Common use of Baseball Arbitration Clause in Contracts

Baseball Arbitration. All Disputes arising under [***], shall be determined by arbitration administered by the International Centre for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by the Parties. If the Parties are unable to select an arbitrator within [***] after commencement of the arbitration, then the arbitrator shall be appointed by the ICDR in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the Dispute. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment of the arbitrator, each Party shall submit to the arbitrator and the other Party a proposed resolution of the Dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearing. Within [***] after such hearing, the arbitrator shall select one of the final Proposals so submitted by one of the Parties as the resolution of the Dispute, but may not alter the terms of either final Proposal and may not resolve the Dispute in a manner other than by selection of one of the submitted final Proposals. If a Party fails to submit a Proposal within the initial [***] time frame set forth above, the arbitrator will select the Proposal of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdiction.

Appears in 1 contract

Samples: Collaboration and Option Agreement (Aptevo Therapeutics Inc.)

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Baseball Arbitration. All This Section 15.11 applies to Disputes arising under Section 14.5(c) to be resolved by baseball arbitration. Baseball arbitration will be conducted by [***], shall be determined by arbitration administered by the International Centre for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by reasonably acceptable to the PartiesParties and who shall be appointed in accordance with the Rules. If the Parties are unable to select an arbitrator within [***] after commencement following notice from either Party that it elects to resolve a Dispute through baseball arbitration under the terms of the arbitrationthis Section 15.11, then the arbitrator shall will be appointed by the ICDR in accordance with its the Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the Dispute. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment selection of the arbitrator, each Party shall submit to the arbitrator and to the other Party a proposed resolution of the Dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). The Parties shall meet and confer on the amount and type of evidence that may be submitted to the arbitrator but, if the Parties are unable to agree, the arbitrator shall decide. Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearing; provided, that a Party may take such actions in preparation for its submission of evidence. Within [***] after such hearing, the arbitrator shall select one of the final Proposals so submitted by one of the Parties as the resolution of the Dispute, but may not alter the terms of either final Proposal and may not resolve the Dispute in a manner other than by selection of one of the submitted final Proposals. The Parties agree that if the final award is rendered after this time period expires, it shall not be a basis for vacatur or grounds to resist enforcement of the award. If a Party fails to submit a Proposal within the initial [***] time frame set forth above, the arbitrator will shall select the Proposal of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdiction.

Appears in 1 contract

Samples: Collaboration and License Agreement (Molecular Partners Ag)

Baseball Arbitration. All Disputes arising If the Parties cannot agree, following escalation to the Executive Officers, on the Agreement Payment pursuant to Section 9.2(c) (such dispute, an “Expert Matter”), at the request of either Party by written notice to the other Party, such Expert Matter will be resolved through binding “baseball” arbitration pursuant to this Exhibit 9.2(c) rather than pursuant to the procedures under Section 17.2. If the Expert Matter is not resolved within [***]**] after referral to the Parties’ Executive Officers, then either Party may send the other Party a written notice requesting to resolve the Expert Matter by using an independent investment banker who shall be determined by arbitration administered by have no less than ten (10) years of experience in the International Centre for Dispute Resolution biotechnology or pharmaceutical industry and relevant expertise and experience with respect to the Expert Matter (the ICDRExpert”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by mutual agreement of the Parties. If the Parties are unable to select agree upon an arbitrator Expert within [*****] after commencement a Party gives the written notice requesting expert resolution, then each Party will have [*****] to choose a single independent expert meeting the Expert criteria, and the Parties shall instruct such experts to use best efforts to mutually select, within [*****] following the selection of the arbitrationsecond of such experts, then an independent third expert who meets such criteria to be the arbitrator shall be appointed by the ICDR in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the DisputeExpert. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment of the arbitratorExpert, each Party shall submit to the arbitrator and Expert, with a copy to the other Party Party, one (1) proposal for resolving the applicable Expert Matter, including the proposed Agreement Payment and a proposed resolution reasonably detailed analysis of the Dispute that is model prepared by such Party taking into account the subject of factors described in Section 9.2(c) to determine the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”)proposed Agreement Payment. Within The Expert will be instructed to select one Party’s proposal no later than [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after following the receipt of both Parties’ proposals and to select the proposal that he or she determines is the most commercially reasonable under the circumstances and best gives effect to the intent of the Parties to effect the Agreed Value under this Agreement. The Expert shall select only one (1) of the proposals submitted by the Parties (without making any changes to such proposal) and shall render such proposal as the Expert’s final decision. Notwithstanding anything to the contrary in this Agreement, the Expert shall not have the authority to render any decision other than selecting one (1) proposal submitted by a Party pursuant to this Exhibit 9.2(c). The Expert’s decision shall be final and binding on the Parties. The out-of-pocket costs of the Expert in making the determination pursuant to this Exhibit 9.2(c) shall be shared equally by the Parties, regardless of the outcome of the determination. All activities undertaken by the Expert will be conducted subject to obligations of confidentiality no less restrictive than those set forth in Article 11. Further, the Parties acknowledge and agree that their final Proposals respective proposals and all information exchanged in connection with the expert proceedings, and the conduct of such proceedings and any information produced thereunder shall be Confidential Information under this Agreement and subject to the provisions of Article 11. ​ ​ ​ Exhibit 12.1 Press Release ​ Affimed and Artiva Biotherapeutics Announce Partnership to Advance Combination Therapy of Innate Cell Engager (ICE®) AFM13 and rebuttalsOff-the-Shelf Allogeneic NK Cell Therapy AB-101 · Companies to combine their clinical programs (AFM13, if anyAB-101) to address high unmet need of CD30-positive lymphoma patients · Affimed’s AFM13 in combination with cord blood-derived NK cells demonstrated exceptionally high response rates in relapsed and refractory CD30-positive lymphoma patients · AB-101 is a clinical-stage, cryopreserved, off-the shelf, non-genetically modified, allogeneic cord blood-derived NK cell manufactured at large scale via Artiva’s AlloNKTM platform as a universal ADCC-enhancing cell therapy · In preclinical studies, the combination of AFM13 and AB-101 demonstrated potent anti-tumor activity · An investigational new drug (IND) submission to the U.S. Food and Drug Administration (FDA) is planned for the first half of 2023 · Affimed to receive 67% of the combination therapy revenues, and Artiva to receive 33% · Companies to host conference call/webcast later today at 10:30 am EDT San Diego and Heidelberg, Germany, November X, 2022 – Affimed N.V. (Nasdaq: AFMD) (“Affimed”), and Artiva Biotherapeutics Inc. (“Artiva”), both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, today announced a new strategic partnership to jointly develop, manufacture, and commercialize a combination therapy comprised of Affimed’s Innate Cell Engager (ICE®) AFM13 and Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101. Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 combination to the FDA requesting feedback on the clinical trial design in relapsed/refractory (r/r) Hodgkin lymphoma (HL) with an exploratory arm evaluating the combination in selected subtypes of r/r CD30-positive peripheral T-cell lymphoma (PTCL) and potential path to registration. FDA responded to this request and guided to providing feedback by Q1 2023. This clinical agreement follows the parties’ existing two-year preclinical collaboration to assess combining elements of the companies’ respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies. ​ ​ “Based on the compelling clinical data we have generated for AFM13 in combination with NK cells, we are committed to finding the fastest path to bringing this potentially life-changing treatment to lymphoma patients,” said Xx. Xxx Xxxxx, CEO of Affimed. “The allogeneic NK field is still at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support a nascent stage, and we selected Artiva because of their argumentscommercially-viable production process that can support a multicenter clinical trial and potentially enable a path to registration.” "We are developing AB-101 as a universal ADCC enhancer when combined with monoclonal antibodies and NK cell engagers,” said Xx. Xxxx Xxxxx, nor compel any production CEO of documents or take any discovery from the other Party Artiva. “The data Affimed has generated to date with AFM13 in preparation for the hearing. Within [***] after such hearingcombination with cord blood-derived NK cells in a patient population with great unmet need is very compelling, the arbitrator shall select and we are excited to partner with Affimed on what could become one of the final Proposals so submitted by one first approvals for an allogeneic NK cell therapy-based regimen.” AFM13 is currently being investigated in combination with allogeneic cord blood-derived NK cells (CBNK) in an investigator-sponsored study together with The University of Texas MD Xxxxxxxx Cancer Center. Data from this study published earlier today for presentation at the 64th ASH Annual Meeting and Exposition demonstrated that all 24 patients in the recommended Phase 2 dose cohort responded (overall response rate of 100%) and showed a complete response rate of 70.8%. The combination was well tolerated with few infusion-related reactions and without cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host disease. The Affimed-Artiva partnership aims to expedite further development of the Parties as combination therapy in CD30-positive lymphoma patients who have exhausted other treatment options. AB-101 has already completed a monotherapy safety cohort in an initial Phase 1 trial and is currently being assessed in combination with the resolution anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory non-Hodgkin lymphoma (NHL). Preclinical results investigating the combination of AFM13 and AB-101 have further demonstrated enhanced anti-tumor activity. The companies plan to file an IND for the Dispute, but may not alter program in relapsed/refractory CD30-positive lymphoma patients during the first half of 2023. Under the terms of either final Proposal the agreement, Affimed and may not resolve Artiva will pursue the Dispute development of the AFM13/AB-101 combination treatment in the United States on a co-exclusive basis. Affimed will lead regulatory activities through the Phase 2 and any confirmatory studies. Affimed will be responsible for funding clinical study costs through Phase 2, while Artiva will be responsible for the costs of supplying AB-101 and IL-2 for such studies. Following a potential accelerated approval, the companies will share confirmatory study costs on a 50/50 basis. Both companies will retain commercialization and distribution rights and book sales for their respective products. Affimed will be responsible for promotional activities and expenses of the combination therapy. Pursuant to the agreement, revenues from the combination will be shared, with Affimed receiving 67% of the combination therapy revenue and Artiva receiving 33%. ​ Conference Call/Webcast Details ​ ​ <To be inserted when available> About AFM13 AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Xxxxxxx’s most advanced ICE® clinical program and is currently being evaluated as a monotherapy in a manner other than by selection of one registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). Additional details can be found at xxx.xxxxxxxxxxxxxx.xxx (NCT04101331). About AB-101 AB-101 is a cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva selects cord blood units with the high affinity variant of the submitted final Proposalsreceptor CD16 and a KIR-B haplotype for enhanced product activity. If Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a Party fails single umbilical cord blood unit while retaining the high and consistent expression of CD16 without the need for engineering. Artiva is conducting a Phase 1/2 multicenter clinical trial (XxxxxxxxXxxxxx.xxx Identifier: NCT04673617) to submit a Proposal within assess the initial [***] time frame set forth abovesafety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, the arbitrator will select the Proposal rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdictiontherapy.

Appears in 1 contract

Samples: Collaboration Agreement (Affimed N.V.)

Baseball Arbitration. All Disputes arising under Any Deadlocked Matters referred to this Section 17.4(c) for resolution in accordance with Section 3.7 shall be submitted to and finally resolved by the following provisions in this Section 17.4(c) (the “baseball-style” arbitration). The Parties will select and agree upon a mutually acceptable single arbitrator with at least ten (10) years’ 119 experience in the licensing, development and commercialization of pharmaceutical products, including biologics, who is independent of each Party (i.e., not a current or former employee, consultant, officer, or director or current stockholder of either Party or their respective Affiliates and who does not otherwise have any current or previous business relationship with either Party or their respective Affiliates), within [***] following the end of the [***] period during which the Executive Officers failed to resolve such Deadlocked Matter, provided that if the Parties are unable or fail to agree upon the arbitrator within [***], shall be determined by arbitration administered by the International Centre for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by the Parties. If the Parties are unable to select an arbitrator within [***] after commencement of the arbitration, then the arbitrator shall be appointed by the ICDR in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training Judicial Arbitration and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the Dispute. Within Mediation Services (“JAMS”) within [***] after commencement of ]. The arbitration shall be conducted in accordance with the arbitration, the responding party shall submit its written Answer JAMS procedures to the Notice of Arbitration. Within [***] after appointment of the arbitrator, each Party shall submit to the arbitrator and the other Party a proposed resolution of the Dispute that is the subject of the arbitration, together extent consistent with any relevant evidence in support thereof (collectively, the “Proposals”this Section 17.4(c). Within [***] after the delivery selection of the last Proposal to the arbitrator, each Party may will submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and to the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for such Party’s proposal on the hearingterms pertaining to such Deadlocked Matter. Within [***] after such hearingreceiving each Parties’ proposal, the arbitrator shall will select one as final and binding the proposal such arbitrator believes is consistent with the successful advancement of the final Proposals so submitted by one relevant Program(s) and the successful Development and Commercialization of relevant Products, in each case, consistent with the express terms and conditions of this Agreement and, to the extent determinable, consistent with the intent of the Parties as when this Agreement was entered into; provided the resolution of the Dispute, but arbitrator may not alter the terms of either final Proposal this Agreement, and may not resolve the Dispute in a manner other than by selection of one of the submitted final Proposals. If a Party fails to submit a Proposal within the initial [***] time frame set forth above, the arbitrator will select not have the Proposal authority to modify either Party’s proposal. The decision of the other Party as arbitrator will be final and binding on the resolution of the DisputeParties. The place of arbitration shall be New York City, New York; Parties agree that the language of the arbitration shall be English; and judgment on the award arbitrator’s decision may be entered enforced in any court of competent jurisdiction.

Appears in 1 contract

Samples: License and Collaboration Agreement (Stoke Therapeutics, Inc.)

Baseball Arbitration. All Disputes This Section 14.10 (Baseball Arbitration) shall apply to disputes arising under [***], shall Section 13.3(b) (Effect of Termination) to be determined resolved by arbitration administered by the International Centre for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified hereinbaseball arbitration. Baseball arbitration shall will be conducted by one (1) arbitrator who shall be selected jointly by reasonably acceptable to the PartiesParties and who shall be appointed in accordance with the JAMS Rules. If the Parties are unable to select an arbitrator within [***] after commencement of the arbitration], then the arbitrator shall be appointed by the ICDR in accordance with its the JAMS Rules. Any arbitrator chosen hereunder under this Section 14.10 (Baseball Arbitration) shall have educational training significant legal or business experience in the pharmaceutical industry, and industry experience sufficient to demonstrate shall not be a reasonable level current or former employee or director, or a current or former shareholder of scientific, financial, medical and industry knowledge relevant to the Disputeeither Party or any of their respective Affiliates or any Sublicensee. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment selection of the arbitrator, each Party shall submit to the arbitrator and the other Party a proposed resolution of the Dispute dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] one (1) hour to argue in support of its Proposal. The Parties may shall not have the right to call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearingmeeting. Within [***] after such hearingmeeting, the arbitrator shall select one of the final Proposals so submitted by one of the Parties as the resolution of the Disputedispute, but may not alter the terms of either final Proposal and may not resolve the Dispute dispute in a manner other than by selection of one of the submitted final Proposals. If a Party fails to submit a Proposal within the initial [***] time frame set forth above, the arbitrator will shall select the Proposal of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdictiondispute.

Appears in 1 contract

Samples: License and Collaboration Agreement (Axovant Sciences Ltd.)

Baseball Arbitration. All Disputes arising If the Parties cannot agree, following escalation to the Executive Officers, on the Agreement Payment pursuant to Section 9.2(c) (such dispute, an “Expert Matter”), at the request of either Party by written notice to the other Party, such Expert Matter will be resolved through binding “baseball” arbitration pursuant to this Exhibit 9.2(c) rather than pursuant to the procedures under Section 17.2. If the Expert Matter is not resolved within [***]**] after referral to the Parties’ Executive Officers, then either Party may send the other Party a written notice requesting to resolve the Expert Matter by using an independent investment banker who shall be determined by arbitration administered by have no less than ten (10) years of experience in the International Centre for Dispute Resolution biotechnology or pharmaceutical industry and relevant expertise and experience with respect to the Expert Matter (the ICDRExpert”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by mutual agreement of the Parties. If the Parties are unable to select agree upon an arbitrator Expert within [*****] after commencement a Party gives the written notice requesting expert resolution, then each Party will have [*****] to choose a single independent expert meeting the Expert criteria, and the Parties shall instruct such experts to use best efforts to mutually select, within [*****] following the selection of the arbitrationsecond of such experts, then an independent third expert who meets such criteria to be the arbitrator shall be appointed by the ICDR in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the DisputeExpert. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment of the arbitratorExpert, each Party shall submit to the arbitrator and Expert, with a copy to the other Party Party, one (1) proposal for resolving the applicable Expert Matter, including the proposed Agreement Payment and a proposed resolution reasonably detailed analysis of the Dispute that is model prepared by such Party taking into account the subject of factors described in Section 9.2(c) to determine the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”)proposed Agreement Payment. Within The Expert will be instructed to select one Party’s proposal no later than [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after following the receipt of both Parties’ proposals and to select the proposal that he or she determines is the most commercially reasonable under the circumstances and best gives effect to the intent of the Parties to effect the Agreed Value under this Agreement. The Expert shall select only one (1) of the proposals submitted by the Parties (without making any changes to such proposal) and shall render such proposal as the Expert’s final decision. Notwithstanding anything to the contrary in this Agreement, the Expert shall not have the authority to render any decision other than selecting one (1) proposal submitted by a Party pursuant to this Exhibit 9.2(c). The Expert’s decision shall be final and binding on the Parties. The out-of-pocket costs of the Expert in making the determination pursuant to this Exhibit 9.2(c) shall be shared equally by the Parties, regardless of the outcome of the determination. All activities undertaken by the Expert will be conducted subject to obligations of confidentiality no less restrictive than those set forth in Article 11. Further, the Parties acknowledge and agree that their final Proposals respective proposals and all information exchanged in connection with the expert proceedings, and the conduct of such proceedings and any information produced thereunder shall be Confidential Information under this Agreement and subject to the provisions of Article 11. ​ Exhibit 12.1 Press Release ​ Affimed and Artiva Biotherapeutics Announce Partnership to Advance Combination Therapy of Innate Cell Engager (ICE®) AFM13 and rebuttalsOff-the-Shelf Allogeneic NK Cell Therapy AB-101 · Companies to combine their clinical programs (AFM13, if anyAB-101) to address high unmet need of CD30-positive lymphoma patients · Affimed’s AFM13 in combination with cord blood-derived NK cells demonstrated exceptionally high response rates in relapsed and refractory CD30-positive lymphoma patients · AB-101 is a clinical-stage, cryopreserved, off-the shelf, non-genetically modified, allogeneic cord blood-derived NK cell manufactured at large scale via Artiva’s AlloNKTM platform as a universal ADCC-enhancing cell therapy · In preclinical studies, the combination of AFM13 and AB-101 demonstrated potent anti-tumor activity · An investigational new drug (IND) submission to the U.S. Food and Drug Administration (FDA) is planned for the first half of 2023 · Affimed to receive 67% of the combination therapy revenues, and Artiva to receive 33% · Companies to host conference call/webcast later today at 10:30 am EDT ​ San Diego and Heidelberg, Germany, November X, 2022 - Affimed N.V. (Nasdaq: AFMD) (“Affimed”), and Artiva Biotherapeutics Inc. (“Artiva”), both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, today announced a new strategic partnership to jointly develop, manufacture, and commercialize a combination therapy comprised of Affimed’s Innate Cell Engager (ICE®) AFM13 and Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101. Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 combination to the FDA requesting feedback on the clinical trial design in relapsed/refractory (r/r) Hodgkin lymphoma (HL) with an exploratory arm evaluating the combination in selected subtypes of r/r CD30-positive peripheral T-cell lymphoma (PTCL) and potential path to registration. FDA responded to this request and guided to providing feedback by Q1 2023. This clinical agreement follows the parties’ existing two-year preclinical collaboration to assess combining elements of the companies’ respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies. ​ “Based on the compelling clinical data we have generated for AFM13 in combination with NK cells, we are committed to finding the fastest path to bringing this potentially life-changing treatment to lymphoma patients,” said Xx. Xxx Xxxxx, CEO of Affimed. “The allogeneic NK field is still at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support a nascent stage, and we selected Artiva because of their argumentscommercially-viable production process that can support a multicenter clinical trial and potentially enable a path to registration.” "We are developing AB-101 as a universal ADCC enhancer when combined with monoclonal antibodies and NK cell engagers,” said Xx. Xxxx Xxxxx, nor compel any production CEO of documents or take any discovery from the other Party Artiva. “The data Affimed has generated to date with AFM13 in preparation for the hearing. Within [***] after such hearingcombination with cord blood-derived NK cells in a patient population with great unmet need is very compelling, the arbitrator shall select and we are excited to partner with Affimed on what could become one of the final Proposals so submitted by one first approvals for an allogeneic NK cell therapy-based regimen.” AFM13 is currently being investigated in combination with allogeneic cord blood-derived NK cells (CBNK) in an investigator-sponsored study together with The University of Texas MD Xxxxxxxx Cancer Center. Data from this study published earlier today for presentation at the 64th ASH Annual Meeting and Exposition demonstrated that all 24 patients in the recommended Phase 2 dose cohort responded (overall response rate of 100%) and showed a complete response rate of 70.8%. The combination was well tolerated with few infusion-related reactions and without cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host disease. The Affimed-Artiva partnership aims to expedite further development of the Parties as combination therapy in CD30-positive lymphoma patients who have exhausted other treatment options. AB-101 has already completed a monotherapy safety cohort in an initial Phase 1 trial and is currently being assessed in combination with the resolution anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory non-Hodgkin lymphoma (NHL). Preclinical results investigating the combination of AFM13 and AB-101 have further demonstrated enhanced anti-tumor activity. The companies plan to file an IND for the Dispute, but may not alter program in relapsed/refractory CD30-positive lymphoma patients during the first half of 2023. Under the terms of either final Proposal the agreement, Affimed and may not resolve Artiva will pursue the Dispute development of the AFM13/AB-101 combination treatment in the United States on a co-exclusive basis. Affimed will lead regulatory activities through the Phase 2 and any confirmatory studies. Affimed will be responsible for funding clinical study costs through Phase 2, while Artiva will be responsible for the costs of supplying AB-101 and IL-2 for such studies. Following a potential accelerated approval, the companies will share confirmatory study costs on a 50/50 basis. Both companies will retain commercialization and distribution rights and book sales for their respective products. Affimed will be responsible for promotional activities and expenses of the combination therapy. Pursuant to the agreement, revenues from the combination will be shared, with Affimed receiving 67% of the combination therapy revenue and Artiva receiving 33%. ​ Conference Call/Webcast Details ​ <To be inserted when available> About AFM13 AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Xxxxxxx’s most advanced ICE® clinical program and is currently being evaluated as a monotherapy in a manner other than by selection of one registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). Additional details can be found at xxx.xxxxxxxxxxxxxx.xxx (NCT04101331). About AB-101 AB-101 is a cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva selects cord blood units with the high affinity variant of the submitted final Proposalsreceptor CD16 and a KIR-B haplotype for enhanced product activity. If Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a Party fails single umbilical cord blood unit while retaining the high and consistent expression of CD16 without the need for engineering. Artiva is conducting a Phase 1/2 multicenter clinical trial (XxxxxxxxXxxxxx.xxx Identifier: NCT04673617) to submit a Proposal within assess the initial [***] time frame set forth abovesafety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, the arbitrator will select the Proposal rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdictiontherapy.

Appears in 1 contract

Samples: Collaboration Agreement (Affimed N.V.)

Baseball Arbitration. All Disputes arising under [***]Subject to Section 14.1, any Combination Product Dispute (pursuant to Section 1.60) shall be determined by arbitration administered submitted to and finally resolved by the International Centre for Dispute Resolution following provisions (i.e., “baseball-style” arbitration). The Parties shall promptly designate in writing a single mutually acceptable arbitrator experienced in the “ICDR”) in accordance licensing, development, and commercialization of pharmaceutical products, who is independent of each Party (i.e., not a current or former employee, consultant, officer, or director or current stockholder of either Party or their respective Affiliates and who does not otherwise have any current or previous business relationship with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by the Partieseither Party or their respective Affiliates). If the Parties are unable to select cannot agree on an arbitrator within [***] after commencement referral of the arbitrationsuch matter, then the arbitrator shall be appointed selected by the ICDR President of the Chamber of Commerce of New York. The arbitration shall be conducted in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant the Rules to the Disputeextent consistent with this Section 14.2(b). Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment of the arbitrator’s appointment, each Party shall prepare and deliver to both the arbitrator and other Party its last, best offer for the applicable unresolved terms and a memorandum in support thereof. The Parties shall also provide the arbitrator with a copy of the relevant provisions of this Agreement. Each Party may submit to the arbitrator and (with a copy to the other Party Party) a proposed resolution of rebuttal to the Dispute that is other Party’s support memorandum and will at such time have the subject of opportunity to amend its last such offer based on any new information contained in the arbitration, together with any relevant evidence in other Party’s support thereof (collectively, the “Proposals”)memorandum. Within [***] after the delivery of the last Proposal to the arbitrator’s appointment, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within will select from the [***] after proposals provided by the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for proposal such arbitrator believes is most consistent with the hearing. Within [***] after such hearing, the arbitrator shall select one of the final Proposals so submitted by one intent of the Parties as when this Agreement was entered into provided the resolution of the Dispute, but arbitrator may not alter the terms of either final Proposal and may not resolve the Dispute in a manner other than by selection of one this Agreement. The decision of the submitted arbitrator shall be final Proposals. If a Party fails to submit a Proposal within and binding on the initial [***] time frame set forth above, the arbitrator will select the Proposal of the other Party as the resolution of the DisputeParties. The place of foregoing “baseball-style” arbitration shall be New York City, New York; the language exclusive remedy of either Party if the arbitration shall be English; and judgment Parties cannot agree on the award may be entered in any court of competent jurisdictiona Combination Product Dispute.

Appears in 1 contract

Samples: License Agreement (Keros Therapeutics, Inc.)

Baseball Arbitration. All Subject to Section 14.1(a), any Disputes arising under over any amounts [***], disputes over matters set forth in Sections 4.2(b)(iii), 4.2(b)(iv), 4.2(b)(v), or 8.5(c)(i), Reversion Disputes and Transition Disputes shall be determined by arbitration administered submitted to and finally resolved by the International Centre for Dispute Resolution following provisions in this Section 14.1(c) (the “ICDR”) baseball-style” arbitration). The Parties shall [***] designate in accordance writing a single mutually acceptable arbitrator experienced in the licensing, development, and commercialization of pharmaceutical products, who is independent of each Party (i.e., not a current or former employee, consultant, officer, or director or current stockholder of either Party or their respective Affiliates and who does not otherwise have any current or previous business relationship with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by the Partieseither Party or their respective Affiliates). If the Parties are unable to select cannot agree on an arbitrator within [***] after commencement referral of the arbitrationsuch matter, then the arbitrator shall be appointed by the ICDR selected in accordance with its the Rules. Any arbitrator chosen hereunder The arbitration shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant be conducted in accordance with the Rules to the Disputeextent consistent with this Section 14.1(c). Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment of the arbitrator’s appointment, each Party shall submit prepare and deliver to both the arbitrator and the other Party its last, best offer for the applicable unresolved terms and a proposed resolution memorandum in support thereof. The Parties shall also provide the arbitrator with a copy of the Dispute that is relevant provisions of this Agreement. Each Party may submit to the subject of arbitrator (with a copy to the arbitration, together with other Party) a rebuttal to the other Party’s support memorandum and will at such time have the opportunity to amend its last such offer based on any relevant evidence new information contained in the other Party’s support thereof (collectively, the “Proposals”)memorandum. Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearing. Within [***] after such hearingappointment, the arbitrator shall will select one of from the final Proposals so submitted two (2) proposals provided by one the Parties the proposal such arbitrator believes is the most consistent with the intent of the Parties as when this Agreement was entered into; provided, however, the resolution arbitrator may not select any compromise or combination of the Dispute, but two (2) proposals and may not alter the terms of either final Proposal and may not resolve the Dispute in a manner other than by selection of one this Agreement. The decision of the submitted arbitrator shall be final Proposalsand binding on the Parties. If a The foregoing “baseball-style” arbitration shall be the exclusive remedy of either Party fails to submit a Proposal within if the initial Parties cannot agree on any Disputes over any amounts [***] time frame ], disputes over matters set forth abovein Sections 4.2(b)(iii), the arbitrator will select the Proposal of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City4.2(b)(iv), New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdiction.4.2(b)(v), or 8.5(c)(i),

Appears in 1 contract

Samples: Collaboration, Option and License Agreement (Exicure, Inc.)

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Baseball Arbitration. All Any Disputes arising over any amounts invoiced under [***]this Agreement, Disputes over matters set forth in Sections 2.10.2 (Decision-making for DT Co-Co Plans), 5.10.3(b) (Payments under Co-Co Moderna In-License Agreements), 5.10.4(b) (Payments under Co-Co Metagenomi In-License Agreements) and 12.6.2(b) (Reversion), shall be determined by arbitration administered submitted to and finally resolved by the International Centre for Dispute Resolution following provisions in this Section 13.4 (Baseball Arbitration). The Parties shall promptly designate in writing a single mutually acceptable arbitrator experienced in the “ICDR”) in accordance licensing, development, and commercialization of pharmaceutical products, who is independent of each Party (i.e., not a current or former employee, consultant, officer, or director or current stockholder of either Party or their respective Affiliates and who does not otherwise have any current or previous business relationship with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified herein. Baseball arbitration shall be conducted by one (1) arbitrator who shall be selected jointly by the Partieseither Party or their respective Affiliates). If the Parties are unable to select cannot agree on an arbitrator within [***] after commencement referral of the arbitrationsuch matter, then the arbitrator shall be appointed selected by the ICDR President of Greater Boston Chamber of Commerce. The arbitration shall be conducted in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant the ICC Arbitration Rules to the Disputeextent consistent with this Section 13.4 (Baseball Arbitration). Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment of the arbitrator’s appointment, each Party shall submit prepare and deliver to both the arbitrator and the other Party its last, best offer for the applicable unresolved terms and a proposed resolution memorandum in support thereof. The Parties shall also provide the arbitrator with a copy of the Dispute that is relevant provisions of this Agreement. Each Party may submit to the subject of arbitrator (with a copy to the arbitration, together with other Party) a rebuttal to the other Party’s support memorandum and shall at such time have the opportunity to amend its last such offer based on any relevant evidence new information contained in the other Party’s support thereof (collectively, the “Proposals”)memorandum. Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearing. Within [***] after such hearingappointment, the arbitrator shall select one of from the final Proposals so submitted two (2) proposals provided by one the Parties the proposal such arbitrator believes is the most consistent with the intent of the Parties as when this Agreement was entered into provided the resolution of the Dispute, but arbitrator may not alter the terms of either final Proposal and may not resolve the Dispute in a manner other than by selection of one this Agreement. The decision of the submitted arbitrator shall be final Proposals. If a Party fails to submit a Proposal within and binding on the initial [***] time frame set forth above, the arbitrator will select the Proposal of the other Party as the resolution of the DisputeParties. The place of foregoing “baseball-style” arbitration shall be New York Citythe exclusive remedy of either Party if the Parties cannot agree on any Disputes over any amounts invoiced under this Agreement, New York; the language of the arbitration shall be English; or Disputes over matters set forth in Sections 2.10.2 (Decision-making for DT Co-Co Plans), 5.10.3(b) (Payments under Co-Co Moderna In-License Agreements), 5.10.4(b) (Payments under Co-Co Metagenomi In-License Agreements) and judgment on the award may be entered in any court of competent jurisdiction12.6.2(b) (Reversion).

Appears in 1 contract

Samples: Collaboration and License Agreement (Metagenomi Technologies, LLC)

Baseball Arbitration. All Disputes This Section 13.12 (Baseball Arbitration) shall apply to disputes arising under [***], shall Section 12.3(b) (Effect of Termination) to be determined resolved by arbitration administered by the International Centre for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified hereinbaseball arbitration. Baseball arbitration shall will be conducted by one (1) arbitrator who shall be selected jointly by reasonably acceptable to the PartiesParties and who shall be appointed in accordance with the [***]. If the Parties are unable to select an arbitrator within [***] after commencement of the arbitration, then the arbitrator shall be appointed by the ICDR in accordance with its Rulesthe [***]. Any arbitrator chosen hereunder under this Section 13.12 (Baseball Arbitration) shall have educational training significant legal or business experience in the pharmaceutical industry, and industry experience sufficient to demonstrate shall not be a reasonable level current or former employee or director, or a current significant shareholder, of scientific, financial, medical and industry knowledge relevant to the Disputeeither Party or any of their respective Affiliates or any Sublicensee. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment selection of the arbitrator, each Party shall submit to the arbitrator and the other Party a proposed resolution of the Dispute dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] one (1) hour to argue in support of its Proposal. The Parties may shall not have the right to call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearingmeeting. Within [***] after such hearingmeeting, the arbitrator shall select one of the final Proposals so submitted by one of the Parties as the resolution of the Disputedispute, but may not alter the terms of either final Proposal and may not resolve the Dispute dispute in a manner other than by selection of one of the submitted final Proposals. If a Party fails to submit a Proposal within the initial [***] time frame set forth above, the arbitrator will shall select the Proposal of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdictiondispute.

Appears in 1 contract

Samples: License Agreement (Roivant Sciences Ltd.)

Baseball Arbitration. All Disputes arising under [***]Subject to Section 14.1, shall be determined by arbitration administered by the International Centre for any Development Participation Costs Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rulespursuant to Section 4.7(b)), as modified herein. Baseball arbitration shall be conducted by one Joint Clinical Trial Costs Dispute (1) arbitrator who shall be selected jointly by the Parties. If the Parties are unable pursuant to select an arbitrator within Section 4.3(b)(iii)), [***] or Combination Product Dispute (pursuant to Section 1.55) shall be submitted to and finally resolved by the following provisions (i.e., “baseball-style” arbitration). The Parties shall promptly designate in writing a single mutually acceptable arbitrator experienced in the licensing, development, and commercialization of pharmaceutical products, who is independent of each Party (i.e., not a current or former employee, consultant, officer, or director or current stockholder of either Party or their respective affiliates and who does not otherwise have any current or previous business relationship with either Party or their respective Affiliates). If the Parties cannot agree on an arbitrator within fifteen (15) Business Days after commencement referral of the arbitrationsuch matter, then the arbitrator shall be appointed selected by the ICDR President of the Chamber of Commerce of New York. The arbitration shall be conducted in accordance with its Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant the Rules to the Disputeextent consistent with this Section 14.2(b). Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment fifteen (15) Business Days of the arbitrator’s appointment, each Party shall prepare and deliver to both the arbitrator and other Party its last, best offer for the applicable unresolved terms and a memorandum in support thereof. The Parties shall also provide the arbitrator with a copy of the relevant provisions of this Agreement. Each Party may submit to the arbitrator and (with a copy to the other Party Party) a proposed resolution of the Dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). Within [***] after the delivery of the last Proposal rebuttal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal support memorandum and may also will at such time have the opportunity to amend and reits last such offer based on any new information contained in the other Party’s support memorandum. Within forty-submit its original Proposal. The Parties and the arbitrator shall meet within [***] five (45) Business Days after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] to argue in support of its Proposal. The Parties may not call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearing. Within [***] after such hearingarbitrator’s appointment, the arbitrator shall will select one of from the final Proposals so submitted two (2) proposals provided by one the Parties the proposal such arbitrator believes is most consistent with the intent of the Parties as when this Agreement was entered into provided the resolution of the Dispute, but arbitrator may not alter the terms of either final Proposal and may not resolve the Dispute in a manner other than by selection of one this Agreement. The decision of the submitted arbitrator shall be final Proposalsand binding on the Parties. If The foregoing “baseball-style” arbitration shall be the exclusive remedy of either Party if the Parties cannot agree on a Party fails to submit a Proposal within the initial Development Participation Costs Dispute, Joint Clinical Trial Costs Dispute, [***] time frame set forth above, the arbitrator will select the Proposal of the other Party as the resolution of the or Combination Product Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdiction.

Appears in 1 contract

Samples: Collaboration and License (Glycomimetics Inc)

Baseball Arbitration. All Disputes This Section 14.10 (Baseball Arbitration) shall apply to disputes arising under [***], shall Section 13.3(b) (Effect of Termination) to be determined resolved by arbitration administered by the International Centre for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified hereinbaseball arbitration. Baseball arbitration shall will be conducted by one (1) arbitrator who shall be selected jointly by reasonably acceptable to the PartiesParties and who shall be appointed in accordance with the JAMS Rules. If the Parties are unable to select an arbitrator within [***] after commencement of the arbitration*, then the arbitrator shall be appointed by the ICDR in accordance with its the JAMS Rules. Any arbitrator chosen hereunder under this Section 14.10 (Baseball Arbitration) shall have educational training significant legal or business experience in the pharmaceutical industry, and industry experience sufficient to demonstrate shall not be a reasonable level current or former employee or director, or a current or former shareholder of scientific, financial, medical and industry knowledge relevant to the Disputeeither Party or any of their respective Affiliates or any Sublicensee. Within [***] * after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment selection of the arbitrator, each Party shall submit to the arbitrator and the other Party a proposed resolution of the Dispute dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). Within [***] * after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] * after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] one (1) hour to argue in support of its Proposal. The Parties may shall not have the right to call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearingmeeting. Within [Confidential material omitted and filed separately with the Commission 71 ***] * after such hearingmeeting, the arbitrator shall select one of the final Proposals so submitted by one of the Parties as the resolution of the Disputedispute, but may not alter the terms of either final Proposal and may not resolve the Dispute dispute in a manner other than by selection of one of the submitted final Proposals. If a Party fails to submit a Proposal within the initial [***] * time frame set forth above, the arbitrator will shall select the Proposal of the other Party as the resolution of the Dispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdictiondispute.

Appears in 1 contract

Samples: License and Collaboration Agreement (Benitec Biopharma LTD/ADR)

Baseball Arbitration. All Disputes This Section 13.10 (Baseball Arbitration) shall apply to disputes arising under [***], shall Section 12.3(b) (Effect of Termination) to be determined resolved by baseball arbitration administered by and in connection with the International Centre calculation of Net Sales for Dispute Resolution (the “ICDR”) in accordance with its International Arbitration Rules and the Final Offer Supplementary Arbitration Rules, as modified hereinCombination Products. Baseball arbitration shall will be conducted by one (1) arbitrator who shall be selected jointly by reasonably acceptable to the PartiesParties and who shall be appointed in accordance with the JAMS Rules. If the Parties are unable to select an arbitrator within [***] after commencement of the arbitration], then the arbitrator shall be appointed by the ICDR in accordance with its the JAMS Rules. Any arbitrator chosen hereunder under this Section 13.10 (Baseball Arbitration) shall have educational training significant legal or business experience in the pharmaceutical industry, and industry experience sufficient to demonstrate shall not be a reasonable level current or former employee or director, or a current significant shareholder, of scientific, financial, medical and industry knowledge relevant to the Disputeeither Party or any of their respective Affiliates or any Sublicensee. Within [***] after commencement of the arbitration, the responding party shall submit its written Answer to the Notice of Arbitration. Within [***] after appointment selection of the arbitrator, each Party shall submit to the arbitrator and the other Party a proposed resolution of the Dispute dispute that is the subject of the arbitration, together with any relevant evidence in support thereof (collectively, the “Proposals”). Within [***] after the delivery of the last Proposal to the arbitrator, each Party may submit a written rebuttal of the other Party’s Proposal and may also amend and re-submit its original Proposal. The Parties and the arbitrator shall meet within [***] after the Parties have submitted their final Proposals (and rebuttals, if any), at which time each Party shall have [***] one (1) hour to argue in support of its Proposal. The Parties may shall not have the right to call any witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the hearingmeeting. Within [***] after such hearingmeeting, the arbitrator shall select one of the final Proposals so submitted by one of the Parties as the resolution of the Disputedispute, but may not alter the terms of either final Proposal and may not resolve the Dispute dispute in a manner other than by selection of one of the submitted final Proposals. If a Party fails to submit a Proposal within the initial [***] time frame set forth above, the arbitrator will shall select the Proposal of the other Party as the resolution of the Disputedispute. The place of arbitration shall be New York City, New York; the language of the arbitration shall be English; and judgment on the award may be entered in any court of competent jurisdiction[***].

Appears in 1 contract

Samples: License Agreement (Roivant Sciences Ltd.)

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