Co-Development Option. ARCHEMIX shall have the option, exercisable on a one-time basis for each IL-23 Aptamer undergoing Development as a potential IL-23 Product (the “Co-Development Option”), but not the obligation, to Co-Develop any IL-23 Aptamer (within the applicable Indication and formulation and, as to the Psoriatic Diseases Co-Development Option, within the applicable Co-Development Territory(ies)), and to share a certain percentage of the Operating Income (Loss) applicable to that IL-23 Aptamer within the applicable Co-Development Territory(ies), Indication and formulation by providing written notice to ELAN, which notice shall specify the applicable potential IL-23 Aptamer, the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. applicable Co-Development Territory(ies) (as to the Psoriatic Diseases Co-Development Option) and the applicable ARCHEMIX Co-Development Percentage (the “Co-Development Option Notice”). The Co-Development Option shall only be exercised upon ARCHEMIX’ payment of the applicable Co-Development Option Exercise Fee (as defined in Section 4.11.1(b) below) either (i) with respect to each Psoriatic Diseases Co-Development Option, at any time during the period commencing on the Effective Date and ending on the Psoriatic Diseases Option Termination Date (the “Psoriatic Diseases Option Exercise Period”) or (ii) with respect to each Non-Parenteral Co-Development Option, at any time during the period commencing on the Effective Date and ending on the Non-Parenteral Option Termination Date (the “Non-Parenteral Option Exercise Period”). If such payment is timely made as provided in the previous sentence, (i) the IL-23 Aptamer that is the subject of the Co-Development Option shall thereafter be deemed to be a Co-Developed Product (within the applicable Indication and formulation and, as to the Psoriatic Diseases Co-Development Option, for the applicable Co-Development Territory(ies)) for purposes of this Agreement, (ii) ARCHEMIX shall thereafter pay to ELAN the ARCHEMIX Co-Development Percentage of all Development Costs and Commercialization Costs applicable to that Co-Developed Product, either for the Territory and relevant formulations as to the Non-Parenteral Co-Development Option or for the applicable Co-Development Territory(ies), Indications and formulations as to the Psoriatic Diseases Co-Development Option, and (iii) ARCHEMIX shall share in the fraction of Operating Income (Loss) derived from such Co-Developed Product in the Territory for the relevant formulation (as to the Non-Parenteral Co-Development Option) or the applicable Co-Development Territory(ies), Indications and formulations (as to the Psoriatic Diseases Co-Development Option) in accordance with Section 4.11.3, equal to the applicable ARCHEMIX Co-Development Percentage multiplied by the applicable Operating Income (Loss) for that Co-Development Product within the applicable Co-Development Territory(ies), Indications and formulations. The Net Sales used to calculate Operating Income (Loss) for purposes of the Psoriatic Diseases Co-Development Option shall consist only of Net Sales derived from prescriptions written by Board-certified dermatologists and any other medical professionals whose prescriptions for Psoriatic Diseases (versus other Indications) are capable of being segregated, as reasonably determined in good faith by the JMC. The appropriate method of allocating Development Costs and Commercialization Costs on a Co- Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. Development Territory by Co-Development Territory basis shall be discussed in good faith between the Parties at the time the Psoriatic Diseases Co-Development Option Notice is given to ARCHEMIX, and shall be subject to the dispute resolution procedure set forth in Section 13.1 if the Parties cannot mutually agree upon such matter within [***] days after such discussions commence. ARCHEMIX shall not be entitled to receive milestone payments or royalties for milestone events or Net Sales occurring with respect to such Co-Developed Product for the applicable Co-Development Territory (or the Territory for Non-Parenteral Co-Developed Products) and for the relevant Indications and formulations being Co-Developed, after ARCHEMIX has given the applicable Co-Development Option Notice. If ARCHEMIX does not timely exercise its Co-Development Option within the applicable Option Exercise Period and timely pay the applicable Co-Development Option Exercise Fee, ELAN shall be free thereafter to Develop the applicable IL-23 Aptamer and/or IL-23 Product on its own or have it Developed under sublicense to a Third Party for any and all Indications and formulations throughout the Territory with no further option exercisable by ARCHEMIX. Notwithstanding any of the foregoing, in no event shall ARCHEMIX be entitled to co-promote any Product (whether or not it has Co-Developed such Product) with ELAN.
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)
Co-Development Option. ARCHEMIX On a Royalty-Bearing Product-by-Royalty-Bearing Product basis, Agenus shall have the option, exercisable on a oneoption to co-time basis for each IL-23 Aptamer undergoing fund Development as a potential IL-23 of such Royalty-Bearing Product (the “Co-Development Option”) as follows:
(a) Within [**] prior to the anticipated Initiation of the first Pivotal Clinical Trial of a Royalty-Bearing Product, Incyte shall notify Agenus of such anticipated initiation and shall provide Agenus with the following information: all material pre-clinical and clinical data and related analysis and regulatory information submitted to any Regulatory Authorities (to the extent such data and information was not provided by or on behalf of Agenus), but not the obligation, to Co-Develop any IL-23 Aptamer (within the applicable Indication and formulation and, as an update to the Psoriatic Diseases then-current Development Plan and associated budget (including an estimate of the overall costs of each Clinical Trial, annualized over the course of such Clinical Trial) with respect to such Royalty-Bearing Product (collectively, the “Triggering Information”). Agenus shall have the option to co-fund further Development of such Royalty-Bearing Product, exercisable by providing Incyte written notice within [**] after receipt of such information, in which case Agenus shall co-fund thirty percent (30%) of the Development Costs for such Royalty-Bearing Product incurred after the date on which such Pivotal Clinical Trial is Initiated.
(b) If Agenus timely exercises the Co-Development Option, within the applicable Co-Development Territory(ies))then, and to share a certain percentage of the Operating Income (Loss) applicable to that IL-23 Aptamer within the applicable Co-Development Territory(ies), Indication and formulation by providing written notice to ELAN, which notice shall specify the applicable potential IL-23 Aptamer, the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. applicable Co-Development Territory(ies) (as to the Psoriatic Diseases Co-Development Option) and the applicable ARCHEMIX Co-Development Percentage (the “Co-Development Option Notice”). The Co-Development Option shall only be exercised upon ARCHEMIX’ payment of the applicable Co-Development Option Exercise Fee (as defined in Section 4.11.1(b) below) either (i) with respect to each Psoriatic Diseases Co-Development Option, at any time during the period commencing on the Effective Date and ending on the Psoriatic Diseases Option Termination Date (the “Psoriatic Diseases Option Exercise Period”) or (ii) with respect to each Non-Parenteral Co-Development Option, at any time during the period commencing on the Effective Date and ending on the Non-Parenteral Option Termination Date (the “Non-Parenteral Option Exercise Period”). If such payment is timely made as provided in the previous sentence, (i) the IL-23 Aptamer that is the subject of the Co-Development Option shall thereafter be deemed to be a Co-Developed Product (within the applicable Indication and formulation and, as to the Psoriatic Diseases Co-Development Option, for the applicable Co-Development Territory(ies)) for purposes of this Agreement, (ii) ARCHEMIX shall thereafter pay to ELAN the ARCHEMIX Co-Development Percentage of all Development Costs and Commercialization Costs applicable to that Co-Developed Product, either for the Territory and relevant formulations as to the Non-Parenteral Co-Development Option or for the applicable Co-Development Territory(ies), Indications and formulations as to the Psoriatic Diseases Co-Development Option, and (iii) ARCHEMIX shall share in the fraction of Operating Income (Loss) derived from such Co-Developed Product in the Territory for the relevant formulation (as to the Non-Parenteral Co-Development Option) or the applicable Co-Development Territory(ies), Indications and formulations (as to the Psoriatic Diseases Co-Development Option) in accordance with Section 4.11.3, equal to the applicable ARCHEMIX Co-Development Percentage multiplied by the applicable Operating Income (Loss) for that Co-Development Product within the applicable Co-Development Territory(ies), Indications and formulations. The Net Sales used to calculate Operating Income (Loss) for purposes of the Psoriatic Diseases Co-Development Option shall consist only of Net Sales derived from prescriptions written by Board-certified dermatologists and any other medical professionals whose prescriptions for Psoriatic Diseases (versus other Indications) are capable of being segregated, as reasonably determined in good faith by the JMC. The appropriate method of allocating Development Costs and Commercialization Costs on a Co- Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. Development Territory by Co-Development Territory basis shall be discussed in good faith between the Parties at the time the Psoriatic Diseases Co-Development Option Notice is given to ARCHEMIX, and shall be subject to the dispute resolution procedure set forth in Section 13.1 if the Parties cannot mutually agree upon such matter within [***] days after following the end of each Calendar Quarter, Incyte shall prepare and deliver to Agenus a quarterly report detailing its Development Costs incurred during such discussions commence. ARCHEMIX shall not be entitled to receive milestone payments or royalties for milestone events or Net Sales occurring period with respect to such Co-Developed Product for and Agenus shall prepare and deliver to Incyte a quarterly report detailing its Development Costs incurred during such period with respect to such Co-Developed Product. Each Party shall submit any supporting information reasonably requested by the applicable other Party related to such Development Costs included in its report within [**] after its receipt of such request. Incyte shall issue an invoice to Agenus so that Agenus shall have paid thirty percent (30%) of the aggregate Development Costs identified in such quarterly reports (the “Co-Development Territory (or Quarterly Payment”); provided that such invoiced amount, together with all other Development Costs invoiced to Agenus for Development activities conducted by the Territory for Non-Parenteral Co-Developed Products) Parties and for the relevant Indications and formulations being Co-Developedtheir respective Affiliates during such Calendar Year, after ARCHEMIX has given the applicable Co-Development Option Notice. If ARCHEMIX does not timely exercise exceed o[**] of the total Development Costs budgeted in the Development Plan (except to the extent such excess is approved by the JSC pursuant to Section 4.1(c) hereof). Agenus shall pay all amounts payable under any such invoice within forty-five (45) days after its receipt of such invoice, subject to this Section 4.4(b).
(c) If Agenus exercises its Co-Development Option within with respect to a Royalty-Bearing Product and pays all reasonably undisputed Co-Development Quarterly Payments, the applicable Option Exercise Period royalty rate in Section 7.6(a)(iii) (the “Co-Development Royalty”) shall apply on annual Net Sales of such Co-Developed Product.
(d) Agenus may, at any time upon [**] prior written notice to Incyte (or [**] prior written notice following consummation of a Change in Control of Incyte), elect to cease funding its portion of Development Costs with respect to a Co-Developed Product. In such an event, (i) such Product shall no longer be considered a Co-Developed Product and timely (ii) Incyte shall be obligated to pay the applicable Co-Development Royalty on Net Sales of such Product, if any, only until such time as Agenus has received Incremental Royalties equal to [**] of the total amount of Development Costs paid by Agenus with respect to the Development of such Product after the exercise of the Co-Development Option Exercise Feeunder Section 4.4(b), ELAN after which time the royalty rate in Section 7.6(a)(i) shall be free thereafter to Develop the applicable IL-23 Aptamer and/or IL-23 Product on its own or have it Developed under sublicense to a Third Party for any and all Indications and formulations throughout the Territory with no further option exercisable by ARCHEMIX. Notwithstanding any of the foregoing, in no event shall ARCHEMIX be entitled to co-promote any Product (whether or not it has Co-Developed such Product) with ELANapply.
Appears in 1 contract
Samples: License, Development and Commercialization Agreement (Incyte Corp)
Co-Development Option. ARCHEMIX shall have i. Subject to the optionprovisions of this Agreement, exercisable on a oneTakeda grants to MTEM an option to Co-time basis for each IL-23 Aptamer undergoing Develop the Licensed Products that are under Development in accordance with this Agreement, as a potential IL-23 Product further set forth herein (the “Co-Development Option”). For clarity, but not MTEM’s rights and obligations under the obligation, to Co-Develop Development Option shall extend to any IL-23 Aptamer (within or all Licensed Products that are Developed under this Agreement during the applicable Indication and formulation andTerm. Following delivery by Takeda of the Post Phase Ia Program Plan as set forth in Section 2.1.2(a), as if MTEM desires to the Psoriatic Diseases exercise its Co-Development Option, within the applicable Co-Development Territory(ies)), and to share a certain percentage of the Operating Income (Loss) applicable to that IL-23 Aptamer within the applicable Co-Development Territory(ies), Indication and formulation then it shall do so by providing written notice to ELANTakeda within [***] after such delivery has occurred, which notice shall specify the applicable potential IL-23 Aptamerprovided, the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. applicable Co-Development Territory(ies) (as to the Psoriatic Diseases Co-Development Option) and the applicable ARCHEMIX Co-Development Percentage (the “however, that MTEM may not exercise its Co-Development Option Notice”). The unless it has paid all Co-Development Option shall only be exercised upon ARCHEMIX’ payment Costs that have come due pursuant to this Agreement as of the applicable date of such election (and for clarity shall pay Co-Development Option Exercise Fee (as defined in Section 4.11.1(b) below) either (i) with respect to each Psoriatic Diseases Co-Development Option, at any time Costs during the period commencing on the Effective Date and ending on the Psoriatic Diseases Option Termination Date (the “Psoriatic Diseases Option Exercise Period”) or (ii) with respect to each Non-Parenteral Co-Development Option, at any time during the period commencing on the Effective Date and ending on the Non-Parenteral Option Termination Date (the “Non-Parenteral Option Exercise Period”). If such payment is timely made as provided in the previous sentence, (i) the IL-23 Aptamer that is the subject pendency of the Co-Development Option shall thereafter be deemed to be a Co-Developed Product (within period).
ii. If MTEM exercises the applicable Indication and formulation and, as to the Psoriatic Diseases Co-Development Option, for then, and [***], at the applicable Co-beginning of [***], the Joint Steering Committee or designated subcommittee shall prepare an updated Post Phase Ia Program Plan that covers future Development Territory(ies)) for purposes of this Agreement, (ii) ARCHEMIX shall thereafter pay to ELAN the ARCHEMIX Co-Development Percentage of all Development Costs and Commercialization Costs applicable to that Co-Developed Product, either for the Territory and relevant formulations as to the Non-Parenteral Co-Development Option or for the applicable Co-Development Territory(ies), Indications and formulations as to the Psoriatic Diseases Co-Development Option, and (iiiof Licensed Product(s) ARCHEMIX shall share in the fraction of Operating Income (Loss) derived from such Co-Developed Product in the Territory for the relevant formulation (as to the Non-Parenteral Co-Development Option) or the applicable Co-Development Territory(ies), Indications and formulations (as to the Psoriatic Diseases Co-Development Option) in accordance with Section 4.11.3, equal to the applicable ARCHEMIX Co-Development Percentage multiplied by the applicable Operating Income (Loss) for that Co-Development Product within the applicable Co-Development Territory(ies), Indications and formulations. The Net Sales used to calculate Operating Income (Loss) for purposes of the Psoriatic Diseases Co-Development Option shall consist only of Net Sales derived from prescriptions written by Board-certified dermatologists and any other medical professionals whose prescriptions for Psoriatic Diseases (versus other Indications) are capable of being segregated, as reasonably determined in good faith by the JMC. The appropriate method of allocating Development Costs and Commercialization Costs on a Co- Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. Development Territory by Co-Development Territory basis shall be discussed in good faith between the Parties at the time the Psoriatic Diseases Co-Development Option Notice is given to ARCHEMIX, and shall be subject to the dispute resolution procedure set forth in Section 13.1 if the Parties cannot mutually agree upon such matter within [***] days after detailed projection on costs and activities for MTEM’s budgeting process. MTEM shall have the opportunity to provide input into the [***] updated Post Phase Ia Program Plan, such discussions commenceinput to be reasonably considered by Takeda. ARCHEMIX Takeda, at the JSC level, shall not be entitled have [***] decision making regarding any of the annual updates to receive milestone payments or royalties for milestone events or Net Sales occurring with respect the Post Phase Ia Program Plan subject to such Co-Developed Product for the applicable Co-Development Territory (or the Territory for Non-Parenteral Co-Developed Products) and for the relevant Indications and formulations being Co-Developed, after ARCHEMIX has given the applicable Co-Development Option NoticeSection 4.3.4.
iii. If ARCHEMIX MTEM does not timely exercise its elect the Co-Development Option within the applicable Option Exercise Period and timely pay the applicable Co-Development Option Exercise Feetime period specified in this Section 2.1.2(b), ELAN then MTEM shall be free thereafter to Develop the applicable IL-23 Aptamer and/or IL-23 Product on its own or have it Developed under sublicense to a Third Party for any and all Indications and formulations throughout the Territory with no further option exercisable by ARCHEMIX. Notwithstanding any right to fund or participate in the conduct of the foregoing, in no event shall ARCHEMIX be entitled to co-promote any Product (whether or not it has Co-Developed such Product) with ELANPost Phase Ia Program Plan.
Appears in 1 contract
Samples: Development Collaboration and Exclusive License Agreement (Molecular Templates, Inc.)