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Disclosure against Section 10.2.10(iii) (Additional Representations and Warranties of HotSpot): The Scheduled Third Party has (a) an exclusive license to use the Project DELs within the Scheduled Third Party Exclusive Field for any commercial or research purpose and (b) a non-exclusive license to use the Technology (as... |
Schedule 13.7.3 |
ADR Procedures |
Any Dispute referred to ADR under this Agreement shall be resolved as follows: |
1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within fourteen (14) days after its receipt of such notice, the other Party may, by written notice to the Party initiating the arbitration, add additional issues to be resolved within the same AD... |
2. Within twenty-one (21) days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within su... |
3. No earlier than twenty-eight (28) days or later than fifty-six (56) days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place in New York, New York unless a different location is agreed upon by the Parties. If the Parties canno... |
4. At least seven (7) days prior to the hearing, each Party shall submit the following to the other Party and the Neutral: (a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral; (b) a list of any witnesses such Party intends to call at the hearing, and a short... |
5. The hearing shall be conducted on two (2) consecutive days and shall be governed by the following rules: (a) Each Party shall be entitled to five (5) hours of hearing time to present its case. The Neutral shall determine whether each Party has had the five (5) hours to which it is entitled. (b) Each Party shall be e... |
6. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the Neutral 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 limitation sh... |
7. The Neutral shall rule on each disputed issue within fourteen (14) days following receipt of post-hearing briefs. 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 proposed rulings and remedies on some issues and the ... |
8. The Neutral shall be paid a reasonable fee plus expenses. These 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) ... |
9. The rulings of the Neutral 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. |
10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall hav... |
11. All ADR proceedings shall be conducted in the English language. |
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding. |
Confidential EXECUTION VERSION |
COLLABORATION AND OPTION TO LICENSE AGREEMENT |
between |
HEPTARES THERAPEUTICS LIMITED |
and |
ABBVIE IRELAND UNLIMITED COMPANY |
Dated as of June 24, 2020 |
TABLE OF CONTENTS |
ARTICLE 1 DEFINITIONS ...................................................................................................................... 1 |
ARTICLE 2 COLLABORATION MANAGEMENT ........................................................................... 21 |
2.1 Joint Governance Committee .............................................................................. 21 2.2 General Provisions Applicable to Joint Committees ........................................... 21 2.3 Working Groups .......................................................................................... |
ARTICLE 3 INITIAL DEVELOPMENT .............................................................................................. 23 |
3.1 Research Plans ..................................................................................................... 23 3.2 Performance of the Research Plans ..................................................................... 23 3.3 Material Research Plan Amendment ................................................... |
ARTICLE 4 LICENSE OPTION ............................................................................................................ 34 |
4.1 License Option Grant to AbbVie ......................................................................... 34 4.2 Exercise of the License Option ............................................................................ 34 4.3 Consequences of Exercise ................................................................... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION AFTER LICENSE OPTION EXERCISE .................................................................................. 36 |
5.1 In General ............................................................................................................ 36 5.2 Diligence ............................................................................................................. 36 5.3 Manufacturing after License Option Effective Date ............... |
ARTICLE 6 GRANT OF RIGHTS ........................................................................................................ 37 |
6.1 Grants to AbbVie on the Effective Date .............................................................. 37 6.2 Grants to AbbVie on the License Option Effective Date .................................... 38 6.3 Grant to Heptares .............................................................................................. |
ARTICLE 7 PAYMENTS AND RECORDS ......................................................................................... 40 |
7.1 One-Time Payments ............................................................................................ 40 7.2 Research Milestones ............................................................................................ 40 7.3 Clinical Development Milestones ................................................. |
ARTICLE 8 INTELLECTUAL PROPERTY ....................................................................................... 47 |
8.1 Ownership of Intellectual Property ..................................................................... 47 8.2 Maintenance and Prosecution of Patents ............................................................. 48 8.3 Enforcement of IP ................................................................................. |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE ......................................................... 57 |
9.1 Product Information ............................................................................................ 57 9.2 Confidentiality Obligations ................................................................................. 57 9.3 Permitted Disclosures ............................................................ |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES ............................................................... 61 |
10.1 Mutual Representations and Warranties .............................................................. 61 10.2 Additional Representations and Warranties of Heptares ..................................... 61 10.3 Mutual Covenants ............................................................................................ |
ARTICLE 11 INDEMNITY .................................................................................................................... 66 |
11.1 Indemnification of Heptares ................................................................................ 66 11.2 Indemnification of AbbVie.................................................................................. 66 11.3 Notice of Claim ..................................................................... |
ARTICLE 12 TERM AND TERMINATION ........................................................................................ 69 |
12.1 Term .................................................................................................................... 69 12.2 Termination for Material Breach ......................................................................... 69 12.3 Additional Termination Rights by AbbVie .................................. |
ARTICLE 13 MISCELLANEOUS ......................................................................................................... 76 |
13.1 Force Majeure ...................................................................................................... 76 13.2 Change in Control of Heptares ............................................................................ 77 13.3 Export Control ............................................................... |
SCHEDULES |
Schedule 1.58 Corporate Names Schedule 1.180 Research Plans Schedule 3.2.3 Approved Subcontractors Schedule 7.6.2 Example Calculation Schedule 9.5 Form of Press Releases Schedule 10.2 Heptares Disclosures Schedule 10.2.1 Existing Patents Schedule 10.7 Representations and Warranties for Updated Disclosure Schedule Sched... |
COLLABORATION AND OPTION TO LICENSE AGREEMENT |
This Collaboration and Option to License Agreement (the "Agreement") is made and entered into effective as of June 24, 2020 (the "Effective Date") by and between Heptares Therapeutics Limited, a company registered in England having its principal place of business at Steinmetz Building, Granta Park, Great Abington, Camb... |
RECITALS |
WHEREAS, Heptares Controls (as defined herein) or will Control certain intellectual property rights with respect to the Reserved Compounds (as defined herein), Reserved Products (as defined herein), Compounds (as defined herein) and Products (as defined herein) in the Territory (as defined herein); and |
WHEREAS, Heptares wishes to grant, and AbbVie wishes to take, exclusive options to take one or more Exclusive Licenses under such intellectual property rights to Exploit Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below. |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, 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 "AbbVie" has the meaning set forth in the preamble hereto. |
1.2 "AbbVie Grantback Know-How" means, as used in connection with a Grantback Product and any related grant back license provided in Section 12.7.1(d) or 12.8.2, that certain Know-How Controlled by AbbVie or its Affiliates that (a) is specifically directed to the Grantback Product or Exploitation thereof and is being u... |
1.3 "AbbVie Grantback Patents" means, as used in connection with a Grantback Product and any related grant back license provided in Section 12.7.1(d) or 12.8.2, those certain Patents Controlled by AbbVie or its Affiliates that specifically claim an invention that (a) is directed to the Grantback Product or Exploitation... |
1.4 "AbbVie Indemnitees" has the meaning set forth in Section 11.2. |
1.5 "AbbVie Prosecuted Infringement" has the meaning set forth in Section 8.3.3. |
1.6 "Accounting Standards" means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with (a) United States Generally Accepted Accounting Principles or (b) to the extent applicable, International Financial Reporting Standards as issued by the International Accounting Sta... |
1.7 "Acquired Affiliates" means those Affiliates of Heptares that becomes Affiliates of Heptares after the Effective Date as a result of a merger or acquisition with, by or of a Third Party(ies). |
1.8 "Acquiring Program" has the meaning set forth in Section 6.9.2. |
1.9 "Additional Option Program" means Heptares' Development program for therapeutic agents directed at the Additional Option Target in the Designated Pharmacology, as described in the Additional Target Research Plan, which shall become an Option Program upon selection of an Available Target by AbbVie as set forth in Se... |
1.10 "Additional Option Target" means an Available Target selected by AbbVie pursuant to Section 3.6.1. |
1.11 "Additional Target Research Plan" has the meaning set forth in Section 3.6.1. |
1.12 "ADR" has the meaning set forth in Section 13.7.1. |
1.13 "Adverse Ruling" has the meaning set forth in Section 12.2.1. |
1.14 "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. For purposes of this definition, "control" and, with correlative meanings, the terms "controlled by" and "under common co... |
1.15 "Agreement" has the meaning set forth in the preamble hereto. |
1.16 "Alliance Manager" has the meaning set forth in Section 2.2.6. |
1.17 "Alternate Pharmacology" has the meaning set forth in Section 3.8.2. |
1.18 "Alternate Pharmacology Exercise Notice" has the meaning set forth in Section 3.8.3. |
1.19 "Alternate Pharmacology Notice" has the meaning set forth in Section 3.8.3. |
1.20 "Alternate Pharmacology Option End Date" has the meaning set forth in Section 3.8.2. |
1.21 "Alternate Pharmacology Option Fee" has the meaning set forth in Section 7.1.4. |
1.22 "Alternate Pharmacology Option Program" has the meaning set forth in Section 3.8.3(ii). |
1.23 "Alternate Pharmacology Research Plan" has the meaning set forth in Section 3.8.3(ii). |
1.24 "Annual Net Sales Milestone Threshold" has the meaning set forth in Section 7.5.1. |
1.25 "Annual Net Sales-Based Milestone Payment" has the meaning set forth in Section 7.5.1. |
1.26 "Annual Net Sales-Based Milestone Payment Date" has the meaning set forth in Section 7.5.1. |
1.27 "Annual Net Sales-Based Milestone Table" has the meaning set forth in Section 7.5.1. |
1.28 "Applicable Law" means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be ... |
1.29 "Arising Heptares Platform Intellectual Property Rights" means the Arising Heptares Platform Know-How and the Arising Heptares Platform Patents. |
1.30 "Arising Heptares Platform Know-How" means any and all Information and inventions to the extent directly related to the Heptares Platform that are conceived, reduced to practice, discovered, developed or otherwise made (a) by or on behalf of AbbVie or its Affiliates under this Agreement by using Heptares Know-How,... |
1.31 "Arising Heptares Platform Patents" means all of the Patents that claim inventions to the extent directly related to the Heptares Platform that are conceived, reduced to practice, discovered, developed or otherwise made (a) by or on behalf of AbbVie or its Affiliates under this Agreement, or (b) jointly by or on b... |
1.32 "Audit Arbitrator" has the meaning set forth in Section 7.15. |
1.33 "Available Target" means any Target that is not, as of the date selected by AbbVie (a) the subject of an existing agreement, including an option or covenant, between Heptares or its Affiliate and a Third Party, as evidenced by a definitive agreement, a binding letter of intent or similar binding agreement, (b) the... |
1.34 "Bankruptcy Code" has the meaning set forth in Section 12.6.1. |
1.35 "Bayh-Dole Act" means the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401. |
1.36 "Board of Directors" has the meaning set forth Section 1.44.1. |
1.37 "Breaching Party" has the meaning set forth in Section 12.2.1. |
1.38 "Business Day" means a day, other than a Saturday or Sunday, on which banking institutions in Chicago, Illinois and London, England are open for business. |
1.39 "Calendar Quarter" means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or Oc... |
1.40 "Calendar Year" means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the... |
1.41 "Candidate Selection" means the date on which AbbVie delivers its selection of the Option Compound in accordance with Section 2.2.3 that will be the subject of a Toxicology Study pursuant to Section 3.9, provided that the criteria set forth in Appendix A, B, C and Stage 4a in Appendix D of the applicable Research ... |
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