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ARTICLE 13 INDEMNITY ....................................................................................................... 163 |
13.1 Indemnification of Capsida. ................................................................................ 163 |
13.2 Indemnification of AbbVie. ................................................................................ 163 |
13.3 Certain Losses. .................................................................................................... 164 |
13.4 Indemnification Procedures. ............................................................................... 165 |
13.5 Insurance. ............................................................................................................ 167 |
13.6 Limitation of Liability......................................................................................... 167 |
ARTICLE 14 TERM AND TERMINATION ............................................................................ 167 |
14.1 Term and Expiration. .......................................................................................... 167 |
14.2 Termination. ........................................................................................................ 168 |
14.3 Rights in Bankruptcy. ......................................................................................... 169 |
14.4 Modification In Lieu of Termination. ................................................................. 170 |
14.5 Consequences of Termination............................................................................. 171 |
14.6 Remedies. ............................................................................................................ 175 |
14.7 Accrued Rights; Surviving Obligations. ............................................................. 175 |
ARTICLE 15 MISCELLANEOUS ............................................................................................ 175 |
15.1 Force Majeure. .................................................................................................... 176 |
15.2 Export Control. ................................................................................................... 176 |
15.3 Assignment. ........................................................................................................ 176 |
15.4 Certain Strategic Transactions. ........................................................................... 178 |
15.5 Severability. ........................................................................................................ 179 |
15.6 Dispute Resolution. ............................................................................................. 179 |
15.7 Governing Law, Jurisdiction and Service. .......................................................... 180 |
15.8 Notices. ............................................................................................................... 180 |
15.9 Entire Agreement; Amendments......................................................................... 181 |
15.10 English Language................................................................................................ 181 |
15.11 Equitable Relief. ................................................................................................. 182 |
15.12 Waiver and Non-Exclusion of Remedies. ........................................................... 182 |
15.13 No Benefit to Third Parties. ................................................................................ 182 |
15.14 Further Assurance. .............................................................................................. 182 |
15.15 Relationship of the Parties. ................................................................................. 182 |
15.16 References. .......................................................................................................... 183 |
15.17 Construction. ....................................................................................................... 183 |
15.18 Counterparts. ....................................................................................................... 183 |
ARTICLE 16 AMENDMENT AND RESTATEMENT ............................................................ 183 |
16.1 Amendment and Restatement. ............................................................................ 183 |
SCHEDULES AND EXHIBITS |
Exhibit A Capsid Program Research Plan |
Exhibit B Collaboration Program Research Plan |
Exhibit C POC Plan |
Exhibit D Ophthalmology Research Plan |
Exhibit E Initial Target List |
Schedule 1.56 Trademarks and logos |
Schedule 1.1.75 Existing Capsids |
Schedule 1.88 FTE Rate |
Schedule 5.1.2 Existing CMO Agreements |
Schedule 6.3.3 Co-Promotion Readiness Plan |
Schedule 11.5A Press Release for Neurology Program |
Schedule 11.5B Press Release for Ophthalmology Program |
Schedule 12.2 Initial Neurology Disclosure Schedule |
Schedule 12.2.1 Existing In-License Agreements for Neurology Program |
Schedule 12.2.4 Existing NP Patents |
Schedule 12.3.1 Existing In-License Agreements for Ophthalmology Program |
Schedule 12.3.4 Existing OP Patents |
Schedule 15.6.3 ADR Procedures |
AMENDED AND RESTATED COLLABORATION AND OPTION AGREEMENT |
This Amended and Restated Collaboration and Option Agreement (this "Agreement") is made and entered into as of February 17, 2023 (the "Effective Date") by and between Capsida Biotherapeutics, Inc., a Delaware corporation ("Capsida") and AbbVie Global Enterprises Ltd., a Bermuda corporation ("AbbVie"). Capsida and AbbVi... |
RECITALS |
WHEREAS, Capsida owns and controls certain intellectual property rights with respect to the Capsida Platform (as defined below) in the Territory (as defined below); |
WHEREAS, AbbVie controls certain intellectual property rights relating to the AbbVie Cargo (as defined below); |
WHEREAS, Capsida and AbbVie entered into that certain Collaboration and Option Agreement, dated April 26, 2021 (such agreement the "Original Agreement" and such date the "Original Agreement Effective Date"), pursuant to which (i) the Parties agreed to collaborate on research activities aimed at identifying and optimizi... |
WHEREAS, the Parties now desire to amend and restate the Original Agreement as of the Effective Date (i) to include an Ophthalmology Research Program (as defined below) under which the Parties desire to collaborate on research activities aimed at identifying and optimizing capsids using the Capsida Platform for deliver... |
WHEREAS, the Parties have agreed to amend and restate the Original Agreement as set out in this Agreement and effective as of the Effective Date, to replace and supersede the Original Agreement with this Agreement. |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: |
ARTICLE 1 DEFINITIONS |
Unless otherwise specifically provided herein, the following terms shall have the following meanings: |
1.1 "α-syn" means the alpha synuclein gene designated SNCA (as exemplified by NCBI Reference Sequence Database record NM_000345) including all DNA haplotypes, gene duplications, polymorphisms, mutations or allelic variants of the SNCA locus, all mRNA products derived from the complete or partial SNCA gene (e.g., splice... |
1.2 "AbbVie Background IP" means the AbbVie Background Know-How and the AbbVie Background Patents. |
1.3 "AbbVie Background Know-How" means all information (including regulatory data, Know-How relating to Manufacture of Capsids, files, approvals and other documentation) and other Know-How that (a) with respect to the Research Program, (i) is owned or Controlled by AbbVie or any of its Affiliates as of the Original Agr... |
1.4 "AbbVie Background Patents" means all Patents owned or Controlled by AbbVie or its Affiliates and issued or filed (a) with respect to the Research Program, (i) as of the Original Agreement Effective Date or (ii) that is conceived, discovered, generated, created, developed, acquired or otherwise made outside of the ... |
1.5 "AbbVie Cargo" means (a) any compound, molecule, biologic or other moiety directed to α-syn, Tau or TDP-43 made available by AbbVie for use in the Research Program, or otherwise included by or on behalf of AbbVie in a Licensed Product during the Term, and any polynucleotide or other genetic material that encodes su... |
1.6 "AbbVie Indications" means collectively dAMD, GA, wAMD, DME, DR, and Glaucoma, each of which individually is an "AbbVie Indication". |
1.7 "AbbVie Ophthalmology Cargo" means any (a) compound, molecule, biologic or other moiety directed to an Ophthalmology Target that is made available by AbbVie for use in the Ophthalmology Research Program or otherwise included by or on behalf of AbbVie in a Licensed Ophthalmology Product during the Term, and any poly... |
1.8 "Accounting Standards" means, with respect to a Party or any of its Affiliates or its or their Sublicensees, United States generally accepted accounting principles, consistently applied. |
1.9 "Acquirer" has the meaning set forth in the definition of Change of Control. |
1.10 "AD/PD Indication" means, with respect to a product, an indication for the treatment, prevention, mitigation, cure of, or for the relief of symptoms associated with, Alzheimer's disease or Parkinson's disease. |
1.11 "Adaptive Trial" means a Clinical Trial that does not meet the criteria for a Registrational Trial at the time such Clinical Trial is initiated and includes a prospectively planned opportunity for such Clinical Trial to be modified based on interim analyses to change to a Registrational Trial following an analysis... |
1.12 "Additional Capsid Program Option Period" means, with respect to each of α-syn and Tau, the time period commencing on AbbVie's exercise of the Initial Capsid Program Option with respect to α-syn or Tau, respectively, and ending the later of (a) sixty (60) days following the delivery by Capsida to AbbVie of the Fin... |
1.13 "Affiliate" means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party at any time for so long as such Person controls, is controlled by or is under common control with such Party. For purpos... |
1.14 "Allowable Expenses" means, subject to the other provisions of this Agreement, the FTE Costs (charged in accordance with Section 9.15) and the Out-of-Pocket Costs that are specifically identifiable or reasonably allocable to the Commercialization of the ALS Product (including a Co-Promotion Product) in the Territo... |
(a) Sales and Marketing Costs; |
(b) Distribution Costs; |
(c) Manufacturing Costs for an ALS Product (including any components thereof) Manufactured for sale or distribution in the Territory (including manufacturing start-up in advance of launch of the applicable ALS Product and Manufacturing of samples of the applicable ALS Product distributed for use in the Territory, inven... |
(d) Medical Affairs Costs; |
(e) Costs associated with patient assistance programs in the Territory; |
(f) Product liability insurance with respect to the ALS Products in the Territory in the event the Parties obtain a joint policy; |
(g) Third Party Payments specifically identifiable or reasonably allocable to the ALS Products in the Territory; |
(h) Costs associated with recall, withdrawal or field corrections of an ALS Product in the Territory, except to the extent such costs arise from either Party's (i) gross negligence, recklessness, willful misconduct or (ii) breach of this Agreement, the Co-Promotion Agreement, the clinical supply agreement entered into ... |
(i) Losses specifically identifiable or reasonably allocable to the Commercialization of the ALS Product in the Territory, or the Manufacture of the ALS Product in support thereof, to the extent treated as Allowable Expenses pursuant to Section 13.3; |
(j) Patent Costs and Trademark Costs to the extent related to the ALS Product in the Territory (to the extent not otherwise reimbursed through recoveries obtained in connection with any litigation or otherwise reimbursed as contemplated under Article 10 and, in the case of either Party, to the extent such Patent Costs ... |
(k) Regulatory Expenses (except to the extent included in Development Costs); |
in each case, to the extent not deducted from Net Sales of ALS Products in the Territory, and provided, that except as provided above, Allowable Expenses (i) shall exclude Development Costs, with respect to which Capsida shall bear its fifty percent (50%) share pursuant to Section 4.2.5(a) and (ii) shall be calculated ... |
1.15 "ALS Product" means a product containing a Collaboration Program Capsid and the ALS Cargo (including any such product that becomes a Licensed Product). |
1.16 "ALS Reversion Product" means, with respect to an ALS Reversion Triggering Event, the ALS Product for which final individual Capsid-cargo characterization is conducted pursuant to Section 2.3.8 and a Final Data Package is delivered to AbbVie, in the forms, formulations and therapeutic regimens and for the uses tha... |
1.17 "ALS Reversion Triggering Event" means (a) failure to exercise the Collaboration Program Option during the Collaboration Program Option Period other than for Good Reason, (b) termination of this Agreement by AbbVie pursuant to Section 14.2.2 with respect to the Collaboration Research Program other than for Good Re... |
1.18 "Applicable Law" means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of Regulatory Authorities, that may be in effect from time to time, which, with respect to each Research, Development or Manufacturing activity that will or would reasonably be expected... |
1.19 "Biosimilar Product" means, with respect to a particular Licensed Product or a particular Licensed Ophthalmology Product, as applicable, in a particular country in the Territory, any pharmaceutical product that is claimed to be biosimilar to or interchangeable with such Licensed Product or such Licensed Ophthalmol... |
1.20 "BLA" means a Biologics License Application as described in 21 C.F.R. §601.2, or equivalent application in any applicable foreign jurisdiction in the Territory. |
1.21 "BPCI Act" means the Biologics Price Competition and Innovation Act of 2009, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto). |
1.22 "Business Day" means a day other than a Saturday or Sunday or a day on which banking institutions in Chicago, Illinois or Los Angeles, California are permitted or required to be closed. |
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