Royalty Term. The period during which the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payable, on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 First Commercial Sale of such Licensed Product in such country (each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale of a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product in such country.
Appears in 4 contracts
Samples: Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.)
Royalty Term. The period during which “Royalty Term” means the royalties set forth time from the first post-Marketing Authorization sale of the first Licensed Product in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payablea 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 and 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 commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “be reduced to […***]”. 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 …] percent (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 First Commercial Sale of such Licensed Product in such country (each such periodotherwise applicable rates, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale with respect to Net Sales of a Licensed Product in a countrycountry during any portion of the Royalty Term when there is not a Valid Claim of Licensed Patents that would be infringed, Manufacturing Claims shall no longer constitute but for the license of this Agreement or joint ownership of the particular Valid Claims with respect to such 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.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. ***Confidential Treatment Requested
Appears in 4 contracts
Samples: Collaboration and License Agreement (MorphoSys AG), Collaboration and License Agreement (Xencor Inc), Collaboration and License Agreement (Xencor Inc)
Royalty Term. The period during which In accordance with the terms of Article 6 of this Agreement, Xxxxxxx shall pay to PPD the royalties set forth in Section 12.4.1 below on Net Sales of all Licensed Products, subject to any royalty rate reduction made pursuant to subsection (Royalty Ratesii) and the sales milestones set forth in Section 12.3.2 or (Sales Milestonesiii) below. Such royalties shall be payable, on a country-by-country and Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 First Commercial Sale of such Licensed Product in such country (each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the beginning upon First Commercial Sale of a Licensed Product in a particular country until the later of (a) the [*] ([*]) year anniversary of the First Commercial Sale of that Licensed Product in that country, Manufacturing Claims shall no longer constitute (b) the expiration of the last to expire Valid Claims with respect to Claim of the Royalty Patents covering such Licensed Product in such country, or (c) the end of the period during which the Licensed Product is subject to Regulatory Exclusivity in the relevant country (such period for a particular country and Licensed Product, the “Royalty Term”). Aggregate Annual Calendar Year Net Sales of All Licensed Products Royalty Rate The portion of combined worldwide Net Sales of all Licensed Products during a particular Calendar Year less than or equal to [*] dollars ($[*]) [*] percent ([*]%) of Net Sales The portion of combined worldwide Net Sales of all Licensed Products during a particular Calendar Year greater than [*] dollars ($[*]) but less than or equal to [*] dollars ($[*]) [*] percent ([*]%) of Net Sales The portion of combined worldwide Net Sales of all Licensed Products during a particular Calendar Year greater than [*] dollars ($[*]) [*] percent ([*]%) of Net Sales [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. For example, in the instance of a full Calendar Year, if annual Net Sales of such Licensed Product in such Calendar Year are $[*] in the aggregate, the royalty due will be $[*] ([*]% of the first $[*] (or $[*]) in the first increment, plus [*]% of the next $[*] (or $[*]) in the second increment, plus [*]% of the remaining $[*] (or $[*]) in the third increment).
Appears in 2 contracts
Samples: Topo Development and License Agreement (Pharmaceutical Product Development Inc), Topo Development and License Agreement (Furiex Pharmaceuticals, Inc.)
Royalty Term. The period during which Purchaser shall pay royalties hereunder with respect to Net Sales in each country in the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payable, on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Territory through [***]”. 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) [***] years from the [***] in such country, whichever is longer. For avoidance of doubt, no royalty shall be payable for sales in the United States of America and the date of first commercial sale of the First Commercial Sale of such Licensed Product in such a country (each such period, a “Royalty Term”). For shall be the date on which the Licensed Product was first deemed sold for purposes of the foregoing clause (a), following the [***] ]. Terms not otherwise defined in this Schedule 4.3.1 shall be as defined in the [***]. [***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. EXHIBIT A TRANSITION SERVICES AGREEMENT This Transition Services Agreement is made and entered into as of April 1, 2012 (this “Agreement”), by and among Bayer Pharma AG (“Bayer”) and such Affiliates of Bayer as listed on Exhibit A as may hereafter execute Exhibit B which is attached hereto, and Spectrum Pharmaceuticals Cayman, L.P., a Cayman Islands Exempted Limited Partnership (“Spectrum”) and such Affiliates of Spectrum as listed on Exhibit A as may hereafter execute Exhibit B which is attached hereto. This Agreement shall be effective as of the First Commercial Sale Closing Date under the License and Asset Purchase Agreement entered into by Bayer and Spectrum as of a Licensed Product in a countryJanuary 23, Manufacturing Claims 2012 (the “License Agreement”). Capitalized terms used and not otherwise defined herein shall no longer constitute Valid Claims with respect have the meanings ascribed to such Licensed Product terms in such countrythe License Agreement. Bayer and Spectrum and their Affiliates that execute Exhibit B are sometimes referred to herein collectively as the “Parties,” and individually each of Bayer and Spectrum or their Affiliates that execute Exhibit B may be referred to herein as a “Party.”
Appears in 1 contract
Samples: License and Asset Purchase Agreement (Spectrum Pharmaceuticals Inc)
Royalty Term. The period during which the Millennium shall pay royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payable, with respect to each Licensed Product on a country-by-country and Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 basis until the latest later 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 [***] years from the date of the First Commercial Sale of such Licensed Product in such country or (each b) the expiration of the last to expire Valid Claim within the Licensed Patent Rights that Covers the Licensed Product in such period, a country (the “Royalty Term”). For purposes of On a country-by-country and Licensed Product-by-Licensed Product basis, the foregoing clause (a), following the first [***] of the First Commercial Sale of a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to Royalty Term for such Licensed Product in such countrycountry is sometimes referred to herein as the “Base Royalty Term,” and the portion, if any, of the Royalty Term for such Licensed Product in such country following the Base Royalty Term is sometimes referred to herein as the “Extended Royalty Term.” For purposes of determining whether a Valid Claim Covers the Licensed Product under this Section 5.4, (i) any Valid Claim within the Licensed Patent Rights that is jointly owned by Millennium (or any of its Affiliates) with ImmunoGen (or any of its Affiliates) shall be deemed to be owned solely by ImmunoGen or an Affiliate of ImmunoGen, and (ii) claims contained in [***] that [***], as of the date in question, [***] will be [***] for purposes of determining the expiration of the Royalty Term for a Licensed Product in such country under this Section 5.4. Anything contained in this Agreement to the contrary notwithstanding, the Millennium [***] ImmunoGen/Millennium Confidential Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract
Royalty Term. The period during On a Licensed Product-by-Licensed Product and country-by country basis, in each country in which a Licensed Product has been Covered by any issued Valid Claim in such country prior to the date on which any such Valid Claim ceases to be a Valid Claim in such country, royalties shall be paid on Net Sales of such Licensed Product commencing upon First Commercial Sale of such Licensed Product in such country until the latest of: (a) the date on which the royalties set forth last Valid Claim within the Patent Rights Covering the applicable Licensed Product in Section 12.4.1 such country ceases to be a Valid Claim in such country; (b) the date on which the period of regulatory exclusivity associated with such Licensed Product in such country expires; or (c) [***] years after the First Commercial Sale of such Licensed Product in such country (the “Covered Product Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payable, on Term”). On a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of if royalties on a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “that has been Covered by any issued Valid Claim in such country prior to the date on which any such Valid Claim ceases to be a Valid Claim in such country are payable under this Section 4.4.2 (Royalty Term) after the later of (i) the date on which the last Valid Claim within the Patent Rights Covering the applicable Licensed Product in such country ceases to be a Valid Claim in such country and (ii) the date on which the period of regulatory exclusivity associated with such Licensed Product in such country expires, then the royalty rate applied to Net Sales of such Licensed Product shall be reduced to a rate of [***] 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 applied 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 First Commercial Sale Net Sales of such Licensed Product in such country during the remainder of the Royalty Term of such Licensed Product in such country. On a Licensed Product-by-Licensed Product and country-by-country basis, in each country in which a Non-Covered Product is sold, royalties shall be paid on Net Sales of such Non-Covered Product in such Calendar Year commencing upon First Commercial Sale of such Non-Covered Product in such country until the date [***] years after the First Commercial Sale of such Non-Covered Product in such country (the “Non-Covered Product Royalty Term,” together with the Covered Product Royalty Term, each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale of a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product in such country.
Appears in 1 contract
Royalty Term. The period during which the royalties set forth in Royalties under Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones9.3(a) shall be payable, payable on a Licensed Product-by-Licensed Product and countryRegion-by-country basis, shall commence with Region basis from the Effective Date until the latest of: (i) ten (10) years from First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 Region; (ii) expiration of all Regulatory Exclusivity for such Product in such Region; and continue until the latest of (aiii) subject to the last sentence of this Section 12.4.2, the expiration of the last last-to-expire Valid Claim of the (i) Voyager Patent Rights, Voyager Collaboration Patent Rights or Tocagen Patents and Joint Collaboration Patent Rights owned by Voyager (either solely or jointly with Genzyme) or exclusively licensed to Voyager Patents Covering the Manufacturemanufacture, 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 import of such Licensed Product in the country of sale; (b) the expiration of Regulatory Exclusivity for such Licensed Product in such country; or Region (c) the [***] of the First Commercial Sale of such Licensed Product in such country (each such period, a “Royalty Term”). For purposes ; provided, however, that: (A) during any portion of the foregoing clause (a)Royalty Term for a Product in a Region when no Valid Claim of the Tocagen Patents or Joint Patents Covers the manufacture, following use, sale, offer for sale or import of such Product in such Region, but there is 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 […***] …]; and (B) during any portion of the First Commercial Sale of Royalty Term for a Licensed Product in a countryRegion when (1) no Valid Claim of the Tocagen Patents or Joint Patents Covers the manufacture, Manufacturing Claims 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 no longer constitute Valid Claims be […***…]. On a Product-by-Product and Region-by-Region basis, upon expiration of the Royalty Term for a Product in a Region, Apollo’s License with respect to such Licensed Product in such countryRegion shall become non‑exclusive, royalty‑free, fully-paid, irrevocable and perpetual.
Appears in 1 contract
Samples: License Agreement (Tocagen Inc)
Royalty Term. The period during which the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) Royalties shall be payable, payable on a Licensed BioNTech Product-by-Licensed BioNTech Product basis and on a country-by-country basisbasis for the longer of: (i) the life of the Patents so long as at least one Valid Claim of such Patents Covers the BioNTech Product or until lawful generic competition (regardless of whether the form or dosage of the generic differs from the BioNTech Product) achieves, shall commence with in a certain calendar year, a market share ([***]) in such country, whichever is earlier; (ii) the First Commercial Sale of a Licensed period that Regulatory Data Exclusivity has not expired for such BioNTech Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH for the country at issue or until lawful generic THE SYMBOL “[***]”. A COMPLETE VERSION OF THIS EXHIBIT ” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN FILED SEPARATELY WITH EXCLUDED FROM 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 EXHIBIT BECAUSE IT IS BOTH (i) Voyager Patent RightsNOT MATERIAL, 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 AND (ii) SMA WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED competition (regardless of whether the form or dosage of the generic differs from BioNTech Product-Specific Patent Rights or HD Product-Specific Patent Rights Covering the Manufacture) achieves, usein a certain calendar year, offer for sale, sale or importation of such Licensed Product in the country of sale; a market share (b[***]) the expiration of Regulatory Exclusivity for such Licensed Product in such country, whichever is earlier; or and (ciii) the [***] of the years from First Commercial Sale of such Licensed Product in such country (each such period, a “Royalty Term”)the last Major Market Country. For purposes of the foregoing clause (a), following the All royalties will be payable in U.S. Dollars within [***] days of the First Commercial Sale end of a Licensed Calendar Quarter at issue. Upon the expiration of the above royalty term for a particular BioNTech Product in within a particular country, Manufacturing Claims the BioNTech Company at issue shall have no longer constitute Valid Claims further obligations to make any further royalty payments with respect to such Licensed BioNTech Product and country at issue. Moreover, in the event that the Royalty has not expired solely because of subsection (iii) above, then the royalties otherwise owed to Lilly under this Agreement shall be reduced [***] with respect to such BioNTech Product at issue. For purpose of this Section 7.3 of this Agreement, a Valid Claim “Cover(s)” the BioNTech Product only if the manufacture, use or sale of BioNTech Product by a Third Party (without a license to the relevant Patent related thereto) in the country at issue would infringe a Valid Claim. Furthermore, notwithstanding the foregoing, if a Valid Claim that claims an FDA or EMA (or equivalent regulatory authority) approved use/indication for the BioNTech Product in that country expires, is abandoned, or otherwise becomes invalid, then any other FDA or EMA (or equivalent regulatory authority) approved use/indication for such countryBioNTech Product in that country that has not expired that would otherwise be a Valid Claim will be deemed to not be a Valid Claim.
Appears in 1 contract
Royalty Term. Zogenix’s royalty obligations to Tevard under this Section 6.5 shall commence on a country-by-country and Licensed Product-by-Licensed Product basis on the date of the First Commercial Sale by Zogenix, its Affiliates, Licensees, or Sublicensees of the relevant Licensed Product in the relevant country and shall expire on a country-by-country basis and Licensed Product-by-Licensed Product basis on the latest of the following, as applicable: (a) the expiration of Patent-Based Exclusivity with respect to such Licensed Product in such country, (b) the expiration of Regulatory-Based Exclusivity with respect to such Licensed Product in such country, and (c) the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in such country by Zogenix, its Affiliates, Licensees, or Sublicensees, provided that there is Patent-Based Exclusivity for the Licensed Product in at least one country in the Territory at the time of such First Commercial Sale (the “Royalty Term”). The period during which foregoing provisions of this Section 6.5 notwithstanding, the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (payable with respect to Net Sales Milestones) of Licensed Products shall be payablereduced, on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 First Commercial Sale of such amounts otherwise payable pursuant to Section 6.5.1 (with respect to Licensed Product in such country (each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the Products [***] of ]. Notwithstanding anything to the First Commercial Sale contrary herein, in no event shall the aggregate royalty payment, as adjusted by this Section 6.5.3, due from Zogenix to Tevard with respect to the Development, Commercialization and Manufacture of a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims be less than the aggregate amount that Tevard is required to pay to the Inbound Licensors of the Tevard In-License with respect to such Licensed Product. If any amount that Zogenix is entitled to deduct from the royalty payments due to Tevard under Section 6.5.1 with respect to a Licensed Product in is not fully offset against such countryroyalty amounts as a result of the preceding sentence, such amount may be carried forward and applied to future periods until fully exhausted.
Appears in 1 contract
Samples: License Agreement (Zogenix, Inc.)
Royalty Term. The period during which the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) Royalties shall be payable, payable on a Licensed Product-by-Licensed Product basis and on a country-by-country basisbasis for the longer of: (i) the life of the Patents licensed from BioNTech Companies hereunder to Lilly so long as at least one Valid Claim of such Patents Covers the Product or until lawful generic competition (regardless of whether the form or dosage of the generic differs from Product) achieves, shall commence with in a certain calendar year, a market share [***] in such country, whichever is earlier; (ii) the period that Regulatory Data Exclusivity has not expired for such Product for the country at issue or until lawful generic competition (excluding generics and biosimilars marketed directly or indirectly by Lilly Companies and/or any of their Sublicensees) (regardless of whether the form or dosage of the generic differs from the Product) achieves, in a certain calendar year, a market share ([***]) in such country, whichever earlier; and (iii) [***] years from First Commercial Sale in the last Major Market Country (collectively, the “Royalty Term”). All royalties will be payable in U.S. Dollars within[***] days of the end of a Licensed Calendar Quarter at issue. Upon the expiration of the Royalty Term for a particular Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH within a particular country, Xxxxx shall have no further obligations to make any further royalty payments with respect to such Product and country at issue. Moreover, in the event that the Royalty has not expired solely because of subsection (iii) above, then the royalties otherwise owed to BCGT under this Agreement shall be reduced by [***] with respect to such Product at issue. THE SYMBOL “[***]”. A COMPLETE VERSION OF THIS EXHIBIT ” DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN FILED SEPARATELY WITH EXCLUDED FROM THE SECRETARY OF EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL, AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO 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 COMPANY IF PUBLICLY DISCLOSED For purpose of this Section 12.4.26.6 of this Agreement, the expiration of the last a Valid Claim “Cover(s)” the Product only if the manufacture, use or sale of Product by a Third Party (without a license to the (irelevant Patent related thereto) 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 at issue would infringe a Valid Claim. Furthermore, notwithstanding the foregoing, if a Valid Claim that claims an FDA or EMA (iior equivalent regulatory authority) SMA Product-Specific Patent Rights or HD Product-Specific Patent Rights Covering approved use/indication for the Manufacture, use, offer for sale, sale or importation of such Licensed Product in the that country of sale; expires, is abandoned, or otherwise becomes invalid, then any other FDA or EMA (bor equivalent regulatory authority) the expiration of Regulatory Exclusivity approved use/indication for such Licensed Product in such country; or (c) the [***] of the First Commercial Sale of such Licensed Product in such that country (each such period, that has not expired that would otherwise be a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale of Valid Claim will be deemed to not be a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product in such countryClaim.
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Royalty Term. The period during which the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall Royalties will be payable, paid by BMS on a Licensed Product-by-Licensed Royalty Bearing Product by Royalty Bearing Product and country-by-country basis, shall commence with the basis for each Royalty Bearing Product in each country for each year until ten (10) years after First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 such 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 Royalty Bearing Product-Specific Patent Rights or HD Product-Specific Patent Rights Covering the Manufacture; provided, usehowever, 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 that royalties shall continue in such country; or (c) the [***] of the First Commercial Sale of country for each Calendar Quarter that such Licensed Royalty Bearing Product sold in such country is a Patented Royalty Bearing Product in such country (each i.e., the actual commercial manufacture of such periodRoyalty Bearing Product in such country, the sale of such Royalty Bearing Product in such country, or the use for which such Royalty Bearing Product is sold in such country by BMS, its Affiliates or (sub)licensees is Covered by a Valid Claim of an AMRI Patent Right in such country and/or a Valid Claim of a BMS Licensed Patent Right in such country) or * (the “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale of and if in such case such Patented Royalty Bearing Product is a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Patented Royalty Bearing Product in such country., the royalty in such country shall not be reduced, and if in such case such Patented Royalty Bearing Product is not a Patented Royalty Bearing Product in such country but is * the royalty in such country shall be reduced by * percent, and further provided if there are no Valid Claims in the AMRI Patent Rights and/or the BMS Patent Rights in such country that are able, by filing of an infringement Action, to prevent a Third Party or Third Parties from marketing a product or products containing the same Licensed Compound as that contained in such Royalty Bearing Product (or any salt, solvate, crystalline or noncrystalline form of such Licensed Compound), whether filed under an NDA or ANDA (Abbreviated New Drug Application) or otherwise and such Third Party or Third Parties are not authorized by BMS, its Affiliates or its (sub)licensees to sell such product or products (each such product a “Generic Product”), royalties shall be reduced in such country in a Calendar Quarter by: (a) * percent (*%) if sales of such Generic Products in such country in such Calendar Quarter exceed * percent (*%) of the sum of all prescriptions for such form of such Royalty Bearing Product sold by BMS, its Affiliates and (sub)licensees and by the Third Party seller(s) of such Generic Product(s) (based on unit-equivalent data for all dosage strengths of such form) in such country during such Calendar Quarter, (b) by * percent (*%) if such sales of such Generic Product(s) in such country in such Calendar Quarter exceed * percent (*%) of the sum of all prescriptions for such form of such Royalty Bearing Product sold by BMS, its Affiliates and (sub)licensees and by the Third Party seller(s) of such Generic Product(s) (based on unit-equivalent data for all dosage strengths of such form) in such country during such Calendar Quarter, and (c) by * percent (*%) if sales of such Generic Product(s) in such country in such Calendar Quarter exceed * percent (*%) of the sum of all prescriptions for such form of such Royalty Bearing Product sold by BMS, its Affiliates and (sub)licensees and by the Third Party seller(s) of such Generic Product(s) (based on unit-equivalent data for all dosage strengths of such form) in such country in such Calendar Quarter. If the prescriptions are not reportable in a given country, then the Parties will use another mutually agreed upon method for such country. Such adjustments shall be retroactive to the beginning of the applicable Calendar Quarter
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Samples: License and Research Agreement (Albany Molecular Research Inc)
Royalty Term. The period during which the Licensee will pay to Licensor royalties set forth in under this Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payable, 8.4 on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with as follows (the “Royalty Term”): (i) in countries where Product is covered or claimed by any of the Licensor Patents or Joint Patents, from the time of the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 such country and continue until the latest of (a) subject to the last sentence of this Section 12.4.2, the expiration or final revocation of the last Valid Claim of claim within the (i) Voyager Patent Rights, Voyager Collaboration Patent Rights Licensor Patents or Joint Collaboration Patent Rights owned by Voyager (either solely Patents covering 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 claiming Product in the country of sale; (b) provided that, notwithstanding the expiration foregoing, the Royalty Term will expire and royalties will no longer be payable on Net Sales of Regulatory Exclusivity for such Licensed Product in such countrycountry beginning on (i) the date following the launch of a Generic Product in such country (or, with respect to the EEA, following the launch of a Generic Product in any one or more countries in the EEA), the Percentage Generic Market Penetration in such country (or, with respect to the EEA, in any one or more countries in the EEA) reaches during any Calendar Quarter an amount equal to or greater than ***** percent *****, or (ii) the date of entry of a second Generic Product in such country (or, with respect to the EEA, in any one or more countries in the EEA); or (cii) in countries where a Product is not covered or claimed by any of the [Licensor Patents or Joint Patents, but where the Product is Derived from the use of Technology, the royalty shall be payable, at a rate that is reduced by ***] ** percent ***** from the royalty rate payable under Section 8.4(a) or (b), as applicable, and as such royalties may have been further reduced as set forth herein, from the time of the First Commercial Sale of Product in such Licensed country until the date that is ***** after the date of First Commercial Sale of Product in such country; provided that, notwithstanding the foregoing, the Royalty Term will expire and royalties will no longer be payable on Net Sales of Product in such country beginning on (i) the date following the launch of a Generic Product in such country (each such periodor, a “Royalty Term”). For purposes of with respect to the foregoing clause (a)EEA, following the [launch of a Generic Product in any one or more countries in the EEA), the Percentage Generic Market Penetration in such country (or, with respect to the EEA, in any one or more countries in the EEA) reaches during any Calendar Quarter an amount equal to or greater than ***] ** percent *****, or (ii) the date of the First Commercial Sale entry of a Licensed second Generic Product in a countrysuch country (or, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product the EEA, in such any one or more countries in the EEA). (iii) Upon the expiry of the Royalty Term in a given country., the license granted to Licensee pursuant to Section 4.1(a) will become a fully paid-up and royalty free license for that country. (f)
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Royalty Term. The period during which In consideration of the royalties set forth in Section 12.4.1 (Royalty Rates) licenses granted hereunder with respect to the BMS Patent Rights, the BMS Platform Patent Rights and the sales milestones set forth in Section 12.3.2 (Sales Milestones) BMS Know-How, royalties shall be payable, payable on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with basis on Net Sales of Licensed Products from the First Commercial Sale of a particular Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 during the period between the first commercial sale of such Licensed Product in such country until the latest later of (ai) subject to twelve (12) years from the last sentence of this Section 12.4.2First Commercial Sale in such country, or (ii) the expiration of the last Valid Claim to expire BMS Patent Right or BMS Platform Patent Right (with respect to a BMS Platform Patent Right, solely to the extent claiming the composition of matter or use of [***] of the Licensed Compounds specifically), (iincluding any extension therefor under applicable laws, such as patent term extensions, pediatric exclusivity or supplemental protection or their equivalent in any country) Voyager Patent Rightswith a claim covering the applicable Licensed Compound or Licensed Product, 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, their respective use, offer for saleimportation or manufacture with respect to such country, 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; (biii) the expiration of Regulatory any Regulatory/Marketing Exclusivity for such Licensed Product in such country; country (the “Royalty Term”). The above royalty rates will be reduced during the Royalty Term for a given country where no BMS Patent Right or BMS Platform Patent Right (c) with respect to a BMS Platform Patent Right, solely to the extent claiming the composition of matter or use of [***] of the First Commercial Sale of such Licensed Product Compounds specifically) claims the Licensed Compound or Licensed Product, their respective use, importation or manufacture in that country. The royalty rate for such country (each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the in that event will be [***] of the First Commercial Sale weighted average royalty rate for all other countries in which the manufacture, use, sale or importation of the Licensed Compound or Licensed Product would otherwise infringe a BMS Patent Right but for the license rights granted hereunder; provided however that the royalty rate paid on Net Sales of a Licensed Product that is subject to clause (iii) shall be at the same rate as the normal (unadjusted) royalty rate described in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product in such countrythe table above.
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Royalty Term. The period during which “Royalty Term” means the royalties set forth time from the first post-Marketing Authorization sale of the first Licensed Product in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payablea 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 and 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 commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “be reduced to […***]”. 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 …] percent (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 First Commercial Sale of such Licensed Product in such country (each such periodotherwise applicable rates, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale with respect to Net Sales of a Licensed Product in a countrycountry during any portion of the Royalty Term when there is not a Valid Claim of Licensed Patents that would be infringed, Manufacturing Claims shall no longer constitute but for the license of this Agreement or joint ownership of the particular Valid Claims with respect to such 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 countrythe 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.
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Royalty Term. The Subject to Section 8.3.5, the period during which the royalties set forth in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) 8.3.1 shall be payable, on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a the Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 such 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 Alnylam Patents or any Patent Rights, Voyager Collaboration Patent Rights or Right included in the Joint Collaboration Patent Rights owned by Voyager (either solely or jointly with Genzyme) or exclusively licensed to Voyager IP 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) subject to Section 8.3.3, the [***] twenty-fifth (25th) anniversary of the First Commercial Sale of such the Licensed Product in such country (each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] twelfth (12) anniversary of the First Commercial Sale of a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product in such country. Notwithstanding the foregoing, at any time during the Royalty Term for a Licensed Product in a country following the latest of (a) the expiration of the last Valid Claim of the Alnylam Patents or any Patent Right included in the Joint Collaboration IP Covering the Manufacture, use, offer for sale, sale or importation of such Licensed Product in such country, (b) the expiration of Regulatory Exclusivity for such Licensed Product in such country, or (c) the twelfth (12th) anniversary of the First Commercial Sale of such Licensed Product in such country, Genzyme may terminate the Royalty Term with respect to such Licensed Product in such country (and its obligation to pay royalties under this Section 8.3 with respect to such Licensed Product in such country) by providing written notice to Alnylam, which termination will be effective commencing in the next full Calendar Quarter commencing at least thirty (30) days following the date of such notice.
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Samples: License and Collaboration Agreement (Alnylam Pharmaceuticals, Inc.)
Royalty Term. The period during which the royalties set forth in Royalties payable under this Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) 9.3 shall be payablepaid by Incyte on a Licensed Product-by-Licensed Product and country-by-country basis from the Effective Date until the later of: (i) the last to expire of any Valid Claim Covering such Licensed Product in such country, (ii) the expiration of Regulatory Exclusivity for such Licensed Product in such country and (iii) [ * ] following First Commercial Sale of such Licensed Product in such country (each such term with respect to a Licensed Product and a country, a “Royalty Term”). Notwithstanding the foregoing, on a Licensed Product-by-Licensed Product and country-by-country basisbasis in [ * ], shall commence in the event that Generic Competition exists with the First Commercial Sale of respect to a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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 [ * ], then the royalty rates in such 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 will be reduced by [ * ] of the applicable rate in Section 9.3(a) during each Calendar Quarter in which such Generic Competition exists in such country; or (c) . If the [***foregoing royalty reductions do not apply in a particular country of the Territory, in the event that no Valid Claim Covering a Licensed Product exists in such country, then the royalty rates in such country will be reduced by [ * ] of the First Commercial Sale applicable rate in Section 9.3(a) during each Calendar Quarter in which no such Valid Claim Covering a Licensed Product exists in such country. Notwithstanding anything herein to the contrary, if the royalty rates under this Agreement have been reduced at a time when a claim of a pending patent application issues pursuant to the last proviso of Section 1.96, the issuance of such claim shall not cause or be the basis for an increase in the then-current applicable royalty rate. For clarity, any payments due under this Section 9.3 shall be subject to reduction in accordance with Section 8.4(c); provided that in no event will the royalties for any Licensed Product and country in such country (each such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***any Calendar Quarter be reduced [ * ] of the First Commercial Sale amounts otherwise due without such reduction except in the case of a Licensed Product Generic Competition as set forth above (in a country, Manufacturing Claims which case the royalties payable under this Section 9.3 for any Calendar Quarter shall no longer constitute Valid Claims with respect to such Licensed Product in such countrynot be reduced [ * ].
Appears in 1 contract
Samples: Collaboration and License Agreement (Calithera Biosciences, Inc.)
Royalty Term. The period during which the (i) Buck’s right to receive royalties set forth in under Section 12.4.1 (Royalty Rates3.5(c) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) above shall be payable, expire on a Licensed Productproduct-by-Licensed Product product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. 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, basis upon the expiration of the last to expire Valid Claim of in the (i) Voyager Patent Rights, Voyager Collaboration Patent Rights or Joint Collaboration the Mayo Patent Rights owned by Voyager (either solely covering the composition of matter of such Patent Product in such country. Thereafter, if there is also at least one Valid Claim within the Patent Rights or jointly with Genzyme) the Mayo Patent Rights covering the method of making or exclusively licensed to Voyager Covering method of using the ManufactureLicensed Product in such country and such Valid Claim is still in effect on the date on which the last-to-expire composition of matter claim expires in such country, use, offer for sale, sale or importation of Sponsor will pay royalties on such Licensed Product at the royalty rate applicable for Patent Products under Section 3.5(b) above until the date of expiration of the last-to-expire Valid Claim in the country of sale or (ii) SMA Product-Specific Patent Rights or HD Product-Specific the Mayo Patent Rights Covering covering the Manufacture, use, offer for sale, sale method of making or importation method of such Licensed Product in the country of sale; (b) the expiration of Regulatory Exclusivity for using such Licensed Product in such country; . If the last-to-expire Valid Claim in the Patent Rights or the Mayo Patent Rights covering the method of making or method of using such Licensed Product in such country expires prior to the earlier of (cA) the [***] 13th anniversary of the First Commercial Sale of the first Royalty Product anywhere in the world or (B) January 1, 2037, then to the extent that such Licensed Product in such country (each such periodsatisfies the definition of a Know-How Product, a “Royalty Term”). For purposes Sponsor will, as of the foregoing clause date on which such claim expires, continue to pay royalties on such Licensed Product at the royalty rate under Section 3.5(a) until the earlier of (a), following A) the [***] 13th anniversary of the First Commercial Sale of a the first Royalty Product anywhere in the world or (B) January 1, 2037. If there is no unexpired Valid Claim within the Patent Rights or the Mayo Patent Rights covering the method of making or method of using the Licensed Product as of the date of the last-to-expire composition of matter claim expires in a such country, Manufacturing Claims shall no longer constitute Valid Claims with respect then to the extent that such Licensed Product satisfies the definition of a Know-How Product, Sponsor will to pay royalties on such Licensed Product at the royalty rate under Section 3.5(a) until the earlier of (1) the 13th anniversary of the First Commercial Sale of the first Royalty Product anywhere in such countrythe world or (2) January 1, 2037.
Appears in 1 contract
Samples: Stock Purchase Agreement (Unity Biotechnology, Inc.)
Royalty Term. The 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 during which 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)” by application of the foregoing clause “(iv)” then the royalties set forth otherwise payable for the relevant Product and relevant country under Section 3.4 for such period shall be payable at the rates indicated in Section 12.4.1 (Royalty Rates) and the sales milestones set forth in Section 12.3.2 (Sales Milestones) shall be payable, on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of a Licensed Product 104 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “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. 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 1933For avoidance of doubt, AS AMENDEDthe Royalty Term shall be determined on a country by country basis. For purposes of this Section, “Publication” means to be made publicly known by means other than by Recordati, its Affiliates or Sublicensees in breach of this Agreement. Notwithstanding the above, and 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 [***] 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 and continue until the latest of for a six (a6) 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 month period exceed [***] of the First Commercial Sale total sales (measured in number of such Licensed units) of the Product in such country (each for such period, a “Royalty Term”). For purposes of the foregoing clause (a), following the [***] of the First Commercial Sale of a Licensed Product in a country, Manufacturing Claims shall no longer constitute Valid Claims with respect to such Licensed Product in such country.
Appears in 1 contract