whether or not such a filing may be in violation of any Regulatory Exclusivity Period or infringe the Licensor Patents, the Licensee Patents or the Joint Patents or (b) receives any notice of certification regarding the Licensor Patents, Joint Patents or Licensee Patents pursuant to the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 (21 United States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) claiming that any such Patents are invalid or unenforceable or claiming that any such Patents will not be infringed by the Manufacture, use, marketing or sale of a product for which an ANDA is filed or (c) receives any equivalent or similar certification or notice in any other jurisdiction, it shall notify the other Party in writing, identifying the alleged applicant or potential applicant and furnishing the information upon which such determination is based, and provide the other Party a copy of any such notice of certification within ten (10) days of receipt and the Parties’ rights and obligations with respect to any legal action as a result of such certification shall be as set forth in Section 8.3.1; provided, however, that if the enforcing Party elects not to bring suit against the Third Party providing notice of such certification within thirty (30) days of receipt of such notice with respect to any Licensor Patent, Joint Patent or Licensee Patent, then the other Party shall have the right, but shall not the obligation, to bring suit against such Third Party and to join the enforcing Party as a Party plaintiff if necessary to bring such a suit, in which event the other Party shall hold the enforcing Party harmless from and against any and all costs and expenses of such litigation, including reasonable attorney’s fees and expenses.
Generic Competition. Royalties payable following establishment of Generic Competition with respect to the sale by a Third Party of product that is a Biosimilar Biologic Product to such Agreement Product in such country shall be payable at *** of the otherwise applicable rate prior to application of this Section 5.4.3(a) “Generic Competition” means with respect to a given Calendar Year with respect to an Agreement Product in any country, that during such Calendar Year, *** have received Regulatory Approval to sell in such country a Biosimilar Biologic Product, such Biosimilar Biologic Product shall be commercially available in such country and such Biosimilar Biologic Product shall have, in the aggregate, *** or more market share of the aggregate of such Agreement Product and Biosimilar Biologic Product (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably determined by Pfizer and agreed by MacroGenics (such agreement not to be unreasonably withheld)) as measured by sales. In the event IMS International data (or such other agreed data source) is not sufficient to determine the percentage market share for each country in the EU, the percent market share for the EU countries for which data is not available will be deemed to be the average percent market share for those EU countries in which the data is available. A product shall be a “Biosimilar Biologic Product” with respect to an Agreement Product if such product (1) has been licensed as a biosimilar or interchangeable product by FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as may be amended, or any subsequent or superseding law, stature or regulation, (2) has been licensed as a similar biological medicinal product by EMEA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, stature or regulation, or (3) has otherwise achieved analogous Regulatory Marketing Approval from another applicable Regulatory Authority.
Generic Competition. At any time after Generic Competition exists in a country of the LICENSEE Territory, in each Calendar Quarter during the Royalty Period, Net Sales from such country shall be reduced by [*] before including same into Net Sales in all countries in the LICENSEE Territory for the purpose of calculating the applicable royalty rates set forth in Section 5.3.1.
Generic Competition. The royalty rates specified in Sections 5.5(a) and 5.5(b) shall be reduced by [CONFIDENTIAL TREATMENT REQUESTED] /*/ ([CONFIDENTIAL TREATMENT REQUESTED] /*/) on a country-by-country basis at any such time where the sale of one or more Generic Product(s) in such country exceeds [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of the unit sales volume for the applicable Licensed Product in that country, as measured by IMS Health or its successor. Such reduction shall be first applied with respect to such country starting with sales in the calendar quarter following the first calendar quarter where the sales of the Generic Product(s) in such country exceed [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of the unit sales volume of the applicable Licensed Product.
Generic Competition. On a country-by-country and Product-by-Product basis, if the Product is generating Net Sales in a country during the applicable Royalty Term and a Generic Product with respect to the Product is sold in such country, then the royalty rate applicable to Net Sales of the Product in such country shall be reduced to [***]percent ([***]%) of the royalty rate set forth above in Section 10.5(a) (as reduced by conversion to a non-exclusive license pursuant to a Development Delay, if applicable), commencing with the Net Sales made after the first calendar quarter during which the unit volume of all such Generic Products sold by Third Parties in such country exceeds, in each month during such calendar quarter, [***]percent ([***]%) of the combined unit volume of the Product and such Generic Product sold in such month in such country. All such determinations of unit volume shall be based on a mutually acceptable calculation method and using market share data provided by a reputable and mutually agreed upon provider, such as IMS Health.
Generic Competition. If at any time during the Royalty Term Generic Competition exists in a given country with respect to a Product, then the Marginal Royalty Rates used to calculate Royalties for such Product in such country shall be reduced by [***] for so long as such Generic Competition exists.
Generic Competition. Subject to Section 9.2.3(d) (Cumulative Reductions Floor), if during any Calendar Quarter during the Royalty Term for a given Licensed Product in a country the Generic Competition Percentage in such country is (i) greater than or equal to [***], but less than [***], then the Royalties owed with respect to Net Sales of such Licensed Product in such country in such Calendar Quarter will be reduced by [***]; or (ii) greater than or equal to [***], then the Royalties owed with respect to Net Sales of such Licensed Product in such country in such Calendar Quarter will be reduced by [***].
Generic Competition. If, in any country in the Territory, the Net Sales of any Product in any rolling four Calendar Quarter period following the first sale of a Generic Product to such Product in such country is less than [ * ] of the Net Sales for such Product in such country in the immediately preceding four Calendar Quarter period, then the royalty rate for such Product in such country shall be reduced to [ * ] that would otherwise have been applicable under Section 8.6(a) for Net Sales of such Product in such country. For clarity, if the Generic Product is barred or withdrawn from sale in such country and the Net Sales in such country in any rolling four Calendar Quarter period is greater than [ * ] of the value for the rolling four quarter period prior to the first sale of a Generic Product, then the foregoing reduction shall no longer apply effective as of the Calendar Quarter in which the Generic Product is barred or withdrawn from sale. The calculation of the royalty reduction under this Section 8.6(c) shall be conducted separately for each Product in each country. By way of example, if during the first Calendar Quarter of a particular Calendar Year in which the foregoing reduction applies, the Net Sales in such Calendar Quarter in a country in which the foregoing reduction applies are one billion five hundred million Dollars ($1,500,000,000), and the Net Sales in such Calendar Quarter in a country in which the foregoing royalty reduction does not apply are one billion Dollars ($1,000,000,000), the following shall apply with respect to the royalty payment owed for such Calendar Quarter: The royalty payment without regard to the reduced rate would be [ * ].
