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3.3 entering into this Amendment No. 2 is not in conflict with any other agreement to which such Party is a party; and |
3.4 this Amendment No. 2 has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforce... |
judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity. |
4. Reference to Agreement. Upon and after the effectiveness of this Amendment No. 2, each reference in the License Agreement and this Amendment No. 2 to "this Agreement," "the License Agreement," "hereunder," "hereof" or words of the like import referring to the License Agreement shall mean and be a reference to the Li... |
5. California Law. This Amendment No. 2 shall be construed and enforced in accordance with the laws of the state of California without regard to its conflicts or choice of law principles thereof. |
6. No Other Waiver. Except as expressly set forth herein, the execution, delivery and effectiveness of this Amendment No. 2 shall not operate as a waiver of any right, power or remedy of either party under the License Agreement, nor constitute a waiver of any provision of the License Agreement. |
7. Counterparts. This Amendment No. 2 may be executed by original or facsimile signature in two or more in counterparts, all of which taken with the same effect as if both Parties had signed the same document, each of which shall be deemed an original, shall be construed together and shall constitute a single one and t... |
[Signature page follows.] |
10.3.3 – 4 [Signature Page to Amendment No. 2 to License Agreement] |
THIS AMENDMENT NO. 2 IS EXECUTED by authorized representatives of the Parties as of the date first written above. |
The Scripps Research Institute |
By: |
Name: |
Title: |
California Institute for Biomedical Research |
By: |
Name: |
Title: |
Schedule 13.5 Arbitration |
The arbitration of a Dispute shall be conducted as follows: |
1. The arbitration shall be administered by JAMS pursuant to its Comprehensive Rules and Procedures, except as modified under this Schedule 13.5. The Parties acknowledge that this Agreement evidences a transaction involving interstate commerce. Notwithstanding any provision with respect to the applicable substantive la... |
2. To begin an arbitration, a Party shall provide written notice to the other Party of the Dispute, including a brief statement of the factual basis for its claim(s) and the relief sought. Within fourteen (14) days after its receipt of such notice, the other Party (the "Respondent") may, by written notice to the Party ... |
3. Within twenty-one (21) days after the commencement of arbitration, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in resolution of all issues in the arbitration. If the Parties are unable to agree on a mutually acceptable arbitrator within such period, wit... |
(a) A person shall be deemed to have a conflict, and shall not be appointed as an Arbitrator absent the consent of both parties, if such person (i) has presided over an evidentiary hearing relating to, or issued a ruling on, the merits of a dispute, involving either Party; (ii) has conducted a mediation involving eithe... |
Party within the last 10 years. The "merits of a dispute" are matters substantially related to the substance of the underlying claim, and do not include procedural or discovery-related matters; |
(b) A person shall be deemed to have a conflict, and shall not be appointed as an Arbitrator absent consent of both parties, if such person previously served as a party-appointed Arbitrator appointed by either Party, or by any party represented in a previous arbitration by one of the law firms representing either Party... |
(c) No earlier than forty-five (45) days or later than ninety (90) days after appointment, the Arbitrator shall hold a hearing to resolve each of the issues identified by the Parties. |
4. At least fourteen (14) days prior to the hearing, each Party shall submit the following to the other Party and the Arbitrator: |
(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Arbitrator; |
(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness; |
(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the pr... |
(d) a brief in support of such Party's proposed rulings and remedies; provided, that the brief shall not exceed twenty (20) pages unless the Arbitrator determines that the number and complexity of issues requires that the page-limit be expanded. |
5. Each Party shall be entitled to ten (10) document requests and two (2) depositions. The Arbitrator may permit additional discovery for good cause shown, subject to the limits specified below, where such discovery is reasonably calculated to lead to evidence regarding liability or damages, and with respect to a reque... |
6. The hearing shall be conducted on no more than five (5) consecutive days and shall be governed by the following rules: |
(a) Each Party shall be entitled to fifteen (15) hours of hearing time to present its case. The Arbitrator shall keep time and shall determine whether each Party has had the fifteen (15) hours to which it is entitled. |
(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examinatio... |
(c) Except when testifying, witnesses shall be excluded from the hearing until closing arguments. |
(d) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. As to all other matters, the Arbitrator shall have sole discretion regarding the admissibility of any evidence. |
7. Prior to the completion of the hearing, a Party may seek leave from the Arbitrator to modify its proposed rulings on one or more issues to be resolved. If the Arbitrator finds good cause for such modification, within seven (7) days following completion of the hearing, the Parties shall file a substitute proposed rul... |
8. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the Arbitrator a post-hearing brief in support of its proposed rulings and remedies; provided, that such brief shall not contain or discuss any new evidence and shall not exceed ten (10) pages. This page limitatio... |
9. Within fourteen (14) days following completion of the hearing, each Party may submit to the other Party and the Arbitrator a post-hearing brief in support of its proposed rulings and remedies; provided, that such brief shall not contain or discuss any new evidence and shall not exceed twenty (20) pages unless the Ar... |
10. The Arbitrator shall rule on each disputed issue within thirty (30) days either following completion of the hearing or the submission of post-hearing briefs, if any. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's ... |
11. All Arbitrator and JAMS fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), and any expenses for a hearing room, shall be paid as follows: |
(a) If the Arbitrator rules in favor of one (1) Party on all disputed issues in the arbitration, the losing Party shall pay one hundred percent (100%) of such fees and expenses. |
(b) If the Arbitrator rules in favor of one (1) Party on some issues and the other Party on other issues, the Arbitrator shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Arbitrator shall allocate fees and expenses in a way that bears a rea... |
12. Except as may be required by law or legal proceedings to confirm or enforce an award, the existence of the Dispute, any settlement negotiations, the arbitration, any submissions (including exhibits, testimony, proposed rulings, and briefs), and any rulings and the award shall be deemed to be Confidential Informatio... |
13. The language of the arbitration shall be English and the seat of arbitration shall be in San Diego, California, USA. |
14. Each Party shall have the right to be represented by counsel in all aspects of any arbitration proceeding. |
EXECUTION VERSION |
Collaboration and License Option Agreement |
Between |
Cugene, Inc. |
and |
AbbVie Global Enterprises Ltd. |
Dated as of May 6, 2022 |
TABLE OF CONTENTS |
ARTICLE 1 DEFINITIONS........................................................................................................... 1 |
ARTICLE 2 INITIAL DEVELOPMENT .................................................................................... 26 |
2.1. Initial Development Plan and Budget ................................................................... 26 |
2.2. Diligence ............................................................................................................... 26 |
2.3. Performance of Initial Development and Regulatory Activities........................... 27 |
2.4. Information and Reports ....................................................................................... 29 |
2.5. Data Packages ....................................................................................................... 30 |
2.6. Expenses ............................................................................................................... 32 |
ARTICLE 3 LICENSE OPTION.................................................................................................. 32 |
3.1. License Option ...................................................................................................... 32 |
3.2. License Option Exercise ....................................................................................... 32 |
3.3. Licensed Therapeutic and Licensed Product Responsibility ................................ 33 |
3.4. Additional Cugene Obligations............................................................................. 34 |
3.5. Termination of License Option............................................................................. 36 |
ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY.................................................................. 36 |
4.1. Grants to AbbVie .................................................................................................. 36 |
4.2. Grants to Cugene................................................................................................... 36 |
4.3. Sublicenses............................................................................................................ 36 |
4.4. No Implied Licenses ............................................................................................. 37 |
4.5. Confirmatory Patent License ................................................................................ 37 |
4.6. Exclusivity ............................................................................................................ 37 |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE........................ 38 |
5.1. In General.............................................................................................................. 38 |
5.2. Diligence ............................................................................................................... 38 |
5.3. Manufacturing Technology Transfer .................................................................... 38 |
5.4. Subcontracting; Distributors ................................................................................. 40 |
5.5. Records; Development and Commercialization Reports...................................... 41 |
5.6. Regulatory Activities ............................................................................................ 42 |
5.7. Adverse Event and Safety Information Agreement .............................................. 42 |
ARTICLE 6 COLLABORATION MANAGEMENT.................................................................. 42 |
6.1. Joint Governance Committee................................................................................ 42 |
6.2. General Provisions Applicable to the JGC ........................................................... 44 |
6.3. Working Groups.................................................................................................... 46 |
6.4. Alliance Managers. ............................................................................................... 46 |
ARTICLE 7 PAYMENTS AND RECORDS............................................................................... 47 |
7.1. Upfront Payment................................................................................................... 47 |
7.2. License Option Exercise Payment ........................................................................ 47 |
7.3. Development Milestone Events ............................................................................ 47 |
7.4. Sales Milestone Events ......................................................................................... 49 |
7.5. Royalties ............................................................................................................... 49 |
7.6. Estimated Sales Levels ......................................................................................... 52 |
7.7. Royalty Payments and Reports ............................................................................. 52 |
7.8. Mode of Payment.................................................................................................. 52 |
7.9. Taxes. .................................................................................................................... 52 |
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