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Settlement Sublicensee |
Shared Capsid |
Single Variant Characterization Studies |
Subject Technology |
Subject Technology Agreement |
Supplied Research Materials |
Supply Transition Event |
Target List |
Target-specific Capsid Libraries |
Tau Program Option |
Technology Transfer Plan |
Term |
Termination Notice |
Third Party Claims |
Third Party Infringement Claim |
Third Party Payments |
Transferred Materials |
Updated Disclosure Schedule |
Variant Optimization Research Stage |
Withholding Party |
Working Group |
ARTICLE 2 RESEARCH PROGRAM |
2.1 General. The principal objectives of the Research Program are for Capsida to: (a) (i) use the Capsida Platform and Capsida Platform IP to engineer, optimize, evaluate and deliver to AbbVie at least three (3) Capsids for each of α-syn and Tau (one (1) lead Capsid and two (2) back-up Capsids) that meet the Initial Ta... |
2.2 Research Plans. |
2.2.1 General. The Parties shall conduct (a) Research Stage One in accordance with a written research plan (i) for each of α-syn and Tau (the "Capsid Program Research Plan") and (ii) for TDP-43 (the "Collaboration Program Research Plan") and (b) if AbbVie exercises the Initial Capsid Program Option with respect to α-sy... |
2.2.2 RP2 Plan. Within thirty (30) days after the Option Exercise Date for an Initial Capsid Program Option, the Parties, through the JGC, shall (a) prepare the RP2 Plan for the applicable Target, which shall be substantially similar to the then-current Capsid Program Research Plan for such Target with any such modific... |
2.2.3 Amendments to Research Plans. The JGC shall review each Research Plan quarterly for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on the JGC, may propose amendments to any Plan at any time. Each Party may propose an amendment to a Research Plan by submitt... |
2.2.4 Modifications to the Research Program. The Parties acknowledge and agree that the Research Plans are not prescriptive, but instead set forth the activities that the Parties reasonably expect as of the Effective Date will need to be performed to achieve the objectives of the Research Program. Based on the further ... |
2.3 Capsid Generation, Optimization and Screening. |
2.3.1 Initial Library Screening. Pursuant to each Research Plan, Capsida shall generate at least one (1) de novo library of Capsids per Target (e.g., with 7-mer insertions at the AA588 loop of AAV9) using the Capsida Platform, comprising approximately thirty-four billion nucleic acid sequences for differentiated engine... |
Each General Capsid Library (including the General Capsid Library for Tau generated prior to the Effective Date) shall be and remain exclusive to AbbVie, and Capsida shall not use or Exploit (except to conduct the Research Program), or grant any Third Party the right to use or Exploit, any Capsid in such General Capsid... |
For each new Reserved Capsid with respect to a Target that AbbVie selects in excess of five (5) Reserved Capsids for such Target under this Section 2.3.1, AbbVie shall have to deselect an existing Reserved Capsid, such that AbbVie does not have more than five (5) Reserved Capsids for such Target under this Section 2.3.... |
2.3.2 Variant Optimization. In accordance with the applicable Research Plans, Reserved Capsids from the initial library screening described in Section 2.3.1 (or with respect to each Research Stage Two, the Selected Capsids for the applicable Licensed Target and such other Reserved Capsids as AbbVie may select (not to e... |
2.3.3 Pooled Screening. For each Target and for each Research Stage, the Reserved Capsids for such Target and such Research Stage and one or more additional Reserved Capsids for other Targets or Research Stages, together with top performing variants and benchmark Capsids (including AAV9) identified and agreed upon by t... |
2.3.4 Preliminary Characterization. Based upon the Data Packages associated with Capsid optimization and pooled screening, each as described above and in the applicable Research Plan, AbbVie shall have the right to determine whether to proceed with preliminary capsid characterization of up to three (3) Reserved Capsids... |
2.3.5 Final Capsid Optimization. In parallel with Preliminary Characterization for each Target for each Research Stage, unless otherwise determined by the JGC, Capsida shall perform further Capsid optimization using the five (5) Reserved Capsids or fewer if so determined by the JGC selected by AbbVie pursuant to Sectio... |
2.3.6 Final Pooled Screening. Following the final capsid optimization, as described in Section 2.3.5, for each Target and for each Research Stage, the Reserved Capsids for such Target and for Research Stage and one or more additional Reserved Capsids for other Targets or Research Stages together with top performing var... |
2.3.7 Vector Design and Optimization. From and after the initial Capsid library screening for a Target for a Research Stage, Capsida shall, in consultation with AbbVie, design, engineer and optimize vectors, using a selection of Capsids that includes certain existing Capsids or Reserved Capsids, the Expression Elements... |
2.3.8 Final Individual Capsid-Cargo Characterization. Based upon all Data Packages from the Screening Period, and upon selection of a final Capsid-Expression Elements-cargo design by the JGC, AbbVie shall have the right to select a single Capsid for final individual Capsid-cargo characterization and two (2) back-up Cap... |
2.3.9 Research Stage Two. If AbbVie exercises the Initial Capsid Program Option with respect to α-syn or Tau, Capsida shall conduct Optimization and Screening Activities to engineer, optimize, characterize, validate and deliver to AbbVie for each such Target with respect to which the Initial Capsid Program Option is ex... |
2.3.10 Existing Capsids. During the Capsid Screening Period, Capsida shall also provide AbbVie with Existing Capsids to enable AbbVie to assess whether they would be suitable for use in the Research Program or as Selected Capsids in accordance with the Capsid Program Research Plan; provided, however, that for purposes ... |
2.4 AbbVie Materials. AbbVie shall provide AbbVie Cargo for each Target and for each Research Stage (which may be the same as the AbbVie Cargo used in the other Research Stage) for use in the validation activities and shall use Commercially Reasonable Efforts to do so in accordance with the timelines set forth in the a... |
2.5 Program Activities and Efforts. Except for those activities assigned to AbbVie in a Research Plan, Capsida shall be responsible for conducting the Research Program, including Manufacturing (including CMC Activities in support thereof) and supplying all Capsids (including Reserved Capsids and Selected Capsids), Expr... |
2.6 Performance of Research Program and other Activities. |
2.6.1 Compliance. All Research, Development, Manufacturing and Commercialization activities to be conducted by a Party under this Agreement shall be conducted in compliance with Applicable Law. |
2.6.2 Subcontracting. |
(a) Subject to Section 12.6.1, AbbVie shall have the right to engage Affiliates or Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners or Distributors) to perform any of its Research, Development, Manufacturing or Commercialization activities under this Agree... |
(b) Subject to Section 12.6.1, Capsida shall have the right to (sub)contract its Research, Development and Manufacturing activities under this Agreement to a Third Party to the extent expressly provided for in a Plan or with the approval of the JGC; provided that no such permitted subcontracting shall relieve Capsida o... |
(c) Any Affiliate or Third Party subcontractor to be engaged by a Party to perform a Party's obligations set forth in this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Any Party engaging an Affiliate o... |
2.6.3 Records. Each Party shall, and shall require its Affiliates and shall use commercially reasonable efforts to require its permitted subcontractors to, maintain materially complete, current and accurate hard or electronic, as applicable, records of all work conducted and results achieved in the performance of the R... |
2.6.4 Information and Reports. |
(a) On a monthly basis (or with such other frequency as may be agreed by the Parties), the Parties shall meet to discuss the progress of the Research Program and the CMC Activities since the last meeting, including any improvements, enhancements or modifications to the Capsida Platform or Capsida's Manufacturing techno... |
(b) At each meeting of the JGC for the Neurology Program (and in any event within thirty (30) days following the end of each Calendar Quarter), (i) Capsida shall provide to such JGC and AbbVie a reasonably detailed report regarding its Research activities under the Research Program, Results and access to or copies of r... |
(c) In addition to the foregoing reports, Capsida promptly shall provide to AbbVie any copies of all material correspondence to and from any Regulatory Authority and copies of any material Regulatory Documentation related to the Capsida Platform to the extent related to Program Capsids, Research Products, Licensed Caps... |
2.7 Research Program Costs. Except as otherwise provided in the Capsid Program Research Plan or the Collaboration Program Research Plan, as applicable, each Party shall bear all costs and expenses incurred by or on behalf of it in the performance of the Research Program. For clarity, neither Party shall be deemed to be... |
2.8 Transferred Materials. From time to time during the Research Program, each Party may transfer certain Transferred Materials to the other Party for use in the Research Program. Except for the licenses granted to the other Party pursuant to Section 8.1 and Section 8.2, the transferring Party shall retain all right, t... |
2.9 No Guarantee. Subject to Capsida's obligations to (a) complete the activities set forth in the Research Plans and (b) use Commercially Reasonable Efforts to do so on the timelines set forth therein and to achieve the objectives of the Research Program, Capsida provides no representation, warranty or guarantee that ... |
2.10 Specific Performance. Capsida acknowledges and agrees that Capsida's obligations under this Article 2 are unique and that AbbVie would not have entered into this Agreement in the absence of such obligations, and that any material breach or threatened material breach of this Article 2 by Capsida will result in irre... |
ARTICLE 2A OPHTHALMOLOGY RESEARCH PROGRAM |
2.11 General. The principal objectives of the Ophthalmology Research Program are for the Parties to collaborate using the Capsida Platform and Capsida Platform IP combined with AbbVie's capabilities in the ophthalmology space to generate, engineer, optimize, evaluate and deliver to AbbVie three (3) Capsids (one (1) lea... |
2.12 Ophthalmology Research Plan. |
2.12.1 General. The Parties shall conduct activities under the Ophthalmology Research Program in accordance with a written research plan (the "Ophthalmology Research Plan"). The initial Ophthalmology Research Plan is attached hereto as Exhibit D. The Ophthalmology Research Plan shall detail (a) the responsibilities and... |
2.12.2 Amendments to Ophthalmology Research Plan. The JGC for the Ophthalmology Program shall review the Ophthalmology Research Plan quarterly for the purpose of considering appropriate amendments thereto, and either Party, through its representatives on such JGC, may propose amendments to the Ophthalmology Research Pl... |
2.12.3 Modifications to the Ophthalmology Research Program. The Parties acknowledge and agree that the Ophthalmology Research Plan is not prescriptive, but instead sets forth the activities that the Parties reasonably expect as of the Effective Date will need to be performed to achieve the objectives of the Ophthalmolo... |
2.13 Ophthalmology Research Program Activities. |
2.13.1 Build and Platform Development. Pursuant to the Ophthalmology Research Plan, Capsida shall undertake preliminary activities focused on method validation, process optimization, preliminary screening and method development prior to non-human primate screening (the "Build and Platform Development Research Stage"). ... |
2.13.2 Initial Library Screening (Round 1 and Round 2). In support of the initial library screenings of applicable Capsids to enable selection of Capsids for the IC, IVT and SCS Routes of Administration, pursuant to the Ophthalmology Research Plan, AbbVie would be responsible for performing certain in-life activities u... |
Each General Ophthalmology Capsid Library shall be and remain exclusive to AbbVie, and Capsida shall not use or Exploit (except to conduct the Ophthalmology Research Program), or grant any Third Party the right to use or Exploit, any Capsid in such General Ophthalmology Capsid Library, until the earlier of the end of t... |
For each new Reserved Ophthalmology Capsid with respect to a Route of Administration that AbbVie selects in excess of five (5) Reserved Ophthalmology Capsids for such Route of Administration under this Section 2.13.2, AbbVie shall deselect an existing Reserved Ophthalmology Capsid, such that AbbVie does not have more t... |
2.13.3 First Pooled Candidate Identification Studies. In accordance with the Ophthalmology Research Plan, the then-selected Reserved Ophthalmology Capsids, together with the other top performing Capsids identified in the Initial Library Screening Research Stage, and any applicable control Capsids from Capsida's enginee... |
2.13.4 Variant Optimization (Round 1 and Round 2). In accordance with the Ophthalmology Research Plan, the then-selected Reserved Ophthalmology Capsids, together with the other top performing Capsids identified in the First Pooled Candidate Identification Studies Research Stage will proceed to re-diversification and st... |
2.13.5 Secondary Pooled Candidate Identification Studies. In accordance with the Ophthalmology Research Plan, for each applicable library (for each serotype and Route of Administration), unless otherwise agreed by the Research Working Group for the Ophthalmology Program, Capsida shall pool the then-selected Reserved Op... |
2.13.6 Final Variant Optimization (Round 1 and Round 2). In accordance with the Ophthalmology Research Plan, Capsida shall perform further Capsid optimization (the "Final Variant Optimization Research Stage") using the then-selected Reserved Ophthalmology Capsids for each Route of Administration, together with other to... |
2.13.7 Final Pooled Candidate Identification Studies. In accordance with the Ophthalmology Research Plan, following the Final Variant Optimization Research Stage for a Route of Administration, the JGC for the Ophthalmology Program shall identify and determine certain Capsids, including the then-selected Reserved Ophtha... |
2.13.8 Single Variant Characterization Studies. In accordance with and as more fully described in the Ophthalmology Research Plan, following the Final Pooled Ophthalmology CIS or as otherwise agreed by the JGC for a Route of Administration, AbbVie shall have the right to select up to five (5) Capsids to be evaluated fo... |
2.13.9 Vector Design and Optimization. |
(a) AbbVie may further engineer and improve the AbbVie Ophthalmology Cargo and Expression Elements for each Route of Administration outside of the Ophthalmology Research Program (i) as necessary to generate an Ophthalmology Research Product that is direct towards meeting the Ophthalmology Target Capsid Profile for such... |
(b) In accordance with Ophthalmology Research Plan, from and after the initial Capsid library screening for a Route of Administration and until the later of (i) designation of the Selected Ophthalmology Capsids for such Route of Administration and (ii) if AbbVie exercises its Ophthalmology Program Option for such Route... |
2.13.10 Research Study Materials Supply. Capsida shall in respect of the Ophthalmology Research Program and in addition to and without limiting (a) those provided for in Section 2.3.7 with respect to the Research Program and (b) supply for the activities contemplated by the Ophthalmology Research Stages in Sections 2.1... |
2.13.12 Existing Capsids. During the Capsid Screening Period, Capsida shall also provide AbbVie with Existing Capsids to enable AbbVie to assess whether they would be suitable for use in the Ophthalmology Program or as Selected Ophthalmology Capsids in accordance with the Ophthalmology Research Plan; provided, however,... |
2.14 Target Selection. |
2.14.1 Target List. AbbVie shall select Ophthalmology Targets of interest for the Ophthalmology Research Program from a rolling list of not more than twenty (20) Ophthalmology Targets (the "Target List"). The initial Target List is attached hereto as Exhibit E, and the JGC shall review the Target List every six (6) mon... |
2.14.2 Target List Substitutions. If AbbVie desires to substitute an Ophthalmology Target on the Target List with a different Ophthalmology Target that is not on the Target List, AbbVie shall notify Capsida in writing. Promptly (and in any event within fifteen (15) Business Days) after such notice by AbbVie, Capsida sh... |
2.14.3 Target Selection. AbbVie shall have twenty-four (24) months following delivery of a Final Ophthalmology Data Package for the first Route of Administration to select from the Target List its initial three (3) Ophthalmology Targets (each such selected Ophthalmology Target, a "Selected Ophthalmology Target"). After... |
2.15 AbbVie Materials. As set forth in the Ophthalmology Research Plan, AbbVie shall have the right to provide AbbVie Ophthalmology Cargo or research tools for each Route of Administration (which may be the same as the AbbVie Ophthalmology Cargo used for other Routes of Administration) for use in the validation activit... |
2.16 Program Activities and Efforts. Except for those activities assigned to AbbVie in the Ophthalmology Research Plan or herein, Capsida shall be responsible for conducting the Ophthalmology Research Program, including Manufacturing (including CMC Activities in support thereof) and supplying all Capsids (including Res... |
2.17 Performance of Research Program and other Activities. |
2.17.1 Compliance. All Research, Development, Manufacturing and Commercialization activities to be conducted by a Party under this Agreement shall be conducted in compliance with Applicable Law. |
2.17.2 Subcontracting. |
(a) Subject to Section 12.6.1, AbbVie shall have the right to engage Affiliates or Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners or Distributors) to perform any of its Research, Development, Manufacturing or Commercialization activities under this Agree... |
(b) Subject to Section 12.6.1, Capsida shall have the right to (sub)contract its Research, Development and Manufacturing activities under this Agreement to a Third Party to the extent expressly provided for in a Plan or with the approval of the applicable JGC; provided that no such permitted subcontracting shall reliev... |
(c) Any Affiliate or Third Party subcontractor to be engaged by a Party to perform a Party's obligations set forth in this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Any Party engaging an Affiliate o... |
2.17.3 Records. Each Party shall, and shall require its Affiliates and shall use commercially reasonable efforts to require its permitted subcontractors to, maintain materially complete, current and accurate hard or electronic, as applicable, records of all work conducted and results achieved in the performance of the ... |
2.17.4 Information and Reports. |
(a) On a monthly basis (or with such other frequency as may be agreed by the Parties), the Parties shall meet to discuss the progress of the Research Program and the CMC Activities since the last meeting, including any improvements, enhancements or modifications to the Capsida Platform or Capsida's Manufacturing techno... |
(b) At each meeting of the JGC for the Ophthalmology Program (and in any event within thirty (30) days following the end of each Calendar Quarter), (i) Capsida shall provide to such JGC and AbbVie a reasonably detailed report regarding its Research activities under the Ophthalmology Research Program, Results and access... |
(c) In addition to the foregoing reports, Capsida promptly shall provide to AbbVie any copies of all material correspondence to and from any Regulatory Authority and copies of any material Regulatory Documentation related to the Capsida Platform to the extent related to Ophthalmology Program Capsids, Ophthalmology Rese... |
2.18 Ophthalmology Research Program Costs. Except as otherwise provided in the Ophthalmology Research Plan, as applicable, each Party shall bear all costs and expenses incurred by or on behalf of it in the performance of the Ophthalmology Research Program. For clarity, neither Party shall be deemed to be performing any... |
2.19 Transferred Materials. From time to time during the Ophthalmology Research Program, each Party may transfer certain Transferred Materials to the other Party for use in the Ophthalmology Research Program. Except for the licenses granted to the other Party pursuant to Section 8.1 and Section 8.2, the transferring Pa... |
2.20 No Guarantee. Subject to Capsida's obligations to (a) complete the activities set forth in the Ophthalmology Research Plan and (b) use Commercially Reasonable Efforts to do so on the timelines set forth therein and to achieve the objectives of the Ophthalmology Research Program, Capsida provides no representation,... |
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