|
Cayman Islands
(State or other jurisdiction of
incorporation or organization) |
| |
6770
(Primary Standard Industrial
Classification Code Number) |
| |
Not Applicable
(I.R.S. Employer
Identification No.) |
|
|
Mitchell S. Nussbaum, Esq.
Giovanni Caruso, Esq. Loeb & Loeb LLP 345 Park Avenue New York, NY 10154 Tel: (212) 407-4000 Fax: (212) 407-4990 |
| |
Ari Edelman, Esq.
Eric S. Klee, Esq. McDermott Will & Emery LLP One Vanderbilt Avenue New York, NY 10017 Tel: (212) 547-5400 Fax: (212) 547-5444 |
|
|
Large accelerated filer
☐
|
| |
Accelerated filer
☐
|
|
|
Non-accelerated
☒
|
| |
Smaller reporting company
☒
|
|
| | | |
Emerging growth company
☒
|
|
|
/s/
Someit Sidhu
Chief Executive Officer JATT Acquisition Corp , 2023 |
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| | | | F-1 | | | |
| | | | A-1 | | |
| | |
No Further
Redemption Scenario |
| |
50% Further
Redemption Scenario |
| |
Maximum Redemption Scenario
|
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| ||||||||||||||||||
JATT Public Shareholders(1)
|
| | | | 1,688,978 | | | | | | 6.3% | | | | | | 844,489 | | | | | | 3.2% | | | | | | — | | | | | | — | | |
JATT Initial Shareholders(2)
|
| | | | 3,450,000 | | | | | | 12.9% | | | | | | 3,450,000 | | | | | | 13.0% | | | | | | 3,450,000 | | | | | | 13.0% | | |
PIPE Investor(3)
|
| | | | 2,000,000 | | | | | | 7.5% | | | | | | 2,000,000 | | | | | | 7.6% | | | | | | 2,000,000 | | | | | | 7.5% | | |
FPA Investors(4)
|
| | | | 3,000,000 | | | | | | 11.2% | | | | | | 3,582,077 | | | | | | 13.5% | | | | | | 4,500,000 | | | | | | 16.9% | | |
Eli Lilly(5)
|
| | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | |
Zura Holdco Shareholders(6)
|
| | | | 16,053,700 | | | | | | 60.0% | | | | | | 16,053,700 | | | | | | 60.6% | | | | | | 16,053,700 | | | | | | 60.5% | | |
Amit Munshi(7)
|
| | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | |
Total Shares at the Closing(8)
|
| | | | 26,742,678 | | | | | | 100% | | | | | | 26,480,266 | | | | | | 100% | | | | | | 26,553,700 | | | | | | 100% | | |
Total Equity Value Post-Redemption(9)
|
| | | $ | 274,379,876 | | | | | | | | | | | $ | 271,687,531 | | | | | | | | | | | $ | 272,440,962 | | | | | | | | |
Assumed Per Share Value
|
| | | $ | 10.26 | | | | | | | | | | | $ | 10.26 | | | | | | | | | | | $ | 10.26 | | | | | | | | |
| | |
No Further
Redemptions(1) |
| |
50% Further
Redemptions(2) |
| |
Maximum
Redemptions(3) |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| ||||||||||||||||||
JATT Public Shareholders
|
| | | | 1,688,978 | | | | | | 4.2% | | | | | | 844,489 | | | | | | 2.1% | | | | | | — | | | | | | 0 | | |
JATT Initial Shareholders
|
| | | | 3,450,000 | | | | | | 8.6% | | | | | | 3,450,000 | | | | | | 8.6% | | | | | | 3,450,000 | | | | | | 8.6% | | |
PIPE Investor
|
| | | | 2,000,000 | | | | | | 5.0% | | | | | | 2,000,000 | | | | | | 5.0% | | | | | | 2,000,000 | | | | | | 5.0% | | |
FPA Investors
|
| | | | 3,000,000 | | | | | | 7.4% | | | | | | 3,582,077 | | | | | | 9.0% | | | | | | 4,500,000 | | | | | | 11.2% | | |
Eli Lilly
|
| | | | 550,000 | | | | | | 1.4% | | | | | | 550,000 | | | | | | 1.4% | | | | | | 550,000 | | | | | | 1.4% | | |
Zura Holdco Shareholders
|
| | | | 16,053,700 | | | | | | 39.8% | | | | | | 16,053,700 | | | | | | 40.1% | | | | | | 16,053,700 | | | | | | 40.0% | | |
Amit Munshi(5)
|
| | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | |
Exercising Redeemable Public Warrants(6)
|
| | | | 6,900,000 | | | | | | 17.1% | | | | | | 6,900,000 | | | | | | 17.2% | | | | | | 6,900,000 | | | | | | 17.2% | | |
Exercising JATT Private Placement
Warrants(7) |
| | | | 5,910,000 | | | | | | 14.7% | | | | | | 5,910,000 | | | | | | 14.8% | | | | | | 5,910,000 | | | | | | 14.7% | | |
Exercising Lender Warrants(8)
|
| | | | 300,000 | | | | | | 0.7% | | | | | | 300,000 | | | | | | 0.7% | | | | | | 300,000 | | | | | | 0.8% | | |
| | |
No Further
Redemptions(1) |
| |
50% Further
Redemptions(2) |
| |
Maximum
Redemptions(3) |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| ||||||||||||||||||
Exercising Holdco Options(9)
|
| | | | 446,300 | | | | | | 1.1% | | | | | | 446,300 | | | | | | 1.1% | | | | | | 446,300 | | | | | | 1.1% | | |
Total Additional Dilution Sources
|
| | | | 13,556,300 | | | | | | 33.6% | | | | | | 13,556,300 | | | | | | 33.9% | | | | | | 13,556,300 | | | | | | 33.8% | | |
Total Fully-Diluted Shares
|
| | | | 40,298,978 | | | | | | 100% | | | | | | 40,036,566 | | | | | | 100% | | | | | | 40,110,000 | | | | | | 100% | | |
| | |
No Further
Redemptions |
| |
50% Further
Redemptions |
| |
Maximum
Redemptions |
| |||||||||
Public Ordinary Shares plus PIPE Investor and FPA Investors Shares
|
| | | | 6,688,978(1) | | | | | | 6,426,566(2) | | | | | | 6,500,000(3) | | |
Deferred underwriting commission
|
| | | $ | 4,010,000 | | | | | $ | 4,010,000 | | | | | $ | 4,010,000 | | |
Deferred underwriting commission at $10 per share
|
| | | | 401,000 | | | | | | 401,000 | | | | | | 401,000 | | |
Deferred underwriting commissions as a percentage of post-redemption shares
|
| | | | 6.0% | | | | | | 6.2% | | | | | | 6.2% | | |
|
US Toll Free
|
| | | | 1-800-450-7155 | | |
|
International Toll (Standard rates apply)
|
| | | | 1-857-999-9155 | | |
|
Participant Passcode
|
| | | | [ ]# | | |
| | |
No Further
Redemption Scenario |
| |
50% Further
Redemption Scenario |
| |
Maximum
Redemption Scenario |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| ||||||||||||||||||
JATT Public Shareholders(1)
|
| | | | 1,688,978 | | | | | | 6.3% | | | | | | 844,489 | | | | | | 3.2% | | | | | | — | | | | | | — | | |
JATT Initial Shareholders(2)
|
| | | | 3,450,000 | | | | | | 12.9% | | | | | | 3,450,000 | | | | | | 13.0% | | | | | | 3,450,000 | | | | | | 13.0% | | |
PIPE Investor(3)
|
| | | | 2,000,000 | | | | | | 7.5% | | | | | | 2,000,000 | | | | | | 7.6% | | | | | | 2,000,000 | | | | | | 7.5% | | |
FPA Investors(4)
|
| | | | 3,000,000 | | | | | | 11.2% | | | | | | 3,582,077 | | | | | | 13.5% | | | | | | 4,500,000 | | | | | | 16.9% | | |
Eli Lilly(5)
|
| | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | |
Zura Holdco Shareholders(6)
|
| | | | 16,053,700 | | | | | | 60.0% | | | | | | 16,053,700 | | | | | | 60.6% | | | | | | 16,053,700 | | | | | | 60.5% | | |
Amit Munshi(7)
|
| | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | |
Total Shares at the Closing(8)
|
| | |
|
26,742,678
|
| | | |
|
100%
|
| | | |
|
26,480,266
|
| | | |
|
100%
|
| | | |
|
26,553,700
|
| | | |
|
100%
|
| |
Total Equity Value
Post-Redemption(9) |
| | | $ | 274,379,876 | | | | | | | | | | | $ | 271,687,531 | | | | | | | | | | | $ | 272,440,962 | | | | | | | | |
Assumed Per Share Value
|
| | | $ | 10.26 | | | | | | | | | | | $ | 10.26 | | | | | | | | | | | $ | 10.26 | | | | | | | | |
| | |
No Further redemptions(1)
|
| |
50% Further Redemptions(2)
|
| |
Maximum Redemptions(3)
|
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| ||||||||||||||||||
JATT Public Shareholders
|
| | | | 1,688,978 | | | | | | 4.2% | | | | | | 844,489 | | | | | | 2.1% | | | | | | — | | | | | | 0 | | |
JATT Initial Shareholders
|
| | | | 3,450,000 | | | | | | 8.6% | | | | | | 3,450,000 | | | | | | 8.6% | | | | | | 3,450,000 | | | | | | 8.6% | | |
PIPE Investor
|
| | | | 2,000,000 | | | | | | 5.0% | | | | | | 2,000,000 | | | | | | 5.0% | | | | | | 2,000,000 | | | | | | 5.0% | | |
FPA Investors
|
| | | | 3,000,000 | | | | | | 7.4% | | | | | | 3,582,077 | | | | | | 9.0% | | | | | | 4,500,000 | | | | | | 11.2% | | |
Eli Lilly
|
| | | | 550,000 | | | | | | 1.4% | | | | | | 550,000 | | | | | | 1.4% | | | | | | 550,000 | | | | | | 1.4% | | |
Zura Holdco Shareholders
|
| | | | 16,053,700 | | | | | | 39.8% | | | | | | 16,053,700 | | | | | | 40.1% | | | | | | 16,053,700 | | | | | | 40.0% | | |
Amit Munshi(5)
|
| | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | |
Exercising Redeemable Public Warrants(6)
|
| | | | 6,900,000 | | | | | | 17.1% | | | | | | 6,900,000 | | | | | | 17.2% | | | | | | 6,900,000 | | | | | | 17.2% | | |
Exercising JATT Private Placement Warrants(7)
|
| | | | 5,910,000 | | | | | | 14.7% | | | | | | 5,910,000 | | | | | | 14.8% | | | | | | 5,910,000 | | | | | | 14.7% | | |
Exercising Lender Warrants(8)
|
| | | | 300,000 | | | | | | 0.7% | | | | | | 300,000 | | | | | | 0.7% | | | | | | 300,000 | | | | | | 0.8% | | |
Exercising Holdco Options(9)
|
| | | | 446,300 | | | | | | 1.1% | | | | | | 446,300 | | | | | | 1.1% | | | | | | 446,300 | | | | | | 1.1% | | |
Total Additional Dilution Sources
|
| | | | 13,556,300 | | | | | | 33.6% | | | | | | 13,556,300 | | | | | | 33.9% | | | | | | 13,556,300 | | | | | | 33.8% | | |
Total Fully-Diluted Shares
|
| | | | 40,298,978 | | | | | | 100% | | | | | | 40,954,489 | | | | | | 100% | | | | | | 40,110,000 | | | | | | 100% | | |
| | |
No Further
Redemptions |
| |
50% Further
Redemptions |
| |
Maximum
Redemptions |
| |||||||||
Public Ordinary Shares plus PIPE Investor and FPA Investors Shares
|
| | | | 6,688,978(1) | | | | | | 6,426,566(2) | | | | | | 6,500,000(3) | | |
Deferred underwriting commission
|
| | | $ | 4,010,000 | | | | | $ | 4,010,000 | | | | | $ | 4,010,000 | | |
Deferred underwriting commission in shares (at
$10 per share) |
| | | | 401,000 | | | | | | 401,000 | | | | | | 401,000 | | |
Deferred underwriting commissions as a
percentage of post-redemption shares |
| | | | 6.0% | | | | | | 6.2% | | | | | | 6.2% | | |
Jurisdiction
|
| |
Status
|
|
Canada | | |
Granted (active)*
|
|
Europe: France, Germany, Ireland, Italy, Spain, UK | | |
Granted (active)*
|
|
Japan | | |
Granted (active)*
|
|
Japan | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
PCT | | | Phase Ended | |
|
US Toll Free
|
| | | | 1-800-450-7155 | | |
|
International Toll (Standard rates apply)
|
| | | | 1-857-999-9155 | | |
|
Participant Passcode
|
| | | | [ ]# | | |
Company
|
| |
Most Recent
Clinical Trial Completion Date |
| |
Total Trials
Enrollment |
| |
Date of Latest
Raise |
| |
Total Capital
Raised to Latest Raise Date |
| |
Invested
Capital per Trial Subject |
| |||||||||||||||
Acticor Biotech
|
| | | | Sep-21 | | | | | | 220 | | | | | | Sep-21 | | | | | $ | 36 | | | | | $ | 0.16 | | |
GamaMabs Pharma
|
| | | | Feb-21 | | | | | | 143 | | | | | | Sep-21 | | | | | $ | 31 | | | | | $ | 0.22 | | |
Kymab
|
| | | | Nov-20 | | | | | | 177 | | | | | | Apr-21 | | | | | $ | 258 | | | | | $ | 1.46 | | |
ILiAD Biotechnologies
|
| | | | Jun-20 | | | | | | 300 | | | | | | Mar-21 | | | | | $ | 30 | | | | | $ | 0.10 | | |
LENZ Therapeutics
|
| | | | May-20 | | | | | | 78 | | | | | | Nov-20 | | | | | $ | 12 | | | | | $ | 0.15 | | |
AptaTargets
|
| | | | Mar-20 | | | | | | 46 | | | | | | Oct-20 | | | | | $ | 13 | | | | | $ | 0.28 | | |
Star Therapeutics
|
| | | | Feb-20 | | | | | | 97 | | | | | | Feb-22 | | | | | $ | 100 | | | | | $ | 1.03 | | |
ImaginAb
|
| | | | Aug-18 | | | | | | 72 | | | | | | Jun-21 | | | | | $ | 59 | | | | | $ | 0.82 | | |
Pfenex
|
| | | | May-18 | | | | | | 342 | | | | | | Oct-20 | | | | | $ | 70 | | | | | $ | 0.21 | | |
Reprixys Pharmaceuticals
|
| | | | Mar-16 | | | | | | 198 | | | | | | Nov-16 | | | | | $ | 52 | | | | | $ | 0.26 | | |
NKT Therapeutics
|
| | | | May-15 | | | | | | 21 | | | | | | Jun-18 | | | | | $ | 28 | | | | | $ | 1.33 | | |
Minka Therapeutics
|
| | | | Dec-14 | | | | | | 33 | | | | | | May-15 | | | | | $ | 19 | | | | | $ | 0.58 | | |
Biosceptre
|
| | | | Apr-14 | | | | | | 21 | | | | | | Jul-14 | | | | | $ | 5 | | | | | $ | 0.22 | | |
Avaxia Biologics
|
| | | | Dec-13 | | | | | | 33 | | | | | | Jul-15 | | | | | $ | 24 | | | | | $ | 0.72 | | |
Theraclone Sciences
|
| | | | Mar-13 | | | | | | 88 | | | | | | Apr-15 | | | | | $ | 59 | | | | | $ | 0.67 | | |
Ligocyte Pharmaceuticals
|
| | | | Oct-09 | | | | | | 61 | | | | | | May-10 | | | | | $ | 28 | | | | | $ | 0.46 | | |
Invested Capital per Clinical Trial Subject
|
| |
Median
|
| |
Average
|
| ||||||
Invested Capital per Trial Subject
|
| | | $ | 0.37 | | | | | $ | 0.54 | | |
Company Total Trials Enrollment
|
| | | | 117 | | | | | | 117 | | |
Estimated Invested Capital
|
| | | $ | 44 | | | | | $ | 64 | | |
Target Company
|
| |
IPO Date
|
| |
Development-stage
at IPO Date |
| |
Pre-$ IPO
Equity Value |
| |
Capital Raised Prior
to IPO |
| |
Return on IC
Pre-$ IPO Equity Value / Capital Raised |
| |
Current
Market Cap |
| ||||||||||||
AN2 Therapeutics (NAS: ANTX)
|
| |
Mar-22
|
| |
Clinical Trials – Phase 1
|
| | | $ | 212 | | | | | $ | 92 | | | | | | 2.31x | | | | | $ | 158 | | |
Arcellx (NAS: ACLX)
|
| |
Feb-22
|
| |
Clinical Trials – Phase 1
|
| | | $ | 379 | | | | | $ | 229 | | | | | | 1.66x | | | | | $ | 639 | | |
Vigil Neuro (NAS: VIGL)
|
| |
Jan-22
|
| |
Clinical Trials – Phase 1
|
| | | $ | 298 | | | | | $ | 140 | | | | | | 2.13x | | | | | $ | 82 | | |
Immix Biopharma (NAS: IMMX)
|
| |
Dec-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 17 | | | | | $ | 1 | | | | | | 22.51x | | | | | $ | 34 | | |
Xilio Therapeutics (NAS: XLO)
|
| |
Oct-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 309 | | | | | $ | 246 | | | | | | 1.26x | | | | | $ | 65 | | |
Ventyx Biosciences (NAS: VTYX)
|
| |
Oct-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 631 | | | | | $ | 275 | | | | | | 2.30x | | | | | $ | 662 | | |
Cognition Therapeutics (NAS: CGTX)
|
| |
Oct-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 211 | | | | | $ | 36 | | | | | | 5.95x | | | | | $ | 46 | | |
Theseus (NAS: THRX)
|
| |
Oct-21
|
| |
Clinical Trials – General
|
| | | $ | 440 | | | | | $ | 122 | | | | | | 3.61x | | | | | $ | 194 | | |
Dermata (NAS: DRMA)
|
| |
Aug-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 40 | | | | | $ | 25 | | | | | | 1.64x | | | | | $ | 5 | | |
Eliem Therapeutics (NAS: ELYM)
|
| |
Aug-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 237 | | | | | $ | 140 | | | | | | 1.69x | | | | | $ | 124 | | |
Adagio Therapeutics (NAS: ADGI)
|
| |
Aug-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 1,535 | | | | | $ | 466 | | | | | | 3.30x | | | | | $ | 290 | | |
IN8bio (NAS: INAB)
|
| |
Jul-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 148 | | | | | $ | 35 | | | | | | 4.21x | | | | | $ | 39 | | |
Erasca (NAS: ERAS)
|
| |
Jul-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 1,558 | | | | | $ | 420 | | | | | | 3.71x | | | | | $ | 592 | | |
Imago BioSciences (NAS: IMGO)
|
| |
Jul-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 379 | | | | | $ | 161 | | | | | | 2.36x | | | | | $ | 430 | | |
TransCode Therapeutics (NAS: RNAZ)
|
| |
Jul-21
|
| |
Clinical Trials – General
|
| | | $ | 23 | | | | | $ | 1 | | | | | | 19.03x | | | | | $ | 16 | | |
Aerovate Therapeutics (NAS:
AVTE) |
| |
Jun-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 202 | | | | | $ | 82 | | | | | | 2.48x | | | | | $ | 282 | | |
Elevation Oncology (NAS: ELEV)
|
| |
Jun-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 265 | | | | | $ | 95 | | | | | | 2.79x | | | | | $ | 33 | | |
Lyell (NAS: LYEL)
|
| |
Jun-21
|
| |
Clinical Trials – General
|
| | | $ | 3,703 | | | | | $ | 851 | | | | | | 4.35x | | | | | $ | 1,113 | | |
Verve Therapeutics (NAS: VERV)
|
| |
Jun-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 609 | | | | | $ | 216 | | | | | | 2.83x | | | | | $ | 570 | | |
Janux Therapeutics (NAS: JANX)
|
| |
Jun-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 485 | | | | | $ | 201 | | | | | | 2.41x | | | | | $ | 444 | | |
Day One Biopharmaceuticals
(NAS: DAWN) |
| |
May-21
|
| |
Clinical Trials – General
|
| | | $ | 807 | | | | | $ | 190 | | | | | | 4.25x | | | | | $ | 980 | | |
Singular Genomics (NAS: OMIC)
|
| |
May-21
|
| |
Clinical Trials – General
|
| | | $ | 1,302 | | | | | $ | 70 | | | | | | 18.60x | | | | | $ | 202 | | |
Vera Therapeutics (NAS: VERA)
|
| |
May-21
|
| |
Clinical Trials – General
|
| | | $ | 177 | | | | | $ | 131 | | | | | | 1.35x | | | | | $ | 347 | | |
Target Company
|
| |
IPO Date
|
| |
Development-stage
at IPO Date |
| |
Pre-$ IPO
Equity Value |
| |
Capital Raised Prior
to IPO |
| |
Return on IC
Pre-$ IPO Equity Value / Capital Raised |
| |
Current
Market Cap |
| ||||||||||||
Talaris Therapeutics (NAS: TALS)
|
| |
May-21
|
| |
Clinical Trials – Phase 3
|
| | | $ | 551 | | | | | $ | 215 | | | | | | 2.56x | | | | | $ | 323 | | |
Werewolf Therapeutics (NAS: HOWL)
|
| |
Apr-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 321 | | | | | $ | 128 | | | | | | 2.50x | | | | | $ | 130 | | |
Rain Therapeutics (NAS: RAIN)
|
| |
Apr-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 316 | | | | | $ | 92 | | | | | | 3.44x | | | | | $ | 64 | | |
Biomea Fusion (NAS: BMEA)
|
| |
Apr-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 336 | | | | | $ | 56 | | | | | | 6.00x | | | | | $ | 249 | | |
VectivBio (NAS: VECT)
|
| |
Apr-21
|
| |
Clinical Trials – Phase 3
|
| | | $ | 451 | | | | | $ | 145 | | | | | | 3.11x | | | | | $ | 214 | | |
Connect Biopharmaceuticals
(NAS: CNTB) |
| |
Mar-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 758 | | | | | $ | 230 | | | | | | 3.30x | | | | | $ | 40 | | |
Finch (NAS: FNCH)
|
| |
Mar-21
|
| |
Clinical Trials – Phase 3
|
| | | $ | 674 | | | | | $ | 194 | | | | | | 3.47x | | | | | $ | 127 | | |
Longboard Pharmaceuticals
(NAS: LBPH) |
| |
Mar-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 191 | | | | | $ | 56 | | | | | | 3.40x | | | | | $ | 73 | | |
NexImmune (NAS:
NEXI) |
| |
Feb-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 256 | | | | | $ | 73 | | | | | | 3.49x | | | | | $ | 47 | | |
Terns Pharmaceuticals (NAS:
TERN) |
| |
Feb-21
|
| |
Clinical Trials – Phase 2
|
| | | $ | 280 | | | | | $ | 197 | | | | | | 1.42x | | | | | $ | 49 | | |
Landos Biopharma (NAS: LABP)
|
| |
Feb-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 527 | | | | | $ | 70 | | | | | | 7.52x | | | | | $ | 32 | | |
Sensei Biotherapeutics (NAS:
SNSE) |
| |
Feb-21
|
| |
Clinical Trials – Phase 1
|
| | | $ | 429 | | | | | $ | 93 | | | | | | 4.59x | | | | | $ | 60 | | |
Silverback Therapeutics (NAS: SBTX)
|
| |
Dec-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 453 | | | | | $ | 232 | | | | | | 1.95x | | | | | $ | 141 | | |
Kinnate Biopharma (NAS: KNTE)
|
| |
Dec-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 591 | | | | | $ | 195 | | | | | | 3.04x | | | | | $ | 384 | | |
Olema Oncology (NAS: OLMA)
|
| |
Nov-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 523 | | | | | $ | 151 | | | | | | 3.45x | | | | | $ | 134 | | |
Atea Pharmaceuticals (NAS:
AVIR) |
| |
Oct-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 1,638 | | | | | $ | 283 | | | | | | 5.78x | | | | | $ | 555 | | |
Foghorn Therapeutics (NAS:
FHTX) |
| |
Oct-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 451 | | | | | $ | 189 | | | | | | 2.39x | | | | | $ | 525 | | |
Aligos Therapeutics (NAS: ALGS)
|
| |
Oct-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 403 | | | | | $ | 225 | | | | | | 1.79x | | | | | $ | 57 | | |
Kiromic (NAS: KRBP)
|
| |
Oct-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 73 | | | | | $ | 20 | | | | | | 3.72x | | | | | $ | 7 | | |
Tarsus Pharmaceuticals (NAS: TARS)
|
| |
Oct-20
|
| |
Clinical Trials – Phase 3
|
| | | $ | 220 | | | | | $ | 64 | | | | | | 3.44x | | | | | $ | 333 | | |
Spruce Biosciences (NAS: SPRB)
|
| |
Oct-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 244 | | | | | $ | 116 | | | | | | 2.10x | | | | | $ | 37 | | |
Immunome (NAS:
IMNM) |
| |
Oct-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 81 | | | | | $ | 43 | | | | | | 1.90x | | | | | $ | 36 | | |
Graybug Vision (NAS: GRAY)
|
| |
Sep-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 231 | | | | | $ | 159 | | | | | | 1.45x | | | | | $ | 17 | | |
Prelude Therapeutics (NAS: PRLD)
|
| |
Sep-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 648 | | | | | $ | 145 | | | | | | 4.47x | | | | | $ | 204 | | |
Target Company
|
| |
IPO Date
|
| |
Development-stage
at IPO Date |
| |
Pre-$ IPO
Equity Value |
| |
Capital Raised Prior
to IPO |
| |
Return on IC
Pre-$ IPO Equity Value / Capital Raised |
| |
Current
Market Cap |
| ||||||||||||
Athira Pharma (NAS: ATHA)
|
| |
Sep-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 274 | | | | | $ | 113 | | | | | | 2.43x | | | | | $ | 302 | | |
Metacrine (NAS: MTCR)
|
| |
Sep-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 252 | | | | | $ | 135 | | | | | | 1.87x | | | | | $ | 19 | | |
Inhibrx (NAS: INBX)
|
| |
Aug-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 504 | | | | | $ | 55 | | | | | | 9.24x | | | | | $ | 333 | | |
Checkmate
Pharmaceuticals |
| |
Aug-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 247 | | | | | $ | 175 | | | | | | 1.41x | | | | | $ | 231 | | |
Annexon Biosciences (NAS: ANNX)
|
| |
Jul-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 361 | | | | | $ | 254 | | | | | | 1.42x | | | | | $ | 121 | | |
Inozyme Pharma (NAS: INZY)
|
| |
Jul-20
|
| |
Clinical Trials – General
|
| | | $ | 245 | | | | | $ | 150 | | | | | | 1.64x | | | | | $ | 181 | | |
Nurix (NAS: NRIX)
|
| |
Jul-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 495 | | | | | $ | 223 | | | | | | 2.21x | | | | | $ | 434 | | |
Relay Therapeutics (NAS: RLAY)
|
| |
Jul-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 1,338 | | | | | $ | 520 | | | | | | 2.57x | | | | | $ | 1,507 | | |
Poseida Therapeutics (NAS:
PSTX) |
| |
Jul-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 765 | | | | | $ | 324 | | | | | | 2.36x | | | | | $ | 131 | | |
Generation Bio (NAS: GBIO)
|
| |
Jun-20
|
| |
Clinical Trials – General
|
| | | $ | 648 | | | | | $ | 235 | | | | | | 2.75x | | | | | $ | 313 | | |
Lantern Pharma (NAS: LTRN)
|
| |
Jun-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 67 | | | | | $ | 5 | | | | | | 14.29x | | | | | $ | 53 | | |
Applied Molecular Transport
(NAS: AMTI) |
| |
Jun-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 300 | | | | | $ | 99 | | | | | | 3.04x | | | | | $ | 117 | | |
ORIC Pharmaceuticals (NAS: ORIC)
|
| |
Apr-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 341 | | | | | $ | 173 | | | | | | 1.97x | | | | | $ | 156 | | |
Zentalis Pharmaceuticals (NAS: ZNTL)
|
| |
Apr-20
|
| |
Clinical Trials – General
|
| | | $ | 456 | | | | | $ | 85 | | | | | | 5.36x | | | | | $ | 1,212 | | |
Imara (NAS: IMRA)
|
| |
Mar-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 190 | | | | | $ | 114 | | | | | | 1.67x | | | | | $ | 28 | | |
Revolution Medicines (NAS:
RVMD) |
| |
Feb-20
|
| |
Clinical Trials – Phase 1
|
| | | $ | 729 | | | | | $ | 226 | | | | | | 3.23x | | | | | $ | 1,248 | | |
Arcutis Biotherapeutics (NAS: ARQT)
|
| |
Jan-20
|
| |
Clinical Trials – Phase 3
|
| | | $ | 463 | | | | | $ | 166 | | | | | | 2.79x | | | | | $ | 1,019 | | |
Annovis Bio (NYS:
ANVS) |
| |
Jan-20
|
| |
Clinical Trials – Phase 2
|
| | | $ | 27 | | | | | $ | 11 | | | | | | 2.56x | | | | | $ | 91 | | |
| | |
Return on IC
Pre-$ Initial Public Offering Equity Value/Capital Raised |
| |
Observed
Value - Median Estimated Invested Capital ($44) |
| |
Observed
Value - Average Estimated Invested Capital ($64) |
| | | | |||||||||
Lower (First) Quartile:
|
| | | | 2.10x | | | | | $ | 92 | | | | | $ | 134 | | | | ||
Median:
|
| | | | 2.79x | | | | | $ | 121 | | | | | $ | 177 | | | | | |
Average:
|
| | | | 4.0x | | | | | $ | 174 | | | | | $ | 254 | | | | | |
Upper (Third) Quartile:
|
| | | | 3.71x | | | | | $ | 162 | | | | | $ | 236 | | | | | |
| | |
Return on IC
Pre-$ Initial Public Offering Equity Value/Capital Raised |
| |
Observed
Value - Median Estimated Invested Capital ($44) |
| |
Observed
Value - Average Estimated Invested Capital ($64) |
| |||||||||
Lower (First) Quartile:
|
| | | | 2.33x | | | | | $ | 102 | | | | | $ | 148 | | |
Median:
|
| | | | 3.30x | | | | | $ | 144 | | | | | $ | 210 | | |
Average:
|
| | | | 4.62x | | | | | $ | 201 | | | | | $ | 293 | | |
Upper (Third) Quartile:
|
| | | | 4.23x | | | | | $ | 184 | | | | | $ | 269 | | |
| | |
Pre-$ Initial
Public Offering Equity Value/Capital Raised |
| |||
Lower (First) Quartile:
|
| | | $ | 309 | | |
Median:
|
| | | $ | 518 | | |
Average:
|
| | | $ | 471 | | |
Upper (Third) Quartile:
|
| | | $ | 552 | | |
| | |
Current
Market Cap |
| |||
Lower (First) Quartile:
|
| | | $ | 66 | | |
Median:
|
| | | $ | 136 | | |
Average:
|
| | | $ | 274 | | |
Upper (Third) Quartile:
|
| | | $ | 343 | | |
Target Company
|
| |
Most Recent Deal
Date |
| |
Development
Stage at Deal Date |
| |
Deal
Type |
| |
Pre-
money Valuation |
| |
Post-money
Valuation |
| |||||||||||||||
Electra Therapeutics
|
| | | | Feb-2022 | | | | | | ClinicalTrials – Phase 1 | | | | | | EarlyStageVC | | | | | $ | 250 | | | | | $ | 334 | | |
Q32 Bio
|
| | | | Oct-2020 | | | | | | ClinicalTrials – Phase 1 | | | | | | LaterStageVC | | | | | $ | 72 | | | | | | 132 | | |
| | |
No Further Redemption
Scenario |
| |
50% Further Redemption
Scenario |
| |
Maximum Further Redemption
Scenario |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| ||||||||||||||||||
JATT Public Shareholders(1)
|
| | | | 1,688,978 | | | | | | 6.3% | | | | | | 844,489 | | | | | | 3.2% | | | | | | — | | | | | | — | | |
JATT Initial Shareholders(2)
|
| | | | 3,450,000 | | | | | | 12.9% | | | | | | 3,450,000 | | | | | | 13.0% | | | | | | 3,450,000 | | | | | | 13.0% | | |
PIPE Investor(3)
|
| | | | 2,000,000 | | | | | | 7.5% | | | | | | 2,000,000 | | | | | | 7.6% | | | | | | 2,000,000 | | | | | | 7.5% | | |
FPA Investors(4)
|
| | | | 3,000,000 | | | | | | 11.2% | | | | | | 3,582,077 | | | | | | 13.5% | | | | | | 4,500,000 | | | | | | 16.9% | | |
Eli Lilly(5)
|
| | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | |
Zura Holdco Shareholders(6)
|
| | | | 16,053,700 | | | | | | 60.0% | | | | | | 16,053,700 | | | | | | 60.6% | | | | | | 16,053,700 | | | | | | 60.5% | | |
Amit Munshi(7)
|
| | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | |
Total Shares at the Closing(8)
|
| | |
|
26,742,678
|
| | | |
|
100%
|
| | | |
|
26,480,266
|
| | | |
|
100%
|
| | | |
|
26,553,700
|
| | | |
|
100%
|
| |
Total Equity Value Post-Redemption(9)
|
| | | $ | 274,379,876 | | | | | | | | | | | $ | 271,687,531 | | | | | | | | | | | $ | 272,440,962 | | | | | | | | |
Assumed Per Share Value
|
| | | $ | 10.26 | | | | | | | | | | | $ | 10.26 | | | | | | | | | | | $ | 10.26 | | | | | | | | |
| | |
No Further
Redemptions(1) |
| |
50% Further
Redemptions(2) |
| |
Maximum
Redemptions(3) |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| |
Shares
|
| |
%(4)
|
| ||||||||||||||||||
JATT Public Shareholders
|
| | | | 1,688,978 | | | | | | 4.2% | | | | | | 844,489 | | | | | | 2.1% | | | | | | — | | | | | | 0 | | |
JATT Initial Shareholders
|
| | | | 3,450,000 | | | | | | 8.6% | | | | | | 3,450,000 | | | | | | 8.6% | | | | | | 3,450,000 | | | | | | 8.6% | | |
PIPE Investor
|
| | | | 2,000,000 | | | | | | 5.0% | | | | | | 2,000,000 | | | | | | 5.0% | | | | | | 2,000,000 | | | | | | 5.0% | | |
FPA Investors
|
| | | | 3,000,000 | | | | | | 7.4% | | | | | | 3,582,077 | | | | | | 9.0% | | | | | | 4,500,000 | | | | | | 11.2% | | |
Eli Lilly
|
| | | | 550,000 | | | | | | 1.4% | | | | | | 550,000 | | | | | | 1.4% | | | | | | 550,000 | | | | | | 1.4% | | |
Zura Holdco Shareholders
|
| | | | 16,053,700 | | | | | | 39.8% | | | | | | 16,053,700 | | | | | | 40.1% | | | | | | 16,053,700 | | | | | | 40.0% | | |
Amit Munshi(5)
|
| | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | | | | | — | | | | | | 0 | | |
Exercising Redeemable Public Warrants(6)
|
| | | | 6,900,000 | | | | | | 17.1% | | | | | | 6,900,000 | | | | | | 17.2% | | | | | | 6,900,000 | | | | | | 17.2% | | |
Exercising JATT Private Placement Warrants(7)
|
| | | | 5,910,000 | | | | | | 14.7% | | | | | | 5,910,000 | | | | | | 14.8% | | | | | | 5,910,000 | | | | | | 14.7% | | |
Exercising Lender Warrants(8)
|
| | | | 300,000 | | | | | | 0.7% | | | | | | 300,000 | | | | | | 0.7% | | | | | | 300,000 | | | | | | 0.8% | | |
Exercising Holdco Options(9)
|
| | | | 446,300 | | | | | | 1.1% | | | | | | 446,300 | | | | | | 1.1% | | | | | | 446,300 | | | | | | 1.1% | | |
Total Additional Dilution Sources
|
| | | | 13,556,300 | | | | | | 33.6% | | | | | | 13,556,300 | | | | | | 33.9% | | | | | | 13,556,300 | | | | | | 33.8% | | |
Total Fully-Diluted Shares
|
| | | | 40,298,978 | | | | | | 100% | | | | | | 40,036,566 | | | | | | 100% | | | | | | 40,110,000 | | | | | | 100% | | |
| | |
No Further
Redemptions |
| |
50% Further
Redemptions |
| |
Maximum
Redemptions |
| |||||||||
Public Ordinary Shares plus PIPE Investor and FPA Investors Shares
|
| | | | 6,688,978(1) | | | | | | 6,426,566(2) | | | | | | 6,500,000(3) | | |
Deferred underwriting commission
|
| | | $ | 4,010,000 | | | | | $ | 4,010,000 | | | | | $ | 4,010,000 | | |
Deferred underwriting commission at $10 per share
|
| | | | 401,000 | | | | | | 401,000 | | | | | | 401,000 | | |
Deferred underwriting commissions as a percentage of post-redemption shares
|
| | | | 6.0% | | | | | | 6.2% | | | | | | 6.2% | | |
(i)
|
(a)
|
hold JATT Class A Ordinary Shares, or |
Advisory Governing Documents
Proposal |
| |
JATT’s Existing MAA
|
| |
Proposed MAA
|
|
Advisory Proposal A — Number of Directors
|
| | Pursuant to the Existing MAA, there shall be a board of directors consisting of not less than one person; provided, however, that JATT may, by ordinary resolution, increase or reduce the limits in the number of directors. | | | The Proposed MAA provides that subject to the rights of any holders of preferred share to appoint directors, the number of directors that shall constitute the New JATT board shall be as determined from time to time exclusively by the New JATT board. | |
Advisory Proposal B — Required Vote for the Removal of Directors
|
| | The Existing MAA provides that holders of JATT Class B ordinary shares may, by ordinary resolution, remove any director. A director may be removed if all of the other directors (being not less than two in number) determine that he should be removed as a director, either by a resolution passed by all of the other directors at a meeting of the directors duly convened and held in accordance with the Existing MAA or by a resolution in writing signed by all of the other directors. | | | The Proposed MAA provides that directors may be removed for cause or by the affirmative vote of the holders of at least two-thirds (662∕3%) of the voting power of all then-outstanding shares of New JATT entitled to vote thereon, voting together as a single class. | |
Advisory Proposal C — Required Vote to Amend the Proposed MAA
|
| | The Existing MAA provides that as regards to matters to be dealt with by ordinary resolution, | | | The Proposed MAA provides that the affirmative vote of the holders of a majority of at least | |
Advisory Governing Documents
Proposal |
| |
JATT’s Existing MAA
|
| |
Proposed MAA
|
|
| | | JATT may, by special resolution, alter or add to JATT’s existing amended and restated articles of association. | | | two-thirds (662∕3% ) of the voting power of the outstanding shares entitled to vote thereon, voting together as a single class, shall be required in order for the shareholders of New JATT to alter, amend or repeal, in whole or in part, any provision of the Proposed MAA or to adopt any provision inconsistent therewith. | |
Advisory Proposal D — Shareholder Action by Written Consent; Eliminate Blank Check Status Provisions
|
| | The Existing MAA permits the shareholders to approve resolutions by way of unanimous written resolution. | | | The Proposed MAA provides that any action required or permitted to be taken by the shareholders of New JATT must be effected by a duly called annual or extraordinary general meeting of such shareholders. Further, the specific provisions in the Existing MAA pertaining to blank check status are eliminated. | |
Name and Position
|
| |
Dollar
Value ($)(1) |
| |
Number of
Restricted Stock Units |
| |
Number of
Stock Options |
| |||||||||
Amit Munshi, Non-Employee Executive Chairman
|
| | | $ | 5,810,000 | | | | | | 500,000(2) | | | | | | 270,000(3)(4) | | |
All current executive officers as a group
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | |
All current directors who are not executive officers as a group
|
| | | $ | 5,810,000 | | | | | | 500,000(2) | | | | | | 270,000(3)(4) | | |
All employees, including current officers who are not executive officers
|
| | | | 0 | | | | | | 0 | | | | | | 0 | | |
| | |
Pro Forma Combined
(Assuming No Further Redemptions) |
| |
Pro Forma Combined
(Assuming Maximum Redemptions) |
| ||||||
| | |
(in thousands, except share and per share data)
|
| |||||||||
Selected Unaudited Pro Forma Condensed Combined | | | | | | | | | | | | | |
Statement of Operations – Nine Months Ended September 30, 2022
|
| | | | | | | | | | | | |
Total expenses
|
| | | $ | 11,842 | | | | | $ | 11,842 | | |
Operating loss
|
| | | | (11,842) | | | | | | (11,842) | | |
Net loss
|
| | | $ | (9,924) | | | | | $ | (9,924) | | |
Basic and diluted net loss per share
|
| | | $ | (0.37) | | | | | $ | (0.37) | | |
Basic and diluted weighted average shares outstanding
|
| | | | 26,742,678 | | | | | | 26,553,700 | | |
Selected Unaudited Pro Forma Condensed Combined | | | | | | | | | | | | | |
Statement of Operations – Period Ended March 31, 2022 | | | | | | | | | | | | | |
Total expenses
|
| | | $ | 29,640 | | | | | $ | 29,640 | | |
Operating loss
|
| | | | (29,640) | | | | | | (29,640) | | |
Net loss attributable to common shareholders
|
| | | $ | (32,830) | | | | | $ | (32,830) | | |
Basic and diluted net loss per share
|
| | | $ | (1.23) | | | | | $ | (1.24) | | |
Basic and diluted weighted average shares outstanding
|
| | | | 26,742,678 | | | | | | 26,553,700 | | |
Selected Unaudited Pro Forma Condensed Combined | | | | | | | | | | | | | |
Balance Sheet Data as of September 30, 2022 | | | | | | | | | | | | | |
Total assets
|
| | | $ | 50,727 | | | | | $ | 48,558 | | |
Total liabilities
|
| | | $ | 2,575 | | | | | $ | 2,575 | | |
Temporary equity
|
| | | $ | 22,500 | | | | | $ | 22,500 | | |
Total shareholders’ equity
|
| | | $ | 25,652 | | | | | $ | 23,483 | | |
| | |
Assuming No Further Redemptions
|
| |
Assuming Maximum Redemptions
|
| ||||||||||||||||||
| | |
Shares
|
| |
%
|
| |
Shares
|
| |
%
|
| ||||||||||||
JATT Public shareholders
|
| | | | 1,688,978 | | | | | | 6.3% | | | | | | — | | | | | | 0.0% | | |
JATT shares issued – Lilly license
|
| | | | 550,000 | | | | | | 2.1% | | | | | | 550,000 | | | | | | 2.1% | | |
Redemption Backstop
|
| | | | — | | | | | | 0.0% | | | | | | 1,500,000 | | | | | | 5.6% | | |
JATT Initial Shareholders
|
| | | | 3,450,000 | | | | | | 12.9% | | | | | | 3,450,000 | | | | | | 13.0% | | |
PIPE
|
| | | | 2,000,000 | | | | | | 7.5% | | | | | | 2,000,000 | | | | | | 7.5% | | |
Forward Purchase Agreement
|
| | | | 3,000,000 | | | | | | 11.2% | | | | | | 3,000,000 | | | | | | 11.3% | | |
Zura Equityholders
|
| | | | 16,053,700 | | | | | | 60.0% | | | | | | 16,053,700 | | | | | | 60.5% | | |
Shares outstanding
|
| | | | 26,742,678 | | | | | | 100.0% | | | | | | 26,553,700 | | | | | | 100.0% | | |
| | |
For the
Period From January 18, 2022 (Inception) Through March 31, 2022 |
| |
Transaction
Accounting Adjustments (Note 2) |
| | | | | | | |
For the
Period From January 18, 2022 (Inception) Through March 31, 2022 |
| |
For the
Period From March 10, 2021 (Inception) Through December 31, 2021 |
| |
Transaction
Accounting Adjustments (Assuming No Further Redemptions) (Note 2) |
| | | | |
For the
Period From January 18, 2022 (Inception) Through March 31, 2022 |
| |
Additional
Transaction Accounting Adjustments (Assuming Maximum Redemptions) (Note 2) |
| |
For the
Period From January 18, 2022 (Inception) Through March 31, 2022 |
| ||||||||||||||||||||||||
| | |
Zura
(Historical) |
| | | | | | | |
Pro Forma
Zura |
| |
JATT
(Historical) |
| | | | |
Pro Forma
Combined (Assuming No Further Redemptions) |
| |
Pro Forma
Combined (Assuming Maximum Redemptions) |
| |||||||||||||||||||||||||||||||||
Expenses | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
General and administrative
|
| | | $ | 319 | | | | | $ | — | | | | | | | | | | | $ | 319 | | | | | $ | 720 | | | | | $ | 3,490 | | | |
(dd)
|
| | | $ | 4,529 | | | | | $ | — | | | | | $ | 4,529 | | |
Research and development — license acquired
|
| | | | 7,500 | | | | | | 17,443 | | | | |
|
(aa)
|
| | | | | 24,943 | | | | | | — | | | | | | — | | | | | | | | | 24,943 | | | | | | — | | | | | | 24,943 | | |
General and administrative — related party
|
| | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | 168 | | | | | | — | | | | | | | | | 168 | | | | | | — | | | | | | 168 | | |
Total expenses
|
| | | | 7,819 | | | | | | 17,443 | | | | | | | | | | | | 25,262 | | | | | | 888 | | | | | | 3,490 | | | | | | | | | 29,640 | | | | | | — | | | | | | 29,640 | | |
Operating loss
|
| | | | (7,819) | | | | | | (17,443) | | | | | | | | | | | | (25,262) | | | | | | (888) | | | | | | (3,490) | | | | | | | | | (29,640) | | | | | | — | | | | | | (29,640) | | |
Other income (expense) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Loss upon issuance of private placement
warrants |
| | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | (1,773) | | | | | | — | | | | | | | | | (1,773) | | | | | | — | | | | | | (1,773) | | |
Offering costs associated with derivative warrant liabilities
|
| | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | (747) | | | | | | — | | | | | | | | | (747) | | | | | | — | | | | | | (747) | | |
Change in fair value of derivative warrant
liabilities |
| | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | 10,238 | | | | | | (5,451) | | | |
(ee)
|
| | | | 4,787 | | | | | | — | | | | | | 4,787 | | |
Investment income on Trust Account
|
| | | | — | | | | | | — | | | | | | | | | | | | — | | | | | | 19 | | | | | | (19) | | | |
(ff)
|
| | | | — | | | | | | — | | | | | | — | | |
Interest expense
|
| | | | | | | | | | (400) | | | | | | (bb) | | | | | | (400) | | | | | | — | | | | | | — | | | | | | | | | (400) | | | | | | — | | | | | | (400) | | |
Total other income (expense)
|
| | | | — | | | | | | (400) | | | | | | | | | | | | (400) | | | | | | 7,737 | | | | | | (5,470) | | | | | | | | | 1,867 | | | | | | — | | | | | | 1,867 | | |
Net loss before non-controlling interest
|
| | | | (7,819) | | | | | | (17,843) | | | | | | | | | | | | (25,662) | | | | | | 6,849 | | | | | | (8,960) | | | | | | | | | (27,773) | | | | | | — | | | | | | (27,773) | | |
Non-controlling interest
|
| | | | — | | | | | | 1,907 | | | | | | | | | | | | 1,907 | | | | | | — | | | | | | — | | | | | | | | | 1,907 | | | | | | — | | | | | | 1,907 | | |
Net loss
|
| | | $ | (7,819) | | | | | $ | (15,936) | | | | | | | | | | | $ | (23,775) | | | | | $ | 6,849 | | | | | $ | (8,960) | | | | | | | | $ | (25,866) | | | | | $ | — | | | | | $ | (25,886) | | |
Adjustment to Zura subsidiary’s preferred
stock to redemption value |
| | | | — | | | | | | (6,964) | | | | |
|
(cc)
|
| | | | | (6,964) | | | | | | — | | | | | | — | | | | | | | | | (6,964) | | | | | | — | | | | | | (6,964) | | |
Net loss attributable to common
shareholders |
| | | $ | (7,819) | | | | | $ | (22,900) | | | | | | | | | | | $ | (30,719) | | | | | $ | 6,849 | | | | | $ | (8,960) | | | | | | | | $ | (32,830) | | | | | $ | — | | | | | $ | (32,830) | | |
Weighted average Class A ordinary shares
outstanding, basic and diluted |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | 7,834,343 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic net income (loss) per Class A ordinary share
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | $ | 0.62 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Diluted net income (loss) per Class A ordinary share
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | $ | 0.61 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Weighted average Class B ordinary shares
outstanding, basic |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | 3,130,303 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Weighted average Class B ordinary shares
outstanding, diluted |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | 3,310,606 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic net income per Class B ordinary share
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | $ | 0.62 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Diluted net income per Class B ordinary
share |
| | | | | | | | | | | | | | | | | | | | | | | | | | | $ | 0.61 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted net loss per ordinary share
|
| | | $ | (7,818,712.00) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted weighted average ordinary shares outstanding
|
| | | | 1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted net loss per common share
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
$
|
(1.23)
|
| | | | | | | | | |
$
|
(1.24)
|
| |
Basic and diluted weighted average common
shares outstanding |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 26,742,678 | | | | | | | | | | | | 26,553,700 | | |
| | |
Nine Months
Ended September 30, 2022 |
| |
Nine Months
Ended September 30, 2022 |
| |
Transaction
Accounting Adjustments (Assuming No Further Redemptions) (Note 2) |
| | | | |
Nine Months
Ended September 30, 2022 |
| |
Additional
Transaction Accounting Adjustments (Assuming Maximum Redemptions) (Note 2) |
| |
Nine Months
Ended September 30, 2022 |
| ||||||||||||||||||
| | |
Zura
(Historical) |
| |
JATT
(Historical) |
| | | | |
Pro Forma
Combined (Assuming No Further Redemptions) |
| |
Pro Forma
Combined (Assuming Maximum Redemptions) |
| ||||||||||||||||||||||||
Expenses | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
General and administrative
|
| | | $ | 1,814 | | | | | $ | 1,688 | | | | | $ | — | | | | | | | | $ | 3,502 | | | | | $ | — | | | | | $ | 3,502 | | |
Research and development — license acquired
|
| | | | 7,500 | | | | | | — | | | | | | — | | | | | | | | | 7,500 | | | | | | — | | | | | | 7,500 | | |
Research and development
|
| | | | 500 | | | | | | — | | | | | | — | | | | | | | | | 500 | | | | | | — | | | | | | 500 | | |
General and administrative — related party
|
| | | | — | | | | | | 340 | | | | | | — | | | | | | | | | 340 | | | | | | — | | | | | | 340 | | |
Total expenses
|
| | | | 9,814 | | | | | | 2,028 | | | | | | — | | | | | | | | | 11,842 | | | | | | — | | | | | | 11,842 | | |
Operating loss
|
| | | | (9,814) | | | | | | (2,028) | | | | | | — | | | | | | | | | (11,842) | | | | | | — | | | | | | (11,842) | | |
Other income (expense) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Other
|
| | | | (32) | | | | | | — | | | | | | — | | | | | | | | | (32) | | | | | | — | | | | | | (32) | | |
Offering costs associated with derivative warrant liabilities
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | — | | | | | | — | | |
Change in fair value of derivative warrant liabilities
|
| | | | — | | | | | | 4,020 | | | | | | (2,070) | | | |
(ee)
|
| | | | 1,950 | | | | | | — | | | | | | 1,950 | | |
Investment income on Trust Account
|
| | | | — | | | | | | 885 | | | | | | (885) | | | |
(ff)
|
| | | | — | | | | | | — | | | | | | — | | |
Total other income (expense)
|
| | | | (32) | | | | | | 4,905 | | | | | | (2,955) | | | | | | | | | 1,918 | | | | | | — | | | | | | 1,918 | | |
Net loss
|
| | | $ | (9,846) | | | | | $ | 2,877 | | | | | $ | (2,955) | | | | | | | | $ | (9,924) | | | | | $ | — | | | | | $ | (9,924) | | |
Weighted average Class A ordinary shares outstanding, basic and diluted
|
| | | | | | | | | | 13,800,000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted net income (loss) per Class A ordinary share
|
| | | | | | | | | $ | 0.17 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Weighted average Class B ordinary shares outstanding, basic and diluted
|
| | | | | | | | | | 3,450,000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted net income per Class B ordinary share
|
| | | | | | | | | $ | 0.17 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted net loss per ordinary share
|
| | | $ | (6,205.28) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted weighted average ordinary
shares outstanding |
| | | $ | 1,587 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted net loss per share
|
| | | | | | | | | | | | | | | | | | | | | | | | $ | (0.37) | | | | | | | | | | | $ | (0.37) | | |
Basic and diluted weighted average shares outstanding
|
| | | | | | | | | | | | | | | | | | | | | | | | | 26,742,678 | | | | | | | | | | | | 26,553,700 | | |
| | |
Public
|
| |
Private
|
| |
Total
|
| |||||||||
IPO, fair value
|
| | | $ | 8,625,000 | | | | | $ | 7,683,000 | | | | | $ | 16,308,000 | | |
Change in fair value
|
| | | $ | (5,451,000) | | | | | $ | (4,787,000) | | | | | $ | (10,238,000) | | |
December 31, 2021, fair value
|
| | | $ | 3,174,000 | | | | | $ | 2,896,000 | | | | | $ | 6,070,000 | | |
Change in fair value
|
| | | $ | (2,070,000) | | | | | $ | (1,950,400) | | | | | $ | (4,020,400) | | |
September 30, 2022, fair value
|
| | | $ | 1,104,000 | | | | | $ | 945,600 | | | | | $ | 2,049,600 | | |
| | |
Assuming No
Further Redemptions |
| |
Assuming Maximum
Redemptions |
| ||||||
Nine Months Ended September 30, 2022 | | | | | | | | | | | | | |
Pro forma net loss
|
| | | $ | (9,924,000) | | | | | $ | (9,924,000) | | |
Pro forma weighted average shares outstanding – basic and
diluted |
| | | | 26,742,678 | | | | | | 26,553,700 | | |
Net loss per share – basic and diluted
|
| | | $ | (0.37) | | | | | $ | (0.37) | | |
Period Ended March 31, 2022 | | | | | | | | | | | | | |
Pro forma net loss attributable to common shareholders
|
| | | $ | (32,830,000) | | | | | $ | (32,830,000) | | |
Pro forma weighted average shares outstanding – basic and
diluted |
| | | | 26,742,678 | | | | | | 26,553,700 | | |
Net loss per share – basic and diluted
|
| | | $ | (1.23) | | | | | $ | (1.24) | | |
Pro Forma Weighted Average Shares | | | | | | | | | | | | | |
JATT Public shareholders
|
| | | | 1,688,978 | | | | | | — | | |
JATT shares issued – Lilly license
|
| | | | 550,000 | | | | | | 550,000 | | |
Redemption Backstop
|
| | | | — | | | | | | 1,500,000 | | |
JATT Founders
|
| | | | 3,450,000 | | | | | | 3,450,000 | | |
PIPE
|
| | | | 2,000,000 | | | | | | 2,000,000 | | |
Forward Purchase Agreement
|
| | | | 3,000,000 | | | | | | 3,000,000 | | |
Zura Equityholders
|
| | | | 16,053,700 | | | | | | 16,053,700 | | |
Pro forma weighted average shares outstanding, basic and diluted
|
| | | | 26,742,678 | | | | | | 26,553,000 | | |
AE, MedDRA version 19.1 preferred term
|
| |
ZB-168
1 mg/kg Q2W (n= 8) |
| |
ZB-168
3 mg/kg Q2W (n= 9) |
| |
ZB-168
8 mg/kg Q2W (n= 8) |
| |
ZB-168
6 mg/kg Q1wk (n= 5) |
| |
Placebo
(n= 7) |
|
Headache
|
| |
2 (25.0)
|
| |
2 (22.2)
|
| |
3 (37.5)
|
| |
—
|
| |
—
|
|
Hypoglycemia
|
| |
1 (12.5)
|
| |
1(11.1)
|
| |
—
|
| |
1 (20.0)
|
| |
2 (28 .6)
|
|
Fatigue
|
| |
1 (12.5)
|
| |
—
|
| |
1 (12.5)
|
| |
—
|
| |
2 (28 .6)
|
|
Lymphocytes decreased
|
| |
1 (12.5)
|
| |
—
|
| |
1 (12.5)
|
| |
2 (40.0)
|
| |
—
|
|
Nasopharyngitis
|
| |
—
|
| |
—
|
| |
2 (25 .0)
|
| |
1 (20.0)
|
| |
1 (14.3)
|
|
Nausea
|
| |
1 (12.5)
|
| |
2 (22.2)
|
| |
—
|
| |
1 (20.0)
|
| |
—
|
|
Cough
|
| |
1 (12.5)
|
| |
—
|
| |
1 (12.5)
|
| |
1 (20.0)
|
| |
—
|
|
Diarrhea
|
| |
—
|
| |
—
|
| |
1 (12.5)
|
| |
1 (20.0)
|
| |
1 (14.3)
|
|
Injection site erythema
|
| |
—
|
| |
—
|
| |
1 (12.5)
|
| |
1 (20.0)
|
| |
1 (14.3)
|
|
Injection site pain
|
| |
—
|
| |
—
|
| |
1 (12.5)
|
| |
1 (20.0)
|
| |
1 (14.3)
|
|
Lymphadenopathy
|
| |
1 (12.5)
|
| |
—
|
| |
1 (12 .5)
|
| |
1 (20.0)
|
| |
—
|
|
Oropharyngeal pain
|
| |
1 (12.5)
|
| |
—
|
| |
1 (12.5)
|
| |
1 (20.0)
|
| |
—
|
|
WBC decreased
|
| |
1 (12.5)
|
| |
—
|
| |
—
|
| |
1 (20.0)
|
| |
1 (14.3)
|
|
Abdominal distension
|
| |
—
|
| |
1 (11.1)
|
| |
—
|
| |
—
|
| |
1 (14.3)
|
|
Hyperhidrosis
|
| |
1 (12.5)
|
| |
—
|
| |
—
|
| |
—
|
| |
1 (14.3)
|
|
Injection site bruising
|
| |
—
|
| |
1 (11.1)
|
| |
—
|
| |
1 (20.0)
|
| |
—
|
|
Injection site pruritus
|
| |
—
|
| |
—
|
| |
1 (12.5)
|
| |
—
|
| |
1 (14.3)
|
|
Lethargy
|
| |
—
|
| |
1 (11.1)
|
| |
—
|
| |
1 (20.0)
|
| |
—
|
|
Neutrophils decreased
|
| |
—
|
| |
—
|
| |
—
|
| |
1 (20.0)
|
| |
1 (14.3)
|
|
Rash
|
| |
1 (12.5)
|
| |
—
|
| |
—
|
| |
—
|
| |
1 (14.3)
|
|
Vomiting
|
| |
—
|
| |
1 (11.1)
|
| |
—
|
| |
—
|
| |
1 (14.3)
|
|
Jurisdiction
|
| |
Status
|
| |
Number
|
| |
Expiration Date
|
|
Canada | | |
Granted (active)*
|
| |
3039232
|
| |
24-Oct-37
|
|
Europe: France, Germany, Ireland, Italy, Spain, UK
|
| |
Granted (active)*
|
| |
3532499
|
| |
24-Oct-37
|
|
Japan | | |
Granted (active)*
|
| |
6830533
|
| |
24-Oct-37
|
|
US | | |
Granted (active)*
|
| |
10501536
|
| |
24-Oct-37
|
|
US | | |
Granted (active)*
|
| |
10913793
|
| |
25-Oct-39
|
|
PCT | | | | | |
WO2018/081075
|
| | | |
Jurisdiction
|
| |
Status
|
|
Canada | | |
Granted (active)*
|
|
Europe: France, Germany, Ireland, Italy, Spain, UK
|
| |
Granted (active)*
|
|
Japan | | |
Granted (active)*
|
|
Japan | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
US | | |
Granted (active)*
|
|
PCT | | | Phase Ended | |
Name
|
| |
Age
|
| |
Position
|
|
Someit Sidhu, MD | | |
33
|
| | Chairman and Chief Executive Officer | |
Tauhid Ali, PhD, | | |
54
|
| | Chief Operating Officer and Director | |
Verender S. Badial | | |
49
|
| | Chief Financial Officer | |
Arnout Ploos van Amstel | | |
58
|
| | Director | |
Javier Cote-Sierra, PhD | | |
59
|
| | Director | |
Graeme Sloan | | |
58
|
| | Director | |
Yuan-Hua Ding, PhD | | | | | | Advisor | |
Name
|
| |
Age
|
| |
Position(s)
|
|
Executive Officers | | | | | | | |
Someit Sidhu | | | 33 | | | Chief Executive Officer and Director | |
Javier Cote-Sierra | | | 58 | | | Chief Scientific Officer | |
Non-employee Directors | | | | | | | |
Amit Munshi | | | 53 | | | Non-Employee Executive Chairman | |
Sandeep Kulkarni | | | 41 | | | Director | |
[Other non-employee directors to be added.] | | | | | | | |
| | |
Pre-Business
Combination(2) |
| |
Post-Business Combination
|
| ||||||||||||||||||||||||||||||||||||||||||
| | |
Number of Shares
|
| |
Assuming
No Further Redemption(3) |
| |
Assuming
50% Further Redemption(4) |
| |
Assuming
Maximum Redemption(5) |
| ||||||||||||||||||||||||||||||||||||
Name and Address of Beneficial Owner(1)
|
| |
Number
of Shares |
| |
% of
Class |
| |
Number
of Shares |
| |
% of
Class |
| |
Number
of Shares |
| |
% of
Class |
| |
Number
of Shares |
| |
% of
Class |
| ||||||||||||||||||||||||
Directors and executive officers of JATT prior to the Business Combination
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Someit Sidhu(6)
|
| | | | 3,255,000 | | | | | | 63.3% | | | | | | 3,255,000% | | | | | | 12.1% | | | | | | 3,255,000 | | | | | | 12.3% | | | | | | 3,255,000 | | | | | | 12.2% | | |
Verender S. Badial
|
| | | | 30,000 | | | | | | * | | | | | | 30,000 | | | | | | * | | | | | | 30,000 | | | | | | * | | | | | | 30,000 | | | | | | * | | |
Tauhid Ali, PhD
|
| | | | 30,000 | | | | | | * | | | | | | 30,000 | | | | | | * | | | | | | 30,000 | | | | | | * | | | | | | 30,000 | | | | | | * | | |
Javier Cote-Sierra, PhD
|
| | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | |
Arnout Ploos van Amstel
|
| | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | |
Graeme Sloan
|
| | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | |
All directors and executive officers of JATT
prior to the Business Combination as a group (6 individuals) |
| | | | 3,375,000(7) | | | | | | 65.7% | | | | | | 3,375,000 | | | | | | 12.6% | | | | | | 3,375,000 | | | | | | 12.7% | | | | | | 3,375,000 | | | | | | 12.7% | | |
| | |
Pre-Business
Combination(2) |
| |
Post-Business Combination
|
| ||||||||||||||||||||||||||||||||||||||||||
| | |
Number of Shares
|
| |
Assuming
No Further Redemption(3) |
| |
Assuming
50% Further Redemption(4) |
| |
Assuming
Maximum Redemption(5) |
| ||||||||||||||||||||||||||||||||||||
Name and Address of Beneficial Owner(1)
|
| |
Number
of Shares |
| |
% of
Class |
| |
Number
of Shares |
| |
% of
Class |
| |
Number
of Shares |
| |
% of
Class |
| |
Number
of Shares |
| |
% of
Class |
| ||||||||||||||||||||||||
Directors and executive officers of New JATT
after consummation of the Business Combination |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Someit Sidhu(6)
|
| | | | 3,255,000 | | | | | | 63.3% | | | | | | 3,255,000 | | | | | | 12.1% | | | | | | 3,255,000 | | | | | | 12.2% | | | | | | 3,255,000 | | | | | | 12.2% | | |
Javier Cote-Sierra
|
| | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | | | | | 20,000 | | | | | | * | | |
Sandeep Kulkarni(8)
|
| | | | — | | | | | | — | | | | | | 81,534 | | | | | | * | | | | | | 81,534 | | | | | | * | | | | | | 81,534 | | | | | | * | | |
Amit Munshi(9)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
All directors and executive officers following
the Business Combination as a group (7 individuals) |
| | | | 3,275,000 | | | | | | 63.7% | | | | | | 3,356,534 | | | | | | 12.5% | | | | | | 3,356,534 | | | | | | 12.6% | | | | | | 3,356,534 | | | | | | 12.6% | | |
Five Percent Holders: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
JATT Ventures, L.P.
|
| | | | 3,255,000 | | | | | | 63.3% | | | | | | 3,255,000 | | | | | | 12.1% | | | | | | 3,255,000 | | | | | | 12.3% | | | | | | 3,255,000 | | | | | | 12.2% | | |
Athanor Capital LP(10)
|
| | | | — | | | | | | — | | | | | | 3,000,000 | | | | | | 11.2% | | | | | | 3,582,077 | | | | | | 13.5% | | | | | | 4,500,000 | | | | | | 16.9% | | |
Hana Immunotherapeutics LLC(11)
|
| | | | — | | | | | | — | | | | | | 12,491,135 | | | | | | 46.5% | | | | | | 12,491,135 | | | | | | 47.0% | | | | | | 12,491,135 | | | | | | 46.9% | | |
Pfizer Inc.(12)
|
| | | | — | | | | | | — | | | | | | 3,122,753 | | | | | | 11.6% | | | | | | 3,122,753 | | | | | | 11.8% | | | | | | 3,122,753 | | | | | | 11.7% | | |
Ewon Comfortech Co., Ltd.(13)
|
| | | | — | | | | | | — | | | | | | 2,000,000 | | | | | | 7.5% | | | | | | 2,000,000 | | | | | | 7.5% | | | | | | 2,000,000 | | | | | | 7.5% | | |
| | |
Page
|
| |||
| | | | F-2 | | | |
| | | | F-3 | | | |
| | | | F-4 | | | |
| | | | F-5 | | | |
| | | | F-6 | | | |
| | | | F-7 | | | |
Financial Statements | | | | | | | |
| | | | F-22 | | | |
| | | | F-23 | | | |
| | | | F-24 | | | |
| | | | F-25 | | | |
| | | | F-26 | | |
| | | | | F-47 | | | |
| | | | | F-48 | | | |
| | | | | F-49 | | | |
| | | | | F-50 | | | |
| | | | | F-51 | | | |
| | | | | F-52 | | |
| | | | | F-59 | | | |
| | | | | F-60 | | | |
| | | | | F-61 | | | |
| | | | | F-62 | | | |
| | | | | F-63 | | |
| Assets | | | | | | | |
| Current assets: | | | | | | | |
|
Cash
|
| | | $ | 729,223 | | |
|
Prepaid expenses
|
| | | | 422,894 | | |
|
Total current assets
|
| | | | 1,152,117 | | |
|
Investments held in Trust Account
|
| | | | 139,399,054 | | |
|
Total Assets
|
| | | $ | 140,551,171 | | |
|
Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Shareholders’ Deficit
|
| | | | | | |
| Current liabilities: | | | | | | | |
|
Accounts payable
|
| | | $ | 69,855 | | |
|
Accrued expenses
|
| | | | 199,565 | | |
|
Due to related party
|
| | | | 2,872 | | |
|
Total current liabilities
|
| | | | 272,292 | | |
|
Deferred underwriting commissions
|
| | | | 4,010,000 | | |
|
Derivative warrant liabilities
|
| | | | 6,069,900 | | |
|
Total Liabilities
|
| | | | 10,352,192 | | |
| Commitments and Contingencies (Note 5) | | | | | | | |
|
Class A ordinary shares subject to possible redemption; 13,800,000 shares subject to possible redemption at $10.10 per share
|
| | | | 139,380,000 | | |
| Shareholders’ Deficit: | | | | | | | |
|
Preference shares, $0.0001 par value; 1,000,000 shares authorized; none issued or outstanding
|
| | | | — | | |
|
Class A ordinary shares, $0.0001 par value; 200,000,000 shares authorized; no non-redeemable shares issued or outstanding
|
| | | | — | | |
|
Class B ordinary shares, $0.0001 par value; 20,000,000 shares authorized; 3,450,000 shares issued and outstanding
|
| | | | 345 | | |
|
Accumulated deficit
|
| | | | (9,181,366) | | |
|
Total shareholders’ deficit
|
| | | | (9,181,021) | | |
|
Total Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Shareholders’
Deficit |
| | | $ | 140,551,171 | | |
|
General and administrative expenses
|
| | | $ | 720,696 | | |
|
General and administrative expenses – related party
|
| | | | 167,849 | | |
|
Loss from operations
|
| | | | (888,545) | | |
| Other income (expenses): | | | | | | | |
|
Loss upon issuance of private placement warrants
|
| | | | (1,773,000) | | |
|
Income from investments held in Trust Account
|
| | | | 19,054 | | |
|
Change in fair value of derivative warrant liabilities
|
| | | | 10,238,100 | | |
|
Interest earned
|
| | | | 51 | | |
|
Offering costs associated with derivative warrant liabilities
|
| | | | (747,015) | | |
|
Total other income (expenses)
|
| | | | 7,737,190 | | |
|
Net Income
|
| | | $ | 6,848,645 | | |
|
Weighted average number of shares of Class A ordinary shares – basic and diluted
|
| | |
|
7,834,343
|
| |
|
Basic net income per share, Class A ordinary shares
|
| | | $ | 0.62 | | |
|
Diluted net income per share, Class A ordinary shares
|
| | | $ | 0.61 | | |
|
Weighted average number of shares of Class B ordinary shares – basic
|
| | |
|
3,130,303
|
| |
|
Weighted average number of shares of Class B ordinary shares – diluted
|
| | |
|
3,310,606
|
| |
|
Basic net income per share, Class B ordinary shares
|
| | | $ | 0.62 | | |
|
Diluted net income per share, Class B ordinary shares
|
| | | $ | 0.61 | | |
| | |
Ordinary Shares
|
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Shareholders’ Deficit |
| ||||||||||||||||||||||||||||||
| | |
Class A
|
| |
Class B
|
| ||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||
Balance – March 10, 2021 (inception)
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | |
Issuance of Class B ordinary shares to Sponsor
|
| | | | — | | | | | | — | | | | | | 3,450,000 | | | | | | 345 | | | | | | 24,655 | | | | | | — | | | | | | 25,000 | | |
Deemed capital contribution by from Sponsor
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 4,738,051 | | | | | | — | | | | | | 4,738,051 | | |
Fair value adjustment to Class A ordinary shares subject to redemption
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (4,762,706) | | | | | | (16,030,011) | | | | | | (20,792,717) | | |
Net income
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 6,848,645 | | | | | | 6,848,645 | | |
Balance – December 31, 2021
|
| | | | — | | | | | $ | — | | | | | | 3,450,000 | | | | | $ | 345 | | | | | $ | — | | | | | $ | (9,181,366) | | | | | $ | (9,181,021) | | |
| Cash Flows from Operating Activities: | | | | | | | |
|
Net income
|
| | | | 6,848,645 | | |
| Adjustments to reconcile net income to net cash used in operating activities: | | | | | | | |
|
Change in fair value of derivative warrant liabilities
|
| | | | (10,238,100) | | |
|
Income on investments held in the Trust Account
|
| | | | (19,054) | | |
|
Offering costs associated with warrants
|
| | | | 747,015 | | |
|
Loss upon issuance of private placement warrants
|
| | | | 1,773,000 | | |
|
General and administrative expenses paid by related parties
|
| | | | 25,950 | | |
| Changes in operating assets and liabilities: | | | | | | | |
|
Prepaid expenses
|
| | | | (422,894) | | |
|
Due to related party
|
| | | | 2,872 | | |
|
Accounts payable
|
| | | | 69,855 | | |
|
Accrued expenses
|
| | | | 114,565 | | |
|
Net cash used in operating activities
|
| | | | (1,098,146) | | |
| Cash Flows from Investing Activities | | | | | | | |
|
Cash deposited in Trust Account
|
| | | | (139,380,000) | | |
|
Net cash used in investing activities
|
| | | | (139,380,000) | | |
| Cash Flows from Financing Activities: | | | | | | | |
|
Proceeds from issuance of Class B ordinary shares to Sponsor
|
| | | | 25,000 | | |
|
Repayment of loan to related party
|
| | | | (117,381) | | |
|
Proceeds received from initial public offering, gross
|
| | | | 138,000,000 | | |
|
Proceeds received from private placement
|
| | | | 5,910,000 | | |
|
Reimbursement from underwriter
|
| | | | 480,000 | | |
|
Offering costs paid
|
| | | | (3,090,250) | | |
|
Net cash provided by financing activities
|
| | | | 141,207,369 | | |
|
Net change in cash
|
| | | | 729,223 | | |
|
Cash – beginning of the period
|
| | |
|
—
|
| |
|
Cash – end of the period
|
| | | | 729,223 | | |
| Supplemental disclosure of non-cash investing and financing activities: | | | | | | | |
|
Offering costs included in accrued expenses
|
| | | | 85,000 | | |
|
Offering costs paid by related party under promissory note
|
| | | | 91,431 | | |
|
Deferred underwriting commissions
|
| | | | 4,010,000 | | |
|
Fair value adjustment to Class A ordinary shares subject to redemption
|
| | | | 20,792,717 | | |
| | |
For The Period From March 10, 2021
(Inception) through December 31, 2021 |
| |||||||||
| | |
Class A
|
| |
Class B
|
| ||||||
Basic and diluted net income per ordinary share: | | | | | | | | | | | | | |
Numerator: | | | | | | | | | | | | | |
Allocation of net income (loss) – basic
|
| | | $ | 4,893,422 | | | | | $ | 1,955,233 | | |
Allocation of net income (loss) – diluted
|
| | | | 4,814,256 | | | | | | 2,034,389 | | |
Denominator: | | | | | | | | | | | | | |
Basic and diluted weighted average ordinary shares outstanding
|
| | | | 7,834,343 | | | | | | 3,130,303 | | |
Diluted weighted average ordinary shares outstanding
|
| | | | 7,834,343 | | | | | | 3,310,606 | | |
Basic net income per ordinary share
|
| | | $ | 0.62 | | | | | $ | 0.62 | | |
Diluted net income per ordinary share
|
| | | $ | 0.61 | | | | | $ | 0.61 | | |
|
Gross proceeds
|
| | | $ | 138,000,000 | | |
| Less: | | | | | | | |
|
Proceeds allocated to Public Warrants
|
| | | | (8,625,000) | | |
|
Class A ordinary share issuance costs, net of reimbursement from underwriter
|
| | | | (10,787,717) | | |
| Plus: | | | | | | | |
|
Fair value adjustment of carrying value of Class A ordinary shares to redemption
value |
| | | | 20,792,717 | | |
|
Class A ordinary shares subject to possible redemption
|
| | | $ | 139,380,000 | | |
Description
|
| |
Quoted Prices in Active
Markets (Level 1) |
| |
Significant Other
Observable Inputs (Level 2) |
| |
Significant Other
Unobservable Inputs (Level 3) |
| |||||||||
Assets: | | | | | | | | | | | | | | | | | | | |
Investments held in Trust Account – U.S. Treasury Securities
|
| | | $ | 139,399,054 | | | | | $ | — | | | | | $ | — | | |
Liabilities: | | | | | | | | | | | | | | | | | | | |
Derivative warrant liabilities – Public Warrants
|
| | | $ | 3,174,000 | | | | | $ | — | | | | | $ | — | | |
Derivative warrant liabilities – Private Warrants
|
| | | $ | — | | | | | $ | — | | | | | $ | 2,895,900 | | |
| | | |
At initial issuance
|
| |
As of December 31, 2021
|
|
|
Exercise price
|
| |
$ 11.50
|
| |
$11.50
|
|
|
Stock price
|
| |
$9.34
|
| |
$9.87
|
|
|
Volatility
|
| |
23.0%
|
| |
9.5%
|
|
|
Term (years)
|
| |
5
|
| |
0.54
|
|
|
Risk-free rate
|
| |
0.07% – 1.10%
|
| |
1.43%
|
|
|
Probability of completing business combination
|
| |
95.0%
|
| |
95.0%
|
|
|
Dividend yield
|
| |
0.0%
|
| |
0.0%
|
|
|
Derivative warrant liabilities at March 10, 2021
|
| | | $ | — | | |
|
Issuance of Public and Private Warrants – Level 3 – July 2021
|
| | | | 16,308,000 | | |
|
Transfer of Public Warrants to Level 1 measurement
|
| | | | (8,625,000) | | |
|
Change in fair value of derivative warrant liabilities
|
| | | | (4,787,100) | | |
|
Derivative warrant liabilities at December 31, 2021 – Level 3
|
| | | $ | 2,895,900 | | |
| | |
September 30, 2022
|
| |
December 31, 2021
|
| ||||||
| | |
(unaudited)
|
| | | | | | | |||
Assets | | | | ||||||||||
Current assets: | | | | | | | | | | | | | |
Cash
|
| | | $ | 74,453 | | | | | $ | 729,223 | | |
Prepaid expenses
|
| | | | 122,202 | | | | | | 422,894 | | |
Total current assets
|
| | | | 196,655 | | | | | | 1,152,117 | | |
Investments held in Trust Account
|
| | | | 140,283,110 | | | | | | 139,399,054 | | |
Total Assets
|
| | | $ | 140,479,765 | | | | | $ | 140,551,171 | | |
Liabilities, Class A Ordinary Shares Subject to Possible Redemption and
Shareholders’ Deficit |
| | | | | | | | | | | | |
Current liabilities: | | | | | | | | | | | | | |
Accounts payable
|
| | | $ | 159,240 | | | | | $ | 69,855 | | |
Accounts payable – related party
|
| | | | 48,893 | | | | | | 2,872 | | |
Accrued expenses
|
| | | | 836,165 | | | | | | 199,565 | | |
Note Payable – related party
|
| | | | 299,981 | | | | | | — | | |
Total current liabilities
|
| | | | 1,344,279 | | | | | | 272,292 | | |
Deferred underwriting commissions
|
| | | | 4,010,000 | | | | | | 4,010,000 | | |
Derivative warrant liabilities
|
| | | | 2,049,600 | | | | | | 6,069,900 | | |
Total Liabilities
|
| | | | 7,403,879 | | | | | | 10,352,192 | | |
Commitments and Contingencies | | | | | | | | | | | | | |
Class A ordinary shares subject to possible redemption; 13,800,000
shares subject to possible redemption at $10.16 and $10.10 per share as of September 30, 2022 and December 31, 2021, respectively |
| | | | 140,183,110 | | | | | | 139,380,000 | | |
Shareholders’ Deficit: | | | | | | | | | | | | | |
Preference shares, $0.0001 par value; 1,000,000 shares authorized;
none issued or outstanding at September 30, 2022 and December 31, 2021 |
| | | | — | | | | | | — | | |
Class A ordinary shares, $0.0001 par value; 200,000,000 shares authorized; no non-redeemable shares issued or outstanding at September 30, 2022 and December 31, 2021
|
| | | | — | | | | | | — | | |
Class B ordinary shares, $0.0001 par value; 20,000,000 shares authorized; 3,450,000 shares issued and outstanding at September 30, 2022 and December 31, 2022
|
| | | | 345 | | | | | | 345 | | |
Accumulated deficit
|
| | | | (7,107,569) | | | | | | (9,181,366) | | |
Total shareholders’ deficit
|
| | | | (7,107,224) | | | | | | (9,181,021) | | |
Total Liabilities, Class A Ordinary Shares Subject to Possible Redemption and Shareholders’ Deficit
|
| | | $ | 140,479,765 | | | | | $ | 140,551,171 | | |
| | |
Three Months
Ended September 30, 2022 |
| |
Three Months
Ended September 30, 2021 |
| |
For the Nine Months
Ended September 30, 2022 |
| |
For the Period from
March 10, 2021 (inception) through September 30, 2021 |
| ||||||||||||
General and administrative expenses
|
| | | $ | 491,890 | | | | | $ | 242,013 | | | | | $ | 1,688,021 | | | | | $ | 294,193 | | |
General and administrative expenses –
related party |
| | | | 51,708 | | | | | | 79,850 | | | | | | 339,708 | | | | | | 79,850 | | |
Loss from operations
|
| | | | (543,598) | | | | | | (321,863) | | | | | | (2,027,729) | | | | | | (374,043) | | |
Other income (expenses): | | | | | | | | | | | | | | | | | | | | | | | | | |
Loss upon issuance of private placements warrants
|
| | | | — | | | | | | (1,773,000) | | | | | | — | | | | | | (1,773,000) | | |
Income from investments held in Trust Account
|
| | | | 686,544 | | | | | | 6,919 | | | | | | 884,056 | | | | | | 6,919 | | |
Change in fair value of derivative warrant liabilities
|
| | | | 315,300 | | | | | | 8,622,000 | | | | | | 4,020,300 | | | | | | 8,622,000 | | |
Interest income on operating account
|
| | | | 224 | | | | | | 29 | | | | | | 280 | | | | | | 29 | | |
Offering costs associated with derivative
warrant liabilities |
| | | | — | | | | | | (747,015) | | | | | | — | | | | | | (747,015) | | |
Total other income
|
| | | | 1,002,068 | | | | | | 6,108,933 | | | | | | 4,904,636 | | | | | | 6,108,933 | | |
Net Income
|
| | | $ | 458,470 | | | | | $ | 5,787,070 | | | | | $ | 2,876,907 | | | | | $ | 5,734,890 | | |
Weighted average number of shares of Class A ordinary shares – basic and diluted
|
| | |
|
13,800,000
|
| | | |
|
11,491,304
|
| | | |
|
13,800,000
|
| | | |
|
5,157,073
|
| |
Basic net income per share, Class A ordinary shares
|
| | | $ | 0.03 | | | | | $ | 0.39 | | | | | $ | 0.17 | | | | | $ | 0.70 | | |
Diluted net income per share, Class A ordinary shares
|
| | | $ | 0.03 | | | | | $ | 0.39 | | | | | $ | 0.17 | | | | | $ | 0.68 | | |
Weighted average number of shares of Class B ordinary shares – basic and diluted(1)
|
| | |
|
3,450,000
|
| | | |
|
3,361,957
|
| | | |
|
3,450,000
|
| | | |
|
2,986,829
|
| |
Weighted average number of shares of Class B ordinary shares – basic and diluted
|
| | |
|
3,450,000
|
| | | |
|
3,450,000
|
| | | |
|
3,450,000
|
| | | |
|
3,248,049
|
| |
Basic net income per share, Class B ordinary shares
|
| | | $ | 0.03 | | | | | $ | 0.39 | | | | | $ | 0.17 | | | | | $ | 0.70 | | |
Diluted net income per share, Class B ordinary shares
|
| | | $ | 0.03 | | | | | $ | 0.39 | | | | | $ | 0.17 | | | | | $ | 0.68 | | |
| | |
Ordinary Shares
|
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Shareholders’ Deficit |
| ||||||||||||||||||||||||||||||
| | |
Class A
|
| |
Class B
|
| ||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||
Balance – December 31, 2021
|
| | | | — | | | | | $ | — | | | | | | 3,450,000 | | | | | $ | 345 | | | | | $ | — | | | | | $ | (9,181,366) | | | | | $ | (9,181,021) | | |
Net income
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 147,856 | | | | | | 147,856 | | |
Balance – March 31, 2022
(unaudited) |
| | | | — | | | | | | — | | | | | | 3,450,000 | | | | | | 345 | | | | | | — | | | | | | (9,033,510) | | | | | | (9,033,165) | | |
Increase in redemption value of Class A ordinary shares subject to possible redemption
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (116,566) | | | | | | (116,566) | | |
Net income
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | | | 2,270,581 | | | | | | 2,270,581 | | |
Balance – June 30, 2022
(unaudited) |
| | | | — | | | | | | — | | | | | | 3,450,000 | | | | | | 345 | | | | | | — | | | | | | (6,879,495) | | | | | | (6,879,150) | | |
Net income
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | | | 458,470 | | | | | | 458,470 | | |
Increase in redemption value of Class A ordinary shares subject to possible redemption
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | | | (686,544) | | | | | | (686,544) | | |
Balance – September 30, 2022 (unaudited)
|
| | | | — | | | | | $ | — | | | | | | 3,450,000 | | | | | $ | 345 | | | | | $ | — | | | | | $ | (7,107,569) | | | | | $ | (7,107,224) | | |
| | |
Ordinary Shares
|
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Shareholders’ Deficit |
| ||||||||||||||||||||||||||||||
| | |
Class A
|
| |
Class B
|
| ||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||
Balance – March 10, 2021 (inception)
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | |
Issuance of Class B ordinary shares
to Sponsor(1) |
| | | | — | | | | | | — | | | | | | 3,450,000 | | | | | | 345 | | | | | | 24,655 | | | | | | — | | | | | | 25,000 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (33,039) | | | | | | (33,039) | | |
Balance – March 31, 2021 (unaudited)
|
| | | | — | | | | | | — | | | | | | 3,450,000 | | | | | | 345 | | | | | | 24,655 | | | | | | (33,039) | | | | | | (8,039) | | |
Net loss
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | | | (19,141) | | | | | | (19,141) | | |
Balance – June 30, 2021
(unaudited) |
| | | | — | | | | | | — | | | | | | 3,450,000 | | | | | | 345 | | | | | | 24,655 | | | | | | (52,180) | | | | | | (27,180) | | |
Deemed capital contribution by Sponsor (restated)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 4,738,051 | | | | | | — | | | | | | 4,738,051 | | |
Fair value adjustment to Class A ordinary share redemption amount (restated)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (4,762,706) | | | | | | (16,030,011) | | | | | | (20,792,717) | | |
Net income
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 5,787,070 | | | | | | 5,787,070 | | |
Balance – September 30, 2021 (unaudited)
|
| | | | — | | | | | $ | — | | | | | | 3,450,000 | | | | | $ | 345 | | | | | $ | — | | | | | $ | (10,295,121) | | | | | $ | (10,294,776) | | |
| | |
For the Nine Months
Ended September 30, 2022 |
| |
For The Period From
March 10, 2021 (Inception) through September 30, 2021 |
| ||||||
Cash Flows from Operating Activities: | | | | | | | | | | | | | |
Net income
|
| | | $ | 2,876,907 | | | | | $ | 5,734,890 | | |
Adjustments to reconcile net income to net cash used in operating activities:
|
| | | | | | | | | | | | |
Change in fair value of derivative warrant liabilities
|
| | | | (4,020,300) | | | | | | (8,622,000) | | |
Income from investments held in the Trust Account
|
| | | | (884,056) | | | | | | (6,919) | | |
Offering costs associated with warrants
|
| | | | — | | | | | | 747,015 | | |
Loss upon issuance of private placement warrants
|
| | | | — | | | | | | 1,773,000 | | |
General and administrative expenses paid by related parties
|
| | | | — | | | | | | 25,950 | | |
Changes in operating assets and liabilities: | | | | | | | | | | | | | |
Prepaid expenses
|
| | | | 300,692 | | | | | | (531,248) | | |
Due form related party
|
| | | | — | | | | | | (9,573) | | |
Accounts payable
|
| | | | 89,385 | | | | | | 29,885 | | |
Accounts payable – related party
|
| | | | 46,021 | | | | | | — | | |
Accrued expenses
|
| | | | 636,600 | | | | | | 18,278 | | |
Net cash used in operating activities
|
| | | | (954,751) | | | | | | (840,722) | | |
Cash Flows from Investing Activities | | | | | | | | | | | | | |
Cash deposited in Trust Account
|
| | | | — | | | | | | (139,380,000) | | |
Net cash used in investing activities
|
| | |
|
—
|
| | | | | (139,380,000) | | |
Cash Flows from Financing Activities: | | | | | | | | | | | | | |
Cash deposited in Trust Account
|
| | | | — | | | | | | 25,000 | | |
Proceeds received from note payable
|
| | | | 299,981 | | | | | | (117,381) | | |
Proceeds from issuance of Clas B ordinary share to Sponsor
|
| | | | — | | | | | | 138,000,000 | | |
Proceeds received from private placement
|
| | | | — | | | | | | 5,910,000 | | |
Reimbursement from underwriter
|
| | | | — | | | | | | 480,000 | | |
Offering costs paid
|
| | | | — | | | | | | (3,090,250) | | |
Net cash provided by financing activities
|
| | | | 299,981 | | | | | | 141,207,369 | | |
Net change in cash
|
| | | | (654,770) | | | | | | 986,647 | | |
Cash – beginning of the period
|
| | |
|
729,223
|
| | | |
|
—
|
| |
Cash – end of the period
|
| | | $ | 74,453 | | | | | $ | 986,647 | | |
Supplemental disclosure of non-cash investing and financing activities:
|
| | | | | | | | | | | | |
Offering costs included in accounts payable
|
| | |
|
—
|
| | | | | | | |
Offering costs included in accrued expenses
|
| | | | — | | | | | | 85,000 | | |
Offering costs paid by related party under promissory note
|
| | | | — | | | | | | 91,431 | | |
Deferred underwriting commissions
|
| | | | — | | | | | | 4,010,000 | | |
Increase in redemption value of Class A common stock subject to
possible redemption |
| | | | 803,110 | | | | | | — | | |
Fair value adjustment to Class A ordinary shares subject to possible redemption
|
| | | | — | | | | | | 20,792,717 | | |
| | |
For the Three Months Ended
September 30, 2022 |
| |
For the Nine Months Ended
September 30, 2022 |
| ||||||||||||||||||
| | |
Class A
|
| |
Class B
|
| |
Class A
|
| |
Class B
|
| ||||||||||||
Basic and diluted net income per ordinary share: | | | | | | | | | | | | | | | | | | | | | | | | | |
Numerator: | | | | | | | | | | | | | | | | | | | | | | | | | |
Allocation of net income – basic and diluted
|
| | | $ | 366,776 | | | | | $ | 91,694 | | | | | $ | 2,301,526 | | | | | $ | 575,381 | | |
Denominator: | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic and diluted weighted average ordinary shares outstanding
|
| | | | 13,800,000 | | | | | | 3,450,000 | | | | | | 13,800,000 | | | | | | 3,450,000 | | |
Basic and diluted net income per ordinary share
|
| | | $ | 0.03 | | | | | $ | 0.03 | | | | | $ | 0.17 | | | | | $ | 0.17 | | |
| | |
For the Three Months Ended
September 30, 2021 |
| |
For the Period from March 10, 2021
(inception) through September 30, 2021 |
| ||||||||||||||||||
| | |
Class A
|
| |
Class B
|
| |
Class A
|
| |
Class B
|
| ||||||||||||
Basic and diluted net income per ordinary share:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Numerator: | | | | | | | | | | | | | | | | | | | | | | | | | |
Allocation of net income – basic
|
| | | $ | 4,477,198 | | | | | $ | 1,309,873 | | | | | $ | 3,631,582 | | | | | $ | 2,103,308 | | |
Allocation of net income – diluted
|
| | | $ | 4,450,815 | | | | | $ | 1,336,255 | | | | | $ | 3,518,717 | | | | | $ | 2,216,173 | | |
Denominator: | | | | | | | | | | | | | | | | | | | | | | | | | |
Basic weighted average ordinary shares outstanding
|
| | | | 11,491,304 | | | | | | 3,361,957 | | | | | | 5,157,073 | | | | | | 2,986,829 | | |
Diluted weighted average ordinary shares outstanding
|
| | | | 11,491,304 | | | | | | 3,450,000 | | | | | | 5,157,073 | | | | | | 3,248,049 | | |
Basic net income per ordinary share
|
| | | $ | 0.39 | | | | | $ | 0.39 | | | | | $ | 0.70 | | | | | $ | 0.70 | | |
Diluted net income per ordinary share
|
| | | $ | 0.39 | | | | | $ | 0.39 | | | | | $ | 0.68 | | | | | $ | 0.68 | | |
|
Gross proceeds
|
| | | $ | 138,000,000 | | |
| Less: | | | | | | | |
|
Proceeds allocated to Public Warrants
|
| | | | (8,625,000) | | |
|
Class A ordinary share issuance costs, net of reimbursement from underwriter
|
| | | | (9,150,115) | | |
| Plus: | | | | | | | |
|
Accretion of carrying value to redemption value
|
| | | | 19,155,115 | | |
|
Class A common stock subject to possible redemption – December 31, 2021
|
| | | | 139,380,000 | | |
|
Increase in redemption value of Class A common stock subject to possible redemption
|
| | | | 803,110 | | |
|
Class A common stock subject to possible redemption – September 30, 2022
|
| | | $ | 140,183,110 | | |
Description
|
| |
Quoted Prices in Active
Markets (Level 1) |
| |
Significant Other
Observable Inputs (Level 2) |
| |
Significant Other
Unobservable Inputs (Level 3) |
| |||||||||
Assets: | | | | | | | | | | | | | | | | | | | |
Investments held in Trust Account – U.S. Treasury
Securities |
| | | $ | 140,283,110 | | | | | $ | — | | | | | $ | — | | |
Liabilities: | | | | | | | | | | | | | | | | | | | |
Derivative warrant liabilities – Public Warrants
|
| | | $ | 1,104,000 | | | | | $ | — | | | | | $ | — | | |
Derivative warrant liabilities – Private Warrants
|
| | | $ | — | | | | | $ | — | | | | | $ | 945,600 | | |
Description
|
| |
Quoted Prices in
Active Markets (Level 1) |
| |
Significant Other
Observable Inputs (Level 2) |
| |
Significant Other
Unobservable Inputs (Level 3) |
| |||||||||
Assets: | | | | | | | | | | | | | | | | | | | |
Investments held in Trust Account – U.S. Treasury Securities
|
| | | $ | 139,399,054 | | | | | $ | — | | | | | $ | — | | |
Liabilities: | | | | | | | | | | | | | | | | | | | |
Derivative warrant liabilities – Public Warrants
|
| | | $ | 3,174,000 | | | | | $ | — | | | | | $ | — | | |
Derivative warrant liabilities – Private Warrants
|
| | | $ | — | | | | | $ | — | | | | | $ | 2,895,900 | | |
| | |
As of September 30,
2022 |
| |
As of December 31,
2021 |
| ||||||
Exercise price
|
| | | $ | 11.50 | | | | | $ | 11.50 | | |
Stock price
|
| | | $ | 10.05 | | | | | $ | 9.87 | | |
Volatility
|
| | | | 1.0% | | | | | | 9.5% | | |
Term (years)
|
| | | | 4.71 | | | | | | 0.54 | | |
Risk-free rate
|
| | | | 4.09% | | | | | | 1.43% | | |
Dividend yield
|
| | | | 0.0% | | | | | | 0.0% | | |
|
Derivative warrant liabilities at December 31, 2021 – Level 3
|
| | | $ | 2,895,900 | | |
|
Change in fair value of derivative warrant liabilities
|
| | | | (336,870) | | |
|
Derivative warrant liabilities at March 31, 2022 – Level 3
|
| | | | 2,559,030 | | |
|
Change in fair value of derivative warrant liabilities
|
| | | | (1,436,130) | | |
|
Derivative warrant liabilities at June 30, 2022 – Level 3
|
| | | | 1,122,900 | | |
|
Change in fair value of derivative warrant liabilities
|
| | | | (177,300) | | |
|
Derivative warrant liabilities at September 30, 2022 – Level 3
|
| | | $ | 945,600 | | |
| | |
March 31,
2022 |
| |||
ASSETS | | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents
|
| | | $ | 4,720 | | |
Total current assets
|
| | | | 4,720 | | |
Total assets
|
| | | $ | 4,720 | | |
LIABILITIES, PREFERRED SHARES AND SHAREHOLDERS’ DEFICIT | | | | | | | |
Current liabilities | | | | | | | |
Accounts payable and accrued expenses
|
| | | $ | 39 | | |
Total current liabilities
|
| | | | 39 | | |
Total liabilities
|
| | | | 39 | | |
Commitments and contingencies – Note 6 | | | | | | | |
Convertible preferred shares | | | | | | | |
Series A-1 convertible preferred shares, $0.001 par value per share; 125,000 shares authorized as
of March 31, 2022, 125,000 shares issued and outstanding as of March 31, 2022 |
| | | | 12,500 | | |
Shareholders’ deficit | | | | | | | |
Ordinary Shares, $0.001 par value per share; 1 share authorized as of March 31, 2022; 1 share issued and outstanding as of March 31, 2022
|
| | | | — | | |
Accumulated deficit
|
| | | | (7,819) | | |
Total shareholders’ deficit
|
| | | | (7,819) | | |
Total liabilities, convertible preferred shares and shareholders’ deficit
|
| | | $ | 4,720 | | |
| | |
For the Period from
January 18, 2022 (date of inception) to March 31, 2022 |
| |||
Operating expenses: | | | | | | | |
General and administrative
|
| | | $ | 319 | | |
Research and development – license acquired
|
| | | | 7,500 | | |
Total operating expenses
|
| | | | 7,819 | | |
Loss from operations
|
| | |
|
(7,819)
|
| |
Net loss
|
| | | $ | (7,819) | | |
Net loss per Ordinary Share, basic and diluted
|
| | | $ | (7,818,712) | | |
Weighted average Ordinary Shares outstanding, basic and diluted
|
| | | | 1 | | |
| | |
Convertible
Preferred Shares |
| | |
Ordinary Shares
|
| |
Accumulated
Deficit |
| |
Total
Shareholders’ Deficit |
| ||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| | |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||
Balance as of January 18, 2022 (date of inception)
|
| | | | — | | | | | $ | — | | | | | | | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | |
Issuance of Ordinary Share at inception
|
| | | | — | | | | | | — | | | | | | | 1 | | | | | | — | | | | | | — | | | | | | — | | |
Issuance of Series A-1 convertible preferred shares for cash
|
| | | | 100,000 | | | | | | 10,000 | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Issuance of Series A-1 convertible preferred shares for license
|
| | | | 25,000 | | | | | | 2,500 | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Net loss
|
| | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (7,819) | | | | | | (7,819) | | |
Balance as of March 31, 2022
|
| | | | 125,000 | | | | | $ | 12,500 | | | | | | | 1 | | | | | $ | — | | | | | $ | (7,819) | | | | | $ | (7,819) | | |
| | |
For the Period from
January 18, 2022 (date of inception) to March 31, 2022 |
| |||
Cash flows from operating activities | | | | | | | |
Net loss
|
| | | $ | (7,819) | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | |
Research and development-acquired license, expensed
|
| | | | 7,500 | | |
Changes in operating assets and liabilities:
|
| | | | | | |
Accounts payable
|
| | | | 39 | | |
Net cash used in operating activities
|
| | | | (280) | | |
Cash flows from investing activities
|
| | | | | | |
Purchase of research and development license
|
| | | | (5,000) | | |
Net cash used in investing activities
|
| | | | (5,000) | | |
Cash flows from financing activities
|
| | | | | | |
Proceeds from issuance of Series A-1 convertible preferred shares
|
| | | | 10,000 | | |
Net cash provided by financing activities
|
| | | | 10,000 | | |
Net increase in cash and cash equivalents
|
| | |
|
4,720
|
| |
Cash and cash equivalents at the beginning of the period
|
| | |
|
—
|
| |
Cash and cash equivalents at the end of the period
|
| | | $ | 4,720 | | |
Supplemental disclosure of cash flow information: | | | | | | | |
Cash paid for income taxes
|
| | | $ | — | | |
Cash paid for interest
|
| | | $ | — | | |
Supplemental disclosure of noncash investing and financing activities: | | | | | | | |
Issuance of Series A-1 convertible preferred shares for license
|
| | | $ | 2,500 | | |
| | |
For the Period from
January 18, 2022 (date of inception) to March 31, 2022 |
| |||
Shares issuable upon conversion of Series A-1 convertible preferred shares
|
| | | | 125,000 | | |
Total
|
| | | | 125,000 | | |
| | |
For the Period from
January 18, 2022 (date of inception) to March 31, 2022 |
| |||
Statutory income tax rate
|
| | | | 19.0% | | |
Change in valuation allowance
|
| | | | (19.0)% | | |
Income tax provision (benefit)
|
| | | | 0.0% | | |
| | |
March 31,
2022 |
| |||
Deferred tax assets: | | | | | | | |
Net operating loss carryforward
|
| | | $ | 522 | | |
License
|
| | | | 964 | | |
Total deferred income tax assets
|
| | | | 1,486 | | |
Valuation allowance
|
| | | | (1,486) | | |
Deferred tax assets, net of valuation allowance
|
| | | $ | — | | |
| | |
September 30,
2022 |
| |
March 31,
2022 |
| ||||||
| | |
(Unaudited)
|
| | | | | | | |||
ASSETS | | | | | | | | | | | | | |
Current assets: | | | | | | | | | | | | | |
Cash and cash equivalents
|
| | | $ | 3,049 | | | | | $ | 4,720 | | |
Prepaid expenses and other current assets
|
| | | | 211 | | | | | | — | | |
Total current assets
|
| | | | 3,260 | | | | | | 4,720 | | |
Deferred offering costs
|
| | | | 1,911 | | | | | | — | | |
Total assets
|
| | | $ | 5,171 | | | | | $ | 4,720 | | |
LIABILITIES, PREFERRED SHARES AND SHAREHOLDERS’ DEFICIT | | | | | | | | | | | | | |
Current liabilities | | | | | | | | | | | | | |
Accounts payable and accrued expenses
|
| | | $ | 2,196 | | | | | $ | 39 | | |
Total current liabilities
|
| | | | 2,196 | | | | | | 39 | | |
Total liabilities
|
| | | | 2,196 | | | | | | 39 | | |
Commitments and contingencies – Note 7 | | | | | | | | | | | | | |
Convertible preferred shares | | | | | | | | | | | | | |
Series A-1 convertible preferred shares, $0.001 par value per share; 125,000 shares
authorized as of September 30, 2022 and March 31, 2022, 125,000 shares issued and outstanding as of September 30, 2022 and March 31, 2022 |
| | | | 12,500 | | | | | | 12,500 | | |
Shareholders’ deficit | | | | | | | | | | | | | |
Ordinary Shares, $0.001 par value per share; 17,437 shares and 1 share authorized
as of September 30, 2022 and March 31, 2022, respectively; 3,548 shares and 1 share issued and outstanding as of September 30, 2022 and March 31, 2022, respectively |
| | | | — | | | | | | — | | |
Additional paid-in capital
|
| | | | 321 | | | | | | — | | |
Accumulated deficit
|
| | | | (9,846) | | | | | | (7,819) | | |
Total shareholders’ deficit
|
| | | | (9,525) | | | | | | (7,819) | | |
Total liabilities, convertible preferred shares and shareholders’ deficit
|
| | | $ | 5,171 | | | | | $ | 4,720 | | |
| | |
Three Months
Ended September 30, 2022 |
| |
Six Months
Ended September 30, 2022 |
| ||||||
Operating expenses: | | | | | | | | | | | | | |
General and administrative
|
| | | $ | 653 | | | | | $ | 1,495 | | |
Research and development
|
| | | | 415 | | | | | | 500 | | |
Total operating expenses
|
| | | | 1,068 | | | | | | 1,995 | | |
Loss from operations
|
| | | | (1,068) | | | | | | (1,995) | | |
Other expense
|
| | | | (34) | | | | | | (32) | | |
Net loss
|
| | | $ | (1,102) | | | | | $ | (2,027) | | |
Net loss per Ordinary Share, basic and diluted
|
| | | $ | (310.26) | | | | | $ | (908.48) | | |
Weighted average Ordinary Shares outstanding, basic and diluted
|
| | | | 3,548 | | | | | | 2,230 | | |
| | |
Convertible
Preferred Shares |
| | |
Ordinary
Shares |
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Shareholders’ Deficit |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| | |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||
Balance as of June 30, 2022
|
| | | | 125,000 | | | | |
$
|
12,500
|
| | | | | | 3,548 | | | | |
$
|
—
|
| | | |
$
|
309
|
| | | |
$
|
(8,744)
|
| | | |
$
|
(8,435)
|
| |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 12 | | | | | | — | | | | | | 12 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,102) | | | | | | (1,102) | | |
Balance as of September 30, 2022
|
| | | | 125,000 | | | | | $ | 12,500 | | | | | | | 3,548 | | | | | $ | — | | | | | $ | 321 | | | | | $ | (9,846) | | | | | $ | (9,525) | | |
| | |
Convertible
Preferred Shares |
| | |
Ordinary
Shares |
| |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Total
Shareholders’ Deficit |
| |||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| | |
Shares
|
| |
Amount
|
| ||||||||||||||||||||||||||||||
Balance as of March 31, 2022
|
| | | | 125,000 | | | | |
$
|
12,500
|
| | | | | | 1 | | | | |
$
|
—
|
| | | |
$
|
—
|
| | | |
$
|
(7,819)
|
| | | |
$
|
(7,819)
|
| |
Exercises of stock options
|
| | | | — | | | | | | — | | | | | | | 3,547 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 321 | | | | | | — | | | | | | 321 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | (2,027) | | | | | | (2,027) | | |
Balance as of September 30, 2022
|
| | | | 125,000 | | | | | $ | 12,500 | | | | | | | 3,548 | | | | | $ | — | | | | | $ | 321 | | | | | $ | (9,846) | | | | | $ | (9,525) | | |
| | |
Six Months
Ended September 30, 2022 |
| |||
Cash flows from operating activities | | | | | | | |
Net loss
|
| | | $ | (2,027) | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | |
Share-based compensation expense
|
| | | | 321 | | |
Foreign exchange transaction loss
|
| | | | 32 | | |
Changes in operating assets and liabilities:
|
| | | | | | |
Prepaid expenses and other current assets
|
| | | | (211) | | |
Accounts payable and accrued expenses
|
| | | | 598 | | |
Net cash used in operating activities
|
| | | | (1,287) | | |
Cash flows from financing activities | | | | | | | |
Payment of deferred offering costs
|
| | | | (358) | | |
Net cash used in financing activities
|
| | | | (358) | | |
Effect of foreign exchange rates on cash
|
| | | | (26) | | |
Net decrease in cash and cash equivalents
|
| | | | (1,671) | | |
Cash and cash equivalents at the beginning of the period
|
| | | | 4,720 | | |
Cash and cash equivalents at the end of the period
|
| | | $ | 3,049 | | |
Supplemental disclosure of cash flow information: | | | | | | | |
Cash paid for income taxes
|
| | | $ | — | | |
Cash paid for interest
|
| | | $ | — | | |
Supplemental disclosure of noncash investing and financing activities: | | | | | | | |
Unpaid deferred offering costs included in accounts payable and accrued expenses
|
| | | $ | 1,553 | | |
| | |
Three Months Ended
September 30, 2022 |
| |
Six Months Ended
September 30, 2022 |
| ||||||
Shares issuable upon conversion of Series A-1 convertible preferred shares
|
| | | | 125,000 | | | | | | 125,000 | | |
Shares issuable upon exercise of options to purchase ordinary shares
|
| | | | 3,547 | | | | | | 3,547 | | |
Total
|
| | | | 128,547 | | | | | | 128,547 | | |
| | |
September 30,
2022 |
| |
March 31,
2022 |
| ||||||
Accounts payable
|
| | | $ | 1,148 | | | | | $ | 7 | | |
Accrued offering costs
|
| | | | 682 | | | | | | — | | |
Research and development costs
|
| | | | 189 | | | | | | — | | |
Accrued legal costs
|
| | | | 166 | | | | | | 32 | | |
Other accrued expenses
|
| | | | 11 | | | | | | — | | |
Total
|
| | | $ | 2,196 | | | | | $ | 39 | | |
| | |
Number of
Options |
| |
Weighted
Average Exercise Price (per share) |
| |
Weighted
Average Remaining Contractual Life (in years) |
| |
Aggregate
Intrinsic Value (in thousands) |
| ||||||||||||
Outstanding as of April 1, 2022
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | |
Granted
|
| | | | 3,547 | | | | | | — | | | | | | 9.7 | | | | | | 295 | | |
Exercised
|
| | | | (3,547) | | | | | | — | | | | | | — | | | | | | 295 | | |
Outstanding as of September 30, 2022
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Exercisable as of September 30, 2022
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | |
|
Risk-free interest rate
|
| | | | 3.0% | | |
|
Expected dividend yield
|
| | | | — | | |
|
Expected term (years)
|
| | | | 5.9 | | |
|
Expected volatility
|
| | | | 95.1% | | |
| | |
Number of
Options |
| |
Weighted
Average Exercise Price (per share) |
| |
Weighted
Average Remaining Contractual Life (in years) |
| |
Aggregate
Intrinsic Value (in thousands) |
| ||||||||||||
Outstanding as of April 1, 2022
|
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | |
Granted
|
| | | | 3,547 | | | | | | 90.50 | | | | | | 9.7 | | | | | | — | | |
Exercised
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Outstanding as of September 30, 2022
|
| | | | 3,547 | | | | | | 90.50 | | | | | | 9.7 | | | | | | — | | |
Exercisable as of September 30, 2022
|
| | | | 409 | | | | | $ | 90.50 | | | | | | 9.7 | | | | | $ | — | | |
| | | | | A-2 | | | |
| | | | | A-2 | | | |
| | | | | A-15 | | | |
| | | | | A-15 | | | |
| | | | | A-15 | | | |
| | | | | A-15 | | | |
| | | | | A-16 | | | |
| | | | | A-16 | | | |
| | | | | A-16 | | | |
| | | | | A-16 | | | |
| | | | | A-16 | | | |
| | | | | A-16 | | | |
| | | | | A-16 | | | |
| | | | | A-17 | | | |
| | | | | A-17 | | | |
| | | | | A-17 | | | |
| | | | | A-17 | | | |
| | | | | A-18 | | | |
| | | | | A-18 | | | |
| | | | | A-18 | | | |
| | | | | A-18 | | | |
| | | | | A-18 | | | |
| | | | | A-18 | | | |
| | | | | A-20 | | | |
| | | | | A-21 | | | |
| | | | | A-21 | | | |
| | | | | A-21 | | | |
| | | | | A-21 | | | |
| | | | | A-21 | | | |
| | | | | A-22 | | | |
| | | | | A-23 | | | |
| | | | | A-23 | | | |
| | | | | A-23 | | | |
| | | | | A-23 | | | |
| | | | | A-24 | | | |
| | | | | A-26 | | | |
| | | | | A-27 | | | |
| | | | | A-28 | | | |
| | | | | A-28 | | | |
| | | | | A-28 | | | |
| | | | | A-28 | | |
| | | | | A-30 | | | |
| | | | | A-30 | | | |
| | | | | A-31 | | | |
| | | | | A-31 | | | |
| | | | | A-31 | | | |
| | | | | A-32 | | | |
| | | | | A-32 | | | |
| | | | | A-32 | | | |
| | | | | A-32 | | | |
| | | | | A-33 | | | |
| | | | | A-34 | | | |
| | | | | A-34 | | | |
| | | | | A-34 | | | |
| | | | | A-34 | | | |
| | | | | A-35 | | | |
| | | | | A-35 | | | |
| | | | | A-36 | | | |
| | | | | A-36 | | | |
| | | | | A-37 | | | |
| | | | | A-37 | | | |
| | | | | A-37 | | | |
| | | | | A-37 | | | |
| | | | | A-37 | | | |
| | | | | A-37 | | | |
| | | | | A-38 | | | |
| | | | | A-38 | | | |
| | | | | A-38 | | | |
| | | | | A-39 | | | |
| | | | | A-39 | | | |
| | | | | A-40 | | | |
| | | | | A-40 | | | |
| | | | | A-40 | | | |
| | | | | A-40 | | | |
| | | | | A-41 | | | |
| | | | | A-41 | | | |
| | | | | A-41 | | | |
| | | | | A-45 | | | |
| | | | | A-45 | | | |
| | | | | A-45 | | | |
| | | | | A-45 | | | |
| | | | | A-45 | | | |
| | | | | A-45 | | |
| | | | | A-46 | | | |
| | | | | A-46 | | | |
| | | | | A-46 | | | |
| | | | | A-47 | | | |
| | | | | A-50 | | | |
| | | | | A-50 | | | |
| | | | | A-50 | | | |
| | | | | A-51 | | | |
| | | | | A-51 | | | |
| | | | | A-51 | | | |
| | | | | A-52 | | | |
| | | | | A-52 | | | |
| | | | | A-52 | | | |
| | | | | A-52 | | | |
| | | | | A-52 | | | |
| | | | | A-52 | | | |
| | | | | A-53 | | | |
| | | | | A-53 | | | |
| | | | | A-53 | | | |
| | | | | A-54 | | | |
| | | | | A-54 | | | |
| | | | | A-54 | | | |
| | | | | A-54 | | | |
| | | | | A-54 | | | |
| | | | | A-55 | | | |
| | | | | A-55 | | | |
| | | | | A-55 | | | |
| | | | | A-56 | | | |
| | | | | A-56 | | | |
| | | | | A-56 | | | |
| | | | | A-57 | | | |
| | | | | A-57 | | | |
| | | | | A-57 | | | |
| | | | | A-58 | | | |
| | | | | A-58 | | | |
| | | | | A-59 | | | |
| | | |
|
| |
| Notices to ZB Companies | | | with copies to (which shall not constitute notice): | |
|
Zura Bio Limited
3rd Floor 1 Ashley Road Altrincham WA14 2DT Attention: Oliver Levy Email: oliver.levy@zurabio.com |
| |
McDermott Will & Emery, LLP
110 Bishopsgate London EC2N 4AY Attention: Gary Howes Email: ghowes@mwe.com |
|
| Notices to SPAC, Merger Sub and Merger Sub 2: | | | with copies to (which shall not constitute notice): | |
|
JATT Acquisition Corp.
PO Box 309, Ugland House Grand Cayman, Cayman Islands Attention: Verender Badial E-mail: verender.badial@jattacquisition.com |
| |
Loeb & Loeb LLP
345 Park Avenue New York, NY 10154 Attention: Mitchell Nussbaum E-Mail: mnussbaum@loeb.com |
|
Address: |
|
Shareholder
|
| |
Number of
Shares |
| |
Address for Notices
|
|
JATT Ventures, L.P.
|
| |
3,255,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Someit Sidhu, MD*
|
| |
3,255,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Tauhid Ali, PhD
|
| |
30,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Verender S. Badial
|
| |
30,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Josh Distler, J.D.
|
| |
75,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Arnout Ploos van Amstel
|
| |
20,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Javier Cote-Sierra, PhD
|
| |
20,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Graeme Sloan
|
| |
20,000
|
| |
c/o JATT Acquisition Corp,
c/o Maples Corporate Services Limited, PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands |
|
Shareholder
|
| |
Number of
Ordinary Shares |
| |
Number
of Shares |
| |
Notice Details
|
| ||||||
Hana Immunotherapeutics LLC
|
| | | | 1 | | | | | | 100,000 | | | | chris.kim@hanaimmunotx.com | |
Pfizer Inc.
|
| | | | 0 | | | | | | 25,000 | | | |
Email address: rana.al-hallaq@pfizer.com
Correspondence address: For the attention of
Rana Al-Hallaq, Pfizer Inc., 235 East 42nd Street, New York, NY 10017
With a copy (which shall not constitute
notice) to:
Email address: Brandon.Miller@pfizer.com
Correspondence address: For the attention of
Brandon Miller, Pfizer Inc., 235 East 42nd Street, New York, NY 10017 |
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Oliver Levy
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David Brady
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By: |
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Date: |
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Exhibit
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Description
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| 10.26 | | | | |
| 10.27 | | | Letter Agreement, dated as of December 8, 2022, by and among Zura Bio Limited and Stone Peach Properties LLC.*** | |
| 10.28* | | | | |
| 10.29* | | | Zura Bio Limited 2022 Equity Incentive Plan.*** | |
| 10.30* ** | | | | |
| 10.31 | | | Form of Employment Agreement for Someit Sidhu.*** | |
| 10.32 | | | Form of Employment Agreement for Javier Cote-Sierra.*** | |
| 21.1 | | | | |
| 21.2 | | | | |
| 23.1 | | | Consent of WithumSmith+Brown, PC, independent registered public accounting firm of Zura.*** | |
| 23.2 | | | | |
| 23.3 | | | | |
| 23.4 | | | | |
| 23.5 | | | | |
| 24.1 | | | | |
| 99.1 | | | | |
| 99.2+ | | | Consent of [ ] to be named as a director nominee. | |
| 99.3 | | | | |
| 99.4 | | | | |
| 101. INS | | | XBRL Instance Document.*** | |
| 101. SCH | | | XBRL Taxonomy Extension Schema Document.*** | |
| 101. CAL | | | XBRL Taxonomy Extension Calculation Linkbase Document.*** | |
| 101. DEF | | | XBRL Taxonomy Extension Definition Linkbase Document.*** | |
| 101. LAB | | | XBRL Taxonomy Extension Labels Linkbase Document.*** | |
| 101. PRE | | | XBRL Taxonomy Extension Presentation Linkbase Document.*** | |
| 104 | | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).*** | |
| 107 | | | |
| | | | JATT Acquisition Corp | | |||
| | | | By: | | |
/s/ Someit Sidhu
Name: Someit Sidhu
Title: Chairman and Chief Executive Officer |
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Signature
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Title
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Date
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/s/ Someit Sidhu, MD
Someit Sidhu, MD
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Chairman and Chief Executive Officer
(Principal Executive Officer) |
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February 17, 2023
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/s/ Verender S. Badial
Verender S. Badial
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Chief Financial Officer and Director
(Principal Financial and Accounting Officer) |
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February 17, 2023
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*
Tauhid Ali, PhD
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Director
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February 17, 2023
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*
Javier Cote-Sierra, PhD
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Director
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February 17, 2023
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*
Arnout Ploos van Amstel
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Director
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February 17, 2023
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*
Graeme Sloan
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Director
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February 17, 2023
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*By:
/s/ Verender S. Badial
Name: Verender S. Badial
Title: Attorney-in-fact |
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Exhibit 10.11
Zura
Bio LIMITED
2023 Equity Incentive Plan
1. Purpose
The purpose of this Zura Bio Limited 2023 Equity Incentive Plan (the “Plan”) is to promote and closely align the interests of employees, officers, non-employee directors and other service providers of Zura Bio Limited, a Cayman Islands exempted company formerly known as JATT Acquisition Corp (the “Company”), and its shareholders by providing share-based compensation and other performance-based compensation. The objectives of the Plan are to attract and retain the talented employees and service providers for positions of substantial responsibility and to motivate Participants to optimize the profitability and growth of the Company through incentives that are consistent with the Company’s goals and that link the personal interests of Participants to those of the Company’s shareholders. The Plan provides for the grant of Options, Stock Appreciation Rights, Restricted Stock Units, Restricted Stock and Other Share-Based Awards and for Incentive Bonuses, which may be paid in cash, Common Shares or a combination thereof, as determined by the Committee.
2. Definitions
As used in the Plan, the following terms shall have the meanings set forth below:
“Act” means the U.S. Securities Exchange Act of 1934, as amended.
“Affiliate” means any entity in which the Company has a substantial direct or indirect equity interest, as determined by the Committee from time to time.
“Award” means an Option, Stock Appreciation Right, Restricted Stock Unit, Restricted Stock, Other Share-Based Award or Incentive Bonus granted to a Participant pursuant to the provisions of the Plan, any of which may be subject to performance conditions.
“Award Agreement” means a written or electronic agreement or other instrument as may be approved from time to time by the Committee and designated as such implementing the grant of each Award. An Award Agreement may be in the form of an agreement to be executed by both the Participant and the Company (or an authorized representative of the Company) or certificates, notices or similar instruments as approved by the Committee and designated as such.
“Beneficial Owner” shall have the meaning set forth in Rule 13d-3 under the Act.
“Board” means the Board of Directors of the Company.
“Cause” has the meaning set forth in the written employment, offer, services or severance agreement or letter between the Participant and the Company or an Affiliate, or, if there is no such agreement or no such term is defined in such agreement, means a Participant’s Termination of Employment by the Company or an Affiliate by reason of (i) the Participant’s material breach of any agreement between the Participant and the Company or an Affiliate or any policy of the Company of an Affiliate; (ii) the willful failure or refusal by the Participant to substantially perform his or her duties; (iii) the commission or conviction of the Participant of, or the entering of a plea of nolo contendere by the Participant with respect to, (A) a felony or (B) a misdemeanor involving moral turpitude; or (iv) the Participant’s gross misconduct that causes harm to the reputation of the Company. A Participant’s employment or service will be deemed to have been terminated for Cause if it is determined subsequent to such Participant’s Termination of Employment that grounds for a Termination of Employment for Cause existed at the time of such Termination of Employment, as determined by the Committee.
“Change in Control” means, except as otherwise provided in an Award Agreement, the occurrence of any one of the following:
(i) any Person is or becomes the Beneficial Owner, directly or indirectly, of securities of the Company (not including in the securities beneficially owned by such Person or any securities acquired directly from the Company or its Affiliates) representing 50% or more of the combined voting power of the Company’s then outstanding securities, excluding any Person who becomes such a Beneficial Owner in connection with a transaction described in Section 2(h)(iii) below;
(ii) the following individuals cease for any reason to constitute a majority of the number of directors then serving: (A) individuals who, on the Effective Date (as defined below), constitute the Board and (B) any new director (other than a director whose initial assumption of office is in connection with an actual or threatened election contest, including a consent solicitation, relating to the election of directors of the Company) whose appointment or election by the Board or nomination for election by the Company’s shareholders was approved or recommended by a vote of at least a majority of the directors then still in office who were either directors on the Effective Date or whose appointment, election or nomination for election was previously so approved or recommended;
(iii) there is consummated a merger or consolidation of the Company or any direct or indirect subsidiary of the Company with any other corporation, other than a merger or consolidation which would result in the holders of the voting securities of the Company outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof) at least 50% of the combined voting power of the securities of the Company or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation; or
(iv) there is consummated a sale or disposition by the Company of all or substantially all of the Company’s assets, other than a sale or disposition by the Company of all or substantially all of the Company’s assets to an entity, at least 50% of the combined voting power of the voting securities of which is owned by shareholders of the Company in substantially the same proportions as their ownership of the Company immediately prior to such sale.
“Code” means the U.S. Internal Revenue Code of 1986, as amended from time to time, and the rulings and regulations issued thereunder.
“Committee” means the Compensation Committee of the Board (or any successor committee) or such other committee as designated by the Board to administer the Plan under Section 6.
“Common Share” means shares of the Company’s common stock, or such other class or kind of shares or other securities as may be applicable under Section 16.
“Company” means Zura Bio Limited, a Cayman Islands exempted company formerly known as JATT Acquisition Corp, and except as utilized in the definition of Change in Control, any successor corporation.
“Disability” has the meaning set forth in a written employment, offer, services or severance agreement or letter between the Participant and the Company or an Affiliate, or, if there is no such agreement or no such term is defined in such agreement, means the inability of the Participant to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment. A determination of Disability shall be made by the Committee on the basis of such medical evidence as the Committee deems warranted under the circumstances, and in this respect, Participants shall submit to an examination by a physician upon request by the Committee.
“Dividend Equivalent” mean an amount payable in cash or Common Shares, as determined by the Committee, equal to the dividends that would have been paid to the Participant if the Common Share with respect to which the Dividend Equivalent relates had been owned by the Participant.
“Effective Date” means the date on which the Plan takes effect, as defined pursuant to Section 4.
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“Eligible Person” any current or prospective employee, officer, non-employee director or other service provider of the Company or any of its Subsidiaries; provided however that Incentive Stock Options may only be granted to employees of the Company or any of its “subsidiary corporations” within the meaning of Section 424 of the Code.
“Fair Market Value” means as of any date, the value of a Common Share determined as follows: (i) if the Common Shares are listed on any established stock exchange, system or market, the Fair Market Value shall be the closing price for a Common Share as quoted on such exchange, system or market as reported in the Wall Street Journal or such other source as the Committee deems reliable (or, if no sale of Common Shares is reported for such date, on the next preceding date on which any sale shall have been reported); and (ii) in the absence of an established market for the Common Shares, the Fair Market Value thereof shall be determined in good faith by the Committee by the reasonable application of a reasonable valuation method, taking into account factors consistent with Treas. Reg. §409A-1(b)(5)(iv)(B) as the Committee deems appropriate.
“Good Reason” shall have the meaning set forth in the written employment, offer, services or severance agreement or letter between the Participant and the Company or an Affiliate, or, if there is no such agreement or no such term is defined in such agreement, shall mean any action taken by the Participant’s employer that results in a material negative change to the Participant’s employment relationship, such as the duties to be performed, the conditions under which such duties are to be performed (including a relocation of where services art to be performance that is over thirty 30 miles) or the total compensation to be received for performing such services. A termination of employment by the Participant shall not constitute termination for Good Reason unless the Participant shall first have delivered to the employer written notice setting forth with specificity the occurrence deemed to give rise to a right to terminate for Good Reason (which notice must be given no later than 90 days after the occurrence of such event), and there shall have passed a reasonable time (not less than 30 days) within which the employer may take action to correct, rescind or otherwise substantially reverse the occurrence supporting termination for Good Reason as identified by the Participant.
“Incentive Bonus” means a bonus opportunity awarded under Section 12 pursuant to which a Participant may become entitled to receive an amount based on satisfaction of such performance criteria established for a specified performance period as specified in the Award Agreement.
“Incentive Stock Option” means an Option that is intended to qualify as an “incentive stock option” within the meaning of Section 422 of the Code.
“Nonqualified Stock Option” means an Option that is not intended to qualify as an “incentive stock option” within the meaning of Section 422 of the Code.
“Option” means a right to purchase a number of Common Shares at such exercise price, at such times and on such other terms and conditions as are specified in or determined pursuant to an Award Agreement. Options granted pursuant to the Plan may be Incentive Stock Options or Nonqualified Stock Options.
“Other Share-Based Award” means an Award granted to an Eligible Person under Section 11.
“Participant” means any Eligible Person to whom Awards have been granted from time to time by the Committee and any authorized transferee of such individual.
“Person” shall have the meaning given in Section 3(a)(9) of the Act, as modified and used in Sections 14(d) and 15(d) thereof, except that such term shall not include (i) the Company or any of its Affiliates, (ii) a trustee or other fiduciary holding securities under an employee benefit plan of the Company or any of its Subsidiaries, (iii) an underwriter temporarily holding securities pursuant to an offering of such securities or (iv) a corporation owned, directly or indirectly, by the shareholders of the Company in substantially the same proportions as their ownership of the Company’s stock.
“Restricted Stock” means an Award or issuance of Common Share the grant, issuance, vesting and/or transferability of which is subject during specified periods of time to such conditions (including continued employment or engagement or performance conditions) and terms as the Committee deems appropriate.
“Restricted Stock Unit” means an Award denominated in units of Common Shares under which the issuance of Common Shares (or cash payment in lieu thereof) is subject to such conditions (including continued employment or engagement or performance conditions) and terms as the Committee deems appropriate.
“Separation from Service” or “Separates from Service” means a Termination of Employment that constitutes a “separation from service” within the meaning of Section 409A of the Code.
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“Stock Appreciation Right” or “SAR” means a right granted that entitles the Participant to receive, in cash or Common Shares or a combination thereof, as determined by the Committee, value equal to the excess of (i) the Fair Market Value of a specified number of Common Shares at the time of exercise over (ii) the exercise price of the right, as established by the Committee on the date of grant.
“Subsidiary” means any business association (including a corporation or a partnership, other than the Company) in an unbroken chain of such associations beginning with the Company if each of the associations other than the last association in the unbroken chain owns equity interests (including shares or partnership interests) possessing 50% or more of the total combined voting power of all classes of equity interests in one of the other associations in such chain.
“Substitute Awards” means Awards granted or Common Shares issued by the Company in assumption of, or in substitution or exchange for, awards previously granted, or the right or obligation to make future awards, by a company acquired by the Company or any Subsidiary or with which the Company or any Subsidiary combines.
“Termination of Employment” means ceasing to serve as an employee of the Company and its Subsidiaries or, with respect to a non-employee director or other service provider, ceasing to serve as such for the Company and its Subsidiaries, except that with respect to all or any Awards held by a Participant (i) the Committee may determine that a leave of absence or employment on a less than full-time basis is considered a “Termination of Employment,” (ii) the Committee may determine that a transition from employment to service with a partnership, joint venture or corporation not meeting the requirements of a Subsidiary in which the Company or a Subsidiary is a party is not considered a “Termination of Employment,” (iii) service as a member of the Board (or another capacity as a service provider) shall constitute continued employment with respect to Awards granted to a Participant while he or she served as an employee, (iv) service as an employee of the Company or a Subsidiary shall constitute continued employment with respect to Awards granted to a Participant while he or she served as a member of the Board or other service provider, and (v) the Committee may determine that a transition from employment with the Company or a Subsidiary to service to the Company or a Subsidiary other than as an employee shall constitute a “Termination of Employment”. The Committee shall determine whether any corporate transaction, such as a sale or spin-off of a division or Subsidiary that employs or engages a Participant, shall be deemed to result in a Termination of Employment with the Company and its Subsidiaries for purposes of any affected Participant’s Awards, and the Committee’s decision shall be final and binding.
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3. Eligibility
Any Eligible Person is eligible for selection by the Committee to receive an Award.
4. Effective Date and Termination of Plan
This Plan became effective on [_____] (the “Effective Date”). The Plan shall remain available for the grant of Awards until the 10th anniversary of the Effective Date. Notwithstanding the foregoing, the Plan may be terminated at such earlier time as the Board may determine. Termination of the Plan will not affect the rights and obligations of the Participants and the Company arising under Awards theretofore granted.
5. Shares Subject to the Plan and to Awards
(a) Aggregate Limits. The maximum aggregate number of Common Shares issuable under the Plan shall be equal to [______]1. The reserved number of Common Shares will increase on January 1st of each calendar year beginning on January 1, 2024 and ending on and including January 1, 2029 (each, an “Evergreen Date”), in an amount equal to the lesser of (i) 5.0% of the total number of Common Shares outstanding on the December 31st immediately preceding the applicable Evergreen Date, (ii) [____]2 Common Shares or (iii) such lesser number of shares of Common Stock as determined to be appropriate by the Committee in its sole discretion.
(b) Adjustment of Share Pool. The aggregate number of Common Shares available for grant under this Plan and the number of Common Shares subject to Awards outstanding at the time of any event described in Section 16 shall be subject to adjustment as provided in Section 16. The Common Shares issued pursuant to Awards granted under this Plan may be shares that are authorized and unissued or shares that were reacquired by the Company, including shares purchased in the open market.
(c) Issuance of Shares. For purposes of Section 5(a), the aggregate number of Common Shares issued under this Plan at any time shall equal only the number of Common Shares actually issued upon exercise or settlement of an Award. Common Shares subject to Awards that have been canceled, expired, forfeited or otherwise not issued under an Award and Common Shares subject to Awards settled in cash shall not count as Common Shares issued under this Plan. The aggregate number of shares available for issuance under this Plan at any time shall not be reduced by (i) shares subject to Awards that have been terminated, expired unexercised, forfeited or settled in cash, (ii) shares subject to Awards that have been retained or withheld by the Company in payment or satisfaction of the exercise price, purchase price or tax withholding obligation of an Award, or (iii) shares subject to Awards that otherwise do not result in the issuance of shares in connection with payment or settlement thereof. In addition, shares that have been delivered (either actually or by attestation) to the Company in payment or satisfaction of the exercise price, purchase price or tax withholding obligation of an Award shall be available for issuance under this Plan.
(d) Substitute Awards. Substitute Awards shall not reduce the Common Shares authorized for issuance under the Plan or authorized for grant to a Participant in any calendar year. Additionally, in the event that a company acquired by the Company or any Subsidiary, or with which the Company or any Subsidiary combines, has shares available under a pre-existing plan approved by shareholders and not adopted in contemplation of such acquisition or combination, the shares available for grant pursuant to the terms of such pre-existing plan (as adjusted, to the extent appropriate, using the exchange ratio or other adjustment or valuation ratio or formula used in such acquisition or combination to determine the consideration payable to the holders of Common Share of the entities party to such acquisition or combination) may be used for Awards under the Plan and shall not reduce the Common Shares authorized for issuance under the Plan; provided that, Awards using such available shares (i) shall not be made after the date awards or grants could have been made under the terms of the pre-existing plan, absent the acquisition or combination, (ii) shall only be made to individuals who were employees of such acquired or combined company before such acquisition or combination, and (iii) shall comply with the requirements of any stock exchange or market or quotation system on which the Common Share is traded, listed or quoted.
1 This number will be 10% of the SPAC Class A Shares (as defined in the BCA) outstanding on a fully diluted basis immediately following the effectiveness of the Merger (as defined in the BCA).
2 This number will be two times the number in footnote 1.
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(e) Tax Code Limits. The aggregate number of Common Shares that may be issued pursuant to the exercise of Incentive Stock Options granted under this Plan shall be equal to [_______], which number shall be calculated and adjusted pursuant to Section 16 only to the extent that such calculation or adjustment will not affect the status of any Option intended to qualify as an Incentive Stock Option under Section 422 of the Code.
(f) Limits on Non-Employee Director Compensation. The aggregate dollar value of equity-based (based on the grant date Fair Market Value of equity-based Awards) and cash compensation granted under this Plan or otherwise during any calendar year to any non-employee director shall not exceed $750,000; provided, however, that (i) in the calendar year in which a non-employee director first joins the Board, the maximum aggregate dollar value of equity-based and cash compensation granted to the non-employee director may be up to $1,000,000, (ii) effective as of the closing of the merger of Zura Bio Limited with JATT Acquisition Corp (the “Closing”), the Chair of the Board shall receive a special one-time grant of 500,000 time-based restricted stock units and 250,000 performance-based restricted stock units, and (iii) the Chair of the Board in place as of the Closing shall receive $25,000 per month for so long as he is providing expanded responsibilities in such capacity, as agreed to in writing by the Company, and after completion of such responsibilities, annual retainers that are in no event more than $200,000 per calendar year.
6. Administration of the Plan
(a) Administrator of the Plan. The Plan shall be administered by the Committee. Any power of the Committee may also be exercised by the Board, except to the extent that the grant or exercise of such authority would cause any Award or transaction to become subject to (or lose an exemption under) the short-swing profit recovery provisions of Section 16 of the Act. To the extent that any permitted action taken by the Board conflicts with action taken by the Committee, the Board action shall control. To the maximum extent permissible under applicable law, the Committee (or any successor) may by resolution delegate any or all of its authority to one or more subcommittees composed of one or more directors and/or officers of the Company, and any such subcommittee shall be treated as the Committee for all purposes under this Plan. Notwithstanding the foregoing, if the Board or the Committee (or any successor) delegates to a subcommittee the authority to grant Awards, the resolution so authorizing such subcommittee shall specify the total number of Common Shares such subcommittee may award pursuant to such delegated authority, and no such subcommittee shall designate any officer serving thereon or any officer (within the meaning of Section 16 of the Act) or non-employee director of the Company as a recipient of any Awards granted under such delegated authority. The Committee may further designate and delegate to one or more additional officers or employees of the Company or any Subsidiary, and/or one or more agents, authority to assist the Committee in any or all aspects of the day-to-day administration of the Plan and/or of Awards granted under the Plan.
(b) Powers of Committee. Subject to the express provisions of this Plan, the Committee shall be authorized and empowered to do all things that it determines to be necessary or appropriate in connection with the administration of this Plan, including:
(i) to prescribe, amend and rescind rules and regulations relating to this Plan and to define terms not otherwise defined herein;
(ii) to determine which Persons are Eligible Persons, to which of such Eligible Persons, if any, Awards shall be granted hereunder and the timing of any such Awards;
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(iii) to prescribe and amend the terms of the Award Agreements, to grant Awards and determine the terms and conditions thereof;
(iv) to establish and verify the extent of satisfaction of any performance goals or other conditions applicable to the grant, issuance, retention, vesting, exercisability or settlement of any Award;
(v) to prescribe and amend the terms of or form of any document or notice required to be delivered to the Company by Participants under this Plan;
(vi) to determine the extent to which adjustments are required pursuant to Section 16;
(vii) to interpret and construe this Plan, any rules and regulations under this Plan and the terms and conditions of any Award granted hereunder, and to make exceptions to any such provisions if the Committee, in good faith, determines that it is appropriate to do so;
(viii) to approve corrections in the documentation or administration of any Award;
(ix) to make all other determinations deemed necessary or advisable for the administration of this Plan; and
(x) to adopt such procedures and sub-plans as are necessary or appropriate (A) to permit or facilitate participation in this Plan by persons eligible to receive Awards under this Plan who are not citizens of or subject to taxation by, or who are employed outside, the United States or (B) to allow Awards to qualify for special tax treatment in a jurisdiction other than the United States. Committee approval will not be necessary for immaterial modifications to this Plan or any Award Agreement that are required for compliance with the laws of the relevant jurisdiction.
Notwithstanding anything in this Plan to the contrary, the Committee shall exercise its discretion in a manner that causes Awards to be compliant with or exempt from the requirements of Section 409A of the Code. Without limiting the foregoing, unless expressly agreed to in writing by the Participant holding an Award that is “deferred compensation” under Section 409A of the Code, the Committee shall not take any action with respect to any Award which constitutes (x) a modification of a stock right within the meaning of Treas. Reg. § 1.409A-1(b)(5)(v)(B) so as to constitute the grant of a new stock right, (y) an extension of a stock right, including the addition of a feature for the deferral of compensation within the meaning of Treas. Reg. § 1.409A-1 (b)(5)(v)(C), or (z) an impermissible acceleration of a payment date or a subsequent deferral of a stock right subject to Section 409A of the Code within the meaning of Treas. Reg. § 1.409A-1(b)(5)(v)(E).
The Committee may, in its sole and absolute discretion, without amendment to the Plan but subject to the limitations otherwise set forth in Section 20, waive or amend the operation of Plan provisions respecting exercise after Termination of Employment. The Committee or any member thereof may, in its sole and absolute discretion, except as otherwise provided in Section 20, waive, settle or adjust any of the terms of any Award so as to avoid unanticipated consequences or address unanticipated events (including any temporary closure of an applicable stock exchange, disruption of communications or natural catastrophe).
(c) Determinations by the Committee. All decisions, determinations and interpretations by the Committee regarding the Plan, any rules and regulations under the Plan and the terms and conditions of, or operation of, any Award granted hereunder, shall be final and binding on all Participants, beneficiaries, heirs, assigns or other persons holding or claiming rights under the Plan or any Award. The Committee shall consider such factors as it deems relevant, in its sole and absolute discretion, to making such decisions, determinations and interpretations, including the recommendations or advice of any officer or other employee of the Company and such attorneys, consultants and accountants as it may select. Members of the Board and members of the Committee acting under the Plan shall be fully protected in relying in good faith upon the advice of counsel and shall incur no liability except for as a result of gross negligence or willful misconduct in the performance of their duties.
(d) Subsidiary Awards. In the case of a grant of an Award to any Participant employed by a Subsidiary, such grant may, if the Committee so directs, be implemented by the Company issuing any subject Common Shares to the Subsidiary, for such lawful consideration as the Committee may determine, upon the condition or understanding that the Subsidiary will transfer the Common Shares to the Participant in accordance with the terms of the Award specified by the Committee pursuant to the provisions of the Plan. Notwithstanding any other provision hereof, such Award may be issued by and in the name of the Subsidiary and shall be deemed granted on such date as the Committee shall determine.
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7. Plan Awards
(a) Terms Set Forth in Award Agreement. Awards may be granted to Eligible Persons as determined by the Committee at any time and from time to time prior to the termination of the Plan. The terms and conditions of each Award shall be set forth in an Award Agreement in a form approved by the Committee for such Award, which Award Agreement may contain such terms and conditions as specified from time to time by the Committee, provided such terms and conditions do not conflict with the Plan. The Award Agreement for any Award (other than Restricted Stock Awards) shall include the time or times at or within which and the consideration, if any, for which any Common Shares or cash, as applicable, may be acquired from the Company. The terms of Awards may vary among Participants, and the Plan does not impose upon the Committee any requirement to make Awards subject to uniform terms. Accordingly, the terms of individual Award Agreements may vary.
(b) Termination of Employment. Subject to the express provisions of the Plan, the Committee shall specify before, at, or after the time of grant of an Award the provisions governing the effect(s) upon an Award of a Participant’s Termination of Employment.
(c) Rights of a Shareholder. A Participant shall have no rights as a shareholder with respect to Common Shares covered by an Award (including voting rights) until the date the Participant becomes the holder of record of such Common Shares. No adjustment shall be made for dividends or other rights for which the record date is prior to such date, except as provided in Sections 10(b), 11(b) or 16 of this Plan or as otherwise provided by the Committee.
8. Options
(a) Grant, Term and Price. The grant, issuance, retention, vesting and/or settlement of any Option shall occur at such time and be subject to such terms and conditions as determined by the Committee or under criteria established by the Committee, which may include conditions based on continued employment or engagement, passage of time, attainment of age and/or service requirements, and/or satisfaction of performance conditions. The term of an Option shall in no event be greater than 10 years; provided, however, the term of an Option (other than an Incentive Stock Option) shall be automatically extended if, at the time of its scheduled expiration, the Participant holding such Option is prohibited by law or the Company’s insider trading policy from exercising the Option, which extension shall expire on the 30th day following the date such prohibition no longer applies. The Committee will establish the price at which Common Shares may be purchased upon exercise of an Option, which in no event will be less than the Fair Market Value of such shares on the date of grant; provided, however, that the exercise price per Common Share with respect to an Option that is granted as a Substitute Award may be less than the Fair Market Value of the Common Shares on the date such Option is granted if such exercise price is based on a formula set forth in the terms of the options held by such optionees or in the terms of the agreement providing for such merger or other acquisition that satisfies the requirements of (i) Section 409A of the Code, if such options held by such optionees are not intended to qualify as “incentive stock options” within the meaning of Section 422 of the Code, and (ii) Section 424(a) of the Code, if such options held by such optionees are intended to qualify as “incentive stock options” within the meaning of Section 422 of the Code. The exercise price of any Option may be paid in cash or such other method as determined by the Committee, including an irrevocable commitment by a broker to pay over such amount from a sale of the Common Shares issuable under an Option, the delivery of previously owned Common Shares or withholding of Common Shares deliverable upon exercise.
(b) Repricing. Other than in connection with a change in the Company’s capitalization (as described in Section 16) or within the first twenty-four months after the Effective Date, the Committee shall not, without shareholder approval, reduce the exercise price of a previously awarded Option, provided, however, that at any time when the exercise price of an Option previously awarded at least two years ago is at least 100% greater than the Fair Market Value of a Common Share over a period of 90 trading days, the Committee may, in its sole discretion and without shareholder approval, cancel and re-grant or exchange such Option for cash or a new Award with a lower (or no) exercise price.
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(c) No Reload Grants. Options shall not be granted under the Plan in consideration for, and shall not be conditioned upon the delivery of, Common Shares to the Company in payment of the exercise price and/or tax withholding obligation under any other employee stock option.
(d) Incentive Stock Options. Notwithstanding anything to the contrary in this Section 8, in the case of the grant of an Incentive Stock Option, if the Participant owns shares possessing more than 10% of the combined voting power of all classes of shares of the Company, the exercise price of such Option must be at least 110% of the Fair Market Value of the Common Shares on the date of grant and the Option must expire within a period of not more than five years from the date of grant. Notwithstanding anything in this Section 8 to the contrary, Options designated as Incentive Stock Options shall not be eligible for treatment under the Code as Incentive Stock Options (and will be deemed to be Nonqualified Stock Options) to the extent that either (i) the aggregate Fair Market Value of the Common Shares (determined as of the time of grant) with respect to which such Options are exercisable for the first time by the Participant during any calendar year (under all plans of the Company and any Subsidiary) exceeds $100,000, taking Options into account in the order in which they were granted, or (ii) such Options otherwise remain exercisable but are not exercised within three months (or such other period of time provided in Section 422 of the Code) of separation of service (as determined in accordance with Section 3401(c) of the Code and the regulations promulgated thereunder).
(e) No Shareholder Rights. Participants shall have no voting rights and will have no rights to receive dividends or Dividend Equivalents in respect of an Option or any Common Shares subject to an Option until the Participant has become the holder of record of such shares.
9. Stock Appreciation Rights
(a) General Terms. The grant, issuance, retention, vesting and/or settlement of any Stock Appreciation Right shall occur at such time and be subject to such terms and conditions as determined by the Committee or under criteria established by the Committee, which may include conditions based on continued employment or engagement, passage of time, attainment of age and/or service requirements, and/or satisfaction of performance conditions. Stock Appreciation Rights may be granted to Participants from time to time either in tandem with or as a component of Options granted under the Plan (“tandem SARs”) or not in conjunction with other Awards (“freestanding SARs”). Upon exercise of a tandem SAR as to some or all of the shares covered by the grant, the related Option shall be canceled automatically to the extent of the number of shares covered by such exercise. Conversely, if the related Option is exercised as to some or all of the shares covered by the grant, the related tandem SAR, if any, shall be canceled automatically to the extent of the number of shares covered by the Option exercise. Any Stock Appreciation Right granted in tandem with an Option may be granted at the same time such Option is granted or at any time thereafter before exercise or expiration of such Option, provided that the Fair Market Value of Common Share on the date of the SAR’s grant is not greater than the exercise price of the related Option. All freestanding SARs shall be granted subject to the same terms and conditions applicable to Options as set forth in Section 8 and all tandem SARs shall have the same exercise price as the Option to which they relate. Subject to the provisions of Section 8 and the immediately preceding sentence, the Committee may impose such other conditions or restrictions on any Stock Appreciation Right as it shall deem appropriate. Stock Appreciation Rights may be settled in Common Share, cash, Restricted Stock or a combination thereof, as determined by the Committee and set forth in the applicable Award Agreement.
(b) No Repricing without Shareholder Approval. Other than in connection with a change in the Company’s capitalization (as described in Section 16) or within the first twenty-four months after the Effective Date, the Committee shall not, without shareholder approval, reduce the exercise price of a previously awarded Stock Appreciation Right, and at any time when the exercise price of a previously awarded Stock Appreciation Right is above the Fair Market Value of a Common Share, the Committee shall not, without shareholder approval, cancel and re-grant or exchange such Stock Appreciation Right for cash or a new Award with a lower (or no) exercise price.
(c) No Shareholder Rights. Participants shall have no voting rights and will have no rights to receive dividends or Dividend Equivalents in respect of an Award of Stock Appreciation Rights or any Common Shares subject to an Award of Stock Appreciation Rights until the Participant has become the holder of record of such shares.
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10. Restricted Stock and Restricted Stock Units
(a) Vesting and Performance Criteria. The grant, issuance, vesting and/or settlement of any Award of Restricted Stock or Restricted Stock Units shall occur at such time and be subject to such terms and conditions as determined by the Committee or under criteria established by the Committee, which may include conditions based on continued employment or engagement, passage of time, attainment of age and/or service requirements, and/or satisfaction of performance conditions. In addition, the Committee shall have the right to grant Restricted Stock or Restricted Stock Unit Awards as the form of payment for grants or rights earned or due under other shareholder-approved compensation plans or arrangements of the Company.
(b) Dividends and Distributions. Participants in whose name Restricted Stock is granted shall be entitled to receive all dividends and other distributions paid with respect to those Common Shares, unless determined otherwise by the Committee. The Committee will determine whether any such dividends or distributions will be automatically reinvested in additional shares of Restricted Stock and/or subject to the same restrictions on transferability as the Restricted Stock with respect to which they were distributed or whether such dividends or distributions will be paid in cash. Shares underlying Restricted Stock Units shall be entitled to dividends or distributions only to the extent provided by the Committee. Notwithstanding anything herein to the contrary, in no event will dividends or Dividend Equivalents be paid during the performance period with respect to unearned Awards of Restricted Stock or Restricted Stock Units that are subject to performance-based vesting criteria. Dividends or Dividend Equivalents accrued on such shares shall become payable no earlier than the date the performance-based vesting criteria have been achieved and the underlying shares or Restricted Stock Units have been earned.
11. Other Share-Based Awards
(a) General Terms. The Committee is authorized, subject to limitations under applicable law, to grant to Eligible Persons such other Awards that may be denominated or payable in, valued in whole or in part by reference to, or otherwise based on, or related to, Common Shares, as deemed by the Committee to be consistent with the purposes of the Plan. The Committee shall determine the terms and conditions of such Other Share-Based Awards. Common Shares delivered pursuant to an Other Share-Based Award in the nature of a purchase right granted under this Section 11 shall be purchased for such consideration, paid for at such times, by such methods, and in such forms, including cash, Common Shares, other Awards, or other property, as the Committee shall determine.
(b) Dividends and Distributions. Shares underlying Other Share-Based Awards shall be entitled to dividends or distributions only to the extent provided by the Committee. Notwithstanding anything herein to the contrary, in no event will Dividend Equivalents be paid during the performance period with respect to unearned Other Share-Based Awards that are subject to performance-based vesting criteria. Dividend Equivalents accrued on such shares shall become payable no earlier than the date the performance-based vesting criteria have been achieved and the shares underlying the Other Share-Based Award have been earned.
12. Incentive Bonuses
(a) Performance Criteria. The Committee shall establish the performance criteria and level of achievement versus such criteria that shall determine the amount payable under an Incentive Bonus, which may include a target, threshold and/or maximum amount payable and any formula for determining such achievement, and which criteria may be based on performance conditions.
(b) Timing and Form of Payment. The Committee shall determine the timing of payment of any Incentive Bonus. Payment of the amount due under an Incentive Bonus may be made in cash or in Common Share, as determined by the Committee.
(c) Discretionary Adjustments. Notwithstanding satisfaction of any performance goals and, the amount paid under an Incentive Bonus on account of either financial performance or personal performance evaluations may be adjusted by the Committee on the basis of such further considerations as the Committee shall determine.
13. Performance Awards
The Committee may establish performance criteria and level of achievement versus such criteria that shall determine the number of Common Shares, Restricted Stock Units, or cash to be granted, retained, vested, issued or issuable under or in settlement of or the amount payable pursuant to an Award (any such Award, a “Performance Award”). A Performance Award may be identified as “Performance Share,” “Performance Equity,” “Performance Unit” or other such term as chosen by the Committee.
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14. Section 457A
To the extent that any Award is determined to constitute “nonqualified deferred compensation” from a nonqualified entity within the meaning of Section 457A (a “457A Award”), the Award shall be subject to such additional rules and requirements as may be specified by the Committee from time to time. It is intended that any such 457A Award will either be in full compliance with or be exempt from Section 457A of the Code. The Company makes no representation or warranty and shall have no liability to any Participant under the Plan or any other Person with respect to any penalties or taxes under Section 457A that are, or may be, imposed with respect to any Award.
15. Conditions and Restrictions Upon Securities Subject to Awards
The Committee may provide that the Common Shares issued upon exercise of an Option or Stock Appreciation Right or otherwise subject to or issued under an Award shall be subject to such further agreements, restrictions, conditions or limitations as the Committee in its discretion may specify prior to the exercise of such Option or Stock Appreciation Right or the grant, vesting or settlement of such Award, including conditions on vesting or transferability, forfeiture or repurchase provisions and method of payment for the Common Shares issued upon exercise, vesting or settlement of such Award (including the actual or constructive surrender of Common Shares already owned by the Participant) or payment of taxes arising in connection with an Award. Without limiting the foregoing, such restrictions may address the timing and manner of any resales by the Participant or other subsequent transfers by the Participant of any Common Shares issued under an Award, including (a) restrictions under an insider trading policy or pursuant to applicable law, (b) restrictions designed to delay and/or coordinate the timing and manner of sales by the Participant and holders of other Company equity compensation arrangements, (c) restrictions as to the use of a specified brokerage firm for such resales or other transfers and (d) provisions requiring Common Shares be sold on the open market or to the Company in order to satisfy tax withholding or other obligations.
16. Adjustment of and Changes in the Shares
(a) The number and kind of Common Shares available for issuance under this Plan (including under any Awards then outstanding), and the number and kind of Common Shares subject to the limits set forth in Section 5, shall be equitably adjusted by the Committee to reflect any reorganization, reclassification, combination of shares, share split, reverse share split, spin-off, extraordinary dividend or distribution of securities, property or cash (and not regular, quarterly cash dividends), or any other event or transaction that affects the number or kind of Common Shares outstanding. Such adjustment may be designed to comply with Section 424 of the Code or may be designed to treat the Common Shares available under the Plan and subject to Awards as if they were all outstanding on the record date for such event or transaction or to increase the number of such Common Shares to reflect a deemed reinvestment in Common Shares of the amount distributed to the Company’s securityholders. The terms of any outstanding Award shall also be equitably adjusted by the Committee as to price, number or kind of Common Shares subject to such Award, vesting, and other terms to reflect the foregoing events, which adjustments need not be uniform as between different Awards or different types of Awards. No fractional Common Shares shall be issued or issuable pursuant to such an adjustment.
(b) In the event there shall be any other change in the number or kind of outstanding Common Shares, or any shares or other securities into which such Common Shares shall have been changed, or for which it shall have been exchanged, by reason of a Change in Control, other merger, consolidation or otherwise, then the Committee shall determine the appropriate and equitable adjustment to be effected, which adjustments need not be uniform between different Awards or different types of Awards. In addition, in the event of such change described in this paragraph, the Committee may accelerate the time or times at which any Award may be exercised, consistent with and as otherwise permitted under Section 409A of the Code and may provide for cancellation of such accelerated Awards that are not exercised within a time prescribed by the Committee in its sole discretion.
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(c) Unless otherwise expressly provided in the Award Agreement or another contract, including an employment, offer, services or severance agreement or letter, or under the terms of a transaction constituting a Change in Control, the Committee shall provide that any or all of the following shall occur upon a Participant’s Termination of Employment by the Company without Cause or by the Participant for Good Reason within twenty-four (24) months following a Change in Control: (i) in the case of an Option or Stock Appreciation Right, the Participant shall have the ability to exercise any portion of the Option or Stock Appreciation Right not previously exercisable, (ii) in the case of any Award the vesting of which is in whole or in part subject to performance criteria or an Incentive Bonus, all conditions to the grant, issuance, retention, vesting or transferability of, or any other restrictions applicable to, such Award shall immediately lapse and the Participant shall have the right to receive a payment based on target level achievement or actual performance through a date determined by the Committee, and (iii) in the case of outstanding Restricted Stock, Restricted Stock Units or Other Share-Based Awards (other than those referenced in subsection (ii)), all conditions to the grant, issuance, retention, vesting or transferability of, or any other restrictions applicable to, such Award shall immediately lapse. Notwithstanding anything herein to the contrary, in the event of a Change in Control in which the acquiring or surviving company in the transaction does not assume or continue outstanding Awards or issue substitute awards upon the Change in Control, immediately prior to the Change in Control, all Awards that are not assumed, continued or substituted for shall be treated as follows effective immediately prior to the Change in Control: (A) in the case of an Option or Stock Appreciation Right, the Participant shall have the ability to exercise such Option or Stock Appreciation Right, including any portion of the Option or Stock Appreciation Right not previously exercisable, (B) in the case of any Award the vesting of which is in whole or in part subject to performance criteria or an Incentive Bonus, all conditions to the grant, issuance, retention, vesting or transferability of, or any other restrictions applicable to, such Award shall immediately lapse and the Participant shall have the right to receive a payment based on target level achievement or actual performance through a date determined by the Committee, as determined by the Committee, and (C) in the case of outstanding Restricted Stock, Restricted Stock Units or Other Share-Based Awards (other than those referenced in subsection (B)), all conditions to the grant, issuance, retention, vesting or transferability of, or any other restrictions applicable to, such Award shall immediately lapse. In no event shall any action be taken pursuant to this Section 16(c) that would change the payment or settlement date of an Award in a manner that would result in the imposition of any additional taxes or penalties pursuant to Section 409A of the Code.
(d) Notwithstanding anything in this Section 16 to the contrary, in the event of a Change in Control, the Committee may provide for the cancellation and cash settlement of all outstanding Awards upon such Change in Control.
(e) Notwithstanding anything in this Section 16 to the contrary, an adjustment to an Option or Stock Appreciation Right under this Section 16 shall be made in a manner that will not result in the grant of a new Option or Stock Appreciation Right under Section 409A of the Code.
17. Transferability
Each Award may not be sold, transferred for value, pledged, assigned, or otherwise alienated or hypothecated by a Participant other than by will or the laws of descent and distribution, and each Option or Stock Appreciation Right shall be exercisable only by the Participant during his or her lifetime. Notwithstanding the foregoing, (a) outstanding Options may be exercised following the Participant’s death by the Participant’s beneficiaries or as permitted by the Committee and (b) a Participant may transfer or assign an Award as a gift to an entity wholly owned by such Participant (an “Assignee Entity”), provided that such Assignee Entity shall be entitled to exercise assigned Options and Stock Appreciation Rights only during the lifetime of the assigning Participant (or following the assigning Participant’s death, by the Participant’s beneficiaries or as otherwise permitted by the Committee) and provided further that such Assignee Entity shall not further sell, pledge, transfer, assign or otherwise alienate or hypothecate such Award.
18. Compliance with Laws and Regulations
(a) This Plan, the grant, issuance, vesting, exercise and settlement of Awards hereunder, and the obligation of the Company to sell, issue or deliver Common Shares under such Awards, shall be subject to all applicable foreign, federal, state and local laws, rules and regulations, stock exchange rules and regulations, and to such approvals by any governmental or regulatory agency as may be required. The Company shall not be required to register in a Participant’s name or deliver Common Shares prior to the completion of any registration or qualification of such shares under any foreign, federal, state or local law or any ruling or regulation of any government body which the Committee shall determine to be necessary or advisable. To the extent the Company is unable to or the Committee deems it infeasible to obtain authority from any regulatory body having jurisdiction, which authority is deemed by the Company’s counsel to be necessary to the lawful issuance and sale of any Common Shares hereunder, the Company and its Subsidiaries shall be relieved of any liability with respect to the failure to issue or sell such Common Shares as to which such requisite authority shall not have been obtained. No Option shall be exercisable and no Common Share shall be issued and/or transferable under any other Award unless a registration statement with respect to the Common Share underlying such Option is effective and current or the Company has determined, in its sole and absolute discretion, that such registration is unnecessary.
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(b) In the event an Award is granted to or held by a Participant who is employed or providing services outside the United States, the Committee may, in its sole discretion, modify the provisions of the Plan or of such Award as they pertain to such individual to comply with applicable foreign law or to recognize differences in local law, currency or tax policy. The Committee may also impose conditions on the grant, issuance, exercise, vesting, settlement or retention of Awards in order to comply with such foreign law and/or to minimize the Company’s obligations with respect to tax equalization for Participants employed outside their home country.
19. Withholding
To the extent required by applicable federal, state, local or foreign law, the Committee may, and/or a Participant shall, make arrangements satisfactory to the Company for the satisfaction of any withholding tax obligations that arise with respect to any Award or the issuance or sale of any Common Shares. The Company shall not be required to recognize any Participant rights under an Award, to issue Common Shares or to recognize the disposition of such Common Shares until such obligations are satisfied. To the extent permitted or required by the Committee, these obligations may or shall be satisfied by the Company withholding cash from any compensation otherwise payable to or for the benefit of a Participant, the Company withholding a portion of the Common Shares that otherwise would be issued to a Participant under such Award or any other Award held by the Participant, or by the Participant tendering to the Company cash or, if allowed by the Committee, Common Shares.
20. Amendment of the Plan or Awards
The Board may amend, alter or discontinue this Plan, and the Committee may amend or alter any Award Agreement or other document evidencing an Award made under this Plan; however, except as provided pursuant to the provisions of Section 16, no such amendment shall, without the approval of the shareholders of the Company:
(a) increase the maximum number of Common Shares for which Awards may be granted under this Plan;
(b) reduce the price at which Options may be granted below the price provided for in Section 8(a);
(c) reprice outstanding Options or SARs other than under the exceptions described in Sections 8(b) and 9(b);
(d) extend the term of this Plan;
(e) change the class of Persons eligible to be Participants;
(f) increase the individual maximum limits in Section 5(e); or
(g) otherwise amend the Plan in any manner requiring shareholder approval by law or the rules of any stock exchange or market or quotation system on which the Common Share is traded, listed or quoted.
No amendment or alteration to the Plan or an Award or Award Agreement shall be made which would materially impair the rights of the holder of an Award without such holder’s consent; provided that no such consent shall be required if the Committee determines in its sole discretion and prior to the date of any Change in Control that such amendment or alteration either (i) is required or advisable in order for the Company, the Plan or the Award to satisfy any law or regulation or to meet the requirements of, or avoid adverse financial accounting consequences under, any accounting standard, or (ii) is not reasonably likely to significantly diminish the benefits provided under such Award, or that any such diminishment has been adequately compensated.
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21. No Liability of Company
The Company, any Subsidiary or Affiliate which is in existence or hereafter comes into existence, the Board and the Committee shall not be liable to a Participant or any other person as to: (a) the non-issuance or sale of Common Shares as to which the Company has been unable to obtain from any regulatory body having jurisdiction the authority deemed by the Company’s counsel to be necessary to the lawful issuance and sale of any Common Shares hereunder; and (b) any tax consequence expected, but not realized, by any Participant or other person due to the receipt, vesting, exercise or settlement of any Award granted hereunder.
22. Non-Exclusivity of Plan
Neither the adoption of this Plan by the Board nor the submission of this Plan to the shareholders of the Company for approval shall be construed as creating any limitations on the power of the Board or the Committee to adopt such other incentive arrangements as either may deem desirable, including the granting of Restricted Stock or Options otherwise than under this Plan, and such arrangements may be either generally applicable or applicable only in specific cases.
23. Governing Law
This Plan and any agreements or other documents hereunder shall be interpreted and construed in accordance with the laws of the Cayman Islands (without regard to its choice of law provisions). Any reference in this Plan or in the agreement or other document evidencing any Awards to a provision of law or to a rule or regulation shall be deemed to include any successor law, rule or regulation of similar effect or applicability.
24. No Right to Employment, Reelection or Continued Service
Nothing in this Plan or an Award Agreement shall interfere with or limit in any way the right of the Company, its Subsidiaries and/or its Affiliates to terminate any Participant’s employment, service on the Board or service at any time or for any reason not prohibited by law, nor shall this Plan or an Award itself confer upon any Participant any right to continue his or her employment or service for any specified period of time. Neither an Award nor any benefits arising under this Plan shall constitute an employment contract with the Company, any Subsidiary and/or its Affiliates. Subject to Sections 4 and 20, this Plan and the benefits hereunder may be terminated at any time in the sole and exclusive discretion of the Board without giving rise to any liability on the part of the Company, its Subsidiaries and/or its Affiliates.
25. Specified Employee Delay
To the extent any payment under this Plan is considered deferred compensation subject to the restrictions contained in Section 409A of the Code, such payment may not be made to a specified employee (as determined in accordance with a uniform policy adopted by the Company with respect to all arrangements subject to Section 409A of the Code) upon Separation from Service before the date that is six months after the specified employee’s Separation form Service (or, if earlier, the specified employee’s death). Any payment that would otherwise be made during this period of delay shall be accumulated and paid on the sixth month plus one day following the specified employee’s Separation from Service (or, if earlier, as soon as administratively practicable after the specified employee’s death).
26. No Liability of Committee Members
No member of the Committee shall be personally liable by reason of any contract or other instrument executed by such member or on his or her behalf in his or her capacity as a member of the Committee nor for any mistake of judgment made in good faith, and the Company shall indemnify and hold harmless each member of the Committee and each other employee, officer or director of the Company to whom any duty or power relating to the administration or interpretation of the Plan may be allocated or delegated, against any cost or expense (including counsel fees) or liability (including any sum paid in settlement of a claim) arising out of any act or omission to act in connection with the Plan, unless arising out of such Person’s own fraud or willful bad faith; provided, however, that approval of the Board shall be required for the payment of any amount in settlement of a claim against any such Person. The foregoing right of indemnification shall not be exclusive of any other rights of indemnification to which such Persons may be entitled under the Company’s Certificate of Incorporation and Bylaws (as each may be amended from time to time), as a matter of law, or otherwise, or any power that the Company may have to indemnify them or hold them harmless.
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27. Severability
If any provision of the Plan or any Award is or becomes or is deemed to be invalid, illegal, or unenforceable in any jurisdiction or as to any Person or Award, or would disqualify the Plan or any Award under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to the applicable laws, or if it cannot be construed or deemed amended without, in the determination of the Committee, materially altering the intent of the Plan or the Award, such provision shall be stricken as to such jurisdiction, Person or Award, and the remainder of the Plan and any such Award shall remain in full force and effect.
28. Unfunded Plan
The Plan is intended to be an unfunded plan. Participants are and shall at all times be general creditors of the Company with respect to their Awards. If the Committee or the Company chooses to set aside funds in a trust or otherwise for the payment of Awards under the Plan, such funds shall at all times be subject to the claims of the creditors of the Company in the event of its bankruptcy or insolvency.
29. Clawback/Recoupment
Awards granted under this Plan will be subject to recoupment in accordance with any clawback policy that the Company adopts or is required to adopt pursuant to the listing standards of any national securities exchange or association on which the Company’s securities are listed or as is otherwise required by the Dodd-Frank Wall Street Reform and Consumer Protection Act or other applicable law. In addition, the Committee may impose such other clawback, recovery or recoupment provisions in an Award Agreement as the Committee determines necessary or appropriate, including a reacquisition right in respect of previously acquired Common Shares or other cash or property upon the occurrence of misconduct. No recovery of compensation under such a clawback policy will be an event giving rise to a right to resign for Good Reason or otherwise be deemed to be a form of “constructive termination” (or any similar term) as such terms are used in any agreement between any Participant and the Company.
30. Failure to Accept Award. If a Participant has not accepted an Award to the extent such acceptance has been requested or required by the Company or has not taken all administrative and other steps (e.g., setting up an account with a broker designated by the Company) necessary for the Company to issue Common Shares upon the vesting, exercise, or settlement of the Award prior to the first date the Common Shares subject to such Award are scheduled to vest, then the portion of the Award scheduled to vest on such date will be cancelled on such date and such Shares subject to the Award immediately will revert to the Plan for no additional consideration unless otherwise provided by the Administrator.
31. Interpretation
Headings are given to the Sections and subsections of the Plan solely as a convenience to facilitate reference and shall not be deemed in any way material or relevant to the construction or interpretation of the Plan or any provision thereof. Words in the masculine gender shall include the feminine gender, and where appropriate, the plural shall include the singular and the singular shall include the plural. The use herein of the word “including” following any general statement, term or matter shall not be construed to limit such statement, term or matter to the specific items or matters set forth immediately following such word or to similar items or matters, whether or not non-limiting language (such as “without limitation”, “but not limited to”, or words of similar import) is used with reference thereto, but rather shall be deemed to refer to all other items or matters that could reasonably fall within the broadest possible scope of such general statement, term or matter. References herein to any agreement, instrument or other document means such agreement, instrument or other document as amended, supplemented and modified from time to time to the extent permitted by the provisions thereof and not prohibited by the Plan.
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Exhibit 10.12
ZURA BIO LIMITED
2023 EMPLOYEE SHARE PURCHASE PLAN
1. GENERAL; PURPOSE.
(a) The Plan provides a means by which Eligible Employees of the Company and certain Designated Companies may be given an opportunity to purchase Common Shares. The Plan permits the Company to grant a series of Purchase Rights to Eligible Employees under an “employee stock purchase plan” as such term is defined by Section 423 of the Code. In addition, the Plan permits the Company to grant a series of Purchase Rights to Eligible Employees that do not meet the requirements of an employee stock purchase plan.
(b) The Plan includes two components: a 423 Component and a Non-423 Component. The Company intends (but makes no undertaking or representation to maintain) the 423 Component to qualify as an employee stock purchase plan. The provisions of the 423 Component, accordingly, will be construed in a manner that is consistent with the requirements of Section 423 of the Code. Except as otherwise provided in the Plan or determined by the Board, the Non-423 Component will operate and be administered in the same manner as the 423 Component.
(c) The Company, by means of the Plan, seeks to retain the services of Eligible Employees, to secure and retain the services of new Employees and to provide incentives for such persons to exert maximum efforts for the success of the Company and its Related Corporations.
2. ADMINISTRATION.
(a) The Board or the Committee will administer the Plan. References herein to the Board shall be deemed to refer to the Committee except where context dictates otherwise.
(b) The Board will have the power, subject to, and within the limitations of, the express provisions of the Plan:
(i) To determine how and when Purchase Rights will be granted and the provisions of each Offering (which need not be identical).
(ii) To designate from time to time (A) which Related Corporations will be eligible to participate in the Plan as Designated 423 Corporations, (B) which Related Corporations or Affiliates will be eligible to participate in the Plan as Designated Non-423 Corporations, and (C) which Designated Companies will participate in each separate Offering (to the extent that the Company makes separate Offerings).
(iii) To construe and interpret the Plan and Purchase Rights, and to establish, amend and revoke rules and regulations for its administration. The Board, in the exercise of this power, may correct any defect, omission or inconsistency in the Plan, in a manner and to the extent it deems necessary or expedient to make the Plan fully effective.
(iv) To settle all controversies regarding the Plan and Purchase Rights granted under the Plan.
(v) To suspend or terminate the Plan at any time as provided in Section 12.
(vi) To amend the Plan at any time as provided in Section 12.
(vii) Generally, to exercise such powers and to perform such acts as it deems necessary or expedient to promote the best interests of the Company and its Related Corporations and to carry out the intent that the Plan be treated as an Employee Share Purchase Plan with respect to the 423 Component.
(viii) To adopt such rules, procedures and sub-plans as are necessary or appropriate to permit or facilitate participation in the Plan by Employees who are foreign nationals or employed or located outside the United States. Without limiting the generality of, and consistent with, the foregoing, the Board specifically is authorized to adopt rules, procedures, and sub-plans regarding, without limitation, eligibility to participate in the Plan, the definition of eligible “earnings,” handling and making of Contributions, establishment of bank or trust accounts to hold Contributions, payment of interest, conversion of local currency, obligations to pay payroll tax, determination of designation requirements, withholding procedures and handling of share issuances, any of which may vary according to applicable requirements, and which, if applicable to a Designated Non-423 Corporation, do not have to comply with the requirements of Section 423 of the Code.
(c) The Board may delegate some or all of the administration of the Plan to a Committee or Committees. If administration is delegated to a Committee, the Committee will have, in connection with the administration of the Plan, the powers theretofore possessed by the Board that have been delegated to the Committee, including the power to delegate to a subcommittee any of the administrative powers the Committee is authorized to exercise (and references in this Plan to the Board will thereafter be to the Committee or subcommittee), subject, however, to such resolutions, not inconsistent with the provisions of the Plan, as may be adopted from time to time by the Board. Further, to the extent not prohibited by Applicable Law, the Board or Committee may, from time to time, delegate some or all of its authority under the Plan to one or more officers of the Company or other persons or groups of persons as it deems necessary, appropriate or advisable under conditions or limitations that it may set at or after the time of the delegation. The Board may retain the authority to concurrently administer the Plan with the Committee and may, at any time, revest in the Board some or all of the powers previously delegated. Whether or not the Board has delegated administration of the Plan to a Committee, the Board will have the final power to determine all questions of policy and expediency that may arise in the administration of the Plan.
(d) All determinations, interpretations and constructions made by the Board in good faith will not be subject to review by any person and will be final, binding and conclusive on all persons.
3. COMMON SHARES SUBJECT TO THE PLAN.
(a) Subject to the provisions of Section 11(a) relating to Capitalization Adjustments, the maximum number of Common Shares that may be issued under the Plan will not exceed [·]1 Common Shares, plus the aggregate number of Common Shares that are added under the Zura Bio Limited 2023 Equity Incentive Plan on January 1st of each calendar year beginning on January 1, 2024 and ending on and including January 1, 2029. For the avoidance of doubt, up to the maximum number of Common Shares reserved under this Section 3(a) may be used to satisfy purchases of Common Shares under the 423 Component and any remaining portion of such maximum number of shares may be used to satisfy purchases of Common Shares under the Non-423 Component.
(b) If any Purchase Right granted under the Plan terminates without having been exercised in full, the Common Shares not purchased under such Purchase Right will again become available for issuance under the Plan.
(c) The shares purchasable under the Plan will be authorized but unissued or reacquired Common Shares, including shares repurchased by the Company on the open market.
4. GRANT OF PURCHASE RIGHTS; OFFERING.
(a) The Board may from time to time grant or provide for the grant of Purchase Rights to Eligible Employees under an Offering (consisting of one or more Purchase Periods) on an Offering Date or Offering Dates selected by the Board. Each Offering will be in such form and will contain such terms and conditions as the Board will deem appropriate, and, with respect to the 423 Component, will comply with the requirement of Section 423(b)(5) of the Code that all Employees granted Purchase Rights will have the same rights and privileges. The terms and conditions of an Offering shall be incorporated by reference into the Plan and treated as part of the Plan. The provisions of separate Offerings need not be identical, but each Offering will include (through incorporation of the provisions of this Plan by reference in the document comprising the Offering or otherwise) the period during which the Offering will be effective, which period will not exceed 27 months beginning with the Offering Date, and the substance of the provisions contained in Sections 5 through 8, inclusive.
(b) If a Participant has more than one Purchase Right outstanding under the Plan, unless he or she otherwise indicates in forms delivered to the Company or a third party designated by the Company (each, a “Company Designee”): (i) each form will apply to all of his or her Purchase Rights under the Plan, and (ii) a Purchase Right with a lower exercise price (or an earlier-granted Purchase Right, if different Purchase Rights have identical exercise prices) will be exercised to the fullest possible extent before a Purchase Right with a higher exercise price (or a later-granted Purchase Right if different Purchase Rights have identical exercise prices) will be exercised.
(c) The Board will have the discretion to structure an Offering so that if the Fair Market Value of a Common Share on the first Trading Day of a new Purchase Period within that Offering is less than or equal to the Fair Market Value of a Common Share on the Offering Date for that Offering, then (i) that Offering will terminate immediately as of that first Trading Day, and (ii) the Participants in such terminated Offering will be automatically enrolled in a new Offering beginning on the first Trading Day of such new Purchase Period.
1 | This number will be 10% of the SPAC Class A Shares (as defined in the BCA) outstanding on a fully diluted basis immediately following the effectiveness of the Merger (as defined in the BCA). |
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5. ELIGIBILITY.
(a) Purchase Rights may be granted only to Employees of the Company or, as the Board may designate in accordance with Section 2(b), to Employees of a Related Corporation or an Affiliate. Except as provided in Section 5(b) or as required by Applicable Law, an Employee will not be eligible to be granted Purchase Rights unless, on the Offering Date, the Employee has been in the employ of the Company or the Related Corporation or an Affiliate, as the case may be, for such continuous period preceding such Offering Date as the Board may require, but in no event will the required period of continuous employment be equal to or greater than one year. In addition, the Board may (unless prohibited by Applicable Law) provide that no Employee will be eligible to be granted Purchase Rights under the Plan unless, on the Offering Date, such Employee’s customary employment with the Company, the Related Corporation, or the Affiliate is more than 20 hours per week and more than five months per calendar year or such other criteria as the Board may determine consistent with Section 423 of the Code with respect to the 423 Component. The Board may also exclude from participation in the Plan or any Offering Employees who are “highly compensated employees” (within the meaning of Section 423(b)(4)(D) of the Code) of the Company or a Related Corporation or a subset of such highly compensated employees.
(b) The Board may provide that each person who, during the course of an Offering, first becomes an Eligible Employee will, on a date or dates specified in the Offering which coincides with the day on which such person becomes an Eligible Employee or which occurs thereafter, receive a Purchase Right under that Offering, which Purchase Right will thereafter be deemed to be a part of that Offering. Such Purchase Right will have the same characteristics as any Purchase Rights originally granted under that Offering, as described herein, except that:
(i) the date on which such Purchase Right is granted will be the “Offering Date” of such Purchase Right for all purposes, including determination of the exercise price of such Purchase Right;
(ii) the period of the Offering with respect to such Purchase Right will begin on its Offering Date and end coincident with the end of such Offering; and
(iii) the Board may provide that if such person first becomes an Eligible Employee within a specified period of time before the end of the Offering, he or she will not receive any Purchase Right under that Offering.
(c) No Employee will be eligible for the grant of any Purchase Rights under the 423 Component if, immediately after any such Purchase Rights are granted, such Employee owns shares possessing five percent or more of the total combined voting power or value of all classes of shares of the Company or of any Related Corporation. For purposes of this Section 5(c), the rules of Section 424(d) of the Code will apply in determining the share ownership of any Employee, and shares which such Employee may purchase under all outstanding Purchase Rights and options will be treated as shares owned by such Employee.
(d) As specified by Section 423(b)(8) of the Code, an Eligible Employee may be granted Purchase Rights under the 423 Component only if such Purchase Rights, together with any other rights granted under all Employee Share Purchase Plans of the Company and any Related Corporations, do not permit such Eligible Employee’s rights to purchase shares of the Company or any Related Corporation to accrue at a rate which, when aggregated, exceeds US $25,000 of Fair Market Value of such shares (determined at the time such rights are granted, and which, with respect to the Plan, will be determined as of their respective Offering Dates) for each calendar year in which such rights are outstanding at any time.
(e) Officers of the Company and any Designated Company, if they are otherwise Eligible Employees, will be eligible to participate in Offerings under the Plan. Notwithstanding the foregoing, the Board may (unless prohibited by Applicable Law) provide in an Offering that Employees who are highly compensated Employees within the meaning of Section 423(b)(4)(D) of the Code will not be eligible to participate.
(f) Notwithstanding anything in this Section 5 to the contrary, in the case of an Offering under the Non-423 Component, an Eligible Employee (or group of Eligible Employees) may be excluded from participation in the Plan or an Offering if the Board has determined, in its sole discretion, that participation of such Eligible Employee(s) is not advisable or practical for any reason.
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6. PURCHASE RIGHTS; PURCHASE PRICE.
(a) On each Offering Date, each Eligible Employee, pursuant to an Offering made under the Plan, will be granted a Purchase Right to purchase up to that number of Common Shares purchasable either with a percentage or with a maximum dollar amount, as designated by the Board, but in either case not exceeding [15%] of such Employee’s earnings (as defined by the Board in each Offering) during the period that begins on the Offering Date (or such later date as the Board determines for a particular Offering) and ends on the date stated in the Offering, which date will be no later than the end of the Offering.
(b) The Board will establish one or more Purchase Dates during an Offering on which Purchase Rights granted for that Offering will be exercised and Common Shares will be purchased in accordance with such Offering.
(c) In connection with each Offering made under the Plan, the Board shall specify a maximum number of Common Shares that may be purchased by any Participant on any Purchase Date during such Offering, and may specify (i) a maximum aggregate number of Common Shares that may be purchased by all Participants pursuant to such Offering and/or (ii) a maximum aggregate number of Common Shares that may be purchased by all Participants on any Purchase Date under the Offering. If the aggregate purchase of Common Shares issuable upon exercise of Purchase Rights granted under the Offering would exceed any such maximum aggregate number, then, in the absence of any Board action otherwise, a pro rata (based on each Participant’s accumulated Contributions) allocation of the Common Shares (rounded down to the nearest whole share) available will be made in as nearly a uniform manner as will be practicable and equitable.
(d) The purchase price of Common Shares acquired pursuant to Purchase Rights will be specified by Board prior to the commencement of an Offering and will not be less than the lesser of:
(i) an amount equal to 85% of the Fair Market Value of the Common Shares on the Offering Date; or
(ii) an amount equal to 85% of the Fair Market Value of the Common Shares on the applicable Purchase Date.
7. PARTICIPATION; WITHDRAWAL; TERMINATION.
(a) An Eligible Employee may elect to participate in an Offering and authorize payroll deductions as the means of making Contributions by completing and delivering to the Company or a Company Designee, within the time specified for the Offering, an enrollment form provided by the Company or Company Designee. The enrollment form will specify the amount of Contributions not to exceed the maximum amount specified by the Board. Each Participant’s Contributions will be credited to a bookkeeping account for such Participant under the Plan and will be deposited with the general funds of the Company except where Applicable Law requires that Contributions be deposited with a third party. If permitted in the Offering, a Participant may begin such Contributions with the first payroll occurring on or after the Offering Date (or, in the case of a payroll date that occurs after the end of the prior Offering but before the Offering Date of the next new Offering, Contributions from such payroll will be included in the new Offering). If permitted in the Offering, a Participant may thereafter reduce (including to zero) or increase his or her Contributions. If required under Applicable Law or if specifically provided in the Offering and to extent permitted by Section 423 of the Code with respect to the 423 Component, in addition to or instead of making Contributions by payroll deductions, a Participant may make Contributions through payment by cash, check or wire transfer prior to a Purchase Date.
(b) During an Offering, a Participant may cease making Contributions and withdraw from the Offering by delivering to the Company or a Company Designee a withdrawal form provided by the Company. The Company may impose a deadline before a Purchase Date for withdrawing. Upon such withdrawal, such Participant’s Purchase Right in that Offering will immediately terminate and the Company will distribute as soon as practicable to such Participant all of his or her accumulated but unused Contributions and such Participant’s Purchase Right in that Offering shall thereupon terminate. A Participant’s withdrawal from that Offering will have no effect upon his or her eligibility to participate in any other Offerings under the Plan, but such Participant will be required to deliver a new enrollment form to participate in subsequent Offerings.
(c) Unless otherwise required by Applicable Law, Purchase Rights granted pursuant to any Offering under the Plan will terminate immediately if the Participant either (i) is no longer an Employee for any reason or for no reason (subject to any post-employment participation period required by Applicable Law) or (ii) is otherwise no longer eligible to participate. The Company will distribute as soon as practicable to such individual all of his or her accumulated but unused Contributions.
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(d) Unless otherwise determined by the Board, a Participant whose employment transfers or whose employment terminates with an immediate rehire (with no break in service) by or between the Company and a Designated Company or between Designated Companies will not be treated as having terminated employment for purposes of participating in the Plan or an Offering; however, if a Participant transfers from an Offering under the 423 Component to an Offering under the Non-423 Component, the exercise of the Participant’s Purchase Right will be qualified under the 423 Component only to the extent such exercise complies with Section 423 of the Code. If a Participant transfers from an Offering under the Non-423 Component to an Offering under the 423 Component, the exercise of the Purchase Right will remain non-qualified under the Non-423 Component. The Board may establish different and additional rules governing transfers between separate Offerings within the 423 Component and between Offerings under the 423 Component and Offerings under the Non-423 Component.
(e) During a Participant’s lifetime, Purchase Rights will be exercisable only by such Participant. Purchase Rights are not transferable by a Participant, except by will, by the laws of descent and distribution, or, if permitted by the Company, by a beneficiary designation as described in Section 10.
(f) Unless otherwise specified in the Offering or as required by Applicable Law, the Company will have no obligation to pay interest on Contributions.
8. EXERCISE OF PURCHASE RIGHTS.
(a) On each Purchase Date, each Participant’s accumulated Contributions will be applied to the purchase of Common Shares, up to the maximum number of Common Shares permitted by the Plan and the applicable Offering, at the purchase price specified in the Offering. No fractional shares will be issued unless specifically provided for in the Offering.
(b) Unless otherwise provided in the Offering, if any amount of accumulated Contributions remains in a Participant’s account after the purchase of Common Shares on the final Purchase Date of an Offering, then such remaining amount will not roll over to the next Offering and will instead be distributed in full to such Participant after the final Purchase Date of such Offering without interest (unless otherwise required by Applicable Law).
(c) No Purchase Rights may be exercised to any extent unless the Common Shares to be issued upon such exercise under the Plan are covered by an effective registration statement pursuant to the Securities Act and the Plan is in material compliance with all applicable U.S. federal and state, foreign and other securities, exchange control and other laws applicable to the Plan. If on a Purchase Date the Common Shares are not so registered or the Plan is not in such compliance, no Purchase Rights will be exercised on such Purchase Date, and, subject to Section 423 of the Code with respect to the 423 Component, the Purchase Date will be delayed until the Common Shares are subject to such an effective registration statement and the Plan is in material compliance, except that the Purchase Date will in no event be more than 27 months from the Offering Date. If, on the Purchase Date, as delayed to the maximum extent permissible, the Common Shares are not registered and the Plan is not in material compliance with all Applicable Laws, as determined by the Company in its sole discretion, no Purchase Rights will be exercised and all accumulated but unused Contributions will be distributed to the Participants without interest (unless the payment of interest is otherwise required by Applicable Law).
9. COVENANTS OF THE COMPANY.
The Company will seek to obtain from each U.S. federal or state, foreign or other regulatory commission, agency or other Governmental Body having jurisdiction over the Plan such authority as may be required to grant Purchase Rights and issue and sell Common Shares thereunder unless the Company determines, in its sole discretion, that doing so is not practical or would cause the Company to incur costs that are unreasonable. If, after commercially reasonable efforts, the Company is unable to obtain the authority that counsel for the Company deems necessary for the grant of Purchase Rights or the lawful issuance and sale of Common Shares under the Plan, and at a commercially reasonable cost, the Company will be relieved from any liability for failure to grant Purchase Rights and/or to issue and sell Common Shares upon exercise of such Purchase Rights.
10. DESIGNATION OF BENEFICIARY.
(a) The Company may, but is not obligated to, permit a Participant to submit a form designating a beneficiary who will receive any Common Shares and/or Contributions from the Participant’s account under the Plan if the Participant dies before such shares and/or Contributions are delivered to the Participant. The Company may, but is not obligated to, permit the Participant to change such designation of beneficiary. Any such designation and/or change must be on a form approved by the Company.
(b) If a Participant dies, and in the absence of a valid beneficiary designation, the Company will deliver any Common Shares and/or Contributions to the executor or administrator of the estate of the Participant. If no executor or administrator has been appointed (to the knowledge of the Company), the Company, in its sole discretion, may deliver such Common Shares and/or Contributions, without interest (unless the payment of interest is otherwise required by Applicable Law), to the Participant’s spouse, dependents or relatives, or if no spouse, dependent or relative is known to the Company, then to such other person as the Company may designate.
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11. ADJUSTMENTS UPON CHANGES IN COMMON SHARES CORPORATE TRANSACTIONS.
(a) In the event of a Capitalization Adjustment, the Board will appropriately and proportionately adjust: (i) the class(es) and maximum number of securities subject to the Plan pursuant to Section 3(a), (ii) the class(es) and maximum number of securities by which the share reserve is to increase each year pursuant to Section 3(a), (iii) the class(es) and number of securities subject to, and the purchase price applicable to outstanding Offerings and Purchase Rights, and (iv) the class(es) and number of securities that are the subject of the purchase limits under each ongoing Offering. The Board will make these adjustments, and its determination will be final, binding and conclusive.
(b) In the event of a Corporate Transaction, then: (i) any surviving corporation or acquiring corporation (or the surviving or acquiring corporation’s parent company) may assume or continue outstanding Purchase Rights or may substitute similar rights (including a right to acquire the same consideration paid to the shareholders in the Corporate Transaction) for outstanding Purchase Rights, or (ii) if any surviving or acquiring corporation (or its parent company) does not assume or continue such Purchase Rights or does not substitute similar rights for such Purchase Rights, then the Participants’ accumulated Contributions will be used to purchase Common Shares (rounded down to the nearest whole share) within ten business days (or such other period specified by the Board) prior to the Corporate Transaction under the outstanding Purchase Rights, and the Purchase Rights will terminate immediately after such purchase.
12. AMENDMENT, TERMINATION OR SUSPENSION OF THE PLAN.
(a) The Board may amend the Plan at any time in any respect the Board deems necessary or advisable. However, except as provided in Section 11(a) relating to Capitalization Adjustments, shareholder approval will be required for any amendment of the Plan for which shareholder approval is required by Applicable Law.
(b) The Board may suspend or terminate the Plan at any time. No Purchase Rights may be granted under the Plan while the Plan is suspended or after it is terminated.
Any benefits, privileges, entitlements and obligations under any outstanding Purchase Rights granted before an amendment, suspension or termination of the Plan will not be materially impaired by any such amendment, suspension or termination except (i) with the consent of the person to whom such Purchase Rights were granted, (ii) as necessary to facilitate compliance with any laws, listing requirements, or governmental regulations (including, without limitation, the provisions of Section 423 of the Code and the regulations and other interpretive guidance issued thereunder relating to Employee Share Purchase Plans) including without limitation any such regulations or other guidance that may be issued or amended after the date the Plan is adopted by the Board, or (iii) as necessary to obtain or maintain favorable tax, listing, or regulatory treatment. To be clear, the Board may amend outstanding Purchase Rights without a Participant’s consent if such amendment is necessary to ensure that the Purchase Right and/or the Plan complies with the requirements of Section 423 of the Code with respect to the 423 Component or with respect to other Applicable Laws.
Notwithstanding anything in the Plan or any Offering Document to the contrary, the Board will be entitled to: (i) establish the exchange ratio applicable to amounts withheld in a currency other than U.S. dollars; (ii) permit Contributions in excess of the amount designated by a Participant in order to adjust for mistakes in the Company’s processing of properly completed Contribution elections; (iii) establish reasonable waiting and adjustment periods and/or accounting and crediting procedures to ensure that amounts applied toward the purchase of Common Shares for each Participant properly correspond with amounts withheld from the Participant’s Contributions; (iv) amend any outstanding Purchase Rights or clarify any ambiguities regarding the terms of any Offering to enable the Purchase Rights to qualify under and/or comply with Section 423 of the Code with respect to the 423 Component; and (v) establish other limitations or procedures as the Board determines in its sole discretion advisable that are consistent with the Plan. The actions of the Board pursuant to this paragraph will not be considered to alter or impair any Purchase Rights granted under an Offering as they are part of the initial terms of each Offering and the Purchase Rights granted under each Offering.
13. TAX QUALIFICATION; TAX WITHHOLDING.
(a) Although the Company may endeavor to (i) qualify a Purchase Right for special tax treatment under the laws of the United States or jurisdictions outside of the United States or (ii) avoid adverse tax treatment, the Company makes no representation to that effect and expressly disavows any covenant to maintain special or to avoid unfavorable tax treatment, notwithstanding anything to the contrary in this Plan. The Company will be unconstrained in its corporate activities without regard to the potential negative tax impact on Participants.
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(b) Each Participant will make arrangements, satisfactory to the Company and any applicable Related Corporation, to enable the Company or the Related Corporation to fulfill any withholding obligation for Tax-Related Items. Without limitation to the foregoing, in the Company’s sole discretion and subject to Applicable Law, such withholding obligation may be satisfied in whole or in part by (i) withholding from the Participant’s salary or any other cash payment due to the Participant from the Company or a Related Corporation; (ii) withholding from the proceeds of the sale of Common Shares acquired under the Plan, either through a voluntary sale or a mandatory sale arranged by the Company; or (iii) any other method deemed acceptable by the Board. The Company shall not be required to issue any Common Shares under the Plan until such obligations are satisfied.
(c) The 423 Component is exempt from the application of Section 409A of the Code, and any ambiguities herein shall be interpreted to so be exempt from Section 409A and Section 457A of the Code. The Non-423 Component is intended to be exempt from the application of Section 409A and Section 457A of the Code under the short-term deferral exception and any ambiguities shall be construed and interpreted in accordance with such intent. In furtherance of the foregoing and notwithstanding any provision in the Plan to the contrary, if the Committee determines that an option granted under the Plan may be subject to Section 409A and/or Section 457A of the Code or that any provision in the Plan would cause an option under the Plan to be subject to Section 409A and/or Section 457A, the Committee may amend the terms of the Plan and/or of an outstanding option granted under the Plan, or take such other action the Committee determines is necessary or appropriate, in each case, without the participant’s consent, to exempt any outstanding option or future option that may be granted under the Plan from or to allow any such options to comply with Section 409A and/or Section 457A of the Code, but only to the extent any such amendments or action by the Committee would not violate Section 409A or Section 457A of the Code. Notwithstanding the foregoing, the Company shall have no liability to a participant or any other party if the option under the Plan that is intended to be exempt from or compliant with Section 409A and/or Section 457A of the Code is not so exempt or compliant or for any action taken by the Committee with respect thereto.
14. EFFECTIVE DATE OF PLAN.
The Plan will become effective immediately prior to and contingent upon the Effective Date. No Purchase Rights will be exercised unless and until the Plan has been approved by the shareholders of the Company, which approval must be within 12 months before or after the date the Plan is adopted (or if required under Section 12(a) above, materially amended) by the Board.
15. MISCELLANEOUS PROVISIONS.
(a) Proceeds from the sale of Common Shares pursuant to Purchase Rights will constitute general funds of the Company.
(b) A Participant will not be deemed to be the holder of, or to have any of the rights of a holder with respect to, Common Shares subject to Purchase Rights unless and until the Participant’s Common Shares acquired upon exercise of Purchase Rights are recorded in the books of the Company (or its transfer agent).
(c) The Plan and Offering do not constitute an employment contract. Nothing in the Plan or in the Offering will in any way alter the at will nature of a Participant’s employment or amend a Participant’s employment contract, if applicable, or be deemed to create in any way whatsoever any obligation on the part of any Participant to continue in the employ of the Company or a Related Corporation or an Affiliate, or on the part of the Company, a Related Corporation or an Affiliate to continue the employment of a Participant.
(d) The Plan and any documents hereunder shall be interpreted and construed in accordance with the laws of the Cayman Islands (without regard to its choice of law provisions). Any reference in this Plan or in any document to a provision of law or to a rule or regulation shall be deemed to include any successor law, rule or regulation of similar effect or applicability.
(e) If any particular provision of the Plan is found to be invalid or otherwise unenforceable, such provision will not affect the other provisions of the Plan, but the Plan will be construed in all respects as if such invalid provision were omitted.
(f) If any provision of the Plan does not comply with Applicable Law, such provision shall be construed in such a manner as to comply with Applicable Law.
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16. DEFINITIONS.
As used in the Plan, the following definitions will apply to the capitalized terms indicated below:
“423 Component” means the part of the Plan, which excludes the Non-423 Component, pursuant to which Purchase Rights that satisfy the requirements for an Employee Share Purchase Plan may be granted to Eligible Employees.
“Affiliate” means any entity, other than a Related Corporation, whether now or subsequently established, which is at the time of determination, a “parent” or “subsidiary” of the Company as such terms are defined in Rule 405 promulgated under the Securities Act. The Board may determine the time or times at which “parent” or “subsidiary” status is determined within the foregoing definition.
“Applicable Law” means shall mean the Code and any applicable securities, federal, state, foreign, material local or municipal or other law, statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, listing rule, regulation, judicial decision, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Body (or under the authority of the NASDAQ Stock Market, the New York Stock Exchange or the Financial Industry Regulatory Authority).
“Board” means the board of directors of the Company.
“Capitalization Adjustment” means any change that is made in, or other events that occur with respect to, the Common Shares subject to the Plan or subject to any Purchase Right after the date the Plan is adopted by the Board without the receipt of consideration by the Company through merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, large nonrecurring cash dividend, stock split, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or other similar equity restructuring transaction, as that term is used in Financial Accounting Standards Board Accounting Standards Codification Topic 718 (or any successor thereto). Notwithstanding the foregoing, the conversion of any convertible securities of the Company will not be treated as a Capitalization Adjustment.
“Code” means the U.S. Internal Revenue Code of 1986, as amended, including any applicable regulations and guidance thereunder.
“Committee” means a committee of one or more members of the Board to whom authority has been delegated by the Board in accordance with Section 2(c).
“Common Share” means shares of the Company’s common stock, par value [$0.0001].
“Company” means Zura Bio Limited, a Cayman Islands exempted company formerly known as JATT Acquisition Corp, and except as utilized in the definition of Change in Control, any successor corporation.
“Contributions” means the payroll deductions and other additional payments specifically provided for in the Offering that a Participant contributes to fund the exercise of a Purchase Right. A Participant may make additional payments into his or her account if specifically provided for in the Offering, and then only if the Participant has not already had the maximum permitted amount withheld during the Offering through payroll deductions and, with respect to the 423 Component, to the extent permitted by Section 423 of the Code.
“Corporate Transaction” means the consummation, in a single transaction or in a series of related transactions, of any one or more of the following events:
(i) a sale or other disposition of all or substantially all, as determined by the Board in its sole discretion, of the consolidated assets of the Company and its subsidiaries;
(ii) a sale or other disposition of more than 50% of the outstanding securities of the Company;
(iii) a merger, consolidation or similar transaction following which the Company is not the surviving corporation; or
(iv) a merger, consolidation or similar transaction following which the Company is the surviving corporation but the Common Shares outstanding immediately preceding the merger, consolidation or similar transaction are converted or exchanged by virtue of the merger, consolidation or similar transaction into other property, whether in the form of securities, cash or otherwise.
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- “Designated 423 Corporation” means any Related Corporation selected by the Board to participate in the 423 Component.
“Designated Company” means any Designated Non-423 Corporation or Designated 423 Corporation, provided, however, that at any given time, a Related Corporation participating in the 423 Component shall not be a Related Corporation participating in the Non-423 Component.
- “Designated Non-423 Corporation” means any Related Corporation or Affiliate selected by the Board to participate in the Non-423 Component.
“Director” means a member of the Board.
-“Effective Date” means the date on which the Plan takes effect, which is the date of the closing of the transactions contemplated by the Business Combination Agreement by and among JATT Acquisition Corp, JATT Merger Sub, JATT Merger Sub 2, Zura Bio Holdings Ltd and Zura Bio Limited, dated as of June 16, 2022, provided that this Plan is approved by the JATT’s shareholders prior to such date.
-“Eligible Employee” means an Employee who meets the requirements set forth in the document(s) governing the Offering for eligibility to participate in the Offering, provided that such Employee also meets the requirements for eligibility to participate set forth in the Plan.
“Employee” means any person, including an Officer or Director, who is “employed” for purposes of Section 423(b)(4) of the Code by the Company or a Related Corporation, or solely with respect to the Non-423 Component, an Affiliate. However, service solely as a Director, or payment of a fee for such services, will not cause a Director to be considered an “Employee” for purposes of the Plan.
“Employee Share Purchase Plan” means a plan that grants Purchase Rights intended to be options issued under an “employee stock purchase plan,” as that term is defined in Section 423(b) of the Code.
-“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended and the rules and regulations promulgated thereunder.
“Fair Market Value” means, as of any date, the value of a Common Share determined as follows:
(i) If the Common Shares are listed on any established stock exchange or traded on any established market, the Fair Market Value of a Common Share will be the closing sales price for such share as quoted on such exchange or market (or the exchange or market with the greatest volume of trading in the Common Shares) on the date of determination, as reported in such source as the Board deems reliable. Unless otherwise provided by the Board, if there is no closing sales price for the Common Shares on the date of determination, then the Fair Market Value will be the closing sales price on the last preceding date for which such quotation exists.
(ii) In the absence of such markets for the Common Shares, the Fair Market Value will be determined by the Board in good faith in compliance with Applicable Laws and regulations and, to the extent applicable as determined in the sole discretion of the Board, in a manner that complies with Sections 409A of the Code
“Governmental Body” means any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; (c) governmental or regulatory body, or quasi-governmental body of any nature (including any governmental division, department, administrative agency or bureau, commission, authority, instrumentality, official, ministry, fund, foundation, center, organization, unit, body or entity and any court or other tribunal, and for the avoidance of doubt, any tax authority) or other body exercising similar powers or authority; or (d) self-regulatory organization (including the NASDAQ Stock Market, the New York Stock Exchange and the Financial Industry Regulatory Authority).
“Non-423 Component” means the part of the Plan, which excludes the 423 Component, pursuant to which Purchase Rights that are not intended to satisfy the requirements for an Employee Share Purchase Plan may be granted to Eligible Employees.
“Offering” means the grant to Eligible Employees of Purchase Rights, with the exercise of those Purchase Rights automatically occurring at the end of one or more Purchase Periods. The terms and conditions of an Offering will generally be set forth in the “Offering Document” approved by the Board for that Offering.
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“Offering Date” means a date selected by the Board for an Offering to commence.
“Officer” means a person who is an officer of the Company or a Related Corporation within the meaning of Section 16 of the Exchange Act.
“Participant” means an Eligible Employee who holds an outstanding Purchase Right.
“Plan” means this Zura Bio Limited 2023 Employee Share Purchase Plan, as amended from time to time, including both the 423 Component and the Non-423 Component.
“Purchase Date” means one or more dates during an Offering selected by the Board on which Purchase Rights will be exercised and on which purchases of Common Shares will be carried out in accordance with such Offering.
“Purchase Period” means a period of time specified within an Offering, generally beginning on the Offering Date or on the first Trading Day following a Purchase Date, and ending on a Purchase Date. An Offering may consist of one or more Purchase Periods.
“Purchase Right” means an option to purchase Common Shares granted pursuant to the Plan.
“Related Corporation” means any “parent corporation” or “subsidiary corporation” of the Company whether now or subsequently established, as those terms are defined in Sections 424(e) and (f), respectively, of the Code.
“Securities Act” means the U.S. Securities Act of 1933, as amended.
“Tax-Related Items” means any income tax, social insurance, payroll tax, fringe benefit tax, payment on account or other tax-related items arising out of or in relation to a Participant’s participation in the Plan, including, but not limited to, the exercise of a Purchase Right and the receipt of Common Shares or the sale or other disposition of Common Shares acquired under the Plan.
“Trading Day” means any day on which the exchange(s) or market(s) on which the Common Shares are listed, including but not limited to the New York Stock Exchange, Nasdaq Global Select Market, the Nasdaq Global Market, the Nasdaq Capital Market or any successors thereto, is open for trading.
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Exhibit 10.14
CONFIDENTIAL
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS
EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT
THE REGISTRANT NORMALLY TREATS AS PRIVATE AND CONFIDENTIAL.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (“Agreement”) is made effective as of the __ day of ________, 2022 (the “Effective Date”), by and between Zura Bio Limited, a company organized and existing under the laws of England whose registered office is at 3rd Floor, 1 Ashley Road, Altrincham, Cheshire, UK, WA14 (“Licensee”) and Pfizer Inc., a corporation organized and existing under the laws of Delaware with offices at 235 East 42nd Street, New York, New York 10017 (“Pfizer”). Licensee and Pfizer may, from time-to-time, be individually referred to as a “Party” and collectively referred to as the “Parties”.
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WHEREAS, Pfizer Controls the Licensed Technology (hereinafter defined); and
WHEREAS, Licensee wishes to obtain, and Pfizer wishes to grant, certain licenses under the Licensed Technology on the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual agreements and covenants set forth herein and other good and valuable consideration, the receipt and sufficiency of which the Parties hereby acknowledge, the Parties, intending to be legally bound hereby, agree to the foregoing and as follows:
1. | DEFINITIONS. | |
1.1. | “Adjusted Payment” [***] | |
1.2. | “Affiliate” means, with respect to a Party, any Person that, on the Effective Date or during the Term, controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall refer to: (a) the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of an entity, whether through the ownership of voting securities or other ownership interest, by contract or otherwise, or (b) the ownership, directly or indirectly, of fifty percent (50%) or more of the voting securities or other ownership interest of such entity. | |
1.3. | “Agreement” is defined in the introduction to this Agreement. | |
1.4. | “Applicable Law” means any applicable law, statute, rule, regulation, order, judgment or ordinance of any Governmental Authority. | |
1.5. | “Bankruptcy Code” is defined in Section 13.3. | |
1.6. | “Bankruptcy Event” is defined in Section 13.3. |
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1.7. | “Biosimilar Notice” means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the Public Health Service Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biopharmaceutical product, which application identifies a Product as the reference product with respect to such product, and other information that describes the process or processes used to manufacture the biopharmaceutical product. | |
1.8. | “Business Day” means any day other than a Saturday, a Sunday or a day on which commercial banks located in New York, New York are authorized or required by Applicable Law to remain closed. | |
1.9. | “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. | |
1.10. | “Calendar Year” means each calendar year. | |
1.11. | “Cap” is defined in Section 12.2. | |
1.12. | “CDA” is defined in Section 17.11.1. | |
1.13. | “Change of Control” means, with respect to a Party, whether effected in a single transaction or a series of related transactions, (a) the acquisition of beneficial ownership, directly or indirectly, by any Person (other than such Party or an Affiliate of such Party) of securities or other voting interest of such Party representing a majority or more of the combined voting power of such Party’s then-outstanding securities or other voting interests; (b) any merger, reorganization, consolidation, share exchange, business combination or similar transaction involving such Party (i) pursuant to which [***] or more of the outstanding voting securities of such Party (or, if applicable, the ultimate parent of such Party) would be converted into cash or securities of any other Person or (ii) that results in the holders of beneficial ownership of the voting securities or other voting interests of such Party (or, if applicable, the ultimate parent of such Party) immediately prior to such merger, reorganization, consolidation or business combination ceasing to hold beneficial ownership of at least [***] of the combined voting power of the surviving entity immediately after such merger, reorganization, consolidation, share exchange, business combination or similar transaction; (c) any sale, lease, exchange, contribution or other transfer of all or any material portion of the assets of such Party and its subsidiaries taken as a whole, other than the sale or disposition of such assets to an Affiliate of such Party; (d) any sale, lease, exchange, contribution or other transfer of the assets to which this Agreement relates; or (e) the approval of any plan or proposal for the liquidation or dissolution of such Party. [***] | |
1.14. | “Claims” is defined in Section 11.1. | |
1.15. | “Clinical Trial” means a Phase I Clinical Trial, Phase II Clinical Trial, or Phase III Clinical Trial. |
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1.16. | “CMO” means a contract manufacturing organization. | |
1.17. | “Combination Product” means a product that includes or incorporates a Compound in combination with one (1) or more other active agents. | |
1.18. | “Commercialize” or “Commercialization” means to market, promote, distribute, offer for sale, sell, import, have imported, export, have exported or otherwise commercialize a compound or product. When used as a noun, “Commercialization” means any and all activities involved in Commercializing. | |
1.19. | “Commercially Reasonable Efforts” means, with respect to the Development or Commercialization of a Compound or Product as determined on a country-by-country basis, [***]. | |
1.20. | “Compliance Laws” is defined in Section 10.2.4. | |
1.21. | “Compound” means Pfizer’s [***]. | |
1.22. | “Confidential Information” is defined in Section 9.1. | |
1.23. | “Control” or “Controlled” means, with respect to any Intellectual Property Rights or other rights to provide data or other information, the legal authority or right (whether by ownership, license or otherwise) of a Party to grant a license or a sublicense of or under such Intellectual Property Rights to the other Party or provide such data or other information to such other Party without breaching the terms of any agreement with a Third Party. | |
1.24. | “CRO” means a contract research organization. | |
1.25. | “Cumulative Preferred Consideration” means an amount equal to [***]. | |
1.26. | “Develop” or “Development” means to conduct any and all research and development activities necessary to obtain Regulatory Approval. | |
1.27. | “Developed IP” means any Intellectual Property Rights that are conceived or reduced to practice by a Party, its Affiliates or sublicensees, alone or together with one or more Third Parties, during the Term in connection with the Development, Manufacture or use of the Compound or Product. | |
1.28. | "Development Exclusion” is defined in Section 2.3. | |
1.29. | “Development Milestone” is defined in Section 5.3. | |
1.30. | “Development Milestone Payment” is defined in Section 5.3. | |
1.31. | “Development Plan” is defined in Section 4.6. | |
1.32. | “Disputes” is defined in Section 16.1.1. |
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1.33. | [***]. | |
1.34. | “Effective Date” is defined in the introduction to this Agreement. | |
1.35. | “Election Notice” is defined in Section 7.2.3. | |
1.36. | “EMA” means the European Medicines Agency, or a successor agency thereto. | |
1.37. | “EU” or “European Union” means the European Union as constituted from time to time. | |
1.38. | [***] | |
1.39. | “FDA” means the United States Food and Drug Administration, or a successor federal agency thereto. | |
1.40. | “Fees” is defined in Section 12.2. | |
1.41. | “Field” means the treatment, diagnosis or prevention of diseases in humans. | |
1.42. | “First Commercial Sale” means the first sale of a Product by Licensee or Licensee’s Affiliate or sublicensee to a Third Party in a country in the Territory following receipt of Regulatory Approval for such Product in such country. | |
1.43. | “Force Majeure Event” is defined in Section 17.4. | |
1.44. | “GAAP” means United States generally accepted accounting principles or an alternative international generally accepted standard of accounting principles used by Licensee, including International Reporting Financial Standards, in each case consistently applied. | |
1.45. | “Generic Competition” means, with respect to a Product in a particular country in the Territory, when a Generic Product has achieved more [***] of the market share in such country by unit volume of combined unit sales of such Product and such Generic Product. | |
1.46. | “Generic Product” means, with respect to a Product in a particular country in the Territory, any pharmaceutical product that (a) is marketed for sale by a Third Party, not authorized by Pfizer or Licensee, (b) receives Regulatory Approval in such country in reliance on the Regulatory Approval of such Product, and (c) is determined by a Regulatory Authority to be therapeutically equivalent to, interchangeable with, or substitutable for, such Product. | |
1.47. | “Governmental Authority” means any United States federal, state or local authority, or any foreign government or political subdivision thereof, or any multinational organization or authority, or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, |
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bureau or division thereof), or any governmental arbitrator or arbitral body. For clarity, any Regulatory Authority shall be a Governmental Authority.
1.48. | “Government Official” is defined in Section 10.3.4. | |
1.49. | “Good Manufacturing Practice” or “cGMP” means the regulatory requirements for current good manufacturing practices for pharmaceuticals promulgated by the FDA, as the same may be amended from time to time, and such standards of good manufacturing practice as are required by the Regulatory Authorities of the EU and other organizations and Governmental Authorities in countries in which the Product is intended to be manufactured or sold, to the extent such standards are not less stringent than United States GMP; provided that a Party shall not be held to any standards required by countries outside the United States and EU unless such standards have been specifically identified and approved for implementation by the mutual written agreement of the Parties. | |
1.50. | “IND” means: (a) an investigational new drug application filed with the FDA for authorization for the investigation of the Product, and (b) any of its foreign equivalents as filed with the applicable Regulatory Authorities in other countries or regulatory jurisdictions in the Territory, as applicable. | |
1.51. | “Indemnitee” is defined in Section 11.3. | |
1.52. | “Indemnitor” is defined in Section 11.3. | |
1.53. | “Initial Period” is defined in Section 7.2.1. | |
1.54. | “Intellectual Property Rights” means all trade secrets, copyrights, Patent Rights, trademarks, moral rights, Know-How and any and all other intellectual property or proprietary rights now known or hereafter recognized in any jurisdiction. | |
1.55. | [***] | |
1.56. | [***] | |
1.57. | “Know-How” means any proprietary invention, discovery, development, data, information, process, method, technique or other know-how, whether or not patentable. | |
1.58. | “Knowledge” means actual knowledge of the individuals listed on Schedule 1.58 and is not meant to require or imply that any particular inquiry or investigation has been undertaken, including, without limitation, obtaining any type of search (independent of that performed by the actual Governmental Authority during the normal course of patent prosecution, as applicable, in a jurisdiction) or opinion of counsel. | |
1.59. | “Licensee Indemnitees” is defined in Section 11.2. |
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1.60. | “Licensed Know-How” means all Know-How Controlled by Pfizer as of the Effective Date that is (a) listed in Schedule 1.60, or (b) required to be transferred by Pfizer to Licensee in accordance with Schedule 3. | |
1.61. | “Licensed Patent Rights” means all Patent Rights listed on Schedule 1.61 and any Patent Rights related thereto. | |
1.62. | “Licensed Technology” means, collectively, the Licensed Patent Rights and Licensed Know-How. | |
1.63. | “Major Market Country” means any of [***]. | |
1.64. | [***]. | |
1.65. | “Manufacture” or “Manufacturing” means to make, produce, manufacture, process, fill, finish, package, label, perform quality assurance testing, release, ship or store a compound or product or any component thereof. When used as a noun, “Manufacture” or “Manufacturing” means any and all activities involved in Manufacturing a compound or product or any component thereof. | |
1.66. | “Marginal Royalty Rate” means the royalty rates set forth in Section 5.5. | |
1.67. | “Milestone Payments” means, collectively, the Development Milestone Payments and Sales Milestone Payments. | |
1.68. | “NDA” means, with respect to a pharmaceutical product, a New Drug Application or Biologics License Application submitted to the FDA in accordance with the United States Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder, or any analogous application or submission with any Regulatory Authority outside of the United States such as a marketing authorization application for the EU. | |
1.69. | “Net Sales” means, with respect to all Products distributed or sold in the Territory to Third Parties by Licensee, its Affiliates and sublicensees, the gross amount invoiced for sales of such Products in the Territory, less in each case [***]. | |
If a Product is sold as part of a Combination Product, for purposes of determining payments due hereunder, Net Sales of such Product shall be deemed to be an amount equal to the following: [***]
1.70. | “Party” and “Parties” is defined in the introduction to this Agreement. | |
1.71. | “Patent Rights” means any and all (a) issued patents, (b) pending patent applications, including all provisional applications, divisions, continuations, substitutions, and renewals, and all patents granted thereon, (c) patents-of-addition, re-examinations, reissues and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) |
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inventor’s certificates, (e) other forms of government-issued rights substantially similar to any of the foregoing and (f) United States and foreign counterparts of any of the foregoing.
1.72. | “Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, Governmental Authority or any other form of entity not specifically listed herein. | |
1.73. | “Phase I Clinical Trial” means a clinical trial that generally provides for the first introduction into humans of a pharmaceutical product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such product, in a manner that is generally consistent with 21 CFR § 312.21(a), as amended (or its successor regulation). | |
1.74. | “Phase II Clinical Trial” means a clinical trial, the principal purpose of which is to make a preliminary determination as to whether a pharmaceutical product is safe for its intended use and to obtain sufficient information about such product’s efficacy, in a manner that is generally consistent with 21 CFR § 312.21(b), as amended (or its successor regulation), to permit the design of further clinical trials. | |
1.75. | “Phase III Clinical Trial” means a pivotal clinical trial with a defined dose or a set of defined doses of a pharmaceutical product designed to ascertain efficacy and safety of such product, in a manner that is generally consistent with 21 CFR § 312.21(c), as amended (or its successor regulation), for the purpose of enabling the preparation and submission of an NDA. | |
1.76. | “Pfizer Indemnitees” is defined in Section 11.1. | |
1.77. | “PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency, or a successor agency thereto. | |
1.78. | [***] | |
1.79. | [***] | |
1.80. | “Preferred Investor” means an acquiror of Preferred Shares, including under the Series A-1 Preferred Share Purchase Agreement and any other Preferred Investment. | |
1.81. | “Preferred Share” means each share of preferred shares or equivalent shares of Licensee. | |
1.82. | “Product” means a product that includes or incorporates a Compound, alone or in combination with one or more other active agents. For clarity, multiple formulations (or combinations) that contain the same Compound would be deemed one Product for purposes of any Royalty calculation. |
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1.83. | “Quality Assurance Release” means Qualified Person release in accordance with Applicable Law. | |
1.84. | “Qualified Person” means a person responsible for certifying each individual batch of finished product within the European Economic Area (the “EEA”) before it is released for sale or supply (i) in the EEA; or (ii) for export out of the EEA, in accordance with Article 51 of Directive 2001/83/EC, EudraLex - Volume 4 - Annex 16 (Certification by a Qualified person and Batch Release) and other Applicable Law, and, in respect of jurisdictions outside the EEA, a person having equivalent responsibilities and qualifications under Applicable Law. | |
1.85. | “Recipients” is defined in Section 9.2. | |
1.86. | “Regulatory Approval” means, with respect to the Product in any country or jurisdiction, any approval, registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction. | |
1.87. | “Regulatory Authority” means any governmental agency or authority responsible for granting Regulatory Approvals for the Product in the Territory. | |
1.88. | “Regulatory Filings” means, with respect to the Product, any submission to a Regulatory Authority of any appropriate regulatory application, including, without limitation, any IND, NDA, any submission to a regulatory advisory board, any marketing authorization application, and any supplement or amendment thereto. | |
1.89. | “Relevant Records” is defined in Section 6.1. | |
1.90. | “Residuals” is defined in Section 2.4. | |
1.91. | [***] | |
1.92. | “Review Period” is defined in Section 14.3. | |
1.93. | “Royalties” is defined in Section 5.5. | |
1.94. | “Royalty Term” means, with respect to each Product in each country in the Territory, the period commencing on the First Commercial Sale of such Product in such country and expiring upon the latest to occur of: (a) ten (10) years following the date of First Commercial Sale of such Product in such country, (b) the expiration of all regulatory or data exclusivity for such Product in such country or (c) the date upon which the Manufacture, use, sale, offer for sale or importation of such Product in such country would no longer infringe, but for the license granted herein, a Valid Claim of a Licensed Patent Right. | |
1.95. | “Sales Milestone Payment” is defined in Section 5.4. | |
1.96. | “Senior Officer” shall mean, [***] | |
1.97. | “Series A-1 Investment” means the financing of Licensee, whereby Licensee obtains at least [***] from the sale and issuance of Licensee’s Series A-1 Preferred Shares in one closing pursuant to the Series A-1 Preferred Share Purchase Agreement. |
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1.98. | “Series A-1 Preferred Share Purchase Agreement” means that certain Series A-1 Subscription and Shareholders Agreement to be executed and delivered by Pfizer, Licensee, and Hana Immunotherapeutics LLC simultaneously with this Agreement. | |
1.99. | “Shares” is defined in Section 5.1. | |
1.100. | “Tax Action” is defined in Section 5.14.2. | |
1.101. | “Term” is defined in Section 13.1. | |
1.102. | “Territory” means all countries in the world. | |
1.103. | “Third Party” means any Person other than a Party or an Affiliate of a Party. | |
1.104. | “Third Party Infringement” is defined in Section 8.1. | |
1.105. | “Third Party License” means any license under any Third Party Intellectual Property Rights necessary or useful in order to Develop, Manufacture, Commercialize, use or otherwise exploit any Compound or Product in the Territory. | |
1.106. | “Transaction Completion Payment” is defined in Section 5.9.1. | |
1.107. | “Upfront Payment” is defined in Section 5.2. | |
1.108. | [***] | |
1.109. | “Valid Claim” means with respect to a particular country, a claim of a Patent Right within the Licensed Patent Rights that (a) with respect to an issued and unexpired patent, (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, which decision is unappealed or unappealable within the time allowed for appeal and (ii) has not expired or been cancelled, withdrawn, abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, and (b) with respect to a pending patent application, has not been abandoned or finally disallowed without the possibility of appeal or refiling of such application, and such application has not been pending for more than seven (7) years from the date of filing of such pending patent application. | |
1.110. | Interpretation. Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”, (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such |
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amendments, supplements or modifications set forth herein), (e) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections, Exhibits or Schedules shall be construed to refer to Sections, Exhibits or Schedules of this Agreement, and references to this Agreement include all Exhibits and Schedules hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or.”
2. | LICENSE GRANT. | ||
2.1. | License Grant. | ||
2.1.1. | Licensed Patent Rights. Subject to the terms and conditions of this Agreement, including Pfizer’s retained rights set forth in Section 2.3, Pfizer hereby grants to Licensee an exclusive (even as to Pfizer), sublicensable (subject to Section 2.2), royalty-bearing license under the Licensed Patent Rights to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise exploit Compound and Products in the Field within the Territory. | ||
2.1.2. | Licensed Know How. Subject to the terms and conditions of this Agreement, including Pfizer’s retained rights set forth in Section 2.3, Pfizer hereby grants to Licensee an exclusive, sublicensable (subject to Section 2.2), royalty-bearing license under the Licensed Know-How to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized and otherwise exploit Compound and Products in the Field within the Territory. | ||
2.1.3. | Affiliates. To the extent any of the Licensed Technology is Controlled by an Affiliate of Pfizer, then promptly following the Effective Date, Pfizer shall cause such Affiliate to take all necessary actions to give effect to the licenses granted under this Section 2.1. | ||
2.2. | Sublicense Rights. Subject to Section 5.9, Licensee may sublicense the rights granted to it by Pfizer under this Agreement during the Term to (a) any of its |
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Affiliates without Pfizer’s approval or (b) any Third Party, provided such Third Party is not a CMO or CRO, upon Pfizer’s prior written approval, which approval shall not be unreasonably withheld or delayed. Pfizer shall, within thirty (30) days, give notice to Licensee either approving such request or providing reasons for its refusal to provide consent, provided that where Licensee has submitted sublicense requests in respect of more than seven (7) Third Parties, Pfizer shall only be obliged to use commercially reasonable efforts to respond within thirty (30) days following receipt of Licensee’s written request. Any and all sublicenses shall be subject to the following requirements:
2.2.1. | All sublicenses shall be subject to and consistent with the terms and conditions of this Agreement and shall: [***] | ||
2.2.2. | Licensee shall furnish to Pfizer a true and complete copy of each sublicense agreement and each amendment thereto, within thirty (30) days after the sublicense or amendment has been executed, provided that Licensee shall be entitled to redact any commercially sensitive information from such copy of the sublicense agreement (or amendment thereto, as applicable). | ||
2.3. | Retained Rights. Licensee acknowledges and agrees that (a) Pfizer retains the right to make, have made, use and import the Compound and Product for all internal research, development and regulatory purposes; provided, that Pfizer shall not have the right to conduct Clinical Trials to Develop the Compound or Product in the Field (the “Development Exclusion”), (b) Pfizer is free to use the Licensed Patent Rights and Licensed Know-How for purposes other than those exclusively licensed to Licensee under this Agreement and (c) Pfizer retains the rights that have been provided by Pfizer to (i) a reagent supplier, such as Sigma Aldrich Co., to make or sell the Compound or (ii) a non-commercial entity to use the Compound, in each case in the form of non-cGMP samples of the Compound in mg quantities solely as a research reagent. | ||
2.4. | Residuals. Subject always to Pfizer’s obligations under Section 9, Pfizer may use for any purpose the Residuals resulting from access to or work with the Product and Licensed Know-How. As used herein, “Residuals” means information in non-tangible form which may be retained by persons who have had access to the Product and Licensed Know-How, including ideas, concepts, know-how or techniques contained therein. | ||
2.5. | No Additional Rights. Nothing in this Agreement shall be construed to confer any rights upon Licensee by implication, estoppel, or otherwise as to any technology or Intellectual Property Rights of Pfizer or its Affiliates other than the rights in Licensed Technology expressly granted herein, regardless of whether such technology or Intellectual Property Rights shall be dominant or subordinate to any Licensed Technology. |
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3. | TRANSFER ACTIVITIES. Schedule 3 sets forth the documentation and materials that Pfizer will transfer to Licensee, personnel support, and related activities to be performed by the Parties. | ||
4. | DEVELOPMENT; COMMERCIALIZATION; MANUFACTURING. | ||
4.1. | General. Subject to the terms of this Agreement, including Section 2.3, Licensee shall have sole responsibility for the cost and expense of, and the sole authority over and control of, the Development, Manufacture (except for any existing supply of the Compound transferred as part of the transfer activities set forth on Schedule 3), Regulatory Approval and Commercialization of Compound and Product in the Field in the Territory. | ||
4.2. | Diligence. | ||
4.2.1. | Development. Licensee shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts, pursuant to the Development Plan, to Develop and seek Regulatory Approval for the Product in France, Germany, Italy, Japan, Spain, and the United States. | ||
4.2.2. | Commercialization. Licensee shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts, pursuant to the Development Plan, to Commercialize each Product in each Major Market Country in the Territory where Licensee or its designated Affiliates or sublicensees have received Regulatory Approval for such Product. | ||
4.3. | Regulatory Filings. In connection with its efforts to Develop the Product, Licensee shall bear all responsibility and expense for submitting Regulatory Filings and obtaining Regulatory Approval for the Product. Licensee will undertake such activities at its sole expense. | ||
4.4. | Progress Reporting. At least [***] prior to the start of each [***] Licensee shall provide to Pfizer a report including [***]. | ||
4.5. | CROs and CMOs. Licensee may contract with Third Party CROs or CMOs to handle certain clinical Development or Manufacturing activities, in Licensee’s reasonable discretion, consistent with the then-current Development Plan. As between the Parties, all costs of CROs or CMOs will be borne solely by Licensee. For clarity, Licensee shall not be required to obtain Pfizer’s consent of a sublicense to a CRO or CMO if the applicable contract is (a) in the case of a CRO, limited to a license for such CRO to perform research with regard to a Product on behalf of Licensee or (b) in the case of a CMO, limited to a license for such CMO to Manufacture Product on behalf of Licensee. | ||
4.6. | Development Plan. All Development and Commercialization activities to be conducted in connection with any Compound or Product will be performed by Licensee consistent with Section 4.2 and the terms and conditions set forth in this |
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Section 4.6 and the development plan as set forth in Schedule 4.6, as amended by Licensee pursuant to this Section 4.6 (the “Development Plan”). The Development Plan shall include all Development and Commercialization activities in detail (including the territories in which and timelines on which such activities are anticipated to occur) and that are reasonably anticipated to be undertaken by Licensee to advance a Compound or Product. Licensee will provide Pfizer with an updated and detailed Development Plan semi-annually (to be provided every other Calendar Quarter thereafter). Licensee shall make available on a quarterly basis for a reasonable period of time, and at no cost to Pfizer, knowledgeable personnel to respond to questions from Pfizer or its Affiliates pertaining to the Development and Commercialization of the Product in order to assist Pfizer or its Affiliates with fulfilling any of Pfizer’s or its Affiliates revenue recognition procedures as they pertain to payments owed or potentially owed to Pfizer under this Agreement. [***] The obligations set forth in this Section 4.6 shall expire on a Product-by-Product basis on the First Commercial Sale of such Product in each of the Major Market Countries.
5. | PAYMENT TERMS. | |
5.1. | Equity. In consideration of the licenses and rights granted to Licensee hereunder, Licensee will issue and grant to Pfizer, such number of shares of the Licensee’s Series A-1 Preferred Shares (the “Shares”) equivalent on an aggregate basis to eighteen percent (18%) of all shares of Licensee’s capital shares on a fully-diluted basis immediately following the closing of Licensee’s Series A-1 Investment, and in any event pursuant to that certain Series A-1 Preferred Share Purchase Agreement, to be executed and delivered by Pfizer and certain other investors simultaneously with this Agreement. Pfizer, as the owner of Shares, shall have rights and obligations on parity with, and with the same terms and conditions as, other investors purchasing shares of Series A-1 Preferred Shares. | |
5.2. | Upfront Payment. In consideration of the licenses and rights granted to Licensee hereunder, Licensee shall pay to Pfizer a one-time, upfront, non-refundable and non-creditable payment of [***] on the Effective Date (“Upfront Payment”). | |
5.3. | Development Milestone Payments. In consideration of the licenses and rights granted to Licensee hereunder, Licensee shall pay to Pfizer the amounts set forth below within [***] following the first occurrence of each event described below (each event, a “Development Milestone” and each payment, a “Development Milestone Payment”), and such payment shall be accompanied by a report identifying the amount payable to Pfizer under this Section 5.3. |
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DEVELOPMENT MILESTONE | DEVELOPMENT MILESTONE PAYMENT |
(1) [***] | [***] |
(2) [***] | [***] |
(3) [***] | [***] |
(4) [***] | [***] |
(5) [***] | [***] |
(6) [***] | [***] |
(7) [***] | [***] |
(8) [***] | [***] |
(9) [***] | [***] |
(10) [***] | [***] |
(11) [***] | [***] |
(12) [***] | [***] |
[***]
For the avoidance of doubt: (i) each Development Milestone Payment shall be payable [***] and (ii) satisfaction of a Development Milestone by a sublicensee or assignee of, or Third Party retained by, Licensee or its Affiliates shall be deemed to have been satisfied by Licensee for purposes of this Section 5.3. As used herein, “First Indication” means any disease or condition set forth in the first NDA (or NDA-equivalent) seeking Regulatory Approval accepted by the FDA, EMA or PMDA. “Second Indication” means any disease or condition other than the First Indication. “Indication” means either the First Indication or the Second Indication, as applicable. [***]
If a Development Milestone is achieved without achieving a Development Milestone that would otherwise have occurred prior to the Development Milestone that was achieved [***] then all prior Development Milestones shall be deemed to have been achieved, and if not previously paid, the corresponding Development Milestone Payments shall become payable.
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5.4. | Sales Milestone Payments. In consideration of the licenses and rights granted to Licensee hereunder, Licensee shall pay to Pfizer the following one-time payments (each, a “Sales Milestone Payment”) when aggregate Net Sales of Products in a Calendar Year in the Territory (the “Total Annual Net Sales”) first reach the respective thresholds indicated below. |
TOTAL ANNUAL NET SALES | SALES MILESTONE PAYMENT |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
For the avoidance of doubt, each Sales Milestone Payment shall be paid only once upon achievement of the applicable Total Annual Net Sales threshold. The total amount payable with respect to these Sales Milestone Payments shall not exceed [***]. If more than one of the above Total Annual Net Sales thresholds are achieved in a particular Calendar Year ([***]), then all unpaid Sales Milestone Payments achieved in such Calendar Year shall become payable.
Licensee shall make any Sales Milestone Payment payable within [***] after the [***] in which Total Annual Net Sales reach the applicable threshold, and such payment shall be accompanied by a report identifying the amount payable to Pfizer under this Section 5.4.
5.5. | Royalty Payments. Subject to Sections 5.6 and 5.7, in consideration of the licenses and rights granted to Licensee hereunder, Licensee shall pay to Pfizer non-refundable, non-creditable royalties in the amount of the “Marginal Royalty Rates” (set forth below) on the aggregate Net Sales resulting from the sale of Products, on a Product by Product basis, in the Territory during each Calendar Year (collectively, “Royalties”). |
NET SALES | MARGINAL ROYALTY RATE |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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[***] | [***] |
[***] | [***] |
Each Marginal Royalty Rate set forth in the table above shall apply only to that portion of the Net Sales of each Product in the Territory during a given [***] that falls within the indicated range. Licensee shall pay to Pfizer the applicable Royalties within [***] following the expiration of each [***] after the date of the First Commercial Sale. Royalties will be payable on a Product-by-Product and country-by-country basis during the Royalty Term for such Product in each country until the expiration of the Royalty Term for such Product in each country. All Royalty payments shall be accompanied by a report that includes reasonably detailed information regarding a total [***] sales calculation of Net Sales of Product (including all deductions), calculations of any deductions applicable under Sections 5.6 and 5.7, and all Royalties payable to Pfizer for the applicable [***] (including any foreign exchange rates employed).
5.6. | Royalty Adjustment for Generic Competition. If at any time during the Royalty Term Generic Competition exists in a given country with respect to a Product, then the Marginal Royalty Rates used to calculate Royalties with respect to such Product in such country shall be reduced by [***] for so long as such Generic Competition exists. | ||
5.7. | Royalty Adjustment for Third Party Licenses. Licensee may deduct from any royalty payments to Pfizer under this Article 5 in respect of a given Calendar Quarter [***] of any royalties paid by Licensee to a Third Party in consideration for a license under such Third Party’s Intellectual Property Rights that are necessary for the Commercialization of a Product. | ||
5.8. | Maximum Adjustments. Notwithstanding Sections 5.6 and 5.7 to the contrary, under no circumstances shall the adjustments set forth in Sections 5.6 and 5.7 cause the total Royalties payable to Pfizer in any Calendar Quarter to be reduced by more than [***] of the amount that would otherwise be due without giving effect to this Section 5.8. Licensee may carry forward to subsequent Calendar Quarters any deductions under this Section 5.8 that were not previously deducted by Licensee. | ||
5.9. | Transaction Completion Payment. | ||
5.9.1. | Licensee shall pay to Pfizer a one-time, non-refundable and non-creditable payment of [***] upon the earlier to occur of either of the following, provided a definitive agreement for either such transaction is executed within [***] of the Effective Date: (a) Licensee completes its first Change of Control prior to the IPO [***], or (b) Licensee completes a transaction to sublicense or divest to a Third Party any rights related to a Product (excluding to a CMO or CRO) (such [***] payment in (a) or (b), the “Transaction Completion Payment”). For clarity, (i) should |
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Licensee complete its IPO prior to the occurrence of the first Change of Control of Licensee, no Transaction Completion Payment would be owed upon completion of such Change of Control under clause (a) of this Section 5.9.1 and (ii) the Transaction Completion Payment shall be payable only once under this Section 5.9.1.
5.9.2. | For a Transaction Completion Payment due under clause (a) of Section 5.9.1, such payment shall be accompanied by a report that includes (a) a calculation of the Return to Preferred Investors, or (b) a copy of any relevant documents to allow Pfizer to confirm the accuracy of such payment. | ||
5.9.3. | For a Transaction Completion Payment due under clause (a) of Section 5.9.1, Licensee or its Affiliate shall make such Transaction Completion Payment within [***] following (i) the closing of Licensee’s first Change of Control, if the Adjusted Payments actually received at such closing cause clause (a) of Section 5.9.1 to be satisfied, or (ii) the subsequent receipt of any Adjusted Payments that cause clause (a) of Section 5.9.1 to be satisfied, if not satisfied previously based on previously received Adjusted Payments, as applicable. | ||
5.9.4. | For any Transaction Completion Payment due as a result of a sublicense or divestiture under clause (b) of Section 5.9.1, Licensee or its Affiliate shall make such Transaction Completion Payment within [***] following the closing of such transaction. | ||
5.10. | Other Payments. Except as otherwise set forth in this Agreement, Licensee shall pay to Pfizer any other amounts due under this Agreement within [***] following receipt of invoice. | ||
5.11. | Late Payments. Any amount required to be paid by a Party hereunder which is not paid on the date due shall bear interest compounded daily, to the extent permitted by law, at [***] above the Federal Funds Effective Rate EFFR (or any successor to such rate) effective for the date such payment was due, as reported by the Federal Reserve of New York (https://apps.newyorkfed.org/markets/autorates/fed%20funds). Such interest shall be computed on the basis of a year of three hundred sixty (360) days for the actual number of days payment is delinquent. | ||
5.12. | Currency. Any payments under this Article 5 that are recorded in currencies other than the U.S. Dollar shall be converted into U.S. Dollars at the average of the daily foreign exchange rates using the BFIX currency exchange ratio on Bloomberg as at 12:30 pm New York time for the calendar month in which such payments or expenses occurred. Such rates can be found via Bloomberg or the website https://www.bloomberg.com/markets/currencies/fx-fixings. |
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5.13. | Method of Payment. All payments from Licensee to Pfizer shall be made by wire transfer via immediately available funds in U.S. dollars to credit the bank account set forth below or such other bank account as designated by Pfizer in writing to Licensee at least thirty (30) days before payment is due. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day. |
[***]
5.14. | Taxes. | ||
5.14.1. | General. It is understood and agreed between the Parties that any payments made under this Agreement are exclusive of any value added or similar tax (“VAT”), which shall be added thereon as applicable. Pfizer shall provide any tax forms to Licensee that may be reasonably necessary in order for Licensee not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT. | ||
5.14.2. | Tax Actions. Notwithstanding anything in this Agreement to the contrary, if an action, including but not limited to any assignment or sublicense of its rights or obligations under this Agreement, or any failure to comply with Applicable Laws or filing or record retention requirements (a “Tax Action”) by a Party leads to the imposition of withholding tax liability or VAT on the other Party that would not have been imposed in the absence of a Tax Action or in an increase in such liability above the liability that would have been imposed in the absence of such Tax Action, then (i) any sum payable by the Party that caused the Tax Action (in respect of which such deduction or withholding is required to be made or VAT has been imposed) shall be increased to the extent necessary to ensure that the other Party receives a sum equal to the sum which it would have received had no Tax Action occurred and (ii) any sum receivable by the Party that caused a Tax Action (in respect of which such deduction or withholding is required to be made or VAT has been imposed) shall be made to that Party after deduction of the amount required to be so deducted or withheld or adjusting for any amounts in respect of such VAT to ensure that the other Party’s overall liability in respect of such payment remains the same as it would have been had no Tax Action occurred, and any applicable deducted or withheld amount shall be remitted to the relevant taxation authority in accordance with Applicable Law. For the avoidance of doubt, a Party shall only be liable for increased payments pursuant to this Section 5.14.2 to the extent such Party engaged in a Tax Action that created or |
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increased a withholding tax or VAT liability on the other Party.
5.14.3. | Cooperation. The Parties agree to cooperate and produce on a timely basis any tax forms or reports, including an IRS Form W-8BEN, reasonably requested by the other Party in connection with any payment made by Licensee to Pfizer under this Agreement. | ||
5.14.4. | Gross-up. In the event that any deductions or withholdings are required by law to be made from any payment by the Licensee under this Agreement, the Licensee shall pay Pfizer, at the same time as making the payment in question, such additional amount as will, after such deduction or withholding has been made, leave Pfizer with the same amount as it would have been entitled to receive in the absence of any such requirement to make a deduction or withholding. | ||
5.14.5. | If the Licensee makes a payment to Pfizer pursuant to Section 5.14.4, and Pfizer determines that it is entitled to a credit against, relief or remission for, or repayment of any Tax (“Tax Credit”) attributable to such payment, and Pfizer has obtained and utilised that Tax Credit, Pfizer shall pay an amount to the Licensee which Pfizer determines will leave it (after that payment) in the same after-Tax position as it would have been in had the payment in Section 5.14.4 not been required to be made by the Licensee. | ||
6. | RECORDS; AUDIT RIGHTS. | ||
6.1. | Relevant Records. Licensee shall maintain accurate financial books and records pertaining to sale of the Product by Licensee, its Affiliates or sublicensees, including any and all calculations of the applicable Fees and any patent prosecution records (collectively, “Relevant Records”). Licensee shall maintain the Relevant Records for the longer of: (a) the period of time required by Applicable Law, or (b) [***] following expiration or termination of this Agreement. Relevant Records shall be treated as Licensee Confidential Information. | ||
6.2. | Audit Request. Pfizer shall have the right during the term of this Agreement and for [***] thereafter to engage, at its own expense, an independent auditor reasonably acceptable to Licensee to examine the Relevant Records from time-to-time, but no more frequently than [***] every [***], as may be necessary to verify (a) the accuracy of Net Sales reported and the basis for royalty and other payments (including any adjustments pursuant to Section 5.6, 5.7 or 5.8) made under this Agreement and (b) the difference, if any, such reported and paid amounts vary from amounts determined as a result of the audit. Such audit shall be requested in writing at least [***] in advance, and shall be conducted during Licensee’s normal business hours and otherwise in a manner that minimizes any interference to Licensee’s business operations. |
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6.3. | Audit Fees and Expenses. Pfizer shall bear any and all fees and expenses it may incur in connection with any such audit of the Relevant Records; provided, however, in the event an audit reveals an underpayment by Licensee of more than [***] as to the period subject to the audit, Licensee shall reimburse Pfizer for any reasonable and documented out-of-pocket costs and expenses of the audit within [***] after receiving invoices thereof, and notwithstanding the provisions of Section 6.2, Pfizer shall have the right to examine the Relevant Records of Licensee up to [***] every [***] for the [***] period following the audit revealing such underpayment. | ||
6.4. | Payment of Deficiency. If any audit establishes that Licensee has underpaid any amounts due to Pfizer under this Agreement, then Licensee shall pay to Pfizer any such deficiency within [***] after receipt of written notice thereof. For the avoidance of doubt, such payment will be considered a late payment, subject to Section 5.11. | ||
7. | INTELLECTUAL PROPERTY RIGHTS. | ||
7.1. | Pre-existing IP. Subject only to the rights expressly granted to the other Party under this Agreement, each Party shall retain all rights, title and interests in and to any Intellectual Property Rights that are owned, licensed or sublicensed by such Party prior to or independent of this Agreement. | ||
7.2. | Patent Prosecution. | ||
7.2.1. | Patent Prosecution and Maintenance. Subject to Pfizer’s rights set forth in Section 7.2.3 below, (a) until the earlier of (i) the [***] anniversary of the Effective Date and (ii) such time as Licensee provides Pfizer written notice that it is able to assume its obligations under Section 7.2.1(b) (the “Initial Period”), Pfizer will continue to file, prosecute (including in connection with any reexaminations, oppositions and the like) and maintain the Licensed Patent Rights in the Territory and in Pfizer’s name on behalf of Licensee and at Licensee’s cost and expense using counsel of Pfizer’s choice, and (b) upon expiration of the Initial Period, Licensee will be responsible for filing, prosecuting (including in connection with any reexaminations, oppositions and the like) and maintaining the Licensed Patent Rights in the Territory and in Pfizer’s name at Licensee’s own cost and expense using, [***] as its lead patent counsel and [***] as its annuity service provider to prepare, file, prosecute and maintain the Licensed Patent Rights. Licensee will select additional qualified patent counsel and foreign agents as necessary, in each case reasonably acceptable to Pfizer, within ten (10) Business Days after the Effective Date. Following the Initial Period and during the Term, Licensee will provide notice of any substitution of such counsel, foreign agents or annuity service providers within thirty (30) days after such substitution. After the Initial Period, before each submission is filed, Licensee will provide |
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Pfizer a reasonable opportunity to review and comment on proposed submissions to any patent office and [***] any comments provided by Pfizer to Licensee. Licensee will keep Pfizer reasonably informed of the status of the Licensed Patent Rights by timely providing Pfizer copies of significant communications relating to such Licensed Patent Rights that are received from any patent office or patent counsel of record or foreign associate.
7.2.2. | Assistance. As reasonably requested by Licensee in writing, Pfizer shall cooperate, at Licensee’s expense, in obtaining patent term restoration (under, but not limited to, the Drug Price Competition and Patent Term Restoration Act), supplementary protection certificates or their equivalents, and patent term extensions with respect to the Licensed Patent Rights. | |
7.2.3. | Failure to Prosecute or Maintain. In the event Licensee elects to forgo filing, prosecution or maintenance of the Licensed Patent Rights, Licensee shall notify Pfizer of such election at least [***] prior to any filing or payment due date, or any other due date that requires action (“Election Notice”). Upon receipt of an Election Notice, Pfizer shall be entitled, upon written notice to Licensee, at its sole discretion and expense, to file or to continue the prosecution or maintenance of such Patent Right in such country in Pfizer’s name using counsel of its own choice and at its own expense, in which case, as of the date Licensee provides Pfizer such Election Notice, the license granted in Section 2.1.1 with respect to such patent rights shall become non-exclusive and non-sublicensable (to the extent Licensee has not sublicensed such Patent Right prior to providing such Election Notice), and Licensee will have no further rights in respect of the filing, maintenance or enforcement of such Patent Right. | |
7.2.4. | Developed IP. Ownership of any Developed IP shall be determined in accordance with Applicable Laws relating to inventorship set forth in U.S. patent laws. Each Party retains the sole right to prepare, prosecute and maintain Patent Rights included within any Developed IP Controlled by such Party. | |
7.2.5. | Liability. To the extent Pfizer is obtaining, prosecuting or maintaining a Patent Right included in the Licensed Patent Rights, Pfizer, its Affiliates, employees, agents or representatives, shall not be liable to Licensee in respect of any act, omission, default or neglect on the part of Pfizer, or its Affiliates, employees, agents or representatives, in connection with such activities undertaken in good faith. |
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8. | INFRINGEMENT; MISAPPROPRIATION. | |||
8.1. | Notification. Each Party will promptly notify the other Party in writing of any (a) actual or threatened infringement, misappropriation or other violation by a Third Party of any Licensed Technology in the Field and in the Territory of which it becomes aware, including but not limited to the receipt of a Biosimilar Notice with respect to a Product or (b) declaratory judgment action against any Licensed Patent Right in the Territory in connection with any infringement described in clause (a) (any of (a) or (b) constituting a (“Third Party Infringement”)). | |||
8.2. | Infringement Action. | |||
8.2.1. | Right of First Enforcement. | |||
(a) | Licensee shall have the first right (but not the obligation), at its own expense, to control enforcement of the Licensed Technology against any Third Party Infringement within the scope of its exclusive license and may name Pfizer as a party for standing purposes. Pfizer has the right to join and cooperate with any such action at Licensee’s cost, or to retain separate counsel at Pfizer’s own expense. Prior to commencing any such action, Licensee shall consult with Pfizer and shall give due consideration to Pfizer’s recommendations regarding the proposed action. Licensee shall give Pfizer timely notice of any proposed settlement of any such action instituted by Licensee and shall not, without the prior written consent of Pfizer, enter into any settlement that would: (i) adversely affect the validity, enforceability or scope of any of the Licensed Patent Rights, (ii) give rise to liability of Pfizer or its Affiliates, (iii) admit non-infringement of any Licensed Patent Rights, or (iv) otherwise impair Pfizer’s rights in any Licensed Technology or this Agreement. | |||
(b) | If Licensee does not, with respect to its first right of enforcement under Section 8.2.1(a), obtain agreement from the alleged infringer to desist or fails or refuses to initiate an infringement action by the earlier of [***] then Pfizer shall have the right, at its sole discretion, to control such enforcement of the Licensed Technology at its sole expense. | |||
8.2.2. | Recoveries. Any recoveries resulting from an action relating to a claim of Third Party Infringement shall first be applied to reimburse each Party’s costs and expenses incurred in connection therewith. Any remaining recoveries shall be retained by (or if received by Pfizer, paid to) Licensee; provided, however, [***]. If Licensee fails to institute an action or proceeding and Pfizer exercises its right to prosecute such |
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infringement pursuant to Section 8.2.1(b), any remaining recoveries shall be retained by Pfizer.
9. | CONFIDENTIALITY. | ||
9.1. | Definition. “Confidential Information” of a Party means the existence, terms and provisions of this Agreement and all other proprietary information and data of a financial, commercial or technical nature that the disclosing Party or any of its Affiliates has supplied or otherwise made available to the other Party or its Affiliates, which are disclosed in writing or, if disclosed orally or visually, summarized in writing and provided to the receiving Party after disclosure. All Licensed Know-How shall be considered Pfizer’s Confidential Information. Confidential Information shall not include information that: (a) is, at the time of disclosure or becomes, after the time of disclosure, known to the public or part of the public domain through no breach of this Agreement by the receiving Party or any Recipients to whom it disclosed such information; (b) was known to, or was otherwise in the possession of, the receiving Party prior to the time of disclosure by the disclosing Party; (c) is disclosed to the receiving Party on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the disclosing Party; or (d) is independently developed by or on behalf of the receiving Party or any of its Affiliates, as evidenced by its written records, without use or access to the Confidential Information. | ||
9.2. | Obligations. The receiving Party will protect all Confidential Information against unauthorized disclosure to Third Parties with the same degree of care as the receiving Party uses for its own similar information, but in no event less than a reasonable degree of care. The receiving Party may disclose the Confidential Information to its Affiliates, and their respective directors, officers, employees, subcontractors, current and prospective sublicensees, consultants, attorneys, accountants, banks and investors (collectively, “Recipients”) who have a need to know such information for purposes related to this Agreement, provided that the receiving Party shall hold such Recipients to written obligations of confidentiality with terms and conditions at least as restrictive as those set forth in this Agreement. All obligations of confidentiality under this Agreement shall survive expiration or termination of this Agreement for a period of [***]. | ||
9.3. | Exceptions. | ||
9.3.1. | Disclosure Required by Law. The restrictions set forth in this Article 9 shall not apply to any Confidential Information that the receiving Party is required to disclose under Applicable Laws or a court order or other governmental order, provided that the receiving Party: (a) provides the disclosing Party with prompt notice of such disclosure requirement if legally permitted, (b) affords the disclosing Party an opportunity to oppose, limit or secure confidential treatment for such required disclosure and (c) if the disclosing Party is unsuccessful in its efforts pursuant to subsection (b), discloses only that portion of the |
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Confidential Information that the receiving Party is legally required to disclose as advised by the receiving Party’s legal counsel.
9.3.2. | Disclosure to Assignee of Payments. In the event that Pfizer wishes to assign, pledge or otherwise transfer its rights to receive some or all of the Milestone Payments, Royalties and Transaction Completion Payment payable hereunder, Pfizer may disclose to a Third Party Confidential Information of Licensee in connection with any such proposed assignment solely to the extent reasonably necessary in connection with such transaction, provided that Pfizer shall hold such Third Parties to written obligations of confidentiality and non-use with terms and conditions at least as restrictive as those set forth in this Agreement. | ||
9.4. | Right to Injunctive Relief. The Parties agree that breaches of this Article 9 may cause irreparable harm to the non-breaching Party and shall entitle the non-breaching Party, in addition to any other remedies available to it (subject to the terms of this Agreement), the right to seek injunctive relief enjoining such action. | ||
9.5. | Ongoing Obligation for Confidentiality. Upon expiration or termination of this Agreement, the receiving Party shall, and shall cause its Recipients to, destroy or return (as requested by the disclosing Party) any Confidential Information of the disclosing Party, except that the receiving Party (a) may retain a single copy of Confidential Information for the sole purpose of ascertaining its rights and responsibilities in respect of such information and (b) shall not be required to destroy any computer files stored securely by the receiving Party that are created by automatic system back up. | ||
10. | REPRESENTATIONS, WARRANTIES AND COVENANTS. | ||
10.1. | Representations and Warranties by Each Party. Each Party represents and warrants to the other Party as of the Effective Date that: | ||
10.1.1. | it is a company duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation; | ||
10.1.2. | it has full corporate power and authority to execute, deliver, and perform under this Agreement, and has taken all corporate action required by Applicable Law and its organizational documents to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement; | ||
10.1.3. | this Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms; | ||
10.1.4. | all consents, approvals and authorizations from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and |
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10.1.5. | the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby do not and shall not: (i) conflict with or result in a breach of any provision of its organizational documents, (ii) result in a breach of any agreement to which it is a party that would impair the performance of its obligations hereunder; or (iii) violate any Applicable Law. | ||
10.2. | Representations and Warranties by Pfizer. With the exception of the claims described in Schedule 10.2, Pfizer represents and warrants to Licensee as of the Effective Date that: | ||
10.2.1. | Pfizer has the right to grant right, title and interest in the licenses and other rights granted to Licensee under this Agreement; | ||
10.2.2. | there is no ongoing and, to Pfizer’s Knowledge, there is no threatened litigation, opposition or challenge involving the Licensed Patent Rights. | ||
10.2.3. | Pfizer is the sole and exclusive owner of the Licensed Patent Rights, free of any encumbrance, lien or claim of ownership by any Third Party. | ||
10.2.4. | Pfizer have complied in all material respects with all Applicable Laws, including the U.S. Foreign Corrupt Practices Act, U.K. Bribery Act, and any other applicable anti-bribery or anti-corruption laws (“Compliance Laws”) with respect to the filing, prosecution and maintenance of the Licensed Patent Rights, paid all maintenance and annuity fees with respect to the Licensed Patent Rights, and no dispute regarding inventorship has been alleged or threatened with respect to the Licensed Patent Rights. | ||
10.2.5. | to Pfizer’s Knowledge, Pfizer has not infringed or misappropriated any valid and enforceable Patents or Know-How of a Third Party in connection with Developing the Licensed Technology. | ||
10.2.6. | it is beneficially entitled to all payments made under this Agreement and fulfils all conditions which must be fulfilled under the United Kingdom and the United States of America double taxation agreement to obtain full exemption from the United Kingdom taxation on royalty payments. | ||
10.3. | Representations, Warranties and Covenants by Licensee. | ||
10.3.1. | Licensee covenants to Pfizer that it shall comply with all Applicable Law with respect to the performance of its obligations hereunder. | ||
10.3.2. | Licensee covenants to Pfizer that it will use Commercially Reasonable Efforts to Develop, seek Regulatory Approval and Commercialize the Product consistent with the timelines set forth in the Development Plan. |
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10.3.3. | [***] | |
10.3.4. | Without limiting the generality of Section 10.3.1, Licensee shall comply, and has at all times complied in all material respects, with Compliance Laws. Licensee represents and warrants that neither it, nor its respective Affiliates, nor to its knowledge, any director, officer, employee, consultant, agent or representative or other person acting on its behalf has taken or will take any action, directly or indirectly, to pay, offer, promise or authorize the payment, or giving of anything of value to any Government Official, or to any person, and has not accepted and will not accept a payment or any item of value: (a) for the purpose of (i) influencing any act or decision of such Government Official(s) in their official capacity, including the failure to perform an official function, in order to assist that Licensee or its Affiliates or any beneficiary of Licensee in obtaining or retaining business, or directing business to any third party, (ii) securing an improper business advantage, (iii) inducing such Government Official(s) to use their influence to affect or influence any act or decision of a government entity in order to assist Licensee, its Affiliates or any beneficiary of Licensee in obtaining or retaining business, or directing business to any third party, or (v) providing an unlawful personal gain or benefit, of financial or other value, to such Government Official(s); or (b) otherwise for the benefit of Licensee, or any of its Affiliates in violation of any federal, state, local, municipal, foreign, international, multinational or other administrative law. As used herein, “Government Official” means: (A) any elected or appointed government official (e.g., a member of a ministry of health), (B) any employee or person acting for or on behalf of a government official, agency, or enterprise performing a governmental function, (C) any political party officer, employee, or person acting for or on behalf of a political party or candidate for public office, (D) an employee or person acting for or on behalf of a public international organization, or (E) any person otherwise categorized as a government official under local law. “Government” is meant to include all levels and subdivisions of non-U.S. governments (i.e., local, regional, or national and administrative, legislative, or executive). Moreover, Licensee represents and warrants that it has maintained and will maintained books, records, and accounts which, in reasonable detail, accurately and fairly reflect the transactions and dispositions of Licensee’s assets. | |
10.3.5. | Licensee has, and has caused each of its subsidiaries and Affiliates to, cease all of its or their respective activities, as well as remediate any actions taken by the Licensee, its subsidiaries or Affiliates in violation of Compliance Laws. The Licensee has, and has caused, each of its Affiliates and subsidiaries to, maintain and will continue to maintain systems or internal controls (including, but not limited to, accounting systems, purchasing systems and billing systems) intended to ensure compliance with Compliance Laws. |
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10.3.6. | Neither Licensee nor any of its directors, officers, managers or employees are, with respect to Licensee’s operations, the subject of any allegation, voluntary disclosure, investigation, prosecution or other enforcement action related to Compliance Laws. | ||
10.4. | No Action Required Which Would Violate Law. In no event shall Pfizer be obligated under this Agreement to take any action or omit to take any action that Pfizer believes, in good faith, would cause Pfizer to violate any Applicable Law, including without limitation the Compliance Laws. | ||
10.5. | No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 10, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO WARRANTIES OF TITLE, NON-INFRINGEMENT, VALIDITY, ENFORCEABILITY, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. ANY INFORMATION OR MATERIALS, INCLUDING ANY MATERIALS SET FORTH ON SCHEDULE 3, PROVIDED BY PFIZER OR ITS AFFILIATES IS MADE AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED. | ||
11. | INDEMNIFICATION. | ||
11.1. | Indemnification by Licensee. [***] | ||
11.2. | Indemnification by Pfizer. [***] | ||
11.3. | Indemnification Procedure. In connection with any Claim for which a Pfizer Indemnitee or Licensee Indemnitee (the relevant “Indemnitee”) seeks indemnification from Licensee or Pfizer (the relevant “Indemnitor”) pursuant to this Agreement, Pfizer or Licensee, respectively, shall: (a) give the Indemnitor prompt written notice of the Claim; provided, however, that failure to provide such notice shall not relieve the Indemnitor from its liability or obligation hereunder, except to the extent of any material prejudice as a direct result of such failure; (b) cooperate with the Indemnitor, at the Indemnitor’s expense, in connection with the defense and settlement of the Claim; and (c) permit the Indemnitor to control the defense and settlement of the Claim; provided, however, that the Indemnitor may not settle the Claim without Pfizer or Licensee’s, respectively, prior written consent, which shall not be unreasonably withheld or delayed, in the event that such settlement materially adversely impacts any relevant Indemnitee’s rights or obligations. Further, Pfizer or Licensee, respectively, shall have the right to participate (but not control) and be represented in any suit or action by advisory counsel of its selection and at its own expense. |
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12. | LIMITATION OF LIABILITY. | |
12.1. | Consequential Damages Waiver. EXCEPT FOR A BREACH OF ARTICLE 9 OR OBLIGATIONS ARISING UNDER ARTICLE 11, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, INCLUDING DAMAGES FOR LOST PROFITS OR LOST REVENUES REGARDLESS OF WHETHER IT HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE). | |
12.2. | Liability Cap. EXCEPT IN THE EVENT OF GROSS NEGLIGENCE, FRAUD OR WILLFUL MISCONDUCT OF A PARTY OR ITS AFFILIATES, IN NO EVENT SHALL EITHER PARTY’S LIABILITY FOR DAMAGES IN CONNECTION WITH THIS AGREEMENT EXCEED THE CAP, REGARDLESS OF WHETHER THE OTHER PARTY HAS BEEN INFORMED OF THE POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES OR THE TYPE OF CLAIM, CONTRACT OR TORT (INCLUDING NEGLIGENCE). “Cap” means [***]. | |
13. | TERM; TERMINATION. | |
13.1. | Term. The term of this Agreement (“Term”) shall commence as of the Effective Date and shall expire upon the last-to-expire Royalty Term. Upon expiry of this Agreement pursuant to this Section 13.1, the licenses granted to Licensee under this Agreement shall become fully paid-up, royalty-free, perpetual and irrevocable. | |
13.2. | Termination for Cause. Each Party shall have the right, without prejudice to any other remedies available to it at law or in equity, to terminate this Agreement in the event the other Party materially breaches any of its obligations hereunder and fails to cure such breach within [***] of receiving notice thereof; provided, however, (i) if a notice under this Section 13.2 is served alleging material breach, the parties shall first seek to resolve such alleged breach and any related dispute between the Senior Officers within [***] of receiving notice, and (ii) should the Senior Officers be unable to resolve the dispute within such [***] period, if such breach is capable of being cured, but cannot be cured within such [***] period, and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the breaching Party shall have such additional period as is reasonable to cure such breach, but in no event will such additional period exceed [***]. Any termination by a Party under this Section 13.2 shall be without prejudice to any damages or other legal or equitable remedies to which it may be entitled from the other Party. For the avoidance of doubt, Licensee’s failure to use Commercially Reasonable Efforts in accordance with this Agreement to Develop and Commercialize the Product or failure to make a Milestone Payment or Royalty payment shall constitute a material breach by Licensee under this Agreement. |
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13.3. | Termination for a Bankruptcy Event. Pfizer shall have the right to terminate this Agreement in the event of a Bankruptcy Event with respect to Licensee. “Bankruptcy Event” means the occurrence of any of the following: (a) the institution of any bankruptcy, receivership, insolvency, reorganization or other similar proceedings by or against Licensee under any bankruptcy, insolvency, or other similar law now or hereinafter in effect, including any section or chapter of the United States Bankruptcy Code, as amended or under any similar laws or statutes of the United States or any state thereof (the “Bankruptcy Code”), where in the case of involuntary proceedings such proceedings have not been dismissed or discharged within thirty (30) days after they are instituted, (b) the insolvency or making of an assignment for the benefit of creditors or the admittance by Licensee of any involuntary debts as they mature, (c) the institution of any reorganization, arrangement or other readjustment of debt plan of Licensee not involving the Bankruptcy Code, (d) appointment of a receiver for all or substantially all of Licensee’s assets, or (e) any corporate action taken by the board of directors of Licensee in furtherance of any of the foregoing actions. | |||
13.4. | Effects of Termination. | |||
13.4.1. | Termination by Licensee for Cause. In the event that Licensee terminates this Agreement pursuant to Section 13.2, the following shall apply: | |||
(a) | Rights and Obligations. Except as otherwise provided herein, all rights and obligations of each Party hereunder shall cease, including, subject to Section 13.4.1(b), the licenses granted to Licensee pursuant to Section 2.1. | |||
(b) | Licensee Inventory. Licensee shall have the right to sell its remaining inventory of Product so long as Licensee has fully paid, and continues to pay when due, all Royalties, Milestone Payments and any Transaction Completion Payment owed to Pfizer, and Licensee is otherwise not in material breach of this Agreement. | |||
13.4.2. | Termination by Pfizer for Cause, Bankruptcy Event. In the event that Pfizer terminates this Agreement pursuant to Section 13.2 or Section 13.3, the following shall apply: | |||
(a) | Rights and Obligations. Except as otherwise provided herein, all rights and obligations of each Party hereunder shall cease. | |||
(b) | Licenses. Pfizer shall have a perpetual, irrevocable, worldwide, fully-paid up, royalty-free exclusive right and license, with the right to grant sublicenses, under the Developed IP Controlled by Licensee, as it exists as of the effective date of termination, to |
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use, Develop, Commercialize and Manufacture Compound and Products.
(c) | Transition. During the notice period provided in Section 13.2, or as soon as practicable upon notice of termination pursuant to Section 13.3, as applicable to such termination, at Pfizer’s sole option, Pfizer shall prepare and the Parties shall negotiate a transition plan that will include, at a minimum, a plan for accomplishing the activities described in this Section 13.4.2(c). | ||
(i) | Continued Development. At Pfizer’s request and expense, Licensee shall continue on-going Development for a mutually agreed-upon period following terminating of this Agreement, which period shall not be less than [***] unless otherwise agreed to by the Parties. For avoidance of doubt, if Pfizer chooses not to continue a Clinical Trial initiated by Licensee, Licensee shall be solely responsible for the cost of winding down such trial, including compliance with any ethical or other requirements imposed by an applicable Regulatory Authority. | ||
(ii) | Technology Transfer. At Pfizer’s request, Licensee shall make available to Pfizer all currently available records and data which exist and are Controlled by Licensee as of the effective date of termination and are necessary or useful for Pfizer to continue using, Developing, Commercializing and Manufacturing the Product. | ||
(iii) | Regulatory Matters. At Pfizer’s request, Licensee shall transfer and assign to Pfizer (or its designee) all Regulatory Approvals, pricing approvals and Regulatory Filings held by Licensee with respect to the Product, provided that if such transfer and assignment is not permitted by the applicable Regulatory Authority, Licensee shall permit Pfizer to cross-reference and rely upon such Regulatory Approvals, pricing approvals and Regulatory Filings. Licensee shall make available to Pfizer copies of all regulatory documentation and records related to the Product, including information contained in the regulatory and safety databases. The Parties shall cooperate to ensure the prompt transition of regulatory responsibilities for the Product from Licensee to Pfizer. |
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(iv) | Trademarks. Pfizer shall have a fully paid-up, royalty-free, worldwide, transferable, sublicensable, perpetual and irrevocable license to use the trademarks associated with a Product solely for the purpose of using, Developing, Commercializing and Manufacturing the Product. Pfizer shall have a transitional license to use Licensee’s trademarks and promotional materials solely for the purpose of using, Developing, Commercializing and Manufacturing the Product. | |||
(v) | Inventory and Supply. At Pfizer’s request, Licensee shall transfer to Pfizer (or its designee) all Product, components and in-process inventory produced or held by Licensee with respect to the Manufacture of Products. At Pfizer’s request, if Licensee has sublicensed to a CMO to Manufacture the Product, Licensee shall promptly assign such sublicense to Pfizer, or if not, Licensee shall continue to Manufacture or have Manufactured the Product for a period of not less than [***], including, at Pfizer’s request, a reasonable stock build. Pfizer shall pay to Licensee the actual cost of manufacturing associated with inventory and Product received by Pfizer pursuant to this Section 13.4.2(c)(v). | |||
(vi) | Third Party Agreements. At Pfizer’s request, to the extent Licensee is able to do so, Licensee shall assign to Pfizer (or its designee) any agreements with Third Parties with respect to the Development, Commercialization and Manufacture of the Product. With respect to Third Party agreements that Licensee is not able to assign to Pfizer, Licensee shall cooperate to give Pfizer the benefit of such contracts for a reasonable transitional period. | |||
13.5. | Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing hereunder prior to such expiration or termination. Without limiting the foregoing, the provisions of Articles 6, 9, 11, 12, 15, 16 and Sections 2.2.1, 5.7, 7.1, 8.2.2, 10.3.3,13.4, 13.5, 17.3 and 17.8 shall survive expiration or termination of this Agreement. | |||
14. | PUBLICITY; PUBLICATIONS. | |||
14.1. | Use of Names. Subject to Pfizer’s rights pursuant to Section 13.4.2(c)(iv), neither Party (nor any of its Affiliates or agents) shall use the registered or unregistered trademarks, service marks, trade dress, trade names, logos, insignia, domain names, symbols or designs of the other Party or its Affiliates in any press release, |
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publication or other form of promotional disclosure without the prior written consent of the other Party in each instance.
14.2. | Press Releases. The Parties acknowledge that one or both Parties, either singly or jointly, may desire to publish one or more press releases relating to this Agreement, the rights granted hereunder, and developments made thereto. However, each Party agrees not to issue any press release or other public statement, whether written, electronic, oral or otherwise, disclosing the existence of this Agreement, the terms hereof or any information relating to this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed. Neither Party will be prevented from complying with any duty of disclosure it may have pursuant to Applicable Law or the rules of any recognized stock exchange so long as the disclosing Party provides the other Party at least ten (10) Business Days prior written notice to the extent practicable and only discloses information to the extent required by Applicable Law or the rules of any recognized stock exchange. | |
14.3. | Publications. During the Term, Licensee shall submit to Pfizer for review and approval any proposed academic, scientific or medical publication or public presentation that contains Pfizer’s Confidential Information. Such review and approval will be conducted for the purposes of preserving the value of the Licensed Technology and determining whether any portion of the proposed publication or presentation containing Pfizer’s Confidential Information should be modified or deleted. Written copies of such proposed publication or presentation required to be submitted hereunder shall be submitted to Pfizer no later than sixty (60) days before submission for publication or presentation (the “Review Period”). Pfizer shall provide its comments with respect to such publications and presentations within thirty (30) days of its receipt of such written copy. The Review Period may be extended for an additional thirty (30) days in the event Pfizer can, within ten (10) days of receipt of the written copy, demonstrate reasonable need for such extension including for the preparation and filing of patent applications. Licensee will comply with standard academic practice regarding authorship of scientific publications and recognition of contribution of other parties in any publication governed by this Section 14.3, including International Committee of Medical Journal Editors standards regarding authorship and contributions. | |
15. | LICENSEE INSURANCE. | |
15.1. | Insurance Requirements. Licensee will maintain during the Term and until the later of: (a) [***] after termination or expiration of this Agreement, or (b) the date that all statutes of limitation covering claims or suits that may be instituted for personal injury based on the sale or use of the Product have expired, commercial general liability insurance from a minimum [***] AM Best rated insurance company, including contractual liability and product liability or clinical trials with coverage limits of not less than [***]. Licensee has the right to provide the total limits required by any combination of primary and umbrella/excess coverage. The minimum level of insurance set forth herein shall not be construed to create a limit on Licensee’s liability hereunder. Such policies shall name Pfizer and its Affiliates |
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as additional insured (usually for US, Canada and Puerto Rico exposures) or indemnify Pfizer and its Affiliates, as principal (usually for rest of world exposures) and provide a waiver of subrogation in favor of Pfizer and its Affiliates. Such insurance policies shall be primary and non-contributing with respect to any other similar insurance policies available to Pfizer or its Affiliates. Any deductibles for such insurance shall be assumed by Licensee.
15.2. | Policy Notification. Licensee shall provide Pfizer with certified copies of such policies or original certificates of insurance evidencing such insurance: (a) prior to execution by both Parties of this Agreement, and (b) prior to expiration of any one coverage. Licensee shall provide that Pfizer shall be given at least thirty (30) days written notice prior to cancellation, termination or any material change to restrict the coverage or reduce the limits afforded. | |||
16. | DISPUTE RESOLUTION. | |||
16.1. | Arbitration. | |||
16.1.1. | General. Any disputes, controversies or other claims arising out of this Agreement, its interpretation, validity, performance, enforceability, breach or termination (“Disputes”) that are not settled amicably shall be referred by sending written notice of the Dispute to the other Party for final and binding arbitration with the office of the American Arbitration Association in New York County, New York in accordance with the then-prevailing commercial arbitration rules of the American Arbitration Association. | |||
16.1.2. | Number of Arbitrators. The arbitration shall be settled by one (1) arbitrator who is neutral to the Parties, and the Parties shall endeavor to jointly appoint the arbitrator. If the Parties fail to jointly appoint the arbitrator within (15) fifteen days of the arbitration being initiated, the appointment shall be made by the American Arbitration Association. | |||
16.1.3. | Powers of the Arbitrator. | |||
(a) | The arbitrator is authorized to award to the prevailing Party, if a prevailing party is determined by the arbitrator, such Party’s costs and expenses, including attorneys’ fees. | |||
(b) | The arbitrator may not award punitive, exemplary, or consequential damages, nor may the arbitrator apply any multiplier to any award of actual damages, except as may be required by statute. | |||
(c) | The arbitrator shall have the discretion to hear and determine at any stage of the arbitration any issue asserted by any Party to be dispositive of any claim or counterclaim, in whole or part, in accordance with such procedure as the arbitrator may deem |
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appropriate, and the arbitrator may render an award on such issue.
(d) | In addition to the authority conferred on the arbitrator by the rules designated in this Agreement, and without prejudice to any provisional measures that may be available from a court of competent jurisdiction, the arbitrator shall have the power to grant any provisional measures that the arbitrator deems appropriate, including but not limited to provisional injunctive relief, and any provisional measures ordered by the arbitrator may, to the extent permitted by Applicable Law, be deemed to be a final award on the subject matter of the measures and shall be enforceable as such. | |||
16.1.4. | Confidentiality. No information concerning an arbitration, beyond the names of the parties and the relief requested, may be unilaterally disclosed to a Third Party by any Party unless required by Applicable Law. Any documentary or other evidence given by a Party or witness in the arbitration shall be treated as confidential by any Party whose access to such evidence arises exclusively as a result of its participation in the arbitration, and shall not be disclosed to any Third Party (other than a witness or expert), except as may be required by Applicable Law. | |||
16.2. | No Trial By Jury. THE PARTIES EXPRESSLY WAIVE AND FOREGO ANY RIGHT TO TRIAL BY JURY. | |||
17. | GENERAL PROVISIONS. | |||
17.1. | Assignment. Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent, except that: (a) Pfizer may assign to a Third Party its rights to receive some or all of the payments payable hereunder, (b) each Party may assign its rights and obligations under this Agreement or any part hereof to one or more of its Affiliates without the consent of the other Party; and (c) either Party may assign this Agreement in the event of a Change of Control of such Party. The assigning Party shall provide the other Party with prompt written notice of any such assignment. Any permitted assignee pursuant to clauses (b) and (c) above shall assume all obligations of its assignor under this Agreement, and no permitted assignment shall relieve the assignor of liability for its obligations hereunder. Any attempted assignment in contravention of the foregoing shall be void. | |||
17.2. | Severability. Should one or more of the provisions of this Agreement become void or unenforceable as a matter of law, then such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement, and the Parties agree to substitute a valid and enforceable provision therefor which, as nearly as possible, achieves the desired economic effect and mutual understanding of the Parties under this Agreement. |
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17.3. | Governing Law. This Agreement shall be governed by and construed under the laws in effect in the State of New York, U.S. without giving effect to any conflicts of laws provision thereof or of any other jurisdiction that would produce a contrary result. Article 16 does not intend to deprive any New York court of competent jurisdiction with respect to its power to issue a pre-arbitral injunction, pre-arbitral attachment or other order in aid of arbitration proceedings or the enforcement of any judgment or award. In any such action, the courts located in the Southern District of New York shall have exclusive jurisdiction over any action brought to enforce this Agreement, and each of the Parties hereto irrevocably: (a) submits to such exclusive jurisdiction for such purpose; (b) waives any objection which it may have at any time to the laying of venue of any proceedings brought in such courts; (c) waives any claim that such proceedings have been brought in an inconvenient forum, (d) further waives the right to object with respect to such proceedings that any such court does not have jurisdiction over such Party, and (e) consents to service of process in the manner provided by Section 17.8 or by first class certified mail, return receipt requested, postage prepaid. | |
17.4. | Force Majeure. Except with respect to delays or nonperformance caused by the negligent or intentional act or omission of a Party, any delay or nonperformance by such Party (other than payment obligations under this Agreement) will not be considered a breach of this Agreement to the extent such delay or nonperformance is caused by acts of God, natural disasters, acts of the government or civil or military authority, fire, floods, epidemics, quarantine, energy crises, war or riots or other similar cause outside of the reasonable control of such Party (each, a “Force Majeure Event”), provided that the Party affected by such Force Majeure Event will promptly begin or resume performance as soon as reasonably practicable after the event has abated. If the Force Majeure Event prevents a Party from performing any of its obligations under this Agreement for one hundred eighty (180) days or more, then the other Party may terminate this Agreement immediately upon written notice to the non-performing Party. | |
17.5. | Waivers and Amendments. The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party. | |
17.6. | Relationship of the Parties. Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between Pfizer and Licensee, or to constitute one Party as the agent of the other. Moreover, each Party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for, bind, or commit the other Party. |
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17.7. | Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. | |
17.8. | Notices. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt), or (b) when received by the addressee, if sent by an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses set forth below (or to such other addresses as a Party may designate by written notice): |
If to Pfizer:
Pfizer Inc.
[***]
with copies to:
Pfizer Inc.
[***]
Pfizer Inc.
[***]
If to Licensee:
[***]
with copies to:
Zura Bio Limited
[***]
17.9. | Further Assurances. Licensee and Pfizer hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary or appropriate to carry out the intent and purposes of this Agreement. | ||
17.10. | No Third Party Beneficiary Rights. This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including, without limitation, any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby. | ||
17.11. | Entire Agreement; Confidentiality Agreement. | ||
17.11.1. | This Agreement, together with its Schedules, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter, |
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including, without limitation, that certain Confidentiality Agreement by and between the Parties, dated November 10, 2020 (“CDA”). The Parties acknowledge and agree that, as of the Effective Date, all Confidential Information (as defined in the CDA) disclosed by Pfizer or its Affiliates pursuant to the CDA shall be considered Pfizer’s Confidential Information and subject to the terms set forth in this Agreement.
17.11.2. | In the event of any conflict between a material provision of this Agreement and any Schedule hereto, the Agreement shall control. | ||
17.12. | Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. | ||
17.13. | Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law. | ||
17.14. | Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, any rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply. |
[Signature page to follow]
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
ZURA BIO LIMITED | PFIZER INC. | |||
By: | By: | |||
Name: | Name: | |||
Title: | Title: |
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SCHEDULE 1.58: KNOWLEDGE
[***]
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SCHEDULE 1.60: LICENSED KNOW-HOW
[***]
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SCHEDULE 1.60: LICENSED KNOW-HOW
EXHIBIT 1
Non-Clinical Toxicology
[***]
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SCHEDULE 1.60: LICENSED KNOW-HOW
EXHIBIT 2
Non-Clinical Research and Development
[***]
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SCHEDULE 1.60: LICENSED KNOW-HOW
EXHIBIT 3
Clinical Studies
[***]
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SCHEDULE 1.60: LICENSED KNOW-HOW
EXHIBIT 4
Toxicology Specimens
[***]
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SCHEDULE 1.61: LICENSED PATENT RIGHTS
[***]
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SCHEDULE 3: TRANSFER ACTIVITIES
[***]
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SCHEDULE 4.6 DEVELOPMENT PLAN
[***]
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SCHEDULE 10.2 CLAIMS
[***]
Exhibit 10.17
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT NORMALLY TREATS AS PRIVATE AND CONFIDENTIAL.
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[***]
LICENCE AGREEMENT
between
LONZA SALES AG
and
ZURA BIO LIMITED
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INDEX
ARTICLE | TITLE | PAGE |
1. | DEFINITIONS AND INTERPRETATION | 3 |
2. | SUPPLY OF SYSTEM KNOW-HOW | 6 |
3. | OWNERSHIP OF PROPERTY AND INTELLECTUAL PROPERTY | 7 |
4. | LICENCES | 7 |
5. | PAYMENTS | 9 |
6. | ROYALTY PROCEDURES | 10 |
7. | LIABILITY AND WARRANTIES | 11 |
8. | CONFIDENTIALITY | 12 |
9. | INTELLECTUAL PROPERTY ENFORCEMENT | 13 |
10. | TERM AND TERMINATION | 14 |
11. | ASSIGNMENT | 15 |
12. | GOVERNING LAW AND DISPUTE RESOLUTION | 15 |
13. | FORCE MAJEURE | 16 |
14. | ILLEGALITY | 16 |
15. | MISCELLANEOUS | 16 |
16. | NOTICE | 17 |
APPENDIX
1 | Vectors |
2 | [***] |
THIS AGREEMENT is made the day of 2022
BETWEEN
LONZA SALES AG incorporated and registered in Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland (hereinafter referred to as "Lonza"),
and
ZURA BIO LIMITED incorporated and registered in UK whose registered office is at 3rd Floor 1 Ashley Road, Altrincham, Cheshire, WA14 2DT, UK (hereinafter referred to as "Licensee")
The Licensee and Lonza shall jointly be referred to as the “Parties” and individually as the “Party”.
WHEREAS
A | Lonza is the proprietor of the System and has the right to grant certain Intellectual Property Rights in relation thereto (all as defined below). |
B. | The Licensee has entered into an agreement with Pfizer Inc. a Delaware corporation having an office at 235 East 42nd Street, New York, New York 10017, U.S.A. (“Pfizer”), pursuant to which Licensee has been granted certain rights in respect of Product (as hereinafter defined). |
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C. | The Licensee wishes to take a licence under Intellectual Property Rights of which Lonza is the proprietor in order to use the System (together with the Transfected Cell Line) to commercially exploit the Product on the terms set out in this Agreement. |
NOW THEREFORE the Parties hereby agree as follows
1. | Definitions and Interpretation |
1.1 | In this Agreement the following words and phrases shall have the following meanings: |
1.1.1 | “Affiliate” means any company, corporation, limited liability company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control, directly or indirectly, with the relevant Party to this Agreement. "Control" means the ownership of more than fifty percent (50%) of the issued share capital of the entity in question or the legal power to direct or cause the direction of the general management and policies of the entity in question. Such entity shall be deemed an Affiliate only so long as it satisfies the foregoing definition. |
1.1.2 | “Cell Line(s)" means [***]. |
1.1.3 | “Confidential Information” means any Know-How and confidential information (in any format and on any media) disclosed by one Party to the other in connection with this Agreement including for the avoidance of doubt the terms of this Agreement itself. In the case of Lonza, Confidential Information shall mean all information relating to the System and any other materials, specifications or information which is provided and/or disclosed by Lonza, its Affiliates and their respective officers, employees, agents and advisors to the Licensee and its officers, employees, agents and advisors, whether directly or indirectly, including, without limitation, all agreements, research databases, trade secrets, Intellectual Property Rights, business and/ or commercial and/ or financial data, specifications, technical designs, documents and drawings which are related to the System and/or Lonza’s business. |
*All trade marks (®) are registered in CH, EU or USA
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1.1.4 | “Drug Product” means [***]. |
1.1.5 | “Drug Product Activities” means [***]. |
1.1.6 | “Drug Substance” means [***]. |
1.1.7 | “Effective Date” means the date first above written. |
1.1.8 | “First Commercial Sale” means the date of the first sale or other disposal of Product for consideration by or on behalf of Licensee in that particular country following regulatory approval in such country. |
1.1.9 | “Initiation” means, with respect to any clinical trial, the first date that a human subject is dosed in such clinical trial. |
1.1.10 | “Intellectual Property Rights” means all rights, title and interests, vested and/or arising out of any industrial or intellectual property, whether protected at common law or under statute, which includes (without limitation) any rights and interests in patents, copyrights, designs, trademarks, service marks, trade- names, technology, business names, logos, commercial symbols, processes, developments, licenses, trade secrets, goodwill, drawings, computer software, formulae, technical information, research data, procedures, designs, Confidential Information and any other knowledge of any nature whatsoever throughout the world whether in existence today or which will come into existence in the future, and including all applications for patents, copyrights, trademarks, trade names, rights to apply and any amendments/modifications or renewals thereto; and all other intellectual property rights. |
1.1.11 | “Know-How” means any technical and other information, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how, inventions, discoveries, data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques and assay protocols. |
1.1.12 | “Licensed Know-How” means the System Know-How. |
1.1.13 | “Net Sale(s)” means all revenues recorded by or on behalf of Licensee or its Sublicensees for sales of Product in the Territory, less the permitted deductions. |
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The permitted deductions booked on an accrual basis by Licensee and its Sublicensees under their respective accounting standards to calculate the recorded net sales from gross sales are as follows:
[***]
1.1.14 | [***] means [***]. |
1.1.15 | [***] means [***]. |
1.1.16 | [***] means [***]. |
1.1.17 | [***] means [***]. |
1.1.18 | “Product” means [***]. |
1.1.19 | “Protected” means [***]. |
1.1.20 | “Royalty Term” shall have the meaning ascribed to it in Clause 5.2. |
1.1.21 | “Strategic Partner” means [***]. |
1.1.22 | “Sublicensee” means [***]. |
1.1.23 | “System” means [***]. |
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1.1.24 | “System Know-How” means [***]. |
1.1.25 | “System Materials” means [***]. |
1.1.26 | “Territory” means [***]. |
1.1.27 | “Third Party” means any individual or entity other than Lonza or Licensee. |
1.1.28 | “Transfected Cell Lines” means [***]. |
1.1.29 | “Vectors” means [***]. |
1.2 | The headings of this Agreement are inserted only for convenience and shall not affect the construction hereof. |
1.3 | Where appropriate words denoting a singular number only shall include the plural and vice versa. |
1.4 | References to the recitals, clauses and appendix shall be deemed to be a reference to the recitals, clauses and appendix to this Agreement and shall form an integral part of this Agreement. |
1.5 | References to any statute or statutory provision include a reference to the statute or statutory provision as from time to time amended, extended or re-enacted. |
1.6 | Reference in this Agreement to Lonza shall, unless repugnant to the subject or context thereof, include its Affiliates, successors and assigns. |
2. | Supply of System Know-How |
2.1 | Unless previously supplied by Lonza under a separate agreement, Lonza shall, if requested by Licensee in writing, supply further System Know-How as required by Licensee solely for regulatory purposes (and which shall, when permitted and at Lonza’s sole discretion, only be supplied directly to the regulatory agency by Lonza). Any such System Know-How provided hereunder (together with all other applicable components of the System previously received by Licensee) shall be used strictly in accordance with the terms of this Agreement. |
2.2 | Should any transportation of the System be arranged by Lonza on behalf of Licensee, such transportation shall be made at sole risk of the Licensee. The Licensee shall indemnify Lonza against all losses, expenses, demands, claims, actions, judgments, assessments, damages, liabilities, fines, penalties, costs and fees incurred by Lonza by reason of such transportation. |
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3. | Ownership of Property and Intellectual Property |
3.1 | Save for any Intellectual Property Rights licensed to Lonza, it is hereby acknowledged and agreed that, as between the Parties, any and all property and Intellectual Property Rights in the System is vested in Lonza. Similarly, it is hereby acknowledged as between the Parties that any and all Intellectual Property Rights in the Product and any gene proprietary to Licensee (or any of its licensors or sublicensees) inserted into the System, or used with the System, for the purpose of producing Product is vested in Licensee (or its applicable licensors and sublicensees) to the extent that this is severable from and does not utilise, disclose, infringe or reveal any Intellectual Property Rights of Lonza. |
4. | Licences |
Commercial Activities Licence
4.1 | Lonza hereby grants to Licensee on the Effective Date a [***] licence [***] to market, sell, offer for sale, distribute, import and export Product in the Territory ("Commercial Activities"). |
4.2 | Subject to the provisions of this Clause 4.2 and the terms and conditions of this Agreement, Licensee shall be entitled to grant a sublicence to the rights granted by Clause 4.1 (each a “Commercial Activities Sublicence”) to any one or more Third Parties, including a Strategic Partner, for the purposes of any such Third Party undertaking Commercial Activities (each a “Commercial Activities Sublicensee”) provided always: |
4.2.1 | [***] |
4.2.2 | [***] |
4.2.3 | [***] |
4.2.4 | [***] |
Manufacturing Activities Licence:
4.3 | Lonza hereby grants to Licensee on the Effective Date a [***] licence under the System (with the right to sublicence, subject to Clause 4.4 below) to use, develop and manufacture Drug Substance and Product at: [***] (“Manufacturing Activities”). |
4.4 | Subject to the provisions of this Clause 4.4 and the terms and conditions of this Agreement, Licensee shall be entitled to grant a sublicence to [***] for the purposes of any such Third Party undertaking Manufacturing Activities for or on behalf of Licensee (or for the benefit of Licensee’s Strategic Partner, subject to Clause 4.4.1 below) (each a “Manufacturing Sublicensee”) provided always: |
4.4.1 | Any Manufacturing Sublicence shall be granted directly by Licensee, and it is expressly acknowledged and agreed that in no event shall tiered sublicensing of such Manufacturing Sublicences be permitted; and |
4.4.2 | Licensee shall ensure such Manufacturing Sublicensee’s use of the System and Lonza’s Intellectual Property Rights (subject always to Clause 4.6) is undertaken solely for undertaking Manufacturing Activities for or on behalf of Licensee (or for the benefit of Licensee’s Strategic Partner, subject to Clause 4.4.1 above); and |
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4.4.3 | The Manufacturing Sublicensee shall not, by virtue of this Agreement, be granted any right or licence, either express or implied, under any patent or proprietary right vested in Lonza or otherwise, to use the System Lonza’s Intellectual Property Rights or the Product other than for undertaking Manufacturing Activities for or on behalf of Licensee (or for the benefit of Licensee’s Strategic Partner, subject to Clause 4.4.1 above). Licensee agrees to ensure that such Manufacturing Sublicensee shall not assign, transfer, further sublicense or otherwise make over the benefit or the burden of the rights granted to it pursuant to this Agreement; and |
4.4.4 | [***]; and |
4.4.5 | [***]; and |
4.4.6 | [***] following termination or expiry of this Agreement or Licensee’s arrangements with any such Manufacturing Sublicensee (whichever occurs earlier), Licensee shall confirm in writing to Lonza that Transfected Cell Lines and Licensed Know-How (including materials provided to Manufacturing Sublicensee relating directly or indirectly to the System) are destroyed and/or returned to Licensee. |
General Licence Restrictions (Commercial Activities and Manufacturing Activities)
4.5 | Any Manufacturing Sublicence or Commercial Activities Sublicence granted by Licensee shall be granted expressly subject to the terms of this Agreement, and it shall be Licensee’s responsibility to ensure the strict adherence by each Manufacturing Sublicensee and Commercial Activities Sublicensee hereunder to the terms and conditions of this Agreement. Licensee shall be responsible and liable for the acts or omissions of each Manufacturing Sublicensee and Commercial Activities Sublicensee herein and Licensee shall indemnify Lonza against all costs, expenses, claims, loss or damage incurred or suffered by Lonza, or for which Lonza may become liable arising out of any act or omission of any Sublicensee, including any product liability claim relating to Product manufactured, supplied or put into use by the Sublicensee. |
4.6 | Notwithstanding any other provision, Licensee shall not transfer the Cell Lines and/or Vectors to any Third Party without Lonza’s prior and express written consent, provided, however, that Licensee is allowed to transfer the Transfected Cell Lines to a Manufacturing Sublicensee for the purposes of and subject to Clause 4.4. Licensee shall not transfer any Licensed Know-How without prior written approval by Lonza, which shall only be granted to the extent strictly required for Manufacturing Activities. |
4.7 | Licensee hereby undertakes that it will neither reverse engineer nor make any modifications, adaptations or improvements to the System and/or Transfected Cell Lines (including for the avoidance of doubt but not by way of limitation inserting alternate cell lines and/or vectors) without Lonza’s prior written consent, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation. |
4.8 | Licensee shall use the System only in accordance with the licences granted under Clause 4, and shall not use, cause the use of or permit to be used the System for any purpose not directly authorised by this Agreement. |
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4.9 | The provisions of Clauses 4.1 to 4.8 shall continue to apply with respect to: (i) the System Materials (together with the Transfected Cell Line(s)); and (ii) the Licensed Know-How [***]. |
4.10 | [***]. |
4.11 | No licence is granted save as expressly provided herein and no licence in addition thereto shall be deemed to have arisen or be implied by way of estoppel or otherwise. |
Additional Licensee Obligations
4.12 | Licensee shall notify Lonza within [***] days of when Product changes its phase of clinical trial and/or when it is first offered for commercial sale. |
4.13 | Licensee shall obtain at its own expense all licences, permits and consents necessary to manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory. |
4.14 | Licensee acknowledges and agrees that the exercise of the licence granted to the Licensee under this Agreement is subject to all applicable laws, enactments, regulations and other similar instruments in the Territory, and the Licensee understands and agrees that it shall at all times be solely liable and responsible for such due observance and performance. |
5. | Payments |
5.1 | In consideration of the licences granted to Licensee pursuant to Clauses 4.1 and 4.3 above, and in consideration for the right to sublicence the rights granted by Clauses 4.1 and 4.3 (pursuant to Clauses 4.2 and 4.4 respectively), Licensee shall pay Lonza as follows: |
5.1.1 | [***] |
5.1.2 | where Licensee, Licensee’s Affiliate or Licensee’s Strategic Partner manufactures Drug Substance (whether for clinical or commercial purposes): |
5.1.2.1 | a payment of US [***] due annually and being first payable upon Initiation of phase II clinical trials for Product and thereafter on each anniversary of such date during the term of this Agreement; and |
5.1.2.2 | a royalty of [***] of Net Sales of Product [***]. |
5.1.3 | where any person or entity other than Lonza, Licensee, Licensee’s Affiliate or Licensee’s Strategic Partner manufactures Drug Substance (whether for clinical or commercial purposes) (“Third Party Manufacturer”): |
5.1.3.1 | a payment of [***] due annually during the course of such sublicence (irrespective as to the years of manufacture) [***]; and |
5.1.3.2 | a royalty of [***] of Net Sales of Product [***]. |
5.1.4 | [***] |
5.2 | Any royalties due under this Clause 5 shall be payable in respect of each country of the world on a country-by-country basis until ten (10) years from the First Commercial Sale of the Product in that particular country, save for when the provisions of Clause 5.3 apply (the “Royalty Term”). For the avoidance of doubt, upon expiration of a Royalty Term in any individual country, all other terms and conditions of this Agreement shall remain in full force and effect. |
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5.3 | The Royalty Term may end earlier than ten (10) years from the First Commercial Sale of the Product in that particular country [***]. |
5.4 | For the avoidance of doubt, the royalty rates and fees applicable under Clause 5.1 are determined by reference to the party manufacturing the Drug Substance [***]. |
5.5 | The provisions of this Clause 5 shall remain in effect notwithstanding termination or expiry of this Agreement until the settlement of all subsisting claims by Lonza. |
6. | Royalty Procedures |
6.1 | Licensee shall, and shall ensure that its Sublicensees keep true and accurate records and books of account containing all data necessary for the calculation of royalties payable to Lonza. Such records and books of account shall, upon reasonable notice having been given by Lonza [***], be open at all reasonable times during regular business hours for inspection by independent auditors selected by Lonza and reasonably acceptable to Licensee. Such independent auditors shall agree to maintain the confidentiality of the information and materials disclosed during the audit. Any such audit shall be conducted in a manner that does not interfere unreasonably with the operations of Licensee’s business. Lonza may perform an audit once each calendar year. Each audit shall begin upon the date specified by Lonza and shall be completed as soon as reasonably practicable. Lonza shall pay the costs of the independent auditors conducting such audit, unless the results of the audit reveal an underpayment of [***], in which case, Licensee shall pay the reasonable costs of the independent auditors. If an audit concludes that an [***] underpayment has occurred during the audited period, such payment shall be remitted by the Party responsible for such payment to the other Party [***]. |
6.2 | Licensee shall prepare a statement in respect of each calendar quarter which shall show for the immediately preceding quarter details of the sales of Product on a country by country basis, including a full list of all of the permitted deductions which have been applied by Licensee when calculating the Net Sales from the gross sales, and the royalty due and payable to Lonza thereon. |
Such statement shall be submitted to Lonza within [***] days after the end of the calendar quarter to which it relates, together with a remittance for the royalties due to Lonza to which Lonza shall issue a receipted invoice in return.
6.3 | All sums due under this Agreement: |
6.3.1 | shall be paid in [***] to Lonza. |
6.3.2 | are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, and shall be paid by Licensee (other than taxes on Lonza’s income). [***] |
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6.4 | To the extent that Licensee reports Net Sales otherwise than in [***] then royalty payments due to Lonza shall be first calculated in the local currency in which Net Sales are reported and then shall be converted to a [***] value at the rate of exchange first published in the Financial Times (London) on the first business day after the relevant quarterly reporting period. |
6.5 | Where Lonza does not receive payment of any sum by the due date, interest shall accrue thereafter on the sum due and owing to Lonza at the rate of [***] per annum over the base rate from time to time of [***], interest to accrue on a day-to-day basis without prejudice to Lonza’s right to receive payment on the due date. |
7. | Liability and Warranties |
7.1 | Lonza hereby warrants that [***]. |
The Licensee hereby acknowledges: (i) this is a licence to the Licensed Know-How and not to any other Lonza Intellectual Property Rights; and (ii) that in order to exploit the rights granted herein the Licensee may require licences under Lonza patent rights or under Third Party patent rights (including those vested in Affiliates of Lonza) that may be infringed by the use by the Licensee of the rights licensed herein. It is hereby agreed that it shall be the Licensee's responsibility to satisfy itself as to the need for such licences and if necessary to obtain such licences; provided that where any such patent rights or other Know-How vested in Lonza or its Affiliates would prevent the Licensee and its Sublicensees from operating the System as permitted by the terms of this Agreement, then such patent rights or other Know-How shall be automatically included within the Intellectual Property Rights licensed to Licensee hereunder.
7.2 | Each Party (“Indemnifying Party”) shall indemnify and hold harmless the other Party and its Affiliates, and their respective officers, employees and agents (each an “Indemnified Party”) at all times in respect of any and all losses, damages, costs and expenses (collectively “Losses”) suffered or incurred as a result of any contractual, tortious or other claims or proceedings by Third Parties (collectively “Third Party Claims”) against Indemnified Party arising out of the Indemnifying Party’s breach of this Agreement, including breach of representations or warranties, violation of applicable law, negligence or wilful misconduct; provided that with respect to any Third Party Claim for which each Party is entitled hereunder to seek indemnification from the other Party, each Party as the Indemnifying Party shall indemnify the other Party for its Losses only to the extent of the Indemnifying Party’s relative responsibility for the facts underlying the Third Party Claim . |
7.3 | With respect to product liability claims or proceedings, the following shall apply: (a) except to the extent provided in (b) below, Licensee shall indemnify and hold harmless Lonza, its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury relating to the Product, and (b) Lonza shall indemnify and hold harmless Licensee, its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury relating to the Product to the extent such claims or proceedings result directly from defects in the Cell Lines and Vectors. |
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7.4 | Any condition or warranty other than those relating to title which might otherwise be implied or incorporated within this Agreement by reason of statute or common law or otherwise is hereby expressly excluded. |
7.5 | EXCEPT FOR EITHER PARTY’S BREACH OF CLAUSE 8 HEREOF, SUBJECT TO CLAUSE 7.6, IN NO EVENT SHALL EITHER PARTY AND/OR THEIR RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY, THEIR AFFILIATES AND THEIR RESPECTIVE OFFICERS, EMPLOYEES AND AGENTS WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT WHETHER IN CONTRACT IN TORT IN NEGLIGENCE OR FOR BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY LOSS OF PROFITS, OR FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES. |
7.6 | Nothing in this Agreement shall exclude or limit the liability of either Party for fraud or for death or personal injury caused by its negligence or for wilful or deliberate breach of this Agreement or for any other liability that may not be limited or excluded as a matter of law. |
8. | Confidentiality |
8.1 | Licensee expressly acknowledges that Confidential Information disclosed by Lonza pursuant to this Agreement is supplied in circumstances imparting an obligation of confidence and Licensee shall keep such Confidential Information secure, secret and confidential and undertakes to respect Lonza’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any reason whatsoever to disclose, cause or permit to be disclosed such Confidential Information to any Third Party other than its Sublicensee hereunder for use in accordance with and subject to the terms of this Agreement. Licensee shall procure that only its employees and employees of its Sublicensee hereunder shall have access to Confidential Information and then only on a need to know basis and that all such employees shall be informed of their secret and confidential nature and shall be subject to the same obligations as Licensee and its Sublicensee hereunder pursuant to this Clause 8.1. |
8.2 | Lonza expressly acknowledges and undertakes that any Confidential Information disclosed by the Licensee to Lonza pursuant to this Agreement is disclosed in circumstances imparting an obligation of confidence and Lonza shall keep such Licensee's Confidential Information secure, secret and confidential and undertakes to respect Licensee’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any reason whatsoever disclose and/or cause and/or permit to be disclosed such Licensee's Confidential Information to any Third Party. |
8.3 | Each Party will restrict the disclosure of the terms of this Agreement to such officers, employees, professional advisers, finance-providers, and consultants of itself and its Affiliates (“Representatives”) who have been informed of the confidential nature of the same and who have a need to know such terms. Prior to disclosure to such persons, the disclosing Party shall bind its and its Affiliates’ Representatives to confidentiality and non-use obligations no less stringent than those set forth herein. The receiving Party shall notify the disclosing Party as promptly as practicable of any unauthorized use or disclosure. To the extent that either Party wishes to disclose any other Confidential Information to any of its Representatives, save as expressly permitted by this Clause 8, this shall be subject to obtaining the prior written consent of the other Party. |
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8.4 | The obligations of confidence referred to in this Clause 8 shall not extend to any information which the receiving Party demonstrates: |
8.4.1 | is or shall become generally available to the public otherwise than by reason of a breach by the recipient Party of such information of the provisions of this Clause 8; |
8.4.2 | is known to the recipient Party of such information and is at its free disposal prior to its receipt from the other; |
8.4.3 | is subsequently disclosed to the recipient Party without obligations of confidence by a Third Party owing no such obligation of confidentiality to the disclosing Party; or |
8.4.4 | can be demonstrated by competent written evidence as having been independently developed by the recipient of the information in question without access to or use or knowledge of the information of the disclosing Party. |
8.5 | Notwithstanding the foregoing it is acknowledged between the Parties that Lonza or Licensee may be required to disclose Confidential Information to a government agency for the purpose of any statutory, regulatory or similar legislative requirement applicable to the production of Product, or to a court of law or to meet the requirements of any Stock Exchange to which the Parties may be subject. In such circumstances the disclosing Party will inform the other Party prior to disclosure being made as to the nature of the required disclosure, shall only make the disclosure to the extent legally required and shall seek to impose obligations of secrecy wherever possible. Notwithstanding such disclosure such Confidential Information shall otherwise remain subject to this Clause 8. |
8.6 | Each Party expressly agrees that any breach or threatened breach of the undertakings of confidentiality provided hereunder by a Party may cause irreparable harm to the other Party (“Non-Breaching Party”) and that money damages may not provide a sufficient remedy to the Non-Breaching Party for any breach or threatened breach. In the event of any breach and/or threatened breach, then in addition to all other remedies available at law or in equity, the Non-Breaching Party shall be entitled to seek injunctive relief and any other relief deemed appropriate by the Non-Breaching Party. |
9. | Intellectual Property Enforcement |
9.1 | Lonza hereby undertakes and agrees that at its own cost and expense it will pursue, as determined by Lonza in its commercially reasonable discretion, all necessary actions against any Third Party that Lonza reasonably believes is infringing, misappropriating or violating any Lonza Intellectual Property Rights. |
9.2 | Licensee shall promptly notify Lonza in writing of any infringement or improper or unlawful use of or of any challenge to the validity of the Licensed Know-How. Lonza undertakes and agrees to take all such steps and proceedings and to do all other acts and things as may in Lonza’s sole discretion be necessary to restrain any such infringement or improper or unlawful use or to defend such challenge to validity and Licensee shall permit Lonza to have the sole conduct of any such steps and proceedings including the right to settle them whether or not Licensee is a party to them. |
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10. | Term and Termination |
10.1 | This Agreement shall commence on the Effective Date and shall continue in full force and effect in each country of the world unless terminated earlier in accordance with the provisions of this Clause 10 or Clause 13. |
10.2 | Licensee may terminate this Agreement by giving sixty (60) days’ notice in writing to Lonza. |
10.3 | Either Lonza or Licensee may terminate this Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events: |
10.3.1 | if the other commits a breach of this Agreement which is irremediable or (in the case of a breach capable of remedy) shall not have been remedied within thirty (30) days of the receipt by the other of a notice identifying the breach and requiring its remedy; or |
10.3.2 | if the other is unable to pay its debts or enters into compulsory or voluntary liquidation (other than for the purpose of effecting a reconstruction or amalgamation in such manner that the company resulting from such reconstruction or amalgamation if a different legal entity shall agree to be bound by and assume the obligations of the relevant Party under this Agreement) or compounds with or convenes a meeting of its creditors or has a receiver or administrator appointed over all or any part of its assets or takes or suffers any similar action in consequence of a debt, or ceases for any reason to carry on business. |
10.4 | Without prejudice to any rights that have accrued under this Agreement or any of its rights or remedies, Lonza may terminate this Agreement immediately by giving written notice to Licensee if: |
10.4.1 | there is a change of control of Licensee (within the meaning of section 1124 of the Corporation Tax Act 2010) [***]; or |
10.4.2 | the Licensee contests [***]. |
10.5 | Subject to Clause 10.6, if this Agreement expires or is terminated for any reason any and all licences and sublicences granted hereunder shall terminate with effect from the date of termination and Licensee shall destroy (or otherwise procure the destruction of) all System Materials, Transfected Cell Lines and Product and all Confidential Information which is provided by Lonza (including all Know-How and all System Know-How) forthwith and shall certify such destruction immediately thereafter in writing to Lonza; provided, however, that the Licensee and its Sublicensees shall have the right to sell or otherwise dispose of all Product then on hand, subject to the payment of royalties and the other terms of this Agreement. |
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10.6 | [***] |
10.7 | Termination for whatever reason or expiration of this Agreement shall not affect the accrued rights of the Parties arising in any way out of this Agreement as at the date of termination. The right to recover damages against the other and all provisions which are expressed to survive this Agreement shall remain in full force and effect. |
10.8 | The terms of Clauses 3, 4.5 to 4.9 (subject always to the consequences of termination in Clause 10.5), 5, 6, 7, 8, 10, 11 and 12 shall survive expiration or termination of this Agreement for whatever reason. |
11. | Assignment |
11.1 | Subject to Licensee’s rights to sublicence in accordance with Clause 4 and subject to Clause 11.2 below, neither Party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other Party (which consent shall not be unreasonably withheld or delayed). |
11.2 | [***] |
11.3 | This Agreement shall be binding upon the successors and assigns of the parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns provided always that nothing herein shall permit any assignment by either Party except as expressly provided herein. |
12. | Governing Law and Dispute Resolution |
12.1 | This Agreement shall be governed by and construed in accordance with the laws of England and Wales. |
12.2 | Any dispute arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination, shall be referred to and finally resolved by arbitration under the London Court of International Arbitration (LCIA) Rules, which Rules are deemed to be incorporated by reference into this Clause, by a panel of three (3) arbitrators appointed in accordance with the said Rules. The seat, or legal place of arbitration shall be London, England and the arbitration shall be conducted in the English language. The arbitrator’s award shall be final and binding. |
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13. | Force Majeure |
Neither Party shall be in breach of this Agreement if there is any total or partial failure of performance by it of its duties and obligations under this Agreement occasioned by any act of God [***], fire), act of government or state, war, civil commotion, insurrection, embargo, [***], prevention from or hindrance in obtaining any raw materials, energy or other supplies, labour disputes of whatever nature and any other reason beyond the control of that Party. If that Party is unable to perform its duties and obligations under this Agreement as a direct result of the effect of one of the reasons set out in this Clause 13 such Party shall give written notice to the other of such inability stating the reason in question. The operation of this Agreement shall be suspended during the period (and only during the period) in which the reason continues. Forthwith upon the reason ceasing to exist the Party relying upon it shall give written notice to the other of this fact. If the reason continues for a period of more than ninety (90) days and substantially affects the commercial basis of this Agreement the Party not claiming under this Clause 13 shall have the right to terminate this Agreement by giving written notice of such termination to the other Party.
14. | Illegality |
14.1 | If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the Parties or this Agreement (including the EC Commission or the European Court of Justice, to the extent applicable): |
(i) | such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the Parties and shall be deemed not to be included in this Agreement; |
(ii) | the other provisions of this Agreement shall be binding on the Parties as if such provision was not included therein; and |
(iii) | the Parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the Parties without rendering such provision invalid or unenforceable. |
15. | Miscellaneous |
15.1 | This Agreement embodies and sets forth the entire agreement and understanding of the Parties and supersedes all prior oral and written agreements, representations, misrepresentations (where innocently or negligently made), understandings or arrangements relating to the subject matter of this Agreement (“Understandings”). Neither Party shall be entitled to rely on any Understandings which are not expressly set forth in this Agreement. |
15.2 | This Agreement shall not be amended, modified, varied or supplemented except in writing signed by duly authorised representatives of the Parties. |
15.3 | No failure or delay on the part of either Party to exercise any right or remedy under this Agreement shall be construed or operated as a waiver thereof nor shall any single or partial exercise of any right or remedy under this Agreement preclude the exercise of any other right or remedy or preclude the further exercise of such right or remedy as the case may be. The rights and remedies provided in this Agreement are cumulative and are not exclusive of any rights or remedies provided by law. |
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15.4 | Except as required by law, the text of any press release or other communication to be published by or in the media whether of a scientific nature or otherwise and concerning this Agreement (or Lonza’s System) shall require the prior written approval of Lonza and Licensee. |
15.5 | Each of the Parties shall be responsible for its respective legal and other costs incurred in relation to the preparation of this Agreement. |
15.6 | The Parties do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999, or by any other statute or common-law principle, by any person who is not a party to this Agreement. |
16. | Notice |
16.1 | Any notice or other document to be given under this Agreement shall be in writing and shall be deemed to have been duly given if sent by registered post or by a reputable overnight courier or by email to a Party or delivered in person to a Party at the address set out below for such Party or such other address as the Party may from time to time designate by written notice to the other(s): |
Address of Lonza | |
Lonza Sales AG, Muenchensteinerstrasse 38 CH-4002, Basel, Switzerland | |
With a copy to: | Lonza Biologics Plc |
228 Bath Road, Slough, Berkshire SL1 4DX, UK | |
Email: GSLonza@lonza.com | |
For the attention of the Head of Legal Services |
Address of Licensee
Zura Bio Limited, 3rd Floor, 1 Ashley Road, Altrincham, Cheshire WA14 2DT, UK
E-mail: notices@zurabio.com
With a copy to: [***]@zurabio.com and [***]@zurabio.com For the attention of: CEO and CFO
16.2 | All such notices and documents shall be in the English language. Any such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date of dispatch of the notice or other document by post or, where the notice or other document is delivered by hand, at the time of such delivery or if by email simultaneously with the transmission. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched. |
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AS WITNESS the hands of the duly authorised representatives of the Parties hereto
Signed for and on behalf of | ||
LONZA SALES AG | ||
Associate General Counsel | ||
TITLE | ||
. | ||
Signed for and on behalf of | ||
LONZA SALES AG | ||
Senior Director, Licensing | ||
TITLE | ||
. | ||
Signed for and on behalf of | ||
ZURA BIO LIMITED | ||
CFO, Zura Bio Ltd | ||
TITLE |
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APPENDIX 1
VECTORS
• | [***] |
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APPENDIX 2
[***]
*All trade marks (®) are registered in CH, EU or USA
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Exhibit 10.22
EXECUTION VERSION
CONFIDENTIAL
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS
BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT NORMALLY TREATS AS
PRIVATE AND CONFIDENTIAL.
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
DATED AS OF DECEMBER 8, 2022
BY AND BETWEEN
ELI LILLY AND COMPANY
AND
Z33 BIO INC.
TABLE OF CONTENTS
Page | ||
ARTICLE 1 DEFINITIONS | 1 | |
ARTICLE 2 LICENSES | 15 | |
2.1 | Grant to Licensee | 15 |
2.2 | Additional Licensing Provisions | 15 |
2.3 | Performance by Affiliates and Sublicensees | 16 |
2.4 | Restrictive Covenants | 17 |
2.5 | Right of First Negotiation | 17 |
2.6 | Data Transfer | 18 |
2.7 | Material Transfer | 18 |
2.8 | Technology Transfer | 19 |
2.9 | Lilly Programs | 19 |
ARTICLE 3 DEVELOPMENT | 20 | |
3.1 | Overview of Development | 20 |
3.2 | Objectives under the Development Plan | 20 |
3.3 | Development Plan | 21 |
3.4 | Development Costs | 21 |
3.5 | Records, Reports and Information | 21 |
3.6 | Ownership of Development Data | 22 |
3.7 | Development Diligence Failures | 22 |
ARTICLE 4 REGULATORY | 22 | |
4.1 | Regulatory Data and Regulatory Materials | 22 |
4.2 | Regulatory Filings and Regulatory Approvals | 23 |
4.3 | No Other Regulatory Filings | 23 |
4.4 | Pharmacovigilance and Medical Inquiries | 24 |
4.5 | Regulatory Authority Communications Received by a Party | 24 |
4.6 | Recall, Withdrawal, or Market Notification of Product | 25 |
4.7 | Regulatory Diligence | 25 |
ARTICLE 5 COMMERCIALIZATION | 25 | |
5.1 | Commercialization in the Field in the Territory | 25 |
5.2 | Licensee’s Performance | 25 |
5.3 | Reports | 26 |
5.4 | Promotional Materials | 26 |
5.5 | Product Trademarks and Product Trade Dress | 27 |
5.6 | Commercialization Data | 27 |
ARTICLE 6 MANUFACTURING | 28 | |
6.1 | General | 28 |
6.2 | Manufacturing | 28 |
6.3 | Packaging and Labeling; Certain Other Manufacturing Activities | 28 |
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TABLE OF SCHEDULES AND APPENDICES
Schedule A | Compounds |
Schedule B | Licensed Patents |
Schedule C | Technical Information, Materials, Processes and Regulatory Filings |
Schedule D | Lilly Animal Care and Use Requirements |
Schedule E | Initial Development Plan |
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LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This License, Development and Commercialization Agreement (this “Agreement”), dated as of December 8, 2022 (the “Effective Date”), is made by and between Eli Lilly and Company, an Indiana corporation (“Lilly”), and Z33 Bio Inc., a Delaware corporation, having its principal place of business at MWE Corporate Services, LLC, 1007 N. Orange St., 10th Fl., Wilmington, Delaware 19801, USA (“Licensee”). Lilly and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Lilly developed a certain compound relating to IL-33 as further described herein;
WHEREAS, Lilly wishes to grant a license to Licensee under certain Lilly intellectual property rights related to such Compound (as defined below) to develop, manufacture and commercialize the Product in the Field in the Territory, as more fully set forth herein, and Licensee wishes to take such license, in each case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged and agreed, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following initially capitalized terms shall have the meanings set forth in this Article 1:
1.1 “Active Component” means a component that confers a therapeutic effect on a standalone basis.
1.2 “Affiliate” means any entity directly or indirectly controlled by, controlling or under common control with a Person, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by,” “controlling” and “under common control with”) means (a) possession, direct or indirect, of the power to direct or cause direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise), or (b) beneficial ownership of more than 50% (or the maximum ownership interest permitted by Applicable Law) of the voting securities or other ownership or general partnership interest (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity interests of an entity.
1.3 “Analytical Release Testing and Characterization” means all activities associated with carrying out the analytical testing and release of the Product in the Territory. Such activities shall include: transferring test methods, developing and validating new analytical tests required in the Territory, amending the release specifications to be in compliance with local Applicable Laws, conducting the release testing of the Product in the Territory and final release of the Product (including any of its raw materials, intermediates, drug substance and drug product).
1.4 “Applicable Law” means any applicable United States federal, state or local, or foreign or multinational law (including data protection and privacy laws), statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law. For the avoidance of doubt, any specific references to any Applicable Law or any portion thereof shall be deemed to include all then-current amendments thereto or any replacement or successor law, statute, standard, ordinance, code, rule, regulation, resolution, order, writ, judgment, injunction, decree, stipulation, ruling or determination thereto.
1.5 “Business Day” means a day other than a Saturday, Sunday, or bank or other public holiday in New York, New York, Indianapolis, Indiana, United States, or London, United Kingdom.
1.6 “Calendar Quarter” means each three (3)-month period commencing January 1, April 1, July 1 or October 1 of any year; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first full Calendar Quarter thereafter and (b) the last Calendar Quarter of the Term shall end upon the expiration or termination of this Agreement.
1.7 “Calendar Year” means the period beginning on January 1 and ending on December 31 of the same year; provided, however, that (a) the first Calendar Year of the Term shall extend from the Effective Date through December 31 of the same year and (b) the last Calendar Year of the Term shall commence on January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of expiration or termination of this Agreement.
1.8 “Clinical Trial” means a Phase I Clinical Trial, Phase II Clinical Trial (including a Phase IIa Clinical Trial and Phase IIb Clinical Trial), Phase III Clinical Trial, a Phase IIIb Clinical Trial or a Phase IV Clinical Trial, as the case may be.
1.9 “Combination Product” means (a) any product containing the Product and one or more other Active Components in a fixed-dose formulation, or (b) any combination of the Product sold together with another product containing an Active Component in a single package or container for a single price.
1.10 “Commercialize” means to promote, market, distribute, sell (and offer for sale or contract to sell), import, export, or otherwise commercially exploit or provide product support for the Product and to conduct activities, other than Development or Manufacturing, in preparation for conducting the foregoing activities, including activities to produce commercialization support data and to secure and maintain market access and reimbursement. “Commercializing” and “Commercialization” shall have correlative meanings. For the avoidance of doubt, Commercialization does not include Development or Manufacturing.
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1.11 ”Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective, those reasonable, good-faith efforts to accomplish such objective in a diligent manner within a reasonable time period [***] With respect to any efforts relating to the Development, Regulatory Approval, Manufacturing or Commercialization, as applicable, of the Compound or Product by a Party, generally or with respect to any particular country in the Territory, such Party will be deemed to have exercised Commercially Reasonable Efforts if such Party, subject to this Section 1.11, has exercised those efforts [***], with respect to a compound, product or product candidate, as applicable, (a) which is of similar market potential in such country, and (b) which is at a similar stage in its development or product life cycle, as the applicable Product, in each case, taking into account, at the time such efforts are to be expended, issues of [***]; and other relevant scientific, technical, operational and commercial factors. [***].
1.12 “Common Stock” means the common stock of Licensee, par value $0.001 per share.
1.13 “Competing Product” means, with respect to the Compound or Product, any compound or product with the same or substantially similar mechanism of action as such Compound or Product.
1.14 “Compound” means (a) the compounds described in Schedule A, (b) any salt, free acid, free base, crystal, co-crystal, hydrate, hemihydrate, anhydride, solvate, polymorph, complex, prodrug, metabolite, ester, isomer, tautomer or enantiomer of such compounds or any fragment, conjugate, derivatives or modifications of such compounds, and (c) any compound derived or optimized from any of the foregoing or which constitutes an improvement of any of the foregoing, to the extent having the same or substantially similar mechanism of action as any of the foregoing. [***]
1.15 “Control” and “Controlled by” means, with respect to any Know-How, Invention, Patent, technology, copyright, trademark or other intellectual property right, a Person’s possession (whether by ownership, license grant or other means) of the legal right to grant the right to access or use, or to grant a license or a sublicense to, such Know-How, Invention, Patent Right, technology, copyright, trademark or other intellectual property right as provided for herein without violating the proprietary rights of any Third Party or any terms of any agreement or other arrangement between such Person (or any of its Affiliates) and any Third Party.
1.16 “CTA” means an application to the applicable Regulatory Authority, such as a clinical trial application or a clinical trial exemption, the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
1.17 “Designated Officer” means a representative appointed by a Party for purposes of dispute resolution.
1.18 “Develop” means to research, develop, analyze, test and conduct preclinical trials, Clinical Trials (including, for the avoidance of doubt, Phase IV Clinical Trials and any preclinical/clinical/CMC commitments following Regulatory Approval) and all other regulatory trials, for the Compound and Product, as well as any and all activities pertaining to manufacturing development, formulation development, medical affairs and lifecycle management (including the conduct of Phase IIIb Clinical Trials and Phase IV Clinical Trials not explicitly for registrational purposes and non-interventional studies), including new indications, new formulations and all other activities, including regulatory activities, related to securing and maintaining Regulatory Approval, for the Compound and Product, all in accordance with the Development Plan. “Developing” and “Development” shall have correlative meanings.
1.19 “Development Activities” means those Development activities undertaken by or on behalf of Licensee with respect to the Product in the Field in the Territory.
1.20 “Dollar” or “$” means the legal tender of the United States of America.
1.21 “Equity Securities” means (a) capital stock or other equity interests in Licensee that are issued and outstanding, (b) obligations, evidences of indebtedness or other securities or interests convertible or exchangeable into capital stock or other equity interests in Licensee and (c) warrants, options or other rights to purchase or otherwise acquire capital stock or other equity interests in Licensee, vested or unvested.
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1.22 “Exclusivity Period” means the period beginning on the Effective Date and ending [***].
1.23 “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.
1.24 “FDA” means the United States Food and Drug Administration and any successor Regulatory Authority having substantially the same function.
1.25 “Field” means all uses including any and all human therapeutic, diagnosis, prevention, amelioration and prophylactic uses.
1.26 “First Commercial Sale” means, with respect to the Product in any country in the Territory, the first shipment of the Product to a Third Party in such country for end use or consumption of the Product in such country after Regulatory Approval of the Product in such country or, if earlier, the invoicing of a Third Party for such shipment.
1.27 “First Indication Regulatory Approval” means, with respect to a specified jurisdiction, the receipt of Regulatory Approval in such jurisdiction for the Product for any Indication (being an Indication for which no Regulatory Approval has previously been received for such Product in such jurisdiction).
1.28 “Force Majeure” means any circumstances whatsoever which are not within the reasonable control of the Party affected thereby, including any such act of God, war, act of terrorism, pandemic, insurrection, riot, strike or labor dispute, shortage of materials, fire, explosion, flood, government requisition or allocation, breakdown of or damage to plant, equipment or facilities, interruption or delay in transportation, fuel supplies or electrical power, embargo, boycott, order, or act of civil, military, or other Governmental Authority.
1.29 “Fully-Diluted Capital Stock” means, the sum of (i) the number of shares of Common Stock underlying all Equity Securities of Licensee (including, for the avoidance of doubt, shares of Common Stock issuable upon exercise or conversion of Equity Securities, and regardless of whether the Equity Securities are vested or unvested) and (ii) any shares of Common Stock reserved for issuance pursuant to any stock option, restricted stock or other equity-based incentive plan.
1.30 “Generic Product” means, with respect to a Product with a single active pharmaceutical ingredient, and with respect to a particular country, a pharmaceutical product that (a) contains the Compound, (b) is approved for use in such country pursuant to a Regulatory Approval process governing approval of generic, interchangeable, or biosimilar biologics based on the then-current standards for Regulatory Approval in such country, whether or not such Regulatory Approval was based upon clinical data generated by one or more parties pursuant to this Agreement or was obtained using an abbreviated, expedited, or other process, and (c) is sold in the same country as such Product by any Third Party that is not a Related Party and did not purchase such product directly or indirectly from any of Licensee or its Related Parties. A Product shall not constitute a Generic Product under this Agreement with respect to any other Product.
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1.31 “Good Clinical Practices” or “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity and confidentiality of trial subjects.
1.32 “Good Laboratory Practices” or “GLP” means the then-current standards for laboratory activities for pharmaceuticals, as set forth in the FDA’s Good Laboratory Practice regulations as defined in 21 C.F.R. Part 58, the Council Directive 87/18/EEC, as amended, the principles for Good Laboratory Practice and/or the Good Laboratory Practice principles of the Organization for Economic Co-Operation and Development (“OECD”), and such standards of good laboratory practice as are required by the European Union and other organizations and governmental agencies in countries in which a Product is intended to be sold, to the extent such standards are not less stringent than United States Good Laboratory Practice.
1.33 “Good Manufacturing Practices” or “GMP” means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the WHO TRS 986 Annex 2, TRS 961 Annex 6, TRS 957 Annex 2 and TRS 999 Annex 2,(d) ICH Q7 guidelines, and (e) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.
1.34 “Government Official” means: (a) any officer or employee of: (i) a government, or any department, agency, or instrumentality thereof; (ii) a government-owned or -controlled company, institution or other entity, including a government-owned hospital or university; or (iii) a public international organization (such as the United Nations, the International Monetary Fund, the International Committee of the Red Cross, and the World Health Organization), or any department, agency, or instrumentality thereof; (b) any political party or party official or candidate for public or political party office; and (c) any person acting in an official capacity on behalf of any of the foregoing.
1.35 “Governmental Authority” means any United States federal, state or local, or any foreign government or political subdivision thereof, or any multinational organization or authority, or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body. For clarity, any Regulatory Authority shall be a Governmental Authority.
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1.36 “IND” means an investigational new drug application, clinical trial authorization or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.37 “Indication” means any disease or condition that a product can be used to treat or prevent, which use is the subject of a separate Regulatory Approval.
1.38 “Initiation” means, with respect to a Clinical Trial, the first dosing of the first human patient in such Clinical Trial.
1.39 “Internal Compliance Codes” means a Party’s internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party-Specific Regulations, and such Party’s internal ethical, medical and similar standards.
1.40 “Invention” means any discovery or invention, whether or not patentable, conceived or otherwise made by or on behalf of either Party, or by both Parties, or, in each case, their respective Affiliates, under this Agreement.
1.41 “Know-How” means all technical, scientific, regulatory and other information, results, knowledge, techniques and data, in whatever form and whether or not confidential, patented or patentable, including Inventions, invention disclosures, discoveries, plans, processes, practices, methods, knowledge, trade secrets, know-how, instructions, skill, experience, ideas, concepts, data (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality control, and preclinical and clinical data), formulae, formulations, compositions, specifications, marketing, pricing, distribution, cost, sales and manufacturing data or descriptions. Know-How does not include any Patent claiming any of the foregoing.
1.42 “Licensed Know-How” means all Know-How, whether or not patented or patentable, to the extent Controlled by Lilly or its Subsidiaries and that is set forth on Schedule C. For the avoidance of doubt, “Licensed Know-How” shall not include, and Licensee shall have no rights to use, any manufacturing technology or processes or device technology (including any cell-based media or any of its components) or processes, or any other technology of Lilly and its Affiliates (other than Lilly and its Subsidiaries as of the Effective Date).
1.43 “Licensed Patents” means the Patents set forth on Schedule B and any Related Patents, in each case, to the extent Controlled by Lilly or its Subsidiaries as of the Effective Date or at any time during the Term.
1.44 “Licensed Technology” means the Licensed Know-How and Licensed Patents.
1.45 “Licensee Know-How” means any and all Know-How, whether or not patented or patentable, to the extent Controlled by, or on behalf of, Licensee or its Affiliates as of the Effective Date or at any time during the Term that is necessary or reasonably useful in connection with the Development, Manufacture, Commercialization or other use of the Compound or Product.
1.46 “Licensee Patent” means any Patent that (a) is Controlled by Licensee (or its Affiliates) as of the Effective Date or comes under the Control of Licensee (or its Affiliates) during the Term (other than as a result of the licenses granted by Lilly to Licensee under this Agreement); (b) is based upon, an enhancement of or improvement to any part of the Licensed Technology [***]
1.47 “Licensee Technology” means the Licensee Know-How and Licensee Patents.
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1.48 “Major European Country” means, individually, [***], which collectively are the “Major European Countries.”
1.49 “Major Financing Completion” means the date the Aggregate Gross Proceeds received by Licensee and its Subsidiaries pursuant to one or a series of Major Financing Events (whether such events are related or unrelated), first exceeds[***].
1.50 “Major Financing Event” means (i) a sale, pledge, lease, transfer, assignment, license, conveyance or other disposition, in a single transaction or series of related transactions, of any assets or Subsidiaries of Licensee, (ii) a sale or transfer of any Equity Securities of Licensee or any of its subsidiaries or parent companies, including, without limitation, an initial public offering or a de-SPAC transaction, (iii) a merger, reorganization, or recapitalization of Licensee or any of its subsidiaries or parent companies (including, for the avoidance of doubt, a de-SPAC transaction), or (iv) any similar event or transaction as described in subsections (i) through (iii) herein, in each case, which results in Aggregate Gross Proceeds of at least [***] to Licensee and its Subsidiaries. “Aggregate Gross Proceeds” as used in this Agreement with respect to any Major Financing Event shall include all potential proceeds to be received in connection with such Major Financing Event, including, but not limited to, cash proceeds and the fair market value of other property or consideration received upon the closing of the Major Financing Event, any escrow or indemnification reserves, any and all future or deferred consideration in the form of earnouts, fees (including, but not limited to, license fees), milestone payments (contingent or otherwise), contingent value rights or any other future or contingent payments (excluding any royalties), in each case, undiscounted, and regardless of the timing or probability of receiving such proceeds, calculated based on the maximum face value of the proceeds on the effective date of the closing of the Major Financing Event. For the avoidance of doubt, by way of example, a contingent value right for [***], which may or may not be achieved, would not be discounted based on the probability of achievement, but rather [***] would be included in its entirety in the calculation of “Aggregate Gross Proceeds”. Additionally, and without limiting the foregoing, the aggregate value of any uncompensated services (or for any services provided below fair market value, the difference between the fair market value for such services and the amount paid therefor) or other in-kind contributions provided by any Affiliate or Third Party to Licensee, including pursuant to Section 2.3, shall be deemed Aggregate Gross Proceeds received by Licensee pursuant to one or a series of Major Financing Events.
1.51 “Manufacture” means the receipt, handling and storage of active pharmaceutical ingredients, drug substance or drug product, medical devices and other materials, the manufacturing, processing, packaging and labeling, holding (including storage), quality assurance and quality control testing (including release) of the Product (other than quality assurance and quality control related to development of the manufacturing process, which activities shall be considered Development activities) and shipping of the Product. “Manufactured” or “Manufacturing” shall have correlative meanings.
1.52 “Manufacturing Development Activities” means development of test methods, stability testing, formulation development, process development, quality assurance activities, quality control activities, qualification and validation activities, analytic process development, manufacturing process validation, scale-up, and all other activities, including CMC-related activities, necessary for or related to the Manufacture of the Product for use in the Field in the Territory.
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1.53 “Marketing Authorization Application” or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.
1.54 “Medical Science Liaison” means an individual who is employed by or on behalf of Licensee or its Affiliates and who provides educational services and other educational efforts directed towards the medical or scientific community.
1.55 “Milestone Payment” means any Development Milestone Payment, the Major Financing Event Milestone Payment or Product Sales Milestone Payment.
1.56 “Net Sales” means the gross amount invoiced by Licensee or a Related Party thereof to any Non-Related Party for the Product in the Territory, less the following items consistent with U.S. Generally Accepted Accounting Principles (“GAAP”) consistently applied (but only to the extent attributable to the Product and to the extent actually incurred, given, accrued or specifically allocated for)[***]:
In the event that the Product is sold as part of a Combination Product, the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A / (A+B) where A is the weighted average sale price of the Product when sold separately in finished form, and B is the weighted average sale price of the other compound(s) or ingredient(s) sold separately in finished form.
In the event that the weighted average sale price of the Product can be determined but the weighted average sale price of the other compound(s) or ingredient(s) cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A / C where A is the weighted average sale price of the Product when sold separately in finished form and C is the weighted average sale price of the Combination Product.
In the event that the weighted average sale price of the other compound(s) or ingredient(s) can be determined but the weighted average sale price of the Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the following formula: one (1) minus (B / C) where B is the weighted average sale price of the other compound(s) or ingredient(s) when sold separately in finished form and C is the weighted average sale price of the Combination Product.
In the event that the weighted average sale price of both the Product and the other compound(s) or ingredient(s) in the Combination Product cannot be determined, the Net Sales of the Product shall be deemed to be equal to the mutually agreed percentage of the Net Sales of the Combination Product; provided, that if the Parties are unable to agree on such relative value within 30 days of commencement of discussions with respect to such relative value, despite their good-faith efforts, then such dispute regarding the percentage shall, within 30 days, be referred to a panel of two (2) individuals, experienced in a field relevant to such a valuation exercise, comprising one expert selected by each of the Parties, who shall review and select between, without any modification thereto, one of the Parties’ proposals on the calculation of such percentage, and whose determination shall be final and binding on the Parties.
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The weighted average sale price for a Product, other compound(s) or ingredient(s), or Combination Product shall be calculated once each Calendar Year and such price shall be used during all applicable royalty-reporting periods for the entire following Calendar Year. When determining the weighted average sale price of a Product, other compound(s) or ingredient(s), or Combination Product, the weighted average sale price shall be calculated by dividing the sales dollars (translated into Dollars) by the units of active ingredient sold during the twelve (12) months (or the number of months sold in a partial calendar year) of the preceding Calendar Year for the respective Product, other compound(s) or ingredient(s), or Combination Product. In the initial Calendar Year, a forecasted weighted average sale price will be used for the Product, other compound(s) or ingredient(s), or Combination Product. Any over or under payment due to a difference between forecasted and actual weighted average sale prices will be paid or credited in the first royalty payment of the following Calendar Year. Such amounts shall be determined from the books and records of Licensee or a Related Party maintained in accordance with GAAP, consistently applied. Licensee further agrees in determining such amounts, it will use and will require its Related Parties to use Licensee’s then-current standard procedures and methodology, including currency conversion as provided in Section 7.11.
For the avoidance of doubt, under no circumstances will Net Sales be reduced by any costs associated with marketing and promotional activities (even if such costs are appropriate reductions of Net Sales for financial reporting purposes in accordance with GAAP).
In no event shall any particular amount of deduction identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions).
1.57 “Non-Related Parties” means, with respect to a Party, any Person that is not a Related Party of such Person.
1.58 “Party-Specific Regulations” means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Party’s activities contemplated by this Agreement.
1.59 “Patent Rights” means Lilly’s rights in any subject matter claimed in any U.S. or foreign patent applications or patents that claim priority to any of the Licensed Patents.
1.60 “Patent Term Extension” means any term extensions, supplementary protection certificates, Regulatory Exclusivity and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.
1.61 “Patents” means any and all patent applications and issued patents.
1.62 “Person” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, Governmental Authority, association or other entity.
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1.63 “Personal Information” means, in addition to any definition for any similar term (e.g., “personal data” or “personally identifiable information” or “PII”) provided by Applicable Laws, or by either Party in any of its own privacy policies, notices or contracts, all information that identifies, could be used to identify or is otherwise associated with an individual person, whether or not such information is associated with an identified individual person.
1.64 “Phase I Clinical Trial” means a human clinical trial in a country, the principal purpose of which is preliminary determination of the safety, metabolism and pharmacokinetic properties and clinical pharmacology of the Compound in healthy individuals or patients as described in 21 C.F.R. § 312.21(a), or similar clinical study in a country other than the U.S.
1.65 “Phase II Clinical Trial” means an adequate and well-controlled human clinical trial in a country, the principal purpose of which is a preliminary determination of the efficacy and safety of a Product for an indication in a target population of patients being studied, at the intended clinical dose or doses or range of doses, on a sufficient number of subjects and for a sufficient period of time to confirm the optimal manner of use of the Compound (dose and dose regimen) for such indication prior to initiation of the pivotal Phase III Clinical Trials for such indication as described in 21 C.F.R. §312.21(b), or similar clinical study in a country other than the U.S.
1.66 “Phase IIa Clinical Trial” means that part of the Phase II Clinical Trial designed to assess dosing requirements and efficacy of a Product. For the purposes of this Agreement, “completion of a Phase IIa Clinical Trial” means that stage of the Phase II Clinical Trial when the efficacy of a Product as specified in the Development Plan has been observed and properly recorded.
1.67 “Phase IIb Clinical Trial” means a clinical study subsequent to a Phase IIa Clinical Trial, specifically designed to include a comparison of a Product to an accepted standard of care in a larger number of patients which represents a more rigorous demonstration of the efficacy and safety of the Product in the target patient population to define the optimal regimen to evaluate in a Phase III Clinical Trial.
1.68 “Phase III Clinical Trial” means a human clinical trial of a compound or product for an indication on a sufficient number of subjects that is designed to establish that the compound or product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and to support Regulatory Approval of the compound or product for such indication or label expansion of the compound or product as described in 21 C.F.R. §312.21(c), or similar clinical study in a country other than the U.S. For clarity, the term “Phase III Clinical Trials” includes early access and compassionate use programs.
1.69 “Phase IIIb Clinical Trial” means a human clinical trial of a compound or product for an indication that (a) is not required for receipt of Regulatory Approval for such indication for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval or, as applicable, Pricing Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (b) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval).
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1.70 “Phase IV Clinical Trials” means a human clinical trial, or other test or study, of a compound or product for an indication that is commenced after receipt of the initial Regulatory Approval for such indication in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the compound or product for such indication (and which may include investigator sponsored clinical trials), including a clinical trial conducted due to the request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval, that would satisfy the requirements of 21 C.F.R. 312.85.
1.71 “Pre-Marketing” means all sales and marketing activities undertaken prior to and in preparation for the launch of the Product in the Territory. Pre-Marketing shall include market research, key opinion leader development, advisory boards, medical education, disease-related public relations, health care economic studies, sales force training and other pre-launch activities prior to the First Commercial Sale of a Product in a given country or other regulatory jurisdiction in the Territory.
1.72 “Pricing Approval” means, with respect to any country where a Governmental Authority authorizes reimbursement or access, or approves or determines pricing, for pharmaceutical products, receipt (or, if required to make such authorization, approval of determination effective publication) of such reimbursement or access authorization or pricing approval or determination (as the case may be).
1.73 “Product” means any and all pharmaceutical products containing or comprising the Compound in any form, dosage, presentation or formulation, and whether alone, or in combination with, one or more other pharmaceutically active or inactive ingredients. [***]
1.74 “Product Approval” means, with respect to a Product, the approval of a Governmental Authority necessary for the marketing and sale of such Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).
1.75 “Product Complaint” means any written, verbal or electronic expression of dissatisfaction regarding the Product sold by or on behalf of Licensee (or any of its Related Parties or permitted distributors) in the Territory, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.
1.76 “Product Specifications” means those Manufacturing, performance, quality-control, and Packaging and Labeling specifications for the Product in the Territory, as such specifications may be amended from time to time pursuant to the terms of this Agreement.
1.77 “Promotional Materials” means all written, printed, video or graphic advertising, promotional, educational and communication materials (other than the Product labels and package inserts) for marketing, advertising and promoting of the Product in the Field in the Territory, for use (a) by a Sales Representative or (b) in advertisements, web sites or direct mail pieces.
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1.78 “Regulatory Approval” means, with respect to a Product in any regulatory jurisdiction for a given indication, approval from the applicable Regulatory Authority permitting the manufacture, distribution, use and sale of such Product in such regulatory jurisdiction for such indication in accordance with Applicable Law, including any Pricing Approvals.
1.79 “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval or, to the extent required in such country or regulatory jurisdiction, Pricing Approval of a Product in such country or regulatory jurisdiction.
1.80 “Regulatory Data” means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including information in any applicable Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).
1.81 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Governmental Authority with respect to the Product other than a Patent right.
1.82 “Regulatory Materials” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority that are necessary in order to Develop, Manufacture, obtain marketing authorization, market, sell or otherwise Commercialize the Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, MAAs, CTAs, Imported Drug Licenses (IDLs), presentations, responses and applications for other Product Approvals.
1.83 “Related Parties” means, (a) with respect to Lilly, its Subsidiaries, and (b) with respect to Licensee, its (i) Affiliates and (ii) Sublicensees of the rights granted to Licensee hereunder (excluding distributors).
1.84 “Related Patents” means, with respect to a Patent, (a) any provisionals, re-examinations, continuations, continuations-in-part claiming the same subject matter, extensions, term restorations, renewals, divisionals, reissues, renewals and any Patents resulting therefrom; (b) corresponding international patent applications, including supplementary protection certificates, or other administrative protections; and (c) all rights to apply in any or all countries of the world for such patent applications and issued patents including all rights provided by multinational treaties or conventions for any of the foregoing.
1.85 “Royalty Term” means, with respect to the Product on a country-by-country basis in the Territory, the period of time beginning on the First Commercial Sale of the Product in such country and ending the later of (a) the expiration of the last to expire Valid Claim claiming or covering the Compound or Product or the Manufacture or use thereof in such country, (b) twelve (12) years from the First Commercial Sale of the Product in such country, or (c) expiry of the Regulatory Exclusivity period for the Product in such country.
1.86 “Sales Representative” means an individual who is employed by a Party and who performs details and other promotional efforts with respect to the Product.
1.87 “Sanction Territories” means [***] and any geographies subject to U.S. comprehensive sanctions at the relevant time.
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1.88 “Second Indication Regulatory Approval” means, with respect to a specified jurisdiction, the receipt of a further Regulatory Approval in such jurisdiction for the Product, being for a second Indication.
1.89 “Specified Person” means any company in the biopharmaceutical industry with greater than [***] of pharmaceutical net sales or a market capitalization that exceeds[***].
1.90 “Submission and Filing Acceptance” means, with respect to a Marketing Authorization Application, the receipt of notice from the relevant Regulatory Authority that such Marketing Authorization Application has met all the criteria for filing acceptance (expressly, or by the passing of such time period as comprises deemed acceptance) or, if such Regulatory Authority does not provide notices of such type, acceptance by such Regulatory Authority of such Marketing Authorization Application for filing.
1.91 “Subsidiary” means, with respect to any Person, any corporation, partnership, limited liability company, association or other business entity of which, (a) if a corporation, a majority of the total voting power of shares of stock entitled (irrespective of whether, at the time, stock of any other class or classes of such corporation shall have or might have voting power by reason of the happening of any contingency) to vote in the election of directors, managers or trustees thereof is at the time owned or controlled, directly or indirectly, by that Person or one or more of the other Subsidiaries of that Person or a combination thereof, or (b) if a partnership, limited liability company, association or other business entity, either (i) a majority of the partnership or other similar ownership interest thereof is at the time owned or controlled, directly or indirectly, by that Person or one or more Subsidiaries of that Person or a combination thereof, or (ii) such Person is a general partner, managing member or managing director of such partnership, limited liability company, association or other entity.
1.92 “Territory” means worldwide.
1.93 “Third Party” means any Person other than Lilly, Licensee or their respective Affiliates.
1.94 “Training Materials” means all Product-related training materials, including learning units and other printed, audio, web-based or video training materials, branded or unbranded, relating or referring to Product, Product-related disease states and Product sales orientation assessment tests and refresher tests.
1.95 “United States” or “U.S.” means the United States of America and its possessions and territories.
1.96 “Valid Claim” means, with respect to a particular country in the Territory, (a) a claim of an issued and unexpired Licensed Patent, or Licensee Patent (as the case may be) that (i) has not been held permanently revoked, unenforceable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, which decision is unappealed or unappealable within the time allowed for appeal, and (ii) has not been cancelled, withdrawn, abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) a bona fide claim of a pending patent application included within the Licensed Patents or Licensee Patents (as the case may be) that has not been (i) cancelled, withdrawn or abandoned without being re-filed in another application in the applicable jurisdiction, or (ii) finally rejected by an administrative agency action from which no appeal can be taken or that has not been appealed within the time allowed for appeal.
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1.97 Additional Definitions. The following terms have the meanings set forth in the corresponding Sections of this Agreement:
Term | Section |
“Anti-Corruption Laws” | 9.5.1 |
“Audit” | 7.14 |
“Bankrupt Party” | 13.8 |
“Breaching Party” | 12.2 |
“Claim” | 10.1 |
“Commercialization Data” | 5.6 |
“Completion Date” | 2.5.1 |
“Completion Notice” | 2.5.1 |
“Confidential Information” | 11.1.1 |
“COVID Event” | 15.2 |
“Definitive Offer” | 2.5.4 |
“Development Data” | 3.6 |
“Development Milestone” | 7.2 |
“Development Milestone Notice” | 7.2 |
“Development Milestone Payment” | 7.2 |
“Development Plan” | 3.3.1 |
“Dispute” | 14.1 |
“Evaluation Period” | 2.5.2 |
“Foreground IP Rights” | 8.1 |
“Indemnified Party” | 10.3.1 |
“Indemnifying Party” | 10.3.1 |
“Initial Development Plan” | 3.3.2 |
“Lilly Programs” | 2.9 |
“Losses” | 10.1 |
“Major Financing Event Milestone Payment” | 7.4 |
“Negotiation Notice” | 2.5.3 |
“Packaging and Labeling” | 6.3 |
“Product Sales Milestone” | 7.3 |
“Product Sales Milestone Notice” | 7.3 |
“Product Sales Milestone Payment” | 7.3 |
“Product Trade Dress” | 5.5.1 |
“Product Trademark” | 5.5.1 |
“Relevant Transaction” | 2.5.4 |
“Royalty Payments” | 7.5 |
“Sublicensee” | 2.3.2 |
“Technology Transfer Period” | 2.8 |
“Term” | 12.1 |
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Term | Section |
“Trade Laws” | 9.5.1 |
[***] | [***] |
“Upfront License Fee” | 7.1 |
“VAT” | 7.10.1 |
ARTICLE 2
LICENSES
2.1 Grant to Licensee. Subject to the terms and conditions of this Agreement, Lilly hereby grants to Licensee during the Term an exclusive (even as to Lilly and its Affiliates, but subject to Sections 2.2.3 and 2.9), payment-bearing license (with the right to sublicense solely in accordance with Section 2.3.2) under and with respect to the Licensed Technology to (a) Develop and Manufacture the Product in the Field in the Territory for purposes of Commercializing the Product in the Field in the Territory and (b) Commercialize the Product in the Field in the Territory.
2.2 Additional Licensing Provisions.
2.2.1 Negative Covenant. Licensee covenants that it will not use or practice any of the Patent Rights or other intellectual property rights licensed (or sublicensed, as applicable) to it under this Article 2, except for the purposes expressly permitted in the applicable license grant.
2.2.2 No Implied Licenses. It is understood that nothing in this Agreement shall be construed to grant Licensee or any of its Affiliates any assignment, license, option, or other right or interest, express or implied, in, to, or under any Licensed Technology, other intellectual property right or Confidential Information owned or otherwise controlled by Lilly except for the licenses and other rights and interests expressly granted hereunder.
2.2.3 Reserved Rights. The Parties hereby agree and acknowledge that nothing contained herein shall limit or otherwise restrict the ability of Lilly or its Affiliates or licensees to use the Licensed Technology for Lilly’s and its Affiliates’ research purposes. Subject to the terms of this Agreement, and subject specifically to the exclusive license granted to Licensee as set forth in Section 2.1, Lilly shall otherwise have the right to practice, license, and exploit any Licensed Patents and Licensed Know-How for any purpose.
2.2.4 Sanction Territories. Notwithstanding the grant to the Licensee under Section 2.1 being for the Territory, Licensee shall have no right to exercise the rights and licenses granted under Section 2.1 in the Sanction Territories, for so long as any jurisdiction is or remains a Sanction Territory.
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2.3 Performance by Affiliates and Sublicensees.
2.3.1 Performance by Affiliates. Lilly recognizes that Licensee may perform some or all of its obligations under this Agreement through Affiliates; provided, however, that Licensee shall remain responsible for and be guarantor of the performance by its Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance, and Licensee shall be liable for the acts or omissions of its Affiliates under or in connection with this Agreement (as if such acts or omission were those of Licensee). Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against an Affiliate, for any obligation or performance hereunder prior to proceeding directly against Licensee. Wherever in this Agreement Licensee delegates responsibility to Affiliates, Licensee agrees that such entities may not make decisions inconsistent with this Agreement, amend the terms of this Agreement or act contrary to its terms in any way.
2.3.2 Sublicensees. Licensee shall have the right (but not the obligation) to sublicense those rights granted to it under Section 2.1 only as set forth in, and subject to the terms and conditions of, Section 2.5 and this Section 2.3.2, to (a) any Person (other than a Specified Person) with the prior written consent of Lilly, which consent will not be unreasonably withheld, conditioned or delayed; provided that Licensee may contract in the ordinary course of business with any Third Party contract research organization (“CRO”) or contract development and manufacturing organization (“CMO”) to handle certain clinical Development or Manufacturing activities, in Licensee’s reasonable discretion, without requiring Lilly’s consent; provided further that such CRO or CMO are working on Licensee’s behalf, (b) any of its Affiliates (only for so long as they remain Affiliates), provided that Licensee provides prior written notice (at least 20 Business Days in advance) to Lilly of any sublicenses to be granted to any Affiliate or its request for approval of any sublicense to be granted to any other Person, which shall include in each case a description of the rights to be granted and the purpose therefor, the identity of the proposed Sublicensee and the countries involved, or (c) a Specified Person. Each Affiliate or other Person to which any such sublicense is granted is referred to herein as a “Sublicensee.” Licensee shall remain responsible for the performance by each of its Sublicensees and shall cause each of its Sublicensees to comply with the applicable provisions of this Agreement, and Licensee shall be liable for the acts or omissions of its Sublicensees under or in connection with this Agreement (as if such acts or omission were those of Licensee). Without limiting the foregoing, Licensee shall: (x) ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder; (y) under the agreements between Licensee and each of its Sublicensees, include a provision pursuant to which either (a) Lilly is named as a third-party beneficiary or (b) a mechanism (for example, a power of attorney) is implemented for Lilly to enforce all applicable terms and conditions of this Agreement against the Sublicensee in a manner reasonably satisfactory to Lilly, provided that, in each case, Lilly shall not proceed against any Sublicensee unless Lilly has first provided Licensee with written notice of the Sublicensee’s breach and Licensee has not, within 90 days after receipt of such notice, caused the Sublicensee to cease the breaching activity or otherwise cure the breach, in each case, to the reasonable satisfaction of Lilly; and (z) terminate all relevant agreements with any such Sublicensee in the case of any breach of such terms and conditions by such Sublicensee. A Sublicensee shall have the right to grant further sublicenses, subject to complying with the terms of this Section 2.3.2 with respect to further Sublicensees. For the avoidance of doubt, (i) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (ii) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.2.1 and 2.4, respectively. Licensee hereby expressly waives any requirement that Lilly exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee. Notwithstanding anything to the contrary, (A) all sublicenses granted hereunder shall automatically terminate upon expiration or termination of this Agreement for any reason and (B) if the Parties enter into an agreement pursuant to Section 2.5 with respect to the Product, then as of the effective date of such agreement all sublicenses granted with respect to the Product shall automatically terminate, except as otherwise mutually agreed by the Parties in writing (and in no event shall any negotiations for any such agreement pursuant to Section 2.5 be conditioned on or otherwise affected by whether Lilly agrees to allow any such sublicenses to continue).
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2.4 Restrictive Covenants. Licensee hereby covenants and agrees that it shall not (and shall cause its Related Parties not to), either directly or indirectly, develop, manufacture or commercialize (including submitting any application(s) for Regulatory Approval for and selling) any Competing Products in the Territory.
2.5 Right of First Negotiation.
2.5.1 Completion Notice. Upon completion of the [***] with respect to the Product (the date of such completion, the “Completion Date”), Licensee shall promptly notify Lilly in writing of such completion, which notice shall include all information from [***] that is reasonably necessary to evaluate the results of such [***] and the likelihood of successfully further Developing and Commercializing such Product (the “Completion Notice”).
2.5.2 Evaluation Period. For such [***], during the period beginning on the Completion Date and continuing until [***] after the date of Lilly’s receipt of the Completion Notice (or such other date as may be mutually agreed in writing from time to time) (such period, an “Evaluation Period”), Lilly shall have the exclusive right to evaluate the results of such [***] and determine whether it wishes to negotiate an agreement for the further Development and Commercialization by Lilly of the Product that was the subject of such Completion Notice. Licensee shall cooperate in good faith with Lilly with respect to such evaluation and conduct of due diligence by Lilly so as to fully inform Lilly’s evaluation of the Product, and promptly provide access to any Persons, subcontractors, sub-licensees, sub-distributors, facilities, or additional material information that has been used in, or Developed regarding, such [***] or the Manufacture or Development of the Product or Compound as reasonably requested by Lilly (for which Lilly shall reimburse Licensee for its direct reasonable out-of-pocket costs). If the Completion Notice failed to include any material information required by Section 2.5.1, then Licensee shall promptly provide such information and the Evaluation Period shall be automatically extended by the number of days between the date on which all such material information is received by Lilly and the date on which Lilly received the Completion Notice. If Licensee does not promptly provide any information required to by this Section 2.5.2, and such information would reasonably be expected to be material to Lilly’s evaluation hereunder, the Evaluation Period shall be extended until a reasonable time period following Lilly’s receipt of such information.
2.5.3 Negotiation Notice. If, on or before the last day of the Evaluation Period, Lilly provides written notice to Licensee that Lilly wishes to seek to negotiate an agreement for the further Development and Commercialization by Lilly of the applicable Product (a “Negotiation Notice”), then the Evaluation Period shall be automatically extended by [***] (or such longer period as may be mutually agreed in writing from time to time) and the Parties shall, until the end of the Evaluation Period, negotiate in good faith regarding such an agreement on commercially reasonable terms and conditions. Should the parties fail to agree such an agreement within the agreed timescale, Lilly’s right of first negotiation shall be at an end, and the Exclusivity Period shall be deemed to have expired.
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2.5.4 Exclusivity Period. During the Exclusivity Period, Licensee shall not, and shall cause its Affiliates not to, directly or indirectly solicit, accept or conduct negotiations with any Person regarding (i) the further Development of the Product, (ii) the Commercialization of the Product, or (iii) a sublicense for any rights hereunder with respect thereto or (iv) a license or other similar right for any Know-How, Invention, Patent, technology, copyright, trademark or other intellectual property right Controlled by Licensee or any of its Affiliates with respect to the Product (a “Relevant Transaction”). [***].
2.5.5 Lilly’s Right to Match a Definitive Offer. Should Licensee receive any Definitive Offer from a Third Party in accordance with Section 2.5.4, as soon as reasonably practical thereafter it shall provide written notice to Lilly that it has received a Definitive Offer, and providing a complete and accurate copy of such Definitive Offer. [***] following provision by Licensee, Lilly shall respond to Licensee confirming that it wishes to negotiate in good faith regarding an agreement either: (a) including all the terms and conditions of the Definitive Offer; or (b) upon such alternative terms and conditions as Lilly proposes in its response, which terms and conditions are objectively and commercially more beneficial to Licensee than those contained in the Definitive Offer. [***], the parties shall commence negotiating in good faith regarding such an agreement which shall otherwise be on commercially reasonable terms and conditions. Should (i) the Parties fail to agree such an agreement [***] thereafter, or (ii) Lilly not respond to the Licensee within the [***] period following notification of the Definitive Offer, Lilly’s right to match or better this or any other Definitive Offer shall be at an end and Lilly shall be deemed to have declined to match, or better, the Definitive Offer. Licensee shall have [***] thereafter to consummate the transaction contemplated by such Definitive Offer. Should Licensee not sign definitive documents formalizing the transaction contemplated by the Definitive Offer [***], Lilly’s rights under this Section shall reset.
2.5.6 Exchange of Information. Licensee shall keep Lilly fully and promptly informed as to its progress and activities relating to the Development, Manufacture and Commercialization of the Product in the Field in the Territory, including with respect to regulatory matters and meetings with Regulatory Authorities, by way of semi-annual updates to Lilly and as otherwise specified in this Agreement, or as reasonably requested from time to time by Lilly. In connection therewith, Licensee shall provide Lilly with such information regarding such progress and activities under the Development Plan or otherwise relating to the Product as Lilly may reasonably request from time to time.
2.6 Data Transfer. [***] after the Effective Date, Lilly will make information and Licensed Know-How as set forth on Schedule C available to Licensee. All such information and Licensed Know-How will be provided “as is”.
2.7 Material Transfer. Within three (3) months after Lilly’s receipt of the payment of the Upfront License Fee set forth in Section 7.1, Lilly shall, at Lilly’s expense, transfer to Licensee FOB Lilly’s facility the active pharmaceutical ingredient and other materials as described in Schedule C.
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2.8 Technology Transfer. [***] following the Effective Date (the “Technology Transfer Period”), Lilly shall, at Lilly’s expense, transfer to Licensee the (i) technical information and processes as set forth on Schedule C, (ii) regulatory filings or applications in Lilly’s name for the Product as set forth on Schedule C, and (iii) other information reasonably requested by Licensee [***] of the Technology Transfer Period and used exclusively for the Development of the Product by Lilly; provided that such information is controlled by and reasonably available to Lilly, and Lilly is under no obligation to keep such information confidential. For clarity, except for the foregoing clause (iii), Lilly will only provide the items specifically listed on Schedule C and there shall be no further obligation by Lilly to provide any technical information, materials, processes, regulatory filings or applications beyond those listed therein. For the avoidance of doubt, the foregoing shall not include, and Licensee shall have no rights to use, any manufacturing technology (including any cell-based media or any of its components) or processes or device technology or processes, or any other technology, of Lilly and its Affiliates (other than Lilly and its Subsidiaries as of the Effective Date). The technology transfer shall occur in an orderly fashion and in a manner such that the value, usefulness and confidentiality of the transferred Licensed Know-How and regulatory documentation are preserved in all material respects. The implementation and transfer of information pursuant hereto shall be conducted through electronic, email and teleconference consultation between the Parties; provided that Lilly shall not be required to conduct any on-site or in-person consultation in connection therewith unless Licensee reimburses Lilly for any travel expenses. For clarity, Licensee shall be responsible for any Development or Manufacturing related costs associated with such technology transfer, including lab runs, pilot scale testing and demo batches and Lilly will not be obligated to provide any assistance, support, advice, guidance, technology transfer, information, data, or cooperation to Licensee other than what is specifically described in this Agreement.
2.9 Lilly Programs. Licensee acknowledges that Lilly or its Affiliates may research, develop, analyze, test, manufacture, conduct preclinical or clinical trials, promote, market, distribute, sell (and offer for sale or contract to sell), import, export, or otherwise commercially exploit or provide product support for one or more compounds or products (other than the Compound or Products) that are claimed or covered by, and would infringe, the Licensed Patents Controlled by Lilly or its Subsidiaries as of the Effective Date, and that some or all of such compounds or products may be at a later stage of development than the Compound. Notwithstanding anything to the contrary: (a) nothing in this Agreement prohibits or restricts Lilly or its Affiliates from researching, developing, analyzing, testing, manufacturing, conducting preclinical or clinical trials, promoting, marketing, distributing, selling (and offering for sale or contracting to sell), importing, exporting, or otherwise commercially exploiting or providing product support for any such compounds or products (or any natural evolutions or successors thereto, not being the Compound or Product) (collectively the “Lilly Programs”) or, other than with respect to a Compound or Product, from licensing or transferring to any other Person, or prosecuting or enforcing, any of its Know-How, Inventions, Patents, technology, copyrights, trademarks or other intellectual property rights with respect thereto; (b) Lilly has no obligation to share with Licensee any information regarding any Lilly Program; and (c) Licensee shall have no right to assert, and hereby covenants not to assert, any Licensed Patents or Licensed Know-How against Lilly or any of its Affiliates (or any of their sublicensees, distributors, third-party providers or customers) with respect to any Lilly Programs. In the event of Lilly selling (or offering for sale or contracting to sell) any compounds or products that Lilly directly controls as of the Effective Date (or comes under Lilly’s direct control [***]) and that are [***] under any Lilly Program in a country following approval from the applicable Regulatory Authority permitting the manufacture, distribution, use and sale of such product in such country, [***].
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ARTICLE 3
DEVELOPMENT
3.1 Overview of Development. Subject to the terms and conditions of this Agreement, Licensee shall be responsible for the Development of the Product for use in the Field in the Territory as set forth herein. Licensee shall use [***] to conduct, in accordance with the Development Plan, the Development Activities, including bridging studies, clinical studies, and Clinical Trials (including post-Regulatory Approval studies). Licensee shall use [***] to perform the Development Activities for the Product to (a) enable obtaining Regulatory Approval in the Territory for the Product in the Field and (b) maximize the commercial potential for the Product in the Field in the Territory. Notwithstanding the foregoing, Lilly acknowledges that [***]. Lilly also acknowledges the experimental and uncertain nature of Development and that the Development Plan may not yield the intended results. Accordingly, Lilly acknowledges that Licensee cannot guarantee it will obtain Regulatory Approval.
3.2 Objectives under the Development Plan.
3.2.1 Development Activities. Licensee shall [***] carry out the Development Activities for the Product under the applicable Development Plan in accordance with the time frames set forth therein and in a manner designed to achieve successful Development and Regulatory Approval of the Compound or Product in the Territory.
3.2.2 Compliance. Licensee shall conduct the Development Activities in accordance with sound and ethical business and scientific practices, and in compliance with (i) all Applicable Laws, including GCPs, GMPs, and GLPs, and also including all applicable pharmacovigilance, data privacy and data protection laws in the Territory as applicable, and (ii) Lilly animal care and use requirements referenced in the attached Schedule D. In addition, Licensee shall not use in any capacity, in connection with its Development (or Commercialization) of the Compound or Product hereunder, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Applicable Laws outside of the U.S.), or who is the subject of a conviction described in such section, and Licensee shall inform Lilly in writing promptly if it or any Person who is performing services for Licensee hereunder is debarred or is the subject of a conviction described in Section 306 (or similar Applicable Laws outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensee’s knowledge, is threatened, relating to the debarment of Licensee or any Person used in any capacity by Licensee in connection with its Development (or Commercialization) of the Compound or Product hereunder.
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3.3 Development Plan.
3.3.1 General. In connection with the Development of the Product for use in the Field in the Territory, Licensee shall conduct Development Activities pursuant to a comprehensive development plan (the “Development Plan”). The Development Plan shall set forth, among other things, the following:
(a) any preclinical studies, toxicology studies, pharmaco-economic studies and other clinical studies (including Phase IV Clinical Trials) necessary for obtaining and maintaining Regulatory Approval in the Territory, in the Field in the Territory;
(b) all regulatory plans for obtaining and maintaining Regulatory Approvals in the Field for the Product in each country or regulatory jurisdiction in the Territory; and
(c) the timeline for completing such Development Activities.
3.3.2 Initial Development Plan. The initial Development Plan for the Product (the “Initial Development Plan”) is attached hereto as Schedule E.
3.3.3 Updating and Amending Development Plan. Licensee shall, during the fourth (4th) Calendar Quarter of each Calendar Year, review and update, as appropriate, the then-current Development Plan to reflect any material changes, reprioritizations of, or additions to the Development Plan. Licensee shall provide such updated Development Plan to Lilly within ten (10) days of its creation. Lilly may, at its discretion, provide comments on such updated Development Plan within 30 days of receipt and Licensee will consider any such comments in good faith. Once Licensee has considered, and to the extent applicable, incorporated at Licensee’s discretion any comments by Lilly (but in no case later than 30 days from receipt of such comments), it shall provide Lilly with a copy of such amended Development Plan, which will become effective and supersede the previous Development Plan upon Lilly’s receipt or, if no comments are provided by Lilly, at the end of Lilly’s 30-day comment period.
3.4 Development Costs. Licensee shall be solely responsible for 100% of all (a) Development costs incurred with respect to any Development Activities or any Analytical Release Testing and Characterization and (b) costs incurred associated with any Manufacturing Development Activities.
3.5 Records, Reports and Information.
3.5.1 General. Licensee shall, and shall cause each of its Related Parties to, maintain current and accurate records of all work conducted by it under the Development Plan and all data and other information resulting from such work (which records shall include, as applicable, books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof (e.g., samples of materials and other graphic or written data generated in connection with the Development Activities)). Such records shall properly reflect all work done and results achieved in the performance of the Development Activities in sufficient detail and in good scientific manner appropriate for regulatory and patent purposes. Licensee shall document all clinical trials and relevant preclinical studies to be conducted pursuant to the Development Plan in formal written study reports according to applicable national and international (e.g., ICH, GCP and GLP) guidelines.
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3.5.2 Status Updates in the Territory. Licensee shall provide Lilly with bi-annual reports detailing the Development Activities under the Development Plan (including the amounts spent and the value of any uncompensated services and other in-kind contributions received by Licensee to conduct the Development Activities), and the results thereof; provided that upon the later of (i) the expiry of the Exclusivity Period, or (ii) Lilly or its Affiliates ceasing to hold any Equity Securities of Licensee or its Affiliates, such reports will be provided annually. Without limiting the foregoing, upon request by Lilly, Licensee shall promptly, but in any event within five (5) Business Days after receipt of Lilly’s request, provide to Lilly copies of any material documents or correspondence received from any Regulatory Authority related to Development Activities.
3.5.3 Access to Records. Lilly shall have the right to review all records under the Development Plan maintained by Licensee at reasonable times, upon written request, in accordance with Section 7.14.
3.6 Ownership of Development Data. All data (including pre-clinical, clinical, technical, chemical, safety, and scientific data and information), Know-How and other results generated by or resulting from or in connection with the Development of the Product by Licensee, including relevant laboratory notebook information, screening data, Regulatory Data and synthesis schemes, including descriptions in any form, data and other information (collectively, the “Development Data”), shall be owned solely and exclusively by Licensee and shall be Confidential Information of Licensee (and Licensee shall require that all of its Affiliates, Sublicensees and subcontractors assign to Licensee any of such Affiliates’, Sublicensees’ and subcontractors’ right, title and interest in and to such Development Data to such Party). Lilly acknowledges that such Development Data, in addition to being the Confidential Information of Licensee, may be sensitive information of Licensee. Licensee grants to Lilly a perpetual, irrevocable, fully paid-up, royalty free, non-exclusive license under all Development Data for its internal, research and development purposes, except for research and development in (a) any Lilly Program targeting IL-33; and/or (b) the Development of the Compound or Product licensed to Licensee under Section 2.1.
3.7 Development Diligence Failures. If Licensee fails to satisfy the requirements set forth in Section 3.1 with respect to the Development of the Product in the Field in the Territory, then Lilly may raise such issue by written notice to Licensee, specifying the issue and seeking its remedy. The Parties shall endeavour to resolve the Dispute between them pursuant to the dispute resolution procedures contained in Section 14.1. If, [***], the Dispute has not been resolved in accordance with Section 14.1, or Licensee has not undertaken [***] to recommence Development and remedy the issues identified by Lilly in such notice, then Lilly shall have the right to terminate this Agreement, either in its entirety or on a relevant country-by-relevant country basis, at its option; provided, however, that the aforementioned [***] period shall be tolled for the duration of the dispute resolution procedures contained in Section 14.1.
ARTICLE 4
REGULATORY
4.1 Regulatory Data and Regulatory Materials. Lilly shall use [***] to provide Licensee with such Regulatory Materials and Regulatory Data as set forth on Schedule C in the current “as-is” form and format [***]after the Effective Date. Licensee may only use the Regulatory Materials and Regulatory Data provided by Lilly hereunder in accordance with the rights granted to Licensee under Section 2.1.
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4.2 Regulatory Filings and Regulatory Approvals.
4.2.1 General Responsibilities; Ownership of Regulatory Approvals. Licensee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Product in the Field in the Territory (including in connection with Patient Information Leaflets, labeling and packaging for the Product in the Field in the Territory) and Licensee shall submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities in the Territory. For clarity, to the extent allowed by Applicable Laws, all Regulatory Approvals for the Product in the Field in the Territory shall be held and owned by Licensee in its name.
4.2.2 Pricing Approvals. To the extent that a given country or regulatory jurisdiction in the Territory requires Pricing Approval for sale of the Product in the Field in such country or regulatory jurisdiction, Licensee shall (to the extent permitted by Applicable Laws) be solely responsible for (and shall use [***] toward) obtaining and maintaining Pricing Approvals in such countries and regulatory jurisdictions in the Territory, in its own name. Without limiting the foregoing, Licensee shall use [***] to apply for Pricing Approvals in each country or regulatory jurisdiction in the Territory where Pricing Approvals are required for the sale of the Product in the Field [***] following the receipt of the Product Approval in such country or regulatory jurisdiction.
4.2.3 Cost of Regulatory Activities. All regulatory costs incurred in connection with the preparation of Regulatory Materials for, and obtaining of Product Approvals in, the Field in the Territory for the Product shall be borne solely by Licensee, and Licensee shall be responsible for all regulatory costs involved in the maintenance of all Regulatory Approvals for the Product in the Field in the Territory.
4.2.4 Reporting and Review. Licensee shall keep Lilly reasonably and regularly informed in connection with the preparation of all Regulatory Materials, Regulatory Authority review of Regulatory Materials, Regulatory Approvals and Pricing Approvals, in each case with respect to the Product for sale in the Field in the Territory. Such updates provided to Lilly under this Section 4.2.4 shall be provided in writing and shall include all data and results produced in such Development that is available to Licensee for the preceding Calendar Quarter, together with Licensee’s written assessment of such results. Upon completion of a Phase IIb Clinical Trial of the Product, such reports shall in any event be updated and promptly delivered to Lilly. Licensee shall make appropriate personnel reasonably available to answer questions from Lilly regarding such data or results. The reporting obligations in this Section 4.2.4 would continue for the Product until such Product is sublicensed or sold to a Third Party.
4.3 No Other Regulatory Filings. Except as otherwise expressly set forth in this Article 4, Licensee (and its Affiliates) shall not file any Regulatory Materials or Regulatory Approvals for any products other than the Product that are otherwise based on any Licensed Technology.
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4.4 Pharmacovigilance and Medical Inquiries.
4.4.1 Pharmacovigilance. Licensee, as the holder of the Product Approvals in the Territory, shall be responsible for all Pharmacovigilance responsibilities related to the Product in the Field in the Territory in accordance with Applicable Laws.
4.4.2 Medical Inquiries for the Product. Following the Effective Date, subject to Section 4.2.1, Licensee shall be responsible for handling all medical questions or inquiries in the Field in the Territory, including all Product Complaints, with regard to the Product sold by or on behalf of Licensee (or any of its Related Parties), in each case in accordance with Applicable Laws and this Agreement. Licensee shall be responsible for handling the Product Complaints related to the Development, Commercialization and Manufacture of the Product in the Field in the Territory, and Lilly shall refer all such Product Complaints to Licensee.
4.5 Regulatory Authority Communications Received by a Party.
4.5.1 General. Licensee shall promptly provide Lilly with a summary of notification of any action by, or notification or other information which it receives (directly or indirectly) from, any Regulatory Authority which (a) raises any material concerns regarding the safety or efficacy of the Product, (b) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product, (c) is reasonably likely to lead to a recall, market withdrawal or market notification with respect to the Product, or (d) relates to expedited and periodic reports of adverse events with respect to the Product or Product Complaints, and which may have an adverse impact on Regulatory Approval or the continued Commercialization of the Product. Licensee shall be solely responsible for responding to any such communications relating to the Product in the Field in the Territory. Upon request by Lilly, Licensee shall also promptly provide Lilly with a copy of all material correspondence received from a Regulatory Authority specifically regarding the matters referred to above.
4.5.2 Disclosures. In addition to its obligations under this Agreement, Licensee shall disclose to Lilly the following regulatory information:
(a) All material information pertaining to actions taken by Regulatory Authorities, in connection with the Product in the Field, including any notice, audit notice, notice of initiation by Regulatory Authorities of investigations, inspections, detentions, seizures or injunctions concerning the Product in the Field, notice of violation letter (i.e., an untitled letter), warning letter, service of process or other inquiry; provided, however, that a Party shall be entitled to redact those portions thereof to the extent not related to the Product. Without limiting the generality of the foregoing, Licensee shall promptly, but in any event within two (2) Business Days, inform Lilly of any inspections, proposed regulatory actions, investigations or requests for information or a meeting by any Regulatory Authority with respect to the Product in the Field.
(b) All information pertaining to notices from Regulatory Authorities, regarding non-compliance with Applicable Laws in connection with the Product in the Field, including receipt of a warning letter or other notice of alleged non-compliance from any Regulatory Authority relating to the Product in the Field [***]; provided, however, that Licensee shall be entitled to redact those portions thereof to the extent not related to the Product in the Field.
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4.6 Recall, Withdrawal, or Market Notification of Product. In the event that any Governmental Authority threatens or initiates any action to remove the Product from the market in the Field in the Territory, Licensee shall notify Lilly of such communication promptly, [***] after receipt thereof. Licensee shall determine whether to initiate any recall, withdrawal or market notification of the Product in the Field in the Territory. Licensee shall use [***] to utilize a batch tracing system that will enable Licensee to identify, on a prompt basis, customers within the Territory who have been supplied with Product of any particular batch, and to recall such Product from such customers as set forth in this Section 4.6. All costs and expenses associated with implementing a recall, withdrawal or market notification with respect to the Product in the Field in the Territory shall be borne by Licensee.
4.7 Regulatory Diligence. In the event that Licensee determines at any time during the Term that it is not economically feasible to incur the costs necessary to obtain and maintain Regulatory Approval for the Product in a given country of the Territory, Licensee shall promptly notify Lilly in writing of such determination and Lilly shall have the right to obtain or maintain Regulatory Approval in such country, and may terminate this Agreement with respect to such Product in such country.
ARTICLE 5
COMMERCIALIZATION
5.1 Commercialization in the Field in the Territory. Licensee shall be solely responsible for Commercializing the Product in the Territory for use in the Field, which Commercialization shall be in accordance with this Agreement. Licensee shall be responsible for 100% of the expenses (including Pre-Marketing and other Commercialization expenses) incurred in connection with the Commercialization of the Product in the Territory for use in the Field. Without limiting the foregoing, Licensee shall use [***] to Commercialize the Product for use in the Field in the Territory.
5.2 Licensee’s Performance.
5.2.1 Specific Commercialization Obligations. Without limiting the generality of the provisions of Section 5.1, in connection with the Commercialization of the Product in the Territory for use in the Field by Licensee hereunder:
(a) Licensee shall [***] (i) Commercialize the Product for use in the Field in the Territory, (ii) maximize the commercial potential for the Product in the Field in the Territory, (iii) represent the Product accurately and fairly, and (iv) not sell Product as part of a bundle in any manner that would disadvantage the Product relative to any other product(s) in such bundle including, without limitation, the discount or rebate for any Product is greater than the discount or rebate for any other product(s) included in such bundle.
(b) Licensee shall not (i) utilize deceptive, misleading or unethical business practices, or (ii) take any action or inaction that is incompatible with using [***] to Commercialize the Product, or which the Licensee should reasonably know is likely to prejudice the value of the Product.
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(c) Licensee shall be solely responsible for (i) receiving, accepting and filling orders for the Product in the Field in the Territory, (ii) handling all returns of the Product in the Field in the Territory, (iii) controlling invoicing, order processing and collection of accounts receivable for the sales of the Product in the Field in the Territory, and (iv) distributing and managing inventory of the Product in the Field in the Territory.
(d) Licensee shall [***] (i) launch the Product in each country (or other regulatory jurisdiction) as Licensee deems commercially appropriate to do so in the Territory after all applicable Regulatory Approvals for the Product in such country (or other regulatory jurisdiction) have been obtained; and, (ii) ensure that once launched, the Product remains commercially available in each country in which it has been launched for the duration of the Royalty Term in such country.
5.2.2 Commercialization Diligence Failures. If Licensee fails to satisfy the requirements set forth in Section 5.2.1 with respect to the Commercialization of the Product in the Field in the Territory, then Lilly may raise such issue by notice to Licensee, specifying the issue and seeking its remedy. The Parties shall endeavour to resolve the Dispute between them pursuant to the dispute resolution procedures contained in Section 14.1. If, [***] following Licensee’s receipt of any such notice from Lilly, the Dispute has not been resolved in accordance with Section 14.1, or Licensee has not undertaken [***] identified by Lilly in such notice, then Lilly shall have the right to terminate this Agreement with respect to such Product, either in its entirety or on a relevant country-by-relevant country basis, at its option; provided, however, that the aforementioned [***]for the duration of the dispute resolution procedures contained in Section 14.1.
5.3 Reports. Without limiting Licensee’s other reporting obligations hereunder, Licensee shall, during each Calendar Quarter, provide Lilly a reasonably detailed report regarding its significant Commercialization activities involving the Product during the preceding Calendar Quarter.
5.4 Promotional Materials.
5.4.1 Creation of Promotional Materials. Licensee will [***] create and develop Promotional Materials for the Territory in accordance with the Regulatory Approvals and Applicable Laws.
5.4.2 No Inclusion of Lilly Logos on Packaging and Promotional Materials. Notwithstanding anything to the contrary herein, neither Licensee nor any Related Party of Licensee shall use any of Lilly’s or its Affiliates’ trademarks, names, logos or housemarks in connection with any Promotional Materials or the Product. Without limiting the foregoing, Licensee will take no action that will interfere with or diminish Lilly’s or its Affiliates’ rights in their respective trademarks, names and logos, and if Lilly reasonably believes that the use of any trademarks, names and logos by Licensee hereunder is interfering with or diminishing their respective rights, Lilly shall notify Licensee thereof in writing and Licensee shall promptly cease use of such trademarks, names or logos in such manner.
5.4.3 Licensee Ownership of Promotional Materials. During the Term, Licensee shall own all right, title and interest in and to any Promotional Materials created by Licensee hereunder relating to the Product in the Field in the Territory including copyrights, but excluding trademarks (including the Product trademarks), names, logos and other marks owned by or on behalf of Lilly or its Affiliates.
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5.4.4 Use of Promotional Materials Exclusively for the Product. The Promotional Materials, and any aspects of those uniquely tied to the Product, shall be used by Licensee exclusively in connection with the Manufacturing and Commercialization of the Product in the Field in the Territory in accordance with the terms of this Agreement, and Licensee shall not use, or allow any other Person to use, any such Promotional Materials except in accordance with this Agreement.
5.5 Product Trademarks and Product Trade Dress.
5.5.1 Product Trademarks. Licensee shall [***] Commercialize the Product in the Field in the Territory under the trademark and the trade dress selected by Licensee (the “Product Trademarks” and the “Product Trade Dress”, respectively). Notwithstanding the foregoing, in the event that Lilly reasonably believes that the use or registration of the Product Trademarks or the use of the Product Trade Dress in a particular country in the Territory would be against the Applicable Laws of such country, or in conflict with any Third Party’s intellectual property rights in that country, based on a reasonable review of market research, regulatory research, legal searches, investigation results, legal opinion and any other relevant information that may have been collected by either Party that is relevant to the clearance for use and registration of a trademark or for use and registration of a trade dress, Lilly shall present such concern to Licensee, and Licensee shall take into good faith consideration such concerns.
5.5.2 Use and Ownership of Product Trademarks and Product Trade Dress. All uses of the Product Trademarks and Product Trade Dress by Licensee (and its Related Parties) to identify or in connection with the Commercialization of the Product in the Field in the Territory shall be in accordance with Regulatory Approvals and all Applicable Laws. Licensee (and its Related Parties) shall only use the Product Trademarks and Product Trade Dress pursuant to the terms of this Agreement to identify and in connection with the Commercialization of the Product in the Territory for use in the Field, and Licensee shall not (and shall cause its Related Parties not to) use such Product Trademarks or Product Trade Dress to identify or in connection with the marketing of any other products. Licensee shall own and retain all rights to the Product trademarks and Product trade dress (in each case, together with all goodwill associated therewith throughout the Territory). Licensee shall also own rights to any Internet domain names incorporating the Product trademarks or any variation or part of such trademarks as its URL address.
5.5.3 Maintenance of Product Trademarks. During the Term, Licensee will use [***] to establish, maintain and enforce the Product Trademarks in the Territory, and will bear all costs and expenses relating thereto.
5.6 Commercialization Data. Licensee shall own all marketing and sales data and information resulting from its Commercialization of the Product in the Field in the Territory during the Term (the “Commercialization Data”), including promotional materials, marketing strategies and market research data.
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ARTICLE 6
MANUFACTURING
6.1 General. Licensee will [***] Manufacture (or have Manufactured) reasonable quantities of the Product for clinical and commercial use in the Field in the Territory, in each case in accordance with the terms of this Article 6.
6.2 Manufacturing. Licensee will be solely responsible for, and will bear all the costs and expenses of Manufacturing and supplying, all of its requirements of the Product for its use in the Development of the Product in the Field, and the Commercialization of the Product in the Field within the Territory. All Product Manufactured by or on behalf of Licensee must be manufactured in compliance with Applicable Laws, Regulatory Approvals and applicable GMPs.
6.3 Packaging and Labeling; Certain Other Manufacturing Activities. Notwithstanding anything to the contrary contained herein, Licensee or its designated Third Party shall be responsible (at its sole cost and expense) for all final product labeling and packaging (whether in commercial or clinical packaging presentation), including insertion of materials such as patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying the Product and considered to be part of the finished Product packaging and labeling, and handling, storage, quality control, quality assurance, and the testing and release aspects of Analytical Release Testing and Characterization and related activities, of the Product in connection with the foregoing (collectively, “Packaging and Labeling”). Licensee or its designated Third Party shall ensure that all such Packaging and Labeling complies with Applicable Laws, GMPs and the Regulatory Approvals for the Product in the Territory, including the Product Specifications. Licensee or its designated Third Party shall also be responsible for performing the testing and release aspects of Analytical Release Testing and Characterization of the Product. To the extent that a Third Party is involved in Packaging and Labeling or other activities described in this Section 6.3, Licensee shall be wholly responsible for, and bear 100% of the costs related to, qualifying such Third Party to perform such activities.
ARTICLE 7
PAYMENTS
7.1 Upfront License Fee. In consideration of the license and rights granted hereunder, Licensee shall pay an upfront license fee in an amount equal to $7,000,000 (the “Upfront License Fee”), [***].
7.2 Development Milestone Payments. In consideration of the license and rights granted hereunder, Licensee shall pay to Lilly each of the milestone payments set forth in the table below (each, a “Development Milestone Payment”) upon the occurrence of the corresponding milestone set forth in such table (each, a “Development Milestone”). Licensee shall promptly notify Lilly in writing of, but in no event later than five (5) Business Days after, the occurrence of each Development Milestone for the Product (which notice shall specify the date of such occurrence, and such specified date shall be binding on Licensee) (each, a “Development Milestone Notice”); provided, however, that in no event shall a failure to deliver a Development Milestone Notice relieve Licensee of its obligation to pay the applicable Development Milestone Payment when due pursuant to this Section 7.2. Licensee shall pay each Development Milestone Payment [***] after the occurrence of the applicable Development Milestone.
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Development Milestone | Jurisdiction/Agency | Development Milestone Payment |
Initiation of the [***] Trial | [***] | [***] |
[***] | [***] | [***] |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | [***] |
[***] | [***] | |
[***] | [***] | |
[***] | [***] | [***] |
[***] | [***] | |
[***] | [***] |
Each Development Milestone is a single occurrence event, and accordingly each Development Milestone Payment shall only be payable once for all products that fall within the definition of the Product taken together (e.g., all formulations and dosages), and shall be payable upon the first occurrence of the applicable Development Milestone for the Product (regardless of the specific Product or whether the specific Product for a Development Milestone is the same as the specific Product for any other Development Milestones). For clarity, and by way of example (with each of the following items occurring sequentially in the order set forth below):
(i) | If there is an Initiation of a [***] for a particular formulation/dosage of the Product, the corresponding Development Milestone Payment of [***]would be payable. |
(ii) | If there is an Initiation of a second [***] whether for the same formulation/dosage of the Product as in item (i) or for a different formulation/dosage of the Product, no Development Milestone Payment would be payable. |
(iii) | If there is Submission and Filing Acceptance of the first [***] for the Product in any formulation/dosage or for any indication within the Field, the corresponding milestone payment of [***] (depending on relevant Jurisdiction/Agency) would be payable. |
(iv) | If there is a [***] for the Product in any formulation/dosage within the Field, the corresponding milestone payment of [***] (depending on relevant Jurisdiction/Agency) would be payable. |
(v) | If there is a subsequent [***] for the Product for a different formulation/dosage than in item (iv), no Development Milestone Payment would be payable for the same Jurisdiction/Agency because the applicable Development Milestone Payment has already been made. |
(vi) | If there is a [***] for the Product in any formulation/dosage within the Field, the corresponding milestone payment of [***] (depending on relevant Jurisdiction/Agency) would be payable. |
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For the avoidance of doubt only ten distinct Development Milestones may be achieved and so if all ten of the Development Milestones occur, the total amount of Development Milestone Payments required to be made under this Agreement will be [***].
7.3 Product Sales Milestone Payments. In consideration of the license and rights granted hereunder Licensee shall pay to Lilly each of the milestone payments set forth in the table below (each, a “Product Sales Milestone Payment”) once only, on the first occurrence of the aggregate Net Sales for the Product (by Licensee, and all Related Parties) in any Calendar Year exceeding the corresponding Net Sales threshold set forth in such table (each, a “Product Sales Milestone”). Licensee shall promptly notify Lilly in writing of [***] the occurrence of the Product Sales Milestone (each, a “Product Sales Milestone Notice”); provided, however, that in no event shall a failure to deliver a Product Sales Milestone Notice relieve Licensee of its obligation to pay the applicable Product Sales Milestone Payment when due pursuant to this Section 7.3. Licensee shall pay each Product Sales Milestone Payment [***] after the end of the Calendar Quarter in which the Product Sales Milestone first occurred.
Product Sales Milestone (Annual Net Sales Threshold) |
Product Sales Milestone Payment |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
The aggregate Net Sales of the Product shall be for all products that fall within the definition of the Product taken together (e.g., all formulations and dosages), and shall be calculated on a worldwide basis for all jurisdictions within the Territory. If applicable, the aggregate Net Sales in each jurisdiction shall be converted to Dollars in accordance with Section 7.11 for purposes of determining whether a Product Sales Milestone has occurred. Each Product Sales Milestone Payment shall only be payable once for the Product for all products that fall within the definition of such Product taken together (e.g., all formulations and dosages), and shall be calculated on a worldwide basis for all jurisdictions within the Territory, and shall be payable upon the first occurrence of the applicable Product Sales Milestone. For clarity, the occurrence of a Product Sales Milestone for exceeding a particular Net Sales threshold shall also mean the occurrence of each Product Sales Milestone having a lower Net Sales threshold, and each such Product Sales Milestone Payment shall be separately due and payable (to the extent not previously paid). By way of example, if during a particular Calendar Quarter, the [***] Net Sales threshold for the Product is exceeded, but at the end of the prior Calendar Quarter, the [***] Net Sales threshold for the Product had not yet been exceeded, then the Product Sales Milestone Payments of [***] and [***] would both be due and payable [***] after the end of the Calendar Quarter during which the [***] Net Sales threshold was exceeded.
For the avoidance of doubt, if all of the Product Sales Milestones occur for the Product, the total amount of Product Sales Milestone Payments required to be made will be [***].
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7.4 Major Financing Event Milestone Payment. In consideration of the license and rights granted hereunder, Licensee shall pay Lilly [***] (the “Major Financing Event Milestone Payment”), which shall be due and payable [***] following the Major Financing Completion.
7.5 Royalty Payments. In consideration of the license and rights granted hereunder, Licensee shall pay to Lilly a tiered royalty in an amount equal to the aggregate Net Sales for the Product during the Calendar Year (by Licensee and all Related Parties) multiplied by the applicable royalty rate percentage(s) specified in the table below (with each royalty rate percentage applied only to the corresponding range of Net Sales specified in such table) (collectively, the “Royalty Payments”).
Net Sales (each Calendar Year) |
Royalty Rate Percentage |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Each Royalty Payment shall be calculated based on the aggregate Net Sales of the Product during the Calendar Year, and shall be calculated on a worldwide basis for all jurisdictions within the Territory. If applicable, the aggregate Net Sales in each jurisdiction shall be converted to Dollars in accordance with Section 7.11 for purposes of determining the aggregate Net Sales in all jurisdictions. The aggregate Net Sales of the Product shall be for all products that fall within the definition of the Product taken together (e.g., all formulations and dosages). Each royalty rate percentage in the table above applies only to the specified range of Net Sales for the Product. For example, [***].
7.6 Generic Competition. On a country-by-country basis, if during [***] for which Royalty Payments are payable hereunder for the Product, one or more products (excluding any products manufactured or sold by Licensee or its Related Parties) being sold in a particular country are Generic Products with respect to the Product, with such Generic Products accounting for [***] or more of the total relevant market by volume or revenue then the royalty rate percentage otherwise applicable to the Net Sales of the Product in such country during the second such Calendar Quarter and thereafter (for as long as such Generic Products are sold in such country) shall be reduced by [***], such relevant market defined as approved pharmaceutical products which comprise a similar or identical active ingredient(s). Thereafter, if the Generic Product(s) market penetration falls below [***] during any [***], then the royalty rate percentage otherwise applicable to the Net Sales of the Product in such country (i.e., without reduction subject to this Section 7.6) shall apply for the second such Calendar Quarter and thereafter but only for so long as market penetration remains below [***]. For purposes of this Section 7.6, “market” refers to the aggregate of the unit volume of the Generic Product(s) and the Product in a country.
7.7 Anti-Stacking. In the event the Manufacture or Commercialization of the Product under this Agreement would infringe the intellectual property rights of any Third Party in a given country absent a license thereunder, which Manufacture or Commercialization, at the relevant time, is also encompassed within any Valid Claim of a Licensed Patent, and Licensee determines, after consultation with Lilly, that it is necessary and commercially reasonable in the circumstances to obtain a license under such intellectual property rights, then Licensee may deduct from the Royalty Payments due to Lilly based on Net Sales in such country pursuant to Section 7.5 [***] of the royalty payments actually paid to any such Third Party on an arm’s-length basis for such country, solely as consideration for any such license to such intellectual property rights with respect to such Product; provided that in no event shall the Royalty Payments for the Product due to Lilly for a given Calendar Quarter be reduced, in aggregate, under this Section 7.7 and Section 7.6 by more than [***]. For clarity, any excess of a deduction in the Royalty Payments pursuant to this Section 7.7 and Section 7.6 shall not be rolled over into the following Calendar Quarter, meaning that any amount in excess of Lilly’s [***] sharing of the payments paid by Licensee to such Third Party in a given Calendar Quarter may not be deducted in the following Calendar Quarter, and any such excess shall not be applied to any other amounts payable hereunder.
7.8 Valid Claims. In any Calendar Quarter during the Royalty Term for a Product for which there is no longer a Valid Claim of a Licensed Patent that claims or covers such Product in a country, then (a) during the period of time ending the later of (i) twelve (12) years from the First Commercial Sale of the Product in such country, or (ii) the Regulatory Exclusivity period for the Product in such country, the royalty rate percentage otherwise applicable to the Net Sales of the Product in such country will be reduced in such country by [***] for such Calendar Quarter and thereafter during the Royalty Term; and, (b) following the period in clause (a), where but for the existence of a Valid Claim of a Licensee Patent that claims or covers such Product in a country the Royalty Term would have expired, the royalty rate percentage otherwise applicable to the Net Sales of the Product in such country will be reduced in such country by [***] for such Calendar Quarter and thereafter during the Royalty Term; provided that in no event shall the Royalty Payments for the Product due to Lilly for a given Calendar Quarter be reduced, in aggregate, under this Section 7.8, and Section 7.7 and Section 7.6 in the case of clause (a), by more than [***], or in the case of clause (b), by more than [***], and in no circumstances shall the reductions in clauses (a) and (b) apply simultaneously. For clarity, any excess of a deduction in the Royalty Payments pursuant to this Section 7.8, and Section 7.7 and Section 7.6 shall not be rolled over into the following Calendar Quarter, and any such excess shall not be applied to any other amounts payable hereunder.
7.9 Payments.
7.9.1 General. Licensee shall make all payments required by this Article 7 by wire transfer of then immediately available funds into an account designated by Lilly, and shall make such payments by a U.S. entity from a bank account domiciled in the U.S. and in Dollars. Each payment of the Upfront License Fee and each Milestone Payment shall be nonrefundable and non-creditable against any other payments due hereunder.
7.9.2 Royalty Payments and Reports. Licensee shall pay the Royalty Payments on a Calendar Quarter basis, with respect to the aggregate Net Sales for such Calendar Quarter. At the end of each Calendar Quarter, Licensee shall calculate the Royalty Payments payable to Lilly pursuant to Section 7.5 for such Calendar Quarter, which amounts shall be converted to Dollars at such time in accordance with Section 7.11. Licensee shall pay to Lilly the Royalty Payment due for the Product for Net Sales during a given Calendar Quarter within [***] after the end of such Calendar Quarter. Each Royalty Payment due to Lilly shall be accompanied by (a) a statement of the amount of aggregate gross sales of the Product (i) in the Territory as a whole and (ii) on a country-by-country basis, in each case, during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars), (b) an itemized calculation of Net Sales of the Product (A) in the Territory as a whole and (B) on a country-by country basis, in each case, during the applicable Calendar Quarter, showing for both (A) and (B) deductions provided for in the definition of “Net Sales” during such Calendar Quarter, and (c) information showing the applicable royalty rate percentage applied in accordance with Section 7.5. Without limiting the generality of the foregoing, Licensee shall require its Related Parties (and any distributors) to account for their respective Net Sales and to provide such reports with respect thereto as if such Net Sales were made by Licensee.
7.9.3 Sales Forecast Within [***] after the end of each Calendar Quarter, Licensee shall provide Lilly with a sales forecast for the subsequent [***] Calendar Quarters. Licensee will mail such forecasts to the attention of: Eli Lilly and Company, Lilly Royalty Administration in Finance, Drop Code 1064, Lilly Corporate Center, Indianapolis, Indiana, 46285.
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7.10 Taxes and Withholding.
7.10.1 VAT. The Parties agree to cooperate with one another and use reasonable efforts to ensure that value added tax or similar payment (“VAT”) in respect of any payments made by Licensee to Lilly under this Agreement does not represent an unnecessary cost in respect of payments made under this Agreement. For purposes of clarity, all sums payable under this Agreement shall be made by Licensee exclusive of VAT. In the event that any VAT is owing in any jurisdiction in respect of any such payment, Licensee shall pay such VAT, and (a) if such VAT is owing as a result of any action by Licensee, including any assignment or sublicense (including assignment to, or payment hereunder by, another Licensee-related entity or Affiliate), or any failure on the part of Licensee or its Affiliates to comply with Applicable Laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto, then the payment in respect of which such VAT is owing shall be made without deduction for or on account of such VAT to ensure that Lilly receives a sum equal to the sum which it would have received had such VAT not been due or (b) otherwise, such payment shall be made after deduction of such VAT. In the event that any deducted VAT is later recovered by Licensee or an Affiliate, Licensee shall reimburse Lilly [***] for the deducted amount. For the sake of clarity, any increase in payments to Lilly under this Section 7.10.1 shall reflect only the incremental increase in VAT directly resulting from clause (a) above. In the event that any VAT is owed in any jurisdiction in respect of any such payment, Lilly will provide to Licensee tax invoices showing the correct amount of VAT in respect of such payments hereunder.
7.10.2 Withholding Tax Matters. If Licensee is required to make a payment to Lilly subject to a deduction of tax or withholding tax, the sum payable by Licensee (in respect of which such deduction or withholding is required to be made) shall be made to Lilly after deduction of the amount required to be so deducted or withheld, which deducted or withheld amount shall be remitted in accordance with Applicable Laws. If such withholding tax is owing as a result of any action by Licensee, including any assignment or sublicense (including assignment to, or payment hereunder by, another Licensee-related entity or Affiliate), or any failure on the part of Licensee or its Affiliates to comply with Applicable Laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto, then the payment in respect of which such withholding tax is owing shall be made without deduction for such withholding tax to ensure that Lilly receives a sum equal to the sum which it would have received had such withholding tax not been due.
7.10.3 Tax Cooperation. To the extent Licensee is required to deduct and withhold taxes on any payments to Lilly, Licensee shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to Lilly an official tax certificate or other evidence of such withholding sufficient to enable Lilly to claim such payments of taxes. In the event that Licensee is required to deduct and withhold taxes on payments to Lilly, Licensee shall provide Lilly prompt notice and identify any forms reasonably necessary in order for Licensee not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Lilly shall provide to Licensee any completed tax forms that may be reasonably necessary in order for Licensee not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Lilly shall use reasonable efforts to provide any such tax forms to Licensee [***] prior to the due date for any payments for which Lilly desires that Licensee apply a reduced withholding rate. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Laws, of withholding taxes, VAT or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT.
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7.11 Currency Conversion. All payments hereunder shall be made in Dollars. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), any amount expressed in a foreign currency shall be converted into Dollars in a manner consistent with such Party’s normal practices used to prepare its audited financial statements for external reporting purposes, in accordance with GAAP, consistently applied, or by using a reputable source such as the Wall Street Journal or Reuters, at Lilly’s discretion.
7.12 Late Payments. Any amount required to be paid by a Party hereunder which is not paid on the date due shall bear interest [***]. Such interest shall be computed on the basis of a year of 360 days for the actual number of days payment is delinquent calculated from the last day that payment was due until actual payment.
7.13 Records. Licensee and its Related Parties shall keep full, true and accurate records and books of account in reasonable detail and containing all particulars that may be necessary for the purpose of confirming the accuracy of, and calculating, as applicable, all Royalty Payments and other amounts payable to Lilly hereunder (including records of Net Sales), any records required by Applicable Law or for intellectual property protection purposes with respect to the Compound and Product, and any other records reasonably required to be maintained with respect to Licensee’s obligations under this Agreement [***]. Licensee and its Related Parties shall maintain internal accounting controls sufficient to provide reasonable assurances that all transactions are executed in accordance with management authorization and recorded as necessary to permit the preparation of financial statements that conform to generally accepted accounting principles, that access to assets is permitted only in accordance with management authorization, and that recorded accountability for assets is compared to existing assets regularly and appropriate action is taken for any differences.
7.14 Audits. Lilly shall have a right to request an audit of Licensee in order to confirm the accuracy of the records described in Section 7.13 (an “Audit”); [***].
7.15 Equity Issuance. As consideration for the entry into this Agreement (and for the avoidance of doubt, no other consideration), JATT Acquisition Corp, a Cayman Islands exempted company (“JATT”), has agreed to issue to Lilly securities of JATT in an amount equal to 550,000 JATT ordinary shares listed on the Nasdaq Capital Market, as adjusted for any stock splits, stock dividends, reorganizations, recapitalizations and the like (the “JATT Shares”), on such terms as the Parties have agreed in the Equity Grant Agreement dated as of the date hereof (the “JATT Grant Agreement”). [***] In the event that the “Transaction” as defined in the JATT Grant Agreement closes, and JATT breaches its obligation to issue the JATT Shares pursuant to the terms of the JATT Grant Agreement, Lilly may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety upon written notice to Licensee. For the avoidance of doubt, Lilly shall have the option, in its sole discretion, not to accept any or all of the securities issuable pursuant to this Section 7.15 if it so desires.
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ARTICLE 8
INTELLECTUAL PROPERTY MATTERS
8.1 Ownership. Lilly shall remain the sole and exclusive owner of the Licensed Technology. [***]
8.2 Patent Filing, Prosecution and Maintenance. Subject to the terms and conditions of this Agreement, Licensee shall have responsibility for and control over all actions, [***], relating to Licensee’s Patents or the Licensed Patents, including Patent prosecution, defense, enforcement (subject to Section 8.6), listing in regulatory publications (such as the FDA Orange Book and any foreign equivalent) and Patent Term Extension. [***]
8.3 Patent and Trademark Oppositions. Licensee shall consult with Lilly prior to deciding whether and how to participate in Patent oppositions and other activities intended to invalidate a Third Party’s Patents or trademarks.
8.4 Abandoned Patents. In the event that Licensee desires to abandon or cease Patent prosecution, on a Patent-by-Patent basis, Licensee shall give prompt notice, of at least [***] prior to the deadline for the next filing, office action or payment with the relevant patent office, to Lilly if it elects to discontinue Patent prosecution or any other action described in Section 8.1, or declines to pay costs for the filing, prosecution or maintenance, of a Licensed Patent in any country. Lilly will have the option, but not the obligation, to resume control of such Patent prosecution and maintenance and such Patent shall no longer be a Licensed Patent (including with respect to the license granted in Section 2.1). If Lilly elects to exercise its option to maintain the patent, it shall do so at its own cost. If Lilly provides written notice to Licensee within such [***] period that Lilly has decided to file, prosecute or maintain, or otherwise conduct any such action with respect to, such Patent, Licensee shall promptly deliver to Lilly copies of all necessary files related to such Patent, shall take all actions and execute all documents to the extent reasonably necessary for Lilly to assume the right and responsibility to conduct all such Patent prosecution and other actions with respect to such Patent, and shall, or shall require its Affiliate to, promptly assign such Patent to Lilly.[***]
8.5 Notice. Each Party shall promptly provide written notice to the other Party reasonably detailing any known or alleged infringement of any Licensed Patent or if it receives notice by an ANDA applicant of a certification under 21 USC 355(b)(2)(a) or 355(j)(2)(A)(vii) with respect to any Licensed Patent.
8.6 Enforcement of Intellectual Property Rights. [***] shall have the first right to institute and direct legal proceedings against any Third Party believed to be infringing or misappropriating or otherwise violating a Licensed Patent covering the Compound or Product, and to defend the Licensed Patents from any claim of invalidity or unenforceability in connection therewith. If [***] does not undertake efforts to abate such violation of intellectual property rights, which may include commencement of a lawsuit against the accused person if necessary, within [***] after receiving notice of such infringement of such Licensed Patent, then [***] shall be entitled (but shall not be obligated) to take all actions reasonably necessary to abate such violation, including commencement of a lawsuit against the accused person if necessary; provided, however, that [***] shall consult in advance with Licensee regarding such action. The primary objective of any such patent enforcement action shall be to preserve exclusivity for the Product and uses thereof in the major pharmaceutical markets and other markets with respect to which [***] the Product. All amounts recovered from enforcement of any such rights by an enforcing Party relating to such intellectual property licensed under this Agreement shall be first used to reimburse each Party’s reasonable out-of-pocket costs and expenses incurred in connection with such action, and any remainder of such recovery shall be allocated such that the Party that commenced the lawsuit retains [***] of such remainder, and the other [***] is promptly (but no later than [***] Business Days after receipt by the Party that commenced the lawsuit) paid to the other Party. The Parties shall keep each other informed of the status of and of their respective activities regarding any enforcement action pursuant to this Section 8.6. For the avoidance of doubt, Lilly reserves all rights to institute and direct legal proceedings against any Third Party believed to be infringing or misappropriating or otherwise violating Licensed Know-How and Lilly Confidential Information.
8.7 Cooperation in Enforcement Proceedings. For any action by a Party pursuant to Section 8.6, in the event that such Party is unable to initiate or prosecute such action solely in its own name, the other Party or its Affiliates, as applicable, will join such action voluntarily and will execute all documents necessary for such Party to initiate, prosecute and maintain such action. If either Party initiates an enforcement action pursuant to Section 8.6, then, at such Party’s request, the other Party shall cooperate to the extent reasonably necessary and at the first Party’s sole expense for reasonable, out-of-pocket costs (except for the expenses of the non-controlling Party’s counsel, if any). Upon the reasonable request of the Party instituting any such action or if necessary to continue such action, such other Party shall join the suit and can be represented in any such legal proceedings using counsel of its own choice at its own expense. Each Party shall, if possible, assert and not waive the joint defense privilege with respect to all communications between the Parties reasonably the subject thereof with respect to any such action.
8.8 Defense. Each Party shall notify the other in writing of any allegations it receives from a Third Party that the manufacture, production, use, Development, Commercialization, sale or distribution of the Product, or any technology or intellectual property licensed under this Agreement, infringes the intellectual property rights of such Third Party. Such notice shall be provided promptly [***] following receipt of such allegations.
[***]
The Parties shall keep each other informed of the status of and of their respective activities regarding any infringement litigation initiated by a Third Party concerning the manufacture, production, use, Development, Commercialization sale or distribution of the Product or settlement thereof; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this Section 8.8 may be undertaken by a Party without the consent of the other Party, which consent shall not be unreasonably withheld or delayed.
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8.9 Employees. To the extent allowed by Applicable Laws, Licensee will require all of its (and will cause each of its applicable Affiliates to require all of such Affiliate’s) employees to assign all Inventions that are developed, made or conceived by such employees during the period of such employees’ employment with Licensee (or the applicable Affiliate) to Licensee (or the applicable Affiliate) free and clear of all liens, encumbrances, charges, security interests, mortgages or other similar restrictions. Licensee will also use its [***] to require any agents or independent contractors performing an activity pursuant to this Agreement to assign all Inventions that are developed, made or conceived by such agents or independent contractors on behalf of Licensee during the period of such agents or independent contractors’ relationship with Licensee to Licensee free and clear of all liens, encumbrances, charges, security interests, mortgages or other similar restrictions.
8.10 Patent Marking. Licensee shall mark the Product marketed and sold by Licensee (or its Related Parties) hereunder with appropriate patent numbers or indicia.
8.11. Patent Challenge. Lilly will be permitted to terminate this Agreement upon written notice to Licensee, effective upon receipt, if Licensee or any of its Related Parties, directly or indirectly, (a) initiates or requests an interference or opposition proceeding with respect to, (b) makes, files or maintains any claim, demand, lawsuit or cause of action to challenge the validity or enforceability of, or (c) [***] any Licensed Patent[***].
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS; COMPLIANCE
9.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows, as of the Effective Date:
9.1.1 Corporate Existence and Power. It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.
9.1.2 Authority and Binding Agreement. (a) It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder, and (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity.
9.1.3 No Conflicts. The execution, delivery and performance of this Agreement by it does not (a) conflict with any agreement, instrument or understanding, oral or written, to which it is a party and by which it may be bound or (b) violate any Applicable Laws.
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9.1.4 All Consents and Approvals Obtained. Except with respect to Regulatory Approvals for the Development, Manufacturing or Commercialization of the Product or as otherwise described in this Agreement, (a) all necessary consents, approvals and authorizations of, and (b) all notices to, and filings by such Party with, all Governmental Authorities and other Persons required to be obtained or provided by such Party as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained and provided, except for those approvals, if any, not required at the time of execution of this Agreement.
9.2 Additional Representations and Warranties of Lilly. Lilly hereby represents and warrants to Licensee that, as of the Effective Date:
9.2.1 Lilly has not filed any Marketing Authorization Applications with a Governmental Authority in the Territory for the sale of the Product in the Field in the Territory.
9.2.2 Lilly has not granted or assigned any right to the Licensed Patents and, to its knowledge, the Licensed Know-How in the Field and in the Territory.
9.2.3 Lilly is the owner or licensee of the Licensed Patents and Licensed Know-How.
9.2.4 To its knowledge Lilly has complied with all Applicable Laws in all material respects, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the Licensed Patents owned by Lilly in the Field and in the Territory.
9.2.5 Neither Lilly nor, to the knowledge of Lilly, its subcontractors, has received written notice of any proceedings pending before or threatened by any Regulatory Authority with respect to the Product.
9.2.6 To the knowledge of Lilly, no Third Party [***].
9.2.7 To the knowledge of Lilly, no Undisclosed Third Party IP Rights[***].
9.3 Additional Representations, Warranties and Covenants of Licensee. Licensee hereby represents, warrants and covenants to Lilly that, as of the Effective Date and throughout the Term:
9.3.1 To the knowledge of Licensee, no claim or demand of any Person has been asserted in writing to Licensee that challenges the rights of Licensee to use or license any of the Licensee Technology.
9.3.2 To its knowledge, Licensee has complied and will comply with all Applicable Laws, in all material respects, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the Licensee Patents owned by Licensee in the Territory.
9.3.3 Licensee’s compensation programs for its Sales Representatives will not provide financial incentives for the promotion, sales, and marketing of the Product in violation of any Applicable Laws or any professional requirements.
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9.3.4 Licensee’s medical, regulatory and legal teams will review all training materials and programs prior to use by Licensee to ensure that all training materials and programs are in accordance with the Regulatory Approvals and Applicable Laws.
9.3.5 Product Commercialized or Manufactured by, or under authority of, Licensee shall be packaged, labeled, handled, stored and shipped by Licensee in compliance with all Applicable Laws, including GMPs.
9.4 Financial Representations, Warranties and Covenants of Licensee.
9.4.1 Financial Status. Licensee hereby represents, warrants and covenants to Lilly that, as of the Effective Date and throughout the Term, Licensee has and shall have the financial wherewithal to perform its obligations under this Agreement. Licensee shall promptly notify Lilly of any material adverse change to said financial wherewithal that is adversely impacting, or may adversely impact, Licensee’s ability to perform, or to continue to perform, such obligations. Any such notice will include a description of Licensee’s short- and long-term plans to remediate its current financial situation and to mitigate any impact on the performance of its obligations hereunder. Licensee shall provide Lilly regular updates regarding such remediation plans.
9.4.2 Financial Statements.
(a) As soon as available [***] Licensee shall provide to Lilly a copy of the annual audit report for such year including a copy of the audited consolidated balance sheet of Licensee and its Affiliates as of the end of such year, and the related audited consolidated statements of income and of cash flows for such year, setting forth of Licensee and its Affiliates, in each case in comparative form the figures for the previous year, together with an opinion as to such audit report of Licensee’s independent certified public accountant auditor.
(b) As soon as available [***] Licensee shall provide to Lilly a copy of the unaudited quarterly report of Licensee and its Affiliates for such quarter including a copy of the unaudited consolidated balance sheet of Licensee and its Affiliates as at the end of such quarter and the related unaudited consolidated statements of income and of cash flows for such quarter and the portion of the fiscal year through the end of such quarter, certified by Licensee’s Chief Financial Officer as being fairly stated in all material respects (subject to normal year-end audit adjustments).
(c) All such financial statements shall be complete and correct in all material respects and shall be prepared in reasonable detail and in accordance with GAAP applied (except as approved by such accountants or Chief Financial Officer, as the case may be, and disclosed in reasonable detail therein) consistently throughout the periods reflected therein and with prior periods.
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9.5 Compliance Representations, Warranties and Covenants by Licensee.
9.5.1 Compliance with Laws. In connection with this Agreement, Licensee has complied and will comply with all Applicable Laws and industry codes, including those dealing with government procurement, conflicts of interest, corruption or bribery, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, any anti-corruption or anti-bribery laws in jurisdictions where Licensee operates, and any laws enacted to implement the Organisation of Economic Cooperation and Development Convention on Combating Bribery of Foreign Officials in International Business Transactions (collectively, “Anti-Corruption Laws”), and all Applicable Laws related to sanctions and trade controls, including but not limited to any sanctions or export control laws administered or enforced by the U.S. Department of the Treasury’s Office of Foreign Assets Control, U.S. Department of State, U.S. Department of Commerce, the United Nations Security Council, or other relevant sanctions authority (collectively, “Trade Laws”), and has implemented and will maintain policies and procedures reasonably designed to ensure compliance with Anti-Corruption Laws and Trade Laws.
9.5.2 Prohibited Conduct. In connection with this Agreement, Licensee has not made, offered, given, promised to give, or authorized, and will not make, offer, give, promise to give, or authorize, any bribe, kickback, payment or transfer of anything of value, directly or indirectly, to any person or to any Government Official for the purpose of (a) improperly influencing any act or decision of the person or Government Official, (b) inducing the person or Government Official to do or omit to do an act in violation of a lawful or otherwise required duty, (c) securing any improper advantage, or (d) inducing the person or Government Official to improperly influence the act or decision of any organization, including any government or government instrumentality, to assist Licensee or Lilly in obtaining or retaining business.
9.5.3 Compliance with Privacy Laws. In connection with and to the extent applicable under this Agreement, Licensee and any Person acting for or on its behalf, will comply with all Applicable Laws with respect to the receipt, collection, compilation, use, storage, processing, sharing, safeguarding, security (technical, physical and administrative), disposal, destruction, disclosure, or transfer (including cross-border) of Personal Information, including providing any notice, obtaining any consent or prior authorization, and conducting any assessment required under Applicable Laws.
9.5.4 Requests for Information; Audits. Licensee will make [***] to comply with requests for disclosure of information, including answering questionnaires and audit inquiries, to enable Lilly to ensure compliance with all Applicable Laws, including Anti-Corruption Laws, Trade Laws, and this Agreement, and will comply with the terms of Section 7.14 with regard to any audit requested under that provision that relates to compliance with this Section 9.5.
9.5.5 Notice of Inspections. Licensee shall provide Lilly with immediate notice of any governmental or regulatory review, audit or inspection of its facility, processes or products that might relate to the subject matter of this Agreement. Licensee shall provide Lilly with the results of any such review, audit or inspection. Lilly shall be given the opportunity to provide assistance to Licensee in responding to any such review, audit or inspection.
9.5.6 Cooperation in Investigation. Licensee agrees to cooperate in good faith to investigate the extent of any potential violations of Applicable Law, including Anti-Corruption Laws and Trade Laws, in connection with this Agreement.
9.5.7 Disclosure Rights. At any time, and without notice to the other Party, either Party may disclose information relating to a possible violation of Applicable Law, or the existence of the terms of this Agreement, including the compensation provisions, to a government agency and to anyone that such Party determines to have a legitimate need to know.
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9.6 Additional Compliance Covenants.
9.6.1 Compliance with Party Specific Regulations. The Parties agree to cooperate with each other as may reasonably be required to ensure that each is able to fully meet its obligations with respect to the Party-Specific Regulations applicable to it. Neither Party shall be obligated to pursue any course of conduct that would result in such Party being in material breach of any Party-Specific Regulation applicable to it. All Party-Specific Regulations are binding only in accordance with their terms and only upon the Party to which they relate.
9.6.2 Compliance with Internal Compliance Codes. All Internal Compliance Codes shall apply only to the Party to which they relate. The Parties agree to cooperate with each other to ensure that each Party is able to comply with the substance of its respective Internal Compliance Codes and, to the extent practicable, to operate in a manner consistent with its usual compliance-related processes.
9.7 Disclaimer. Licensee understands that the Product is the subject of ongoing non-clinical and clinical research and development and that Lilly cannot ensure the safety or usefulness of the Product or that the Product will receive Regulatory Approvals. In addition, Lilly makes no warranties except as set forth in this Article 9 concerning the Licensed Technology.
9.8 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD-PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
ARTICLE 10
INDEMNIFICATION
10.1 Indemnification by Lilly. Lilly hereby agrees to save, indemnify, defend and hold Licensee, its Affiliates, and their respective directors, officers, agents and employees harmless from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) arising in connection with any and all charges, complaints, actions, suits, proceedings, hearings, investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions by a Third Party (each, a “Claim”) to the extent resulting or otherwise arising from [***] in each case except to the extent that such Losses are subject to indemnification by Licensee pursuant to Section 10.2.
10.2 Indemnification by Licensee. Licensee hereby agrees to save, indemnify, defend and hold Lilly, its Affiliates, and their respective directors, agents and employees harmless from and against any and all Losses arising in connection with any and all Claims to the extent resulting or otherwise arising from [***] in each case except to the extent that such Losses are subject to indemnification by Lilly pursuant to Section 10.1.
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10.3 Indemnification Procedures.
10.3.1 A Party believing that it is entitled to indemnification under, as applicable, Section 10.1 or Section 10.2 (an “Indemnified Party”) shall give prompt written notification to the other Party (the “Indemnifying Party”) of the commencement of any Claim for which indemnification may be sought or, if earlier, upon the assertion of any such Claim by a Third Party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Claim as provided in this Section 10.3.1 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually materially prejudiced as a result of such failure to give notice). Within 30 days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Claim with counsel reasonably satisfactory to the Indemnified Party. If a Party believes that a Claim presented to it for indemnification is one as to which the Party seeking indemnification is not entitled to indemnification under Section 10.1 or Section 10.2, as applicable, it shall so notify the Party seeking indemnification.
10.3.2 If the Indemnifying Party elects to assume the defense of such Claim, the Indemnified Party may participate in such defense at its own expense; provided, that if the Indemnified Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Claim, the Indemnified Party shall have the right, at its own expense, to appoint its own counsel solely in connection with the defense of such Claim.
10.3.3 The Indemnifying Party shall keep the Indemnified Party advised of the status of such Claim and the defense thereof and shall consider recommendations made by the Indemnified Party with respect thereto.
10.3.4 The Indemnified Party shall not agree to any settlement of such Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld. The Indemnifying Party shall not agree to any settlement of such Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party or adversely affects the Indemnified Party without the prior written consent of the Indemnified Party, which shall not be unreasonably withheld.
10.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES ARISING FROM OR RELATING TO THIS AGREEMENT, WHETHER OR NOT FORESEEABLE AND REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 10.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT, AND THIS SECTION 10.4 SHALL NOT APPLY TO: (A) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 10.1 OR 10.2, (B) A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 11, (C) THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF A PARTY OR ITS RELATED PARTIES, (D) LICENSEE’S OBLIGATIONS TO PAY ANY AMOUNTS REQUIRED TO BE PAID UNDER SECTIONS 7.1, 7.2, 7.3, 7.5, OR 7.9, OR TO ISSUE EQUITY AS REQUIRED UNDER SECTION 7.15, OR (E) LICENSEE’S BREACH OF SECTIONS 2.4 OR 2.5.
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10.5 Insurance. Licensee shall procure and maintain insurance, including clinical trials insurance and product liability insurance, adequate to cover its obligations hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which the Product is being clinically tested in human subjects or commercially distributed or sold by Licensee pursuant to this Agreement, [***].
ARTICLE 11
CONFIDENTIALITY
11.1 Confidential Information.
11.1.1 The Parties agree that during the Term [***] a Party receiving Confidential Information of the other Party will (a) maintain in confidence such Confidential Information to the same extent such Party maintains its own proprietary information of similar kind and value, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the other Party, except as otherwise expressly permitted below, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement. As used herein, “Confidential Information” means all Know-How and other information and materials received by either Party from the other Party or its Affiliates pursuant to this Agreement. The foregoing obligations and the other obligations set forth in this Section 11.1 shall not apply with respect to any portion of such Confidential Information which:
(a) is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party;
(b) was known to the receiving Party or any or its Affiliates, without any obligation to keep it confidential, prior to when it was received from the disclosing Party;
(c) is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party that is lawfully in possession thereof without obligation to keep it confidential;
(d) has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party or any of its Affiliates in breach of this Agreement; or
(e) has been independently developed or acquired by the receiving Party or any of its Affiliates without the aid, application or use of the disclosing Party’s Confidential Information.
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11.1.2 The receiving Party shall have the right to disclose any Confidential Information provided by the other Party hereunder if such disclosure is necessary to comply with the terms and conditions of this Agreement, or the requirements of any Applicable Law, but only to the extent of such necessity or requirements, and no such disclosure shall cause any such information to cease to be Confidential Information hereunder, except to the extent such disclosure results in a public disclosure of such information. Where reasonably possible, the receiving Party shall notify the disclosing Party of the receiving Party’s intent to make such disclosure of Confidential Information pursuant to the preceding sentence sufficiently prior to making such disclosure so as to allow the disclosing Party adequate time to take whatever action the disclosing Party may deem to be appropriate to protect the confidentiality of the Confidential Information.
11.1.3 Except as set forth above, each Party agrees that it shall provide or permit access to Confidential Information of the other Party only to (a) the receiving Party’s attorneys, independent accountants and financial advisors for the sole purpose of enabling such attorneys, independent accountants and financial advisors to provide advice to the receiving Party, (b) the receiving Party’s Affiliates, directors, officers, employees, consultants, advisors and permitted subcontractors, sub-licensees and sub-distributors, and to the directors, officers, employees, consultants, advisors and permitted subcontractors, sub-licensees and sub-distributors of such Affiliates, who have a need to know such Confidential Information to assist the receiving Party with the research, Development, Manufacturing or Commercialization activities contemplated or required of it by this Agreement; provided that in each case the Person to whom Confidential Information is being disclosed is subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 11.1, and (c) potential investors and acquirers in connection with bona fide financing or acquisition due diligence; provided that in each case the Person to whom Confidential Information is being disclosed is subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this Section 11.1; and provided, further, that each Party shall remain responsible for any failure by its attorneys, independent accountants and financial advisors, Affiliates, and its and its Affiliates’ respective directors, officers, employees, consultants, advisors and permitted subcontractors, sub-licensees and sub-distributors, and any other parties to whom such Confidential Information is disclosed, to treat such Confidential Information as required under this Section 11.1.
For clarity, either Party may disclose without any limitation such Party’s U.S. federal income tax treatment and the U.S. federal income tax structure of the transactions relating to such Party that are based on or derived from this Agreement, including a complete copy of this Agreement and any amendments thereto.
11.1.4 Each Party acknowledges that a Party in breach of any of its obligations under this Section 11.1 may cause the non-breaching Party irreparable harm, for which monetary damages may be an inadequate remedy. Therefore, notwithstanding anything to the contrary in this Agreement in the event of any such breach, the non-breaching Party shall be entitled, in addition to any other remedy available to it under this Agreement, at law or in equity, to seek injunctive relief, including an accounting for profits, specific performance of the terms hereof and other equitable relief for such breach, without the posting of bond or other security.
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11.2 Publicity. It is understood that Lilly and Licensee may each desire or be required to issue press releases or other public statements relating to this Agreement or activities hereunder, and Lilly and Licensee each agree not to issue any press release or other public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of such Party, not to be unreasonably withheld. Notwithstanding the foregoing, no such consent shall be required by Lilly or Licensee with respect to (a) the publication of materials or information that have been previously disclosed, so long as the content of such publication remains accurate at the time of disclosure, or (b) any disclosure which is required by Applicable Law or the rules of the U.S. Securities and Exchange Commission or any securities exchange. In addition, following the initial press release announcing this Agreement, either Party shall be free to disclose, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party and those terms of the Agreement which have already been publicly disclosed in accordance herewith.
11.3 Securities Filings. In the event Licensee proposes to file with the U.S. Securities and Exchange Commission or the securities regulators of any state or other jurisdiction under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities law a registration statement or any other disclosure document which describes or refers to this Agreement, Licensee shall notify Lilly of such intention and shall provide Lilly with a copy of relevant portions of the proposed filing [***] prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), and shall use reasonable efforts to obtain confidential treatment of any information that Lilly requests be kept confidential. For clarity, Lilly or any parent of Lilly may, at its discretion, file with the U.S. Securities and Exchange Commission or the securities regulators of any state or other jurisdiction under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities law, a registration statement or any other disclosure document which describes or refers to this Agreement.
11.4 Publications. Except for disclosures permitted under this Agreement, if Licensee, its Affiliates, or their respective employee(s) or consultant(s) wishes to make a publication related to the Product or which otherwise may reasonably contain Licensed Know-How, or other Confidential Information, of Lilly, Licensee shall deliver to Lilly a copy of the proposed written publication or an outline of an oral disclosure [***] prior to submission for publication or presentation. Notwithstanding anything to the contrary herein, neither Licensee nor any Related Party of Licensee shall use any of Lilly’s or its Affiliates’ trademarks, names, logos or housemarks in connection with any publication related to the Product, Licensee, or a Related Party of Licensee’s business without the express written consent of Lilly or its Affiliates.
11.5 Use of Names. Except as otherwise set forth in this Agreement, neither Party shall use the name of the other Party in relation to this transaction in any public announcement, press release or other public document without the written consent of such other Party, which consent shall not be unreasonably withheld; provided, however, that subject to Section 11.4, either Party may use the name of the other Party in any document filed with any Regulatory Authority or Governmental Authority, including the Securities and Exchange Commission.
11.6 Unauthorized Disclosure of Confidential Information. Each Party shall have a response plan in place for any disclosure of Confidential Information that is not authorized or otherwise permitted under this Agreement. Such plan shall include considerations of, among other things, notification, remediation and retrieval. In the event that a Party becomes aware of an unauthorized disclosure of Confidential Information, then such Party shall notify the other Party promptly in writing.
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11.7 Survival. The obligations and prohibitions contained in this Article 11 as they apply to Confidential Information shall survive the expiration or termination of this Agreement for a period of ten (10) years.
ARTICLE 12
TERM AND TERMINATION
12.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 12, shall remain in effect on a country-by-country basis until the expiration of the Royalty Term in such country (the “Term”).
12.2 Termination for Material Breach. Either Party may, first having tried and failed to resolve a Dispute in accordance with Section 14.1, and without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety upon written notice to the other Party in the event that the other Party (the “Breaching Party”) materially breached or defaulted in the performance of any of its obligations (including a failure to perform). Unless the Breaching Party has cured or remedied any such breach or default upon the conclusion of the dispute resolution procedure in Section 14.1, such termination shall become effective upon the Breaching Party’s receipt of the written notice of termination to be given [***] upon the conclusion of the dispute resolution procedure in Section 14.1.
12.2.1 Licensee Option to Continue Agreement. If Lilly materially breaches this Agreement, as finally determined under Article 14, such that Licensee would otherwise have the right to terminate this Agreement under Section 12.2, Licensee shall have the option, in lieu of terminating this Agreement, to terminate Licensee’s diligence obligations under Sections 3.1, 5.1, and 6.1 by written notice to Lilly. Notwithstanding anything to the contrary herein, Licensee’s option to continue this Agreement in accordance with this Section 12.2.1 shall be Licensee’s sole and exclusive remedy for any such material breach by Lilly and to the extent permitted by Applicable Laws, Licensee shall not assert, and hereby waives, any claim against Lilly or any of its Affiliates, on any theory of liability, for any damages or losses (including any direct, actual, special, indirect, consequential or punitive damages or losses) arising out of, in connection with, or as a result of, Lilly’s material breach of this Agreement or any agreement or instrument contemplated hereby. For clarity, this Agreement will continue in accordance with its terms, save as expressly set forth in this Section 12.2.1.
12.3 Termination for Non-Payment. Lilly may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety upon written notice to Licensee in the event that Licensee fails to (a) pay in full, when due and not subject to a bona fide Dispute submitted to Lilly prior to the due date for such payment and subject to the dispute resolution procedure in Section 14.1, any amount required to be paid under Section 7.1, 7.2, 7.3, or 7.4 or (b) pay in full, when due, and not subject to a bona fide Dispute submitted to Lilly prior to the due date for such payment and subject to the dispute resolution procedure in Section 14.1, any Royalty Payment required to be paid under Section 7.9; provided, however, Licensee shall pay all amounts or portions thereof not the subject of a bona fide Dispute when due. [***]
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12.4 Termination Related to Major Financing Event. Lilly may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety upon written notice to Licensee in the event that at the Major Financing Event Deadline there has been no Major Financing Completion as set forth in Section 7.4 and no payment of the Major Financing Event Milestone Payment.[***]
12.5 Termination as a Result of Bankruptcy. Each Party shall have the right to terminate this Agreement upon written notice as a result of the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of its assets for the benefit of creditors by the other Party; provided that such termination shall be effective only if such proceeding is not dismissed within [***] after the filing thereof.
12.6 Termination for Suspected Compliance Breach. Without limitation of its rights under this Article 12, Lilly may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement in its entirety upon written notice in the event of a breach by Licensee of any of the compliance representations, warranties and covenants set forth in Section 9.5.
ARTICLE 13
EFFECTS OF EXPIRATION OR TERMINATION
13.1 Expiration of Licenses. Upon the expiration (but not termination) of this Agreement in accordance with its terms, the licenses granted to Licensee under this Agreement shall become fully paid-up, royalty-free, non-exclusive, perpetual and irrevocable.
13.2 Termination. Upon termination (but not expiration) of this Agreement, in its entirety, or with respect to any given country(ies), [***].
13.3 Rights upon Termination. Except for an uncured material breach by Lilly resulting in termination by Licensee under Section 12.2, upon termination (but not expiration) of this Agreement, in its entirety, or with respect to any given country(ies), Licensee will promptly, [***] and at no cost to Lilly, do the following (but to the extent this Agreement is only terminated with respect to one or more countries, then the following shall only apply with respect to terminated countries; provided that upon such termination by country, where any of the following cannot be conducted, allocated or assigned on a country-by-country basis, Licensee shall, at Lilly’s sole discretion, enter into agreements to provide Lilly or its designee with the benefit of such agreement, right, or interest as if this Agreement had been terminated in its entirety):
(a) assign to Lilly, at Lilly’s sole discretion and direction, all of Licensee’s right, title and interest in and to any agreements (or portions thereof) between Licensee and Third Parties that relate to the Development, Commercialization or Manufacture of the Product, including the right to enforce any such agreements;
(b) With respect to the Product, Licensee (i) hereby grants Lilly, effective upon the expiration or the effective date of termination of this Agreement, as applicable, a perpetual, irrevocable, fully paid-up, royalty free, non-exclusive license, with the right to grant sublicenses at any tier, under all Licensee Technology, and trademarks developed for or used to Commercialize the Product, to Develop, Manufacture, and Commercialize the Product(s) in the Territory and (ii) shall promptly assign and transfer to Lilly or its designee all Product Trademarks and Product Trade Dress developed for or used to Commercialize the Product that are held or controlled by or under authority of Licensee, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the assignment and transfer of such Product Trademarks and Product Trade Dress to Lilly.
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(c) assign to Lilly, at Lilly’s sole discretion and direction, all of Licensee’s right, title and interest in and to any (i) Promotional Materials, (ii) copyrights and trademarks (including the Product trademarks and Product trade dress), including any goodwill associated therewith, and any registrations and design patents for the foregoing, and (iii) any Internet domain name registrations for such trademarks and slogans, all to the extent solely related to the Product; provided, however, that in the event Lilly exercises such right to have assigned such Promotional Materials, Licensee shall grant, and hereby does grant, a royalty-free right and license to any housemarks, trademarks, names and logos of Licensee contained therein [***] in order to use such Promotional Materials in connection with the Commercialization of the Product. The Parties recognize that early termination of this Agreement requires both discussion and coordination between the Parties to ensure patient safety, continuity of treatment, if appropriate, and compliance with Applicable Laws. Upon early termination of this Agreement, the Parties shall cooperate to provide for an orderly transition or cessation of any clinical trials for the Territory, as requested by Lilly. Each Party further agrees to take no action or forego taking action if such action or forbearance would in any manner jeopardize patient safety or cause the other Party to violate any Applicable Laws;
(d) assign to Lilly, at Lilly’s sole discretion and direction, the management and continued performance of any clinical trials for the Product ongoing hereunder as of the effective date of such expiration or termination in respect of which Lilly shall assume full financial responsibility from and after the effective date of such expiration or termination. If Applicable Laws prevent or delay the transfer of ownership of Regulatory Materials to Lilly or its designee, Licensee shall grant, and does hereby grant, to Lilly or its designee an exclusive and irrevocable right of access and reference to such Regulatory Materials for the Licensed Product, and shall cooperate fully to make the benefits of such Regulatory Materials available to Lilly or its designee(s). [***] Licensee shall provide to Lilly or its designee copies of all such Regulatory Materials, and of all preclinical and clinical data (including raw data, original records, investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases) and other Know-How pertaining to the Licensed Product, or the manufacture thereof. Lilly shall be free to use and disclose such Regulatory Materials and other items in connection with the exercise of its rights and licenses under this Article;
(e) transfer to Lilly all of Licensee’s right, title and interest in and to any and all regulatory filings, Regulatory Approvals and other Regulatory Materials for the Product;
(f) transfer to Lilly all of Licensee’s right, title and interest in and to any and all Development Data and Commercialization Data Controlled by Licensee for the Product; and
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(g) provide a copy of (i) the material tangible embodiments of the foregoing and (ii) any other material books, records, files and documents Controlled by Licensee solely to the extent related to the Product and which may be redacted to exclude Confidential Information of Licensee; provided, however, that to the extent that any agreement or other asset described in this Section 13.3 is not assignable by Licensee, then such agreement or other asset will not be assigned, and upon the request of Lilly, Licensee will take such steps as may be reasonably necessary to allow Lilly to obtain and to enjoy the benefits of such agreement or other asset. For purposes of clarity, (A) Lilly shall have the right to request that Licensee take any or all of the foregoing actions in whole or in part, or with respect to all or any portion of the assets set forth in the foregoing provisions and (B) to the extent Lilly requests Licensee to transfer its right, title and interest in the items set forth in this Section 13.3 to Lilly, Licensee shall also cause its Affiliates to transfer and assign to Lilly all of such Affiliates’ right, title and interest in and to the foregoing items set forth in this Section 13.3.
13.4 Disclosure and Delivery. Except for an uncured material breach by Lilly resulting in termination by Licensee under Section 12.2, upon termination (but not expiration) of this Agreement, in its entirety, or with respect to any given country(ies) (in which case such disclosure and delivery shall be with respect to Licensee Know-How relevant to that country(ies)), for use by Lilly only in such country(ies), Licensee will promptly, [***] and at no cost to Lilly, do the following: (a) Licensee will promptly transfer to Lilly copies of any physical embodiment of any Licensee Know-How, to the extent then used in connection with the Development or Commercialization of the Product (in the relevant country(ies) as the case may be); and (b) such transfer shall be effected by the delivery of material documents, to the extent such Licensee Know-How is embodied in such documents, and to the extent that Licensee Know-How is not fully embodied in such documents, Licensee shall make its employees and agents who have knowledge of such Licensee Know-How in addition to that embodied in documents available to Lilly for interviews, demonstrations and training to effect such transfer in a manner sufficient to enable Lilly to practice such Licensee Know-How but only in a manner as set out as follows in this Section 13.4. The appropriate technical teams at Lilly and Licensee will meet to plan transfer for the Licensee Know-How as follows: (i) Licensee’s designated representative(s) for the Product will meet with representatives from Lilly to answer questions with respect to the Licensee Know-How and establish a plan for the transfer for such Licensee Know-How (in the relevant country(ies) as the case may be); and (ii) Licensee will allocate adequate appropriately qualified representatives to work with Lilly to review the Licensee Know-How to enable the completion of the transfer within 30 days of the completion of the initial transfer planning meetings to the extent reasonable [***].
13.5 Disposition of Commercialization-Related Materials. Except for an uncured material breach by Lilly resulting in termination by Licensee under Section 12.2, upon termination (but not expiration) of this Agreement, Licensee will promptly deliver to Lilly in electronic, sortable form (a) a list identifying all wholesalers and other distributors involved in the Commercialization of the Product in the Territory as well as any customer lists (e.g., purchasers) related to the Commercialization of the Product in the Territory and (b) all Promotional Materials, as well as any items bearing the Product trademarks or Product trade dress and/or any trademarks or housemarks otherwise associated with the Product or Lilly; provided that to the extent this Agreement is only terminated with respect to one or more countries, then this Section 13.5 shall only apply with respect to terminated countries.
13.6 Accrued Rights. Expiration or termination of this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to the effective date of such expiration or termination. Such expiration or termination will not relieve a Party from obligations that are expressly indicated to survive the expiration or termination of this Agreement.
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13.7 Survival. Notwithstanding anything to the contrary contained herein, the following provisions shall survive any expiration or termination of this Agreement: Article 1 (Definitions), Article 11 (Confidentiality), Article 13 (Effects of Expiration or Termination), Article 14 (Dispute Resolution) and Article 15 (Miscellaneous) and Sections 7.13, 7.14, 9.5.4 - 9.5.7, 9.7, 9.8, 10.1 - 10.4. Except as set forth in this Article 13 or otherwise expressly set forth herein, upon expiration or termination of this Agreement, all other rights and obligations of the Parties shall cease.
13.8 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Lilly and Licensee are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that each Party, as licensee of certain rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party (such Party, the “Bankrupt Party”) under the U.S. Bankruptcy Code, (a) the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to such other Party and all embodiments of such intellectual property, which, if not already in such other Party’s possession, shall be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon such other Party’s written request therefore, unless the Bankrupt Party elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under clause (i), following the rejection of this Agreement by the Bankrupt Party upon written request therefore by the other Party; and (b) the Bankrupt Party shall not unreasonably interfere with the other Party’s rights to intellectual property and all embodiments of intellectual property, and shall assist and not unreasonably interfere with the other Party in obtaining intellectual property and all embodiments of intellectual property from another entity. The “embodiments” of intellectual property include all tangible, intangible, electronic or other embodiments of rights and licenses hereunder, including all compounds and products embodying intellectual property, Product, filings with Regulatory Authorities and related rights and Licensed Know-How in the case that Lilly is the Bankrupt Party and Licensee Know-How in the case Licensee is the Bankrupt Party.
ARTICLE 14
DISPUTE RESOLUTION
14.1 Disputes. The Parties recognize that, from time to time, disputes, controversies or claim may arise which stem from or are related to a Party’s respective rights or obligations under this Agreement or a Party’s actual or alleged breach of this Agreement (a “Dispute”). It is the desire of the Parties to establish procedures to facilitate the resolution of Disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 14 if and when a Dispute arises under this Agreement. If the Parties are unable to resolve any Dispute within 30 days after such Dispute is submitted to it, either Party may, by written notice to the other Party, have such dispute referred to Designated Officers of each Party for attempted resolution. If the Designated Officers cannot reach resolution of the Dispute within 30 days after such referral, the Dispute shall be referred to the Parties’ designated executive officers or their delegates for attempted resolution. In the event the designated executive officers or their delegates are not able to resolve such Dispute within such 30-day period after receipt of written notice, and a Party wishes to pursue the matter, then each Party may assert any remedy available at law or equity to enforce its rights under this Agreement.
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14.2 Choice of Law; Jurisdiction. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware and the patent laws of the United States without reference to any rules of conflict of laws. Each of the Parties hereby submits to the jurisdiction of the United States Federal District Court for Delaware in any proceeding arising out of or relating to this Agreement, agrees not to commence any suit, action or proceeding relating thereto except in such court, and waives, to the fullest extent permitted by law, the right to move to dismiss or transfer any action brought in such court on the basis of any objection to personal jurisdiction, venue or inconvenient jurisdiction. Each Party further agrees that service or any process, summons, notice or document by U.S. registered mail to such Party’s notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in Delaware with respect to any matters to which it has submitted to jurisdiction in this Section 14.2. Notwithstanding the foregoing, nothing contained in this Agreement will deny any Party the right to seek injunctive relief or other equitable relief from a court of competent jurisdiction applying the laws of the court in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any other ongoing proceeding. Any rights to trial by jury with respect to any suit, action, proceeding or claim (whether based upon contract, tort or otherwise), directly or indirectly, arising out of or relating to this Agreement hereunder are expressly and irrevocably waived by each of the Parties.
ARTICLE 15
MISCELLANEOUS
15.1 Entire Agreement; Amendment. This Agreement, together with the Schedules and Exhibits hereto, contains the entire understanding of the Parties with respect to the subject matter hereof. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter hereof are superseded by the terms of this Agreement. The Schedules and Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of each of the Parties.
15.2 Force Majeure. No Party shall be liable for any failure to perform, or be considered in breach of, its obligations under this Agreement (other than obligations to make payments of money) to the extent such performance has been delayed, interfered with or prevented by an event of Force Majeure, and the obligations of such Party under this Agreement (other than obligations to make payments of money) whose performance is affected by Force Majeure shall be suspended during, but not longer than, the continuance of the event of Force Majeure. Any Party that experiences an event of Force Majeure shall provide prompt notice of such event to the other Party, including and an estimate of the likely period of time during which its performance will be affected, and shall use reasonable efforts to remove the condition constituting Force Majeure. In the event of a prolonged condition of Force Majeure that makes it unreasonable to continue to perform other activities then being performed by the Parties and their Affiliates pursuant to this Agreement, the Parties shall consult directly or through the appropriate committees and may appropriately scale back their respective activities in order to avoid waste or inappropriate usage of resources under the circumstances, and neither Party shall be liable for any such reasonable scale back, or be considered in breach of its obligations under this Agreement (other than obligations to make payments of money to the other Party) as a result of such reasonable scale back. Notwithstanding anything to the contrary contained in this Section 15.2 or elsewhere in this Agreement, the Parties acknowledge and agree that a COVID-19 pandemic and business disruptions related thereto (collectively, the “COVID Event”) are currently occurring as of the Effective Date and may worsen, and the Parties further acknowledge and agree that neither the COVID Event, nor any recurrence thereof, shall be considered to be an event of Force Majeure or otherwise excuse any failure or delay in performance by either Party under this Agreement (so long as performance is not thereby made unlawful).
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15.3 Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given for all purposes if mailed by first class certified or registered mail, postage prepaid (which notice shall be effective five (5) Business Days after such mailing); express delivery service (which notice shall be effective on the first Business Day after delivery to such service); or personally delivered to the appropriate addresses (which notice shall be effective upon delivery to such addresses) set forth below or to such other addresses or numbers for a Party as such Party may inform the other Party by giving five (5) Business Days’ prior written notice:
If to Lilly: | Eli Lilly and Company | |
Lilly Corporate Center | ||
Indianapolis, Indiana 46285 | ||
Attention: General Counsel | ||
If to Licensee: | Z33 Bio Inc. | |
MWE Corporate Services, LLC, 1007 N. Orange St., 10th Fl., | ||
Wilmington, Delaware 19801 | ||
Attention: General Counsel |
15.4 Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, except that a Party may make such an assignment or transfer without the other Party’s written consent (i) to any of its Affiliates (but only for so long as such Person is and remains an Affiliate of such Party, it being agreed that such Party shall cause such assignment to terminate prior to such time, if any, as such Person ceases to be an Affiliate of such Party), and (ii) to any Third Party in connection with (a) the acquisition of such Party by or merger or consolidation of such Party with another entity or (b) a merger, consolidation, sale of stock, sale of all or substantially all of such Party’s assets or other similar transaction in which such Third Party either becomes the owner of all or substantially all of the business and assets of (i) such Party or (ii) that portion of such Party’s business or business unit relating to this Agreement. Any permitted successor or assignee of rights or obligations hereunder shall, in a writing delivered to the other Party, expressly assume the performance of such rights or obligations. Except as set forth in the immediately preceding sentence, in the event of an assignment or transfer as permitted above in this Section 15.4, if this Agreement is assigned or transferred to an Affiliate, the assigning or transferring Party shall remain responsible (jointly and severally) with such Affiliate for the performance of such assigned or transferred obligations. Any assignment or transfer, or attempted assignment or transfer, by either Party in violation of the terms of this Section 15.4 shall be null and void and of no legal effect. This Agreement shall be binding on, and inure to the benefit of, each Party, its successors and permitted assigns.
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15.5 Offset Rights. Notwithstanding anything to the contrary in this Agreement, neither Party may, at any time or for any reason, offset any payments due to the other Party or its Affiliates under this Agreement.
15.6 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, such provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good-faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
15.7 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law.
15.8 Ambiguities; No Presumption. Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party hereto as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
15.9 Headings. The headings for each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.
15.10 Interpretation. Except where the context expressly requires otherwise: (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa); (b) the words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation”; (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”; (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein); (e) any reference herein to any person shall be construed to include the person’s successors and assigns; (f) the words “herein,” “hereof” and “hereunder,” and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof; (g) all references herein to Articles, Sections, Exhibits or Schedules shall be construed to refer to Articles, Sections, Exhibits or Schedules of this Agreement, and references to this Agreement include all Exhibits and Schedules hereto; (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (i) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, email, approved minutes or otherwise (but excluding instant messaging); (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof; (k) the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or”; and (l) the term “to the extent” shall be interpreted to mean the extent or degree to which a subject or thing extends, and shall not simply be construed to mean the word “if.”
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15.11 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or, subject to Section 12.2.1, any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.
15.12 No Third-Party Beneficiaries. No person or entity other than Licensee, Lilly and their respective Affiliates, successors and permitted assignees hereunder, shall be deemed an intended beneficiary hereunder or have any right to enforce any obligation of this Agreement.
15.13 Independent Contractors. It is expressly agreed that Licensee and Lilly shall be independent contractors and that the relationship between Licensee and Lilly shall not constitute a partnership, joint venture or agency. Neither Licensee nor Lilly shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of such other Party.
15.14 Counterparts; Facsimile Signatures. This Agreement may be executed in two 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 delivery of electronically scanned copies of original signatures delivered by facsimile or electronic mail, and such signatures shall be deemed to bind each Party as if they were original signatures.
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IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly authorized representatives as of the date first written above.
Z33 Bio Inc. | Eli Lilly and Company | |||
By: | /s/ Oliver Levy | By: | /s/ Kenneth L. Custer | |
Printed: | Oliver Levy | Printed: | Kenneth L. Custer | |
Title: | President | Title: | Sr. VP of Business Development |
[Signature page to the License, Development and Commercialization Agreement]
Schedule A
COMPOUNDS
[***]
Schedule A - 1
Schedule B
Licensed Patents
[***]
Schedule B - 1
Schedule C
Technical Information, Materials, Processes and Regulatory Filings
[***]
Schedule C - 1
Schedule D
Lilly Animal Care and Use Requirements
[***]
Schedule D - 1
Schedule E
Initial Development
[***]
Schedule E - 1