Royalty Term. “Royalty Term” means the time from the first post-Marketing Authorization sale of the first Licensed Product in a given country, on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a country-by-country basis. The royalties payable with respect to Net Sales of Licensed Products shall be reduced to […***…] percent ([…***…]%) of the otherwise applicable rates, with respect to Net Sales of a Licensed Product in a country during any portion of the Royalty Term when there is not a Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubt, the […***…] percent ([…***…]%) reduction shall in this situation apply to every royalty rate otherwise applicable except for the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) in this case.
Appears in 6 contracts
Sources: Collaboration and License Agreement (Xencor Inc), Collaboration and License Agreement (MorphoSys AG), Collaboration and License Agreement (MorphoSys AG)
Royalty Term. “The period during which the royalties set forth in Section 12.4.1 (Royalty Term” means Rates) and the time from the first post-Marketing Authorization sale of the first Licensed Product sales milestones set forth in a given countrySection 12.3.2 (Sales Milestones) shall be payable, on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a and country-by-country basis. The royalties payable , shall commence with respect to Net Sales the First Commercial Sale of a Licensed Products shall be reduced to Product CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…] percent ]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. in a country and continue until the latest of (a) subject to the last sentence of this Section 12.4.2, the expiration of the last Valid Claim of the (i) Voyager Patent Rights, Voyager Collaboration Patent Rights or Joint Collaboration Patent Rights owned by Voyager (either solely or jointly with Genzyme) or exclusively licensed to Voyager Covering the Manufacture, use, offer for sale, sale or importation of such Licensed Product in the country of sale or (ii) SMA Product-Specific Patent Rights or HD Product-Specific Patent Rights Covering the Manufacture, use, offer for sale, sale or importation of such Licensed Product in the country of sale; (b) the expiration of Regulatory Exclusivity for such Licensed Product in such country; or (c) the […***…]%) ] of the otherwise applicable ratesFirst Commercial Sale of such Licensed Product in such country (each such period, with respect to Net Sales a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale of a Licensed Product in a country during any portion of the Royalty Term when there is not a country, Manufacturing Claims shall no longer constitute Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Claims with respect to such Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubt, the […***…] percent ([…***…]%) reduction shall in this situation apply to every royalty rate otherwise applicable except for the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) in this casesuch country.
Appears in 4 contracts
Sources: Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.)
Royalty Term. “Royalty Term” means 9.2.1. Subject to the time from the first post-Marketing Authorization sale of the first Licensed Product in a given country, on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license provisions of this Agreement or joint ownership of Article 9, GSK’s obligation to pay the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined shall be calculated on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause in those countries of the Territory in which there is a Valid Claim that, either (Yi) falls within any Joint Collaboration IP Covering *** of any Licensed Product or any part of the Licensed Product contained therein in the country of sale; or (ii) but for the licenses granted to GSK, would be infringed by the *** of any Licensed Product or any part of the Licensed Product contained therein in the country of sale. GSK’s obligation to pay the ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Royalty with respect to any Licensed Product shall commence upon the First Commercial Sale of such Licensed Product in a country, and shall expire on the later of (i) the expiration of the last Valid Claim Covering *** in the country of sale; and (ii) the date that is ten (10) years from the First Commercial Sale of such Licensed Product in such country (the “Royalty Term”). To the extent that any Licensed Product is sold in any country prior to First Commercial Sale (such as for compassionate use or on a named patient sales basis), Net Sales from such sales shall be accrued as from the time of sale and Royalties on such Net Sales shall become due in the quarter after First Commercial Sale in accordance with Section 9.14.
9.2.2. For clarity, once the Royalty Term is determined only expires in any country, Net Sales in such country will not be included in the calculation of Cumulative Annual Net Sales in a Calendar Year as set forth in the table in Section 9.1 for purposes of determining the applicable royalty rate. By way of illustration only, if global Net Sales in a Calendar Year are £*** million, and £*** million of such global Net Sales are in countries where the Royalty Term has expired, then the Cumulative Annual Net Sales in a Calendar Year shall be £*** million and not £*** million.
9.2.3. If, on a country-by-country and Licensed Product-by-Licensed Product basis. The royalties payable , the only Valid Claim Covering a Licensed Product is a claim of any pending patent application within the Collaboration Program IP or Joint Background covering *** of such Licensed Product (a “Pending Claim”), then the following shall apply with respect to payment of the Royalty on Net Sales of such Licensed Products shall be reduced to […Product:
(a) then GSK will pay *** percent (***…] percent ([…***…]%) of the applicable Royalty that would otherwise be due under Section 9.1 to Adaptimmune for so long as there is a Pending Claim Covering the *** of the applicable ratesLicensed Product. The rate of Royalty payable to Adaptimmune shall revert to the full Royalty as set out in Section 9.1 with effect from the date of issue of the Pending Claim until the end of the applicable Royalty Term, subject to any reductions as set forth in Sections 9.3, 9.5 or 9.6, as applicable during such Royalty Term. In addition, GSK *** on the date of the First Commercial Sale. ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with respect the Commission.
(b) then the terms of Section 9.2.3(a) shall apply, except that if the *** , then GSK shall be entitled to Net Sales continue to pay the Royalty at the rate that is *** percent (***%) of a Licensed Product in a country what would otherwise be due under Section 9.1 during any portion the remainder of the Royalty Term when there is not a Valid Term, even if such Pending Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubt, the […***…] percent ([…***…]%) reduction shall * , subject to any reductions as set forth in this situation apply to every royalty rate otherwise Section 9.5 and 9.6 as applicable except for the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) in this caseduring such Royalty Term.
Appears in 3 contracts
Sources: Collaboration and License Agreement (Adaptimmune Therapeutics PLC), Collaboration and License Agreement (Adaptimmune Therapeutics PLC), Collaboration and License Agreement (Adaptimmune LTD)
Royalty Term. “Royalty Term” means (i) Royalties payable under this Section 9.7 shall be paid by the time Commercializing Party on a Royalty-Bearing Product-by-Royalty-Bearing Product and country-by-country basis from the first postdate of First Commercial Sale of each Royalty-Marketing Authorization sale of Bearing Product with respect to which royalty payments are due until the first Licensed Product in a given country, on a country by country basis, until latest of:
(A) the last to occur expire of any Valid Claim of Agios Patent Rights or Agios Collaboration Patent Rights, in each case Covering such Royalty-Bearing Product in such country;
(XB) [**] years following the date of First Commercial Sale in such country; and
(C) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but Regulatory Exclusivity for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first postRoyalty-Marketing Authorization sale of the first Licensed Bearing Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a country-by-country basis. The royalties payable each such term with respect to Net Sales a Royalty-Bearing Product and a country, a “Royalty Term”).
(ii) Notwithstanding the foregoing, (A) in the event that the Royalty Term for a Royalty-Bearing Product in a country continues solely due to Section 9.7(f)(i)(B) above (i.e., the Royalty-Bearing Product is not Covered by a Valid Claim of Licensed Products shall Agios Patent Rights or Agios Collaboration Patent Rights in the applicable country, and such Royalty-Bearing Product is not subject to Regulatory Exclusivity in such country) or (B) in the event that, and for so long as, Generic Competition for a Royalty-Bearing Product occurs in a country, then, in either such event, the royalty rates in such country will be reduced to […***…] percent ([…***…]%) of the otherwise applicable ratesrate in Section 9.7(a), with respect to Net Sales of a Licensed Product 9.7(b), 9.7(c), 9.7(d) or 9.7(e) in a country during any portion such country.
(iii) Upon the expiration of the Royalty Term when there is not with respect to a Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, Royalty-Bearing Product in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubta country, the […***…] percent ([…***…]%) reduction shall in this situation apply licenses granted by a Party to every royalty rate otherwise applicable except for the “floor” of […***…] percent ([…***…]%) which Commercializing Party pursuant to Section 8.2 shall be […***…] percent ([…***…]%) deemed to be fully paid-up, irrevocable and perpetual with respect to such Royalty-Bearing Product in this casesuch country.
Appears in 2 contracts
Sources: Discovery and Development Collaboration and License Agreement (Agios Pharmaceuticals Inc), Discovery and Development Collaboration and License Agreement (Agios Pharmaceuticals Inc)
Royalty Term. “Royalty Term” means Royalties payable by BMS to AlderHoldings under Section 8.6 shall be paid on a Licensed Product-by-Licensed Product or Co-Developed Product-by-Co-Developed Product and country-by-country basis as follows.
(a) The following under this Section 8.7(a) shall apply with respect to the time from Licensed Product which is the first post-Marketing Authorization ALD518 LF Product.
(i) In the U.S., if the Cancer Product obtains Regulatory Approval in the Cancer Field prior to the receipt of Regulatory Approval for the Licensed Product in the Licensed Field, if obtaining such Regulatory Approval for the Cancer Product has the effect of shortening the extended patent term of the COM Patent in the U.S. compared to what would have been the extended patent term in the U.S. had the Licensed Product obtained Regulatory Approval in the U.S. prior to the Cancer Product, royalties shall be paid until the later of (A) [***] after First Commercial Sale of the applicable Licensed Product in the U.S. or (B) [***] of the [***] in a [***] that would [***] by the sale of the first applicable [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Licensed Product in a given countrythe Licensed Field in the U.S.; provided however, on a country by country basisthat upon [***] the royalty term shall recommence and shall continue for as long as BMS or its Affiliate or Sublicensee sells the Licensed Product in the U.S. and the royalty rate shall be as set forth in Section 8.6, until the last to occur of provided that Section 8.6(e) shall be revised such that when (Xand so long as) the expiration or invalidation unit volume sales of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described Generic Product(s) in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting U.S. exceed [***] of the Licensed Product’s unit volume sales in the U.S., [***] royalty will then be payable under Section 8.6 (i.e., the royalty rate shall be [***]). For clarity, in the case where the royalty term is recommenced as set forth above, no royalty shall be payable for the period from the initial end of the royalty term to the date that the royalty term is recommenced.
(ii) In any country outside the U.S., if the Cancer Product that is actually sold obtains Regulatory Approval in the Cancer Field prior to the receipt of Regulatory Approval for the Licensed Product in the Licensed Field, and if in such country obtaining such Regulatory Approval for the Cancer Product has the effect of shortening the extended patent term of the COM Patent in which such country compared to what would have been the extended patent term had the Licensed Product is manufactured or soldobtained Regulatory Approval prior to the Cancer Product, and then royalties shall be paid until the later of (YA) eleven (11) years [***] after the first post-Marketing Authorization First Commercial Sale of the applicable Licensed Product in such country or (B) the [***] of the [***] in the [***] that would [***] by the sale of the first applicable Licensed Product in such country [***]; provided however, [***] the royalty term shall recommence, and shall continue until for as long as BMS or its Affiliate or Sublicensee sells the Licensed Product in such country, and the royalty rate shall be as set forth in Section 8.6, provided that Section 8.6(e) shall be revised such that when (and so long as) the unit volume sales of Generic Product(s) in such country exceed [***] of the Licensed Product’s unit volume sales in such country, [***] royalty will then be payable under Section 8.6 (i.e., the royalty rate shall be [***]). Clause Also for clarity, in the case where the royalty term is recommenced as set forth above, no royalty shall be payable for the period from the initial end of the royalty term to the date that the royalty term is recommenced.
(Xiii) In the U.S. or any other country in the Territory, if the Cancer Product obtains Regulatory Approval in the Cancer Field prior to the receipt of Royalty Term Regulatory Approval for the Licensed Product in the Licensed Field, and if in such country obtaining such Regulatory Approval for the Cancer Product does not have the effect of shortening the extended patent term of the COM Patent in such country compared to what would have been the extended patent term had the Licensed Product obtained Regulatory Approval prior to the Cancer Product or if no patent extensions are available, then royalties with respect to such country shall be paid until the later of (A) [***] after First Commercial Sale of the Licensed Product in such country or (B) [***] of the [***] in an [***] that would [***] by the sale of such Licensed Product in such country [***] with respect to such [***] under this Agreement ([***]).
(iv) In the U.S. or any other country of the Territory, if the Licensed Product obtains Regulatory Approval in the Licensed Field prior to the receipt of Regulatory Approval, if any, for the Cancer Product in the Cancer Field in such country, royalties shall be paid until the later of (A) [***] after First Commercial Sale of the Licensed Product in such country or (B) the [***] of the [***] in an [***] that would be [***] by the sale of such Licensed Product in such country [***] with respect to such [***] under this Agreement ([***] [***]). [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(b) With respect to any Licensed Product which is determined other than the ALD518 LF Product, royalties shall be paid on a country-by-country and Licensed Product-by-basis until the later of (i) [***] after First Commercial Sale of the Licensed Product basisin such country or (ii) the [***] of the [***] in an [***] that would [***] by the sale of the applicable Licensed Product [***] in the applicable country [***].
(c) With respect to any Co-Developed Product in the Cancer Territory, whereas clause (Y) of Royalty Term is determined only royalties shall be paid on a country-by-country basis. The royalties payable basis until the later of (i) [***] after First Commercial Sale of the Co-Developed Product in such country or (ii) the [***] of the [***] in an [***] that would [***] by the sale of the applicable Co-Developed Product in the applicable country [***].
(d) As used in this Agreement, any of the above described periods with respect to Net Sales of Licensed Products shall be reduced to […***…] percent ([…***…]%) each of the otherwise applicable ratesALD518 LF Product, with respect any other Licensed Product, or the Co-Developed Product is referred to Net Sales of a Licensed Product in a country during any portion of the Royalty Term when there is not a Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubt, the […***…] percent ([…***…]%) reduction shall in this situation apply to every royalty rate otherwise applicable except for as the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) in this caseRoyalty Term”.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Alder Biopharmaceuticals Inc), Collaboration and License Agreement (Alder Biopharmaceuticals Inc)
Royalty Term. “Royalty Term” means the time from the first post-Marketing Authorization sale of the first Licensed Product in a given country, Royalties under Section 9.3(a) shall be payable on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a countryand Region-by-country basis. The royalties payable with respect to Net Sales of Licensed Products shall be reduced to […***…] percent Region basis from the Effective Date until the latest of: ([…***…]%i) of the otherwise applicable rates, with respect to Net Sales ten (10) years from First Commercial Sale of a Licensed Product in a country Region; (ii) expiration of all Regulatory Exclusivity for such Product in such Region; and (iii) expiration of the last-to-expire Valid Claim of the Tocagen Patents and Joint Patents Covering the manufacture, use, sale, offer for sale or import of such Product in such Region (the “Royalty Term”); provided, however, that: (A) during any portion of the Royalty Term for a Product in a Region when there is not a no Valid Claim of Licensed the Tocagen Patents that would be infringedor Joint Patents Covers the manufacture, use, sale, offer for sale or import of such Product in such Region, but there is Regulatory Exclusivity for the license of this Agreement or joint ownership of the particular Valid Claim, such Product in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubtsuch Region, the […***…] percent ([…***…]%royalties payable under Section 9.3(a) reduction shall with respect to Net Sales of such Product in this situation apply to every royalty rate otherwise applicable except for the “floor” of […***…] percent ([…***…]%) which such Region shall be […***…] percent ]; and (B) during any portion of the Royalty Term for a Product in a Region when (1) no Valid Claim of the Tocagen Patents or Joint Patents Covers the manufacture, use, sale, offer for sale or import of such Product in such Region, and (2) there is no Regulatory Exclusivity for such Product in such Region, the royalties payable under Section 9.3(a) with respect to Net Sales of such Product in such Region shall be […***…]%) . On a Product-by-Product and Region-by-Region basis, upon expiration of the Royalty Term for a Product in this casea Region, Apollo’s License with respect to such Product in such Region shall become non‑exclusive, royalty‑free, fully-paid, irrevocable and perpetual.
Appears in 1 contract
Sources: License Agreement (Tocagen Inc)
Royalty Term. Royalties will be payable by Recordati to Nymox on Net Sales of the Product until the last to occur of the following events with respect to each country in the Territory (i) the last to expire, if any, of the last Nymox Patent with a Valid Claim that covers the manufacture, use, or sale of the Product within, or the importation of the Product into, such country, (ii) the end of any period of Data Exclusivity applicable to the Product in such country, (iii) the end of any period of an SPC applicable to the Product in such country, and (iv) the Publication of the last part of the Nymox Know-How that (A) was previously confidential and that (B) is used by Nymox, or its designee, to manufacture the Compound or Product for Recordati, its Affiliates or Sublicensees, or (C) that is used by Recordati, its Affiliates or Sublicensees in the Commercialization of the Product (the foregoing period is the “Royalty Term”); provided however, that if and to the extent the Royalty Term is extended beyond the period described in the foregoing clauses “(i)”, “(ii)”, and “(iii)” means the time from the first post-Marketing Authorization sale by application of the first Licensed foregoing clause “(iv)” then the royalties otherwise payable for the relevant Product and relevant country under Section 3.4 for such period shall be payable at the rates indicated in a given countrySection 3.4 but reduced by [***] unless and until the foregoing clause “(i)”, “(ii)”, or “(iii)” becomes applicable to such Product and such country again (for example, due to the issuance of another Nymox Patent or SPC applicable to the Product) at which point the full royalties shall again become due and payable. For avoidance of doubt, the Royalty Term shall be determined on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license . For purposes of this Agreement Section, “Publication” means to be made publicly known by means other than by Recordati, its Affiliates or joint ownership Sublicensees in breach of this Agreement. Notwithstanding the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or soldabove, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a country-by-country basis. The royalties payable with respect to Net Sales of Licensed Products shall be reduced to […***…] percent ([…***…]%) of the otherwise applicable rates, with respect to Net Sales of a Licensed Product in a country during any portion of the Royalty Term when there is not a Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubt, the Royalty Term shall expire on a country by country basis upon the successful launch of a Generic Product and in any case the Royalty Term shall expire for all the Territory upon the expiry of the […***…] percent period from the date EMA approves the first MA, after which the license will be considered fully paid up and perpetual as per Section 12.6.4 and Recordati will be able to Commercialize the Product with no further payments to Nymox and will be able to manufacture or have manufactured the Product at its choice. For purposes of this Section, the phrase “successful launch of a Generic Product” means that the total sales (measured in number of units) of products which are generic to a Product by Third Parties (not working with Recordati, directly or indirectly) in a given country for a six (6) month period exceed […***…]%] of the total sales (measured in number of units) reduction shall of the Product in this situation apply to every royalty rate otherwise applicable except such country for the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) in this casesuch period.
Appears in 1 contract
Sources: License and Collaboration Agreement (Nymox Pharmaceutical Corp)
Royalty Term. “Royalty Term” means the time from the first post-Marketing Authorization sale of the first Licensed Product in a given country(i) Royalties under Section 8.8(a), Section 8.8(b) and Section 8.8(c) shall be payable, on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a and country-by-country basis, during the period of time beginning with First Commercial Sale of such Licensed Product in such country within the Territory and ending on the latest of (A) the date that is [ * ] ([ * ]) years after such First Commercial Sale, (B) the expiration of all Regulatory Exclusivity for such Licensed Product in such country within the Territory, or (C) the last to expire Valid Claim within the Licensed Patents that Covers the composition of matter of such Licensed Product (including any components thereof) or method of using such Licensed Product in such country within the Territory (any such period, the “Initial Royalty Term”). The royalties payable with respect to Net Sales of Licensed Products shall be reduced to […***…] percent ([…***…]%) If at any time after the end of the otherwise applicable ratesInitial Royalty Term for a particular Licensed Product in a particular country in the Territory, with respect to Net Sales there becomes (whether through issuance or filing of a Licensed Patent) a Valid Claim within the Licensed Patents that Covers the composition of matter of such Licensed Product (including any components thereof) or method of using such Licensed Product in such country within the Territory, then the Initial Royalty Term for such Licensed Product in such country shall restart and continue until there is no longer any such Valid Claim.
(ii) After the First Commercial Sale of a Licensed Product in a country and during any portion of the Royalty Term when there period that is not within an Initial Royalty Term, royalties under Section 8.8(a), Section 8.8(b) and Section 8.8(c) shall be payable, on a Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Product-by-Licensed Product that is actually sold and country-by-country basis, on the Net Sales of such Licensed Product in such country within the country Territory at the rate of manufacture or sale. For the avoidance of doubt, the […***…[ * ] percent ([…***…[ * ]%) reduction shall (notwithstanding the royalty rates set forth in this situation apply Section 8.8(a), Section 8.8(b) and Section 8.8(c)), provided that, notwithstanding anything to every royalty rate otherwise applicable except for the “floor” of […***…contrary provided herein, such [ * ] percent ([…***…[ * ]%) which royalty rate shall not be […***…] percent ([…***…]%) subject to any further reductions or adjustments under this Agreement except as set forth in this caseSection 8.8(j).
Appears in 1 contract
Sources: Collaboration and License Agreement (4D Molecular Therapeutics, Inc.)
Royalty Term. “Royalty Term” means the time from the first post-Marketing Authorization sale of the first Licensed Royalties payable under this Section 9.5 shall be paid by BeiGene for each Product in a given country, on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country basis from the later of (i) any Co-Development Opt-Out Date (if applicable to such Product) and Licensed Product-by-Licensed (ii) the date of First Commercial Sale of such Product basis, whereas clause (Y) of Royalty Term is determined only on in a country-by-country basis. The royalties payable with respect to Net Sales which royalty payments are due, until the latest of:
(i) the last to expire of Licensed Products shall any Valid Claim of BioAtla Patents, BioAtla Collaboration Patents, BeiGene Collaboration Patents or Joint Patents, in each case Covering such Product in such country;
(ii) ten (10) years following the date of First Commercial Sale of such Product in such country; and
(iii) the last to expire of any Regulatory Exclusivity applicable to such Product in such country; (each such term with respect to a country, a “Royalty Term”). Notwithstanding the foregoing, in the event that the Royalty Term for a Product in a country continues solely due to Section 9.5(c)(ii) above (i.e., the Product is not Covered by a Valid Claim of BioAtla Patents, BioAtla Collaboration Patents, BeiGene Collaboration Patents or Joint Patents in the applicable country, and such Product is not subject to Regulatory Exclusivity in such country) then, in such event, the Royalty Rate or BeiGene Territory Royalty Rate, as applicable, for such Product in such country will be reduced to […***…] percent ([…***…]%) of the otherwise applicable rates, with respect to Net Sales of a Licensed Royalty Rate in Section 9.5(a) or the applicable or BeiGene Territory Royalty Rate in Section 9.5(b) for such Product in a country during any portion such country. Upon the expiration of the Royalty Term when there is not with respect to a Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, Product in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubta country, the […***…] percent ([…***…]%licenses granted by BioAtla to BeiGene pursuant to Section 8.1(a) reduction shall in this situation apply to every royalty rate otherwise applicable except for the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) deemed to be fully paid-up, irrevocable and perpetual with respect to such Product in this casesuch country.
Appears in 1 contract
Sources: Global Co Development and Collaboration Agreement (BioAtla, Inc.)
Royalty Term. “Royalty Term” means the time from the first post-Marketing Authorization sale of the first Licensed Product in a given country, Royalties payable under this Section 9.5 shall be paid by Celgene on a country by country basis, until the last to occur of (X) the expiration or invalidation of the last Valid Claim of Licensed Patents that would be infringed, but for the license of this Agreement or joint ownership of the particular Valid Claim, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the Licensed Product that is actually sold in such country in which such Licensed Product is manufactured or sold, and (Y) eleven (11) years after the first post-Marketing Authorization sale of the first Licensed Product in such country. Clause (X) of Royalty Term is determined on a country-by-country and Licensed Product-by-Licensed Product basis, whereas clause (Y) of Royalty Term is determined only on a and country-by-country basis. The royalties payable basis from the later of (i) the Agios Opt-Out Date and (ii) the date of First Commercial Sale of each Licensed Product in a country of the ROW Territory with respect to Net Sales which royalty payments are due, until the latest of:
(i) the last to expire of any Valid Claim of Agios Patent Rights or Agios Collaboration Patent Rights (including Joint Patents), in each case Covering such Licensed Products shall be reduced to Product in such country of the ROW Territory;
(ii) […***…] percent ([…***…]%) years following the date of First Commercial Sale in such country of the otherwise applicable rates, ROW Territory; and
(iii) the expiration of Regulatory Exclusivity for such Licensed Product in such country of the ROW Territory; (each such term with respect to Net Sales of a Licensed Product and a country, a “Royalty Term”).
(iv) Notwithstanding the foregoing, (A) in the event that the Royalty Term for a Licensed Product in a country during any portion of the ROW Territory continues solely due to Section 9.5(b)(ii) above (i.e., the Licensed Product is not Covered by a Valid Claim of Agios Patent Rights or Agios Collaboration Patent Rights in the applicable country, and such Licensed Product is not subject to Regulatory Exclusivity in such country) or (B) in the event that, and for so long as, Generic Competition for a Licensed Product occurs in a country of the ROW Territory, then, in either such event, the royalty rate in such country will be reduced to [**] percent ([**]%) of the applicable rate in Section 9.5(a) in such country.
(v) Upon the expiration of the Royalty Term when there is not with respect to a Valid Claim Licensed Product in a country of Licensed Patents that would be infringedthe ROW Territory, but for the license of this Agreement or joint ownership of the particular Valid Claimgranted by Agios to Celgene pursuant to Section 8.1(a) shall be deemed to be fully paid-up, in any of the ways described in the definition of “Cover,” by the making, using, selling, offering for sale, importing or exporting of the irrevocable and perpetual with respect to such Licensed Product that is actually sold in the country of manufacture or sale. For the avoidance of doubt, the […***…] percent ([…***…]%) reduction shall in this situation apply to every royalty rate otherwise applicable except for the “floor” of […***…] percent ([…***…]%) which shall be […***…] percent ([…***…]%) in this casesuch country.
Appears in 1 contract
Sources: Collaboration and License Agreement (Agios Pharmaceuticals Inc)