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14.16 Performance by Affiliates. AbbVie may use one (1) or more of its Affiliates to perform its obligations and duties hereunder and such AbbVie Affiliates are expressly granted certain rights herein; provided that each such Affiliate shall be bound by the corresponding obligations of AbbVie and, subject to an assignm... |
14.17 Costs and Expenses. Unless otherwise expressly set forth in this Agreement, each Party shall bear its own costs and expenses incurred in connection with the negotiation, preparation, execution, and performance of this Agreement. |
14.18 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 (1) and the same instrument. This Agreement may be executed by electronically transmitted signatures and such signatures shal... |
14.19 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (b) references in any Section to any clause are references to such clause of such Section, and (c) references to any agreement,... |
14.20 Schedules. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control. |
14.21 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word "or" is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless o... |
[SIGNATURE PAGE FOLLOWS.] |
PRIVILEGED AND CONFIDENTIAL THIS AGREEMENT IS EXECUTED by the duly authorized representatives of the Parties as of the Effective Date. PARVUS PHARMACEUTICALS, INC. ABBVIE GROUP INVESTMENTS LIMITED By: Name: Title: By: Name: Title: Peter M. Strumph Chief Executive Officer |
PRIVILEGED AND CONFIDENTIAL THIS AGREEMENT IS EXECUTED by the duly authorized representatives of the Parties as of the Effective Date. PARVUS PHARMACEUTICALS, INC. ABBVIE GROUP INVESTMENTS LIMITED By: Name: Title: By: Name: Title: Tim Richmond Senior Vice President |
CONFIDENTIAL 103 |
Schedule 1.48 Certain Components |
Figure 1: (1) Iron oxide nanoparticle core (1 – 100nm in size) (2) Aminated crosslinked dextran coating (3) Surface-Antigen MHC conjugated to aminated crosslinked dextran coating with NHS-PEG(2)-Maleimide linker |
Figure 2: Surface-Antigen MHC (IBD-Associated Antigen - DRB4*01:01 hIgG1 KIH-Cys pMHC) |
CONFIDENTIAL 104 |
Schedule 1.56 Corporate Names |
1) Corporate name: Parvus Therapeutics Inc. 2) Corporate name: Parvus Therapeutics US, Inc. 3) Parvus Logo 4) Trademark: NavacimTM |
CONFIDENTIAL 105 |
Schedule 1.83 Excluded Antigens |
Type 1 diabetes: Islet-specific glucose-6-phosphatase catalytic subunit-related protein (IGRP) (excluding microbial mimetics of IGRP), pre-proinsulin (PPI), insulin, glutamic acid decarboxylase 65 (GAD65), insulinoma antigen-2 (IA-2), zinc transporter-8 (ZnT8), chromogranin A (CHGA), islet amyloid polypeptide (IAPP), a... |
Multiple sclerosis: myelin oligodendrocyte glycoprotein (MOG), myelin basic protein (MBP), proteolipid protein antigen (PLP), RASGRP2 |
Neuromyelitis Optica Spectrum Disorder: aquaporin-4 (AQP4) |
Celiac disease: Gliadin, include alpha/beta gliadin, y-gliadin, or w-gliadin |
Autoimmune hepatitis: CYP2D6 (anti-LKM1) and CYP2C9 (anti-LMK2), soluble liver antigen (O-phosphoseryl-tRNA (Sec) selenium transferase, SLA), smooth muscle/filamentous actin antigen (SMA), LC1 (Formiminotransferase cyclodeaminase, FTCD), beta tubulin isotype 5. |
Primary Biliary Cholangitis: PDC-E2. |
Primary Sclerosing Cholangitis: SMA, liver/kidney microsomes (anti-LKM1 and LKM2), SLA, beta tubulin isotype 5, Proteinase 3 (PR3), Zymogen granule membrane glycoprotein 2 (GP2) |
Kidney/Liver transplant rejection: PDC-E2, Uromodulin |
Uveitis: human retinal S-antigen, and/or interphotoreceptor retinoidbinding protein (IRBP). |
Arthritis: type II collagen, glucose-6-phosphate isomerase, elongation factor human cartilage gp39, citrullinated vimentin, alpha enolase, alpha-1-antitrypsin, cathelicidin LL37, fibrillin, desmocollin, keratin, joint antigen nebulin-related anchoring protein (N-RAP), ADAMTSL5, P2RX9, Chondromodulin 1, Osteoglycin, Mel... |
Systemic lupus erythematosus: ribonucleoprotein (RNP), Smith (Sm), Sjogren's-syndrome-related antigen A (SS-A)/Ro, Sjogren's-syndrome-related antigen B (SS-B)/La, RO60, RO52. |
CONFIDENTIAL 106 |
Schedule 1.132 License Option Exercise Data Package |
The Data Package will include all data, results, analyses, assay protocols/developed methods and other information generated by or on behalf of Parvus in the performance of the Research and Development Plan Activities, including: a) Non-clinical and CMC reports and documents as well as associated raw data included in t... |
d) The following top line results and subject-level safety, tolerability, pharmacokinetics, and pharmacodynamics data for the first single ascending dose Phase I Study sponsored by Parvus compliant with ICH E3 guidelines, as set forth in the Research and Development Plan: i) Subject-level data for all subjects, to a mi... |
e) The following top line results and subject-level data for the first multiple ascending dose Phase I Study sponsored by Parvus compliant with ICH E3 guidelines, as set forth in the Research and Development Plan: i) Subject-level data for all subjects, to a minimum of n=24 unless otherwise agreed by the parties or unl... |
CONFIDENTIAL 107 |
Schedule 1.164 Parvus Licensed Know-How |
R&D Know-How • Nanoparticle synthesis and analytical characterization. • Protein engineering, expression and purification, including recombinant Fc fusions, peptide-MHC class I and class II complexes and soluble TCRs from both mice and humans. • Protein conjugation onto NPs using various chemistries. • Engineering of p... |
Parvus Platform Know-How • Product Composition (Raw materials, Intermediates, Formulations) • Nanoparticle Process, Control System, and Release Specifications • Linker Formula, and Release Specification • pMHC Protein manufacturing • Upstream Process • Downstream Purification • Control System • Release Specification te... |
Product Composition The Navacim platform has the following components: pMHC protein • Fc Region is considered "Platform" with a C-terminal Cysteine for proper orientation of the conjugated protein to the Nanoparticle. Linker • NHS-PEG(2)-Maleimide Nanoparticle (NP) • Iron Oxide core (5-8nm diam) • Dextran shell (10-15 ... |
Nanoparticle Know-How Manufacturing • Master Batch Records • Specifications • CoA & CoC • Raw materials Specifications • Analytical Assays protocols and Validation reports • Stability protocol and reports Development • Process Development History Report • R&D Stability report |
Linker Know-How Manufacturing • Specifications • CoA & CoC Development • Engineering Lot CoA • Use testing Report (Parvus R&D) Regulatory • JenKem DMF Reference memo |
pMHC Know-How Manufacturing • Process Description • Master Batch Records • Specifications • CoA & CoC for PVT401 pMHC • Raw materials Specifications • Analytical Assays protocols and Validation reports • Stability protocol and reports • Process equipment list • Product-contact material list and specifications |
Development • Process Development History Report (Upstream and Downstream) • R&D Stability report |
Navacim Know-How Manufacturing • Conjugation Process Description • Master Batch Records • Specifications • CoA & CoC for PVT401 • Raw materials Specifications • Analytical Assays protocols and Validation reports • Stability protocol and reports • Process equipment list • Product-contact material list and specifications |
Development • Process Development History Report • R&D Stability report |
Navacim Formulation Know-How Development • Formulation Development History Report • Excipient specifications • R&D Stability report |
Navacim Drug Product Know-How Manufacturing • Process Description • Master Batch Records • Specifications • CoA & CoC for PVT401 DP • Primary Container Specifications • Analytical Assays protocols and Validation reports • Stability protocol and reports • Process equipment list • Product-contact material list and specif... |
CONFIDENTIAL 110 |
Schedule 1.165 Parvus Licensed Material |
May 9, 2019, Non-Exclusive Biological Materials License Agreement between American Type Culture Collection (ATCC) and Parvus Therapeutics Inc. for ATCC TIB -153 (J.RT3-T3.5), Jurkat cell line |
Crosslinked dextran iron oxide nanoparticle, IO Dextran NH2 NPs Iron oxide core diameter by TEM 5.0 nm – 8.6 nm, Particle size and distribution by DLS Z-average 20 – 40 nm, PDI - ≤ 0.2, Dextran/Fe ratio 0.5-2.0 |
Linker: Maleimide PEG2 Succinimdyl Propionate |
PVT 401 pMHC (Flagellin 381-395 – MHC (DRB4*01:01 hIgG1 KIH-Cys)) |
Tetramers: Four biotinylated PVT 401 pMHC (Flagellin 381-395 – MHC (DRB4*01:01 hIgG1 KIH)) molecules conjugated to Streptavidin-R-phycoerythrin |
CONFIDENTIAL 111 |
Schedule 1.166 Parvus Licensed Patents |
Part A: Owned Patents |
Case Number Appl. No. Filing Date Patent No. Issue Date Type Owner Name PTI0021-101-US 63/505,003 5/30/2023 Platform Parvus Therapeutics PTI0023-101-US 63/505,004 5/30/2023 Product Parvus Therapeutics |
Part B: In-Licensed Patents |
[Table showing a list of in-licensed patents with columns for Case Number, Appl. No., Filing Date, Patent No., Issue Date, Type, and Owner Name. The table contains approximately 60+ patent entries with UTI Limited Partnership or UTI Limited Partnership/General Hospital Corporation as the Owner Name] |
CONFIDENTIAL 118 |
Schedule 1.185 Product IP |
[Table showing a list of Product IP patents with columns for Case Number, Appl. No., Filing Date, Patent No., Issue Date, and Owner Name. Approximately 30+ entries with UTI Limited Partnership as the Owner Name, and one final entry showing Parvus Therapeutics] |
CONFIDENTIAL 120 |
Schedule 1.193 PVT401 |
PVT401 NavacimTM [Diagram showing components: DRB4 0101 MHC Protein, Iron-oxide nanoparticle Core, Dextran polymer Coating, NHS-PEG2-Maleimide linker, FLA 381-395 – pMHC (DRB401:01 hIgG1 KIH-Cys)] |
CONFIDENTIAL 121 |
Schedule 1.202 Research and Development Plan |
[This refers to a detailed Research and Development Plan that spans approximately pages 121-126 of the document] |
CONFIDENTIAL 122 |
Schedule 3.1.2 Approved Subcontractors |
[Table showing approved subcontractors with columns for Activity and Company Address, including companies like JenKem Technology USA Inc., Ardena Oss BV, Resilience Biotechnologies Inc., Vetter Pharma International GmbH, DNA TwoPointO Inc., Sartorius Stedim Cellca GmbH, Excellgene SA, Global Life Sciences Solutions USA... |
CONFIDENTIAL 123 |
Schedule 5.5 Technology Transfer Plan |
• Provide documentation of drug substance ("DS") and drug product ("DP") development in respective development reports (e.g., identification, structural confirmation, process development, analytical development, control strategy, reference standard, stability) |
• Transfer DS/DP analytical methods by: o Providing written methods for all analytical release and stability assays for non-USP methods which support regulatory filings o Formally transferring product-specific methods o Providing consultation to answer questions regarding analytic methods |
• Setup contracts with DS/DP CDMOs conducting stability studies to transfer control of studies to AbbVie |
• Continue to provide storage of DS/DP GMP stability samples and regulatory retains or coordinate transfer to site determined by AbbVie |
• Provide DS/DP release and stability testing of new GMP/clinical lots until transfer of stability studies is complete |
• Assume control and costs for DS/DP stability studies and storage of materials |
• Ship the following Parvus DS/DP materials to a site TBD by AbbVie at the completion of tech transfer, except for materials needed to complete tech transfer: o List materials o DS/DP inventory (SM, INT, DS, DP) o Reference standards o Samples in support of tech transfer or manufacturing Note: Inventory may remain with... |
• Provide DS/DP reports and Information that support technology transfer including, but not limited to: o Developmental history reports o Technical development reports o Executed batch records o CoA's and supporting analytical data o Reports that support CMC section of the IND/CTD o GMP CDMO audit reports and quality a... |
• Provide documentation/communications with Regulatory Authorities |
• DS/DP tech transfer process o Coordinate 3-way CDAs with manufacturing vendors o Setup F2F meetings at manufacturing sites o Provide tech transfer support to manufacturing sites of AbbVie's choosing |
CONFIDENTIAL 124 |
Schedule 8.2.1 Patent Roadmap |
1. File Active Substance (composition of matter) Patent application after GLP tox and prior to IND filing. |
2. If composition of matter Patent application is filed as a genus, the genus should be cohesive and small; split application into multiple filings if needed. |
3. During prosecution, maximize opportunities for Patent term extensions, supplemental protection certificates, and the like. |
4. File method of treatment, method of use claims or dosing Patent applications after actual data from patients, and not healthy volunteers. |
5. File formulations applications after proof of concept is obtained through a Phase II Study and after initiation of pivotal registrational trials. |
6. File commercial manufacturing patent applications after the commercial manufacturing is finalized after initiation of pivotal registrational trials. |
7. Conduct freedom to operate clearance prior to filing the active substance, formulation and manufacturing Patent applications. |
CONFIDENTIAL 125 |
Schedule 10.5 Public Announcements |
Parvus Announces Collaboration with AbbVie to Develop IBD Therapies Based on the Parvus Navacim Platform Technology • The collaboration will combine AbbVie's expertise in Immunology with Parvus' innovative Navacim™ regulatory T cells (Treg) immune tolerization platform technology to develop therapies for Inflammatory B... |
SOUTH SAN FRANCISCO, CA, March [●], 2024 —Parvus Therapeutics announced today that it has entered into an exclusive worldwide license collaboration and option agreement with AbbVie Inc. (NYSE: ABBV) for the development and commercialization of novel treatments for Inflammatory Bowel Disease (IBD), utilizing Parvus' Nav... |
Navacims™ present multivalent peptide major histocompatibility complexes (peptide-MHCs) to T cells, triggering the endogenous expansion and differentiation of the T cells into antigen-specific Tregs. This approach is being evaluated as a potential to halt or cure autoimmune disease by restoring organ-specific immune to... |
"We are excited to collaborate with AbbVie, an industry leader with global development and commercialization expertise, to advance our shared mission of transforming patient care through scientific innovation," said Peter Strumph CEO of Parvus. "This agreement represents a significant validation of our Navacim technolo... |
Under the terms of the agreement, AbbVie receives an exclusive worldwide option to develop and commercialize Navacim therapies for IBD resulting from the collaboration. Parvus will receive an upfront payment and a potential equity investment and is eligible to receive downstream development and commercial milestone pay... |
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