Royalty Term and Adjustments. (i) Forest’s royalty obligations to Adamas with respect to Net Sales of FDC Products in the Territory under Section 6.4(a) shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a Product-by-Product basis, until the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in the Field in the Territory; and (B) the expiration of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for such FDC Product in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product. (ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = 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. (iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectively.
Appears in 2 contracts
Samples: License Agreement (Adamas Pharmaceuticals Inc), License Agreement (Adamas Pharmaceuticals Inc)
Royalty Term and Adjustments. (ia) ForestEISAI’s royalty obligations to Adamas EPIZYME under Section 7.5.1 shall commence on a country-by-country and Licensed Product-by-Licensed Product basis on the date of First Commercial Sale by EISAI, its Affiliates 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 upon the later of the following (the “Royalty Term”), as applicable:
(i) expiration of Patent-Based Exclusivity with respect to such Licensed Product in such country;
(ii) expiration of Regulatory-Based Exclusivity with respect to such Licensed Product in such country; and
(iii) the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in such country by EISAI, its Affiliates or Sublicensees.
(b) The foregoing provisions of this Section 7.5 notwithstanding, the royalties payable with respect to Net Sales of FDC Licensed Products in the Territory under Section 6.4(a) shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafterbe reduced, on a Licensed Product-by-Licensed Product and country-by-country basis, until the later of: to [**] percent (A[**]%) fifteen (15) years after First Commercial Launch of the first FDC amounts otherwise payable pursuant to Section 7.5.1 during any portion of the Royalty Term when neither Patent-Based Exclusivity nor Regulatory-Based Exclusivity applies to such Licensed Product in such country.
(c) With respect to each Licensed Product in the Field in the Territory; U.S., from and (B) after the expiration of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book Royalty Term for such FDC Licensed Product in the TerritoryU.S., except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Licensed Product in the Territory (U.S. shall be excluded for purposes of calculating the “Proprietary Non-Donepezil FDC Royalty Term”Net Sales thresholds and ceilings set forth in Section 7.5.1(a). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = 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.
(iiid) Forest’s EISAI shall have no obligation to pay any royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products any Licensed Product in the Territory under Section 6.4(b) shall commence on any country after the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book Term for such ER Licensed Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectivelycountry has expired.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement (Epizyme, Inc.)
Royalty Term and Adjustments. (i) ForestOSI’s royalty obligations to Adamas AVEO under this Section 6.6 shall expire on a country-by-country and Royalty-Bearing Product-by- Royalty-Bearing Product basis on the later of: (i) the expiration of the last Valid Claim (A) in the case of a Product, within the AVEO Patent Rights, Collaboration Patent Rights, Product Patent Rights, Non-Antibody Compound Patent Rights or OSI Patent Rights Covering such Product in such country, or, (B) in the case of a [**] Product, Patent Rights Covering any associated diagnostic, (ii) the expiration of any Marketing Exclusivity for such Royalty-Bearing Product in such country, and (iii) the tenth (10th) anniversary of the date of the First Commercial Sale by OSI or any of its Affiliates or Sublicensees to an unaffiliated Third Party of such Royalty-Bearing Product in such country (the “Royalty Term”). The foregoing provisions of this Section 6.6(e) notwithstanding, the royalties payable with respect to Net Sales of FDC Products in a Royalty-Bearing Product shall be reduced to [**] percent ([**]%) of the Territory under amounts otherwise payable pursuant to Sections 6.6(a) or 6.6(b) (as applicable, and adjusted pursuant to Section 6.4(a6.7 if applicable) shall commence upon during any portion of the Royalty Commencement Date Term when (as defined in Section 6.4(c)(ivi) below) for there is no Valid Claim within the first FDC AVEO Patent Rights, Collaboration Patent Rights, Product Patent Rights, Non-Antibody Compound Patent Rights or OSI Patent Rights Covering such Royalty-Bearing Product in the Territory such country, and shall continue thereafter, on a Product-by-Product basis, until the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in the Field in the Territory; and (B) the expiration of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for such FDC Product in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC the Royalty-Bearing Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), does not have Marketing Exclusivity in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = 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 amendedcountry.
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectively.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Aveo Pharmaceuticals Inc), Collaboration and License Agreement (Aveo Pharmaceuticals Inc)
Royalty Term and Adjustments. (ia) ForestROCHE’s royalty obligations to Adamas with respect SYNTA pursuant to Net Sales of FDC Products in the Territory under this Section 6.4(a) 7.6 shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a country-by-country and Licensed Product-by-Licensed Product basis, until basis on the First Commercial Sale in such country of such Licensed Product and shall expire on a country-by-country basis and Licensed Product-by-Licensed Product basis on the later of: (A) fifteen (15) years after First Commercial Launch the expiration of the first FDC last Valid Claim of the SYNTA Patent Rights, ROCHE Patent Rights and Joint Patent Rights Covering such Licensed Product in the Field in the Territory; and such country, or (B) the expiration [***] ([***]) anniversary of the last-to-expire Valid Claim date of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for First Commercial Sale of such FDC Licensed Product in the Territory, except that in no event shall such country by or on behalf of ROCHE or any royalty be due in any Calendar Quarter in which there of its Affiliates or Sublicensees to a Third Party who is Generic Competition with respect to the applicable FDC Product in the Field in the Territory not a Sublicensee (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a)Thereafter, the licenses granted by Adamas to Forest ROCHE shall be fully paid-up, royalty-free and non-exclusive with respect to such FDC Licensed Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to in such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continuecountry, on a Licensed Product-by-Licensed Product and country-by-country basis.
(b) Notwithstanding the foregoing, for so long as the royalty rate applicable to such Licensed Product sold in any country in the Territory shall be reduced to [***] percent ([***]%) of the rate otherwise payable pursuant to Section 7.6.1 above during any portion of the Royalty Term when there is at least one no Valid Claim of an Adamas the SYNTA Patent RightRights, including an Adamas Memantine ROCHE Patent Right, Rights or Joint Patent Rights Covering such Licensed Product in each case, such country; provided that such reduction shall not apply if the Licensed Product is listed entitled to Marketing Exclusivity in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which country and there is no Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = 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.
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date market in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectivelycountry.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Synta Pharmaceuticals Corp), Collaboration and License Agreement (Synta Pharmaceuticals Corp)
Royalty Term and Adjustments. (ia) Forest’s Novartis’ royalty obligations to Adamas with respect to Net Sales of FDC Products in the Territory XOMA under this Section 6.4(a) 3.2 shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a CV Canakinumab Product-by-CV Canakinumab Product basis, until and country-by-country basis on the later of: (A) fifteen (15) years after date of First Commercial Launch Sale of the first FDC such CV Canakinumab Product by Novartis, its Affiliates or sublicensees to a Third Party in the Field in relevant country where such CV Canakinumab Product is Covered by a Valid XOMA IL-1 Claim and shall expire on a CV Canakinumab Product-by-CV Canakinumab Product and country-by-country basis upon the Territory; and earlier of (Bi) the date of expiration in such country of the last-to-expire Valid Claim XOMA IL-1 Claim, where the sale of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed the applicable CV Canakinumab Product in the Orange Book applicable country would infringe such Valid XOMA IL-1 Claim but for the license granted to Novartis under this Agreement; or (ii) the date on which [*] occurs in such FDC country with respect to such CV Canakinumab Product (the “Royalty Term”).
(b) Upon the expiration of the Royalty Term for a CV Canakinumab Product in a country in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses and rights granted by Adamas to Forest Novartis under this Agreement with respect to such FDC CV Canakinumab Product under Section 2.1(a)(i) and Section 2.1(a)(ii) in such country shall become fullyfully paid-paidup, perpetual and irrevocable with respect to such FDC Productperpetual, irrevocable, royalty free licenses, which shall continue even after the expiration or termination of this Agreement.
(iic) Notwithstanding Section 6.4(a) aboveanything to the contrary in this Agreement, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] responsible for the payment of [*] and other payment obligations, if any, [*] in connection with (i) any [*] which [*] and [*], or (ii) which relate to [*] relating to any [*] (collectively, the Net Sales “ [*]”). All such payments in respect of such Proprietary Non-Donepezil FDC Products [*] shall be made promptly [*] in the Territoryaccordance with [*] (collectively, and [*] after each such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicablehas been made. Without limiting [*], in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = Certain confidential information contained in this document], marked by bracketsor [*], has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended[*].
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectively.
Appears in 1 contract
Royalty Term and Adjustments. (i) ForestSchering-Plough’s royalty obligations to Adamas AVEO under this Section 7.6 shall commence on a country-by-country and Licensed Product-by-Licensed Product basis on the First Commercial Sale of such Licensed Product and shall expire on a country-by-country basis and Licensed Product-by-Licensed Product basis on the later of: (i) the expiration of the last Valid Claim (that is not a patent claim to a Biomarker) of the AVEO Patent Rights or Joint Patent Rights Covering such Licensed Product in such country, or (ii) the tenth (10th) anniversary of the date of the First Commercial Sale by Schering-Plough or any of its Affiliates or Sublicensees to a non-Sublicensee Third Party of such Licensed Product in such country (the “Royalty Term”). The foregoing provisions of this Section 7.6(c) notwithstanding, the royalties payable with respect to Net Sales of FDC Products a Licensed Product shall be reduced to [**] percent ([**]%) of the amounts otherwise payable pursuant to Section 7.6(a) during any portion of the Royalty Term when there is no Valid Claim (that is not a patent claim to a Biomarker) of the AVEO Patent Rights or Joint Patent Rights Covering such Licensed Product in such country; provided that such reduction shall not apply if the Licensed Product is entitled to Marketing Exclusivity in such country and there are no other products on the market in such country that contain substantially the same active ingredient as that contained in the Territory under Section 6.4(a) shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a Product-by-Product basis, until the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in the Field in the Territory; and (B) the expiration of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for such FDC Product in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Licensed Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = 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.
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectively.
Appears in 1 contract
Samples: Research, Development and License Agreement (Aveo Pharmaceuticals Inc)
Royalty Term and Adjustments. (ia) Forest’s Novartis’ royalty obligations to Adamas with respect to Net Sales of FDC Products in the Territory XOMA under this Section 6.4(a) 4.3 shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a Product-by-Product basisand country-by-country basis on the date of First Commercial Sale of such Product by Novartis, until its Affiliates or sublicensees to a Third Party in the relevant country where such Product is Covered by a Valid XOMA Claim and shall expire on a Product-by-Product and country-by-country basis upon the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in following (the Field in the Territory; and “Royalty Term”), as applicable:
(Bi) the expiration in such country of the last-to-expire Valid Claim XOMA Claim, where the sale of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for such FDC Product in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory applicable country would infringe such Valid XOMA Claim but for the license granted to Novartis under the Agreement; and
(ii) ten (10) years after First Commercial Sale of such Product in the “Proprietary Non-Donepezil FDC Royalty Term”). Upon relevant country in the Territory.
(b) Notwithstanding anything in this Agreement to the contrary, and [*] provided for under this Agreement, for sales of a Product in countries [*] and [*] Further, upon the expiration of Forest’s royalty obligations with respect to the Royalty Term for a particular Proprietary Non-Donepezil FDC Product hereunderin a country in the Territory, the licenses granted by Adamas to Forest Novartis under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable this Agreement with respect to such Proprietary NonProduct in such country shall become fully paid-Donepezil FDC Productup, respectivelyroyalty free licenses, which shall continue even after the expiration or termination of this Agreement. [*] = 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 24b-2 of the Securities Exchange Act of 19331934, as amended.
(iiic) Forest’s If an event of [*] for a Product in any country has occurred, then so long as either (i) [*] such Product in such country, or (ii) [*] such Product in such country, then the royalty obligations to Adamas with respect rate applicable to Net Sales of ER Products such Product in such country in accordance with in Section 4.3.1 shall be [*]
(d) Notwithstanding anything to the contrary in this Agreement subject to Section 2.5.2(c), [*] responsible for the payment of [*] and Other Products other payment obligations, if any, [*] in connection with (i) any [*] which [*] and [*], or (ii) which relate to [*] relating to any [*], (collectively, the Territory under Section 6.4(b) [*]”). All such payments in respect of [*] shall commence on the Royalty Commencement Date be made promptly [*] in the Field in the Territory and shall continueaccordance with [*] (collectively, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in [*] after each case, that is listed in the Orange Book for such ER Product or Other Product, as applicablepayment has been made. Without limiting [*] hereunder, in the Territoryevent that [*] and [*] and [*]
(e) In the event that [*] or [*] or (ii) [*] with respect to [*] (including [*] by [*]; provided, except that to the extent (if at all) [*] provides [*] having [*] under this Agreement, the [*] hereunder shall be [*] as reasonably [*] under this Agreement.
(f) In the event that Novartis [*] or [*] in connection with the [*] under this Agreement, [*] or otherwise and [*] with respect [*] (including [*]) [*] provided, that to the extent (if at all) [*] having [*] under this Agreement, [*] hereunder shall be [*] under this Agreement.
(g) Subject to, and without prejudice to[*], in no event shall any [*] such that the royalty be payments due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations XOMA from Novartis under Section 4.3 [*] with respect to a particular ER Product or Other in a particular country [*] shall be carried forward and Novartis may [*] royalty payment amounts due to XOMA [*] that [*], provided further that [*] for such Product under Section 6.4(b)in such country, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable [*] with respect to any such ER Product or Other Product, respectively[*] any [*] hereunder.
Appears in 1 contract
Samples: License Agreement (XOMA Corp)
Royalty Term and Adjustments. (ia) Forest’s Novartis’ royalty obligations to Adamas with respect to Net Sales of FDC Products in the Territory XOMA under this Section 6.4(a) 4.3 shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a Product-by-Product basis, until the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in the Field in the Territory; and (B) the expiration of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for such FDC Product in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Productcountry-by-country basis on the date of First Commercial Sale of such Product basisby Novartis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect its Affiliates or sublicensees to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. Third Party in [*] = 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 24b-2 of the Securities Exchange Act of 19331934, as amended.
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in . the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory relevant country and shall continue, expire on a Product-by-Product basis, for so long as there is at least one Valid Claim and country-by-country basis upon the later of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Productfollowing (the “Royalty Term”), as applicable:
(i) the expiration in such country of the last-to-expire Valid Claim in the XOMA Core Patents Covering such Product; and
(ii) ten (10) years after First Commercial Sale of such Product in the relevant country in the Territory.
(b) Notwithstanding anything in this Agreement to the contrary, and [*] provided for under this Agreement, for Net Sales of a Product in any country in which [*] such Product, during the Royalty Term the associated royalties pursuant to Section 4.3.1 shall be [*] from what otherwise would be payable by Novartis to XOMA under this Agreement. Further, [*] for a Product in a country in the Territory, except [*] under this Agreement with respect to such Product in such country shall [*], which shall [*] this Agreement.
(c) If an event of [*] for a Product in any country has occurred, then so long as either (i) [*] such Product in such country, or (ii) [*] such Product in such country, then the Royalty Rate applicable to Net Sales of such Product in such country in accordance with in Section 4.3.1 shall be [*].
(d) Notwithstanding anything to the contrary in this Agreement, [*] responsible for the payment of [*] and other payment obligations, if any, [*] in connection with (i) any [*] which [*] and [*] under this Agreement, or (ii) which relate to [*] relating to any [*], (collectively, the “[*]”). All such payments in respect of [*] shall be made promptly [*] in accordance with [*] (collectively, [*] after each such payment has been made. For clarity, any payment obligations that may arise pursuant to Section [*] with respect to the [*] shall not be deemed to be a [*].
(e) In the event that [*] or [*] or [*] or [*], including [*] (collectively, “[*]”), [*] and [*] or otherwise and [*] with respect to [*] (including [*]) by [*]; provided that to the extent (if at all) [*] provides [*] having [*] any [*] under this Agreement, [*] hereunder shall be [*] as reasonably [*] under this Agreement.
(f) In the event that [*] or [*] in connection with the [*] under this Agreement, [*] and [*] or otherwise and [*] with respect to [*] (including [*]) by [*]; provided that to the extent (if at all) [*] provides [*] having [*] any [*] under this Agreement, [*] hereunder shall be [*] as reasonably [*] under this Agreement.
(g) Subject to, and without prejudice to, [*], in no event shall any [*] such that the royalty be payments due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”)XOMA from Novartis under Section 4.3 [*]. Upon expiration of Forest’s royalty obligations [*] with respect to a particular ER Product or Other in a particular country [*] shall be [*] royalty payment amounts due to XOMA [*] that [*], provided further that [*] for such Product under Section 6.4(b)in such country, the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable [*] with respect to such ER Product or Other Product, respectivelyany [*] any [*] hereunder.
Appears in 1 contract
Samples: License Agreement (XOMA Corp)
Royalty Term and Adjustments. (ia) Forest’s Novartis’ royalty obligations to Adamas with respect to Net Sales of FDC Products in the Territory XOMA under this Section 6.4(a) 4.3 shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a Product-by-Product basisand country-by-country basis on the date of First Commercial Sale of such Product by Novartis, until its Affiliates or sublicensees to a Third Party in the relevant -16- Certain confidential portions of this exhibit have been omitted and replaced with “[***]”. such identified information has been excluded from this exhibit because it is (i) not material and (ii) would likely cause competitive harm to the company if disclosed. country and shall expire on a Product-by-Product and country-by-country basis upon the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in following (the Field in the Territory; and “Royalty Term”), as applicable:
(Bi) the expiration in such country of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book XOMA Core Patents Covering such Product; and
(ii) ten (10) years after First Commercial Sale of such Product in the relevant country in the Territory.
(b) Notwithstanding anything in this Agreement to the contrary, and [*] provided for under this Agreement, for Net Sales of a Product in any country in which [*] such FDC Product, during the Royalty Term the associated royalties pursuant to Section 4.3.1 shall be [*] from what otherwise would be payable by Novartis to XOMA under this Agreement. Further, [*] for a Product in a country in the Territory, except [*] under this Agreement with respect to such Product in such country shall [*], which shall [*] this Agreement.
(c) If an event of [*] for a Product in any country has occurred, then so long as either (i) [*] such Product in such country, or (ii) [*] such Product in such country, then the Royalty Rate applicable to Net Sales of such Product in such country in accordance with in Section 4.3.1 shall be [*].
(d) Notwithstanding anything to the contrary in this Agreement, [*] responsible for the payment of [*] and other payment obligations, if any, [*] in connection with (i) any [*] which [*] and [*] under this Agreement, or (ii) which relate to [*] relating to any [*], (collectively, the “[*]”). All such payments in respect of [*] shall be made promptly [*] in accordance with [*] (collectively, [*] after each such payment has been made. For clarity, any payment obligations that may arise pursuant to Section [*] with respect to the [*] shall not be deemed to be a [*].
(e) In the event that [*] or [*] or [*] or [*], including [*] (collectively, “[*]”), [*] and [*] or otherwise and [*] with respect to [*] (including [*]) by [*]; provided that to the extent (if at all) [*] provides [*] having [*] any [*] under this Agreement, [*] hereunder shall be [*] as reasonably [*] under this Agreement.
(f) In the event that [*] or [*] in connection with the [*] under this Agreement, [*] and [*] or otherwise and [*] with respect to [*] (including [*]) by [*]; provided that to the extent (if at all) [*] provides [*] having [*] any [*] under this Agreement, [*] hereunder shall be [*] as reasonably [*] under this Agreement.
(g) Subject to, and without prejudice to, [*], in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of such that the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be payments due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”)XOMA from Novartis under Section 4.3 [*]. Upon expiration of Forest’s royalty obligations [*] with respect to a particular Proprietary Non-Donepezil FDC Product hereunderin a particular country [*] shall be [*] royalty payment amounts due to XOMA [*] that [*], the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable provided further that [*] for such Product in such country, [*] with respect to such Proprietary Non-Donepezil FDC Product, respectively. any [*] = 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.
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”)[*] hereunder. Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectively.
Appears in 1 contract
Samples: License Agreement (XOMA Corp)
Royalty Term and Adjustments. (i) Forest’s royalty obligations to Adamas with respect to Net Sales of FDC Products in the Territory under Section 6.4(a) shall commence upon the Royalty Commencement Date (as defined in Section 6.4(c)(iv) below) for the first FDC Product in the Territory and shall continue thereafter, on a Product-by-Product basis, until the later of: (A) fifteen (15) years after First Commercial Launch of the first FDC Product in the Field in the Territory; and (B) the expiration of the last-to-expire Valid Claim of an Adamas Patent Right, including any Adamas Memantine Patent Right, that is listed in the Orange Book for such FDC Product in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable FDC Product in the Field in the Territory (the “FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to an FDC Product under Section 6.4(a), the licenses granted by Adamas Xxxxxx to Forest with respect to such FDC Product under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid, perpetual and irrevocable with respect to such FDC Product.
(ii) Notwithstanding Section 6.4(a) above, with respect to any FDC Product that contains, as its sole active ingredients, Memantine and a proprietary Cholinesterase Inhibitor owned or Controlled by Forest or its Affiliates, other than Donepezil (a “Proprietary Non-Donepezil FDC Product”), in lieu of the royalty under Section 6.4(a), Forest shall pay Adamas [*] of the Net Sales of such Proprietary Non-Donepezil FDC Products in the Territory, and such payment obligation shall commence upon the Royalty Commencement Date and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such Proprietary Non-Donepezil FDC Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable Product in the Territory (the “Proprietary Non-Donepezil FDC Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular Proprietary Non-Donepezil FDC Product hereunder, the licenses granted by Adamas Xxxxxx to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such Proprietary Non-Donepezil FDC Product, respectively. [*] = 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.
(iii) Forest’s royalty obligations to Adamas with respect to Net Sales of ER Products and Other Products in the Territory under Section 6.4(b) shall commence on the Royalty Commencement Date in the Field in the Territory and shall continue, on a Product-by-Product basis, for so long as there is at least one Valid Claim of an Adamas Patent Right, including an Adamas Memantine Patent Right, in each case, that is listed in the Orange Book for such ER Product or Other Product, as applicable, in the Territory, except that in no event shall any royalty be due in any Calendar Quarter in which there is Generic Competition with respect to the applicable ER Product or Other Product, as the case may be, in the Territory (the “ER Royalty Term”). Upon expiration of Forest’s royalty obligations with respect to a particular ER Product or Other Product under Section 6.4(b), the licenses granted by Adamas Xxxxxx to Forest under Section 2.1(a)(i) and Section 2.1(a)(ii) shall become fully-paid and shall remain perpetual and irrevocable with respect to such ER Product or Other Product, respectively.
Appears in 1 contract