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DS/DP KBI, Pyramid Samsung, Lonza, Catalent, |
Depot/packaging: PCI, Fisher |
Storage Brooks |
Tox Vehicle GE |
Formulation Dev Analytical/Testing Nelson, BioReliance, Kendrick, CRL, AUC Solutions |
Schedule 13.7.1 |
ADR Procedures |
Any dispute shall be conducted by arbitration as follows: |
1. 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 ... |
The arbitration shall be conducted by a neutral arbitrator. The arbitrator shall be selected by the Parties jointly within twenty-one (21) days after the commencement of arbitration. If the Parties are unable to agree on a mutually acceptable arbitrator within such period, within seven (7) days after the allotted time ... |
2. No earlier than twenty-eight (28) days or later than fifty-six (56) days after appointment, the arbitrator(s) shall hold a hearing to resolve each of the issues identified by the Parties. The arbitration shall take place at a location agreed upon by the Parties. If the Parties cannot agree, the arbitrator(s) shall d... |
3. At least fourteen (14) days prior to the hearing, each Party shall submit the following to the other Party and the arbitrator(s): |
(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the arbitrator(s); |
(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(s) determines that the number and complexity of issues requires that the page-limit be expanded. |
Except as expressly set forth in subparagraphs 3(a)-3(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions or production of documents. |
4. 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(s) 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) The Party initiating the arbitration shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in ... |
(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments. |
(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the arbitration hearing also shall not be admissible. As to all other matters, the arbitrator(s) shall have sole discretion regarding the admissibility of any evidence... |
5. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the arbitrator(s) 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 limita... |
6. The arbitrator(s) shall rule on each disputed issue within seven (7) 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 ... |
7. All arbitrator(s) fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows: |
(a) If the arbitrator(s) rule 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(s) rule in favor of one (1) Party on some issues and the other Party on other issues, the arbitrator(s) shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The arbitrator(s) shall allocate fees and expenses in a way that bea... |
8. The rulings of the arbitrator(s) and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction. |
9. Except as may be required by law or legal proceedings to 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 Information of both Pa... |
10. The language of the arbitration shall be English and the seat of arbitration shall be in Chicago, Illinois. |
11. Each Party shall have the right to be represented by counsel in all aspects of any arbitration proceeding. |
CONFIDENTIAL EXECUTION COPY |
COLLABORATION AND OPTION TO LICENSE AGREEMENT |
between |
HOTSPOT THERAPEUTICS, INC. |
and |
ABBVIE GLOBAL ENTERPRISES LTD. |
Dated as of December 2, 2022 |
TABLE OF CONTENTS |
Page |
ARTICLE 1 DEFINITIONS ...................................................................................................................... 1 |
ARTICLE 2 COLLABORATION MANAGEMENT ........................................................................... 30 |
2.1. Joint Governance Committee ................................................................................................. 30 |
2.2. Working Groups ...................................................................................................................... 31 |
2.3. General Provisions Applicable to the JGC ............................................................................ 31 |
2.4. Discontinuation of the JGC or Working Groups .................................................................. 33 |
2.5. Interactions Between the JGC or a Working Group and Internal Teams ......................... 34 |
2.6. Expenses ................................................................................................................................... 34 |
ARTICLE 3 INITIAL DEVELOPMENT .............................................................................................. 34 |
3.1. Development Plan and Budget ............................................................................................... 34 |
3.2. Performance of the Development Plan and Budget .............................................................. 34 |
3.3. Amendments to the Development Plan and Budget ............................................................. 36 |
3.4. Interim Development Reports ................................................................................................ 36 |
3.5. Information Reports and Final Data Package ...................................................................... 36 |
3.6. Expenses ................................................................................................................................... 38 |
3.7. AbbVie Development Activities Prior to License Option Effective Date............................ 38 |
3.8. Manufacturing Prior to License Option Effective Date ....................................................... 38 |
3.9. Regulatory Matters Prior to License Option Effective Date ............................................... 38 |
3.10. Completion of Development Plan Activities after License Option Effective Date. ............ 39 |
ARTICLE 4 LICENSE OPTION ............................................................................................................ 40 |
4.1. License Option Grant to AbbVie ........................................................................................... 40 |
4.2. Exercise of the License Option ............................................................................................... 40 |
4.3. Antitrust Clearances................................................................................................................ 40 |
4.4. Termination of License Option .............................................................................................. 42 |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION AFTER LICENSE OPTION EXERCISE .................................................................................................................. 42 |
5.1. In General ................................................................................................................................. 42 |
5.2. Diligence ................................................................................................................................... 43 |
5.3. HotSpot Cost-Sharing Option ................................................................................................ 44 |
5.4. Manufacturing after License Option ..................................................................................... 45 |
5.5. Manufacturing Supplies Transfer .......................................................................................... 46 |
5.6. Manufacturing Technology Transfer .................................................................................... 46 |
5.7. Regulatory Matters after License Option .............................................................................. 48 |
5.8. Records and Reports ............................................................................................................... 49 |
5.9. Booking of Sales; Distribution ................................................................................................ 49 |
5.10. Product Trademarks ............................................................................................................... 50 |
ARTICLE 6 GRANT OF RIGHTS ......................................................................................................... 50 |
6.1. Grants to AbbVie on the Effective Date ................................................................................ 50 |
6.2. Grants to HotSpot on the Effective Date ............................................................................... 50 |
6.3. Grants to AbbVie on the License Option Effective Date ..................................................... 50 |
6.4. Sublicenses ................................................................................................................................ 51 |
6.5. Distributorships ....................................................................................................................... 51 |
6.6. Co-Promotion Rights ............................................................................................................... 51 |
6.7. Retention of Rights .................................................................................................................. 51 |
6.8. Confirmatory Patent License ................................................................................................. 52 |
6.9. Exclusivity ................................................................................................................................ 52 |
6.10. In-License Agreements ............................................................................................................ 53 |
6.11. HotSpot DNA Encoded Libraries (DELs) ............................................................................. 54 |
ARTICLE 7 PAYMENTS AND RECORDS .......................................................................................... 55 |
7.1. One-Time Payments ................................................................................................................ 55 |
7.2. Research and Development Milestones ................................................................................. 55 |
7.3. Development and Regulatory Milestones .............................................................................. 56 |
7.4. Commercial Milestones ........................................................................................................... 57 |
7.5. Sales-Based Milestones ............................................................................................................ 57 |
7.6. Royalties ................................................................................................................................... 58 |
7.7. Royalty Payments and Reports .............................................................................................. 61 |
7.8. FTE Costs ................................................................................................................................. 61 |
7.9. Supplemental Development Payments. .................................................................................. 62 |
7.10. Other Invoiced Amounts ......................................................................................................... 62 |
7.11. Interest on Late Payments ...................................................................................................... 62 |
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