Reductions. (a) If during the Royalty Term, on a country-by-country and Product by Product basis, such Product ceases to be Covered by a Valid Claim in the country of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-How, the applicable royalty rate will thereafter be reduced to [***] of the applicable royalty rate set forth in Section 8.5. (b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then the royalty rate for such Product in such country will thereafter be reduced to [***] of the applicable royalty rate set forth in Section 8.5 for so long as such reduction in units sold persists. (c) If during the Royalty Term, Mereo pays Third Party Payments with respect to a Product, Mereo may credit [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the Net Sales of that particular Product in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully credited.
Appears in 4 contracts
Samples: Exclusive License and Option Agreement, Exclusive License and Option Agreement (Mereo Biopharma Group PLC), Exclusive License and Option Agreement (Mereo Biopharma Group PLC)
Reductions. In the event that:
(a) If in any country in the Territory during any portion of the Royalty Term, on a country-by-Licensed Product sold in a country and Product by Product basis, such Product ceases to be Covered in the Territory is not claimed by a Valid Claim of the Licensed Patents covering such Licensed Product in such country when the Regulatory Exclusivity Period (if any) for such Licensed Product in such country is in effect, the royalty rates set forth in Section 4.5.1 shall be reduced by [***] percent [***] for such Licensed Product in such country. *** CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(b) in any country in the Territory during any portion of the Royalty Term, a Licensed Product sold in a country in the Territory is not claimed by a Valid Claim of manufacturethe Licensed Patents covering such Licensed Product in such country when no Regulatory Exclusivity Period for such Licensed Product in such country is in effect and, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-Howsolely in the case of an Emerging Market Country, the applicable Generic Competition Threshold for such Licensed Product in such Emerging Market Country has been met, the royalty rate will thereafter rates set forth in Section 4.5.1 shall be reduced by [***] percent [***] for such Licensed Product in such country.
(c) Licensee enters into an agreement with a Third Party other than [***] or its Affiliates (or its or their successors) in order to obtain a license to a Patent of a Third Party (other than any Patents Controlled by [***] or any of its Affiliates or its or their successors in interest with respect to any Patents) that is necessary for the Manufacture, use or sale of a Licensed Product in the Field in a country in the Territory (a “Third Party Patent Right”), Licensee shall be entitled to deduct from royalties payable hereunder in a given Calendar Quarter with respect to such Licensed Product in such country [***] percent [***] of royalties actually paid to such Third Party with respect to such Calendar Quarter under such agreement, solely to the extent that such royalties are (i) triggered by sales of such Licensed Product that would, absent such agreement, infringe such a Third Party Patent Right that is licensed in such country in such Calendar Quarter under such agreement and (ii) otherwise exclusively attributable to such Third Party Patent Right; provided that in no event shall the total deduction under this Section 4.5.3(c) reduce the royalties payable to MedImmune under Section 4.5.1 (as reduced in accordance with Section 4.5.3(a) or Section 4.5.3(b) if applicable) with respect to a given Licensed Product in a given country in any Calendar Quarter by more than [***] percent [***]. Licensee, upon request by MedImmune, shall provide reasonable evidence, including a copy of any applicable agreement, of such royalties actually paid to such Third Party with respect to such Third Party Patent Right. For clarity, Licensee shall be solely responsible for, and the foregoing reduction shall not apply to, any royalty or other amount owed to [***] of the applicable royalty rate set forth in Section 8.5.
(b) If during the Royalty Term, on a country-by-country pursuant to any agreement between Licensee and Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then the royalty rate for such Product in such country will thereafter be reduced to [***] of the applicable royalty rate set forth in Section 8.5 for so long as such reduction in units sold persists.
(c) If during the Royalty Term, Mereo pays Third Party Payments with respect to a the Development or Commercialization of any Licensed Product, Mereo may credit [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the Net Sales of that particular Product in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully credited.
Appears in 2 contracts
Samples: License Agreement (PhaseBio Pharmaceuticals Inc), License Agreement (PhaseBio Pharmaceuticals Inc)
Reductions. Notwithstanding the foregoing, in the event that:
(i) in any country in the Territory during the Royalty Term for a Licensed Product, one or more Generic Products of a Licensed Product is launched in such country, and Net Sales of such Licensed Product in such country decline by the percentages described below relative to the average Net Sales of such Licensed Product in such country for the [**] immediately preceding the Calendar Quarter in which the Generic Product is launched in such country (the “Pre-Generic Launch Net Sales”), the royalty rates provided in Section 7.3.1 shall be reduced in such country by the applicable percentage described below for each Calendar Quarter ending after the Generic Product was launched in which such Net Sales remain below the applicable percentage of the Pre-Generic Launch Net Sales. For clarity, the foregoing sentence shall not preclude the applicability of this Section 7.3.3(i) to future Calendar Quarters if such Generic Product or any other Generic Product is re-launched or launched, as applicable, in such country and Net Sales again fall below the applicable percentage of the Pre-Generic Launch Net Sales. For a decline of:
(a) greater than or equal to [**], but less than [**], of Net Sales of the applicable Licensed Product in such country, a royalty rate reduction of [**]; or
(b) greater than or equal to [**] of Net Sales of the applicable Licensed Product in such country, a royalty rate reduction of [**].
(ii) If Sanofi enters into an agreement with a Third Party in order to obtain a license or other right under a Third Party Patent that is reasonably necessary to avoid infringement of such Third Party Patent by the use, offer for sale, sale or importation of a Licensed Product (or the Licensed Compound contained therein) in a country pursuant to Section 8.8, Sanofi shall be entitled to deduct from any [**] royalties (under this Section 7.3) payable hereunder with respect to such Licensed Product in such country [**] of all upfront payments, milestone payments, royalties, and other amounts paid to such Third Party in respect of such agreement, in each case, to the extent reasonably allocable to such Third Party Right (“Third Party Payments”); provided that, Sanofi may not include in Third Party Payments any amounts paid to Third Party suppliers or contract manufacturers of Licensed Products, Licensed Compounds or raw materials therefor.
(iii) If a court or a governmental agency of competent jurisdiction requires Sanofi or any of its Affiliates or its or their Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country in the Territory, the royalties otherwise due to Lexicon pursuant to this Section 7.3 for Net Sales by compulsory licensees shall, in lieu of the royalties that would otherwise apply, be the lesser of [**] of the amount received by Sanofi from such licensee and the applicable royalties that would otherwise be payable hereunder, and the Licensed Products sold by such Third Party in such country shall be deemed to be Generic Products for purposes of Section 7.3.3(i).
(iv) As to royalties payable on Net Sales in [**], during any period within the applicable Royalty TermTerm when there is no Lexicon Patent or Joint Patent in such country that contains a Valid Claim that Covers the applicable Licensed Product or its Manufacture, use, offer for sale, sale or importation in such country and the Regulatory Exclusivity Period has expired with respect to the applicable Licensed Product in such country, the otherwise applicable royalty rate percentage with respect to such Licensed Product in such country shall be reduced by [**].
(v) On a country-by-country basis with respect to each country in [**] during each period in which there is a [**], Sanofi shall be entitled to deduct from the royalty rate payable on Net Sales in such country [**] of the [**]; provided that such deduction shall not exceed [**]. The [**] is, with respect to a given period and country outside [**], the percentage equal to (x) [**], divided by (y) [**] in such country for such period. The [**] is, with respect to a given period, the percentage equal to [**]. For example, if the [**] for a given period and country equals [**] and the royalty rate for a given country would without application of this clause (v) equal [**], the royalty rate for such country would equal [**]. For clarity, [**] are not required to be calculated on a country-by-country and Product by Product basis, such Product ceases to but may be Covered by calculated using a Valid Claim standard cost basis across multiple countries in the country of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-How, the applicable royalty rate will thereafter be reduced to [***] of the applicable royalty rate accordance with Sanofi’s general internal practices. Any reductions set forth in this Section 8.5.
(b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then 7.3.3 shall be applied to the royalty rate for such Product payable to Lexicon in such country will thereafter be reduced to [***] of the applicable royalty rate set forth following order: clause (i) (in Section 8.5 for so long as such reduction in units sold persists.
(c) If during the Royalty Term, Mereo pays Third Party Payments with respect to a Product, Mereo may credit [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the Net Sales of that particular Product in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo which case no further reductions shall be entitled to carry forward any amount applied under the subsequent clauses of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one 7.3.3), clause (1ii), clause (iii), clause (iv) Calendar Year to the following Calendar Year until such amount is fully creditedand clause (v).
Appears in 2 contracts
Samples: Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.), Collaboration and License Agreement (Lexicon Pharmaceuticals, Inc.)
Reductions. (a) If during In the Royalty Termevent that it is necessary for Mallinckrodt, on in order to Exploit a country-by-country and Product by Product basisLicensed Product, such Product ceases to be Covered obtain a license under any Patents owned by a Valid Claim in Third Party that has claims that Cover [***] such Licensed Product or the country of manufactureLicensed Product, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-How, the applicable royalty rate will thereafter Mallinckrodt shall be reduced entitled to deduct [***] of the applicable royalty rate set forth in Section 8.5.
(b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more Generic Versions amount of the Product are marketed and sold in such country in a given [***] during accrued and payable by Mallinckrodt to such Third Party from the Royalty Termroyalties paid to Silence in any given Quarter (determined in accordance with the Accounting Standards) pursuant to Section 8.6, and such provided always that Generic Versions nothing in this Section 8.6.3 shall operate to reduce the amount of the Product sold in such country equal or exceed in the aggregate royalties otherwise payable to Silence to less than [***] of the total units sold royalties provided for in Section 8.6.1.
(b) On a Licensed Product-by-Licensed Product basis, if the Royalty Term does not end on the date upon which there is no Valid Claim [***] that Covers such Licensed Product in the country of sale or the country of manufacture, then with respect to sales of such Licensed Product occurring from and after such date in such country, the royalty rate used to calculate royalties due on Net Sales of such Licensed Product in such country for the remainder of the Royalty Term for such Licensed Product in such country (subject to further reduction in accordance with Section 8.6.3(c) below, but subject to Section 8.6.4 below), shall be reduced by [***] from the applicable royalty rate (i.e., [***] as applicable).
(c) If, during the Royalty Term with respect to a Licensed Product and a particular country, one or more Generic Version(sProducts of such Licensed Product are sold in such country, then (i) during each Quarter in which there is an Initial Loss of Market Share with respect to such Licensed Product in such country, then the royalty rates used to calculate royalties due on Net Sales of such Licensed Product in such country for such Quarter shall be reduced by [***] from the applicable royalty rate (i.e., [***], as applicable) and (ii) during each Quarter in which there is a Loss of Market Share with respect to such Licensed Product in such country, then the royalty rates used to calculate royalties due on Net Sales of such Licensed Product in such country for such Quarter shall be reduced by [***] from the applicable royalty rate (i.e., [***], as applicable) it being understood that the deduction under part (ii) of this Section 8.6.3(c) is in substitution for, not in addition to, part (i) of this Section 8.6.3(c).
(d) If in a country, the Net Sales of a Licensed Product in that country in a Year are less than [***] of the Net Sales of the Licensed Product in that country in the immediately preceding Year and such decline is demonstrated to be due to a Competing Product of such Licensed Product being sold in such country, then the royalty rate for used to calculate the royalties due on Net Sales of such Licensed Product in such country will thereafter shall be reduced to by [***] of from the applicable royalty rate set forth for such Year (such Net Sales in Section 8.5 such Year the “Baseline Calendar Year Net Sales”) and for so long as such reduction in units sold persists.
(c) If each Year during the remainder of the Percentage Royalty Term, Mereo pays Third Party Payments with Term in which: (i) such Competing Product continues to be sold in such country and (ii) Net Sales of such Licensed Product in such country remain at or below the Baseline Calendar Year Net Sales (the “Competing Product Reduction”). With respect to a Productthe Year in which the Competing Product Reduction first occurs, Mereo may credit then within [***] days after the end of such Third Party Payments paid against Year, Mallinckrodt shall report to Licensor the difference between the royalties otherwise due to AstraZeneca on the actually paid in respect of Net Sales of that particular Product in that [***]; provided, however that such Year and the royalties that should have been paid in such Year taking into consideration the Competing Product Reduction and Licensor shall remit such difference to AstraZeneca on such Net Sales Mallinckrodt promptly after application its receipt of such credit shall not be less than [***] report. For the avoidance of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basisdoubt, provided that Mereo the Competing Product Reduction, if any, shall be entitled in addition to carry forward any amount of Third Party Payments which it is not entitled reduction in the royalty rate pursuant to credit from the royalties due Section 8.6.3(b) or 8.6.3(c) above, but subject to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully credited8.6.4 below.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Silence Therapeutics PLC), License and Collaboration Agreement (Silence Therapeutics PLC)
Reductions. (a) If during Inspire, in its good faith judgment, determines that it is commercially necessary to obtain license rights in any country in the Royalty Term, on Inspire Territory from a country-by-Third Party (a “Third Party License”) under Patent Rights owned or controlled by such Third Party that claim or cover the Compound or its manufacture or use in such country and Product by Product basisare required to develop, such Product ceases to be Covered by a Valid Claim in the country of manufacturemake, have made, use, salecommercialize, offer for sale or sale, sell, and import but does containa particular Inspire Licensed Product in the Field (“Third Party Patent Rights”), incorporate or use any then if Inspire enters into such Third Party License, Inspire may:
(i) reduce the Inspire Royalties owed to Faes based on sales, in such country where such Third Party License grants Inspire license rights under the applicable Third Party Patent Rights, of an Inspire Licensed Product Know-How, covered by such Third Party License by an amount equal to [C.I.] of the amounts of royalties Inspire pays to such Third Party based on such sales of such Inspire Licensed Product under such Third Party License during the applicable royalty rate will thereafter be reduced period, but provided however that such reduction shall not reduce such Inspire Royalties owed to Faes based on such sales of the Inspire Licensed Product in such country (in the applicable royalty period) by more than [***C.I.] of the applicable royalty rate set forth in amounts otherwise owed by Inspire as a result of application of this Section 8.55.10(a)(i).
(b) If The Inspire Royalties payable by Inspire with respect to any particular Inspire Licensed Product in any particular country in the Inspire Territory pursuant to this Article 5 during a particular royalty period may be reduced by the Royalty Term, on a following percentages effective during and after the calendar quarter when Generic Competition occurs at the following sales levels with respect to such Inspire Licensed Product in such country-by-country and Product by Product basis, one (1) or more Generic Versions : Where the sales of the Product Generic Equivalent, as to such Inspire Licensed Product, during a calendar quarter are marketed and sold in equal to or greater than either (w) [C.I.] of total sales of such country in a given [***] during the Royalty Term, and such that Generic Versions of the Inspire Licensed Product sold in such country equal country, expressed in units, or exceed in the aggregate (x) [***C.I.] of the total units sold sales of such Inspire Licensed Product or Generic Version(s) in such country, expressed in local currency, then the royalty rate for Inspire Royalties with respect to such particular Inspire Licensed Product shall be reduced, subject to the last sentence of this subsection (b), by [C.I.] of the amounts otherwise owed in such country. Where the sales of a Generic Equivalent, as to such Inspire Licensed Product, during a calendar quarter are equal to or greater than either (y) [C.I.] of total sales of such Inspire Licensed Product sold in such country, expressed in units, or (z) [C.I.] of the total sales of such Inspire Licensed Product in such country, expressed in local currency, then the Inspire Royalties with respect to such particular Inspire Licensed Product shall be reduced, subject to the last sentence of this subsection (b), by [C.I.] in such country will thereafter (or such lesser percentage as applicable to comply with the last sentence of this subsection 5.10(b)). If such Generic Competition no longer continues at the specific sales levels required under subsection (w) or (x) above (as applicable), then, beginning with the first calendar quarter after such Generic Competition does not exist at such sales levels, the reduction of Inspire Royalties under the above subsection 5.10(b)(w) or (x) (as applicable) with respect to such particular Inspire Licensed Product shall no longer apply, and any reduction of Inspire Royalties (if any) under the above terms shall be limited to the reduction applicable under the above terms to such lower sales levels, if any, in such country until such time as Generic Competition may again exist at such sales levels with respect to such Inspire Licensed Product in such country. Notwithstanding the foregoing, in no event shall the Inspire Royalties payable by Inspire to Faes hereunder with regards to a particular Inspire Licensed Product be reduced to an amount that is below [***C.I.] of applicable Net Sales in the applicable royalty rate set forth in country as a result of application of this Section 8.5 for so long as such reduction in units sold persists5.10(b).
(c) If during the Royalty Term, Mereo pays Third Party Payments The Faes Royalties payable by Faes with respect to any particular Faes Licensed Ophthalmic Product in any particular country in the Faes Ophthalmic Territory pursuant to this Article 5 during a particular royalty period may be reduced by the following percentages effective during and after the calendar quarter when Generic Competition occurs at the following sales levels with respect to such Faes Licensed Ophthalmic Product in such country: Where the sales of the Generic Equivalent, as to such Faes Licensed Ophthalmic Product, Mereo may credit during a calendar quarter are equal to or greater than either (w) [***C.I.] of total sales of such Third Party Payments paid against Faes Licensed Ophthalmic Product sold in such country, expressed in units, or (x) [C.I.] of the royalties total sales of such Faes Licensed Ophthalmic Product in such country, expressed in local currency, then the Faes Royalties with respect to such particular Faes Licensed Ophthalmic Product shall be reduced, subject to the last sentence of this subsection (c), by [C.I.] of the amounts otherwise owed in such country. Where the sales of a Generic Equivalent, as to such Faes Licensed Ophthalmic Product, during a calendar quarter are equal to or greater than either (y) [C.I.] of total sales of such Faes Licensed Ophthalmic Product sold in such country, expressed in units, or (z) [C.I.] of the total sales of such Faes Licensed Ophthalmic Product in such country, expressed in local currency, then the Faes Royalties with respect to such particular Faes Licensed Ophthalmic Product shall be reduced, subject to the last sentence of this subsection (c), by [C.I.] in such country (or such lesser percentage as applicable to comply with the last sentence of this subsection 5.10(c)). If such Generic Competition no longer continues at the specific sales levels required under subsection (w) or (x) above (as applicable), then, beginning with the first calendar quarter after such Generic Competition does not exist at such sales levels, the reduction of Faes Royalties under the above subsection 5.10(c)(w) or (x) (as applicable) with respect to such particular Inspire Licensed Product shall no longer apply, and any reduction of Inspire Royalties (if any) under the above terms shall be limited to the reduction applicable under the above terms to such lower sales levels, if any, in such country until such time as Generic Competition may again exist at such sales levels with respect to such Inspire Licensed Product in such country. Notwithstanding the foregoing, in no event shall the Faes Royalties payable by Faes to Inspire hereunder with regards to a particular Faes Licensed Ophthalmic Product be reduced to an amount that is below [C.I.] of applicable Net Sales in the applicable country as a result of application of this Section 5.10(c).
(d) The Parties anticipate that Inspire, its Affiliates or its sublicensees may sell a Combination Licensed Product during the Inspire Royalty Term. In such event, the Parties shall determine Net Sales for the purpose of calculating royalty payments due on such Combination Licensed Product in a manner to AstraZeneca be mutually agreed in good faith by the Parties based on the Net Sales relative value contributed by each active ingredient of such Combination Licensed Product, such agreement not to be unreasonably withheld.
(e) If Inspire reasonably and in good faith believes that particular a lower royalty rate or minimum royalty amount is required in order to permit Inspire to commercialize the Inspire Licensed Products in a country in the Inspire Territory with a reasonable profit, Inspire may notify Faes of such belief and the basis therefor and, if such notification is made, the Parties shall meet as promptly as practicable to discuss in good faith whether a reduction to the royalty rate or minimum royalty amount for such Inspire Licensed Product in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basiscountry is appropriate, provided that Mereo nothing shall be entitled require Faes to carry forward any amount of Third Party Payments which it is not entitled agree to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully crediteda reduction.
Appears in 1 contract
Reductions. (a1) If, at any time during the Royalty Term for a Royalty-Bearing Product, Generic Competition exists in a given country with respect to a Reference Product, then Buyer may reduce the royalties due hereunder for such Reference Product [***] by [***] for so long as such Generic Competition exists.
(2) If during the Royalty TermTerm for a given Royalty-Bearing Product in a particular country, on a country-by-country and Product by Product basis, such Product ceases to be Covered by a there is no Valid Claim in within the country of manufactureCompany Intellectual Property within such country, usethen, sale, offer for sale or import but does contain, incorporate or use any Product Know-Howas from the date this Section 1.6(f)(iv)(2) applies, the applicable royalty rate will thereafter for Net Sales of such Royalty-Bearing Product otherwise due pursuant to Section 1.6(b)(vi), Section 1.6(c)(viii) and Section 1.6(c)(ix) (as applicable), or Section 1.6(d)(v) shall be reduced by [***].
(3) If after the Effective Date, Company, Buyer or a Selling Party determines that it is in the best interest of one or more Selling Parties to obtain one or more licenses to Third Party patent rights or other intellectual property so as to prevent a claim by a Third Party that the Development, Commercialization or Manufacturing of a Royalty-Bearing Product infringes the intellectual property of a Third Party and a Selling Party obtains any such license, Buyer and its Affiliates may deduct from any royalty payment made hereunder up to an amount equal to [***] of the applicable royalty rate set forth in Section 8.5.
(b) If during royalties paid to such 39881135.1 ACTIVE/118012393.3 Third Party licensors for the Royalty Termuse, on a country-by-country and Product by Product basismanufacture, one (1) import, export or more Generic Versions of the Product are marketed and sold in such country in a given [***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [***] of the total units sold sale of such Product or Generic Version(s) in such country, then the royalty rate for such Royalty-Bearing Product in such country will thereafter be reduced up to an amount equal to [***] of the applicable royalty rate set forth in Section 8.5 royalties owed for so long as such reduction in units sold persists.
(c) If during the Royalty Term, Mereo pays Third Party Payments with respect to a Product, Mereo may credit any fiscal [***] of such hereunder. No Third Party Payments paid against payments that exceeded the royalties otherwise due to AstraZeneca on the Net Sales of that particular Product amount eligible for a deduction in that any fiscal [***]; provided] may be carried over into any succeeding period.
(4) Notwithstanding anything in this Agreement to the contrary, however that under no circumstances shall the reductions set forth in this Section 1.6(f)(iv) cause the total royalties paid due in any financial [***] to AstraZeneca on such Net Sales after application of such credit shall not be less reduced by more than [***] of those the amount that would otherwise be due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled giving effect to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully credited1.6(f)(iv).
Appears in 1 contract
Samples: Unit Purchase Agreement (Ultragenyx Pharmaceutical Inc.)
Reductions. (a) If In the event that in any country in the Territory during the Royalty TermTerm for a Licensed Product, on a country-by-country and Product by Product basis, such Product ceases to be Covered by a Valid Claim in the country unit sales of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-How, the applicable royalty rate will thereafter be reduced to [***] of the applicable royalty rate set forth in Section 8.5.
(b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more all Generic Versions of the Product are marketed and sold Products in such country in a given [Calendar Quarter is:
(i) equal to or greater than *** percent (***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [%) but less than *** percent (***] %) of the total units sold sum of unit sales of such Licensed Product or and all such Generic Version(s) Products in such country, then then, commencing upon that particular Calendar Quarter and for the remainder of the Royalty Term for such Licensed Product in such country thereafter, the royalty rate for such indication(s) set forth in Clause 5.4 (Royalties) with respect to such country, each shall be reduced by *** percent (***%); or
(ii) equal to or greater than *** percent (***%) of the sum of unit sales of such Licensed Product and all such Generic Products in such country, then, commencing upon that particular Calendar Quarter and for the remainder of the Royalty Term for such Licensed Product in such country will thereafter thereafter, the royalty rate for such indication(s) set forth in Clause 5.4(a) (Royalty Rate) with respect to such country, each shall be reduced to [by *** percent (***] %). Unit sales shall be measured by IMS Health Data (or, in the absence of such data, an appropriate end user-level database). Notwithstanding the foregoing, Licensee’s obligation to pay royalties at the full royalty rates shall be reinstated on the first day of the applicable Calendar Quarter immediately following the Calendar Quarter in which sales of such Generic Products account for *** percent (***%) or less of the aggregate unit sales of Licensed Products and Generic Products in such country. If Licensee or its Affiliates are required, or determines in good faith that it is reasonably necessary, to obtain a license to any Patents of such Third Parties to Manufacture or Commercialize the Licensed Compound portion of any Licensed Product and makes any royalty payments to such third parties under any such in-license agreement, Licensee may deduct *** percent (***%) of such royalty payments from royalties thereafter payable to ArQule. Notwithstanding anything to the contrary in this Section 5.4, if any Licensed Product is sold by Licensee or any of its Affiliates or Sublicensees in a country and is not covered by a Valid Claim of the ArQule Patents in such country, the royalty rate in such country shall be reduced by *** percent (***%) of the rate set forth in Section 8.5 for so long as such reduction in units sold persists.
Clause 5.4(a) (c) If during Royalty Rate), continuing until the last day of the applicable Royalty Term, Mereo pays Third Party Payments Term with respect to such Licensed Product. Notwithstanding anything to the contrary in this Clause 5.4 (Royalties), in no event shall any royalty payment payable to ArQule for any Licensed Product in a Product, Mereo may credit [given calendar quarter be reduced as a result of the payment reductions set forth in this Clause 5.4 (Royalties) to less than *** percent (***] %) of such Third Party Payments paid against the royalties amount otherwise due payable to AstraZeneca on the Net Sales of that particular Product in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully creditedArQule.
Appears in 1 contract
Samples: License Agreement (Arqule Inc)
Reductions. (a) If during the Royalty Term[***] Third Party Patent Rights, on a countryKnow-by-How or other technology rights in any country and Product by Product basis, such Product ceases to be Covered by a Valid Claim in the country of manufactureTerritory are necessary for the development of, usehaving developed, salemaking of, offer having made, using of, having used, marketing of, having marketed, commercializing of, having commercialized, offering for sale of, sale of, having sold, importing of or import but does containhaving imported a particular Inspire Licensed Product in the Field and if Inspire then enters into a written license agreement with any such Third Party, incorporate or use any Inspire may:
(i) reduce the Inspire Royalties and Minimum Royalties payable with respect to such Inspire Licensed Product Know-How, the applicable royalty rate will thereafter be reduced in such country pursuant to this Article 5 by [***] of the applicable royalty rate set forth sum of the royalties paid to all Third Parties by Inspire pursuant to all such Third Party licenses combined; provided, however, that in no event shall the Inspire Royalties or Minimum Royalties payable by Inspire to InSite hereunder be reduced by more than [***] as a result of application of this Section 8.55.8(a)(i); and
(ii) offset [***] of any license issue fees (including but not limited to any initial or upfront fees) and milestone payments paid to all Third Parties by Inspire pursuant to all such Third Party licenses against any Inspire Royalties or Minimum Royalties due under this Agreement. Offsets for such payments to Third Parties may be applied in any single calendar quarter or several calendar quarters until the application of such payments in their entirety; provided, however, that in no event shall the aggregate of offsets under this Section 5.8(a)(ii) exceed in any particular calendar quarter [***] of the sum of any Inspire Royalties or Minimum Royalties due hereunder in such quarter.
(b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during to obtain rights in any country in the Royalty TermTerritory from any Third Party, other than the situation described in paragraph (a) above, for Patent Rights, Know-How or other technology to develop, have developed, make, have made, use, have used, market, have marketed, commercialize, have commercialized, offer for sale, sell, have sold, import or have imported a particular Inspire Licensed Product in the Field, then Inspire may notify InSite of its intent to enter into, and may enter into, a license with any such that Generic Versions Third Party at its discretion. Within thirty (30) days of receipt of such notice, InSite shall notify Inspire of its concurrence or lack of concurrence to such Third Party license (which concurrence shall not be unreasonably withheld, conditioned or delayed). If InSite so notifies Inspire of its lack of concurrence, the following royalty reductions shall not apply. Any lack of notice shall not be deemed as concurrence. If InSite has notified Inspire of its concurrence to such Third Party license, and if Inspire then enters into a written license agreement with such Third Party, Inspire may:
(i) reduce the Inspire Royalties and Minimum Royalties payable with respect to such Inspire Licensed Product in such country pursuant to this Article 5 by [***] of the sum of the royalties paid to all Third Parties by Inspire pursuant to all such Third Party licenses combined; provided, however, that in no event shall the Inspire Royalties or Minimum Royalties payable by Inspire to InSite hereunder be reduced by more than [***] as a result of application of this Section 5.8(b)(i); and
(ii) offset [***] of any license issue fees (including but not limited to any initial or upfront fees) and milestone payments paid to all Third Parties by Inspire pursuant to all such Third Party licenses against any Inspire Royalties or Minimum Royalties due under this Agreement. Offsets for such payments to Third Parties may be applied in any single calendar quarter or several calendar quarters until the application of such payments in their entirety; provided, however, that in no event shall the aggregate of offsets under this Section 5.8(b)(ii) exceed in any particular calendar [***] of the sum of any Inspire Royalties or Minimum Royalties due hereunder in such quarter.
(c) The Inspire Royalties payable by Inspire with respect to any Inspire Licensed Product in any country in the Territory pursuant to this Article 5 shall be reduced by the following percentages effective during and after the calendar quarter when Generic Competition occurs at the following sales levels with respect to such Inspire Licensed Product in such country. Where the sales of a Generic Equivalent, as to such Inspire Licensed Product, during a calendar quarter are equal to or greater than either [***] of total sales of such Inspire Licensed Product sold in such country equal country, expressed in units, or exceed in the aggregate (v) [***] of the total units sold sales of such Inspire Licensed Product or Generic Version(s) sold in such country, then expressed in local currency, the royalty rate for Inspire Royalties with respect to such Inspire Licensed Product shall be reduced, subject to Section 5.8(d), by [***] of the amounts otherwise owed in such country will thereafter country. Where the sales of a Generic Equivalent, as to such Inspire Licensed Product, during a calendar quarter are equal to or greater than either (w) [***] of total sales of such Inspire Licensed Product sold in such country, expressed in units, or (x) [***] of the total sales of such Inspire Licensed Product sold in such country, expressed in local currency, the Inspire Royalties with respect to such Inspire Licensed Product shall be reduced, subject to Section 5.8(d), by [***] of the amounts otherwise owed in such country. Where the sales of a Generic Equivalent, as to such Inspire Licensed Product, during a calendar quarter are equal to or greater than either (y) [***] of total sales of such Inspire Licensed Product sold in such country, expressed in units, or (z) [***] of the total sales of such Inspire Licensed Product sold in such country, expressed in local currency, the Inspire Royalties with respect to such Inspire Licensed Product shall be reduced to an amount that is equal to [***] of applicable Net Sales of such Inspire Licensed Product. If such Generic Competition ceases to exist at such sales levels, then, beginning with the first calendar quarter after such Generic Competition does not exist at such sales levels, the reduction of Inspire Royalties with respect to such Inspire Licensed Product in this Section 5.8(c) shall be reduced to the reduction applicable royalty rate set forth to such lower sales levels, if any, in Section 8.5 for so long such country until such time as Generic Competition may again exist at such reduction sales levels with respect to such Inspire Licensed Product in units sold persistssuch country.
(cd) If during Notwithstanding the Royalty Termprovisions of Sections [***] permitting Inspire to reduce Inspire Royalties under certain circumstances, Mereo pays Third Party Payments in no event shall Inspire Royalties payable by Inspire to InSite pursuant to this Article 5 with respect to a Productparticular Inspire Licensed Product in a particular country of the Territory in any single calendar quarter be reduced, Mereo may credit as a result of the application of such provisions, to an amount that is below [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the applicable Net Sales of that particular such Inspire Licensed Product in that [***]; providedsuch country in such quarter. Subject to the foregoing, however that Inspire shall be permitted to apply any reduction or offset to which it is entitled under Section 5.8(a) or Section 5.8(b) in any single calendar quarter or several calendar quarters until the royalties paid to AstraZeneca on such Net Sales after application of such credit amounts in their entirety. For the avoidance of doubt, this Section 5.8(d) shall not limit the application of any other reduction or offset to which Inspire is or may be less than [***] entitled under this Agreement, and shall not preclude Inspire’s exercise of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on any other applicable rights or remedies from time to time.
(e) In the event that Inspire becomes a [***] basisdirect licensee of Pfizer under the Pfizer Patent Rights, provided that Mereo Inspire shall be entitled to carry forward offset, against any amount of Third Party Payments which it is not entitled Inspire Royalties or Minimum Royalties due under this Agreement, any payment made by Inspire to credit from the royalties due to AstraZeneca Pfizer in accordance connection with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully creditedlicense.
Appears in 1 contract
Reductions. (a) If during Subject to Section 6.3.2(c), if one or more Third Parties sell a Competing Product that has received Regulatory Approval for, or is otherwise used for, an Indication in any country in the Territory for which a Licensed Product has received Regulatory Approval for such Indication, then commencing on the date on which sales of the Competing Product by such Third Parties are equal to or greater than [*] of aggregate unit volume of sales of the Licensed Product in such country (as measured by IMS Health data or other similar information available from a Third Party data provider and applicable to such country) and continuing for the remainder of the Royalty Term, on a country-by-country and Product by Product basis, such Product ceases to be Covered by a Valid Claim in the country of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-How, then the applicable royalty rate will thereafter rates in effect with respect to the Licensed Product in such country shall be reduced to [***] of the applicable royalty rate rates set forth in Section 8.56.3.1. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(b) If Subject to Section 6.3.2(c), beginning in the first Calendar Quarter during the Royalty Term, on Term for a country-by-particular Licensed Product in a country and in the Territory for which there is no Valid Claim of a UroGen Patent that Covers such Licensed Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during and continuing for the remainder of the Royalty Term, and Term for such that Generic Versions of the Licensed Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then the applicable royalty rate for in effect with respect to such Licensed Product in such country will thereafter shall be reduced to [***] of the applicable royalty rate rates set forth in Section 8.5 6.3.
1. For clarity, for so long as any particular Licensed Product in any particular country, in the event any pending patent application within any UroGen Patent issues during the Royalty Term but after the royalty reduction under this Section 6.3.2(b) has been triggered, the claims in such pending application shall be deemed “Valid Claims” for the purpose of calculating the Royalty Term for such Licensed Product in such country, but shall not result in the reversal of the royalty rate reduction for such Licensed Product in units sold persistssuch country under this Section 6.3.2(b).
(c) If during Notwithstanding the Royalty Termforegoing, Mereo pays Third Party Payments with respect to a Productif both Section 6.3.2(a) and Section 6.3.2(b) apply, Mereo may credit then the royalty rates shall be [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the Net Sales of that particular Product royalty rates set forth in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully credited6.3.1.
Appears in 1 contract
Reductions. Notwithstanding the foregoing:
(a) If following the first market entry of a Generic Product of a Licensed Product in a given country in the Territory during the Royalty TermTerm for such Licensed Product in such country, on there has been in any Calendar Quarter after such entry a country-by-decline of the Sales of such Licensed Product in such country and greater than [***] of the average level of the Sales of such Licensed Product by Product basisachieved in such country [***] immediately preceding such Calendar Quarter (such percentage drop in Sales following the first market entry of a Generic Product, such Product ceases to be Covered by a Valid Claim “Generic Entry”), then, except as set forth in the country of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-HowSection 8.7.3(c) below, the applicable royalty rate will thereafter on the Net Sales of such Licensed Product in such country shall be reduced to [***] for the remainder of the applicable Royalty Term for such Licensed Product in such country.
(b) Genentech shall be entitled to deduct from any royalties payable hereunder with respect to a Licensed Product for a particular country or other jurisdiction [***] of all [***] paid under Genentech In-License Agreements with respect to such Licensed Product for such country or other jurisdiction; provided that in no case shall such deduction effectively reduce such royalties set forth in Section 8.7.1 below the royalties that would be payable under the royalty rates set forth in Section 8.7.3(d). [***] [***], subject to the preceding proviso.
(c) If in a given country in the Territory in a Calendar Quarter during the Royalty Term for a Licensed Product such Licensed Product is not Covered by a Valid Claim of a [***] that Covers [***] such Licensed Product in such country, the royalty rate set forth in Section 8.5.
(b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in 8.7.1 with respect to such country in a given [***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then the royalty rate for such Licensed Product in such country will thereafter shall be reduced to [***] of replaced by the applicable royalty rate rates set forth in Section 8.5 8.7.3(d) for so long as such reduction in units sold persists.
Calendar Quarter; provided that following the tenth (c10th) If during anniversary of the Royalty Term, Mereo pays Third Party Payments with respect to First Commercial Sale of a Product, Mereo may credit [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the Net Sales of that particular Licensed Product in that [***]; provideda country, however that if the royalties paid to AstraZeneca on such Net Sales after application last Valid Claim of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basisthat Covers such Licensed Product in such country only Covers [***] such Licensed Product, provided that Mereo then [***].
(d) Except as set forth in Section 8.7.3(a), the cumulative reductions set forth in this Section 8.7.3 shall be entitled to carry forward any amount of Third Party Payments which it is not entitled to credit from reduce the royalties due payable to AstraZeneca BicycleTx on any Licensed Product in accordance with this Section 8.5.3 by reason of such limitation from one (1) any Calendar Year Quarter to less than the following Calendar Year until such amount is fully credited.amounts set forth in the table below at each royalty tier. [***] [***] [***] [***] [***] [***] [***] [***]
Appears in 1 contract
Samples: Discovery Collaboration and License Agreement (BICYCLE THERAPEUTICS PLC)
Reductions. Notwithstanding the foregoing:
(ai) If during if, pursuant to Section 6.4(a), any royalties are payable on Net Sales of a Licensed Product attributable to any country in the EQRx Territory where there is [***] (i.e., royalties are payable on Net Sales of a Licensed Product in a country on the basis of clauses (b) or (c) in the definition of Royalty Term), then the royalty rates applicable to those Net Sales of such Licensed Product for such country will be reduced [***] from those set forth in Section 6.4(a); provided, however, that such reduction shall not apply in a country to the extent EQRx abandoned or otherwise caused, intentionally or unintentionally, abandonment, expiration or lapse of all Patents within the Xxxx Licensed Technology containing a Valid Claim covering the sale of such Licensed Product in such country solely in order to take advantage of such reduction.
(ii) on a country-by-country basis and Licensed Product-by-Licensed Product by Product basis, such Product ceases to be Covered by a Valid Claim basis in the country of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-HowEQRx Territory, the applicable royalty rate Net Sales Royalty payable to Xxxx for Net Sales of Licensed Product will thereafter be reduced to (A) [***] of the applicable royalty rate rate(s) set forth in Section 8.5.
(b) If during the Royalty Term6.4(a), on following a country-by-country and Product by Product basislaunch of a Generic Product, one (1) or more Generic Versions of the Product are marketed and sold in if [***]. For clarity, such country in a given reduction will not apply for any [***] during in which the Royalty Term, and such that market share of Generic Versions of the Product sold in such country equal or exceed Products does not meet either threshold in the aggregate preceding sentence. Unless otherwise agreed by the Parties, [***] or any other independent sales auditing firm reasonably agreed upon by the Parties;
(iii) in the event that either Party identifies any Patent or Know-How owned or controlled by a Third Party in a particular country or other jurisdiction that, absent a license or agreement with such Third Party, would be [***] (“Blocking IP”), it will so notify the other Party. EQRx or any of its Affiliates will have the total units sold first right, but not the obligation, to enter into an agreement with a Third Party to acquire or obtain a license, covenant not to xxx or other similar right to any Blocking IP. If EQRx or any of its Affiliates enters into such agreement, [***] payable hereunder with respect to that country the amounts paid to such Third Party in respect of such Product agreement to the extent related to the Licensed Products; provided that such offset will not decrease the Net Sales Royalties otherwise due to Xxxx by more than [***] in a calendar year; provided, further, that any deductions in excess of [***] may be carried forward to reduce subsequent amounts until all such amounts are fully deducted. If EQRx or Generic Version(sany of its Affiliates elect not to enter into an agreement with respect to any Blocking IP, [***] (which agreement will include rights that are (sub)licensable to EQRx hereunder); provided, that (A) [***] will reserve the right in such country, then agreement to disclose the royalty rate for such Product in such country will thereafter be reduced agreement to [***] (subject to confidentiality obligations and reasonable redaction) and if requested by EQRx to otherwise grant a (sub)license to EQRx consistent with the terms herein and (B) Xxxx will not [***]. Xxxx will provide written notification to EQRx of the applicable royalty rate set forth in Section 8.5 for so long as such reduction in units sold persists.
(c) If during the Royalty Term[***], Mereo pays Third Party Payments with respect EQRx may elect to a Product, Mereo may credit [***] and, upon such election, such Blocking IP will be owned or in-licensed by Xxxx or any of its Affiliates and included within the Xxxx Licensed Technology licensed hereunder;
(iv) in the event that a court or a governmental agency of competent jurisdiction requires EQRx or any of its Affiliates or Sublicensees to grant a compulsory license to a Third Party permitting such Third Party Payments paid against to make, use or sell a Licensed Product in a country or other jurisdiction in the EQRx Territory, then, for the purposes of calculating the royalties otherwise due payable with respect to AstraZeneca on sales by EQRx, its Affiliate or Sublicensee of such Licensed Product, a percentage of the Net Sales of that particular such Licensed Product in that [***]such country or other jurisdiction will be disregarded with such percentage being the actual loss of sales by EQRx to the compulsory licensee(s) divided by the total sales of EQRx and the compulsory licensee(s) for a given calendar year; providedfor clarity, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not any reduction under this Section 6.4(d)(iv) will be less than calculated separately for each Licensed Product; and
(v) in no event will [***] of those be required to contribute to, or otherwise due above without such credit. Such credit pay for Third Party Payments allowed hereunder shall apply on a or reimburse, [***] basis, provided that Mereo shall be entitled payments to carry forward any amount of Third Party Payments Parties from which it is not entitled has received (sub)licenses to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully creditedPatents, Know-How or other intellectual property rights that claims or covers any Licensed Compound or Licensed Product.
Appears in 1 contract
Samples: Exclusive License Agreement (CM Life Sciences III Inc.)
Reductions. Notwithstanding the foregoing:
(a) If during the Royalty Termif, on a country-by-in any country and Product by Product basis, such Product ceases to be Covered by a Valid Claim in the ExUS Territory (or the United States with respect to a Non-Co-Promote Product) there is [***].
(b) if Kite or Arcellx enters into an agreement with a Third Party pursuant to Section 8.6 in order to obtain a license or right under Blocking Third Party Technology owned or controlled by such Third Party for a particular country of manufactureor other jurisdiction in the ExUS Territory (or the United States with respect to a Non-Co-Promote Product) [***], useKite shall be entitled to deduct from any royalties payable under this Section 8.4 with respect to such Licensed Product in such country or other jurisdiction in a Calendar Quarter [***], saleas the case may be, offer for sale or import but does contain, incorporate or use any Product Know-Howsuch Blocking Third Party Technology (collectively, the applicable “Kite Third Party Payments”) to [***], and Arcellx shall be entitled to increase any royalties payable under this Section 8.4 with respect to such Licensed Product in such country or other jurisdiction in a Calendar Quarter [***], as the case may be, for such Blocking Third Party Technology [***], (collectively, “Arcellx Third Party Payments”). Additionally, [***]. Notwithstanding the foregoing, the royalty rate will thereafter payable to Arcellx with respect to such Licensed Product for such country or other jurisdiction would not as a result of the net adjustments called for in this Section 8.4.5(b) be reduced to less or more than [***] of the applicable royalty rate set forth in Section 8.5.
(b) If during the Royalty Term, on a country-by-country and Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during the Royalty Term, and such that Generic Versions of the Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then the royalty rate for such Product in such country will thereafter be reduced to [***] of the applicable royalty rate set forth in Section 8.5 for so long as such reduction in units sold persists.
(c) If during the Royalty Term, Mereo pays Third Party Payments with respect to a Product, Mereo may credit [***] of such Third Party Payments paid against the royalties amount otherwise due to AstraZeneca on the Net Sales of that particular Product in that due; [***]; provided;
(c) notwithstanding anything in this Agreement to the contrary, however that under no circumstances shall the reductions set forth in this Section 8.4 cause the royalties paid payable to AstraZeneca on such Net Sales after application of such credit shall not Arcellx with respect to a given Licensed Product in any country in the ExUS Territory (or in the United States with respect to a Non-Co-Promote Product) in any Calendar Quarter to be reduced to less than [***] of those the amount that would otherwise be due above (i.e., without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled giving effect to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca reductions specified in accordance with this Section 8.5.3 by reason of 8.4) with respect to such limitation from one (1) Licensed Product in such country in such Calendar Year to the following Calendar Year until such amount is fully creditedQuarter.
Appears in 1 contract
Samples: Collaboration and License Agreement (Arcellx, Inc.)
Reductions. (a) If during Subject to Section 6.3.2(c), if one or more Third Parties sell a Competing Product that has received Regulatory Approval for, or is otherwise used for, an Indication in any country in the Territory for which a Licensed Product has received Regulatory Approval for such Indication, then commencing on the date on which sales of the Competing Product by such Third Parties are equal to or greater than [*] of aggregate unit volume of sales of the Licensed Product in such country (as measured by IMS Health data or other similar information available from a Third Party data provider and applicable to such country) and continuing for the remainder of the Royalty Term, on a country-by-country and Product by Product basis, such Product ceases to be Covered by a Valid Claim in the country of manufacture, use, sale, offer for sale or import but does contain, incorporate or use any Product Know-How, then the applicable royalty rate will thereafter rates in effect with respect to the Licensed Product in such country shall be reduced to [***] of the applicable royalty rate rates set forth in Section 8.56.3.1.
(b) If Subject to Section 6.3.2(c), beginning in the first Calendar Quarter during the Royalty Term, on Term for a country-by-particular Licensed Product in a country and in the Territory for which there is no Valid Claim of a UroGen Patent that Covers such Licensed Product by Product basis, one (1) or more Generic Versions of the Product are marketed and sold in such country in a given [***] during and continuing for the remainder of the Royalty Term, and Term for such that Generic Versions of the Licensed Product sold in such country equal or exceed in the aggregate [***] of the total units sold of such Product or Generic Version(s) in such country, then the applicable royalty rate for in effect with respect to such Licensed Product in such country will thereafter shall be reduced to [***] of the applicable royalty rate rates set forth in Section 8.5 6.3.
1. For clarity, for so long any particular Licensed Product in any particular country, in the event any pending patent application within any UroGen Patent issues during the Royalty Term but after the royalty reduction under this Section 6.3.2(b) has been triggered, the claims in such pending application shall be deemed “Valid Claims” for the purpose of calculating the Royalty Term for such Licensed Product in such country, but shall not result in the reversal of the royalty rate reduction for such Licensed Product in such country under this Section 6.3.2(b). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as such reduction in units sold persistsamended.
(c) If during Notwithstanding the Royalty Termforegoing, Mereo pays Third Party Payments with respect to a Productif both Section 6.3.2(a) and Section 6.3.2(b) apply, Mereo may credit then the royalty rates shall be [***] of such Third Party Payments paid against the royalties otherwise due to AstraZeneca on the Net Sales of that particular Product royalty rates set forth in that [***]; provided, however that the royalties paid to AstraZeneca on such Net Sales after application of such credit shall not be less than [***] of those otherwise due above without such credit. Such credit for Third Party Payments allowed hereunder shall apply on a [***] basis, provided that Mereo shall be entitled to carry forward any amount of Third Party Payments which it is not entitled to credit from the royalties due to AstraZeneca in accordance with this Section 8.5.3 by reason of such limitation from one (1) Calendar Year to the following Calendar Year until such amount is fully credited6.3.1.
Appears in 1 contract