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(a) Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of the State of New York, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or inter... |
(b) Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 13.6(b) shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
13.6 Notices. |
(a) Notice Requirements. Any notice, request, demand, waiver, consent, approval, or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (i) delivered by hand or sent by facsimile transmission (with transmission ... |
(b) Address for Notice. |
If to Mission, to: |
Mission Therapeutics Limited. McClintock Building Granta Park Great Abington Cambridge CB21 6GP United Kingdom Attention: Chief Executive Officer Facsimile: |
If to AbbVie, to: |
AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 U.S. Attention: Executive Vice President, External Affairs, General Counsel and Corporate Secretary Fax: (847) 935-3294 |
13.7 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises, and representations, whether written or oral... |
13.8 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The... |
13.9 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between ... |
13.10 No Benefit to Third Parties. Except as provided in Sections 11.1 and 11.2, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. |
13.11 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as the other Party m... |
13.12 Relationship of the Parties. It is expressly agreed that AbbVie, on the one hand, and Mission, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture, or agency, including for all tax purposes. Neither AbbVie, on the ... |
13.13 Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such signat... |
13.14 References. Unless otherwise specified, (i) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (ii) references in any Section to any clause are references to such clause of such Section, and (iii) references to any agreeme... |
13.15 Performance by Affiliates. Subject to the terms and conditions of this Agreement, each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party's obligations under this Agreement, and shall caus... |
13.16 Compliance with Applicable Law. Each Party shall comply with Applicable Law in the course of performing its obligations or exercising its rights pursuant to this Agreement. Neither Party (nor any of their Affiliates) shall be required under this Agreement to take any action or to omit to take any action otherwise... |
13.17 Interpretation. The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles, Sections or ... |
[signature page follows] |
Schedule 1.15 |
Agreed Assays |
The Agreed Assays are assays for each of the DUBs set out below. The protocol for each Agreed Assay is as disclosed in the Mission data room made available to AbbVie on or prior to the Effective Date |
BAP1 Cezanne OTUD3 SENP2 TRABID UCHL1 UCHL3 USP1 USP10 USP12 USP14 USP15 USP20 USP21 USP22 USP28 USP30 USP34 USP35 USP4 USP46 USP7 USP8 USP9X YOD1 |
Schedule 1.54 |
Examples of DUB Hits, Restricted Mission Compounds and Unrestricted Mission Compounds |
This Schedule 1.54 is intended to provide examples of Collaboration Compounds or AbbVie Compounds that are DUB Hits, Restricted Mission Compounds and Unrestricted Mission Compounds pursuant to Sections 1.54, 1.160 and 1.188 of this Agreement. This Schedule 1.54 is for illustrative purposes only, and any term or conditi... |
Visual representations of the calculations in Sections 1.54, 1.160, and 1.188 |
*Other than DSS Excluded DUBs that have become Exclusively Licensed DUBs |
Examples of potency relationships for purposes of classifying compounds (IC50 in nM) |
Example Compound No Type A B C D 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 |
1 DUB Hit; Licensed Compound 1 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
2 DUB Hit; Licensed Compound 1 10,000 10,000 10,000 100 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
3 DUB Hit; Licensed Compound 10,000 0.1 10,000 10,000 30 30 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
4 DUB Hit; Licensed Compound 1 100 10,000 10,000 100 100 100 100 100 100 100 100 100 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
5 DUB Hit; Licensed Compound 0.1 1 1 1 30 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
6 DUB Hit; Licensed Compound 100 100 100 100 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
7 Restricted Mission Compound 1 10,000 10,000 10,000 1 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
8 Restricted Mission Compound 100 100 10,000 10,000 100 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
9 Restricted Mission Compound 3 10,000 10,000 10,000 10 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
10 Restricted Mission Compound 1,000 10,000 10,000 10,000 1,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
11 Restricted Mission Compound 1 1 1 1 10 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
12 Restricted Mission Compound 10 10,000 10,000 10,000 3 3 3 3 3 3 3 3 3 3 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
13 Unrestricted Mission Compound 10,000 10,000 10,000 10,000 1 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
14 Unrestricted Mission Compound 100 10,000 10,000 10,000 1 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
15 Unrestricted Mission Compound 100 100 100 100 1 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
16 Unrestricted Mission Compound 30 10,000 10,000 10,000 0.1 10 10 10 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
17 Unrestricted Mission Compound 10,000 10,000 10,000 10,000 100 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
18 Unrestricted Mission Compound 10,000 10,000 10,000 10,000 10,000 10 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 10,000 |
Note: Examples 7-12 above have the potential to become Unrestricted Mission Compounds. For example, if such compound hits a DUB outside of the DSS Excluded DUBs with sufficient selectivity relative to all Exclusively Licensed DUBs (so long as it is not otherwise a DUB Hit/Exclusively Licensed Compound), such compound w... |
Schedule 1.65 |
Definition of Excluded Mission Compound |
"Excluded Mission Compound" means (a) any Initially Excluded Mission Compound (as set forth on Schedule 1.87) and/or (b) any Mission Compound synthesised by Mission outside the Collaboration prior to the end of the Stage 1A Period that, in each case ((a) and (b)), satisfies all of (i), (ii) (Paragraphs A, B, and C), an... |
i) the IC50 of such Mission Compound directed to an Initially Excluded DUB is less than 100 nM; |
ii) such Mission Compound is invented by Mission under a program to Develop or commercialize a molecule that is designed to bind to an Initially Excluded DUB prior to the end of the Stage 1A Period and satisfies all of Paragraphs A, B, and C below: |
(A) such Mission Compound is named and locked in DotMatics database and submitted or undergoing characterization and profiling in ADME/PK studies or selectivity studies as evidenced through contemporaneous written records, prior to the date of the Pre-Selected DUB Nomination Notice with respect to the Nominated Pre-Sel... |
(B) with respect to each Mission Compound (other than any Initially Excluded Mission Compound) directed to an Initially Excluded DUB, the IC50 of such Mission Compound with respect to each such Initially Excluded DUB is less than the IC50 of such Mission Compound with respect to any Initially Selected DUB; |
(C) following a DUB Selectivity Screen of such Mission Compound, such Mission Compound (other than any Initially Excluded Mission Compounds) satisfies the following: with respect to the Excluded DUB to which that Mission Compound is directed, three (3) times the log10 of the IC50 of such Mission Compound with respect t... |
iii) other than in respect of an Initially Excluded Mission Compound, from the date of the Pre-Selected DUB Nomination Notice pursuant to the Note below, subject to the availability of a Suitable Biochemical Assay, such Mission Compound satisfies Paragraph X below: |
(X) with respect to the Excluded DUB to which that Mission Compound is directed, three (3) times the log10 of the IC50 of such Mission Compound with respect to such Excluded DUB less five (5) times the log10 of the IC50 of such Mission Compound with respect to each Nominated Pre-Selected DUB is less than ten (10); |
provided, however, that, on a Nominated Pre-Selected DUB-by-Nominated Pre-Selected DUB basis, this Paragraph X shall not apply, with respect to such Nominated Pre-Selected DUB, to any Mission Compound synthesized by or on behalf of Mission prior to the date of Pre-Selected DUB Nomination Notice with respect to such Nom... |
Note |
At any time during the first eight (8) months of the Stage 1A Period, and as further set forth in Section 3.2(a), AbbVie may provide Mission with Pre-Selected DUB Nomination Notice with respect to a Pre-Selected DUB (such Pre-Selected DUB, a "Nominated Pre-Selected DUB" pursuant to Section 3.2(a)), and promptly followi... |
Schedule 1.86 |
Initially Excluded DUBs |
USP 1 USP 4 USP 10 USP 21 USP 28 USP 30 USP 34 USP 35 TRABID UCHL1 Cezanne |
Schedule 1.87 |
Initially Excluded Mission Compounds |
MTX084799 MTX112093 MTX112952 MTX114379 MTX114399 MTX091206 MTX114393 MTX111865 MTX114112 MTX114402 MTX114570 MTX114641 MTX114664 MTX090795 MTX111545 MTX114097 MTX114601 MTX114625 MTX114677 MTX114727 |
Schedule 1.108 |
Mission Background Patents |
[This is a table of Mission Background Patents with columns for Mission Reference, Title, Country, Case Status, Application No., Application Filing Date, Publication No., Publication Date, Registration No., and Registered Date. The table lists multiple patents under various reference codes (P003, P004, P005, P007, P008... |
Schedule 1.117 |
Mission Patent Countries |
Composition of Matter (COM) Filings |
Argentina (AR) Australia (AU) Brazil (BR) Canada (CA) Colombia (CO) Chile (CL) China (CN) Dominican Republic (DR) Ecuador (EC) European Patent Office (EPO)—Validation in EPC Contracting and Extension States Gulf Cooperation Council (GCC) Guatemala (GT) Hong Kong (HK) Indonesia (ID) Israel (IL) India (IN) Japan (JP) Sou... |
All Other Filings |
Australia (AU) Brazil (BR) Canada (CA) China (CN) European Patent Office (EPO)— Validation in EPC Top 5 States Japan (JP) Mexico (MX) United States of America (US) |
EPC Contracting and Extension States |
Albania (AL) Austria (AT) Belgium (BE) Bulgaria (BG) Switzerland (CH) Cyprus (CY) Czech Republic (CZ) Germany (DE) Denmark (DK) Estonia (EE) Spain (ES) Finland (FI) France (FR) United Kingdom (GB) Greece (GR) Croatia (HR) Hungary (HU) Ireland (IE) Iceland (IS) Italy (IT) Liechtenstein (LI) Lithuania (LT) Luxembourg (LU... |
EPC Top 5 States |
Germany (DE) Spain (ES) France (FR) United Kingdom (GB) Italy (IT) |
Schedule 1.141 |
Pre-Selected DUBs |
Full list of all 107 DUBs minus the 11 Excluded DUBs = 96 DUBs. |
A20 AMSH AMSH_LP ATXN3 ATXN3L BAP1 BRCC3 Cezanne2 CSN5 CSN6 CYLD DESI1 DESI2 EIF3H EIF3F FAM105A FAM188A FAM188B FAM188B2 FAM63A FAM63B JOSD1 JOSD2 MPND MYSM1 OTUB1 OTUB2 OTUD1 OTUD3 OTUD4 OTUD5 OTUD6A |
OTUD6B OTULIN POH1 PRPF8 PSMD7 SENP1 SENP2 SENP3 SENP5 SENP6 SENP7 SENP8 UCHL3 UCHL5 USP11 USP12 USP13 USP14 USP15 USP16 USP17 USP18 USP19 USP2 USP20 USP22 USP24 USP25 USP26 USP27X USP29 USP3 |
USP31 USP32 USP33 USP36 USP37 USP38 USP39 USP40 USP41 USP42 USP43 USP44 USP45 USP46 USP47 USP48 USP49 USP5 USP50 USP51 USP52 USP53 USP54 USP6 USP7 USP8 USP9X USP9Y USPL1 VCPIP YOD1 ZUFSP |
Schedule 1.157 |
Initial Research Plan |
DUB Target Validation, Discovery and Preclinical Development of DUB Small Molecule Inhibitors |
Project Activities, Timelines and Deliverables by Stage |
Research Program |
The scope of the Research Program includes activities from the exploratory discovery phase (Stage 1 of the Research Program) to the candidate nomination phase prior to initiation of GLP toxicology (Stage 2 of the Research Program). The goal of this research is to validate DUB targets for their role in Tau clearance and... |
Stage 1: DUB In Vitro and In Vivo Target Validation. Mission Library Screening and Limited Chemistry |
Overview: Stage 1 of the Research Program includes activities toward the in vitro and in vivo validation of DUB targets for Tau and /or α-synuclein clearance, as well as the screening of Mission's Compound Library and the generation of potential tractable chemical series for up to four (4) DUBs. The activities within S... |
Schedule 1.157 |
Initial Research Plan |
DUB Target Validation, Discovery and Preclinical Development of DUB Small Molecule Inhibitors |
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