Baseball Arbitration. 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 have no less than ten (10) years of experience in the biotechnology or pharmaceutical industry and relevant expertise and experience with respect to the Expert Matter (“Expert”) and shall be selected by mutual agreement of the Parties. If the Parties are unable to agree upon an Expert within [***] after 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 second of such experts, an independent third expert who meets such criteria to be the Expert. Within [***] after appointment of the Expert, each Party shall submit to the Expert, with a copy to the other Party, one (1) proposal for resolving the applicable Expert Matter, including the proposed Agreement Payment and a reasonably detailed analysis of the model prepared by such Party taking into account the factors described in Section 9.2(c) to determine the proposed Agreement Payment. The Expert will be instructed to select one Party’s proposal no later than [***] 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 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.
Appears in 2 contracts
Samples: Collaboration Agreement (Artiva Biotherapeutics, Inc.), Collaboration Agreement (Artiva Biotherapeutics, Inc.)
Baseball Arbitration. 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” Any Dispute for which arbitration pursuant to this Exhibit 9.2(cSection 16.3 is specifically provided for in this Agreement shall be finally decided by expedited arbitration in accordance with the following abbreviated dispute resolution procedures:
(a) rather than pursuant to the procedures under Section 17.2. If the Expert Matter Dispute is not resolved within [***] thirty (30) days after referral to the Parties’ Executive OfficersParty’s respective Senior Officers pursuant to Section 16.2, then either Party may send the other Party a written notice requesting that it wishes to resolve the Expert Matter Dispute by using a neutral Third Party who is an independent investment banker who shall have no less than ten Expert with at least fifteen (1015) years of experience in area of the biotechnology or pharmaceutical industry and relevant expertise and experience with respect to Dispute (the Expert Matter (“Neutral Expert”) and ). The date of the other Party’s receipt of such written notices shall be selected by mutual agreement the “Notice Date.”
(b) Within fifteen (15) Business Days of the PartiesNotice Date, each Party shall notify the other Party in writing of its appointed Expert (each, a “Representative Expert”). If The Representative Experts for each Party shall jointly appoint the Parties are unable to agree upon an Neutral Expert within [***] fifteen (15) Business Days.
(c) Within ten (10) Business Days after 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 second of such experts, an independent third expert who meets such criteria to be the Expert. Within [***] after appointment of the Neutral Expert, each Party shall submit to the Expertother Party and the Neutral Expert a written summary regarding its position with respect to the Dispute. Contemporaneously with the submission of its written summary regarding its position, each Party shall provide the other Party and the Neutral Expert with a copy copies of all documents it relied upon in its written summary; provided that each Party may redact any portion of such documents which are covered by an applicable privilege or do not relate to the subject matter of this Agreement. Within three (3) Business Days of receipt of the other Party's written summary regarding its position, one each Party may submit an opposition statement of no more than five (15) proposal pages in length (excluding exhibits and declarations). Neither Party will be allowed to conduct any discovery. Neither Party may have any communications (either written or oral) with the other Party’s Representative Experts or the Neutral Expert other than for resolving the applicable sole purpose of engaging the expert panel or as expressly permitted in this Section 16.3; provided, that oral presentations and follow-up written submissions may be made to the Neutral Expert Matterat such Neutral Expert's request. The Neutral Expert may consult in writing with the Representative Experts regarding the submissions made by either Party; provided that both Representative Experts are aware of such consultation and provided an opportunity to respond. Evaluating each Party’s written submissions, including the proposed Agreement Payment and a reasonably detailed analysis Neutral Expert shall, within ten (10) Business Days of receipt of the model prepared by such Party taking into account the factors described written opposition statement, select in Section 9.2(c) to determine the proposed Agreement Paymenttotal, either Takeda's submission or Ultragenyx’s submission. The Expert will be instructed to select one Party’s proposal no later than [***] 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 Such decision shall be final final, binding and binding on not appealable.
(d) The Party whose submission is not selected shall be solely responsible for the Parties. The out-of-pocket costs expenses and fees of the Neutral Expert in making and the determination pursuant to this Exhibit 9.2(c) shall be shared equally by the Parties, regardless reasonable costs and fees 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 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 11other Party’s Representative Expert.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Ultragenyx Pharmaceutical Inc.), License and Collaboration Agreement (Ultragenyx Pharmaceutical Inc.)
Baseball Arbitration. 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 have no less than ten (10) years of experience in the biotechnology or pharmaceutical industry and relevant expertise and experience with respect to the Expert Matter (“Expert”) and shall be selected by mutual agreement of the Parties. If the Parties are unable to agree upon an Expert within [*****] after 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 second of such experts, an independent third expert who meets such criteria to be the Expert. Within [*****] after appointment of the Expert, each Party shall submit to the Expert, with a copy to the other Party, one (1) proposal for resolving the applicable Expert Matter, including the proposed Agreement Payment and a reasonably detailed analysis of the model prepared by such Party taking into account the factors described in Section 9.2(c) to determine the proposed Agreement Payment. The Expert will be instructed to select one Party’s proposal no later than [*****] 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 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. · Companies to combine their clinical programs (AFM13, AB-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 a nascent stage, and we selected Artiva because of their commercially-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, CEO of Artiva. “The data Affimed has generated to date with AFM13 in combination with cord blood-derived NK cells in a patient population with great unmet need is very compelling, and we are excited to partner with Affimed on what could become one of the 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 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 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 program in relapsed/refractory CD30-positive lymphoma patients during the first half of 2023. Under the terms of the agreement, Affimed and Artiva will pursue the 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%. <To be inserted when available> 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 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). 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 receptor CD16 and a KIR-B haplotype for enhanced product activity. Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a 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 assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.
Appears in 1 contract
Baseball Arbitration. 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 have no less than ten (10) years of experience in the biotechnology or pharmaceutical industry and relevant expertise and experience with respect to the Expert Matter (“Expert”) and shall be selected by mutual agreement of the Parties. If the Parties are unable to agree upon an Expert within [*****] after 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 second of such experts, an independent third expert who meets such criteria to be the Expert. Within [*****] after appointment of the Expert, each Party shall submit to the Expert, with a copy to the other Party, one (1) proposal for resolving the applicable Expert Matter, including the proposed Agreement Payment and a reasonably detailed analysis of the model prepared by such Party taking into account the factors described in Section 9.2(c) to determine the proposed Agreement Payment. The Expert will be instructed to select one Party’s proposal no later than [*****] 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 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. · Companies to combine their clinical programs (AFM13, AB-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 a nascent stage, and we selected Artiva because of their commercially-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, CEO of Artiva. “The data Affimed has generated to date with AFM13 in combination with cord blood-derived NK cells in a patient population with great unmet need is very compelling, and we are excited to partner with Affimed on what could become one of the 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 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 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 program in relapsed/refractory CD30-positive lymphoma patients during the first half of 2023. Under the terms of the agreement, Affimed and Artiva will pursue the 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%. <To be inserted when available> 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 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). 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 receptor CD16 and a KIR-B haplotype for enhanced product activity. Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a 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 assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.
Appears in 1 contract
Baseball Arbitration. If the Parties fail to agree on any matter described in Section 3.2, Section 8.5, or Section 13.6(c)(iii), and, in any such case, a Party submits such failure to baseball arbitration for final resolution, then relevant failure to agree shall be resolved in accordance with this Section 14.5. Within [***] following a Party’s receipt of any baseball arbitration notice from the other Party, the Parties shall meet and attempt to agree on an independent Third Party expert with at least [***] of experience in the licensing of biopharmaceutical compounds or products. If the Parties cannot agreeagree on such expert within such time period, 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 then each 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 may nominate one independent expert within [***] after referral to such [***] period and the Parties’ Executive Officers, then either Party may send two experts so selected shall nominate the other Party a written notice requesting to resolve the Expert Matter by using an final independent investment banker who shall have no less than ten (10) years of experience in the biotechnology or pharmaceutical industry and relevant expertise and experience with respect to the Expert Matter (“Expert”) and shall be selected by mutual agreement of the Parties. If the Parties are unable to agree upon an Expert expert within [***] after 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 second of such experts, an independent third expert who meets such criteria to be the Experttheir nomination. Within [***] of her or their appointment, the expert(s) shall set a date for the arbitration, which date shall be scheduled as soon as possible and is intended to be scheduled no more than [***] after appointment of the Expertdate the arbitration is demanded. At least [***] prior to the arbitration, each Party shall submit to provide the Expert, expert with a copy complete, written proposal of a proposal of (a) if the matter is referred pursuant to Section 3.2, whether the other Partydecision proposed by Licensee’s Senior Executive (i) would be reasonably expected to create an unnecessary risk to patient safety; or (ii) would reasonably be expected to have a material adverse effect on the development, one (1) proposal for resolving registration, manufacturing or commercialization of Product in the applicable Expert Matter, including the proposed Agreement Payment and a reasonably detailed analysis Verrica Territory or outside of the model prepared by Field in the Territory, (b) if the matter is referred pursuant to Section 8.5, the royalty payments that would be payable to Verrica in lieu of the Transfer Price payment, or (c) if the matter is referred pursuant to Section 13.6(c)(iii), the commercially reasonable terms for the continued practice of the Grant-Back License following termination of this Agreement, in each case of (a)–(c) along with any documentary or other evidence it wishes to provide in support for such Party taking into account proposal. After receiving both Parties’ proposals, the factors described in Section 9.2(cexpert(s) will have the right to determine meet with the proposed Agreement PaymentParties as necessary to inform the expert’s determination and to perform independent research and analysis. The Expert expert(s) will be instructed to select one of the Party’s proposal no later than proposals without modification within [***] 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 Agreementproposals. The Expert shall select only one (1expert(s) will deliver her/their decision regarding the disputed matter in writing, which decision will be made in accordance with the standard for resolution 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 matter set forth 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 Agreement and will be final binding and binding on the conclusive upon both Parties. The out-of-pocket costs Party whose proposal is not selected by the experts is responsible for the fees of the Expert in making experts and the determination pursuant to this Exhibit 9.2(c) shall be shared equally by the Parties, regardless costs and expenses of the outcome baseball arbitration. The provisions of the determination. All activities undertaken by the Expert will be conducted subject Section 14.3 and Section 14.4 apply to obligations of confidentiality no less restrictive than those set forth in Article 11. Further, the Parties acknowledge and agree that their respective proposals and all information exchanged in connection with the expert proceedings, and the conduct of such any baseball arbitration proceedings and any information produced thereunder shall be Confidential Information commenced under this Agreement and subject to the provisions of Article 11Section 14.5 mutatis mutandis.
Appears in 1 contract
Samples: Collaboration and License Agreement (Verrica Pharmaceuticals Inc.)