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 Notwithstanding anything to the Executive Officerscontrary contained herein, on the any dispute which this Agreement Payment explicitly specifies shall be resolved pursuant to this Section 9.2(c16.2 shall be determined in accordance with the procedure specified in Section 16.1, superseded by the arbitration procedure specified in this Section 16.2. There shall be no mediation. The Request for baseball Arbitration may be filed by either party at any time before, during or after the period of exchange of proposals described hereunder. If a party desires to resolve a matter which this Agreement expressly provides shall be determined under this Section 16.2 , such party (the “Initiating Party”) (such dispute, an “Expert Matter”), at the request of either Party by shall give written notice to the other party (the “Responding 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 containing a complete written proposal of the Parties. If resolution for 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 Expertmatter in dispute. Within [***] 10 business days after appointment receipt of any such notice, the Expert, each Responding Party shall submit to the Expert, Initiating Party a written counter proposal. The Initiating Party shall then have 2 ****** - Material has been omitted and filed separately with a copy the Commission. business days after receipt of the counterproposal in which to decide whether to modify its proposal by giving written notice of its revised proposal to the Responding Party. The Responding Party shall then have 2 business days after receipt of the revised proposal in which to decide whether to modify its proposal by giving written notice of its revised proposal to the Initiating Party. This process shall continue with each party sending alternate proposals to the other Party, one party until such time as the earliest of (1) proposal for resolving the applicable Expert Matterparties reach agreement on how to resolve the dispute, including the proposed Agreement Payment and a reasonably detailed analysis (2) one of the model prepared by such Party taking into account parties fails to respond within 2 business days after receipt of a proposal from the factors described in Section 9.2(cother party, or (3) a party determines that it is unwilling to change its proposal further. In the event of clause (2) or (3) of the foregoing sentence, either party may give written notice (a “Baseball Notice”) to other of its election to require the submission of their last, best, written proposals (each a “Sealed Proposal”) within 3 business days after receipt of the Baseball Notice. Each party shall submit its Sealed Proposal directly to the WIPO and the WIPO shall not give any Sealed Proposal to the other party hereto until both such Sealed Proposals have been received by WIPO. If a party fails timely to submit a Sealed Proposal, it shall be deemed to have submitted its last written proposal as its Sealed Proposal. There shall be no further exchange of written briefs other than the Request for baseball Arbitration and the Answer to the Request and the Sealed Proposals, except with special permission of the arbitral tribunal. Within three weeks after the appointment of the arbitrators, a hearing shall be held. Each party shall be afforded such amount of time as is reasonable for the presentation of its case at the hearing, and the hearing shall be sequenced in such a manner, as the arbitrators shall determine the proposed Agreement Paymentto be commercially reasonable. The Expert will be instructed to arbitrators shall select one Partyof the party’s proposal no later than [***] following Sealed Proposals within five (5) business days after conclusion of the receipt hearing. The arbitrators shall be limited to awarding only one or the other of both Parties’ proposals and to select the proposal that he or she determines two Sealed Proposals submitted, without modification. The arbitrator shall be guided by what is the most commercially reasonable equitable under the circumstances and best gives effect to in accordance with the intent principles set forth in the relevant provisions of the Parties to effect the Agreed Value under this Agreement. The Expert selected Sealed Proposal shall select only one (1) of become the proposals submitted by the Parties (without making any changes to such proposal) and shall render such proposal as the Expertarbitrator’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 decision and award, without any modification. Reasons should not be stated in the Parties. The out-of-pocket costs award issued within five (5) business days as provide hereabove, but should be provided subsequently in a separate document, not to be deemed part 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 11award.
Appears in 2 contracts
Samples: www.sec.gov, Agreement (Animas Corp)
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. Exhibit 12.1 Press Release Affimed and Artiva Biotherapeutics Announce Partnership to Advance Combination Therapy of Innate Cell Engager (ICE®) AFM13 and Off-the-Shelf Allogeneic NK Cell Therapy AB-101 · 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%. 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 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 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 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED 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.)
Baseball Arbitration. If Under the Parties cannot agree, following escalation to the Executive Officers, on the Agreement Payment pursuant to circumstances described in Section 9.2(c) (such dispute, an “Expert Matter”3.10.4 or Section 11.5.4(b), at the request of either Party may elect to have the matter resolved by expedited arbitration by an Expert. The arbitration proceeding shall be conducted in accordance with the Commercial Arbitration Rules of the AAA and otherwise as described in this Section 12.1.3. Upon written notice request by either Party to the other Party, such Expert Matter will be resolved through binding “baseball” arbitration pursuant the Parties shall promptly negotiate in good faith 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 appoint 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 (“appropriate Expert”) and shall be selected by mutual agreement of the Parties. If the Parties are unable not able to agree upon an Expert within [***] after a Party gives the written notice requesting expert resolution, then each Party will have [***] to choose ** days after the receipt by a single independent expert meeting Party of the Expert criteriawritten request in the immediately preceding sentence, and the AAA of Washington D.C, or such other similar entity as the Parties may agree, shall instruct such experts to use best efforts to mutually select, be responsible for selecting an Expert with background and experience in pharmaceutical commercialization 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 ** days of the Expert, each Party shall submit to the Expert, with being approached by 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 fees 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 and the determination pursuant to this Exhibit 9.2(cAAA (or such other entity) shall be shared equally (50%/50%) by the Parties. Within ******** days after the designation of the Expert, the Parties shall each simultaneously submit to the Expert and one another a written statement of their respective positions on such disagreement. Each Party shall have ******** Business Days from receipt of the other Party’s submission to submit a written response thereto. The Expert shall have the right to meet with the Parties, either alone or together, as necessary to make a determination. Further, the Expert shall have the right to request information and materials and to require and facilitate discovery as it shall determine is appropriate in the circumstances, taking into account the needs of the Parties and the desirability of making discovery expeditious and cost-effective determinations. No later than ******** days after the designation of the Expert, or as otherwise agreed by the Parties, regardless the Expert shall make a determination by selecting the resolution proposed by one of the outcome of Parties that as a whole is 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 most consistent with the expert proceedings, and the conduct of such proceedings and any information produced thereunder shall be Confidential Information under this Agreement and subject the most fair and reasonable to the provisions Parties in light of Article 11the totality of the circumstances. The Expert shall provide the Parties with a written statement setting forth the basis of the determination in connection therewith. The decision of the Expert shall be final, binding and conclusive, absent manifest error.
Appears in 1 contract
Samples: Assignment and Assumption Agreement (Targacept 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. Exhibit 12.1 Press Release Affimed and Artiva Biotherapeutics Announce Partnership to Advance Combination Therapy of Innate Cell Engager (ICE®) AFM13 and Off-the-Shelf Allogeneic NK Cell Therapy AB-101 · 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%. 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 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 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.
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Baseball Arbitration. If the Parties cannot agree, following escalation Notwithstanding anything to the Executive Officerscontrary contained herein, on the any dispute which this Agreement Payment explicitly specifies shall be resolved pursuant to this Section 9.2(c16.2 shall be determined in accordance with the procedure specified in Section 16.1, superseded by the arbitration procedure specified in this Section 16.2. There shall be no mediation. The Request for baseball Arbitration may be filed by either party at any time before, during or after the period of exchange of proposals described hereunder. If a party desires to resolve a matter which this Agreement expressly provides shall be determined under this Section 16.2, such party (the “Initiating Party”) (such dispute, an “Expert Matter”), at the request of either Party by shall give written notice to the other party (the “Responding Party, such Expert Matter will be resolved through binding “baseball” arbitration pursuant to this Exhibit 9.2(c”) rather than pursuant to containing a complete written proposal of the procedures under Section 17.2resolution for the matter in dispute. 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 Within ten (10) years business days after receipt of experience in any such notice, 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 Responding Party shall submit to the Expert, Initiating Party a written counter proposal. The Initiating Party shall then have two (2) business days after receipt of the counterproposal in which to decide whether to modify its proposal by giving written notice of its revised proposal to the Responding Party. The Responding Party shall then have two (2) business days after receipt of the revised proposal in which to decide whether to modify its proposal by giving written notice of its revised proposal to the Initiating Party. This process shall continue with a copy each party sending alternate proposals to the other Party, one party until such time as the earliest of (1) proposal for resolving the applicable Expert Matterparties reach agreement on how to resolve the dispute, including the proposed Agreement Payment and a reasonably detailed analysis (2) one of the model prepared by such Party taking into account parties fails to respond within two (2) business days after receipt of a proposal from the factors described in Section 9.2(cother party, or (3) a party determines that it is unwilling to determine the proposed Agreement Payment. The Expert will be instructed to select one Party’s proposal no later than [change ***] following *** - Material has been omitted and filed separately with the Commission. its proposal further. In the event of clause (2) or (3) of the foregoing sentence, either party may give written notice (a “Baseball Notice”) to other of its election to require the submission of their last, best, written proposals (each a “Sealed Proposal”) within three (3) business days after receipt of the Baseball Notice. Each party shall submit its Sealed Proposal directly to the WIPO and the WIPO shall not give any Sealed Proposal to the other party hereto until both Parties’ proposals such Sealed Proposals have been received by WIPO. If a party fails timely to submit a Sealed Proposal, it shall be deemed to have submitted its last written proposal as its Sealed Proposal. There shall be no further exchange of written briefs other than the Request for baseball Arbitration and the Answer to the Request and the Sealed Proposals, except with special permission of the arbitral tribunal. Within three weeks after the appointment of the arbitrators, a hearing shall be held. Each party shall be afforded such amount of time as is reasonable for the presentation of its case at the hearing, and the hearing shall be sequenced in such a manner, as the arbitrators shall determine to be commercially reasonable. The arbitrators shall select one of the proposal that he party’s Sealed Proposals within five (5) business days after conclusion of the hearing. The arbitrators shall be limited to awarding only one or she determines the other of the two Sealed Proposals submitted, without modification. The arbitrator shall be guided by what is the most commercially reasonable equitable under the circumstances and best gives effect to in accordance with the intent principles set forth in the relevant provisions of the Parties to effect the Agreed Value under this Agreement. The Expert selected Sealed Proposal shall select only one (1) of become the proposals submitted by the Parties (without making any changes to such proposal) and shall render such proposal as the Expertarbitrator’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 decision and award, without any modification. Reasons should not be stated in the Parties. The out-of-pocket costs award issued within five (5) business days as provided hereabove, but should be provided subsequently in a separate document, not to be deemed part 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 11award.
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Samples: Agreement (Animas Corp)
Baseball Arbitration. If This Section 13.10 (Baseball Arbitration) shall apply to disputes arising under Section 12.3(b) (Effect of Termination) to be resolved by baseball arbitration and in connection with the calculation of Net Sales for Combination Products. Baseball arbitration will be conducted by one (1) arbitrator who shall be reasonably acceptable to 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 and who shall have no less than ten (10) years of experience be appointed in accordance with 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 PartiesJAMS Rules. If the Parties are unable to agree upon select an Expert arbitrator within [***] after a Party gives the written notice requesting expert resolution], then each Party will the arbitrator shall be appointed in accordance with the JAMS Rules. Any arbitrator chosen under this Section 13.10 (Baseball Arbitration) shall have [***] to choose a single independent expert meeting significant legal or business experience in the Expert criteriapharmaceutical industry, and the Parties shall instruct such experts to use best efforts to mutually selectnot be a current or former employee or director, within [***] following the selection or a current significant shareholder, of the second either Party or any of such experts, an independent third expert who meets such criteria to be the Experttheir respective Affiliates or any Sublicensee. Within [***] after appointment the selection of the Expertarbitrator, each Party shall submit to the Expert, with a copy to arbitrator and the other Party, one (1) proposal for resolving the applicable Expert Matter, including the Party a proposed Agreement Payment and a reasonably detailed analysis resolution of the model prepared by such Party taking into account dispute that is the factors described subject of the arbitration, together with any relevant evidence in Section 9.2(c) to determine support thereof (the proposed Agreement Payment“Proposals”). The Expert will be instructed to select one Party’s proposal no later than Within [***] following after the receipt delivery 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 last Proposal to the intent arbitrator, each Party may submit a written rebuttal of the Parties to effect the Agreed Value under this Agreementother Party’s Proposal and may also amend and re-submit its original Proposal. The Expert Parties and the arbitrator shall select only 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 the proposals submitted by the its Proposal. 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 right to render call any decision witnesses in support of their arguments, nor compel any production of documents or take any discovery from the other Party in preparation for the meeting. Within [***] after such meeting, 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 selecting by selection of one (1) proposal of the submitted by final Proposals. If a Party pursuant fails to this Exhibit 9.2(c). The Expert’s decision submit a Proposal within the initial [***] time frame set forth above, the arbitrator shall be final and binding on select the Parties. The out-of-pocket costs Proposal of the Expert in making other Party as the determination pursuant to this Exhibit 9.2(c) shall be shared equally by the Parties, regardless resolution of the outcome of the determinationdispute. 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[***].
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