“Generic Product Competition” - with respect to a Product, on a country-by-country basis, Generic Product Competition shall exist if during any ​ in such country there are one or more Generic Products Commercialized by one or more Third Parties being sold in such country and the sales of such Generic Product(s) account for ​ or more of the sales revenue of the Product and its Generic Product(s) in the given country during such ​ as determined by reference to applicable sales data obtained from IMS Health, Verispan or from such other reasonable source for such sales data as may be used and relied upon by Ovid from time to time, provided however if sale of such Generic Product(s) falls below ​ of the sales revenue of the Product and its Generic Products for more than ​, Generic Product Competition shall be deemed no longer to exist.

In the event that such Licensed Product is regulated as a biologic in a particular jurisdiction, the term Generic Product shall be defined using comparable terms applicable to a follow-on biologic or biosimilar product approved through a similarly abbreviated Regulatory Approval process.

For purposes hereof, “Generic Competition” means, on a country-by-country and Product-by-Product basis, the unit volume of each component of a Biosimilar Product(s) sold in such country in the Licensed Territory by one (1) or more Third Party(ies) in a calendar quarter achieves a market share equal to or higher than ​ of the unit volume of each component of the relevant Product sold in such country by SGI, its Affiliates and (sub)licensees. By way of example, but not limitation, for Generic Competition for a Product to satisfy the definition hereunder, # the applicable Biosimilar Product must meet the definition of Biosimilar Product for each of component of the relevant Product (i.e., there must be a Biosimilar Product for both # the applicable SGI Antibody that specifically targets a Collaboration Antigen in the relevant Product, and # the ACTR T-cells), and # the unit volume of each component of such Biosimilar Product sold in the country the Licensed Territory by one (1) or more Third Party(ies) in a calendar quarter must achieve a market share equal to or higher than ​ of the unit volume of each component of the relevant Product sold in such country by SGI, its Affiliates and (sub)licensees. Unless otherwise agreed by the Parties, the unit volumes of each component of each Biosimilar Product sold during a calendar quarter will be as reported by IMS America Ltd. of Plymouth Meeting, Pennsylvania (“IMS”) or any successor to IMS or any other independent sales auditing firm reasonably agreed upon by the Parties.

“Generic Equivalent” means with respect to a product, a generic pharmaceutical product that is therapeutically equivalent to such product, where “therapeutically equivalent” means: an AA or AB rating is assigned to such product’s entry in the list of drug products with effective approvals published in the then-current edition of FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations” and any current supplement to the publication (also known as the “Orange Book”) referred to in 21 C.F.R. 314.3 and such product is covered by an ANDA.

Notice. Each Party shall promptly report in writing to the other Party # any known or suspected infringement of any of the Althea Patent Rights, # unauthorized use or misappropriation of any of the Althea Know-How of which such Party becomes aware, or # any patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions (a “Paragraph IV Certification”), or any notification under applicable Law by the sponsor of an application for Regulatory Approval of a follow-on biologic or biosimilar product, in connection with the filing of an application for the Regulatory Approval of a Generic Product intending to show that the Generic Product is biosimilar to any Licensed Product that is a reference product as to such Generic Product and for which a claim of infringement of any of the Althea Patent Rights by the manufacture or sale of the Generic Product could reasonably be asserted or # any declaratory judgment, opposition, or similar action alleging the invalidity, unenforceability or non-infringement of the Althea Patent Rights, and shall provide the other Party with all available evidence regarding such known or suspected infringement or unauthorized use.

Biosimilar Products. If one or more Biosimilar Products with respect to a Licensed Product is sold commercially by one Biosimilar (or Interchangeable) Applicant in a particular country in the Territory during a particular calendar quarter (“Biosimilar Product Presence”), and during such calendar quarter the Net Sales of such Licensed Product has decreased by ​ percent (​) or more when compared to peak Net Sales of such Licensed Product in such country in ​, and such decrease is attributable to such Biosimilar Product Presence, then the royalty rate (used with Net Sales to determine royalty payments) for such Licensed Product in such country during such calendar quarter and for the remainder of the Royalty Term will be reduced by ​ percent (​) for purposes of determining Arcus’s obligation to make royalty payments under this Agreement. Notwithstanding any other provision of this Agreement, Arcus will at all times pay a minimum royalty of ​ percent (​) of Net Sales under Section 5.4.

“Generic Launch” mean the first commercial sale of a Generic Product in any country.

Generic Entry. The royalty rates set forth in part ​ of this Fee Schedule that are applied to the Net Revenue of a Product in a country shall be reduced by […​…]% if a Generic Product in respect of that Product is sold in such country, beginning in the first Quarter during which such Generic Product is sold in such country.

“Third Party Generic Launch” means with respect to a Product, the first commercial shipment of Generic Equivalent of such Product by a Third Party to customers in the Territory.

At any time on or after a Third Party Generic Launch with respect to a Product, TRIS shall have the right to manufacture and Market an AG Product of such Product. AYTU is not permitted to Market an AG Product of a Product. If TRIS Markets AG Products during the Term of such Product, it shall pay AYTU on a Fiscal Quarterly basis ​ of TRIS’ Gross Margin for such AG Product for such Fiscal Quarter (the “AG Product Royalty Payment”), and if Gross Margin is negative then AYTU shall pay TRIS ​ of such negative Gross Margin, as more fully set forth in this Section 6.9; provided, however, that if Gross Margin is negative for two consecutive Fiscal Quarters, AYTU may terminate this Agreement by written notice to TRIS on thirty (30) days’ notice delivered within thirty (30) days following delivery of TRIS’ second consecutive AG Quarterly Payment Report showing that AYTU owes amounts to TRIS arising from negative Gross Margin, provided however that if together with such second consecutive AG Quarterly Payment Report, TRIS sends a notice stating that AYTU will no longer be responsible for its share of negative Gross Margin for future quarters, then AYTU may not terminate this Agreement on account of negative Gross Margin.