Generic Entry. If # a Generic Product is sold by a Third Party in the Territory in any Calendar Quarter during the Royalty Term for a Licensed Product and the Generic Competition Percentage in the Territory for such Calendar Quarter is greater than or equal to ​ or # a LP Generic Product is sold by a Third Party in the Territory in any Calendar Quarter during the Royalty Term for a Licensed Product and the LP Generic Competition Percentage in the Territory for such Calendar Quarter is greater than or equal to ​, then the royalty rate under [Section 7.4(a)] shall be reduced by ​ in such Calendar Quarter.

Generic Entry. On a Licensed Product-by-Licensed Product and country-by-country basis, if during any portion of the Royalty Term for a given Licensed Product in a given country in the Royalty Territory or Territory, as applicable, there is an entry of a Licensed Product sold by a Compulsory Sublicensee, a Competitive Product sold by Relay, its Affiliates or Relay Sublicensees or any Generic Product, in each case in a given country in the Territory when such Licensed Product is sold in such country by Licensee, its Affiliates or Licensee Sublicensees and # there has been a decline of the Sales of the applicable Licensed Product in such country greater than ​ of the average quarterly Sales of Licensed Product in such country ​ before the entry of such Licensed Product sold by a Compulsory Sublicensee, Generic Product or Competitive Product in such country, then the royalty rate that would otherwise be owed and payable under Section 11.6.1, 11.6.2 or 11.6.3 (as applicable), in each case, with respect to Net Sales of such Licensed Product in such country will be reduced ​ for ​ of the Royalty Term for such Licensed Product in such country or, if sooner, until further royalty reduction applies pursuant to clause (b) or (c) below, # there has been a decline of the Sales of the applicable Licensed Product in such country ​ of the average quarterly Sales of Licensed Product in such country ​ before the entry of such Licensed Product sold by a Compulsory Sublicensee, Generic Product or Competitive Product in such country, then the royalty rate that would otherwise be owed and payable under Section 11.6.1, 11.6.2 or 11.6.3 (as applicable), in each case, with respect to Net Sales of such Licensed Product in such country will be reduced by ​ for ​ of the Royalty Term for such Licensed Product in such country or, if sooner, until further royalty reduction applies pursuant to clause (c) below, or # there has been a decline of the Sales of the applicable Licensed Product in such country greater than ​ of the average quarterly Sales of Licensed Product in such country ​ before the entry of such Licensed Product sold by a Compulsory Sublicensee, Generic Product or Competitive Product in such country, then the royalty rate that would otherwise be owed and payable under Section 11.6.1, 11.6.2 or 11.6.3, in each case, with respect to Net Sales of such Licensed Product in such country will be reduced to ​ after which time the license for such Licensed Product in such country shall thereafter be fully paid-up and irrevocable for such Licensed Product in such country for so long as such Licensed Product is sold in such country. The royalty reductions in this Section 11.6.6 and the royalty reductions in Section 11.6.5 taken together shall not exceed ​ reduction for a Licensed Product in a country, except where [clause (c) of this Section 11.6.6] applies, in which case the royalty rate will be reduced to ​ and the license for such Licensed Product in such country shall thereafter be fully paid-up and irrevocable for such Licensed Product in such country for so long as such Licensed Product is sold in such country. For the avoidance of doubt, royalty reductions pursuant to Section 11.6.4 will be applied to the royalty as reduced pursuant to Section 11.6.5 and 11.6.6.

Generic Entry Step-Down. If at any time in any particular country in the Territory # a Generic Product receives Regulatory Approval in such country and is introduced for commercial sale into such country, and # the Net Sales of the relevant Licensed Product sold in such country in a given Calendar Quarter (after the first Calendar Quarter in which the Generic Product is sold in such Country) decrease by more than ​ percent (​) but no more than ​ percent (​) compared to the average Net Sales of the two Calendar Quarters immediately preceding the first Calendar Quarter in which the Generic Product is so1d then, the royalties that would otherwise have been payable on Net Sales of such Licensed Product in such country under Section 6.3.1 shall be reduced by ​ percent (​) as from the first Calendar Quarter in which this Section 6.3.2 applies and thereafter for so long as the Net Sales of the relevant Licensed Product sold in a given Calendar Quarter are at least ​ percent (​) but no more than ​ percent (​) less than the average Net Sales of such Licensed Product sold in the two Calendar Quarters immediately preceding the first Calendar Quarter in which the Generic Product is sold. Further, if at any time, in any particular country in the Territory, # a Generic Product receives Regulatory Approval in such country and is introduced for commercial sale into such country and # the Net Sales of the relevant Licensed Product sold in such country in a given Calendar Quarter (after the first Calendar Quarter in which the Generic Product is sold in such country) decrease by more than ​ (​) compared to the average Net Sales of the two Calendar Quarters immediately preceding the first Calendar Quarter in which the Generic Product in sold then (and without prejudice to [[Sanofi:Organization]]’s right to terminate this Agreement with respect to such country in accordance with [Section 12.2]), the royalties that would otherwise have been payable on Net Sales of such Licensed Product in such country under Section 6.3.1 shall be reduced by ​ percent (​) as from the first Calendar Quarter in which this Section 6.3.2 applies and thereafter for so long as the Net Sales of the relevant Licensed Product sold in a given Calendar Quarter are more than ​ (​) less than the average Net Sales of such Licensed Product sold in the two Calendar Quarters immediately preceding the first Calendar Quarter in which the Generic Product is sold. The calculation of the royalty reduction under this Section 6.3.2 shall be conducted on a Licensed Product-by-Licensed Product, and on a country-by-country, basis.

Entry. Following the Effective Date and continuing until the Closing or earlier termination of this Agreement, Seller shall provide the Buyer Parties with reasonable access to the Property in accordance with the terms and conditions of this # in order for Buyer to investigate the Property and the physical conditions thereof, including without limitation such non-invasive environmental, engineering and economic feasibility inspections and testing as Buyer may elect (the “Due Diligence Activities”). In connection with the foregoing, Buyer and Seller each agree that the provisions of this # shall supersede any prior access agreements made by Buyer in favor of Seller as of the date of this Agreement including, without limitation, that certain Entry and Indemnity Agreement dated February 16, 2021, by and between Seller and Buyer. Such access, investigation, inspections, tests and discussions shall be on the following terms and conditions:

Generic Product Entry. Subject to [Section 7.5(e)(iv)], in the event that # a Generic Product for a Product is made commercially available in any country in the Territory during the Royalty Term and # the Net Sales of such Product in such country ​ are ​ of the royalties otherwise due to Cyclerion with respect to such Product in such country.

entry of a Generic Product has occurred;

Generic Products. If a ​of a ​ is ​ by a ​ during the ​, and for so long as any such ​ is on the ​ in the ​ and the ​ of such ​ in the ​ is ​ of the ​ of the corresponding ​ and all such ​ in the ​ in any given ​, then the ​ pursuant to Paragraph II(a) on account of ​ in the ​ in such ​ and each ​ thereafter shall be ​. If the ​ of such ​ of the amount ​ of the corresponding ​ in the ​ in any given ​, then the ​ pursuant to Paragraph II(a) on account of ​ such corresponding ​ in the ​ in such ​ and each ​ for so long as the ​ shall be ​ by the ​ of all ​ in the ​ in the corresponding ​. Should ​ on a ​ be ​, INNOCOLL shall have ​, subject to ​.

Generic Entry. On a Licensed Product-by-Licensed Product and country-by-country basis, and subject to [Section 6.6(c)(iv)], if one or more applicable Generic Products is sold in such country, and if during the Royalty Term for such Licensed Product in such country such Generic Products gain a market share of at least ​ of the aggregate market share of such Licensed Product and Generic Products (based on data provided by IQVIA, or if such data is not available, such other reliable data source as reasonably determined by Anteris in consultation with vTv) as measured by unit volume, then commencing the Calendar Quarter in which such Generic Products gain such market share and for the remainder of the applicable Royalty Term, the royalty rate provided in [Section 6.6(a)] for such Licensed Product shall be reduced in such country by ​.

The term “Generic Product” shall mean a product that is not produced, licensed or owned by the Roche Group that # contains a pharmaceutically active ingredient that is the same as the Compound in the Product which is approved through in reliance, in whole or in part, on the prior Regulatory Approval (or on safety or efficacy data submitted in support of the prior Regulatory Approval) of such Product, pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)), or for countries outside the US, any international equivalent laws, and # has the same or substantially the same labelling as the applicable Product for at least one indication of such Product.

Generic. If during any Calendar Quarter during the Transfer Price Payment Term, # any Generic Product to a Product is sold in the Territory, then the Transfer Price Percentage with respect to Net Sales of such Product in the Territory shall be reduced by ​ of the otherwise applicable rate set forth in Section 8.4(a), and (ii) all of the Generic Products to a Product in the aggregate have a market share of ​ or more in the Territory in a Calendar Quarter (measured in local currency, as reported by an agreed market intelligence service), then the Transfer Price Percentage with respect to Net Sales of the Product in the Territory shall be reduced by ​ of the otherwise applicable rate set forth in Section 8.4(a).