UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C. 20549
 
______________________________________________________________________________________________________________________________________________________________________________________________
 
FORM 10-Q/A
Amendment No. 1
______________________________________________________________________________________________________________________________________________________________________________________________
 
 
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2015
 
OR
 
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE TRANSITION PERIOD FROM                        TO                       .
 
COMMISSION FILE NUMBER: 0-31265
______________________________________________________________________________________________________________________________________________________________________________________________
 
MABVAX THERAPEUTICS HOLDINGS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
______________________________________________________________________________________________________________________________________________________________________________________________
     
DELAWARE
 
93-0987903
(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION)
 
(I.R.S. EMPLOYER
IDENTIFICATION NO.)
 
11588 Sorrento Valley Road, Suite 20, San Diego, CA 92121
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES INCLUDING ZIP CODE)
 
(858) 259-9405
(REGISTRANT’S TELEPHONE NUMBER, INCLUDING AREA CODE)
______________________________________________________________________________________________________________________________________________________________________________________________
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes   x     No   ¨
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer
 
¨
  
Accelerated filer
 
¨
       
Non-accelerated filer
 
¨   (Do not check if a smaller reporting company)
  
Smaller reporting company
 
x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes   ¨     No   x
 
The number of shares of common stock outstanding as of August 3, 2015 was 25,891,075.

 


 

 
 
EXPLANATORY NOTE

This Amendment No. 1 on Form 10-Q/A, or this Amendment, to MabVax Therapeutics Holdings, Inc.’s Quarterly Report on Form 10-Q, or the Initial Form 10-Q, for the quarter ended June 30, 2015, originally filed with the Securities and Exchange Commission on August 10, 2015, is being filed for the purposes of filing Exhibits 10.1 through 10.11 and adding Exhibit 99.1 to provide an updated list of the Company's granted and pending patents and applications.

Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment contains new certifications by our principal executive officer and principal financial officers, which are filed herewith.

This Amendment does not reflect events occurring after the filing of the Initial Form 10-Q or modify or update the disclosures contained in the Initial Form 10-Q in any way other than as discussed above.

PART II – OTHER INFORMATION
 
ITEM 6 - EXHIBITS
 
Exhibit No.
 
Description
 
       
10.1
Non-Employee Director Compensation Policy
   
10.2
Standard Industrial Net Lease, dated as of May 23, 2008, by and between MabVax Therapeutics, Inc. and Sorrento Square
   
10.3
First Amendment to that Standard Industrial Net Lease, dated May 6, 2010, by and between MabVax Therapeutics, Inc. and Sorrento Square

10.4
Second Amendment to that Standard Industrial Net Lease, dated August 1, 2012, by and between the Company and Sorrento Square
     
10.5
Employment Agreement, dated July 21, 2014, by and between MabVax Therapeutics, Inc. and Paul Maffuid, Ph.D.
     
10.6
Development and Manufacturing Services Agreement, dated April 15, 2014, by and between MabVax Therapeutics, Inc. and Gallus BioPharmaceuticals NJ, LLC
 
10.7
Exclusive License Agreement for “Polyvalent Conjugate Vaccines for Cancer” (SK#14491), dated as of June 30, 2008, by and between MabVax Therapeutics, Inc. and Sloan-Kettering Institute for Cancer Research
     
10.8
Research and License Agreement, dated as of April 7, 2008, by and between MabVax Therapeutics, Inc. and Sloan-Kettering Institute for Cancer Research
     
10.9
Exclusive License to Unimolecular Antibodies, dated October 13, 2011, by and between MabVax Therapeutics, Inc. and Sloan-Kettering Institute for Cancer Research
     
10.10
Option Agreement, dated August 29, 2014, by and between MabVax Therapeutics, Inc. and Juno Therapeutics, Inc.

10.11
SBIR Contract from National Cancer Institute
  
         
         
31.1
Certification of Principal Executive Officer required by Section 302 of the Sarbanes-Oxley Act of 2002
                 
31.2
Certification of Principal Financial Officer required by Section 302 of the Sarbanes-Oxley Act of 2002
                 
32
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
                 
     99.1   MabVax Therapeutics, Inc. Granted and Pending Patents and Applications            

 
 

 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
             
Date: August 12, 2015
     
MABVAX THERAPEUTICS HOLDINGS, INC.
       
       
By:
 
/s/ J. David Hansen
           
J. David Hansen
           
President and Chief Executive Officer (Principal Executive Officer authorized to sign on behalf of the registrant)

       
By:
 
/s/ Gregory P. Hanson
           
Gregory P. Hanson
           
Chief Financial Officer (Principal Financial and Accounting Officer authorized to sign on behalf of the registrant)
Exhibit 10.1
 
Effective: September 8, 2014
 
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
 
The Board of Directors of MabVax Therapeutics Holdings, Inc. (the “ Company ”) has approved the following Non-Employee Director Compensation Policy (this “ Policy ”) which establishes compensation to be paid to non-employee directors of the Company, effective as of September 8, 2014 (the “ Effective Time ”), to provide an inducement to obtain and retain the services of qualified persons to serve as members of the Company’s Board of Directors.
 
Applicable Persons
 
This Policy shall apply to each director of the Company who is not an employee of, or compensated consultant to, the Company or any Affiliate (each, an “ Outside Director ”). “Affiliate” shall mean a corporation which is a direct or indirect parent or subsidiary of the Company, as determined pursuant to Section 424 of the Internal Revenue Code of 1986, as amended.
 
Stock Option Grants
 
All stock option amounts set forth herein shall be subject to automatic adjustment in the event of any stock split or other recapitalization affecting the Company’s common stock.
 
Annual Stock Option Grants
 
Each Outside Director shall be granted a non-qualified stock option to purchase 6,948 shares of the Company’s common stock under the Company’s 2014 Employee, Director and Consultant Equity Incentive Plan (the “ Stock Plan ”) each year on the yearly anniversary of such Outside Director’s first date of service as an Outside Director.
 
Unless otherwise specified by the Board of Directors or the Compensation Committee at the time of grant, all Annual Stock Options granted under this Policy shall (i) vest one year from the date of the grant, subject to the Outside Director’s continued service on the Board of Directors; (ii) have an exercise price equal to the fair market value of the Company’s common stock as determined in the Stock Plan on the date of grant; and (iii) contain such other terms and conditions as the Board of Directors or the Compensation Committee shall determine.
 
Initial Stock Option Grant For Newly Appointed or Elected Directors
 
Each new Outside Director shall be granted a non-qualified stock option to purchase 11,116 shares of the Company’s common stock under the Stock Plan on the date of his or her initial appointment or election to the Board of Directors. Unless otherwise specified by the Board of Directors or the Compensation Committee at the time of grant, all Initial Stock Options granted under this Policy shall (i) be fully vested on the date of the grant; (ii) have an exercise price equal to the greater of (x) $4.48 per share or (y) the fair market value of the Company’s common stock as determined in the Stock Plan on the date of grant; and (iii) contain such other terms and conditions as the Board of Directors or the Compensation Committee shall determine.
 
Cash Fees
 
Cash Payments
 
The following annual cash fees shall be paid to the Outside Directors serving on the Board of Directors and the Audit Committee, Compensation Committee and Nominating and Governance Committee, as applicable.
 
Board of Directors or Committee of Board of Directors
  
Amount for Member
 
Board of Directors (Annual)
  
$
12,000
  
Attendance at Board Meeting in person (per meeting)
  
$
1,250
  
Attendance at Board Meeting telephonically (per meeting)
  
$
750
  
 
 
 

 
 
Payment Terms for All Cash Fees
 
Cash payments payable to Outside Directors shall be paid monthly in arrears as of the first day of the calendar month. For any portion of a fiscal year in which the Effective Time occurs, annual payments shall be pro-rated beginning on the first day of the calendar month in which the Effective Time occurs.
 
Following an Outside Director’s first election or appointment to the Board of Directors, such Outside Director shall receive his or her cash compensation pro-rated beginning on the first day of the calendar month in which he or she was initially appointed or elected. If an Outside Director dies, resigns or is removed during any quarter, he or she shall be entitled to a cash payment on a pro rated basis through his or her last day of service.
 
Expenses
 
Upon presentation of documentation of such expenses reasonably satisfactory to the Company, each Outside Director shall be reimbursed for his or her reasonable out-of-pocket business expenses incurred in connection with attending meetings of the Board of Directors and Committees thereof or in connection with other business related to the Board of Directors.
 
Amendments
 
The Compensation Committee or the Board of Directors shall review this Policy from time to time to assess whether any amendments in the type and amount of compensation provided herein should be adjusted in order to fulfill the objectives of this Policy.

 
Exhibit 10.2
 
STANDARD INDUSTRIAL NET LEASE
 
CENTER NAME:
 
Sorrento Square
 
LANDLORD:
 
Sorrento Square, a California limited partnership
 
TENANT:
 
MABVAX Therapeutics, Inc., a Delaware corporation
 
 
 

 
 
STANDARD INDUSTRIAL NET LEASE
TABLE OF CONTENTS
 
                 
1.
 
BASIC LEASE TERMS
  
 
1
  
       
   
1.1
 
Address for Notice
  
 
1
  
   
1.2
 
Description of Premises:
  
 
1
  
   
1.3
 
Commencement Date:
  
 
1
  
   
1.4
 
Lease Term
  
 
1
  
   
1.5
 
Minimum Monthly Rent
  
 
1
  
   
1.6
 
Security Deposit
  
 
1
  
   
1.7
 
Tenant’s Percentage
  
 
1
  
   
1.8
 
Permitted Use
  
 
1
  
   
1.9
 
Tenant’s Guarantor
  
 
1
  
   
1.10
 
Tenant’s Parking Spaces
  
 
2
  
   
1.11
 
Landlord’s Broker
  
 
2
  
   
1.12
 
Additional Provisions
  
 
2
  
   
1.13
 
Exhibits
  
 
2
  
     
2.
 
LEASE OF PREMISES
  
 
2
  
     
3.
 
LEASE TERM
  
 
2
  
       
   
3.1
 
Commencement
  
 
2
  
   
3.2
 
Delay In Commencement
  
 
2
  
   
3.3
 
Early Occupancy
  
 
2
  
     
4.
 
RENT
  
 
2
  
       
   
4.1
 
Minimum Monthly Rent
  
 
2
  
   
4.2
 
Lease Year
  
 
3
  
   
4.3
 
Additional Rent
  
 
3
  
   
4.4
 
Impounds
  
 
3
  
   
4.5
 
Audit Right
  
 
3
  
     
5.
 
SECURITY DEPOSIT
  
 
4
  
     
6.
 
OPERATING COSTS
  
 
4
  
       
   
6.1
 
Payment of Operating Costs by Tenant
  
 
4
  
   
6.2
 
Tenant’s Share
  
 
4
  
   
6.3
 
Operating Costs
  
 
4
  
   
6.4
 
Common Facilities
  
 
5
  
     
7.
 
MAINTENANCE AND REPAIRS
  
 
5
  
       
   
7.1
 
Tenant’s Obligations
  
 
5
  
   
7.2
 
Landlord’s Obligations
  
 
6
  
   
7.3
 
Performance By Landlord
  
 
6
  
     
8.
 
REAL PROPERTY TAXES
  
 
6
  
       
   
8.1
 
Payment of Real Property Taxes by Tenant
  
 
6
  
   
8.2
 
Real Property Taxes Defined
  
 
6
  
   
8.3
 
Personal Property Taxes
  
 
7
  
     
9.
 
INSURANCE
  
 
7
  
       
   
9.1
 
Landlord’s Insurance
  
 
7
  
   
9.2
 
Tenant’s Insurance
  
 
7
  
                 
   
9.3
 
Payment of Insurance Costs
  
 
8
  
   
9.4
 
Waiver of Subrogation
  
 
8
  
   
9.5
 
Tenant’s Use Not to Increase Premium
  
 
9
  
     
10.
 
UTILITIES
  
 
9
  
     
11.
 
USE
  
 
9
  
       
   
11.1
 
Permitted Use
  
 
9
  
   
11.2
 
Compliance with Legal Requirements
  
 
10
  
   
11.3
 
Waste, Quiet Conduct
  
 
10
  
   
11.4
 
Rules and Regulations
  
 
10
  
   
11.5
 
Signs
  
 
10
  
   
11.6
 
Parking
  
 
10
  
   
11.7
 
Entry by Landlord
  
 
10
  
     
12.
 
ACCEPTANCE OF PREMISES; NONUABIUTY OF LANDLORD; DISCLAIMER
  
 
11
  
       
   
12.1
 
Acceptance of Premises
  
 
11
  
   
12.2
 
Landlord’s Exemption From Liability
  
 
11
  
   
12.3
 
No Warranties or Representations
  
 
12
  
   
12.4
 
Keys
  
 
12
  
     
13.
 
INDEMNIFICATION
  
 
12
  
     
14.
 
HAZARDOUS MATERIALS
  
 
13
  
       
   
14.1
 
Definitions
  
 
13
  
   
14.2
 
Use of Hazardous Materials
  
 
13
  
   
14.3
 
Compliance With Laws; Handling Hazardous Materials
  
 
13
  
   
14.4
 
Notice; Reporting; Notice Under Health and Safety Code Section 25359.7
  
 
14
  
   
14.5
 
Indemnity
  
 
14
  
   
14.6
 
Entry and Inspection; Cure
  
 
15
  
   
14.7
 
Termination; Expiration
  
 
15
  
   
14.8
 
Exit Assessment
  
 
15
  
   
14.9
 
Event of Default
  
 
15
  
     
15.
 
ALTERATIONS; LIENS
  
 
16
  
       
   
15.1
 
Alterations by Tenant
  
 
16
  
   
15.2
 
Permits and Governmental Requirements
  
 
16
  
   
15.3
 
Liens
  
 
16
  
   
15.4
 
Remodel
  
 
16
  
     
16.
 
DAMAGE AND DESTRUCTION
  
 
17
  
       
   
16.1
 
Partial Damage
  
 
17
  
   
16.2
 
Total Destruction
  
 
17
  
 
 
 

 
 
                 
   
16.3
 
Partial Destruction of Center or Building
  
 
17
  
   
16.4
 
Insurance Deductible
  
 
17
  
   
16.5
 
Damage Near End of Term
  
 
17
  
   
16.6
 
Landlord’s Termination Notice; Effective Date; Relocation
  
 
17
  
   
16.7
 
Rent Abatement
  
 
18
  
   
16.8
 
Tenant’s Obligations
  
 
18
  
   
16.9
 
Waiver of Inconsistent Statutes
  
 
18
  
     
17.
 
CONDEMNATION
  
 
18
  
       
   
17.1
 
Effect on Lease
  
 
18
  
   
17.2
 
Condemnation Award
  
 
18
  
   
17.3
 
Waiver of Inconsistent Statutes
  
 
19
  
     
18.
 
ASSIGNMENT AND SUBLETTING
  
 
19
  
       
   
18.1
 
Landlord’s Consent Required
  
 
19
  
   
18.2
 
Landlord’s Election
  
 
19
  
   
18.3
 
Costs; Transfer Fee
  
 
20
  
   
18.4
 
Assumption; No Release of Tenant
  
 
20
  
   
18.5
 
No Merger
  
 
20
  
   
18.6
 
Reasonable Restriction
  
 
20
  
     
19.
 
SUBORDINATION; ATTORNMENT; ESTOPPEL CERTIFICATE
  
 
20
  
       
   
19.1
 
Subordination
  
 
20
  
   
19.2
 
Attornment
  
 
21
  
   
19.3
 
Estoppel Certificates
  
 
21
  
     
20.
 
SURRENDER OF PREMISES
  
 
21
  
       
   
20.1
 
Condition of Premises
  
 
21
  
   
20.2
 
Removal of Certain Alterations, Fixtures and Equipment Prohibited
  
 
22
  
   
20.3
 
Holding Over
  
 
22
  
     
21.
 
DEFAULT BY TENANT
  
 
22
  
     
22.
 
REMEDIES
  
 
23
  
       
   
22.1
 
Termination of Lease
  
 
23
  
   
22.2
 
Continuation of Lease
  
 
23
  
   
22.3
 
Performance By Landlord
  
 
24
  
   
22.4
 
Late Charge; Interest on Overdue Payments
  
 
24
  
                 
   
22.5
 
Landlord’s Right to Require Advance Payment of Rent; Cashier’s Checks
  
 
24
  
     
23.
 
DEFAULT BY LANDLORD
  
 
25
  
       
   
23.1
 
Notice to Landlord
  
 
25
  
   
23.2
 
Notice to Mortgagees
  
 
25
  
   
23.3
 
Limitations on Remedies Against Landlord
  
 
25
  
     
24.
 
GENERAL PROVISIONS
  
 
25
  
       
   
24.1
 
Action or Defense by Tenant
  
 
25
  
   
24.2
 
Arbitration and Mediation; Waiver of Jury Trial
  
 
25
  
   
24.3
 
Attorneys’ Fees
  
 
26
  
   
24.4
 
Authority
  
 
26
  
   
24.5
 
Binding Effect; Parties Benefited
  
 
26
  
   
24.6
 
Brokers
  
 
26
  
   
24.7
 
Construction
  
 
26
  
   
24.8
 
Counterparts
  
 
26
  
   
24.9
 
Covenants and Conditions
  
 
27
  
   
24.10
 
Entire Agreement
  
 
27
  
   
24.11
 
Exhibits
  
 
27
  
   
24.12
 
Financial Statements
  
 
27
  
   
24.13
 
Force Majeure
  
 
27
  
   
24.14
 
Governing Law
  
 
27
  
   
24.15
 
Joint and Several Liability
  
 
27
  
   
24.16
 
Modification
  
 
27
  
   
24.17
 
Modification for Lender
  
 
27
  
   
24.18
 
Nondiscrimination
  
 
27
  
   
24.19
 
Notice
  
 
28
  
   
24.20
 
Partial Invalidity
  
 
28
  
   
24.21
 
Quiet Enjoyment
  
 
28
  
   
24.22
 
Recording; Non-Disclosure
  
 
28
  
   
24.23
 
Relationship of the Parties
  
 
28
  
   
24.24
 
Intentionally Omitted
  
 
28
  
   
24.25
 
Time of the Essence
  
 
28
  
   
24.26
 
Transfer of Landlord’s Interest
  
 
28
  
   
24.27
 
Waiver
  
 
28
  
   
24.28
 
OFAC Certification
  
 
29
  
   
24.29
 
Tenant Improvements
  
 
29
  

     
Exhibit “A” – Site/Floor Plan of Premises/Description of Center
  
 
Exhibit “B” – Rules and Regulations
  
 
Exhibit “C” – Sign Criteria
  
 
 
 
 

 
 
STANDARD INDUSTRIAL NET LEASE
 
This STANDARD INDUSTRIAL NET LEASE (“Lease”), dated for reference purposes only May 23, 2008, is entered into by Sorrento Square, a California limited partnership (“Landlord”), and MabVax Therapeutics, Inc., a Delaware corporation (“Tenant”).
 
1.
BASIC LEASE TERMS
 
The basic terms of the Lease set forth in this Article 1 shall be read in conjunction with the other Articles of this Lease, which define and explain the basic terms.
 
1.1  Address for Notice  (see Section 24.19):
 
         
Landlord:
   
  
11750 Sorrento Valley Road, Suite 209
     
  
San Diego, California 92121
     
  
Attention: Sorrento Square Property Management
   
Tenant:
 
At the Premises, or
     
  
Address for Tenant other than at the Premises:
     
  
2907 Wishbone Way
     
  
Encinitas CA 92024
 
1.2  Description of Premises :
 
         
Center Name:
  
Sorrento Square
 
Address: 11588 Sorrento Valley Road
     
  
San Diego CA 92121
   
Suites/Units:
  
19A & 20
 
Approximate Rentable Square Footage (see Exhibit “A”):  3,595
 
1.3  Commencement Date August 1, 2008  (the “Commencement Date”).
 
1.4  Lease Term  (see Article 3): Approximately two (2) years and zero (0) months, beginning on the Commencement Date and ending on the last day of the calendar month of July 2010 (the “Expiration Date”).
 
1.5  Minimum Monthly Rent $7,909.00  per month for the first Lease Year, as provided in Article 4. The Minimum Monthly Rent shall be increased on the first day of the second (2nd) Lease Year and each first day of each succeeding Lease Year as follows:
 
08/01/08 — 07/31/09: $7,909.00 per month
08/01/09 — 07/31/10: $8,268.50 per month
 
1.6  Security Deposit $8.268.50  (see Article 5).
 
1.7  Tenant’s Percentage  (see Article 6):  4.45% .
 
1.8  Permitted Use  (see Article 11):  General office, research & development, and laboratory uses associated with a biotechnology company , and for no other use.
 
1.9  Tenant’s Guarantor  (If none, so state):  None .
 
1.10  Tenant’s Parking Spaces  (Unassigned) (see Section 11.6):  Eleven (11) .
 
1
 
 
 

 
 
1.11  Landlord’s Broker  (If none, so state):  Asset Management Group .
 
Tenant’s Broker  (If none, so state):  Michael Gerrity, Phase 3 Properties .
 
1.12  Additional Provisions : The following additional provisions are attached to and made a part of this Lease (if none, so state):  None .
 
1.13  Exhibits : The following Exhibits are attached to and made a part of this Lease:
 
Exhibit “A” - Description of Premises
Exhibit “B” - Rules and Regulations
Exhibit “C” - Sign Criteria
 
2.
LEASE OF PREMISES
 
Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, the premises (the “Premises”) described in Section 1.2, which Premises are indicated on the site/floor plan attached as Exhibit “A”. The Premises are part of the office or industrial center identified in Section 1.2 (the “Center”). The approximate Rentable Square Footage identified in Section 1.2 is a measurement of the leaseable floor area of the Premises, as determined by Landlord and applied on a consistent basis throughout the Center. As used herein, the term “Building” means the building of which the Premises are a part; if the Premises encompasses the entire Building, then the terms “Premises” and “Building” shall have the same meanings.
 
3.
LEASE TERM
 
3.1  Commencement . The term of this Lease (the “Lease Term”) shall commence on the Commencement Date stated in Section 1.3 and shall continue for the period stated in Section 1.4, unless sooner terminated pursuant to any provision of this Lease.
 
3.2  Delay In Commencement . If Landlord cannot deliver possession of the Premises to Tenant on the Commencement Date specified in Section 1.3 for any reason, Landlord shall not be subject to any liability therefor. Such nondelivery shall not affect the validity of this Lease nor the obligations of Tenant hereunder. However: (a) Tenant shall not be obligated to pay rent until possession of the Premises is delivered to Tenant, (b) If possession of the Premises is not delivered to Tenant within thirty (30) days of the Commencement Date, the last day of the Lease Term shall be extended by the total number of days that possession is so delayed, plus the minimum number of additional days necessary to make the Expiration Date the last day of a calendar month, and (c) if Landlord has not delivered possession of the Premises within forty-five (45) days after the Commencement Date, Tenant may elect to terminate this Lease by delivering written notice to Landlord within ten (10) days thereafter, in which event the parties shall be discharged from all further obligations hereunder.
 
3.3  Early Occupancy . Tenant shall be entitled to occupy the Premises as of the earlier of Landlord’s completion of the Tenant Improvements (as defined below) or July 1, 2008, which occupancy shall be subject to all provisions of this Lease, other than the obligation to pay rent. Such occupancy shall not advance the Expiration Date. Notwithstanding anything to the contrary herein, Tenant shall not be required to pay Minimum Monthly Rent, Additional Rent or any other charges required hereunder for such early occupancy period, except for Utilities that are separately metered to the Premises, which shall be payable as set forth in Article 10.
 
4.
RENT
 
4.1  Minimum Monthly Rent . Tenant shall pay minimum monthly rent (“Minimum Monthly Rent”) in the initial amount stated in Section 1.5. The Minimum Monthly Rent shall be increased as set forth in Section 1.5 and/or elsewhere in this Lease. Tenant shall pay the Minimum Monthly Rent on or before the first day of each calendar month, in advance, at the office of Landlord or at such other place designated by Landlord, without deduction, offset or prior demand. If the Commencement Date is not the first day of a calendar month, the rent for the partial month at the beginning of the Lease Term shall be prorated on a per diem basis and shall be due on the
 
2
 
 
 

 
 
first day of such partial month. Upon execution of this Lease, and before the Commencement Date, Tenant shall pay to Landlord the aggregate of the first month’s Minimum Monthly Rent, the first month’s Monthly Impound Payment (see Section 4.4), and the Security Deposit (see Section 5).
 
4.2  Lease Year . As used in this Lease, the term “Lease Year” means (i) the first period of twelve (12) full calendar months following the Commencement Date (including, if the Commencement Date is rot the first day of a calendar month, the period between the Commencement Date and the next first day of the month), (ii) each period of twelve (12) full calendar months thereafter, and (iii) any remaining period at the end of the Lease Term of less than twelve (12) full calendar months.
 
4.3  Additional Rent . All charges payable by Tenant for Operating Costs (Article 6), Maintenance and Repairs (Article 7), Real Property Taxes (Article 8), Insurance Costs (Article 9), and Utilities (Article 10) are hereinafter referred to herein as “Additional Rent.” All Minimum Monthly Rent, Additional Rent, and all other charges and monetary amounts due Landlord from Tenant under this Lease or otherwise shall constitute “rent”. Unless this Lease provides otherwise, all Additional Rent shall be paid by Tenant, without limitation or offset, within thirty (30) days after Tenant’s receipt of a statement from Landlord. If any Minimum Monthly Rent is abated or waived pursuant to another specific term of this Lease or in any separate agreement, it is understood that such abatement or waiver shall apply only to the Minimum Monthly Rent, and Tenant shall be obligated to pay all Additional Rent and other charges during such periods of abatement or waiver of Minimum Monthly Rent.
 
4.4  Impounds . Landlord shall have the right, but not the obligation, to collect and impound, in advance, any or all components of Additional Rent based upon Landlord’s reasonable estimate of Tenant’s future liability for such amounts under this Lease. Landlord shall initially establish the monthly amount of such impound (“Monthly Impound Payments”), based upon its estimate of one-twelfth of Tenant’s annual liability therefor. Landlord shall have the right at any time to adjust the amount of the Monthly Impound Payment upon thirty (30) days’ prior written notice to Tenant. The Monthly Impound Payment shall be due and payable on the first day of each month throughout the Lease Term. Any failure to pay the Monthly Impound Payment when due shall be considered a failure to pay rent when due under Section 21.1 and other relevant provisions of this Lease, and shall entitle Landlord to exercise any or all of its remedies available in the same manner as for the failure to pay rent. Upon the occurrence of any Event of Default by Tenant hereunder, Landlord shall have the right to apply all unapplied amounts of Monthly Impound Payments to Tenant’s default. Within ninety (90) days after the end of each calendar year, Landlord shall deliver to Tenant an accounting of Tenant’s actual Share of Additional Rent and the estimated amounts previously paid by Tenant. Any overpayment by Tenant shall be credited against next Monthly Impound Payments due hereunder, or, if the Term has expired, shall be remitted to Tenant at the time such accounting is delivered to Tenant. Tenant shall pay the amount of any underpayment within thirty (30) days after receipt of the accounting. Tenant acknowledges that the Monthly Impound Payments are estimates only and not a representation of the amount of Tenant’s ultimate liability for Additional Rent.
 
4.5  Audit Right . Within one hundred twenty (120) days after receipt of an annual reconciliation of Impound amounts (“Statement”) by Tenant (“Review Period”), if Tenant disputes the amount set forth in the Statement, Tenant’s employees or an independent certified public accountant, designated by Tenant, may, provided such accountant is not paid by contingency or compensated in connection with the finding of Tenant’s overpayment, after reasonable notice to Landlord and at reasonable times, inspect Landlord’s records (pertaining to Landlord’s calculation of the costs set forth in this Section 6) at Landlord’s offices, provided that Tenant and such accountant or representative shall, and each of them shall cause their respective agents and employees to, maintain all information contained in Landlord’s records in strict confidence. Notwithstanding the foregoing, Tenant shall only have the right to review Landlord’s records one (1) time during any twelve (12) month period. Within sixty (60) days after receipt of Tenant’s audit, Landlord shall have the right to have an independent certified public accountant review the Tenant’s audit for accuracy (“Landlord’s Audit”). If such Landlord’s Audit confirms that the total amount of any item of costs set forth in this Section 6 were overstated by more than five percent (5%), then the actual, documented and reasonable cost of the accountant shall be paid for by Landlord. Promptly following the parties receipt of such audit results, the parties shall make such appropriate payments or reimbursements, as the case may be, to each other, as are determined to be owing pursuant to such audit.
 
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5.
SECURITY DEPOSIT
 
Upon execution of this Lease, Tenant shall deposit with Landlord the amount specified in Section 1.6 (the “Security Deposit”), to be held by Landlord, without liability for interest, as security for Tenant’s performance of its obligations under this Lease. Landlord shall not be required to keep the Security Deposit separate from its other accounts. Landlord may apply all or a part of the Security Deposit to any unpaid rent (including unpaid Additional Rent or Monthly Impound Payments) or other monetary payments due from Tenant or to cure any other default of Tenant hereunder and to compensate Landlord for all damage and expense sustained as a result of such default. If all or any portion of the Security Deposit is so applied, Tenant shall deposit cash sufficient to restore the Security Deposit to its original amount within fifteen (15) days after receipt of Landlord’s written demand. If Tenant fully and faithfully performs each of its obligations under this Lease, the Security Deposit or any balance thereof shall be returned to Tenant within thirty (30) days of the later of the expiration or earlier termination of this Lease or the vacation of the Premises by Tenant. At Landlord’s request, Tenant shall accompany Landlord or Landlord’s representative on a “walk-through” of the Premises prior to Landlord’s return of the Security Deposit.
 
6.
OPERATING COSTS
 
6.1  Payment of Operating Costs by Tenant . Tenant shall pay its Share of Operating Costs to Landlord on a monthly basis. Tenant shall pay the amount of such Share to Landlord, to the extent such obligation exceeds any amount thereof impounded under Section 4.4, within thirty (30) days after receipt of a statement from Landlord.
 
6.2  Tenant’s Share . Tenants “Share” (sometimes referred to as ‘Pro Rata Share’) is the percentage or proportion of the various components of Additional Rent and certain other charges for which Tenant is responsible under this Lease. Tenants Share for each such component shall be Tenants Percentage as stated in Section 1.7, unless Landlord reasonably determines that Operating Costs should be pooled such that another percentage or proportion would be equitable based on factors such as Tenants use of such in excess of its Percentage, such component of Additional Rent applies to some but not all of the Center, or factors set forth elsewhere in this Lease. Tenants Percentage represents the approximate current ratio of the Rentable Square Footage of the Premises (identified in Section 1.2) to the total Rentable Square Footage of the Center.
 
6.3  Operating Costs . “Operating Costs” includes all costs incurred by Landlord and its Property Manager in operating, managing, repairing and maintaining the Common Facilities, including without limitation: gardening and landscaping; the cost of public liability, property damage and other Insurance carried by Landlord and its Property Manager and applicable to the Common Facilities, including any deductibles thereunder; Real Property Taxes applicable to the Common Facilities; utilities for the Common Facilities; line painting and parking lot repairs; roof repairs; lighting for the Common Facilities; trash and refuse removal for the Common Facilities; supplies; equipment; exterior painting; capital improvements; provided that capital improvements amortized over useful life as reasonably determined by Landlord; the costs of altering, improving, renovating, upgrading or retrofitting any portion of the Common Facilities to comply with all laws, regulations and governmental requirements applicable to the Center put into effect or interpreted differently after the Commencement Date (including without limitation those related to disabled persons, hazardous materials, lighting upgrades, sprinkler and energy-saving retrofits); security service; property management costs (not to exceed 4% of revenues) and administrative fees; bookkeeping services; labor; and the cost of personnel to implement such services and to direct parking. In lieu of including the entire amount of any such expense in Operating Costs in any one period, Landlord, at its election, may spread the inclusion of, or may amortize, any such expenses, in Operating Costs over such multiple periods as Landlord shall determine; provided; however, that any item included in Operating Costs which is capital in nature will be amortized over its useful life as reasonably determined by Landlord. Notwithstanding anything above to the contrary, Operating Costs shall not include (1) the cost of providing any service directly to and paid in full directly by any single tenant other than Tenant (outside of such tenant’s Operating Cost payments); (2) the cost of any items to the extent Landlord is reimbursed by insurance proceeds (except for deductibles), condemnation awards, a tenant of the Building, or otherwise to the extent so reimbursed; (3) any real estate brokerage commissions or other costs incurred in procuring tenants, or any fee in lieu of commissions; (4) ground lease payments (if any); (5) costs incurred by Landlord caused solely by the violation by Landlord of the terms and conditions of any lease of space in the Building; (6) Landlord’s general corporate overhead not attributable to the Center; (7) bad debt expenses and interest, principal, points and fees on debts or amortization on any ground lease, mortgage or mortgages or any other debt instrument encumbering the Building (including the real property on which the Building is situated); (8) costs, including permit, license and inspection costs, incurred with respect to the installation of other tenants’ or occupants’ improvements made for
 
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tenants or other occupants in the Building or incurred in renovating or otherwise improving, decorating, painting or redecorating vacant space for tenants or other occupants in the Building unless improvements to the Building or Common Areas are required; (9) any costs expressly excluded from Operating Costs elsewhere in this Lease; (10) expenses in connection with services or other benefits which are not offered to Tenant; (11) electric power costs to any individual premises in the Building or other utility costs for any individual premises which any tenant directly contracts with the local public service company; (12) any insurance deductible payable for a covered loss in which the casualty covered by such insurance was caused solely by the negligence or willful misconduct of another tenant or occupant of the Center; (13) marketing costs, including leasing commissions and attorneys’ fees in connection with the negotiation and preparation of letters, deal memos, letters of intent, leases, subleases and/or assignments, space planning costs, and other costs and expenses incurred in connection with lease, sublease and/or assignment negotiations and transactions with present or prospective tenants or other occupants of the Building; (14) costs (including in connection therewith all attorneys’ fees and costs of settlement, judgments and/or payments in lieu thereof) arising from claims, disputes or potential disputes in connection with potential or actual claims, litigation or arbitrations pertaining to another tenant of the Building; and (15) costs incurred in connection with any future expansion of the Building or Center.
 
6.4  Common Facilities . “Common Facilities” (sometimes referred to herein as “Common Areas”) means all areas, facilities, utilities, equipment and services provided by Landlord for the common use or benefit of the occupants of the Center and their employees, agents, customers and other invitees, including without limitation, if the same exist: building lobbies, common corridors and hallways, restrooms, pedestrian walkways, driveways and access roads, access facilities for disabled persons (including elevators), truck serviceways, loading docks, garages, driveways, parking lots, landscaped areas, stairways, elevators, retaining walls, all areas required to be maintained under the conditions of governmental approvals for the Center, and other generally understood public or common areas. All Common Facilities shall at all times be subject to the exclusive control and management of Landlord. Landlord reserves the right to relocate, alter, improve, or adjust the size and location of any Common Facilities from time to time without liability to Tenant, provided the same does not unreasonably interfere with Tenant’s access to, or use of, the Premises or materially increase Tenant’s monetary obligations hereunder. Landlord shall have the right from time to time to establish, modify and enforce reasonable rules and regulations with respect to the Common Facilities. Landlord shall have the right to construct, maintain and operate lighting facilities on the Common Facilities; to police the same; from time to time to change the area, level, location and arrangement of parking areas and other facilities; to restrict parking by tenants, their officers, agents and employees to employee parking areas; to close all or any portion of the Common Facilities to such extent, provided the same does not unreasonably interfere with Tenants access to, or use of, the Premises; to close temporarily all or any portion of the Common Facilities for any reason, including for the purpose of preventing a dedication thereof or the accrual of any rights to any person or the public therein; and to do and perform such other acts in and to the Common Facilities which Landlord shall determine, using good business judgment, to be advisable to improve the convenience and use thereof by tenants, their officers, agents, employees and customers. Subject to the foregoing, all Common Facilities not within the Premises, which Tenant may use under a revocable license, on a nonexclusive basis in common with other tenants, and if any such license is revoked, or if the amount of such areas is diminished, Landlord shall not be subject to any liability and Tenant shall not be entitled to any compensation or abatement of rent, nor shall such revocation or diminution be deemed constructive or actual eviction.
 
7.
MAINTENANCE AND REPAIRS
 
7.1  Tenant’s Obligations . Except as provided in Section 7.2, Tenant, at its sole cost, shall keep the Premises in good order, condition and repair during the Lease Term, including without limitation: all nonstructural, interior areas; all heating, ventilation and air conditioning systems and equipment serving the Premises only; all glass, glazing, windows, window moldings, partitions, doors and door hardware which are in the interior of the Premises; all interior painting; all fixtures and appurtenances in the Premises or exclusively serving the Premises including electrical, lighting and plumbing fixtures; and all other portions of the interior of the Premises (collectively, “Maintenance and Repairs”). If any portion or element of the Premises, or the other systems or equipment for which Tenant is responsible hereunder cannot be fully repaired, Tenant shall promptly replace the same at its sole cost and expense regardless of whether the benefit of such replacement extends beyond the Lease Term. It is the intention of Landlord and Tenant that Tenant shall maintain the Premises, at all times during the Lease Term, in an attractive, good and fully operative condition, at Tenant’s expense. If any heating and air conditioning system or equipment exclusively serves the Premises, Tenant shall additionally obtain and keep in
 
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force a preventive maintenance contract providing for the regular (at least quarterly) inspection and maintenance of the heating and air conditioning system (including leaks around ducts, pipes, vents, and other parts of the air conditioning) by a reputable licensed heating and air conditioning contractor acceptable to Landlord. Prior to April 1 of each calendar year, Tenant shall deliver Landlord written confirmation from such contractor verifying that such a contract has been entered into and that the required service will be provided. Landlord shall not undertake the responsibility of maintaining and repairing the heating and air conditioning system for the Premises; provided, however, if upon the surrender of the Premises to Landlord, the heating and air conditioning system for the Premises is not in good working order, Tenant shall reimburse Landlord’s cost to repair plus fifteen percent (15%) of such amount for overhead immediately upon demand.
 
7.2  Landlord’s Obligations . Landlord shall repair and maintain in good condition and in compliance with all Legal Requirements (as defined below) the Common Facilities, the roof, the foundations and structural portions of the Premises and the Building. Tenant shall pay (a) its Share of the costs of such maintenance as part of Operating Expenses, and (b) the full amount of any maintenance and repairs necessitated by any act, omission, conduct or activity of, or breach of this Lease by, Tenant or any of Tenant’s officers, agents, customers or invitees (plus fifteen percent (15%) of the cost thereof to reimburse Landlord for overhead). There shall be no abatement of rent, and no liability of Landlord, by reason of any injury to or interference with Tenant’s business arising from the making of any repairs, alterations, or improvements to any portion of the Premises or the Center. Landlord shall use reasonable efforts to minimize interference with Tenant’s business operations and access to the Premises. Tenant expressly waives all rights to make repairs at the expense of Landlord or deduct any amounts from rent as provided in any statute or ordinance now or hereafter in effect, including its rights under the provisions of California Civil Code Sections 1941 and 1942. Landlord’s obligations under this Section are not intended to alter or modify in any way the provisions of Article 12.
 
7.3  Performance By Landlord . If Tenant refuses or neglects to perform its maintenance obligations hereunder to the reasonable satisfaction of Landlord, Landlord shall have the right (but not the obligation), upon three (3) business days’ prior notice to Tenant, to enter the Premises and perform such repairs and maintenance on behalf of Tenant. Landlord shall also have the right (but not the obligation), without prior notice to Tenant, to correct or remove any dangerous or hazardous condition to repair the plumbing systems, to correct, repair or bring into legal compliance any fire or other life safety systems of the Premises, and to repair or replace any broken glass or glazing which imposes an imminent risk of injury to persons or property, if Tenant fails to correct or repair the same within twenty-four (24) hours after the need arises. Landlord shall not be liable to Tenant for any loss or damage to Tenant’s merchandise, fixtures, or other property or to Tenant’s business in connection with Landlord’s performance hereunder, and Tenant shall pay Landlord’s costs plus fifteen percent (15%) of such amount for overhead, upon presentation of a statement therefor. Tenant shall also pay interest at the rate provided in Section 22.4 from the date of completion of repairs by Landlord to the date paid by Tenant.
 
8.
REAL PROPERTY TAXES
 
8.1  Payment of Real Property Taxes by Tenant . Tenant shall pay all Real Property Taxes applicable to the Premises during the Lease Term. If the Premises are not separately assessed, Tenant shall pay its Share thereof as equitably determined by Landlord based upon the Rentable Square Footage of the Premises compared to the total Rentable Square Footage covered by the tax bill the respective valuations assigned in the assessor’s worksheet, and/or other relevant factors. Tenant shall pay its Share of Real Property Taxes to Landlord, to the extent such obligation exceeds any amount thereof impounded under Section 4.4, within thirty (30) days after receipt of a statement from Landlord.
 
8.2  Real Property Taxes Defined . “Real Property Taxes” means all taxes, assessments, levies, fees and other governmental charges levied on or attributable to the Premises or any part thereof, including without limitation: (a) real property taxes and assessments levied with respect to all or a portion of the Premises, (b) assessments, charges and fees charged by governmental agencies or districts for services or facilities provided to the Premises, (c) transfer, transaction, rental, gross receipts, license or similar taxes or charges measured by rent received by Landlord, excluding any federal or state income, franchise, estate, excise, succession, transfer or inheritance taxes of Landlord, or any taxes incurred prior to the commencement of or after the expiration or other termination of the Lease Term, (d) taxes based upon a reassessment of the Premises due to a transfer or change of ownership, and (e) any assessment, charge or fee that is a substitute in whole or in part for any tax now or previously
 
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included within the definition of Real Property Taxes. If Landlord elects to contest an assessment of any Real Property Taxes, Landlord shall have the right to recover its actual costs of such contest (including attorneys’ fees and costs) as part of Real Property Taxes, but only to the extent such contest has resulted in a reduction of Real Property Taxes and Tenant shall receive a refund in an amount equal to Tenant’s Share of any such reduction. Tenant shall not be entitled to the benefit of any reduction, refund, rebate or credit accruing or payable to Landlord prior to the commencement of or after the expiration or other termination of the Lease Term.
 
8.3  Personal Property Taxes . Tenant shall pay prior to delinquency all taxes charged against trade fixtures, furnishings, equipment or any other personal property belonging to Tenant. Tenant shall attempt to have such personal property taxed separately from the Premises. If any such taxes on Tenant’s personal property are levied against Landlord or the Premises, or if the assessed value of the Premises is increased by inclusion of a value placed upon such personal property of Tenant, then: (a) Landlord, after written notice to Tenant, shall have the right to pay the taxes levied against Landlord, or the taxes based upon such increased valuation, but under protest if so requested by Tenant in writing, and (b) Tenant shall pay to Landlord the taxes levied against Landlord, or the taxes resulting from such increased valuation, within fifteen (15) days after Tenant’s receipt of a written statement from Landlord.
 
9.
INSURANCE
 
9.1  Landlord’s Insurance . During the Lease Term, Landlord shall maintain insurance covering loss or damage to the Premises (excluding Tenant’s Alterations, fixtures, equipment and personal property), insuring against any or all risks of physical loss (and including, at Landlord’s option, flood and earthquake coverage, with the scope and amounts of such coverage as determined by Landlord. Said insurance shall provide for payment of toss thereunder to Landlord or to the holder of a first mortgage or deed of trust on the Premises. Landlord shall also maintain during the Lease Term, as part of its casualty insurance, a policy of rental income insurance covering a period of one (1) year, with loss payable to Landlord. Landlord may also maintain (but shall not be required to maintain) liability and other insurance (including environmental insurance) as Landlord, at its sole option, may elect to maintain. Landlord shall maintain liability insurance.
 
9.2  Tenant’s Insurance .
 
(a) Tenant shall carry, at Tenant’s sole expense, insurance against any or all risks of physical loss in an amount adequate to cover the cost of replacement of all of Tenant’s Alterations, trade fixtures, equipment and personal property. If Tenant’s insurance does not otherwise cover losses caused by breakage or other malfunction of any of Tenant’s machinery or equipment used by Tenant in the Premises, then Tenant shall carry equipment breakdown insurance (so called boiler and machinery insurance) covering Tenant’s equipment and machinery (including any heating, ventilation and air conditioning systems, electrical equipment, and the like). Tenant acknowledges that Landlord’s insurance is not intended to cover Tenant’s Alterations, trade fixtures, equipment, and personal property. My policy proceeds shall be used for the repair or replacement of the property damaged or destroyed unless this Lease shall cease and terminate under the provisions of Article 16, whereupon any insurance proceeds covering any of Tenant’s Alterations, fixtures, equipment and personal property that Tenant is required to leave in the Premises at the expiration or earlier termination of the Lease Term under Article 20 shall be payable to Landlord. Provided, however, that at Landlord’s sole election, Landlord may obtain at Tenant’s expense any or all of the insurance described in this Section if Tenant fails to obtain the insurance required under this Article.
 
(b) Tenant shall carry, at Tenants sole expense, comprehensive or commercial general liability insurance, fully covering any and all claims arising from personal injury, death, and/or property damage occurring in or about the Premises or the Center. Such liability insurance shall include without limitation bodily injury (including wrongful death), property damage, advertising injury, personal injury and contractual liability coverages (including Tenant’s indemnification obligations under Article 13), independent contractors, owned, nonowned, and hired vehicle liability and, if alcoholic beverages are served, sold, consumed or obtained in the Premises, liquor-law liability. The initial limit of such insurance shall be at least $2,000,000 combined single liability limit if the Rentable Square Footage of the Premises (as indicated in Section 1.2) exceeds 3,000 square feet, or $1,000,000 combined single liability limit if such Rentable Square Footage is 3,000 square feet or less. Such liability insurance limits may be met by umbrella coverage of not less than $5,000,000 and shall be subject to periodic increase, at Landlord’s election, based upon inflation, increased liability awards, lender requirements, the
 
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recommendations of Landlord’s professional insurance advisors, and other relevant factors. Tenant shall also, at its sole cost and expense, obtain worker’s compensation coverage in an amount adequate to comply with law, and employer’s liability coverage with a limit of not less than $2,000,000. If Tenant’s use of the Premises involves any use, generation, manufacturing, storage or disposal of any Hazardous Materials, or if any of Tenants activities increases any risk of any liability to Tenant or Landlord under Hazardous Materials Laws, Tenant shall carry such environmental insurance as may be required by Landlord or Landlord’s lender. Tenant shall, at Tenant’s sole expense, maintain such other liability insurance as Tenant deems necessary to protect Tenant.
 
(c) Each policy of Insurance required to be carried by Tenant hereunder shall (i) name Landlord, Landlord’s lender and Landlord’s property manager (if any) as additional insureds, (ii) contain cross-liability and contractual liability provisions, (ii) provide that no cancellation or reduction in coverage shall be effective until thirty (30) days after written notice to Landlord and Landlord’s lender (10 days for nonpayment of premiums), (iii) be issued by an insurer licensed in California and reasonably approved by Landlord, and (iv) be primary and noncontributory to any insurance carried by Landlord, regardless of the absence of negligence or other fault of Tenant for alleged injury, death and/or property damage. The deductible or self-insured retention on any insurance required to be carried by Tenant hereunder shall not exceed, without the prior written consent of Landlord, Twenty-Five Thousand Dollars ($25,000) per occurrence. Tenant shall be responsible for the payment of the full amount of any deductible or self-Insured retention on its insurance unless the reason for such loss is the sole negligence or willful misconduct of Landlord, its agents or employees. No insurance carried or required to be carried by Tenant, nor the amount or limits thereof, shall limit Tenant’s liability nor relieve Tenant of any obligation under this Lease.
 
(d) Each policy of insurance required to be carried by Tenant hereunder shall be obtained by Tenant and maintained in full force and effect throughout the Lease Term and any other period of Tenant’s actual or constructive possession of the Premises. Prior to the Commencement Date or any earlier taking of possession of any part of the Premises, Tenant shall deliver to Landlord (I) an ACORD Form 27 certificate (or such other certificate providing the greatest protection to Landlord reasonably available) evidencing all insurance required to be maintained by Tenant and identifying all additional insureds required to be so designated under the terms of this Lease, and (ii) all additional insured endorsements provided by the insurer in favor of Landlord, Landlord’s property manager and Landlord’s lender as required by this Lease. Tenant shall deliver evidence of a renewal of each required policy, together with all required endorsements, at least thirty (30) days prior to expiration thereof. Tenant shall permit Landlord at all reasonable times to inspect the policies of insurance, and shall deliver copies thereof to Landlord within ten (10) days after Landlord’s request therefor. Tenant shall be in material breach of this Lease if Tenant fails to obtain the insurance required under this Section, or if Tenant obtains insurance with terms, conditions and/or exclusions that are inconsistent with the requirements and terms of this Lease.
 
9.3  Payment of Insurance Costs . Tenant shall pay directly all premiums for its liability insurance required under Section 9.2 and for all other insurance Tenant elects to carry. Tenant shall pay its Share of the premiums for the insurance policies carried by Landlord described in this Article or elsewhere in this Lease (“Insurance Costs”). If the Lease Term expires before the expiration of any such insurance policy, Tenant’s liability for premiums shall be prorated on an annual basis. Tenant shall pay its Share of Insurance Costs to Landlord, to the extent such obligation exceeds any amount thereof impounded under Section 4.5, within thirty (30) days after receipt of a statement from Landlord. If any insurance policy maintained by Landlord covers property other than the Center (under a so-called “blanket” policy or otherwise), Landlord shall reasonably apportion the premium therefor among the properties so covered. In addition, Tenant shall pay its Share of any deductible amount under Landlord’s insurance policies within thirty (30) days after receipt of a statement from Landlord as an Operating Cost. Tenant’s Share of any such deductible shall be equitably determined by Landlord based upon, among other factors, the Rentable Square Footage of the Premises affected compared to the Rentable Square Footage of all other affected areas in the Center, and the Replacement Cost (as defined in Section 16.1) applicable to the damage to the Premises compared to that applicable to all other affected areas.
 
9.4  Waiver of Subrogation . Landlord and Tenant each hereby waive any and all claims against the other party and its officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entities and individuals, and their respective successors and assigns, for any and all loss of or damage to the Premises, Center or other tangible property, or any resulting loss of income, or losses under worker’s compensation laws and benefits, which loss or damage arises out of any peril that is or would be covered
 
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by any physical damage insurance policy actually carried or required to be carried pursuant to this Lease. The foregoing waiver shall apply regardless of whether the party suffering the loss or damage actually carries such insurance, recovers under
such insurance, or self-insures the loss or damage. Inasmuch as the foregoing waiver will preclude the assignment of any such claim by subrogation (or otherwise) to an insurance company (or any other person), Landlord and Tenant each agree to give to each insurance company issuing to it any policy of physical damage insurance written notice of the terms of this mutual waiver, and to have each such insurance policy properly endorsed, if necessary, to prevent the invalidation of such insurance coverage by reason of such waiver. The waiver set forth herein shall apply to any deductible amount under any insurance policy, is not limited by the amount of Insurance carried or required to be carried, and is in addition to any other waiver or release contained in this Lease. If Landlord has contracted with a third party for the management of the Center, the waiver of subrogation by Tenant herein shall also run in favor of such third party.
 
9.5  Tenant’s Use Not to Increase Premium . Tenant shall not keep, use, manufacture, assemble, sell or offer for sale in or upon the Premises any article that may be prohibited by, or that might invalidate, in whole or In part, the coverage afforded by, a standard form of fire or all risk insurance policy. Tenant shall pay the entire amount of any increase in premiums that may be charged during the Lease Term for the insurance that may be maintained by Landlord on the Premises or the Center resulting from the type of materials or products stored, manufactured, assembled or sold by Tenant in the Premises, whether or not Landlord has consented to the same. In determining whether increased premiums are the result of Tenant’s use of the Premises, a schedule issued by the entity making the insurance rate on the Premises showing the various components of such rate shall be conclusive evidence of the items and charges that make up the fire insurance rate on the Premises.
 
10.
UTILITIES
 
Tenant shall pay the cost of all water, gas, heat, light, power, sewer, telephone, refuse disposal, and all other utilities and services supplied to the Premises (collectively, “Utilities”). The Premises is currently separately metered for electricity. Tenant shall make payments for all separately metered utilities, when due, directly to the appropriate supplier. If any utilities or services are not separately metered or monitored with respect to the Premises, Tenant shall pay its Share thereof to landlord, to the extent such obligation exceeds any amount thereof impounded under Section 4.4, within thirty (30) days after receipt of a statement from Landlord. Landlord shall in no way be liable or responsible for any loss, damage or expense that Tenant may sustain or incur by reason of any change, failure, interruption, interference or defect in the supply or character of the electricity or other utilities supplied to the Premises, except to the extent provided In this Section 10 below. Landlord makes no representation or warranty as the suitability of the utility service for Tenants requirements, and no such change, failure, defect, unavailability or unsuitability shall constitute any actual or constructive eviction, in whole or in part, or entitle Tenant to any abatement or diminution of rent, or relieve Tenant of any of its obligations under the Lease, except to the extent provided in this Section 10 below. Landlord shall not be liable in damages or otherwise for any failure or interruption of any utility service, and no such failure or interruption shall entitle Tenant to terminate this Lease or abate the rent due hereunder except to the extent that such failure or interruption Is due to the negligence or willful misconduct of Landlord and prevents Tenant from using all or a portion of the Premises for more than five (5) consecutive business days after Landlord’s receipt of written notice from Tenant, in which case rent shall be reduced to the extent the Premises are unusable.
 
11.
USE
 
11.1  Permitted Use . The Premises shall be used and occupied only for the permitted uses specified in Section 1.8, and shall not be used or occupied for any other purposes without the prior written consent of Landlord. Should Tenant desire to change its use, Tenant shall request Landlord’s consent to such change in writing, and shall provide in writing such reasonably detailed Information about the proposed new use as may be requested by Landlord. Landlord shall not unreasonably withhold its consent to any requested change of use, and shall have the right to impose reasonable restrictions on such new use. Factors that Landlord may take into account in granting or withholding its consent shall include, without limitation: (i) whether the proposed use is compatible with the character and tenant mix of the Center, (ii) whether the proposed use poses any increased risk to Landlord or any other occupant of the Center, (iii) whether any proposed Alterations to accommodate such proposed use might decrease the rental or sale value of the Premises or the Center, and (iv) whether Tenant has the requisite expertise and financial ability to successfully operate in the Premises with the proposed new use.
 
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11.2  Compliance with Legal Requirements . Tenant shall at all times and at its sole expense comply with all federal, state, local and other laws, ordinances, rules, regulations, orders, requirements, and recorded covenants and restrictions applicable to the Center, in effect from and after the Commencement Date (Including without limitation those related to disabled persons, access, hazardous materials, lighting upgrades, energy saving, and sprinkler and seismic retrofits) to the extent required because of Tenant’s particular use of the Premises or due to alterations made to the Premises after the Commencement Date by or on behalf of Tenant (collectively, “Legal Requirements”). Tenant shall not do or permit anything to be done in or about the Premises in conflict with any Legal Requirement. Without limiting the generality of the foregoing, Tenant shall at its sole cost take all actions, make ail alterations, install all additional facilities, and perform all work required to cause the Premises (and any other area of the Center) to comply with all Legal Requirements put into effect or interpreted differently after the Commencement Date to the extent the need for such compliance is triggered by Tenant’s particular use or alterations performed by Tenant after the Commencement Date, but shall not apply to any violation of Legal Requirements outside the Premises existing prior to the Commencement Date and not directly affected by Tenants work or alteration.
 
11.3  Waste, Quiet Conduct . Tenant shall not use or permit the use of the Premises in any manner that tends to create waste or a nuisance that will cause objectionable noise or odors, or that may disturb the quiet enjoyment of any other tenant in the Center.
 
11.4  Rules and Regulations . Tenant shall comply with the Rules and Regulations for the Center attached as Exhibit “B”, as the same may be amended by Landlord from time to time, upon notice to Tenant.
 
11.5  Signs . Tenant shall have the right (but not the obligation), at Tenant’s sole cost, to install a sign in strict conformance with Landlord’s sign criteria attached hereto as Exhibit “C” within fifteen (15) days after first occupying the Premises. Tenant shall maintain all approved signs and other items described herein in good condition and repair at all times. All signs must be fabricated by a contractor selected by Landlord. Prior to construction of any such sign, a detailed drawing of the proposed sign shall be prepared by Landlord’s contractor, at the sole expense of Tenant, and submitted to Landlord and Tenant for written approval. No sign, placard, pennant, flag, awning, canopy, or advertising matter of any kind shall be placed or maintained on any exterior door, wall or window of the Premises or in any area outside the Premises, and no decoration, lettering or advertising matter shall be placed or maintained on the glass of any window or door, or that can be seen through the glass, of the Premises without first obtaining Landlord’s written approval. All signs and sign cases shall be considered fixtures and improvements and shall become the property of Landlord upon expiration or termination of this Lease. Tenant has no rights to signage at the Center except as set forth in this Section. Landlord shall have the right from time to time to revise the sign criteria, and within sixty (60) days after Tenant’s receipt of written notice of any new sign criteria, Tenant shall, at Tenant’s expense, remove all existing exterior signs and replace the same with new signs conforming to the new sign criteria.
 
11.6  Parking . Tenant shall have the nonexclusive right, in common with others, to use the parking areas of the Center at no charge or expense to Tenant provided, however, that Tenant shall not use more than the number of parking spaces designated in Section 1.10, or if no number of such spaces is so indicated, Tenant shall not use more than its reasonable share of parking spaces, as Landlord shall determine. Landlord reserves the right, without liability to Tenant, to modify the parking areas, to designate the specific location of the parking for Tenant and Tenant’s customers and employees, and to adopt reasonable rules and regulations for use of the parking areas; provided that Tenant will at all times have access to the number of parking spaces designated in Section 1.10.
 
11.7  Entry by Landlord . Tenant shell permit Landlord and Landlord’s agents to enter the Premises at all reasonable times upon at least 24 hours’ prior written notice and subject to Tenant’s reasonable safety and security procedures for any of the following purposes: (a) to inspect the Premises, (b) to supply any services or to perform any maintenance obligations of Landlord, including the erection and maintenance of such scaffolding, canopies, fences, and props as may be required, (c) to make such improvements, replacements or additions to the Premises or the Center as Landlord deems necessary or as required by Lease, (d) to post notices of nonresponsibility, (e) to place any usual or ordinary “for sale” signs, or (f) within six (6) months prior to the expiration of this Lease, to place any usual or ordinary “for lease” signs. No such entry shall result in any rebate of rent or any liability to Tenant for any loss of occupation or quiet enjoyment of the Premises. Landlord will use reasonable efforts to minimize interference with Tenants business operations and shall endeavor to enter only at
 
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times scheduled with Tenant and if Tenant so requires, Tenant may have a representative of Tenant escort any persons entering the Premises. Landlord shall give reasonable notice to Tenant prior to any entry except in an emergency (e.g., threat of injury to person or property) or unless Tenant consents at the time of entry. If Tenant is not personally present to open and permit an entry into the Premises, at any time when for any reason an entry therein shall be necessary or permissible as provided herein, Landlord or Landlord’s agents may enter the same by a master key, or may forcibly enter the same without rendering Landlord or such agents liable therefor, and without in any manner affecting the obligations and covenants of this Lease. Nothing herein contained, however, shall be deemed or construed to impose upon Landlord any obligation, responsibility or liability whatsoever for the care, maintenance or repair of the Premises or any part thereof, except as otherwise specifically provided herein.
 
12.
ACCEPTANCE OF PREMISES; NONUABIUTY OF LANDLORD; DISCLAIMER
 
12.1  Acceptance of Premises . By taking possession hereunder, Tenant acknowledges that It has examined the Premises and accepts the condition thereof, other than latent defects. Tenant acknowledges and agrees that Landlord has no obligation to improve the Premises other than as set forth specifically In this Lease, If at all. In particular, Tenant acknowledges that any additional improvements or alterations needed to accommodate Tenant’s intended use shall be made solely at Tenant’s sole cost and expense, and strictly in accordance with the requirements of this Lease (including the requirement to obtain Landlord’s consent thereto), unless such improvements and alterations are specifically required of Landlord including without limitation Landlord’s installation of the Tenant Improvements. Landlord shall have no responsibility to do any work within the Center required under any building codes or other governmental requirements not in effect or applicable as of the time the Premises were constructed, including without limitation any requirements related to sprinkler retrofitting, seismic structural requirements, accommodation of disabled persons, or hazardous materials. Landlord shall be under no obligation to provide utility, telephone or other service or access beyond that which exists at the Premises as of the date of this Lease, unless Landlord specifically agrees in writing to provide the same. If it is anticipated that Tenant will be doing any Alterations or installations prior to taking occupancy, any delays encountered by Tenant in accomplishing such work or obtaining any required permits therefor shall not delay the Commencement Date or the date that Tenant becomes liable to pay rent, or the date that Landlord may effectively deliver possession of the Premises to Tenant. By taking possession hereunder, Tenant acknowledges that it accepts the square footage of the Premises as delivered and as stated in this Lease. No discovery or alleged discovery after such acceptance of any variance in such square footage as set forth in this Lease (or in any proposal, advertisement or other description thereof) shall be grounds for any adjustment in any component of the rent payable hereunder by Landlord or Tenant.
 
12.2  Landlord’s Exemption From Liability . Landlord shall not be liable for injury to Tenant’s business or loss of income therefrom, or for personal injury or property damage that may be sustained by Tenant or any subtenant of Tenant, or their respective employees, invitees, customers, agents or contractors or any other person in or about the Premises, caused by or resulting from fire, flood, earthquake or other natural disaster, or from steam, electricity, gas, water or rain, or dampness of any origin, that may leak, flow or emanate from or into any part of the Premises, or from the breakage, leakage, obstruction or other defects of pipes, sprinklers, wires, appliances, plumbing, air-conditioning, lighting fixtures or computer equipment or software, whether such damage or injury results from conditions arising upon the Premises or upon other portions of the Building, or from other sources, and regardless of whether the cause of such damage or injury or the means of repairing the same is inaccessible to Tenant. Landlord shall not be liable for any damages to property or for personal injury or loss of life arising from any use, act or failure to act of any third parties (including other occupants of the Center) occurring in, or about the Premises or In or about the Center (including without limitation the criminal acts of any third parties). Except as set forth herein, Landlord shall not be liable for any latent defect in the Premises or in the Building; provided that Landlord will correct any latent defect of which it has been notified by Tenant within a reasonable time period after such notice is received by Landlord. All property of Tenant kept or stored on the Premises shall be so kept or stored at the risk of Tenant only, and Tenant shall indemnify, protect, hold harmless and defend Landlord and Landlord’s officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entities and individuals, and their respective successors and assigns, from and against any claims arising out of damage to the same, including subrogation claims by Tenant’s insurance carriers. The indemnifications and waivers of Tenant set forth in this Section shall apply notwithstanding Landlord’s negligence, but shall not apply to damage or liability caused (i) by the gross negligence or willful misconduct of Landlord, and (ii) through no fault of Tenant, its assignees or subtenants, or their respective agents, contractors, employees, customers, invitees or licensees.
 
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12.3  No Warranties or Representations .
 
(a) Neither Landlord nor Landlord’s agents make any warranty or representation with respect to the suitability or fitness of the space for the conduct of Tenant’s business, or for any other purpose.
 
(b) Neither Landlord nor Landlord’s agents make any warranty or representation with respect to any other tenants or users that may or may not construct improvements, occupy space or conduct business within the Center, and Tenant hereby acknowledges and agrees that it is not relying on any warranty or representation relating thereto in entering into this Lease.
 
(c) Landlord specifically disavows any oral representations made by or on behalf of its employees, agents and independent contractors, and Tenant hereby acknowledges and agrees that it is not relying and has not relied on any oral representations in entering into this Lease.
 
(d) Landlord has not made any promises or representations, expressed or implied, that it will renew, extend or modify this Lease in favor of Tenant or any permitted transferee of Tenant, except as may be specifically set forth herein or in a written instrument amending this Lease signed by all necessary parties.
 
(e) Notwithstanding that the rent payable to Landlord hereunder may at times include the cost of guard service or other security measures, It is specifically understood that Landlord does not represent, guarantee or assume responsibility that Tenant will be secure from any damage, injury or loss of life because of such guard service. Landlord shall have no obligation to hire, maintain or provide such services, which may be withdrawn or changed at any time with or without notice to Tenant or any other person and without liability to Landlord. To induce Landlord to provide such service if Landlord elects in its sole discretion to do so, Tenant agrees that (i) Landlord shall not be liable for any damage, injury or loss of life related to the provision or nonprovision of such service, and (ii) Landlord shall have no responsibility to protect Tenant, or its employees or agents, from the acts of any third parties (including other occupants of the Center) occurring in or about the Premises or in or about the Center (including without limitation the criminal acts of any third parties), whether or not the same could have been prevented by any such guard service or other security measures.
 
12.4  Keys . Landlord shall re-key the Premises at its sole cost prior to the Commencement Date. Tenant hereby acknowledges that various persons have had access to the keys to the Premises as keyed prior to Tenant’s possession, and that Landlord disclaims all liability and responsibility for any unauthorized distribution or possession of such prior keys.
 
13.
INDEMNIFICATION
 
Tenant shall indemnify, protect, hold harmless and defend Landlord and Landlord’s officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entities and individuals, and their respective successors and assigns (collectively, “Landlord’s Related Entities”), from and against any and all claims, actions, damages, liability, costs, and expenses, including attorneys’ fees and costs (collectively, *Indemnified Claims”), arising from personal injury, death, and/or property damage and arising from: (a) Tenant’s use or occupation of the Premises or any work or activity done or permitted by Tenant in or about the Premises (including without limitation any storage or display of materials or merchandise, or other activity by Tenant in the Common Facilities), (b) any activity, condition or occurrence in the Premises or other area under the control of Tenant, (c) any breach or failure to perform any obligation imposed on Tenant under this Lease, (d) any breach or failure by Tenant to cause the Premises to comply with all Legal Requirements related to disabled persons or access, or (e) any other act or omission of Tenant or its assignees or subtenants or their respective agents, contractors, employees, customers, invitees or licensees. Tenant’s obligation to indemnify, protect, hold harmless and defend shall include, but not be limited to, claims based on duties, obligations, or liabilities imposed on Landlord or Landlord’s Related Entities by statute, ordinance, regulation, or other law, such as claims based on theories of peculiar risk and nondelegable duty, and to any and all other claims based on the passive negligence or active negligence or willful conduct of Landlord or Landlord’s Related Entities. Upon notice from Landlord, Tenant shall, at Tenant’s sole expense and by counsel satisfactory to Landlord, defend any action or proceeding brought against Landlord or Landlord’s Related Entities by reason of any such claim. If Landlord or any of Landlord’s Related Entities is made a party to any litigation commenced by or against Tenant, then Tenant shall indemnify,
 
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protect, hold harmless and defend Landlord and Landlord’s Related Entities from and against any and all claims, actions, damages, liability, costs, expenses and attorneys’ fees and costs incurred or paid in connection with such litigation. Tenant, as a material part of the consideration to Landlord hereunder, assumes all risk of, and waives all claims against Landlord for personal injury or property damage in, upon or about the Premises, from any cause whatsoever. Provided, however, that the Indemnifications and waivers of Tenant set forth in this Section shall not apply to damage and liability caused (I) by the gross negligence or willful misconduct of Landlord, and (ii) through no fault of Tenant, its assignees or subtenants, or their respective agents, contractors, employees, customers, invitees or licensees. Landlord shall indemnify, defend and hold harmless Tenant and Tenant’s partners, officers, directors, employees, and agents (collectively, “Tenant Indemnified Parties”) from and against any Indemnified Claims to the extent Tenant or Tenant’s Indemnified Parties suffer actual damages caused solely by the gross negligence or willful misconduct of Landlord.
 
14.
HAZARDOUS MATERIALS
 
14.1  Definitions . “Hazardous Materials Laws” means any and all federal, state or local laws, ordinances, rules, decrees, orders, regulations or court decisions relating to hazardous substances, hazardous materials, hazardous waste, toxic substances, environmental conditions on, under or about the Premises, or soil and ground water conditions, including, but not limited to. the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended, 42 U.S.C. ‘9601,  et seq ., the Resource Conservation and Recovery Act, 42 U.S.C. ‘6901,  et seq ., the Hazardous Materials Transportation Act, 49 U.S.C. ‘1801,  et seq ., the California Hazardous Waste Control Act, Cal. Health and Safety Code ‘25100, et seq ., the Carpenter-Presley-Tanner Hazardous Substances Account Act, Cal. Health and Safety Code ‘ 25300,  et seq ., the Safe Drinking Water and Toxic Enforcement Act, Cal. Health and Safety Code 25249.5,  et seq ., the Porter-Cologne Water Quality Control Act, Cal. Water Code 13000,  et seq ., any amendments to the foregoing, and any similar federal, state or local laws, ordinances, rules, decrees, orders or regulations. “Hazardous Materials” means any chemical, compound, material, substance or other matter that: (a) is defined as a hazardous substance, hazardous material, hazardous waste or toxic substance under any Hazardous Materials Law, (b) is controlled or governed by any Hazardous Materials Law or will give rise to any reporting, notice or publication requirements relating to Hazardous Materials hereunder or which Landlord has previously notified Tenant in writing creates any liability, responsibility or duty on the part of Tenant or Landlord with respect to any third person hereunder in Landlord’s good faith business judgment; or (c) is flammable or explosive material, oil, asbestos, urea formaldehyde. radioactive material, nuclear medicine material, drug, vaccine, bacteria, virus, mold, hazardous waste, toxic substance, or related injurious or potentially injurious material (by itself or in combination with other materials).
 
14.2  Use of Hazardous Materials.  Tenant shall not allow any Hazardous Material to be used, generated, manufactured, released, stored or disposed of on, under or about, or transported from, the Premises, unless: (a) such use is specifically disclosed to and approved by Landlord in writing prior to such use, and (b) such use is conducted in compliance with the provisions of this Article. Landlord’s consent may be withheld in Landlord’s sole discretion and, if granted, may be revoked at any time. Landlord may approve such use subject to reasonable conditions to protect the Premises and Landlord’s interests. Landlord may withhold approval if Landlord determines that such proposed use involves a material risk of a release or discharge of Hazardous Materials or a violation of any Hazardous Materials Laws or that Tenant has not provided reasonably sufficient assurances of its ability to remedy such a violation and fulfill its obligations under this Article. Notwithstanding the foregoing, Landlord hereby consents to Tenant’s use, storage or disposal of products containing small quantities of Hazardous Materials that are of a type customarily found in offices and households (such as aerosol cans containing insecticides, toner for copies, paints, paint remover and the like) provided that Tenant shall handle, use, store and dispose of such Hazardous Materials in a safe and lawful manner and shall not allow such Hazardous Materials to contaminate the Premises. Landlord acknowledges that it is not the intent of this Article 14 to prevent Tenant from using the Premises for its intended use, and Landlord will act reasonably in granting any necessary approvals to allow Tenant to use the Premises for its intended use, subject to such reasonable requirements as Landlord may impose.
 
14.3  Compliance With Laws; Handling Hazardous Materials . Tenant shall strictly comply with, and shall maintain the Premises in compliance with, ail Hazardous Materials Laws. Tenant shall obtain, maintain in effect and comply with the conditions of all permits, licenses and other governmental approvals required for Tenant’s operations on the Premises under any Hazardous Materials Laws, including, but not limited to, the
 
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discharge of appropriately treated Hazardous Materials into or through any sanitary sewer serving the Premises. At Landlord’s request, Tenant shall deliver copies of, or allow Landlord to inspect, all such permits, licenses and approvals. All Hazardous Materials removed from the Premises shall be removed and transported by duly licensed haulers to duly licensed disposal facilities, in compliance with all Hazardous Materials Laws. Tenant shall perform any monitoring, testing, investigation, clean-up, removal, detoxification, preparation of closure or other required plans and any other remedial work required by any governmental agency or lender, or recommended by Landlord’s environmental consultants, as a result of any release or discharge or potential release or discharge of Hazardous Materials affecting the Premises or the Center or any violation or potential violation of Hazardous Materials Laws by Tenant or any assignee or subtenant of Tenant or their respective agents, contractors, employees, licensees or invitees (collectively, “Remedial Work”). Landlord shall have the right to intervene in any governmental action or proceeding involving any Remedial Work, and to approve performance of the work, in order to protect Landlord’s interests. Tenant shall not enter into any settlement agreement, consent decree or other compromise with respect to any claims relating to Hazardous Materials without notifying Landlord and providing ample opportunity for Landlord to intervene. Tenant shall additionally comply with the recommendations of Landlord’s and Tenant’s insurers based upon National Fire Protection Association standards or other applicable guidelines regarding the management and handling of Hazardous Materials. If any present or future law imposes any requirement of reporting, survey, investigation or other compliance upon Landlord, Tenant, or the Premises, and if such requirement is precipitated by a transaction to which Tenant is a party, including without limitation any Transfer (as defined in Section 18.1) of this Lease by Tenant, then Tenant shall fully comply with and pay all costs of compliance with such requirement, including Landlord’s attorneys’ fees and costs.
 
14.4  Notice; Reporting; Notice Under Health and Safety Code Section 25359.7 . Tenant shall notify Landlord, in writing, within three (3) days after any of the following: (a) Tenant has knowledge, or has reasonable cause to believe, that any Hazardous Material is located on, under or about the Premises that is different from the list initially submitted to Landlord or if any Hazardous Material has been released or discharged on, under or about the Premises , whether or not the release or discharge is in quantities that would otherwise be reportable to a public agency, (b) Tenant receives any order of a governmental agency requiring any Remedial Work pursuant to any Hazardous Materials Laws, (c) Tenant receives any warning, notice of inspection, notice of violation or alleged violation or Tenant receives notice or knowledge of any proceeding, investigation or enforcement action, pursuant to any Hazardous Materials Laws; or (d) Tenant receives notice or knowledge of any claims made or threatened by any third party against Tenant or the Premises relating to any loss or injury resulting from Hazardous Materials. If the potential risk of any of the foregoing events is material, Tenant shall deliver immediate verbal notice to Landlord, in addition to written notice as set forth above. Tenant shall deliver to Landlord copies of all test results, reports and business or management plans required to be filed with any governmental agency pursuant to any Hazardous Materials Laws. Landlord hereby notifies Tenant, and Tenant hereby acknowledges that, prior to the leasing of the Premises pursuant to this Lease, Tenant has been notified, pursuant to California Health and Safety Code Section 25359.7 (or any successor statue), that Landlord knows, or has reasonable cause to believe that certain hazardous substances (as such term is used in such Section 25359.7) may have come to be located in, on or beneath the Premises. Notwithstanding the foregoing, to Landlord’s actual knowledge, as of the date stated in the first paragraph of this Lease, Landlord has not received any written notice from any governmental entity that the Premises or the Center is currently in breach of any Hazardous Materials Laws.
 
14.5  Indemnity . Tenant shall indemnify, protect, hold harmless and defend Landlord and Landlord’s officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entities and individuals, and their respective successors and assigns, from and against any and all liabilities, claims, suits, judgments, actions, investigations, proceedings, costs and expenses (including attorneys’ fees and costs) arising out of or in connection with any breach of any provisions of this Article or directly or indirectly arising out of the use, generation. storage, release, disposal or transportation of Hazardous Materials by Tenant, or any assignee or subtenant of Tenant, or their respective agents, contractors, employees. licensees, or invitees (Tenant Parties”), on, under or about the Premises during the Lease Term or any other period of Tenant’s actual or constructive occupancy of the Premises, including, but not limited to, all foreseeable and unforeseeable consequential damages and the cost of any Remedial Work. Any defense of Landlord pursuant to this Section shall be by counsel reasonably acceptable to Landlord. Neither the consent by Landlord to the use, generation, storage, release, disposal or transportation of Hazardous Materials nor the strict compliance with ail Hazardous Materials Laws shall excuse Tenant from Tenant’s indemnification obligations pursuant to this Article. The foregoing indemnity shall be in addition to and not a limitation of the indemnification provisions of Article 13 of this Lease. Tenant’s obligations
 
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pursuant to this Article shall survive the termination or expiration of this Lease but only as to Hazardous Materials used or stored by Tenant or the Tenant Parties. Nothing in this Lease shall impose on Tenant any liability (including payment as part of Operating Costs) for Hazardous Materials existing in the Premises as of the Commencement Date, or brought onto the Premises or Center after the expiration of this Lease by persons other than Tenant and Tenant Parties, or any liability in connection with Hazardous Materials brought onto the Premises or Center by Landlord, other tenants or any third parties other than the Tenant Parties.
 
14.6  Entry and Inspection; Cure . Landlord and its agents, employees and contractors, shall have the right (but not the obligation) to enter the Premises at all reasonable times to inspect the Premises and Tenants compliance with the terms and conditions of this Article, or to conduct investigations and tests. No prior notice to Tenant shall be required in the event of an emergency, or if Landlord has reasonable cause to believe that violations of this Article have occurred, or if Tenant consents at the time of entry. In all other cases, Landlord shall give at least twenty-four (24) hours’ prior notice to Tenant. Landlord shall have the right (but not the obligation) to remedy any violation by Tenant of the provisions of this Article pursuant to Section 22.3 of this Lease or to perform any Remedial Work. Tenant shall pay, upon demand, all costs incurred by Landlord in investigating any such violations or potential violations or performing Remedial Work, plus interest thereon at the rate specified in this Lease from the date of demand until the date paid by Tenant provided that Tenant will not be obligated to pay any costs if no violation of this Article 14 was found.
 
14.7  Termination; Expiration . Upon termination or expiration of this Lease, Tenant shall, at Tenants cost, remove any equipment, improvements or storage facilities utilized In connection with any Hazardous Materials and shall clean up, detoxify, repair and otherwise restore the Premises to a condition free of Hazardous Materials, to the extent such condition is caused by Tenant or any assignee or subtenant of Tenant or their respective agents, contractors, employees, licensees or invitees and to the extent such Hazardous Materials are in excess of the amounts of Hazardous Materials present in the Premises as of the Commencement Date.
 
14.8  Exit Assessment . No later than ten (10) business days after the expiration or earlier termination of this Lease, Tenant shall cause to be performed, at its sole expense, an environmental assessment (the “Exit Assessment”) of the Premises. Landlord agrees to allow Tenant access to the Premises for such purpose. The Exit Assessment must be performed by a qualified environmental consultant reasonably acceptable to Landlord, and shall include without limitation the following, as applicable to the Premises and Tenant’s activities; (a) inspection of all floors, walls, ceiling tiles, benches, cabinet Interiors, sinks, the roof and other surfaces for signs of contamination and/or deterioration related to Hazardous Materials, (b) inspection of any and all ducts, hoods and exhaust systems for signs of contamination, deterioration and/or leakage related or potentially related to Hazardous Materials, (c) inspection of all readily accessible drain lines and other discharge piping for signs of deterioration, loss of integrity and leakage, (d) Tenant interviews and review of appropriate Tenant records to determine the uses to which Tenant has put the Premises that involve or may have involved Hazardous Materials, and to determine if any known discharges to the Premises or ground or soils from Tenant’s activities have occurred, (e) documentation in detail of all observations, including dated photographs, (f) if applicable and available at a commercially reasonable cost, a certification that all areas inspected are clean and free of any Hazardous Materials and that the investigation conducted by the consultant does not indicate that any release of any Hazardous Materials has occurred in the Premises or the Center as a result of Tenants activities, (g) if applicable, a detailed description of Hazardous Materials remaining in the Premises and Of any contamination, deterioration and/or leakage observed, together with detailed recommendations for the removal, repair or abatement of the same, and (h) if applicable, a detailed description of evidence of possible or past releases of Hazardous Materials, together with detailed recommendations for the prevention of the same in the future. Landlord shall have the right to require additional evaluations or work in connection with the Exit Assessment based upon Tenant’s use of the Premises, any actual or suspected Hazardous Materials issues, or other reasonable factors if the Exit Assessment discloses any Hazardous Material contamination. The original of the Exit Assessment shall be addressed to Landlord and shall be provided to Landlord within twenty (20) days of the expiration or earlier termination of this Lease. In addition to Tenant’s obligations under Section 14.7, Tenant agrees to fully implement and address all recommended actions contained in the Exit Assessment which were caused by Tenants use of the Premises, at its sole cost, within thirty (30) days of the date thereof.
 
14.9  Event of Default . The release or discharge of any Hazardous Material violation of any Hazardous Materials Law by Tenant or any assignee or subtenant of Tenant shall be a material Event of Default by Tenant under this Lease. In addition to or in lieu of the remedies available under this Lease as a result of such Event of
 
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Default Landlord shall have the right, without terminating this Lease, to require Tenant to suspend its operations and activities in the Premises until Landlord is satisfied that appropriate Remedial Work has been or is being adequately performed; Landlord’s election of this remedy shall not constitute a waiver of Landlord’s right thereafter to declare an Event of Default and pursue any other available remedy.
 
15.
ALTERATIONS; LIENS
 
15.1  Alterations by Tenant . Tenant shall not make any alterations, additions or improvements (“Alterations”) to the Premises without Landlord’s prior written consent, except for nonstructural Alterations that cost $5,000 or less and are not visible from the exterior of the Premises. All Alterations installed by Tenant shall be new or completely reconditioned. Landlord shall have the right to approve the contractor, the method of payment of the contractor, and the plans and specifications for all proposed Alterations. Tenant shall obtain Landlord’s consent to all proposed Alterations requiring Landlord’s consent prior to the commencement of any such Alterations. Tenant’s request for consent shall be accompanied by information identifying the contractor and method of payment and two (2) copies of the proposed plans and specifications. All Alterations of whatever kind and nature shall become at once a part of the realty and shall be surrendered with the Premises upon expiration or earlier termination of the Lease Term, unless Landlord requires Tenant to remove the same as provided in Article 20. If Tenant demolishes or removes any then-existing tenant improvements or other portions of the Premises or the Building (including without limitation any previously-installed Alterations), Tenant shall promptly commence and diligently pursue to completion all Alterations then underway; provided, however, that if Tenant fails to do so, at the election of Landlord. Tenant shall restore the Premises and the Building to its condition and state of Improvement prior to such demolition or removal. During the Lease Term, Tenant agrees to provide, at Tenant’s expense, a policy of insurance covering loss or damage to Alterations made by Tenant, in an amount adequate to repair or replace the same, naming Landlord and Landlord’s property manager (if any) as additional insureds. Provided, however, Tenant may install movable furniture, trade fixtures, machinery or equipment In conformance with applicable governmental rules or ordinances and remove the same upon expiration or earlier termination of this Lease as provided in Article 20.
 
15.2  Permits and Governmental Requirements . Tenant shall obtain, at Tenant’s sole cost and expense, all building permits and other permits of every kind and nature required by any governmental agency having jurisdiction in connection with the Alterations. Tenant shall indemnify, protect, hold harmless and defend Landlord and Landlord’s officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entities and individuals, and their respective successors and assigns, from and against any and all claims, actions, damages, liability, costs, and expenses, including attorneys’ fees and costs, arising out of any failure by Tenant or Tenant’s contractor or agents to obtain all required permits, regardless of when such failure is discovered. Tenant shall do any and all additional construction, alterations, improvements and retrofittings required to be made to the Premises and/or the Center, or any other property of Landlord as a result of, or as may be triggered by, Tenant’s Alterations. Landlord shall have the right to do such construction itself; but in all instances Tenant shall pay all costs directly or indirectly related to such work and shall indemnify, protect, hold harmless and defend Landlord and Landlord’s officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entities and individuals, and their respective successors and assigns, from and against any and all claims, actions, damages, liability, costs, and expenses, including attorneys’ fees and costs, arising out of any such additionally required work. All payment and indemnification obligations under this Section shall survive the expiration or earlier termination cite Lease Term.
 
15.3  Liens . Tenant shall pay when due all claims for any work performed, materials furnished or obligations incurred by or for Tenant, and Tenant shall keep the Premises free from any liens arising with respect thereto. If Tenant fails to cause any such lien to be released within fifteen (15) days after imposition, by payment or posting of a proper bond, Landlord shall have the right (but not the obligation) to cause such release by such means as Landlord deems proper. Tenant shall pay Landlord upon demand for all costs incurred by Landlord in connection therewith (including attorneys’ fees and costs), with interest at the rate specified in Section 22.4 from the date of payment by Landlord to the date of payment by Tenant. Tenant will notify Landlord in writing thirty (30) days prior to commencing any alterations, additions, improvements or repairs in order to allow Landlord time to file a notice of nonresponsibility.
 
15.4  Remodel . Landlord may in the future remodel, renovate or refurbish (“remodel”) all or any portion of the Center, which remodel may include the exterior of the Premises. The remodeling will be done in accordance with design specifications prepared by the project architect and reviewed and approved by Landlord. Copies of such specifications will be made available to Tenant. Tenant shall not, through any act or omission on the part of Tenant, in any way impede, delay or prevent the completion of such remodeling in a timely manner.
 
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16.
DAMAGE AND DESTRUCTION
 
16.1  Partial Damage . If, during the Lease Term, the Premises are damaged or destroyed by fire or other casualty, or if the Building is damaged or destroyed by fire or other casualty and such damage or destruction affects Tenant’s use of the Premises (collectively, ‘Premises Damage”), Landlord shall perform the necessary repairs (other than to Tenant’s Alterations, trade fixtures, equipment, and personal property, the repair of which Tenant shall be solely responsible), and this Lease shall continue in full force and effect. Provided, however, that Landlord may, at its option. elect to terminate this Lease if (i) Landlord’s repairs cannot reasonably be completed within sixty (60) days after the date of the Premises Damage in accordance with applicable laws and regulations, or (ii) the Replacement Cost (defined below) exceeds six (6) months’ Minimum Monthly Rent, or (iii) Landlord does not receive sufficient insurance proceeds to pay the full Replacement Cost and the shortfall exceeds one (1) month’s Minimum Monthly Rent. As used herein, “Replacement Cost” shall mean the cost to repair or rebuild the Premises, Building or Center (other than Tenant’s Alterations, equipment, trade fixtures, and personal property) at the time of the damage or destruction to their condition existing immediately prior thereto, including without limitation all costs of demolition, debris removal, permits, fees and other governmental requirements, and upgrading the Premises, Building or Center as required by law or other requirements, without deduction for depreciation. Within sixty (60) days after the date Landlord learns of the necessity for repairs as a result of Premises Damage, Landlord shall notify Tenant (“Damage Repair Estimate”) of Landlord’s estimated assessment of the period of time in which the repairs will be completed. If Landlord does not elect to terminate this Lease pursuant to Landlords termination right as provided herein, and the Damage Repair Estimate indicates that repairs cannot be completed within one hundred twenty (120) days after being commenced, Tenant may elect, not later than thirty (30) days after Tenant’s receipt of the Damage Repair Estimate, to terminate this Lease by written notice to Landlord effective as of the date of Tenant’s notice.
 
16.2  Total Destruction . Notwithstanding any other provisions of this Lease, a total destruction (including any destruction required by any authorized public authority) of either the Premises or the Building shall, at the election of Landlord or Tenant, terminate this Lease as of the date of such destruction.
 
16.3  Partial Destruction of Center or Building . Notwithstanding any other provision of this Lease, if fifty percent (50%) or more of the rentable area of the Building or the Center is damaged or destroyed, notwithstanding that the Premises may be unaffected, Landlord shall have the right to terminate this Lease.
 
16.4  Insurance Deductible . If Landlord is required or elects to repair any Premises Damage caused by an insured casualty, Tenant shall, within thirty (30) days after receipt of written notice from Landlord, pay the amount of any commercially reasonable deductible or its Share thereof under any insurance policy covering such Premises Damage, in accordance with Section 9.3 above; provided that Tenant will not be required to pay any portion of any deductible where the casualty covered by the insurance giving rise to such deductible was caused solely by the negligence or willful misconduct of another tenant or occupant of the Center.
 
16.5  Damage Near End of Term . If at any time during the last twelve (12) months of the Lease Term there is Premises Damage for which Replacement Cost exceeds one (1) month’s Minimum Monthly Rent, Landlord or Tenant may, at its option, elect to terminate this Lease; provided, however, that if Tenant has any valid, unexercised option to extend the term of this Lease, Tenant may prevent Landlord’s termination under this Section by exercising such option within five (5) business days of receipt of Landlord’s election to terminate.
 
16.6  Landlord’s Termination Notice; Effective Date; Relocation . If Landlord elects to terminate this Lease under any applicable provision of this Article 16, Landlord shall give notice of such election within forty-five (45) days of the date of the damage or destruction. In the case of a total destruction (Section 16.2) or Premises Damage that prevents Tenant from occupying the Premises for its permitted use, the effective date of such termination shall be the date of such Premises Damage; otherwise the effective date of termination shall be a date
 
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selected by Landlord not earlier than thirty (30) days from the date of Landlord’s notice. If Tenant has any right to terminate this Lease as a result of any Premises Damage (whether provided in this Lease, by law or otherwise) Landlord may prevent such termination by exercising, within forty-five (45) days of the Premises Damage, any right to relocate Tenant to new Premises in the Center provided in Section 24.24 of this Lease.
 
16.7  Rent Abatement . If Landlord repairs the Premises or the Building after a Premises Damage as described in this Article 16, Minimum Monthly Rent and Additional Rent shall be equitably reduced from the date of the Premises Damage until the repairs are completed, based upon the extent to which such repairs interfere with the business carried on by Tenant in the Premises, but only to the extent Landlord receives proceeds from the rental income insurance described in Section 9.1. Landlord agrees to take reasonable steps to make a Claim for and collect any rental income insurance proceeds that might be available.
 
16.8  Tenant’s Obligations . Landlord shall not be required to repair any injury or damage by fire or other cause, or to make any restoration or replacement of, any of Alterations, equipment, trade fixtures, and personal property owned, placed or installed in or about the Premises by or on behalf of Tenant. Unless this Lease is terminated pursuant to this Article, Tenant shall promptly repair, restore or replace the same in the event of any damage thereto. If all or any portion of the Premises, Building or Center is damaged or destroyed by reason of any act or omission of Tenant, except as provided in Section 9.4 (Waiver of Subrogation), Tenant shall either make the necessary repairs at Tenant’s expense or pay to Landlord the Replacement Cost arising therefrom, regardless of whether this Lease is terminated. Nothing contained in this Article shall be construed as a limitation on Tenant’s liability for any damage or destruction if such liability otherwise exists.
 
16.9  Waiver of Inconsistent Statutes . The parties’ rights and obligations in the event of damage or destruction shall be governed by the provisions of this Lease; accordingly, Tenant waives the provisions of California Civil Code Sections 1932(2) and 1933(4), and any other statute, code or judicial decisions that grants a tenant a right to terminate a lease in the event of damage or destruction of a leased premises.
 
17.
CONDEMNATION
 
17.1  Effect on Lease . If all of the Premises, or so much thereof that the remaining portion of the Premises cannot be used by Tenant for its permitted use, is taken under the power of eminent domain or sold under the threat of the exercise of such power (collectively “Condemnation”), this Lease shall terminate as of the earlier of the date title vests in the condemnor or the date the condemnor is entitled to possession of the interest condemned (the “Condemnation Date”). In all other cases, Landlord may terminate this Lease as of the Condemnation Date if (i) the Condemnation affects any material portion of the Premises or the Building, (ii) Landlord receives insufficient funds from the condemnor to complete the restoration of the Premises required under this Section, or (iii) if the Condemnation affects such a substantial portion of the Center (including the Common Facilities, parking lots or access to the Center) that it is no longer economically appropriate in Landlord’s business judgment to lease the Premises on the terms and conditions of this Lease. If such Condemnation affects the Premises and this Lease remains in effect, (a) this Lease shall terminate as to the portion of the Premises taken as of the Condemnation Date, (b) the Minimum Monthly Rent shall be equitably adjusted based upon the rental value of the Premises remaining after the Condemnation compared to the rental value of the Premises prior to Condemnation, (c) Tenant’s Share shall be adjusted based on any changes in the Rentable Square Footage of the Premises and/or the Center, and (d) Landlord shall, within a reasonable period of time, undertake such construction or restoration as may be reasonably necessary to place the remaining Premises in a useable condition (provided that the cost of such construction or restoration does not exceed the amount awarded to Landlord by the condemnor for such purpose). Landlord shall not be responsible to restore or replace any of Tenant’s Alterations, fixtures, equipment or personal property.
 
17.2  Condemnation Award . All compensation, damages and other items of value awarded, paid or received in settlement or otherwise (“Award”) upon any partial or total Condemnation shall be paid to Landlord, and Tenant shall have no claim thereto. Tenant hereby irrevocably assigns and transfers to Landlord, and fully waives, releases and relinquishes any and all claims to or interest in the Award, Including, without limitation, any amount attributable to the amount, if any, by which rental value of the Premises exceeds the rent payable for the remainder of the Lease Term, to the value of any unexercised options to extend the term or expand the Premises, or to Tenant’s goodwill. Notwithstanding the foregoing, Tenant shall have the right to make a separate claim and to recover from the condemning authority, but not from Landlord, so long as the Award payable to Landlord is not reduced thereby,
 
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such compensation as may be separately awarded or recoverable by Tenant in Tenant’s own right on account of (a) the taking of the unamortized or undepreciated value of any leasehold improvements owned by Tenant that Tenant has the right to remove at the end of the Lease Term and the Tenant elects not to remove; (b) reasonable removal and relocation costs for any leasehold improvements that Tenant has the right to remove and elects to remove (If the condemning authority approves of the removal); and (c) relocation costs under Government Code Section 7262, the claim for which Tenant may pursue by separate action independent of this Lease.
 
17.3  Waiver of Inconsistent Statutes . The parties’ rights and obligations in the event of Condemnation shall be governed by the provisions of this Lease; accordingly, Tenant waives the provisions of California Code of Civil Procedure Sections 1265.110 through 1265.150, and any other statute, code or judicial decisions that grants a tenant a right to terminate a lease in the event of the Condemnation of a leased premises.
 
18.
ASSIGNMENT AND SUBLETTING
 
18.1  Landlord’s Consent Required . Except as expressly set forth herein, Tenant shall not voluntarily or involuntarily assign, sublease, mortgage, encumber, or otherwise transfer all or any portion of the Premises or its interest in this Lease (collectively, “Transfer”) without Landlord’s prior written consent, which consent Landlord shall not unreasonably withhold. Landlord may withhold its consent until Tenant has complied with the provisions of Sections 182 and 18.3. Any attempted Transfer without Landlord’s written consent shall be void and shall constitute a noncurable Event of Default under this Lease. If Tenant is a corporation, any cumulative Transfer of more than fifty percent (50%) of the voting stock of such corporation shall constitute a Transfer requiring Landlord’s consent hereunder; provided, however, that this sentence shall not apply to any corporation whose stock is publicly traded. If Tenant is a partnership, limited liability company, trust or other entity, any cumulative Transfer of more than fifty percent (50%) of the partnership, membership, beneficial or other ownership interests therein shall constitute a Transfer requiring Landlord’s consent hereunder. Tenant shall not have the right to consummate a Transfer or to request Landlord’s consent to any Transfer if any Event of Default has occurred and is continuing or if Tenant or any affiliate of Tenant is in default under any lease of any other real property owned or managed (in whole or in part) by Landlord or any affiliate of Landlord. Notwithstanding anything to the contrary contained in this Section 18, an assignment or subletting of all or a portion of the Premises to an affiliate (“Affiliate”) of Tenant (an entity which is controlled by, controls, or is under common control with, Tenant, or that becomes a parent, successor or affiliate of Tenant, or is a successor of Tenant by reason of merger, consolidation, public offering, reorganization, dissolution, or sale of stock, membership or partnership interests or assets) shall not be deemed a Transfer under this Article 18, provided that (i) Tenant notifies Landlord of any such assignment or sublease prior to the effective date thereof and promptly supplies Landlord with any documents or information reasonably requested by Landlord regarding such assignment or sublease to such Affiliate (Including, in the event of an assignment, evidence of the assignee’s assumption of Tenant’s obligations under this Lease or, in the event of a sublease, evidence of the sublessee’s assumption, in flit!, of the obligations of Tenant with respect to the portion of the Premises so subleased, other than the payment of rent), (ii) such assignment or sublease is not a subterfuge by Tenant to avoid its obligations under this Lease, (iii) such assignment or sublease does not cause Landlord to be in default under any existing lease at the Center, and (iv) the net worth of such Affiliate is not less than reasonably required to fulfill the terms of this Lease. “Control,” as used in this Section 18.1, shall mean the ownership, directly or indirectly, of greater than fifty-one percent (51%) of the voting securities of, or possession of the right to vote, in the ordinary direction of its affairs, of greater than fifty-one percent (51%) of the voting interest in, an entity. The raising of capital by an offering of stock or ownership interest in Tenant will not be deemed a transfer for purposes of this Lease and will not require Landlord’s consent.
 
18.2  Landlord’s Election . Tenant’s request for consent to any Transfer shall be accompanied by a written statement setting forth the details of the proposed Transfer, including the name, business and financial condition of the prospective Transferee, financial details of the proposed Transfer (e.g., the term and the rent and security deposit payable), and any other related information that Landlord may reasonably require. Landlord shall have the right: (a) to withhold consent to the Transfer, if reasonable, (b) to grant consent, (c) to terminate this Lease as to the portion of the Premises affected by any proposed Transfer, in which event Landlord may enter into a lease directly with the proposed Transferee (which election to terminate shall not be construed to be a consent to the proposed Transfer), provided Tenant may retract its request for consent to such Transfer and negate Landlord’s recapture of such space upon notice from Landlord of Landlord’s intent to recapture the same, or (d) to consent on the condition that Landlord be paid fifty percent (50%) of all subrent or other consideration to be paid to Tenant
 
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under the terms of the Transfer in excess of the total rent due hereunder (including, if such Transfer is an assignment or if such Transfer is to occur directly or indirectly in connection with the sale of any assets of Tenant, fifty percent (50%) of the amount of the consideration attributable to the Transfer, as reasonably determined by Landlord). Landlord may require any permitted subtenant to make rental payments directly to Landlord, in the amount of rent due hereunder. The grounds on which Landlord may reasonably withhold its consent to any requested Transfer include, without limitation, that: (i) the proposed Transferee’s contemplated use of the Premises following the proposed Transfer is not reasonably similar to the use of the Premises permitted hereunder, (ii) in Landlord’s reasonable business judgment, the proposed Transferee lacks sufficient business reputation or experience to operate a successful business of the type and quality permitted under this Lease, (iii) in Landlord’s reasonable business judgment, the proposed Transferee lacks sufficient net worth, working capital, anticipated cash flow and other indications of financial strength to meet all of its obligations under this Lease, (iv) the proposed Transfer would breach any covenant of Landlord respecting a radius restriction, location, use or exclusivity in any other lease, financing agreement, or other agreement relating to the Center, and (v) in Landlord’s reasonable business judgment, the possibility of a release of Hazardous Materials is materially increased as a result of the Transfer or if Landlord does not receive sufficient assurances that the proposed Transferee has the experience and financial ability to remedy a violation of Hazardous Materials and to fulfill its obligations under Articles 13 and 14. In connection with any such Transfer, Landlord shall have the right to require Tenant, at Tenant’s sole cost, to cause environmental testing meeting the requirements of an Exit Assessment described in Section 14.8 to be performed. Landlord need only respond to any request by Tenant hereunder within a reasonable time of not less than ten (10) business days after receipt of all information and other submission required in connection with such request.
 
18.3  Costs; Transfer Fee . Tenant shall pay all reasonable costs and expenses in connection with any permitted Transfer, including any real estate brokerage commissions due with respect to the Transfer. Tenant shall pay all reasonable attorneys’ fees and costs incurred by Landlord and a fee of $500 to reimburse Landlord for costs and expenses incurred in connection with any request by Tenant for Landlord’s consent to a Transfer. Such fee shall be delivered to Landlord concurrently with Tenant’s request for consent. Such payment obligations shall apply regardless of whether Landlord ultimately grants or denies Tenant’s request.
 
18.4  Assumption; No Release of Tenant . Any permitted assignee shall assume in writing all obligations of Tenant under this Lease, utilizing a form of assumption agreement provided or approved by Landlord, and an executed copy of such assumption agreement shall be delivered to Landlord within fifteen (15) days after the effective date of the Transfer. The taking of possession of all or any part of the Premises by any such permitted assignee or subtenant shall constitute an agreement by such person or entity to assume without limitation or qualification all of the obligations of Tenant under this Lease, notwithstanding any failure by such person to execute the assumption agreement required in the immediately preceding sentence. No permitted Transfer shall release or change Tenant’s primary liability to pay the rent and to perform all other obligations of Tenant under this Lease. Landlord’s acceptance of rent from any other person is not a waiver of any provision of this Article nor a consent to any Transfer. Consent to one Transfer shall not constitute a consent to any subsequent Transfer. If any transferee defaults under this Lease, Landlord may proceed directly against Tenant without pursuing remedies against the transferee. Landlord may consent to subsequent Transfers or modifications of this Lease by Tenant’s transferee, without notifying Tenant or obtaining its consent, and such action shall not relieve Tenant of its liability under this Lease.
 
18.5  No Merger . No merger shall result from any Transfer pursuant to this Article, any surrender by Tenant of its interest under this Lease, or any termination hereof in any other manner. In any such event, Landlord may either terminate any or all subleases or succeed to the interest of Tenant thereunder.
 
18.6  Reasonable Restriction . Tenant acknowledges that the restrictions on Transfer contained herein are reasonable restrictions for purposes of Section 22.2 of this Lease and California Civil Code Section 1951.4.
 
19.
SUBORDINATION; ATTORNMENT; ESTOPPEL CERTIFICATE
 
19.1  Subordination . The lien and terms of this Lease are and shall be unconditionally junior and subordinate to the lien and terms of all ground leases, mortgages, deeds of trust, and other security instruments now or hereafter affecting the real property of which the Premises are a part, and to all advances made on the security thereof, and to all renewals, modifications, consolidations, replacements and extensions thereof. If any mortgagee,
 
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beneficiary under deed of trust or ground lessor shall elect to have this Lease prior to its mortgage, deed of trust or ground lease, and gives written notice thereof to Tenant, this Lease shall be deemed prior thereto. Tenant agrees to execute any documents required to effectuate such subordination or to make this Lease prior to the lien of any such mortgage, deed of trust or ground lease, as the case may be, subject to Tenant’s receipt of a commercially reasonable non-disturbance agreement If Tenant fails to deliver such agreement within ten (10) business days after written demand, an Event of Default shall be deemed to have occurred.
 
19.2  Attornment . If Landlord sells, transfers, or conveys its interest in the Premises or this Lease, or if the same is foreclosed judicially or nonjudicially, or is otherwise acquired, by a mortgagee, beneficiary under deed of trust or ground lessor, upon the request and at the sole election of Landlord’s lawful successor, Tenant shall attorn to said successor subject to Tenant’s receipt of a commercially reasonable non-disturbance agreement from such successor. Subject to the foregoing, Tenant shall, upon request of Landlord, execute an attornment agreement in form and substance acceptable to Landlord agreeing in advance to such attornment to any such mortgagee, beneficiary, ground lessor or other successor, provided such attornment agreement contains commercially reasonable non-disturbance language. Such attornment agreement shall provide, among other things, that such mortgagee, beneficiary or ground lessor shall not be (a) bound by any prepayment of more than one (1) month’s rent, (b) liable for the return of any Security Deposit or other sums not actually received by said successor, (c) bound by any act or omission of Landlord arising prior to the succession of such successor to the Landlord’s interest in this Lease, or be subject to any offset, defense or counter-claim that Tenant may have previously accrued against Landlord, or (d) be bound by any material amendment of this Lease made after the later of the initial effective date of this Lease, or the date that such successor’s lien or interest first arose, unless said successor shall have consented to such amendment in writing.
 
19.3  Estoppel Certificates . Within ten (10) business days after written request from Landlord, Tenant at Tenant’s sole cost shall execute, acknowledge and deliver to Landlord a written certificate in favor of Landlord and any prospective lender on or purchaser of the Center or any part thereof, (a) that this Lease is unmodified and in full force and effect (or, if modified, stating the nature of such modifications and certifying that this Lease is in full force and effect as so modified), (b) the amount of any rent paid in advance, and (c) that there are no uncured defaults on the part of Landlord, or specifying the nature of such defaults if any are claimed. In addition to the foregoing, such certificate shall include Tenant’s certification to such other matters of fact, and be on such form, as Landlord or such prospective lender or purchaser shall reasonably require. If Tenant fails to deliver such certificate within said 10-day period, an Event of Default shall be deemed to have occurred. Tenant’s failure to deliver such certificate within said 10-day period shall constitute a conclusive acknowledgment by Tenant (i) that this Lease is in full force and effect without modification except as may be represented by Landlord, (ii) that not more than one month’s rent has been paid in advance, and (iii) that there are no uncured defaults in Landlord’s performance.
 
20.
SURRENDER OF PREMISES
 
20.1  Condition of Premises . Upon the expiration or earlier termination of this Lease, Tenant shall surrender the Premises to Landlord, broom clean and in good condition and repair, except for ordinary wear and tear that Tenant is not otherwise obligated to remedy under the provisions of this Lease. Tenant shall deliver all keys to the Premises and the Building to Landlord. Upon Tenant’s vacation of the Premises, Tenant shall remove all portable furniture, trade fixtures, machinery, equipment, signs and other items of personal property (unless prohibited from doing so under Section 20.2), and shall remove any Alterations (whether or not made with Landlord’s consent) that Landlord may (at Landlord’s election, made at the time such Alterations were installed) require Tenant to remove. Tenant shall repair all damage to the Premises caused by such removal and shall restore the Premises to its prior condition, all at Tenant’s expense. Such repairs shall be performed in a manner satisfactory to Landlord and shall include, but are not limited to, the following: capping all plumbing, capping all electrical wiring, repairing all holes in walls, restoring damaged floor and/or ceiling tiles, and thorough cleaning of the Premises. If Tenant fails to remove any items that Tenant has an obligation to remove under this Section when required by Landlord or otherwise, such items shall, at Landlord’s option, become the property of Landlord and Landlord shall have the right to remove and retain or dispose of the same in any manner, without any obligation to account to Tenant for the proceeds thereof. Tenant waives all claims against Landlord for any damages to Tenant resulting from Landlord’s retention or disposition of such Alterations or personal property. Tenant shall be liable to Landlord for Landlord’s costs of removing, storing and disposing of such items.
 
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20.2  Removal of Certain Alterations, Fixtures and Equipment Prohibited . All Alterations, fixtures (whether or not trade fixtures), machinery, equipment, signs and other Items of personal property that Landlord has not required Tenant to remove under Section 20.1 shall become Landlord’s property and shall be surrendered to Landlord with the Premises, regardless of who paid for the same. In particular and without limiting the foregoing, Tenant shall not remove any of the following materials or equipment without Landlord’s prior written consent, regardless of who paid for the same and regardless of whether the same are permanently attached to the Premises: power wiring and power panels; piping for industrial gasses or liquids; laboratory benches, sinks, cabinets and casework; fume hoods or specialized air-handling and evacuation systems; drains or other equipment for the handling of waste water or hazardous materials; computer, telephone and telecommunications wiring, panels and equipment; lighting and lighting fixtures; wall coverings; drapes, blinds and other window coverings; carpets and other floor coverings; heaters, air conditioners and other heating or air conditioning equipment; fencing; security gates and systems; and other building operating equipment and decorations.
 
20.3  Holding Over . Tenant shall vacate the Premises upon the expiration or earlier termination of this Lease, and Tenant shall indemnify, protect, hold harmless and defend Landlord against all liabilities, damages and expenses incurred by Landlord as a result of any delay by Tenant in vacating the Premises. If Tenant remains in possession of the Premises or any part thereof after the expiration of the Lease Term with Landlord’s written permission, Tenant’s occupancy shall be a tenancy from month-to-month only, and not a renewal or extension hereof. All provisions of this Lease (other than those relating to the term) shall apply to such month-to-month tenancy, except that the Minimum Monthly Rent shall be increased to 150% of the Minimum Monthly Rent in effect during the last month of the Lease Term. No acceptance of rent, negotiation of rent checks or other act or omission of Landlord or its agents shall extend the Expiration Date of this Lease other than a writing executed by Landlord giving Tenant permission to remain in occupancy beyond the Expiration Date under the terms of the immediately preceding sentence.
 
21.
DEFAULT BY TENANT
 
The occurrence of any of the following shall constitute an “Event of Default” under this Lease by Tenant:
 
21.1 Failure to pay when due any Minimum Monthly Rent, Additional Rent or any other monetary sums required to be paid by Tenant under the terms of this Lease.
 
21.2 Failure to perform any other agreement or obligation of Tenant hereunder, if such failure continues for thirty (30) days after written notice by Landlord to Tenant, except as to those Events of Default that are noncurable, in which case no such grace period shall apply. Landlord’s notice described herein is intended to satisfy, and is not in addition to, any and all legal notices required prior to commencement of an unlawful detainer action, including without limitation the notice requirements of California Code of Civil Procedure Sections 1161  et seq .
 
21.3 Abandonment, vacation or failure to occupy the Premises for a period of ten (10) consecutive days, coupled with the non-payment of rent.
 
21.4 If any of the following occurs: (i) a petition is filed for an order of relief under the federal Bankruptcy Code or for an order or decree of insolvency or reorganization or rearrangement under any state or federal law, and such petition is not dismissed within thirty (30) days after the filing thereof; (ii) Tenant makes a general assignment for the benefit of creditors; (iii) a receiver or trustee is appointed to take possession of any substantial part of Tenant’s assets, unless such appointment is vacated within thirty (30) days after the date thereof; or (iv) Tenant consents to or suffers an attachment, execution or other judicial seizure of any substantial part of its assets or its interest under this Lease, unless such process is released or satisfied within thirty (30) days after the occurrence thereof. If a court of competent jurisdiction determines that any of the foregoing events is not a default under this Lease, and a trustee is appointed to take possession (or if Tenant remains a debtor in possession), and such trustee or Tenant transfers Tenant’s interest hereunder, then Landlord shall receive the difference between the rent (or other consideration) paid in connection with such transfer and the rent payable by Tenant hereunder. Any assignee pursuant to the provisions of any bankruptcy law shall be deemed without further act to have assumed all of the obligations of the Tenant hereunder arising on or after the date of such assignment. Any such assignee shall, upon demand, execute and deliver to Landlord an instrument confirming such assumption.
 
21.5 The occurrence of any other event that is deemed to be an Event of Default under any other provision of this Lease, or any other lease to which Landlord (or any affiliate of Landlord) and Tenant (or any affiliate of Tenant) are parties.
 
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22.
REMEDIES
 
Upon the occurrence of any Event of Default by Tenant, Landlord shall have the following remedies, each of which shall be cumulative and in addition to any other remedies now cc hereafter available at law or in equity:
 
22.1  Termination of Lease . Landlord can terminate this Lease and Tenant’s right to possession of the Premises by giving written notice of termination, and then re-enter the Premises and take possession thereof. No act by Landlord other than giving written notice to Tenant of such termination shall terminate this Lease. Upon termination, Landlord has the right to recover all damages incurred by Landlord as a result of Tenant’s default, including:
 
(a) The worth at the time of award of any unpaid rent that had been earned at the time of such termination; plus
 
(b) The worth at the time of award of the amount by which the unpaid rent that would have been earned after the date of termination until the time of award exceeds the amount of the loss of rent that Tenant proves could have been reasonably avoided; plus
 
(c) The worth at the time of award of the amount by which the unpaid rent for the balance of the Lease Term after the time of award exceeds the amount of such rental loss that Tenant proves could have been reasonably avoided; plus
 
(d) Any other amount necessary to compensate Landlord for all the detriment proximately caused by Tenant’s default, including, but not limited to (i) expenses for cleaning, repairing or restoring the Premises, (Ii) expenses for altering, remodeling or otherwise improving the Premises for the purpose of reletting, (Iii) brokers’ fees and commissions, advertising costs and other expenses of retelling the Premises, (iv) costs of carrying the Premises, such as taxes, insurance premiums, utilities and security precautions, (v) expenses in retaking possession of the Premises, (vi) attorneys’ fees and costs, (vii) any unearned brokerage commissions paid in connection with this Lease, and (viii) reimbursement of any previously waived or abated Minimum Monthly Rent, Additional Rent or other charges; plus
 
(e) At Landlord’s election, such other amounts in addition to or in lieu of the foregoing as may be permitted from time to time under applicable law. As used in paragraphs (a) and (b) above, the “worth at the time of award” shall be computed by allowing interest at the maximum permissible legal rate. As used in paragraph (c) above, the “worth at the time of award” shall be computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percent (1%).
 
22.2  Continuation of Lease . Landlord has the remedy described in California Civil Code Section 1951.4 (Landlord may continue this Lease in effect after Tenant’s breach and abandonment and recover rent as it becomes due, if Tenant has the right to sublet or assign, subject only to reasonable limitations), as follows:
 
(a) Landlord can continue this Lease in full force and effect without terminating Tenant’s right of possession, and Landlord shall have the right to collect rent and other monetary charges when due and to enforce all other obligations of Tenant hereunder. Landlord shall have the right to enter the Premises to do acts of maintenance and preservation of the Premises, to make alterations and repairs in order to relet the Premises, and/or to undertake other efforts to relet the Premises. Landlord may also remove personal property from the Premises and store the same in a public warehouse at Tenant’s expense and risk. No act by Landlord permitted under this paragraph shall terminate this Lease unless a written notice of termination is given by Landlord to Tenant or unless the termination is decreed by a court of competent jurisdiction.
 
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(b) In furtherance of the remedy set forth in this Section, Landlord may relet the Premises or any part thereof for Tenant’s account, for such term (which may extend beyond the Lease Term), at such rent, and on such other terms and conditions as Landlord may deem advisable in its sole discretion. Tenant shall be liable immediately to Landlord for all costs Landlord incurs in reletting the Premises. Any rents received by Landlord from such reletting shall be applied to the payment of: (i) any indebtedness other than rent due hereunder from Tenant to Landlord, (ii) the costs of such reletting, including brokerage and attorneys’ fees and costs, and the cost of any alterations and repairs to the Premises, and (iii) the payment of rent due and unpaid hereunder, including any previously waived or abated rent. Any remainder shall be held by Landlord and applied in payment of future amounts as the same become due and payable hereunder. In no event shall Tenant be entitled to any excess rent received by Landlord after an Event of Default by Tenant and the exercise of Landlord’s remedies hereunder. If the rent from such reletting during any month is less than the rent payable hereunder, Tenant shall pay such deficiency to Landlord upon demand.
 
(c) Landlord shall not, by any re-entry or other act, be deemed to have accepted any surrender by Tenant of the Premises or Tenant’s interest therein, or be deemed to have terminated this Lease or Tenant’s right to possession of the Premises or the liability of Tenant to pay rent accruing thereafter or Tenant’s liability for damages under any of the provisions hereof, unless Landlord shall have given Tenant notice in writing that it has so elected to terminate this Lease.
 
(d) Tenant acknowledges and agrees that the restrictions on the Transfer of this Lease set forth in Article 18 of this Lease constitute reasonable restrictions on such transfer for purposes of this Section and California Civil Code Section 1951.4.
 
22.3  Performance By Landlord . If Tenant falls to pay any sum of money or perform any other act to be performed by Tenant hereunder, and such failure continues for fifteen (15) days after notice by Landlord, Landlord shall have the right (but not the obligation) to make such payment or perform such other act without waiving or releasing Tenant from its obligations. All sums so paid by Landlord and all necessary incidental costs, together with interest thereon at the rate specified in Section 22.4, shall be payable to Landlord on demand. Landlord shall have the same rights and remedies in the event of nonpayment by Tenant as in the case of default by Tenant in the payment of the rent.
 
22.4  Late Charge; Interest on Overdue Payments . The parties acknowledge that late payment by Tenant of Minimum Monthly Rent, Additional Rent or other charges hereunder will cause Landlord to incur costs not contemplated by this Lease, the exact amount of which will be extremely difficult and impractical to determine, including, but not limited to, processing and accounting charges, administrative expenses, and additional interest expenses or late charges that Landlord may be required to pay as a result of late payment on Landlord’s obligations. Therefore, if any installment of Minimum Monthly Rent, Additional Rent or other charges is not received by Landlord on the date due, and without regard to whether Landlord gives Tenant notice of such failure or exercises any of its remedies upon an Event of Default, Tenant shall pay a late charge equal to the greater of ten percent (10%) of the overdue amount or One Hundred Dollars ($100). The parties hereby agree that such late charge represents a fair and reasonable estimate of the damages Landlord will incur by reason of late payment by Tenant. In addition, any amount due from Tenant that is not paid when due shall bear interest at a rate equal to two percent (2%) over the then current Bank of America prime or reference rate or ten percent (10%) per annum, whichever is greater, but not in excess of the maximum permissible legal rate, from the date such payment is due until the date paid by Tenant. Landlord’s acceptance of any interest or late charge shall not constitute a waiver of Tenant’s default or prevent Landlord from exercising any other rights or remedies available to Landlord.
 
22.5  Landlord’s Right to Require Advance Payment of Rent; Cashier’s Checks . If Tenant is late in paying any component of rent more than three (3) times during the Lease Term, Landlord shall have the right, upon notice to Tenant, to require that all rent be paid three (3) months in advance. Additionally, if any of Tenant’s checks are returned for nonsufficient funds, or if Landlord at any time serves upon Tenant a Three Day Notice to Pay Rent or Quit (pursuant to California Civil Code Sections 1161  et seq . or any successor or similar unlawful detainer statutes), Landlord may, at its option, require that all future rent (including any sums demanded in any subsequent three (3) day notice) be paid exclusively by money order or cashier’s check.
 
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23.
DEFAULT BY LANDLORD
 
23.1  Notice to Landlord . Landlord shall not be in default under this Lease unless Landlord fails to perform an obligation required of Landlord within a reasonable time, but In no event later than thirty (30) days after written notice by Tenant to Landlord and to each Mortgagee as provided in Section 23.2, specifying the nature of the alleged default; provided, however, that if the nature of the obligation is such that more than thirty (30) days are required for performance, then Landlord shall not be in default if Landlord commences performance within such 30-day period and thereafter diligently prosecutes the same to completion.
 
23.2  Notice to Mortgagees . Tenant agrees to give each mortgagee or trust deed holder on the Premises or the Center whose address has been provided to Tenant (“Mortgagee”), by certified mail, a copy of any notice of default served upon Landlord, provided that Tenant has been previously notified in writing of the address of such Mortgagee. Tenant further agrees that if Landlord fails to cure such default within the time provided for in this Lease, then the Mortgagees shall have an additional thirty (30) days after Tenant’s notice within which to cure such default, or if such default cannot reasonably be cured within that time, then such additional time as may be necessary if, within said 30-day period, any Mortgagee has commenced and is diligently pursuing the remedies necessary to cure the default (including but not limited to commencement of foreclosure proceedings If necessary to affect such cure), in which event this Lease shall not be terminated while such remedies are being so diligently pursued.
 
23.3  Limitations on Remedies Against Landlord . In the event Tenant has any claim or cause of action against Landlord whether for direct injury or for indemnification: (a) Tenant’s sole and exclusive remedy shall be against Landlord’s interest in the Building, and neither Landlord nor any of Landlord’s Related Entities, nor any other property of Landlord or Landlord’s Related Entities shall be liable for any deficiency, (b) none of Landlord’s Related Entitles shall be sued or named as a party in any suit or action (except as may be necessary to secure jurisdiction over Landlord), (c) no service of process shall be made against any of Landlord’s Related Entities (except as may be necessary to secure jurisdiction), and none of Landlord’s Related Entities shall be required to answer or otherwise plead to any service of process, (d) no judgment shall be taken against any of Landlord’s Related Entities and any judgment taken against any of Landlord’s Related Entities may be vacated and set aside at any time, and (e) no writ of execution will ever be levied against the assets of any of Landlord’s Related Entities. The covenants and agreements set forth in this Section shall be enforceable by Landlord and/or by any of Landlord’s Related Entities. If Landlord fails to give any consent that a court later holds Landlord was required to give under the terms of this Lease, Tenant shall be entitled solely to specific performance and such other remedies as may be specifically reserved to Tenant under this Lease, but in no event shall Landlord be responsible for incidental or consequential damages for such failure to give consent.
 
24.
GENERAL PROVISIONS
 
24.1  Action or Defense by Tenant . Any claim, demand or right of defense of any kind by Tenant that Is based upon or arises in any connection with this Lease or negotiations prior to its execution shall be barred unless Tenant commences an action thereon or initiates a legal proceeding or defense by reason thereof within six (6) months after the date Tenant knew or a reasonably diligent tenant would have known of the event, act or omission giving rise to such claim, demand, or right of defense. Tenant acknowledges and understands that, after having had an opportunity to consult with legal counsel, the purpose of this paragraph is to shorten the time period within which Tenant would otherwise have to raise such claims, demands or rights of defense.
 
24.2  Arbitration and Mediation; Waiver of Jury Trial . Except as provided in this Section, if any dispute ensues between Landlord and Tenant arising out of or concerning this Lease, and if said dispute cannot be settled through direct discussions between the parties, the parties shall first to attempt to settle the dispute through mediation before a mutually acceptable mediator. The cost of mediation shall be divided equally between the parties. Thereafter, any remaining, unresolved disputes or claims shall be resolved by binding arbitration in accordance with the rules of the American Arbitration Association, and judgment upon the award rendered by the arbitrator may be entered in any court of competent jurisdiction. The prevailing party in any such arbitration shall be entitled to recover reasonable costs and attorneys’ fees and costs as determined by the arbitrator; provided, however, that the foregoing provisions regarding mediation and arbitration shall not apply to any issue or claim that might properly be adjudicated in an unlawful detainer proceeding. Without limiting the foregoing, Landlord and Tenant hereby waive trial by jury in any action, proceeding or counterclaim (including any claim of injury or damage and any emergency and other statutory remedy in respect thereof) brought by either against the other on any matter arising out of or in any way connected with this Lease, the relationship of Landlord and Tenant, or Tenant’s use or occupancy of the Premises.
 
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24.3  Attorneys’ Fees . If either Landlord or Tenant brings any legal action or proceeding, declaratory or otherwise, against the other arising out of this Lease, including any suit by Landlord to recover rent or possession of the Premises or otherwise to enforce this Lease, the non-prevailing party shall pay the prevailing party’s costs and attorneys’ fees and costs incurred in such proceeding. As used herein, “attorneys’ fees and costs” include without limitation attorneys’ fees and costs, printing, photocopying, duplicating and other expenses, air freight charges, fees billed for law clerks, paralegals and other persons not admitted to the bar but performing services under the supervision of an attorney, experts’ fees, appraisers’ fees, accountants’ fees, court costs, the fees of other professionals, costs incurred in connection with any and all arbitrations, mediations, post-judgment motions, contempt proceedings, garnishments, levies, debtor and third party examination, discovery and bankruptcy litigation. If Landlord issues notice(s) to pay rent, notice(s) to perform covenant, notice(s) of abandonment or similar documents as a result of Tenant’s default under this Lease, and If Tenant cures such default, Tenant shall pay to Landlord within fifteen (15) days of demand, the reasonable costs incurred by Landlord in preparing and delivering the same, including Landlord’s attorneys’ fees and costs.
 
24.4  Authority . Tenant represents and warrants that it has full power and authority to execute and fully perform its obligations under this Lease pursuant to its governing Instruments, without the need for any further action, and that the person(s) executing this Agreement on behalf of Tenant are the duly designated agents of Tenant and are authorized to do so. Prior to execution of this Lease, Tenant shall supply Landlord with such evidence as Landlord may request regarding the authority of Tenant to enter into this Lease. Any actual or constructive taking of possession of the Premises by Tenant shall constitute a ratification of this Lease by Tenant. Landlord represents and warrants that it has full power and authority to execute and fully perform is obligations under this Lease pursuant to its governing instruments, without the need for any further action, and that the person(s) executing this Agreement on behalf of Landlord are the duly designated agents of Landlord and are authorized to do so. Prior to execution of this Lease, Landlord shall supply Tenant with such evidence as Tenant may request regarding the authority of Landlord to enter into this Lease.
 
24.5  Binding Effect; Parties Benefited . Subject to the provisions of Article 18 restricting transfers by Tenant and subject to Section 24.26 regarding transfer of Landlord’s interest, all of the provisions of this Lease shall bind and inure to the benefit of the parties hereto and their respective heirs, legal representatives, successors and assigns. Except for Landlord’s employees and agents (including without limitation any property manager or property management firm engaged by Landlord with respect to the Premises), each of whom shall be entitled to the benefits of and shall be third party beneficiaries of the provisions of Articles 12 and 13. no third person shall be entitled to enforce or be entitled to any rights hereunder or be a third party beneficiary of any term or provision this Lease.
 
24.6  Brokers . Landlord and Tenant warrant to each other that they have had no dealings with any real estate broker or agent in connection with the negotiation of this transaction except only the broker(s) set forth in Section 1.11 of the Basic Lease Provisions, and they know of no other real estate broker or agent who is entitled to a commission in connection with this transaction. Landlord and Tenant each agree to indemnify, protect. hold harmless and defend the other from and against any obligation or liability to pay any commission or compensation to any other party arising from the act or agreement of such first party. Tenant acknowledges that certain partners, affiliates or members of Landlord, or their respective officers, directors, shareholders, members or employees, may hold real estate sales person or broker licenses, and additionally may be employees of Asset Management Group and as such may have negotiated, or may have a financial Interest in, this transaction.
 
24.7  Construction . The headings and captions used in this Lease are for convenience only and are not a part of the terms and provisions of this Lease. In any provision relating to the conduct, acts or omissions of Tenant, the term “Tenant” shall Include Tenant, its subtenants and assigns and their respective agents, employees, contractors, and invitees, and any others using the Premises with Tenant’s express or implied permission.
 
24.8  Counterparts . This Lease may be executed In multiple copies, each of which shall be deemed an original, but all of which shall constitute one Lease binding on all parties after all parties have signed such a counterpart.
 
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24.9  Covenants and Conditions . Each provision to be performed by Tenant under this Lease shall be deemed to be both a covenant and a condition.
 
24.10  Entire Agreement . This Lease, together with any and all exhibits. schedules, riders and addenda attached or referred to herein, constitutes the entire agreement between the parties with respect to the subject matter hereof. There are no oral or written agreements or representations between the parties hereto affecting this Lease, and this Lease supersedes, cancels and merges any and all previous verbal or written negotiations, arrangements, representations, brochures, displays, models, photographs, renderings, floor plans, elevations, projections, estimates, agreements and understandings if any, made by or between Landlord and Tenant and their agents, with respect to the subject matter, and none thereof shall be used to Interpret, construe, supplement or contradict this Lease. This Lease and all amendments thereto is and shall be considered to be the only agreement between the parties hereto and their representatives and agents. There are no other representations or warranties between the parties, and all reliance with respect to representations is solely based upon the representations and agreements contained in this Lease.
 
24.11  Exhibits . Any and all exhibits, schedules, riders and addenda attached or referred to herein are hereby incorporated herein by reference.
 
24.12  Financial Statements . Within ten (10) days after written request from Landlord, but no more often than once per six (6) months, Tenant shall deliver to Landlord such financial statements as are reasonably requested by Landlord to verify the net worth of Tenant, or any assignee, subtenant, or guarantor of Tenant. In addition, Tenant shall deliver to any proposed or actual lender or purchaser of the Premises designated by Landlord any financial statements required by such party to facilitate the sale, financing or refinancing of the Premises, including the past three (3) years’ financial statements. Tenant represents and warrants to Landlord that each such financial statement is a true and accurate statement as of the date of such statement. All such financial statements shall be received in confidence and shall be used only for the purposes set forth herein.
 
24.13  Force Majeure . If Landlord or Tenant is delayed in or prevented from the performance of any act required under this Lease by reason of strikes, lock-outs, labor troubles, inability to procure standard materials, failure of power, restrictive governmental laws, regulations or orders, governmental action or inaction (including failure, refusal or delay in issuing permits, approvals and/or authorizations), riots, civil unrest or insurrection, war, terrorism, bioterrorism, fire, earthquake, flood or other natural disaster, unusual and unforeseeable delay that results from an interruption of any public utilities, or other unusual and unforeseeable delay not within the reasonable control of such party, then performance of such act will be excused for the period of the delay and the period for the performance of any such act will be extended for a period equivalent to the period of such delay: provided that Force Majeure shall not excuse any monetary obligation of Tenant hereunder, including, without limitation, the obligation to pay rent.
 
24.14  Governing Law . This Lease shall be governed, construed and enforced In accordance with the laws of the State of California.
 
24.15  Joint and Several Liability . If more than one person or entity executes this Lease as Tenant, each of them is jointly and severally liable for all of the obligations of Tenant hereunder.
 
24.16  Modification . The provisions of this Lease may not be modified or amended, except by a written instrument signed by all parties.
 
24.17  Modification for Lender . If, in connection with obtaining financing or refinancing for the Premises or the Center, Landlord’s lender requests reasonable modifications to this Lease, Tenant will not unreasonably withhold or delay its consent hereto, provided that such modifications do not increase the obligations of Tenant hereunder or materially and adversely affect Tenant’s rights hereunder.
 
24.18  Nondiscrimination . Tenant for itself and its officers, directors, shareholders, partners, members, principals, employees, agents, representatives, and other related entitles and individuals, and their respective successors and assigns, agrees to comply fully with any and all laws and other requirements prohibiting discrimination against any person or group of persons on account of race, color, religion, creed, sex, marital status,
 
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sexual orientation, national origin, ancestry, age, physical handicap or medical condition, in the use occupancy or patronage of the Premises and/or of Tenant’s business. The indemnification provisions of Article 13 shall apply to a breach of this section.
 
24.19  Notice . Any and all notices to either party shall be personally delivered, sent by recognized courier service (such as Federal Express or United Parcel Service), or sent by certified mail, return receipt requested, postage prepaid, addressed to the party to be notified at the address specified in Section 1.1, or at such other address as such party may from time to time designate in writing. Notice shall be deemed delivered on the date of personal delivery, on the date scheduled for delivery by such courier service. or three (3) business days after deposit in the U.S. Mail, certified, return receipt requested. Provided, however, that any notice required pursuant to California Code of Civil Procedure Sections 1161  et seq . may be given as provided in such sections. Any and all notices provided herein that Landlord may give setting forth or alleging any default or breach of this Lease, or of any failure of Tenant to perform its obligations hereunder shall be deemed to satisfy, and shall not be in addition to, any and all legal notices required prior to the commencement of an unlawful detainer action, Including without limitation the notices required pursuant to California Code of Civil Procedure Sections 1161  et seq .
 
24.20  Partial Invalidity . If any provision of this Lease is determined by a court of competent jurisdiction to be invalid or unenforceable, the remainder of this Lease shall not be affected thereby. Each provision shall be valid and enforceable to the fullest extent permitted by law.
 
24.21  Quiet Enjoyment . Landlord agrees that Tenant, upon paying the rent and performing the terms, covenants and conditions of this Lease, may quietly have the right to use and occupy the Premises as against Landlord during the Lease Term, subject, however, to the lien and provisions of any mortgage or deed of trust to which this Lease is or becomes subordinate.
 
24.22  Recording; Non-Disclosure . Tenant shall not record this Lease or any memorandum hereof without Landlord’s prior written consent. Tenant shall not, without the express written consent of Landlord, disclose the terms or provisions of this Lease to any person, except for Tenant’s employees, agents, attorneys, officers and directors whose duties require such persons to be informed of such matters, or except as required by law.
 
24.23  Relationship of the Parties . Nothing contained in this Lease shall be deemed or construed as creating a partnership, joint venture, principal-agent, or employer-employee relationship between Landlord and any other person or entity (including, without limitation, Tenant) or as causing Landlord to be responsible in any way for the debts or obligations of such other person or entity.
 
24.24  Intentionally Omitted .
 
24.25  Time of the Essence . Time is of the essence of each and every provision of this Lease.
 
24.26  Transfer of Landlord’s Interest . In the event of a sale, assignment, exchange or other disposition of Landlord’s interest in the Premises, other than a transfer for security purposes only, Landlord shall be relieved of all obligations and liabilities accruing hereunder after the effective date of said sale, assignment, exchange or other disposition, provided that any Security Deposit or other funds then held by Landlord In which Tenant has an interest are delivered to Landlord’s successor. The obligations to be performed by Landlord hereunder shall be binding on Landlord’s successors and assigns only during their respective periods of ownership.
 
24.27  Waiver . No provision of this Lease or the breach thereof shall be deemed waived, except by written consent of the party to be charged with such waiver. A waiver of any such breath shall not be deemed a waiver of any preceding or succeeding breach of the same or any other provision. No delay or omission by Landlord or Tenant in exercising any of its remedies shall impair or be construed as a waiver thereof, unless such waiver is expressly set forth in a writing signed by the waiving party. The subsequent acceptance of rent hereunder by Landlord shall not be deemed to be a waiver of any previous breach by Tenant, other than the failure of Tenant to pay the particular rental so accepted, regardless of Landlord’s knowledge of such previous breath at the time of acceptance of such rent.
 
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24.28  OFAC Certification . Tenant hereby certifies, warrants, represents and covenants to and for the benefit of Landlord as follows: (a) to Tenant’s actual knowledge, Tenant and each of its subsidiaries, predecessors, agents, direct and indirect owners and their respective affiliates has at all applicable times been, is now and will in the future be, in compliance with U.S. Executive Order 13224 and no action, proceeding, investigation, charge, claim, report or notice has been filed, commenced or threatened against any of them alleging any failure to so comply; (b) to Tenant’s actual knowledge, neither Tenant nor any Guarantor or any of their respective agents, subsidiaries or other affiliates has, after due investigation and inquiry, knowledge or notice of any fact, event, circumstance, situation or condition which could reasonably be expected to result in any action, proceeding, investigation, charge, claim, report or notice being filed, commenced or threatened against any of them alleging any failure to comply with the Order, or the imposition of any civil or criminal penalty against any of them for any failure to so comply; and (c) Tenant hereby agrees to defend, indemnify, and hold harmless Landlord from and against any and all claims, damages, losses, risks, liabilities, and expenses (including attorney’s fees and costs) arising from or related to any breath of the foregoing certification.
 
24.29  Tenant Improvements . Notwithstanding anything in this Lease to the contrary, promptly after the full execution and delivery of this Lease and prior to the Commencement Date, Landlord shall, at Landlord’s sole cost and expense, cause the following improvements (“Tenant Improvements’) to be completed (i) new carpet installed in that portion of the Premises designated for office use, (ii) repair, strip, wax and seal the vinyl composition tile in that portion of the Premises designated for laboratory use, (iii) lower the laboratory bench in Suite 20 to Tenant’s specifications, (iv) remove a wall in Suite 20 to create a conference room therein, and (v) paint and perform general cleaning of the Premises. Landlord warrants that, as of Landlord’s delivery of the Premises to Tenant, the Tenant Improvements shall be in compliance with all Legal Requirements as of the issuance of the building permits therefor, and Landlord shall, at its sole cost and expense and as Tenant’s sole remedy, correct any breach of such warranty promptly following receipt of written notice thereof from Tenant.
 
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THE SUBMISSION OF THIS LEASE FOR EXAMINATION AND/OR SIGNATURE BY TENANT IS NOT A COMMITMENT BY LANDLORD OR ITS AGENTS TO RESERVE THE PREMISES OR TO LEASE THE PREMISES TO TENANT. THIS LEASE SHALL BECOME EFFECTIVE AND LEGALLY BINDING ONLY UPON FULL EXECUTION AND DELIVERY BY BOTH LANDLORD AND TENANT. UNTIL LANDLORD DELIVERS A FULLY EXECUTED COUNTERPART HEREOF TO TENANT, LANDLORD HAS THE RIGHT TO OFFER AND TO LEASE THE PREMISES TO ANY OTHER PERSON TO THE EXCLUSION OF TENANT.
 
EXECUTED , by Landlord and Tenant as of the date first written above.
 
LANDLORD:
 
   
Sorrento Square, a California limited partnership
 
     
By:
 
CDC Financial Investors GP I, LLC,
 
   
a Delaware limited liability company
 
       
   
By:
 
CDC Financial Investors, LLC,
 
       
a Delaware limited liability company, Its Manager
 
         
       
By:
     
         
       
Its:
     
         
       
By:
     
         
       
Its:
     
 
       
TENANT:
 
   
MabVax Therapeutics, Inc., a Delaware corporation
 
     
By:
     
     
Title:
     
 
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EXHIBIT “A”
SITE/FLOOR PLAN OF PREMISES/
DESCRIPTION OF CENTER
 
     
 
         
         
   
Initial
   
 
EXHIBIT “A”
 
 
 

 
 
EXHIBIT “B”
RULES AND REGULATIONS
 
The following Rules and Regulations shall apply to the Center. Tenant agrees to comply with the same and to require its agents, employees, contractors, customers and invitees to comply with the same. Landlord shall have the right from time to time to amend or supplement these Rules and Regulations, and Tenant agrees to comply, and to require its agents, employees, contractors, customers and invitees to comply, with such amended or supplemented Rules and Regulations, provided that (a) notice of such amended or supplemental Rules and Regulations is given to Tenant, and (b) such amended or supplemental Rules and Regulations apply uniformly to all tenants of the Center. If Tenant or its subtenants, employees, agents, or invitees violate any of these Rules and Regulations, resulting in any damage to the Center or increased costs of maintenance of the Center, or causing Landlord to incur expenses to enforce the Rules and Regulations, Tenant shall pay all such costs to Landlord. In the event of any conflict between the Lease and these or any amended or supplemental Rules and Regulations, the provisions of the Lease shall control.
 
1.
Tenant shall be responsible at its sole cost for the removal of all of Tenant’s refuse or rubbish. All garbage and refuse shall be disposed of outside of the Premises, shall be placed in the kind of container specified by Landlord, and shall be prepared for collection in the manner and at the times and places specified by Landlord. If Landlord provides or designates a service for picking up refuse and garbage, Tenant shall use the same at Tenant’s sole cost. Tenant shall not bum any trash or garbage of any kind in or about the Premises. If Landlord supplies janitorial services to the Premises, Tenant shall not, without Landlord’s prior written consent, employ any person or persons other than Landlord’s janitorial service to clean the Premises.
 
2.
No aerial, satellite dish, transceiver, or other electronic communication equipment shall be erected on the roof or exterior walls of the Premises, or in any other part of the Center, without Landlord’s prior written consent. Any aerial, satellite dish, transceiver, or other electronic communication equipment so installed without Landlord’s prior written consent shall be subject to removal by Landlord without notice at any time and without liability to Landlord.
 
3.
No loudspeakers, televisions, phonographs, radios, or other devices shall be used in a manner so as to be heard or seen outside of the Premises without Landlord’s prior written consent. Tenant shall conduct its business in a quiet and orderly manner so as not to create unnecessary or unreasonable noise. Tenant shall not cause or permit any obnoxious or foul odors that disturb the public or other occupants of the Center. If Tenant operates any machinery or mechanical equipment that causes noise or vibration that is transmitted to the structure of the Building, or to other parts of the Center, to such a degree as to be objectionable to Landlord or to any other occupant of the Center, Tenant shall install and maintain, at Tenant’s expense, such vibration eliminators or other devices sufficient to eliminate the objectionable noise or vibration.
 
4.
Tenant shall keep the outside areas immediately adjoining the Premises clean and free from dirt, rubbish, pallets and other debris to the satisfaction of Landlord. If Tenant fails to cause such outside areas to be maintained as required within twelve (12) hours after verbal notice that the same do not so comply, Tenant shall pay a fee equal to the greater of Fifty Dollars ($50.00) or the costs incurred by Landlord to clean up such outside areas.
 
5.
Tenant shall not store any merchandise, inventory, equipment, supplies, finished or semi-finished products, raw materials, or other articles of any nature outside the Premises (or the building constructed thereon if the Premises includes any outside areas) without Landlord’s prior written consent.
 
6.
Tenant and Tenant’s subtenants, employees, agents, or invitees shall park only the number of cars allowed under the Lease and only in those portions of the parking area designated for that purpose by Landlord. Upon request by Landlord, Tenant shall provide the license plate numbers of the cars of Tenant and Tenant’s employees in order to facilitate enforcement of this regulation. Tenant and Tenant’s employees shall not store vehicles or equipment in the parking areas, or park in such a manner as to block any of the accessways serving the Center and its occupants.
 
EXHIBIT “B”
 
 
 

 
 
7.
The Premises shall not be used for lodging, sleeping, cooking, or for any immoral or illegal purposes, or for any purpose that will damage the Premises or the reputation thereof. Landlord reserves the right to expel from the Center any person who is intoxicated or under the influence of liquor or drugs or who shall act in violation of any of these Rules and Regulations. Tenant shall not conduct or permit any sale by auction on the Premises. No video, pinball, or similar electronic game machines of any description shall be installed, maintained or operated upon the Premises without the prior written consent of Landlord.
 
8.
Neither Tenant nor Tenant’s employees or agents shall disturb, solicit, or canvas any occupant of the Center, and Tenant shall take reasonable steps to discourage others from doing the same.
 
9.
Tenant shall not keep in, or allow to be brought into, the Premises or Center any pet, bird or other animal, other than “seeing-eye” dogs or other animals under the control of and specifically assisting any disabled person.
 
10.
The plumbing facilities shall not be used for any other purpose than that for which they are constructed, and no foreign substance of any kind shall be disposed of therein. The expense of any breakage, stoppage, or damage resulting from a violation of this provision shall be borne by Tenant. Tenant shall not waste or use any excessive or unusual amount of water.
 
11.
Tenant shall use, at Tenant’s cost, such pest extermination contractor as Landlord may direct and at such intervals as Landlord may require.
 
12.
Tenant will protect the carpeting from undue wear by providing carpet protectors under chairs with casters, and by providing protective covering in carpeted areas where spillage or excessive wear may occur.
 
13.
Tenant shall be responsible for repair of any damage caused by the moving of freight, furniture or other objects into, within, or out of the Premises or the Center. No heavy objects (such as safes, furniture, equipment, freight, etc.) shall be placed upon any floor without Landlord’s prior written approval as to the adequacy of the allowable floor loading at the point where the objects are intended to be moved or stored. Landlord may specify the time of moving to minimize any inconvenience to other occupants of the Center. If the Building is equipped with a freight elevator, all deliveries to and from the Premises shall be made using the freight elevator during the time periods specified by Landlord, subject to such reasonable scheduling as Landlord in its discretion shall deem appropriate.
 
14.
Without Landlord’s prior written consent, no drapes or sunscreens of any nature shall be installed in the Premises and the sash doors, sashes, windows, glass doors, lights and skylights that reflect or admit light into the building shall not be covered or obstructed. Landlord shall have the right to specify the type of window coverings that may be installed, at Tenant’s expense. Tenant shall not mark, drive nails, screw or drill into, paint, or in any way deface any surface or part of the building. Notwithstanding the foregoing, Tenant may hang pictures, blackboards, or similar objects, provided Tenant repairs and repaints any nail or screw holes, and otherwise returns the premises to the condition required under the Lease and the expiration or earlier termination of the Lease Term. The expense of repairing any breakage, stoppage, or damage resulting from a violation of this rule shall be borne by Tenant.
 
15.
No electrical wiring, electrical apparatus, or additional electrical outlets shall be installed in the Premises without Landlord’s prior written approval. Any such installation not so approved by Landlord may be removed by Landlord at Tenant’s expense. Tenant may not alter any existing electrical outlets or overburden them beyond their designed capacity. Landlord reserves the right to enter the Premises, with reasonable notice to Tenant, for the purpose of installing additional electrical wiring and other utilities for the benefit of Tenant or adjoining tenants. Landlord will direct electricians as to where and how telephone and affixed wires are to be installed in the Premises. The location of telephones, call boxes, and other equipment affixed to the Premises shall be subject to the prior written approval of Landlord.
 
16.
If Tenant’s use of the Premises involves the sale and/or preparation of food, Tenant shall at all times maintain a health department rating of “A” (or such other highest health department or similar rating as is available). Any failure by Tenant to maintain such “A” rating twice in any twelve (12) month period shall, at the election of Landlord, constitute a noncurable Event of Default under the Lease.
 
EXHIBIT “B”
 
 
 

 
 
17.
Tenant shall comply with all safety, fire protection and evacuation procedures and regulations established by Landlord or any governmental agency.
 
18.
Tenant assumes any and all responsibility for protecting its Premises from theft, robbery and pilferage, which includes keeping doors locked and other means of entry to the Premises closed.
 
19.
If Tenant occupies any air-conditioned space, Tenant shall keep entry doors opening onto corridors, lobby or courtyard closed at all times. All truck and loading doors shall be closed at all times when not in use.
 
20.
Tenant shall rot paint any floor of the Premises without Landlord’s prior written consent. Prior to surrendering the Premises upon expiration or termination of the Lease, Tenant shall remove any paint or sealer therefrom (whether or not previously permitted by Landlord) and restore the floor to its original condition as of the Commencement Date, reasonable wear and tear excepted. Tenant shall not affix any floor covering to the floor of the Premises in any manner except as approved by Landlord.
 
         
         
   
Tenant’s Initials
   
 
EXHIBIT “B”
 
 
 

 
 
EXHIBIT “C”
 
SIGN CRITERIA
 
All proposed signs must be submitted to the Property Manager for approval prior to installation. For information regarding the signage, please contact:
 
Jelita Mayville
Property Manager
Asset Management Group
11750 Sorrento Valley Road
San Diego, CA 92121
(858) 481-7767
     
         
   
Tenant’s Initials
   
 
EXHIBIT “C”
Exhibit 10.3
 
FIRST AMENDMENT TO STANDARD INDUSTRIAL NET LEASE
 
This Amendment, dated May 6, 2010 for reference purposes only, is made to that Standard Industrial Net Lease by and between SORRENTO SQUARE, a California limited partnership (“Landlord”) and MABVAX THERAPEUTICS, Inc., a Delaware corporation (“Tenant”), with reference to the following facts:
 
RECITALS
 
 
A.
Landlord and Tenant have heretofore entered into that certain Standard Industrial Net Lease dated May 23, 2008, (the “Lease”) for the lease of the premises described as Suites 19A & 20 located at 11588 Sorrento Valley Road, San Diego, California, 92121 containing approximately 3,595 Rentable Square Feet.
 
 
B.
The Lease currently expires July 31, 2010. Landlord and Tenant desire to provide for Tenant to surrender a 1,095 Rentable Square Foot portion of the Premises described as Suites 19A after the Expiration of the current Lease and expand the Premises to add Suite 21, containing approximately 2,440 Rentable Square Feet. As of August 1, 2010, the Premises shall consist of 4,940 Rentable Square Feet.
 
 
C.
Landlord and Tenant further desire to modify the Minimum Monthly Rent, Tenants Pro Rata Share of Operating Costs and Parking Spaces, and Security Deposit to reflect the change in the Premises described in Recital B.
 
 
D.
Landlord and Tenant desire to amend the Lease on the terms and conditions set forth herein.
 
 
E.
Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Lease.
 
AMENDMENT
 
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and for other valuable consideration, the receipt and sufficiency of this is hereby acknowledged, the Lease is hereby amended as follows:
 
1. Revision and Expansion of Premises . Commencing on August 1, 2010, (the “Expansion Date”), Tenant shall surrender the Premises described as Suite 19A, containing approximately 1,095 Rentable Square Feet in the condition required for surrender under Section 20 of the Lease and the Premises shall be expanded to include Suite 21 of the Building (The “Expansion Premises”), which contains approximately 2,440 Rentable Square Feet. As of August 1, 2010, Tenant’s leased Premises shall consist of Suites 20 & 21, approximately 4,940 Rentable Square Feet. Attached hereto as Exhibit “A” is a depiction of the Premises, as so contracted by this Amendment, which Exhibit “A” shall be substituted for the Exhibit “A” attached to the Lease.
 
2. Extension of Term . The Lease Term is hereby extended to, and the revised Expiration Date under Section 1.4 of the Lease shall be, July 31, 2015.
 
3. Minimum Monthly Rent (Section 1.5):  Minimum Monthly Rent shall be as follows:
 
         
08/01/2010 — 07/31/2011:
  $    
8,151.00 per month
08/01/2011 — 07/31/2012:
  $    
8,398.00 per month
08/01/2012 — 07/31/2013:
  $    
8,645.00 per month
08/01/2013 — 07/31/2014:
  $    
8,892.00 per month
08/01/2014 — 07/31/2015:
  $    
9,139.00 per month
 
 
 

 
 
Mabvax Therapeutics, Inc.
First Amendment to Standard Industrial Net Lease
Page 2 of 6
 
4. Adjustments to the Security Deposit, Tenant’s Percentage of Operating Costs, and Tenant’s Parking Spaces.
 
(a) Landlord currently holds a Security Deposit of $8,268.50. Upon execution of this Amendment, Tenant shall increase its Security Deposit with Landlord by $870.50 to $9,139.00.
 
(b) As of August 1, 2010, Tenant’s Percentage of Operating Costs (Section 1.7) shall be 6.16%.
 
(c) As of August 1, 2010, Tenant’s Parking Spaces (Section 1.10) shall be increased to fifteen (15) spaces.
 
5. Tenant Improvements.  Landlord hereby agrees to construct the following Tenant Improvements, as illustrated in Exhibit “D.” All improvements shall be completed at Landlord’s sole cost and expense.
 
(a) Add/remove walls in office areas per the mutually acceptable plan,
 
(b) Apply reflective film to glass exterior entry door to Suite 21,
 
(c) Replace carpet in Suite 21 to match Suite 20,
 
(d) Patch, repair, and paint walls throughout the office areas,
 
(e) Replace flooring and fixtures in Suite 21 restrooms as necessary and provide two new insta-hot water heaters,
 
(f) Repair ceiling grid, tiles, and light fixtures as necessary,
 
(g) Remove and relocate data cabling in Suite 21 as necessary,
 
(h) Relocate security alarm devices and motion sensors in Suite 21 as necessary,
 
(i) Cut 6’ 0” x 7’ 0” opening between Suite 20 and Suite 21 lab area,
 
(j) Demo casework, sink, plumbing, and electrical in Suite 21 lab and add a new wall to create a storage area and meeting room, including relocation of existing door with cypher lock, and installing new carpet to storage area and meeting room,
 
(k) Provide new ceiling grid to conceal exposed ductwork and data cabling,
 
(l) Install new sink in Suite 21 lab with plumbing connections to Suite 20,
 
(m) Install an insta-hot water heater for Suite 20 lab sink,
 
(n) Complete flooring and ceiling repairs as necessary and patch, repair, and repaint walls throughout Suite 21 lab and warehouse areas,
 
(o) Relocate lab bench from Suite 20 to Suite 21 where opening between suites will be created.
 
(p) Provide final clean upon completion of all improvements listed above.
 
 
 

 
 
Mabvax Therapeutics, Inc.
First Amendment to Standard Industrial Net Lease
Page 3 of 6
 
Any additional improvements or changes to the above improvements shall be completed only upon Landlord’s approval and solely at Tenant’s cost and expense. Upon completion of Tenant Improvements, a new Exhibit “D” will be incorporated into the lease to reflect the changes made to the Premises. Tenant shall accept the remainder of the Premises in its current state and condition.
 
6. Early Termination Right.  Provided that at the time Tenant exercises any right under this section no uncured Event of Default exists, nor any condition exists that with the passage of time or the giving of notice or both would constitute an Event of Default under the Lease, Tenant shall have the right to terminate this Lease prior to its scheduled expiration by giving Landlord at least six months’ prior written notice of such termination (which notice must be given, for example, no later than January 31, 2013 in order to effect a termination on July 31, 2013). If Tenant exercises its right under this Section to terminate the Lease early, Tenant shall pay to Landlord an Early Termination Penalty, which Tenant must submit to Landlord at the time such notice is given, pursuant to following schedule:
 
(a) Tenant may exercise its right under this Section to terminate the Lease effective August 31, 2013 by providing Landlord with an Early Termination Penalty of $17,784.00,
 
(b) Tenant may exercise its right under this Section to terminate the Lease effective February 28, 2014 by providing Landlord with an Early Termination Penalty of $13,338.00,
 
(c) Tenant may exercise its right under this Section to terminate the Lease effective August 31, 2014 by providing Landlord with an Early Termination Penalty of $9,139.00,
 
(d) Tenant may exercise its right under this Section to terminate the Lease effective February 28, 2015 by providing Landlord with an Early Termination Penalty of $4,569.50,
 
(e) If Tenant relocates into another property where Collins Development Company is general partner, then Landlord shall waive the Early Termination Penalty.
 
7. Right of First Offer on Adjacent Space.  Provided that, at the time Tenant is entitled to any benefit under this Section, there exists no Event of Default on the part of Tenant under this Lease nor any condition that with the giving of notice or the passage of time or both would constitute an Event of Default on the part of Tenant under this Lease, Landlord agrees that it will offer to lease the space known as Suite 19 of the Building (the “Additional Space”) to Tenant prior to offering the Additional Space to any other entity. Tenant shall have five (5) business days after receipt of such offer to accept or reject the same. Tenant’s failure to accept Landlord’s offer in writing unconditionally and without change within such 5-day period shall constitute a rejection of such offer, and Landlord shall be free to lease the Additional Space to any third party entity on terms and conditions acceptable to Landlord, for a period of ninety (90) days from the date of such offer. The rental rate and term of occupancy applicable to the Additional Space shall be as determined by Landlord in its sole discretion.
 
8. Brokerage Commissions.  Tenant warrants that, except for Phase 3 Properties, it has had no dealings with any real estate broker or agent in connection with the negotiation of this transaction who is entitled to a commission. Tenant agrees to indemnify, protect, hold harmless and defend Landlord from and against any obligation or liability to pay any commission or compensation to any other party arising from the act or agreement of Tenant.
 
9. No Other Change.  Except as otherwise expressly set forth in this Amendment, all of the terms and conditions of the Lease remain unchanged and in full force and effect.
 
 
 

 
 
Mabvax Therapeutics, Inc.
First Amendment to Standard Industrial Net Lease
Page 4 of 6
 
IN WITNESS WHEREOF, this First Amendment to Standard Industrial Net Lease is executed as of the date first above written.
 
LANDLORD:
 
   
Sorrento Square, a California limited partnership
 
     
By:
 
CDC Financial Investors GP I, LLC,
a Delaware limited liability company
 
       
   
By:
 
CDC Financial Investors, LLC,
 
       
a Delaware limited liability company, its Manager
 
       
   
By:
 
Collins Development Company, Inc.,
 
       
a California S corporation, its Manager
 
         
       
By:
     
         
       
Its:
     
         
       
By:
     
         
       
Its:
     
   
TENANT:
 
   
MABVAX THERAPEUTICS, INC., a Delaware corporation
 
     
By:
     
     
Its:
     
 
 
 

 
 
EXHIBIT “A”
TENANT IMPROVEMENTS
(Mabvax Therapeutics, Inc. —11588 Sorrento Valley Road)
 
 
 
 

 
 
EXHIBIT “D”
TENANT IMPROVEMENTS
(Mabvax Therapeutics, Inc. – 11588 Sorrento Valley Road)
 
 

Exhibit 10.4
 
SECOND AMENDMENT TO STANDARD INDUSTRIAL NET LEASE
 
This Second Amendment (“ Second Amendment ”), dated AUGUST 1, 2012, is made to that Standard Industrial Net Lease by and between SORRENTO SQUARE, a California limited partnership (“ Landlord ”) and MABVAX THERAPEUTICS, INC., a Delaware corporation (“ Tenant ”), with reference to the following facts:
 
RECITALS
 
 
A.
Landlord and Tenant entered into that certain Standard Industrial Net Lease dated May 23, 2008, as amended by that certain First Amendment to Standard Industrial Net Lease dated May 6, 2010 (the “ Lease ”) for the premises described as Suites 20 and 21, containing 4,940 rentable square feet (the “ Premises ”), located at 11588 Sorrento Valley Road, San Diego, California, 92121 (the “ Building ”).
 
 
B.
By this Second Amendment, Landlord and Tenant desire to expand the Premises to add Suite 19A, containing approximately 1,015 rentable square feet, located at 11588 Sorrento Valley Road, San Diego, California, 92121, and to otherwise modify the Lease as provided herein.
 
 
C.
Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Lease.
 
AMENDMENT
 
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and for other valuable consideration, the receipt and sufficiency of this is hereby acknowledged, the Lease is hereby amended as follows:
 
1.  Revision and Expansion of Premises (Section 1.2) .
 
(a) Commencing on January 1, 2013, (the “ Expansion Date ”), the Premises demised by the Lease shall be expanded to include Suite 19A of the Building (the “Expansion Premises”).
 
(b) On and after the Expansion Date, all references in the Lease and this Amendment to the “Premises” shall be a collective reference to the initial premises lease and the Expansion Premises. As a result of such expansion, on and after January 1, 2013, the Premises will encompass Suites 19A, 20 & 21 of the Building, and will contain approximately 5,955 Rentable Square Feet.
 
(c) Attached hereto as Exhibit “A” is a depiction of the Premises, as so expanded by this Amendment, which Exhibit “A” shall be substituted for the Exhibit “A” attached to the Lease.
 
(d) Tenant shall accept the Expansion Premises in its current state of repair and level of improvements. By taking possession of the Expansion Premises, Tenant acknowledges that it has examined the Expansion Premises and accepts the condition thereof and that Landlord shall not be obligated to provide or pay for any other work or services related to the improvement of the Premises. Tenant also acknowledges that Landlord has made no representation or warranty regarding the condition of the Premises. All of the terms and conditions of Article 12 of the Lease shall be deemed to apply to the Expansion Premises as of August 1, 2012.
 
2.  Minimum Monthly Rent (Section 1.5) : Tenant shall pay to Landlord Minimum Monthly Rent for the Premises during the Extended Term in accordance with the schedule and in the amount set forth below:
 
 
Lease Term
 
Rent for Suite 19A
 
Rent for Suite 20 & 21
(per existing lease)
 
Total
01/01/13-07/31/13
  $    
1,776.25 per month
  $    
8,645.00 per month
  $    
10,421.25 per month
08/01/13-07/31/14
  $    
1,827.00 per month
  $    
8,892.00 per month
  $    
10,719.00 per month
08/01/14-07/31/15
  $    
1,877.75 per month
  $    
9,139.00 per month
  $    
11,016.75 per month
 
 
 

 
 
3.  Coordinating Changes to the Lease .
 
(a) Security Deposit (Section 1.6). Landlord currently holds a Security Deposit in the amount of $9,139.00. Upon execution of this amendment, Tenant shall provide an additional amount of $1,877.75 so that the total Security Deposit held by Landlord shall be $11,016.75.
 
(b) Pro Rata Share. As of the Expansion Date, Tenant’s Pro Rata Share (Section 1.7) shall be  7.40 %.
 
(c) Parking Spaces. As of the Expansion Date, Tenant’s parking spaces (Section 1.10) shall be  eighteen (18)  spaces.
 
4.  Brokers . Each party represents and warrants to the other that no broker, agent or finder negotiated or was instrumental in negotiating or consummating this Second Amendment. Each party further agrees to defend, indemnify and hold harmless the other party from and against any claim for commission or finder’s fee by any person or entity who claims or alleges that they were retained or engaged by the indemnifying party or at the request of such party in connection with this Second Amendment.
 
5.  No Other Change . Except as otherwise expressly set forth in this Amendment, all of the terms and conditions of the Lease remain unchanged and in full force and effect.
 
 
 

 
 
IN WITNESS WHEREOF, this Second Amendment to Standard Industrial Net Lease is executed as of the date first above written.
 
LANDLORD:
 
   
SORRENTO SQUARE, a California limited partnership
 
     
By:
 
CDC Financial Investors GP I, LLC,
a Delaware limited liability company
 
       
   
By:
 
CDC Financial Investors, LLC,
 
       
a Delaware limited liability company, its Manager
 
       
   
By:
 
Collins Development Company, Inc.,
 
       
a California S corporation, its Manager
 
         
       
By:
     
         
       
Its:
     
         
       
By:
     
         
       
Its:
     
   
TENANT:
 
   
MABVAX THERAPEUTICS, INC., a Delaware corporation
 
     
By:
     
     
Its:
     
 
 
 

 
 
EXHIBIT “A”
SITE PLAN OF PREMISES
(Mabvax Therapeutics, Inc.-11588 Sorrento Valley Road)
 
     
 
 
 
 
 
 
 
 
 
 
Exhibit 10.5
 
EMPLOYMENT AGREEMENT
 
This Employment Agreement (“ Agreement ”) is made as of July, 21 2014, between MabVax Therapeutics, Inc. (the “ Company ”), and Paul Maffuid, Ph.D. (the “ Executive ”).
 
WHEREAS, the Company desires to employ the Executive and the Executive desires to be employed by the Company on the terms contained in this Agreement.
 
NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:
 
 
1.
Position and Duties .
 
(a) The Executive shall serve as the Company’s Vice President of Pharmaceutical Development and Operations, reporting to the Company’s President and Chief Executive Officer (collectively, “CEO”).
 
(b) The Executive shall perform those services customary to this office and such other lawful duties that the CEO may be reasonably assign to him. The Executive shall devote all of his business time and best efforts to the performance of his duties under this Agreement and shall be subject to, and shall comply with the Company policies, practices and procedures and all codes of ethics or business conduct applicable to his position, as in effect from time to time. Notwithstanding the foregoing, the Executive shall be entitled to (i) serve as a member of the board of directors of a reasonable number of companies, subject to the advance approval of the CEO, which approval shall not be unreasonably withheld, (ii) serve on civic, charitable, educational, religious, public interest or public service boards, subject to the advance approval of the CEO, which approval shall not be unreasonably withheld, and (iii) manage the Executive’s personal and family investments, in each case, to the extent such activities do not materially interfere, as determined by the CEO in good faith, with the performance of the Executive’s duties and responsibilities hereunder.
 
2.  Term . This Agreement and the Executive’s employment pursuant to this Agreement shall be for a term of three (3) years commencing as of July 21, 2014 (the “Effective Date”) and ending on the third anniversary of the Effective Date (the “Expiration Date”), unless terminated earlier by the Company or the Executive pursuant to Section 4 of this Agreement (the “Term”). In the event either party wishes to renew or extend this Agreement upon the Expiration Date, such party shall notify the other in writing at least 60 days prior to the Expiration Date.
 
 
3.
Compensation and Related Matters .
 
(a)  Base Salary . During the Term, the Executive’s annual base salary shall be $225,000 (the “Base Salary”). The Base Salary shall be payable in accordance with the Company’s normal payroll procedures in effect from time to time and may be increased, but not decreased, at the discretion of the Company.
 
(b)  Annual Bonus . During the Term, the Executive shall be entitled to receive a bonus (the “Annual Bonus”) for each calendar year, payable in cash in accordance with, and subject to the terms and conditions of, the Company’s then applicable short-term bonus or other cash incentive program (each, a “Bonus Program”). The Executive’s aggregate target bonus award for each calendar year will be 75% of his then Base Salary (the “Target Annual Bonus”). The Executive’s actual Annual Bonus may range from a minimum amount of 0% to a maximum of 75% of his Target Annual Bonus, which will be determined by the Company and will be contingent upon the attainment of performance goals reasonably established in good faith by the Company based upon the recommendations of the Executive no later than 90 days after the commencement of each calendar year. Any Annual Bonus compensation payable to the Executive shall be payable by March 15 of the calendar year following the calendar year to which such Annual Bonus relates, subject to the condition that the Executive remain employed by the Company through the date the Annual Bonus is paid, except as set forth in Section 6 herein.
 
 
 

 
 
(c)  Equity . In consideration for his employment and subject to the approval of the Board, the Company will recommend to its current Board that the Executive be granted a stock option to purchase up to 50,000 shares of Company’s common stock (the “Shares”) pursuant to the Company’s 2014 Employee, Director and Consultant Equity Incentive Plan (the “Plan”). Subject to the approval of the Board, the Shares will be granted pursuant to a form of option agreement previously approved by the Board.
 
(d)  Business Expenses . During the Term, the Executive shall be entitled to receive prompt reimbursement for all reasonable business expenses incurred by him in performing services hereunder, in accordance with the policies and procedures then in effect and established by the Company for its senior executive officers.
 
(e)  Other Benefits . During the Term and subject to any contribution therefor required of employees of the Company, the Executive shall be entitled to participate in all equity, pension, savings and retirement plans, welfare and insurance plans, practices, policies, programs and perquisites of employment applicable generally to other senior executives of the Company, except to the extent any employee benefit plan provides for benefits otherwise provided to the Executive hereunder (e.g., annual bonuses and severance). Such participation shall be subject to (i) requirements of applicable law, (ii) the terms of the applicable plan documents, (iii) generally applicable Company policies, and (iv) the discretion of the Board or any administrative or other committee provided for under or contemplated by such plan. The Executive shall have no recourse against the Company under this Agreement in the event that the Company should alter, modify, add to or eliminate any or all of its employee benefit plans.
 
(f)  Vacation; Holidays . During the Term, the Executive shall be entitled to take up to 30 days of paid time off per calendar year, to be taken in accordance with the policies applicable to senior executives of the Company generally. The Executive shall also be entitled to paid holidays in accordance with the policies applicable to senior executives of the Company generally.
 
4.  Termination . The Executive’s employment may be terminated prior to the expiration of the Term hereof and this Agreement may be terminated under the following circumstances:
 
(a)  Death . The Executive’s employment shall terminate upon his death.
 
(b)  Disability . The Company may terminate the Executive’s employment if the Executive becomes subject to a Disability. For purposes of this Agreement, “Disability” means the Executive is unable to perform the essential functions of his position, with or without a reasonable accommodation, for a period of 90 consecutive calendar days or 180 non-consecutive calendar days within any rolling 12 month period.
 
(c)  Termination by Company for Cause . The Company may terminate the Executive’s employment for Cause. For purposes of this Agreement, “Cause” means (i) the Executive’s conviction of a felony or a crime of moral turpitude; (ii) the Executive’s commission of unauthorized acts intended to result in the Executive’s personal enrichment at the material expense of the Company; or (iii) the Executive’s material violation of the Executive’s duties or responsibilities to the Company which constitute willful misconduct or dereliction of duty, provided as to any termination pursuant to subsection (iii), a majority of the members of the Board shall first approve such “Cause” termination before the Company effectuates such termination of employment.
 
(d)  Termination by the Company without Cause . The Company may terminate the Executive’s employment at any time without Cause upon 30 days prior written notice.
 
(e)  Termination by the Executive . The Executive may terminate his employment at any time for any reason other than a Good Reason, upon 30 days prior written notice.
 
(f)  Termination by the Executive for Good Reason . The Executive may terminate his employment for Good Reason. For purposes of this Agreement, “Good Reason” means the existence of any one or more of the following conditions without the Executive’s consent, provided Executive submit written notice to the CEO within 45 days such condition(s) first arose specifying the condition(s): (i) a material change in or reduction of
 
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the Executive’s authority, duties and responsibilities, or the assignment to the Executive of duties materially inconsistent with the Executive’s position with the Company; (ii) a material reduction in the Executive’s then current Base Salary or Target Annual Bonus opportunity; or (iii) the requirement that Executive relocate to an office location more than fifty (50) miles from the San Diego, California area. The Executive’s continued employment subsequent to an event that may constitute Good Reason shall not be deemed to be a waiver of his rights under this provision. Upon receipt of written notice from the Executive regarding a condition constituting Good Reason, the Company shall then have 30 days to correct the condition (the “Cure Period”). If such condition is not corrected by the last day of the Cure Period, the Executive’s resignation for Good Reason shall become effective on the 31st day following the written notice.
 
(g)  Termination in connection with a Change in Control . In the event of a Change in Control of the Company (as such term is defined in the Company’s 2014 Employee, Director and Consultant Equity Incentive Plan), for a period of sixty (60) days after the effective date of such Change in Control, Executive shall be entitled to resign employment with the Company. This subsection shall also prohibit the termination of Executive’s employment without Cause once the Company enters into a letter of intent relating to a transaction that would result in a Change in Control.
 
(h)  Expiration . Executive’s employment shall terminate on the Expiration Date unless renewed or extended pursuant to Section 2.
 
(i)  Termination Date . The “Termination Date” means: (i) if the Executive’s employment is terminated by his death under Section 4(a), the date of his death; (ii) if the Executive’s employment is terminated on account of his Disability under Section 4(b), the date on which the Company provides the Executive a written termination notice; (iii) if the Company terminates the Executive’s employment for Cause under Section 4(c), the date on which the Company provides the Executive a written termination notice; (iv) if the Company terminates the Executive’s employment without Cause under Section 4(d), 30 days after the date on which the Company provides the Executive a written termination notice; (v) if the Executive resigns his employment without Good Reason under Section 4(e), 30 days after the date on which the Executive provides the Company a written termination notice, (vii) if the Executive resigns his employment with Good Reason under Section 4(f), the 31st day following the day the Executive provides the Company with written notice of the conditions constituting same, if the Company has not cured such conditions by the 30th day; (viii) if the Executive provides the Company with written notice of his termination in connection with a Change in Control pursuant to Section 4(g), the 31 st  day following such written notice; and (ix) the Expiration Date if the Executive’s employment terminates under Section 4(h).
 
 
5.
Compensation upon Termination .
 
(a)  Termination by the Company for Cause or by the Executive without Good Reason . If the Executive’s employment with the Company is terminated pursuant to Sections 4(c) or (e), the Company shall pay or provide to the Executive the following amounts through the Termination Date: any earned but unpaid Base Salary, unpaid expense reimbursements, and any vested benefits the Executive may have under any employee benefit plan of the Company (the “Accrued Obligations”) on or before the time required by law but in no event more than 30 days after the Executive’s Termination Date.
 
(b)  Death . If, prior to the expiration of the Term, the Executive’s employment terminates because of his death as provided in Section 4(a), then the Executive’s authorized representative or estate shall be entitled to the following subject to Section 6:
 
(i)  Accrued Obligations . The Company shall pay the Accrued Obligations earned through the Termination Date (payable at the time provided for in Section 5(a)).
 
(ii)  Unpaid Annual Bonus . The Company shall pay the Annual Bonus awarded for the calendar year preceding the Termination Date that remains unpaid as of the Termination Date (payable at the time provided for in Section 3(b)).
 
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(iii)  Pro-Rata Bonus . The Company shall pay a pro-rata portion of the Executive’s Annual Bonus for the calendar year in which the Executive’s termination occurs based on the actual achievement of performance criteria for that year (determined by multiplying the amount of the Annual Bonus which would be due for the full calendar year by a fraction, the numerator of which is the number of days during the calendar year of termination that the Executive is employed by the Company and the denominator of which is 365) (the “Pro-Rata Bonus”) payable in accordance with Section 6.
 
(iv)  Vesting Acceleration . The Company shall vest in full the Executive on the Termination Date for any and all outstanding equity-incentive awards issued to the Executive and any options may be exercised by his authorized representative or estate for a period equal to the earlier of one year from and after the Termination Date and the original expiration date of each option as set forth in the respective grant agreements unless a longer period of time is set forth in the grant agreement evidencing the options.
 
(v)  Continuation of Benefits . Subject to the Executive’s eligible dependents’ timely election of continuation coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“ COBRA ”), the Company shall contribute to the premium cost of the Executive’s participation and that of his eligible dependents’ in the Company’s group health plan (to the extent permitted under applicable law and the terms of such plan) which covers the Executive (and the Executive’s eligible dependents) for a period of twelve (12) months,  provided  the Executive pay the remainder of the premium cost of such participation by payroll deduction (if any) and, provided further that the Executive is eligible and remains eligible for COBRA coverage. If the reimbursement of any COBRA premiums would violate the nondiscrimination rules or cause the reimbursement of claims to be taxable under the Patient Protection and Affordable Care Act of 2010, together with the Health Care and Education Reconciliation Act of 2010 (collectively, the “ Act ”) or Section 105(h) of the Code, the Company paid premiums shall be treated as taxable payments and be subject to imputed income tax treatment to the extent, necessary to eliminate any discriminatory treatment or taxation under the Act or Section 105(h) of the Code. If the Executive’s participation or that of his eligible dependents’ participation would give rise to penalties or taxes against the Company under the Act, as determined by the Company in its sole discretion, the Company shall instead make cash payments to the Executive over the same period in monthly installments in an amount equal to the Company’s portion of the monthly cost of providing such benefits under its group health plan for such period.
 
(c)  Termination by the Company for Disability, or without Cause, by the Executive with Good Reason, for Non-Renewal by the Company, or in connection with a Change in Control . If, prior to the expiration of the Term, the Executive’s employment is terminated as a result of Disability pursuant to Section 4(b), by the Company without Cause pursuant to Section 4(d), the Executive terminates his employment for Good Reason pursuant to Section 4(f), the Executive terminates his employment in connection with a Change in Control pursuant to Section 4(g), or for the expiration of the Term pursuant to Section 4(h) because the Company fails to renew the Agreement pursuant to Section 2, then the Executive shall be entitled to the following subject to Section 6:
 
(i) The Company shall pay and provide the Executive with the benefits set forth in 5(b) (i) (Accrued Obligations), 5(b)(ii) (Unpaid Bonus), 5(b)(iii) (Pro-Rata Bonus), 5(b)(iv) (Vesting Acceleration), and the continuation of benefits for 12 months as set forth in Section 5(b)(v) (Continuation of Benefits) provided that if Executive obtains other employment that offers group health benefits, such continued coverage by the Company under subsection (b)(v) (Continuation of Benefits) shall cease as of such coverage date; and
 
(ii) The Company shall pay the Executive severance in an amount equal to one times the Base Salary at the rate in effect on the Termination Date (but without giving effect to any reduction if one or all of the bases for the Executive’s resignation for Good Reason is a reduction in Base Salary) less, in the case of termination by the Company for Disability, the gross proceeds paid to the Executive on account of Social Security or other similar benefits and Company-provided short-term and long-term disability plans, if any, which shall be payable in twelve (12) equal monthly installments commencing as set forth in Section 6.
 
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6.  Mutual Release; Payment . The payments and benefits provided for in Section 5 shall be conditioned on (a) the Executive’s continued compliance with the obligations of the Executive under Sections 9 and 10 and (b) the Executive or, in the event of his death, his estate, executing and delivering to the Company a full mutual release of all claims that the Executive, his heirs and assigns may have against the Company, its affiliates and subsidiaries and each of their respective directors, officers, employees and agents, and of all claims that the Company shall have against the Executive, his heirs and assigns, in a form reasonably acceptable to the Company and the Executive (the “ Release ”). The Release must become enforceable and irrevocable on or before the sixtieth (60th) day following the Termination Date. If the Executive (or his estate) fails to execute without revocation the Release, he shall be entitled to the Accrued Obligations only and no other benefits. The installments of severance provided under Section 5(c)(ii) shall commence in the calendar month following the month in which the Release becomes enforceable and irrevocable. If, however, the sixty (60) day period in which the Release must become enforceable and irrevocable begins in one year and ends in the following year, the Company shall commence payment of the severance installments in the second year in the later of January and the first calendar month following the month in which the Release becomes effective and irrevocable. The first installment shall include, however, all amounts that would otherwise have been paid to the Executive between the Termination Date and the Executive’s receipt of the first installment, assuming the first installment would otherwise have been paid in the month following the month in which the Termination Date occurs. The Pro-Rata Bonus payable in Section 5 shall be paid when annual bonuses are paid to other senior executives of the Company generally, but in no event later than March 15 of the year following the year in which the Termination Date occurs.
 
 
7.
Section 409A Compliance .
 
(a) All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred by the Executive during the time periods set forth in this Agreement. All reimbursements shall be paid as soon as administratively practicable, but in no event shall any reimbursement be paid after the last day of the taxable year following the taxable year in which the expense was incurred. The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year. Such right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.
 
(b) To the extent that any of the payments or benefits provided for in Section 5 are deemed to constitute non-qualified deferred compensation benefits subject to Section 409A of the United States Internal Revenue Code (the “Code”), the following interpretations apply to Section 5:
 
(i) Any termination of the Executive’s employment triggering payment of benefits under Section 5 must constitute a “separation from service” under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. § 1.409A-l(h) before distribution of such benefits can commence. To the extent that the termination of the Executive’s employment does not constitute a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A- 1(h) (as the result of further services that are reasonably anticipated to be provided by the Executive to the Company or any of its parents, subsidiaries or affiliates at the time the Executive’s employment terminates), any benefits payable under Section 5(b) or (c) that constitute deferred compensation under Section 409A of the Code shall be delayed until after the date of a subsequent event constituting a separation of service under Section 409A(a)(2)(A)(i) of the Code and Treas. Reg. §1.409A-1(h). For purposes of clarification, this Section 7(b)(i) shall not cause any forfeiture of benefits on the Executive’s part, but shall only act as a delay until such time as a “separation from service” occurs.
 
(ii) Because the Executive is a “specified employee” (as that term is used in Section 409A of the Code and regulations and other guidance issued thereunder) on the date his separation from service becomes effective, any benefits payable under Section 5(b) or (c) that constitute non-qualified deferred compensation under Section 409A of the Code shall be delayed until the earlier of (A) the business day following the six-month anniversary of the date his separation from service becomes effective, and (B) the date of the Executive’s death, but only to the extent necessary to avoid such penalties under Section 409A of the Code. On the earlier of (A) the business day following the six-month anniversary of the date his separation from service becomes effective, and (B) the Executive’s death, the Company shall pay the Executive in a lump sum the aggregate value of the non-qualified deferred compensation that the Company otherwise would have paid the Executive prior to that date under Section 5 of this Agreement.
 
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(iii) It is intended that each installment of the payments and benefits provided under Section 5 of this Agreement shall be treated as a separate “payment” for purposes of Section 409A of the Code. In particular, the installment severance payments set forth in Section 7(b)(ii) of this Agreement shall be divided into two portions. That number of installments commencing on the first payment date set forth in Section 7 of this Agreement that are in the aggregate less than two times the applicable compensation limit under Section 401(a)(17) of the Code for the year in which the Termination Date occurs (provided the termination of the Executive’s employment is also a separation from service) shall be payable in accordance with Treas. Reg. § 1.409A-l(b)(9)(iii) as an involuntary separation plan. The remainder of the installments shall be paid in accordance with Sections 7(b)(i) and (ii) above.
 
 
8.
Certain Reductions in Payments .
 
(a) Anything in this Agreement to the contrary notwithstanding, in the event that the Accounting Firm (as defined below) determines that receipt of all Payments (as defined below) would subject the Executive to the tax under Section 4999 of the Code, the Accounting Firm shall determine whether to reduce any of the Agreement Payments (as defined below) to the Executive so that the Parachute Value (as defined below) of all Payments to the Executive, in the aggregate, equals the applicable Safe Harbor Amount (as defined below). Agreement Payments shall be so reduced (the “Reduced Payments”) only if the Accounting Firm determines that the Executive would have a greater Net After-Tax Receipt (as defined below) of aggregate Payments if the Agreement Payments were so reduced. If the Accounting Firm determines that the Executive would not have a greater Net After-Tax Receipt of aggregate Payments if the Agreement Payments were so reduced, the Executive shall receive all Agreement Payments to which the Executive is entitled hereunder.
 
(b) If the Accounting Firm determines that the aggregate Agreement Payments to the Executive should be reduced so that the Parachute Value of all Payments to the Executive, in the aggregate, equals the applicable Safe Harbor Amount, the Company shall promptly give the Executive notice to that effect and a copy of the detailed calculation thereof. All determinations made by the Accounting Firm under this Section 8 shall be binding upon the Company and the Executive and shall be made as soon as reasonably practicable and in no event later than 15 days following the date that there has been an Agreement Payment that would subject the Executive to the tax under Section 4999 of the Code (the “Excise Tax”).
 
(c) For purposes of reducing the Agreement Payments to the Executive so that the Parachute Value of all Payments to the Executive, in the aggregate, equals the applicable Safe Harbor Amount, only Agreement Payments (and no other Payments) shall be reduced. The reduction contemplated by this Section 8, if applicable, shall be made by reducing payments and benefits (to the extent such amounts are considered Payments) under the following sections in the following order: (i) any Payments under Section 5(b)(v) (Continuation of Benefits), (ii) any Payments under Section 5(b)(iii) (Pro-Rata Bonus), (iii) any Payments under Section 5(b)(ii) (Unpaid Bonus), (iv) any Payments under Section 5(b)(iv) (Acceleration of Vesting), and (iv) any other cash Agreement Payments that would be made upon a termination of the Executive’s employment, beginning with payments that would be made last in time.
 
(d) As a result of the uncertainty in the application of Section 4999 of the Code at the time of the initial determination by the Accounting Firm hereunder, it is possible that, under circumstances where the initial determination resulted in Reduced Payments, the Internal Revenue Service may later determine such reduction was not large enough to avoid the Excise Tax on the Payments (making the Net After-Tax Receipt of aggregate Payments less than if no reduction had occurred). Under such circumstances, in the event that the Internal Revenue Service or a court, as applicable, finally and in a decision that has become unappealable or a decision which is nonfinal but which the Company elects not to appeal, determines that the Payments are subject to the Excise Tax, the amount of the Reduced Payments shall be paid or distributed by the Company to or for the benefit of the Executive within 30 days of such final determination; provided that (i) the Executive shall not initiate any proceeding or other contests regarding these matters, other than at the direction of the Company, and shall provide notice to the Company of any proceeding or other contest regarding these matters initiated by the Internal Revenue Service and (ii) the Company shall be entitled to direct and control all such proceedings and other contests, if it commits to do so, it shall pay all fees (including without limitation legal and other professional fees) associated therewith.
 
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(e) In connection with making determinations under this Section 8, the Accounting Firm shall take into account the value of any reasonable compensation for services to be rendered by the Executive before or after the change in control, including the non-competition provisions applicable to the Executive under Section 9(d) and any other non-competition provisions that may apply to the Executive, and the Company shall cooperate in the valuation of any such services, including any non-competition provisions.
 
(f) All fees and expenses of the Accounting Firm in implementing the provisions of this Section 8 shall be borne by the Company.
 
(g) In the event of any controversy with the Internal Revenue Service (or other taxing authority) with regard to the Agreement Payments, the Executive shall permit the Company to control issues related to the Agreement Payments or any excise tax thereon, provided that such issues do not potentially materially adversely affect the Executive. If the Company commits to control such issues, it shall pay all fees (including without limitation legal and other professional fees) associated therewith. In the event of any conference with any taxing authority as to the Agreement Payments, any excise tax thereon, or associated income taxes, the Executive shall permit the representative of the Company to accompany the Executive, and the Executive and any representative of the Executive shall cooperate with the Company and its representative.
 
(h)  Definitions.  The following terms shall have the following meanings for purposes of this Section 8.
 
(i) “Accounting Firm” shall mean a nationally recognized certified public accounting firm or other professional organization that is a certified public accounting firm recognized as an expert in determinations and calculations for purposes of Section 280G of the Code that is selected by the Executive and reasonably acceptable to the Company for purposes of making the applicable determinations hereunder.
 
(ii) “Agreement Payment” shall mean a Payment paid or payable pursuant to this Agreement including, for the avoidance of doubt, any acceleration of vesting of equity awards.
 
(iii) “Net After-Tax Receipt” shall mean the Present Value of a Payment net of all taxes imposed on the Executive with respect thereto under Code Sections 1 and 4999 and under applicable state, local, and foreign laws, determined by applying the applicable highest marginal rate .
 
(iv) “Parachute Value” of a Payment shall mean the present value as of the date of the change in control for purposes of Code Section 280G of the portion of such Payment that constitutes a “parachute payment” under Code Section 280G(b)(2), as determined by the Accounting Firm for purposes of determining whether and to what extent the excise tax under Code Section 4999 will apply to such Payment.
 
(v) A “Payment” shall mean any payment or distribution in the nature of compensation (within the meaning of Code Section 280G(b)(2)) to or for the benefit of the Executive, whether paid or payable pursuant to this Agreement or otherwise.
 
(vi) “Present Value” of a Payment shall mean the economic present value of a Payment as of the date of the change in control for purposes of Code Section 280G, as determined by the Accounting Firm using the discount rate required by Code Section 280G(d)(4).
 
(vii) “Safe Harbor Amount” means (x) 3.0 times the Executive’s “base amount,” within the meaning of Code Section 280G(b)(3), minus (y) $1.00.
 
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9.
Confidentiality and Restrictive Covenants .
 
(a) The Executive acknowledges that:
 
(i) the Company (which, for purposes of this Section 9 shall include the Company and each of its subsidiaries and affiliates) is engaged in the pharmaceutical development business with a focus on the development and testing of monovalent and polyvalent vaccines targeted at cancer for eventual commercialization (the “Business”);
 
(ii) the Company is dependent on the efforts of a certain limited number of persons who have developed, or will be responsible for developing the Company’s Business;
 
(iii) the Company’s Business is national in scope;
 
(iv) the Business in which the Company is engaged is intensely competitive and that Executive’s employment by the Company will require that he have access to and knowledge of nonpublic confidential information of the Company and the Company’s Business, including, but not limited to, certain/all of the Company’s products, plans for creation, acquisition or disposition of products or publications, strategic and expansion plans, formulas, research results, marketing plans, financial status and plans, budgets, forecasts, profit or loss figures, distributors and distribution strategies, pricing strategies, improvements, sales figures, contracts, agreements, then existing or then prospective suppliers and sources of supply and customer lists, undertakings with or with respect to the Company’s customers or prospective customers, and patient information, product development plans, rules and regulations, personnel information and trade secrets of the Company, all of which are of vital importance to the success of the Company’s business (collectively, “Confidential Information”);
 
(v) the direct or indirect disclosure of any Confidential Information would place the Company at a serious competitive disadvantage and would do serious damage, financial and otherwise, to the Company’s business;
 
(vi) by his training, experience and expertise, the Executive’s services to the Company will be special and unique;
 
(vii) the covenants and agreements of the Executive contained in this Section 9 are essential to the business and goodwill of the Company; and
 
(viii) if the Executive leaves the Company’s employ to work for a competitive business, in any capacity, it would cause the Company irreparable harm.
 
(b)  Covenant Against Disclosure . All Confidential Information relating to the Business is, shall be and shall remain the sole property and confidential business information of the Company, free of any rights of the Executive. The Executive shall not make any use of the Confidential Information except in the performance of his duties hereunder and shall not disclose any Confidential Information to third parties, without the prior written consent of the Company.
 
(c)  Return of Company Documents . On the Termination Date or on any prior date upon the Company’s written demand, the Executive will return all memoranda, notes, lists, records, property and other tangible product and documents concerning the Business, including all Confidential Information, in his possession, directly or indirectly, that is in written or other tangible form (together with all duplicates thereof) and that he will not retain or furnish any such Confidential Information to any third party, either by sample, facsimile, film, audio or video cassette, electronic data, verbal communication or any other means of communication.
 
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(d)  Further Covenant . During the Term and through the second anniversary of the Termination Date, the Executive shall not, directly or indirectly, take any of the following actions, and, to the extent the Executive owns, manages, operates, controls, is employed by or participates in the ownership, management, operation or control of, or is connected in any manner with, any business, the Executive will use his best efforts to ensure that such business does not take any of the following actions:
 
(i) Use the Company’s Confidential Information to persuade or attempt to persuade any customer of the Company to cease doing business with the Company, or to reduce the amount of business any customer does with the Company;
 
(ii) in a manner that competes with the Company’s business, use the Company’s Confidential Information to solicit for himself or any entity the business of a customer of the Company or the business of a former customer of the Company within twelve (12) months prior to the termination of the Executive’s employment; or
 
(iii) persuade or attempt to persuade any employee or independent contractor of the Company to leave the service of the Company, or hire or engage, directly or indirectly, any individual who was an employee or independent contractor of the Company within one (1) year prior to the Executive’s Termination Date.
 
(e)  Enforcement . The Executive acknowledges and agrees that any breach by him of any of the provisions of this Section 9 (the “ Restrictive Covenants ”) would result in irreparable injury and damage for which money damages would not provide an adequate remedy. Therefore, if the Executive breaches or threatens to commit a breach of any of the provisions of Section 9, the Company shall have the ability to seek the following rights and remedies, each of which rights and remedies shall be independent of the other and severally enforceable, and all of which rights and remedies shall be in addition to, and not in lieu of, any other rights and remedies available to the Company under law or in equity (including, without limitation, the recovery of damages): (i) the right and remedy to have the Restrictive Covenants specifically enforced (without posting bond and without the need to prove damages) by any court having equity jurisdiction, including, without limitation, the right to an entry against the Executive of restraining orders and injunctions (preliminary, mandatory, temporary and permanent) against violations, threatened or actual, and whether or not then continuing, of such covenants; and (ii) the right and remedy to require the Executive to account for and pay over to the Company all compensation, profits, monies, accruals, increments or other benefits (collectively, “ Benefits ”) derived or received by him as the result of any transactions constituting a breach of the Restrictive Covenants, and the Executive shall account for and pay over such Benefits to the Company and, if applicable, its affected subsidiaries and/or affiliates. The Executive agrees that in any action seeking specific performance or other equitable relief, he will not assert or contend that any of the provisions of this Section 9 are unreasonable or otherwise unenforceable. Other than a material breach of this Agreement, the existence of any claim or cause of action by the Executive, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement of the Restrictive Covenants.
 
 
10.
Intellectual Property .
 
(a)  Works for Hire . All creations, inventions, ideas, designs, software, copyrightable materials, trademarks, and other technology and rights (and any related improvements or modifications), whether or not subject to patent or copyright protection (collectively, “ Creations ”), relating to any activities of the Company which were, are, or will be conceived by the Executive or developed by the Executive in the course of his employment or other services with the Company, whether conceived alone or with others and whether or not conceived or developed during regular business hours, and if based on Confidential Information, after the termination of the Executive’s employment, shall be the sole property of the Company and, to the maximum extent permitted by applicable law, shall be deemed “works made for hire” as that term is used in the United States Copyright Act. The Executive agrees to assign and hereby does assign to the Company all Creations conceived or developed from the start of this employment with the Company through to the Termination Date, and after the Termination Date if the Creation incorporates or is based on any Confidential Information.
 
(b)  Assignment . To the extent, if any, that the Executive retains any right, title or interest with respect to any Creations delivered to the Company or related to his employment with the Company, the Executive hereby grants to the Company an irrevocable, paid-up, transferable, sub-licensable, worldwide right and license: (i) to modify all or any portion of such Creations, including, without limitation, the making of additions to or deletions from such Creations, regardless of the medium (now or hereafter known) into which such Creations
 
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may be modified and regardless of the effect of such modifications on the integrity of such Creations; and (ii) to identify the Executive, or not to identify his, as one or more authors of or contributors to such Creations or any portion thereof, whether or not such Creations or any portion thereof have been modified. The Executive further waives any “moral” rights, or other rights with respect to attribution of authorship or integrity of such Creations that he may have under any applicable law, whether under copyright, trademark, unfair competition, defamation, right of privacy, contract, tort or other legal theory.
 
Notwithstanding the foregoing, pursuant to California Labor Code Section 2870, the foregoing shall not apply to an invention that Executive developed entirely on his own time without using the Company’s equipment, supplies, facilities, or trade secret information except for those inventions that either:
 
 
 
Relate at the time of conception or reduction to practice of the invention to the Company’s business, or actual or demonstrably anticipated research or development of the Company; or
 
 
 
Result from any work performed by the Executive for the Company.
 
(c)  Disclosure . The Executive will promptly inform the Company of any Creations he conceives or develops during the Term. The Executive shall (whether during his employment or after the termination of his employment) execute such written instruments and do other such acts as may be necessary in the opinion of the Company or its counsel to secure the Company’s rights in the Creations, including obtaining a patent, registering a copyright, or otherwise (and the Executive hereby irrevocably appoints the Company and any of its officers as his attorney in fact to undertake such acts in his name). The Executive’s obligation to execute written instruments and otherwise assist the Company in securing its rights in the Creations will continue after the termination of his employment for any reason, the Company shall reimburse the Executive for any out-of-pocket expenses (but not attorneys’ fees) he incurs in connection with his compliance with this Section 10(c).
 
11.  Indemnification . During the Term and thereafter, the Company shall indemnify the Executive to the fullest extent provided in the Company’s bylaws and/or Certificate of Incorporation. The Company shall purchase, and at all times maintain in effect, a policy of directors and officer’s insurance coverage.
 
12.  Integration . This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior agreements between the parties concerning such subject matter, including, without limitation, the Prior Employment Agreement.
 
13.  Successors . This Agreement shall inure to the benefit of and be enforceable by the Executive’s personal representatives, executors, administrators, heirs, distributees, devisees and legatees. In the event of the Executive’s death after his termination of employment but prior to the completion by the Company of all payments due him under this Agreement, the Company shall continue such payments to the Executive’s beneficiary designated in writing to the Company prior to his death (or to his estate, if the Executive fails to make such designation). The Company shall require any successor to the Company to expressly assume and agree to perform this Agreement in the same manner and to the same extent that the Company would be required to perform it if no such succession had taken place.
 
14.  Enforceability . If any portion or provision of this Agreement (including, without limitation, any portion or provision of any section of this Agreement) shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision of this Agreement shall be valid and enforceable to the fullest extent permitted by law.
 
15.  Survival . The provisions of this Agreement shall survive the termination of this Agreement and/or the termination of the Executive’s employment to the extent necessary to effectuate the terms contained herein.
 
16.  Waiver . No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.
 
-10-
 
 
 

 
 
17.  Notices . Any notices, requests, demands and other communications provided for by this Agreement shall be sufficient if in writing and delivered in person or sent by a nationally recognized overnight courier service or by registered or certified mail, postage prepaid, return receipt requested, to the Executive at the last address the Executive has filed in writing with the Company or, in the case of the Company, at its main offices, attention of the Board.
 
18.  Amendment . This Agreement may be amended or modified only by a written instrument signed by the Executive and by a duly authorized representative of the Company.
 
19.  Governing Law . This is a California contract and shall be construed under and be governed in all respects by the laws of California for contracts to be performed in that State and without giving effect to the conflict of laws principles of California or any other State. In the event of any alleged breach or threatened breach of this Agreement, the Executive hereby consents and submits to the jurisdiction of the federal and state courts in and of the State of California.
 
20.  Counterparts . This Agreement may be executed in any number of counterparts, each of which when so executed and delivered shall be taken to be an original; but such counterparts shall together constitute one and the same document.
 
IN WITNESS WHEREOF, the parties have executed this Agreement effective on the date and year first above written.
 
MabVax Therapeutics, Inc.
 
     
 
By:
 
/s/ J. David Hansen
 
Name:
 
J. David Hansen
 
Title:
 
President and Chief Executive Officer
   
 
/s/ Paul Maffuid
 
Executive
 
-11-
 
Exhibit 10.6
 
CONFIDENTIAL TREATMENT REQUESTED
 
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
 
This DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT, effective as of this 15 th  day of April 2014 (the “ Effective Date ”), between, MabVax Therapeutics, a Delaware Corporation (“ Customer ”), having its principal place of business at 11588 Sorrento Valley Road, Suite 20, San Diego CA 92121, and Gallus Biopharmaceuticals NJ, LLC, a Delaware limited liability company with offices at 201 College Road East, Princeton, NJ 08540 (“ Gallus ”). Customer and Gallus are referred to herein each as a “ Party ” and collectively as the “ Parties ”.
 
WHEREAS, Gallus provides a full range of manufacturing and bioprocessing services to the biopharmaceutical industry, including cell line development, process development, protein production, cell culture, protein purification, bioanalytical chemistry and QC testing and product release; and
 
WHEREAS, Customer desires Gallus to perform services in accordance with the terms of this Agreement related to the development, manufacture (including cGMP bioreactor production and purification) and clinical supply of a recombinant protein product produced by Customer’s corresponding cell line, and Gallus desires to perform such services.
 
NOW, THEREFORE, in consideration of the above statements and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties hereto agree as follows:
 
1.  Definitions . Terms defined elsewhere in this Agreement shall have the meanings set forth therein for all purposes of this Agreement unless otherwise specified to the contrary. The following terms shall have the meaning set forth below in this Section 1:
 
(a) “ Affiliate(s) ” means any person, firm, trust, partnership, corporation, company or other entity or combination thereof which directly or indirectly: (i) controls a Party; (ii) is controlled by a Party; or (iii) is under common control with a Party. As used in this definition, the terms “control” and “controlled” shall mean ownership of fifty percent (50%) or more (including ownership by trusts with substantially the same beneficial interests) of the voting and equity rights of such person, firm, trust, partnership, corporation, company or other entity or combination thereof or the power to direct the management of such person, firm, trust, corporation or other entity or combination thereof.
 
(b) “ Agreement ” means this document as signed by the Parties; including the Work Statement, Specifications Document and other Appendices and any referenced attachments and any amendments and additions to any of the foregoing.
 
(c) “ Applicable Laws ” means all relevant federal, state and local laws, statutes, rules, regulations, and ordinances and industry standards and guidelines as in effect on the Effective Date or adopted thereafter and which are applicable to a Party’s activities hereunder.
 
(d) “ Assumptions ” shall have the meaning as set forth in Section9(a).
 
(e) “ Background Technology ” of a Party means any and all Technology that (i) is owned or otherwise controlled by such Party and (ii) is either (1) in existence on or prior to the Effective Date or (2) conceived, created, developed, reduced to practice or made by or on behalf of such Party after the Effective Date independently of the activities contemplated by this Agreement and without use of or reliance on the other Party’s Confidential Information and, in the case of Gallus, without use or our reliance on Customer Provided Materials.
 
(f) “ Batch ” means a specific batch of Product produced in a single manufacturing run.
 
1
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(g) “ Batch Record ” (also referred to as Manufacturing Batch Record (MBR) or Batch Production Record (BPR) means a manufacturing record for a Batch generated by Gallus concurrently with the performance of each step of the production of a specific Batch or Lot of material such that successive steps in such processes may be traced.
 
(h) “ Cell Line ” means the cell line identified in the applicable Work Statement that has been designed and engineered to produce the corresponding recombinant protein product and will be supplied by Customer to Gallus in accordance with the Work Statement.
 
(i) “ Certificate of Analysis ” shall mean a written certificate listing the items tested, manufacturer, specifications, testing methods and test results for a specific Batch or Lot of material.
 
(j) “ cGMP ” means current Good Manufacturing Practice as defined in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002 part II: Basic Requirements for Active Substances used as Starting Materials, and ICHQ7a – as incorporated in the Federal Register volume 66 No 186 (formerly ICHQ7a) and those sections applicable within FDA regulations found at title 21 of the Code of Federal Regulations (CFR) Parts 210, 211, 600, 601 and 610.
 
(k) “ Change Order ” shall have the meaning set forth in Section 9(b).
 
(l) “ Claim ” shall have the meaning set forth in Section 18.
 
(m) “ Confidential Information ” means, with respect to a Party, any and all data, information or materials that is supplied or made available by one Party to the other Party, including Third Party information, whether disclosed directly or indirectly in writing, orally, electronically or by drawings or observation. “Confidential Information” of Customer includes business, technical or financial data concerning the Cell Line or Product, and “Confidential Information” of Gallus includes business, technical or financial data, Gallus’ production and purification methods, Gallus’ equipment and techniques and Gallus Technology.
 
(n) “ Contaminants ” shall have the meaning set forth in Section 16.
 
(o) “ Customer Provided Materials ” means the Cell Line, materials, documents, components and supplies provided by Customer hereunder.
 
(p) “ Defective Batch ” means a Batch, other than a Batch produced in a process verification, pre-engineering or engineering Batch (or the first cGMP Batch if Customer elects not to perform an engineering Batch), which cannot be released or which does not meet the Specifications.
 
(q) “ Disposition ” means a documented decision on the acceptability for use of a specific Batch or Lot of material that is based on a process of reviewing data associated with the production and testing of the material or product.
 
(r) “ Drug Product ” means the final dosage form of an active pharmaceutical ingredient that is intended for human use.
 
(s) “ Drug Substance ” is the bulk purified recombinant protein produced using the Cell Line and purified using the Process.
 
(t) “ Facility ” means Gallus’ manufacturing, laboratory and warehouse facilities located at 201 College Road East, Princeton, NJ 08540, or any other Gallus facility as agreed to in writing by the Parties.
 
2
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(u) “ Gallus Failure ” means a Defective Batch caused by Gallus’s negligence or willful misconduct. For purposes of this Section 1(u), Gallus’s “negligence” will include Gallus’s material failure to (i) follow agreed upon procedures, or (ii) adequately maintain or calibrate equipment or (iii) failure to comply in all material respects with cGMP applicable to the Services or Drug Product or Drug Substance. For the avoidance of doubt, a Gallus Failure shall not include a Defective Batch from any other cause, including any issue that is inherent to the Product or Process.
 
(v) “ Gallus SOP ” means the written standard operating procedures and methods of Gallus, as the same may be amended, in Gallus’ sole discretion, from time to time.
 
(w) “ Gallus Technology ” means any and all Technology developed by Gallus hereunder that is general-purpose in nature, applicable to performance of services for Gallus’ other customers, including any Improvements thereto and not specific to the Product, For the avoidance of doubt, manufacturing technology that is general-purpose in nature and is provided by or on behalf of Customer, is Customer Background Technology, and not Gallus Technology.
 
(x) “ Improvement ” means any modification, enhancement or improvement to a Technology, or any discovery related to such Technology, whether or not patented or patentable, and all associated Intellectual Property Rights therein or thereto.
 
(y) “ Intellectual Property Rights ” means any and all of the following: (i) Patents, (ii) copyrights in both published and unpublished works, (iii) rights (including without limitation trade secret rights) in know-how, (iv) other than trademark and service mark rights, any and all other intellectual property rights and (v) any and all registrations and applications for registration of any of the foregoing.
 
(z) “ Master Batch Record ” means the document containing the formula and procedures for the manufacturing and quality assurance of the Product, as such may be amended by the Parties in accordance with the terms hereof.
 
(aa) “ Materials ” means Customer Provided Materials and Process Consumables.
 
(bb) “ Modification ” shall have the meaning set forth in Section 9.
 
(cc) “ Non-GMP Stages ” means all Stages of the Program identified in the Work Statement, other than the GMP Stages.
 
(dd) “ Patents ” means patents and patent applications and all divisions, renewals, continuations and continuations-in-part thereof, and all patents granted thereon, and all reissues, re-examination certificates, and extensions and foreign counterparts thereof.
 
(ee) “ Person ” means an individual, partnership, corporation, limited liability company, joint stock company, unincorporated organization or association, trust or joint venture, or a governmental agency or political subdivision thereof.
 
(ff) “ Process ” means the processes and procedures used to manufacture the Product in accordance with the Master Batch Record, including all protocols and standard operating procedure documents referenced therein, which are provided by Customer or developed by Gallus and Customer hereunder.
 
(gg) “ Process Consumables ” means media, raw materials, chromatography columns, resins, filters, membranes, disposable analytical test kits, hoses, filter housings, tubing, filling needles,
 
3
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
CONFIDENTIAL TREATMENT REQUESTED
 
disposable bags, disposable glass/plasticware, cleaning supplies and other changeover parts consumed during the manufacture of Product.
 
(hh) “ Process Demonstration Stage ” means the Stage of the Program identified in the Work Statement during which process a verification run of the Process is intended to take place.
 
(ii) “ Produc t” means the Drug Substance and, if the Program includes supply of a final dosage form of Drug Substance that is intended for human use in clinical trials, Drug Product.
 
(jj) “ Product Invention ” means any patentable Improvement to a Product (excluding any Gallus Technology) discovered by Gallus, its employees, agents, consultants or contractors, exclusively as a result of performing the Services under this Agreement.
 
(kk) “ Program ” means all of the services to be performed by Gallus for Customer as described in a Work Statement(s), including any amendments or Change Orders thereto.
 
(ll) “ Quality Agreement ” shall be an agreement between MabVax and Gallus that shall define the quality responsibilities and activities of both Parties in relation to the manufacturing, testing, storage of the MABVAX MONOCLONAL ANTIBODY in compliance with applicable Federal, State, and Local regulatory regulations and industry standards. The Parties will negotiate in good faith to have the Quality Agreement executed within sixty (60) days of the execution of this Agreement.
 
(mm) “ Service Fee ” shall have the meaning set forth in Section 8(a).
 
(nn) “ Services ” means activities to be performed by Gallus for Customer hereunder as a part of a Program.
 
(oo) “ Special Waste ” means waste or effluent which is required to be collected in a special container for external disposal.
 
(pp) “ Specifications ” means the requirements of cGMP (to the extent applicable), and the tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described, as set forth in the Specifications Document.
 
(qq) “ Specifications Documents ” means the document that (i) references this Agreement, (ii) is signed by authorized representatives of both Parties and (iii) sets forth the Specifications, as may be amended by the Parties in accordance with Section 9(b) from time to time.
 
(rr) “ Stage ” means a stage of the Program.
 
(ss) “ Technology ” means all scientific, technical and other information, data, know-how, trade secrets, inventions (whether or not patentable), processes, compositions of matter, materials, methods, techniques, documentation, hardware, software and technology and all associated Intellectual Property Rights related thereto, whether or not protected or protectable under patent, trademark, copyright or similar law.
 
(tt) “ Third Party ” shall mean any party other than Customer, Gallus and their respective Affiliates.
 
(uu) “ Travel Expenses ” means costs and expenses incurred by Gallus for travel and lodging required in order to carry out the Program.
 
4
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(vv) “ Work Statement ” means a detailed document that (i) references this Agreement, (ii) is signed by authorized representatives of both Parties and (iii) sets forth, at a minimum, the Services to be provided by Gallus and the fees to be paid by Customer for such Services, and any modifications to such Work Statement that the Parties may agree to in writing from time to time. The initial agreed Work Statement is attached hereto as  Appendix 1 .
 
2.  Work Statement; Orders for Products .
 
(a) Gallus will use commercially reasonable efforts to perform the Services for Customer in accordance with the applicable Work Statement. Each Work Statement specifies the scope of the Services, information desired, estimated duration of the Program, and all other matters pertinent to completion of the Program, and is deemed a part of this Agreement and is incorporated herein by reference. The timelines set forth in any Work Statement are, or will be, good faith estimates using assumptions based on information available at the time into which a Work Statement is entered.
 
(b) A Program shall be complete when all Stages of the applicable Work Statement have been completed or when a Work Statement or this Agreement has been terminated pursuant to Section 23.
 
(c) With respect to each Work Statement, Gallus will consult with Customer in developing the Work Statement in a manner consistent with then current United States (the “ US ”) regulatory guidelines. Gallus does not, however, represent or warrant that the Program and/or the results of the Services will satisfy the requirements of any regulatory agencies at the time of submission of such results to such agencies. Customer shall be responsible for obtaining all regulatory approvals relating to registration of the Drug Product, shall pay any applicable user fee for such registrations, and shall own the applicable regulatory filings and approvals. Customer shall comply with all Applicable Laws relating to the shipping, distribution and marketing of Drug Product.
 
(d) Gallus  performance of the Program will be based on technical information provided by or for the Customer. This information will be incorporated by Gallus into Program documents (e.g., scale up plans, Master Batch Record, Specifications) that will be reviewed and approved by the Customer prior to use by Gallus.
 
3.  Program Performance .
 
(a) Gallus shall use its commercially reasonable efforts to provide the Facility, Process Consumables and staff necessary to complete the Program in accordance with the terms of this Agreement. In the event of any conflict between the terms and provisions of this document and the terms of a Work Statement, the terms of this document shall control, unless expressly provided otherwise in the applicable Work Statement.
 
(b) Customer acknowledges that the work to be performed hereunder is by its nature developmental and that the Program involves biological processes that are, by their nature, unpredictable such that Gallus does not guarantee to Customer the achievement of a successful outcome. For the avoidance of doubt, it shall not be considered a breach of this Agreement by Gallus if an objective of the Program is not achieved so long as Gallus has complied with its obligations set forth herein. Gallus shall not be responsible for any loss of a Batch in crude or purified form unless it is a Defective Batch caused by a Gallus Failure. Customer’s sole and exclusive remedy for a Gallus Failure shall be as set forth in Section 20(h) below.
 
(c) Gallus will appoint a Gallus representative (the “ Program Manager ”) to be responsible for overseeing the completion of the Program by Gallus. The Program Manager will coordinate performance of the Services with a representative designated by Customer (the “ Customer
 
5
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
Representative ”), which representative shall have responsibility over all matters relating to performance of the Services on behalf of Customer. Unless otherwise agreed in the Work Statement, or mutually agreed to by the Parties, all communications between Gallus and the Customer regarding the conduct of the Services pursuant to the Work Statement shall be addressed to or routed through the Program Manager and Customer Representative. The Program Manager is named in the Work Statement and Gallus may, at its option, substitute the Program Manager during the course of the Program. The Customer Representative is named in the Work Statement and Customer may, at its option, substitute the Customer Representative during the course of the Program.
 
(d) Promptly following the execution of this Agreement, the Parties will negotiate and enter into a detailed agreement specifying the quality and regulatory procedures and responsibilities of the Parties with respect to the manufacture of Product (the “ Quality Agreement ”).
 
(e) Customer may cancel one or more Batches subject to Gallus retention of any deposit or advance payment with respect to that Batch, provided that Gallus will credit any such deposit or advance payment to future Services for the Customer to the extent that Gallus is able, using commercially reasonably efforts, to fill a manufacturing slot for which the deposit or advance payment was made. Notwithstanding the foregoing, if Customer cancels a majority of remaining Batches, the Agreement shall be deemed to have been terminated by Customer under Section 23(b), unless the Parties agree otherwise in writing.
 
4.  Program Materials .
 
(a) Customer will provide Gallus with sufficient amounts of the Customer Provided Materials with which to perform the Services as specified in the Work Statement. Unless the Work Statement includes the development of a manufacturing process by Gallus, Customer also will provide Gallus with all necessary information to effect the reliable transfer of the Process from Customer to Gallus.
 
(b) Gallus shall procure Process Consumables for use in the Program and each manufacturing run as set forth in the Work Statement.
 
(c) Gallus shall procure Product-Dedicated Equipment, provided the equipment is set forth in a Work Statement and pass through the costs to the Customer as set forth in Section 8 without upcharge. For the avoidance of doubt, purchase of any Product-Dedicated Equipment regardless of whether that equipment is set forth in a Work Statement shall require Customer’s approval in advance of the purchase. Customer may procure certain Product-Dedicated Equipment for use in the Program at its own expense, provided that Customer first provides written notice to Gallus and provides Gallus with an opportunity to confirm that such Product-Dedicated Equipment conforms to the requirements of the Work Statement and is otherwise suitable for use in the performance of the Services. All Product-Dedicated Equipment will be subject to charges from Gallus for activities such as evaluation, installation, qualification, calibration and maintenance.
 
(d) Upon completion of the Program, (i) the Product-Dedicated Equipment will be returned to the Customer, at the Customer’s expense, unless the Parties agree that such Product-Dedicated Equipment will be used in connection with additional services to be provided to Customer in the foreseeable future, and (ii) any remaining Materials will be, at Customer’s election (such election to be made by Customer to Gallus in writing no later than sixty (60) days after Gallus’ issuance of a Certificate of Analysis for the applicable Product), returned to the Customer or destroyed/disposed of by Gallus, in either case at the Customer’s expense. If Customer does not provide such notice to Gallus within such 60-day period, Gallus shall, at Gallus’ election and at Customer’s expense, return to the Customer or destroy/dispose of the applicable Materials. Notwithstanding anything to the contrary contained in this Agreement, (i) Gallus may retain Materials as required by Applicable Law,
 
6
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
and (ii) in no event shall Gallus be required to store Materials, Product-Dedicated Equipment or any other materials for more than ninety (90) days after termination or expiration of an applicable Work Statement or this Agreement unless the Parties have entered into an appropriate storage agreement covering such items.
 
5.  Use of Subcontractors .
 
(a) Gallus reserves the right to employ subcontractors from time-to-time to undertake certain activities related to the Program. All subcontractors will be pre-approved by the Customer and will be held under obligations of confidentiality consistent with those set forth in Section 10. A list of known and approved subcontractors will be provided in the Work Statement.
 
(b) Gallus will be responsible for the performance of its subcontractors used for the Program and for any costs, expenses, damage or loss, whether direct or consequential occasioned by the performance of or failure to perform the subcontracted services to the extent the applicable subcontractor is liable to Gallus. Notwithstanding the foregoing, Gallus shall not be held liable or responsible for the performance of any subcontractor that has been approved by Customer to perform sterility, viral testing, cell banking services (each a “ Special Services Provider ”), or for any costs, expenses, damage or loss of any nature, whether direct or consequential occasioned by the Special Services Provider’s performance of or failure to perform sterility, viral testing, cell banking services.
 
6.  Compliance with Government Regulations .
 
(a) Subject to Section 6(b), Gallus will comply in all material respects with cGMP applicable to the Services.
 
(b) Should cGMP applicable to the Services be changed following the Effective Date, Gallus will make commercially reasonable efforts to comply in all material respects with the new requirements. In the event that compliance with such new requirements necessitates, in the sole discretion of Gallus, a change in the Work Statement or the Services or the cost of the Services, Gallus will submit to Customer a proposed Change Order in accordance with Section 9(b).
 
7.  Facility Visits and Audits . Customer’s representatives may visit the Facility to observe the progress of the Program or to audit the Facility as set forth in the Quality Agreement. In addition, Gallus will have the right to audit any sites (including Customer sites) or laboratories used by Customer (except for Customer’s contract manufacturers) or any Third Party analytical subcontractor engaged by Customer in connection with any release assays.
 
8.  Compensation .
 
(a) Customer shall pay Gallus the fees listed in the Work Statement (the “ Service Fees ”), which Service Fees shall be subject to modification in accordance with the provisions of Section 9. Gallus shall issue invoices for Service Fees in accordance with the payment schedule set forth in the Work Statement, and Customer shall pay the amounts set forth in each invoice within thirty (30) days of the date of such invoice.
 
(b) The Service Fees do not include amounts payable by Customer for (i) Process Consumables; (ii) Product-Dedicated Equipment; (iii) Services subcontracted to a Third Party (including shipping charges for delivery of materials to and from a subcontractor); (iv) disposal of Special Waste; or (v) Travel Expenses ((iii) through (v), collectively, “ External Services ”). Gallus shall invoice Customer for all External Services as incurred by Gallus, and Gallus shall invoice Customer for all Process
 
7
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
Consumables and Product-Dedicated Equipment as set forth in Sections 8(c) and 8(d). Product-Dedicated Equipment will include the direct cost to acquire the equipment plus costs to specify, procure, commission and validate the equipment so that it is ready for use. Costs associated with ongoing maintenance and calibration of Product-Dedicated Equipment will be passed through to Customer as incurred by Gallus. An administrative fee of [*****] will be added to all invoices for Process Consumables to cover the cost of vendor qualification, vendor management and incoming quality control, inventory management and warehousing, and Customer shall pay all such invoices in full within thirty (30) days of the date of such invoice.
 
(c) Prior to the initiation of each Stage of the Program, Gallus shall prepare and provide to Customer a good-faith estimate (an “ Estimate ”) of expected costs and expenses to be incurred by Gallus for Process Consumables, Product-Dedicated Equipment and External Services for such Stage. Within five (5) business days of receipt of each Estimate, Customer shall either notify Gallus of Customers acceptance and agreement of such estimate, or notify Gallus with reasonable detail of any disputed items set forth in the Estimate. Failure to so notify Gallus within such 5-day period shall be deemed to be Customer’s agreement and acceptance of such Estimate. If Customer disputes any items set forth in the Estimate within such 5-day period, the Parties shall discuss in good faith the disputed items and Gallus shall re-issue an Estimate to Customer and the review and acceptance process set forth above shall be applied to such re-issued Estimate.
 
(d) Following approval of each Estimate as set forth in Section 8(c), Gallus shall proceed with purchase of Process Consumables and Product-Dedicated Equipment included in such Estimate and shall invoice Customer for same. Upon completion of the applicable Stage or earlier termination of this Agreement, Gallus shall calculate the expenditure actually incurred for Process Consumables, plus an administrative fee of [*****] as outlined in 8(b), and the Product-Dedicated Equipment procured for use during such Stage and associated costs (collectively, the “ Actual Expenditure ”). If the Actual Expenditure is greater than the corresponding Estimate, Gallus shall issue a further invoice for a sum equivalent to the difference between the amount set forth in the Estimate and actually paid by Customer and the Actual Expenditure. If the Actual Expenditure is less than the corresponding Estimate, Gallus shall issue a credit note against the earlier invoice for a sum equivalent to the difference, which credit may be applied to future amounts payable under this Agreement. Customer shall not be responsible for costs of External Services that exceed the amounts set forth in an Estimate without the prior written consent of Customer.
 
(e) In the event Gallus’ performance of Services is delayed or suspended at the request of Customer, or the failure by Customer to fulfill its obligations under this Agreement, then Gallus reserves the right to immediately invoice Customer for all reasonable losses and expenses incurred by Gallus as a direct result of such delay or suspension, provided that a delay or suspension of the manufacturing of a Batch shall be handled in accordance with Section 3(e), above. Such losses and expenses include without limitation idle production capacity caused by such delay or suspension and non-reallocable human resources and materials that would have been used for the Services but for such delay or suspension. Gallus will use reasonable efforts to avoid and/or minimize such expenses and losses by using reasonable efforts to reallocate internal resources and materials. In no event will any invoice submitted pursuant to this Section 8(e) exceed the fees that would have been paid by Customer had the delay or suspension not occurred. Subject to Gallus’s right to retain deposits or advance reservation fees for manufacturing slots, in no event will any invoice submitted pursuant to this Section 8(e) include fees for Services scheduled or reasonably expected to be performed by Gallus more than 60 days from Gallus becoming aware of said delay or suspension.
 
(f) Late payments shall incur an interest charge of the lesser of [*****] per month or the maximum amount permitted by applicable law. Gallus reserves the right to suspend Services in the event of late payments. All payments under this Agreement are exclusive of any taxes that may apply and shall be paid gross, without deductions or set-offs, whether by way of withholding or other
 
8
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
income taxes, and Customer shall ensure that such sum is paid to Gallus as shall, after deduction of such withholding or other income taxes, be equivalent to the consideration payable under this Agreement. If any taxes shall become due, it shall be for the account of Customer
 
(g) All amounts payable to Gallus under this Agreement shall be paid in US Dollars, without deduction, and by authenticated and value dated Swift telegraphic transfer for any such payments made from outside the United States, quoting invoice numbers of payment to the bank account identified in the applicable invoice or by such other means as Gallus shall notify Customer in writing from time to time.
 
9.  Work Statement and Specification Document Changes .
 
(a) The Service Fees are subject to a number of specific and general assumptions. The specific assumptions relate to the Work Statement and Program design and objectives, timing, capital expenditure requirements, if any, and other matters relating to the completion of the Program as set forth in the Work Statement (the “ Program Assumptions ”). Gallus also assumes that the Customer will cooperate and perform its obligations under the Agreement in a timely manner, that no event outside the reasonable control of Gallus will occur, including the events described in Section 21, and that there are no changes to any Applicable Laws that affect the Program (collectively, the “ General Assumptions ,” and together with the Program Assumptions, collectively, the “ Assumptions ”). In the event that any of the Assumptions require modification or the objectives of the Program cannot be achieved based on the Assumptions then the Work Statement may be amended as provided in Section 9(b).
 
(b) Any change in (i) the details of a Work Statement or (ii) the Assumptions upon which the Work Statement is based (including but not limited to, changes regarding the start date for a Work Statement or suspension of a Work Statement), may require changes to the budget, scope of work, and/or timelines (collectively a “Modification”). Either Party may request a Modification to the Work Statement by notifying the other Party of the requested change(s) in reasonable detail. Gallus shall use reasonable efforts to provide the Customer with a change order containing an estimate of the required adjustments to the Service Fees within ten (10) business days of receiving or delivering such notice (the “ Change Order ”). The Customer shall respond in writing to such Change Order promptly, but in any event within three (3) business days. If Customer does not approve such Change Order and has not terminated this Agreement and the Program in accordance with Section 23 but wants the Program to be modified to take into account the Modification, then Customer and Gallus shall use commercially reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Gallus may, in its discretion, continue to work on the Program but Gallus shall not be obligated to continue to work on the Program during any such negotiations. Customer acknowledges and agrees that, due to commitments to its other customers, Gallus may be unable to accommodate a proposed change to the start date for a Work Statement or other change to the agreed upon schedule for the performance of Services. In the event that Gallus is able to accommodate such a proposed change, Gallus reserves the right to charge, and Customer agrees to pay, a reasonable fee for idle capacity that arises as a result of such change, provided that Gallus has first attempted with commercially reasonably efforts to utilize any such idled capacity on other of Gallus’s third party projects. Gallus shall not commence work with respect to a Change Order unless authorized in writing. Any disagreement between the Parties concerning a Change Order (including the failure of the Parties to agree upon a mutually acceptable Change Order) shall be resolved in accordance with the dispute-resolution procedures set forth in Section 17.
 
9
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
10.  Confidential Information/Legal Proceedings/Publicity .
 
(a) In addition to any confidentiality obligations between the Parties existing prior to the Effective Date, each Party (the “ Receiving Party ”) agrees that it shall use the other Party’s (the “ Disclosing Party’s ”) Confidential Information solely to conduct the activities contemplated under this Agreement and for no other purpose. Confidential Information of a Disclosing Party shall only be disclosed to the those employees and agents of the Receiving Party or of Receiving Party’s Affiliates who have a need to know such Confidential Information and only to the extent necessary in order to fulfill the Receiving Party’s obligations or exercise the Receiving Party’s rights under this Agreement, who have been informed of the confidential nature of such information and who are obligated by written agreement to comply with confidentiality provisions no less restrictive than those set forth in this Agreement. Notwithstanding the foregoing, the Receiving Party shall not be prevented from using or disclosing any portion of the Disclosing Party’s Confidential Information that: (i) is or becomes publicly available other than as a result of a breach of this Agreement by the Receiving Party; (ii) is disclosed to the Receiving Party by a Third Party which the Receiving Party reasonably believes is entitled to disclose it without restriction; (iii) is already known to the Receiving Party as shown by its prior written records; (iv) is independently developed by employees of the Receiving Party that were not privy to nor had access to such Confidential Information or (v) is required by any Applicable Law, order decision, decree, subpoena or other legal process to be disclosed. If such disclosure is requested by legal process, the Receiving Party will notify the Disclosing Party of this request promptly prior to any disclosure to permit the Disclosing Party to oppose such disclosure by appropriate legal action and thereafter the Receiving Party will disclose only the minimum information required to be disclosed in order to comply.
 
(b) Gallus will not transfer any Customer Provided Materials to any Third Party without Customer’s written permission, unless such transfer is to a subcontractor pre-approved by Customer and is consistent with the Program.
 
(c) If Gallus becomes obliged to provide testimony or records regarding the Program in any legal or administrative proceeding, Customer shall reimburse Gallus for its reasonable out-of-pocket costs plus an hourly fee of [*****] for its employees or representatives.
 
(d) Neither Party shall make a press release, announcement or other formal publicity relating to the transactions which are the subject of this Agreement, or any ancillary matter, without first obtaining the prior written consent of the other Party. The Party wishing to make such release, announcement or publicity shall provide a copy of the text thereof to the other Party at least ten (10) days prior to the proposed release.
 
11.  Work Product; Records .
 
(a) All work outputs (e.g., reports) will be prepared on Gallus  standard format unless otherwise specified in the Work Statement.
 
(b) For the longer of seven years from the date of manufacture or (ii) the time required by Applicable Law (the “ Retention Period ”), Gallus shall keep and maintain records sufficient to substantiate and verify its duties and obligations relating to Program. In no event shall Gallus be required to store such records for longer than the Retention Period. For clarity, Gallus shall be entitled to retain all original documents relating to the Program and shall provide to Customer an electronic and paper copy of all Batch Records and other reports provided under this Agreement.
 
(c) Customer shall have the right to inspect all records related to work performed on the Work Statement on the premises of Gallus, by giving written notice to Gallus at least ten (10) business days in advance of the date of inspection.
 
10
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
12.  Intellectual Property .
 
(a) If and to the extent applicable under a Work Statement, each Party acknowledges and agrees that the performance of both of Parties’ activities contemplated hereunder is subject to the terms and conditions set forth on  Appendix 2 .
 
(b) As between the Parties, except as expressly provided in this Agreement, each Party will retain exclusive right, title and interest in and to its Background Technology and all Improvements thereto. Except as expressly provided in this Agreement, neither Party has, by virtue of this Agreement, any right, title, or interest to or in the other Party’s Background Technology. Each Party hereby assigns to the other Party, and agrees to assign to the other Party all of its right, title and interest in or to such other Party’s Background Technology.
 
(c) At Customer’s request, which shall be provided in writing by Customer, Gallus will assign to Customer any interest Gallus may have in any Product Invention; provided, that Customer requests such assignment, in writing, within one year of Gallus’s notification to Customer of such Product Invention. If Customer requests in writing, Gallus will, at Customer’s expense, execute any and all applications, assignments or other instruments and give testimony which shall be necessary to apply for and obtain Patents with respect to a Product Invention and Customer shall compensate Gallus at its standard commercial rate for the time devoted to such activities and reimburse it for expenses incurred.
 
(d) Notwithstanding anything to the contrary herein, Gallus shall retain all rights in and to the Gallus Technology. To the extent that Customer retains any interest in such Gallus Technology, Customer hereby assigns to Gallus and agrees to assign to Gallus all of Customer’s right, title and interest in or to such Gallus Technology.
 
(e) Customer hereby grants to Gallus a non-exclusive, royalty-free license to use Customer’s Background Technology, Product Inventions and any other Technology provided to or made available to Gallus hereunder for the sole purpose of performing Gallus’ obligations hereunder.
 
(f) In the event that any Background Technology of Gallus or Gallus Technology is incorporated into the Process hereunder, Gallus hereby grants to Customer a non-exclusive, worldwide, paid-up license to use such Background Technology or Gallus Technology solely to the extent necessary to practice the Process solely in connection with the development or manufacture of Product. The foregoing license shall only apply to such Background Technology of Gallus or Gallus Technology as is used by Gallus in its performance hereunder and incorporated into the Process, and for which Customer cannot develop or acquire an alternative technology without substantial expense or delay.
 
(g) Notwithstanding Sections 10 or 12, Gallus reserves the right to utilize data generated during the course of the Program to support applications, assignments or other instruments necessary to apply for and obtain Patents with respect to Gallus Technology. Gallus shall notify Customer in advance of any such application.
 
13.  Independent Contractor . Gallus shall perform the Services as an independent contractor of Customer and shall have complete and exclusive control over its Facility, equipment, employees and agents. Nothing in this Agreement or other arrangements for which it is made shall constitute Gallus, or anyone furnished or used by Gallus in the performance of the Services, as an employee, joint venture, partner, or servant of Customer. Gallus also agrees that it shall not have any rights to receive any employee benefits such as health insurance and accident insurance, sick leave or vacation as are in effect generally for employees of Customer. Neither Party will enter into any agreements or incur obligations on behalf of the other Party, nor commit the other Party in any other manner without prior written consent from a duly authorized officer or representative of such other Party.
 
11
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
14.  Insurance . During the performance of the Services, Gallus agrees to maintain a standard property insurance policy covering the Product and Materials while under control and care of Gallus. Customer agrees to maintain general liability insurance including bodily injury, death and property damage with limits not less than of Two Million Dollars (US $2,000,000) per occurrence and Five Million Dollars (US $5,000,000) in aggregate, provided that such limits shall, unless otherwise agreed between the Parties, be increased to not less than Five Million Dollars (US $5,000,000) per occurrence and Ten Million Dollars (US $10,000,000) in the aggregate including product liability coverage at all times during the Program when the Product and Materials are being used clinically and thereafter, covering the Cell Line, Product and Materials or any harms caused by the Cell Line, Product and Materials, and to name Gallus as an additional insured under such policy at no cost to Gallus. Customer further agrees to provide Gallus with a Certificate(s) of Insurance issued to Customer for an insurance policy or policies directed to the aforementioned insurance coverage, in which Gallus is named as an additional insured. Customer acknowledges that Customer shall bear (i) risk of loss, destabilization, alteration, aggregation or contamination of the Product or Materials due to any and all causes or hazards unless such of loss, destabilization, alteration, aggregation or contamination of the Product or Materials is a result of negligence or willful misconduct by Gallus, and (ii) risk of injury to Persons or property alleged to have been caused by the design, manufacture, testing, instructions or warnings accompanying the Cell Line, Product or Materials or the use or unavailability of the Cell Line, Product or Materials, including patent or other Intellectual Property Rights of Third Parties alleged to have been infringed by the manufacture, use, importation, or sale of the Product or Materials.
 
15.  Shipping . Gallus shall package for shipment Product, samples or other materials in accordance with the Work Statement and Customer’s written instructions and at the Customer’s expense. All shipments will be EX Works (Incoterms 2010) the Facility and Customer shall bear all packaging, shipping and insurance charges. Gallus will pass through actual shipping and related charges as set forth in the Work Statement. Delivery of Product, samples or other materials by Gallus shall be deemed to have taken place upon delivery to carrier at the Facility. Title and risk of loss shall transfer to Customer on transfer to carrier at the Facility. Gallus shall accept no liability or responsibility and risk associated with failure of the Product to meet Specifications once this transfer has occurred, provided the Product was shown to have met Specifications at the time of such transfer. Gallus reserves the right to retain representative samples of Product for record keeping, testing and regulatory purposes.
 
16.  Contamination . In the event that Customer supplies Product-Dedicated Equipment, Materials or Product, and the handling or use of such Product-Dedicated Equipment, Materials or Product at the Facility in accordance with Gallus SOP and the terms of this Agreement results in contamination of equipment, facilities, personnel of Gallus or any Third Party by noxious or toxic agents, infectious agents (including any microbiological or viral agents of infection (e.g., bacteria, fungae, mycoplasmas, prions, and viruses)) and/or corrosive agents (collectively, “Contaminants”), Customer assumes full responsibility and liability for any and all resulting damages.
 
17.  Dispute Resolution .
 
(a) In the event any dispute shall arise between the Customer and Gallus with respect to any of the terms and conditions of this Agreement or the Program that cannot be resolved by the Customer and Gallus Program Managers or by the Steering Committee, then senior executives of the Customer and Gallus shall meet as promptly as practicable after notice of such dispute to resolve in good faith such dispute.
 
(b) If the Customer and Gallus are unable to satisfactorily resolve the dispute, then such dispute shall be finally settled by arbitration in accordance with this Section 17. The arbitration will be held in New York, New York, and except as noted below, shall be conducted in accordance with the rules
 
12
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
of the American Arbitration Association (or such successor organization) by one mutually agreeable arbitrator. If the Parties cannot agree on an arbitrator within a reasonable period of time, an arbitrator will be appointed by the American Arbitration Association (or such successor organization). The arbitrator shall have no authority to vary from or ignore the terms of this Agreement and shall be bound by controlling law. The Parties may seek judicial intervention for emergency relief, such as restraining orders and injunctions where appropriate.
 
(c) Any decision by the arbitrator shall be binding upon the Parties and may be entered as final judgment in any court having jurisdiction. Each Party shall bear its own costs associated with the arbitration proceeding, unless and to the extent the arbitrator shall determine as part of his or her decision. The arbitrator shall render his or her final decision in writing to the Parties.
 
18.  Indemnification .
 
(a) Customer shall indemnify and hold harmless Gallus and its Affiliates and each of its directors, officers, employees and shareholders (the “ Gallus Parties ”) against any and all Third Party charges, complaints, actions, suits, proceedings, hearings, investigations, claims and demands (“Claims”) imposed upon a Gallus Party and associated damages awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations and expenses payable or awarded to a Third Party with respect to a Claim, together with all reasonable documented out-of-pocket costs and expenses incurred in defending against or complying with any Claims of a Third Party in accordance with the terms of this Agreement (collectively, “Losses”) suffered or incurred in consequence of the following:
 
 
(i)
any material failure by Customer to perform any obligations under this Agreement and any un-remedied breach by Customer of the representations, warranties or covenants given in this Agreement;
 
 
(ii)
any infringement or alleged infringement or breach of any Third Party’s rights, including Intellectual Property Rights, by a Party by use of the Product, Process, Customer’s Confidential Information, Customer’s Background Technology and/or Customer Provided Materials in the performance of the Program in accordance with the terms and conditions of this Agreement;
 
 
(iii)
any product liability or other claims relating to the Product or Customer Provided Materials including any derivatives of the foregoing, conjugated form or formulation of the same to the extent such claim is based on the sale, marketing, distribution or use of the Product following Gallus’ release; or
 
 
(iv)
the negligence of Customer in relation to the use, processing, storage or distribution of the Product or any derivative, conjugated form or formulation thereof;
 
provided, however, that Customer shall have no obligation to indemnify Gallus to the extent that any such Claims and associated Losses are caused by Gallus’ own negligence or willful misconduct in the performance of its rights and obligations under this Agreement or by Gallus’ breach of a representation, warranty or covenant herein or failure by Gallus to perform an express obligation under this Agreement.
 
(b) Gallus shall indemnify and hold harmless Customer and its Affiliates and each of its directors, officers, employees and shareholders (the “ Customer Parties ”) against any and all Third Party Claims and associated Losses that the Customer Parties suffered or incurred in consequence of the following:
 
13
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(i)
any material failure by Gallus to perform any obligations under this Agreement and any un-remedied breach by Gallus of the representations, warranties or covenants given pursuant to Section 20;
 
 
(ii)
any infringement or alleged infringement or breach of any Third Party’s rights, including Intellectual Property Rights, by any Party by performance under this Agreement or the use of the Gallus Technology, Gallus’ Confidential Information and/or Gallus’ Background Technology in the performance of the Program in accordance with the terms and conditions of this Agreement; or
 
 
(iii)
the negligence of Gallus in relation to the manufacture, use, processing or storage of the Product or any derivative, conjugated form or formulation thereof;
 
provided, however, that Gallus shall have no obligation to indemnify Customer to the extent that any such Claims and associated Losses are caused by Customer’s own negligence or willful misconduct in the performance of its rights or obligations hereunder or by Customer’s breach of a representation, warranty or covenant herein or failure by Customer to perform an express obligation under this Agreement.
 
(c) Upon receipt of notice of any Claim that may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification (the “ Indemnified Party ”) shall give written notice thereof to the other Party, (the “ Indemnifying Party ”) of the Claim for indemnity. Such Claim for indemnity shall indicate the nature of the Claim and the basis therefore. Promptly after a claim is made for which the Indemnified Party seeks indemnity, the Indemnified Party shall permit the Indemnifying Party, at its option and expense, to assume the complete defense of such Claim, provided, that, (i) the Indemnified Party will have the right to participate in the defense of any such Claim at its own cost and expense; (ii) the Indemnifying Party will conduct the defense of any such Claim with due regard for the business interests and potential related liabilities of the Indemnified Party; and (iii) the Indemnifying Party will, prior to making any settlement, consult with the Indemnified Party as to the terms of such settlement. The Indemnifying Party will not, in defense of any such Claim, settle or consent to an adverse judgment in any such claim, demand, action or other proceeding that adversely affects the rights or interests of any Indemnified Party or imposes additional obligations (financial or otherwise) on such Indemnified Party, without the prior express written consent of such Indemnified Party (such consent not to be unreasonably withheld). After notice to the Indemnified Party of the Indemnifying Party’s election to assume the defense of such Claim, the Indemnifying Party shall only be liable to the Indemnified Party for such reasonable legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof at the request of the Indemnifying Party. As to those Claims with respect to which the Indemnifying Party does not elect to assume control of the defense, the Indemnifying Party shall be liable for all reasonable legal or other expenses incurred by the Indemnified Party in connection with the defense thereof and the Indemnified Party will afford the Indemnifying Party an opportunity to participate in such defense at the Indemnifying Party’s own cost and expense, and will not settle or otherwise dispose of any of the same without the consent of the Indemnifying Party (such consent not to be unreasonably withheld, conditioned or delayed.) If Gallus shall be obliged to provide testimony or records regarding the subject matter of this Agreement in any legal or administrative proceeding not covered by the indemnity set forth above, Customer shall reimburse Gallus for its reasonable out-of-pocket costs plus a reasonable hourly fee for its employees or representatives at Gallus’ standard commercial rates. If Customer shall be obliged to provide testimony or records regarding the subject matter of this Agreement in any legal or administrative proceeding pursuant to any general inspection of Gallus’ Facility or operations, Gallus shall reimburse Customer for its reasonable out-of-pocket costs plus a reasonable hourly fee for its employees or representatives at cost.
 
19.  Limitations Liability .
 
 
14
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(a)  Consequential Damages Waiver . EXCEPT FOR AMOUNTS PAYABLE TO THIRD PARTIES PURSUANT TO SECTION 18 OR DAMAGES PURSUANT TO SECTION 16, UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES ARISING IN CONNECTION WITH THIS AGREEMENT, THE WORK STATEMENT OR ANY DOCUMENTS OR APPENDICES RELATED THERETO. IN NO EVENT SHALL GALLUS’ LIABILITY UNDER THIS AGREEMENT EXCEED THE SERVICE FEES RECEIVED BY GALLUS WITH RESPECT TO THE BATCH GIVING RISE TO THE LIABILITY IN QUESTION. THE LIMITATIONS OF LIABILITY REFLECT THE ALLOCATION OF RISK BETWEEN THE PARTIES. THE LIMITATIONS SPECIFIED IN THIS SECTION 19(A) WILL SURVIVE AND APPLY EVEN IF ANY LIMITED REMEDY SPECIFIED IN THIS AGREEMENT IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE.
 
20.  Representations, Warranties and Covenants .
 
(a) Customer hereby represents, warrants and covenants to Gallus that the Customer Provided Materials will be provided to Gallus free and clear of all liens and encumbrances and will be free of Contaminants.
 
(b) Customer will notify Gallus immediately if Customer knows or should know that it is no longer entitled to supply the Cell Line, Materials, process patents, Products, any other materials and/or the Customer Confidential Information to Gallus or that the use by Gallus of such materials and/or information infringes or is alleged to infringe any rights (including any intellectual or industrial property rights) vested in any Third Party.
 
(c) Customer hereby represents, warrants and covenants to Gallus that it will comply with all Applicable Laws relating to the use, sale, distribution and testing of the Materials, Cell Line and Product and that such proper use, sale, distribution and testing of the Materials, Cell Line and Product pose no environmental hazards.
 
(d) Customer hereby represents, warrants and covenants to Gallus that any technical or regulatory information or documentation supplied or that will be supplied by Customer or on its behalf to Gallus (including process details, analytical methods, Specifications, development reports, technology transfer documents, plans, engineering documents and other documents) and required for execution of the Program is accurate and suitable for its intended use.
 
(e) Each Party hereby represents, warrants and covenants to the other Party that, as of the Effective Date, it has full power and authority to enter into, deliver and perform its obligations under this Agreement, and it has taken all action required to authorize the execution and delivery of this Agreement and to consummate the transactions contemplated hereby and the Person signing this Agreement on behalf of such Party has been duly authorized to act on behalf of and to bind such Party.
 
(f) Gallus warrants and represents that (i) the Program will be performed in accordance with standard industry custom, and (ii) it will use commercially reasonable efforts to achieve the estimated deadlines for the Program.
 
(g) Gallus warrants and represents that the Services performed hereunder will conform in all material respects to the applicable Work Statement (as may be amended from time to time pursuant to Section 9, above, and will be free from an uncorrected Gallus Failure.
 
15
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(h) Gallus’s sole liability and Customer’s sole and exclusive remedy for a breach by Gallus of a warranty hereunder shall be for Gallus to repeat the applicable Services at no additional cost to Customer and as soon as commercially reasonable (taking into account manufacturing suite availability if applicable), provided that if the applicable Services include a manufacturing run, Customer will be responsible for the cost of Materials for such repeated manufacturing run unless and to the extent the failure of such run is due to Gallus’s gross negligence or willful misconduct, in which case Gallus shall be responsible for the Materials cost. For the avoidance of doubt, in the event Gallus is required to re-perform any aseptic filling services pursuant to this Section 20(h), Customer shall have sole responsibility for any costs or expenses associated with procuring or manufacturing any additional Drug Substance and any filling components that may be required for such re-performance.
 
(i) THE EXPRESS WARRANTIES OF GALLUS SET FORTH IN THIS SECTION 20 ARE IN LIEU OF ALL CONDITIONS, WARRANTIES AND STATEMENTS IN RESPECT OF THE PROGRAM AND/OR THE PRODUCT, WHETHER EXPRESS OR IMPLIED BY STATUTE, CUSTOM OF THE TRADE OR OTHERWISE INCLUDING ANY SUCH CONDITION, WARRANTY OR STATEMENT RELATING TO THE DESCRIPTION OR QUALITY OF THE PRODUCT UPON COMPLETION OF GALLUS’ SERVICES, ITS MERCHANTABILITY ITS FITNESS FOR A PARTICULAR PURPOSE OR USE UNDER ANY CONDITIONS, WHETHER OR NOT KNOWN TO GALLUS, AND THAT ANY SUCH CONDITION, WARRANTY OR STATEMENT IS EXCLUDED FROM THIS AGREEMENT.
 
21.  Force Majeure . Either Party shall be excused from performing its respective obligations under this Agreement, except for any obligation to make payment under a validly issued invoice, if its performance is delayed or prevented by any event beyond such Party’s reasonable control, including weather, disease, war, terrorism, insurrection, civil strife, riots, labor dispute or strike, government action, or power failure exceeding 24 hours, provided that such performance shall be excused only to the extent of and during such disability. Any time specified for completion of performance in the Work Statement falling due during or subsequent to the occurrence of any or such events shall be extended for a period of time reasonably necessary to recover from such disability. Gallus will promptly notify Customer if, by reason of any of the events referred to herein, Gallus is unable to meet any such time for performance specified in the Work Statement. If any part of the Program is invalid as a result of such disability, Gallus will, upon written request from Customer, but at Customer’s sole cost and expense, repeat that part of the Program affected by the disability.
 
22.  Use of Names . Neither Party shall use the name or trademarks of the other Party in the promotion of its business without the prior written consent of such other Party.
 
23.  Term; Termination .
 
(a) This Agreement shall commence on the Effective Date and shall continue in full force and for the longer of (i) a period of five (5) years or (ii) through the completion of Services, unless earlier terminated in accordance with this Section 23.
 
(b) Subject to Section 23(e), this Agreement may be terminated in the following ways:
 
 
(i)
The Parties may terminate this Agreement by mutual written agreement at any time prior to Completion.
 
 
(ii)
Customer may terminate this Agreement for any reason by giving Gallus no less than ninety (90) days written notice.
 
16
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(iii)
Gallus may terminate this Agreement at any time up to completion of the Process Demonstration Stage by giving written notice to Customer if Gallus reasonably believes that it will be unable to carry out and complete the Services in accordance with the Work Statement due to discovery of a factor which:
 
(A) adversely affects the development of the Process; or
 
(B) adversely affects production of Product by the Process when conducted in accordance with the Gallus SOP;
 
Provided that in either case the factor was not known and could not reasonably have been known at the commencement of the applicable Stage of the Program and provided further that Gallus has used commercially reasonable efforts in its attempts to address the factor prior to such termination.
 
 
(iv)
Either Party may terminate this Agreement if the other is in material breach of this Agreement and does not rectify such breach (if such breach is capable of remedy) within fourteen (14) calendar days for monetary defaults or thirty (30) calendar days for non-monetary defaults (or such additional time reasonably necessary to cure such non-monetary default provided the breaching Party has commenced a cure within the thirty (30) day period (or such other period as is reasonably practicable) and is diligently pursuing completion of such cure) after receipt by the breaching Party of written notice of such default.
 
 
(v)
Either Party may terminate this Agreement immediately by giving written notice if the other has a liquidator, receiver, manager receiver or administrator appointed, or ceases to continue trading or is unable to pay debts or the equivalent occurs in any jurisdiction in which the other is resident or carried on business.
 
(c) The following provisions shall apply if the Agreement is terminated by mutual agreement under Section 23(b)(i), Customer terminates for convenience under Section 23(b)(ii), or Gallus terminates due to technical issues under Section 23(b)(iii) or for Customer’s material breach or insolvency under Section 23(b)(iv) or 23(b)(v):
 
 
(i)
Customer shall pay to Gallus all sums incurred up to the date of termination but not yet paid, including sums which have been incurred but not invoiced at the date of termination (including all sums due in relation to items referred to in Section 8), and
 
 
(ii)
Customer shall pay to Gallus:
 
(A) except where Gallus terminates due to technical issues under Section 23(b)(iii) relating to cancellation of such of the Non-GMP Stages as may be uncompleted at termination (including the effect of redeployment of the Program team), an amount as set forth below to cover Gallus’s cost to wind down the Program:
 
(a) [*****]
 
(b) [*****]
 
(c) [*****]
 
17
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(B) for the avoidance of doubt, Gallus shall retain all deposits or advance payments made under an applicable Work Statement, including without limitation, manufacturing suite reservation fees and deposits.
 
(d) If the Agreement is terminated by Customer for Gallus’s un-remedied material breach under Section 23(b)(iv), Customer’s total remedy for such breach shall be equivalent to any monies paid to Gallus, less a sum in consideration for Services provided by Gallus in carrying out the Program and completed as of the date of termination but not affected by the breach. In the absence of agreement upon such sum, the provisions of Section 17 shall apply. On termination for any reason, Gallus will return, ship, or destroy Materials at the Customer’s direction and sole expense, including expenses relating to shipping costs, return fees to vendors and any unreimbursed costs on any non-refundable or non-returnable items.
 
(e) The termination of this Agreement for any reason shall not relieve either Party of its obligation to the other Party for obligations in respect of compensation for services performed prior to the effective date of such expiration or termination. The following provisions shall survive any expiration or termination of this Agreement: Sections 1, , 2(c), 2(d), 4(c), 4(d), 5(b), 8, 10, 11(b), 12, 13, 14, 16 through 20 and 22 through 29.
 
24.  Assignment . This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however, either Party may, without such consent, assign this Agreement (i) in connection with the transfer or sale of all or substantially all of the assets of such Party to which this Agreement relates or, in the case of Customer, the Cell Line or Product; (ii) in the event of the merger or consolidation of a Party hereto with another company; or (iii) to any Affiliate of the assigning Party. Any purported assignment in violation of the preceding sentence shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement, provided however that if Customer assigns this Agreement to an Affiliate, the Customer shall continue to remain obligated under this Agreement.
 
25.  Notice . All notices to be given as required in the Agreement shall be in writing and may be delivered personally, or mailed either by a reputable overnight carrier with required receipt signature or certified mail, postage prepaid to the Parties at the addresses set forth above or at such other address as either Party may provide by written notice to the other Party in accordance with the provisions of this Section 25 Such notice shall be effective: (i) on the date sent, if delivered personally or by email (receipt of which is confirmed); (ii) the date after delivery if sent by overnight carrier; or (iii) on the date received if sent by certified mail.
 
 
(i)
If to Customer
 
MabVax Therapeutics
11588 Sorrento Valley Rd.; Suite 20
San Diego CA 92121
Attn: J. David Hansen
Facsimile: 858-792-7375
 
If to Gallus:
 
Gallus BioPharmaceuticals NJ, LLC
201 College Road East,
Princeton, NJ 08540
Attn: Legal Counsel
email:  george.love@gallusbiopharma.com
 
18
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
26.  Choice of Law . Subject to the dispute resolution procedures set forth in Section 17, this Agreement, and all matters arising directly or indirectly hereunder, shall be governed by, and construed in accordance with the laws of the State of New York, without giving effect to its choice of law provisions.
 
27.  Waiver/Severability . No waiver of any provision of this Agreement, whether by conduct or otherwise, in any one or more instances shall be deemed to be or be construed as a further or continuing waiver of any such provision, or of any other provision or condition of this Agreement. The invalidity of any portion of this Agreement shall not affect the validity, force or effect of the remaining portions of this Agreement. If it is ever held that any provision hereunder is too broad to permit enforcement of such provision to its fullest extent, such provision shall be enforced to the maximum extent permitted by law.
 
28.  Entire Agreement; Modification/Counterparts . This document (and the Work Statement and Appendices attached hereto) sets forth the entire Agreement between the Parties hereto with respect to the performance of the Program by Gallus for Customer and as such, supersedes all prior and contemporaneous negotiations, agreements, representations, understandings, and commitments with respect thereto and shall take precedence over all terms, conditions and provisions on any purchase order form or form of order acknowledgment or other document purporting to address the same subject matter. This Agreement shall not be waived, released, discharged, changed or modified in any manner except by an instrument signed by the duly authorized officers of each of the Parties hereto, which instrument shall make specific reference to this Agreement and shall express the plan or intention to modify same. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. In the event of any conflict between this Agreement and a Work Statement, as it may be modified as provided herein, the terms of this Agreement shall control unless the Work Statement expressly provides otherwise. For purposes of execution, facsimile signatures shall be deemed originals.
 
29.  Construction . Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). The headings and captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.
 
IN WITNESS WHEREOF , the Parties hereto have caused this Agreement to be executed as of the Effective Date by their duly authorized representatives.
 
                 
GALLUS BIOPHARMACEUTICALS NJ, LLC
     
CUSTOMER
         
By:
 
/s/ Mark R. Bamforth
     
By:
 
/s/ J. David Hansen
Name:
 
Mark R. Bamforth
     
Name:
 
J. David Hansen
Title:
 
President and CEO
     
Title:
 
President and CEO
 
19
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
APPENDIX 1
 
Form of Work Statement
 
MabVax 031214-03 Final
Development and Manufacturing of 5B1
Prepared for MabVax Therapeutics
April 11, 2004
Gallus Program Reference: Pasteur
 
20
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
APPENDIX 2
 
Required Third Party Provisions
 
Notwithstanding any other provision of this Agreement to the contrary, the Parties acknowledge and agree that all right, title and interest in and to Xcellerex Technology and Xcellerex Related Inventions shall remain the exclusive property of Xcellerex. Customer hereby assigns and agrees to assign to Xcellerex all of Customer’s right, title and interest to any Xcellerex Related Inventions developed in the course of the performance of any activities under this Agreement, including any patent rights or other Intellectual Property Rights therein.
 
As used in this Appendix 2, the following terms have the corresponding meanings:
 
(a) “ Xcellerex ” means Xcellerex, Inc.
 
(b) “ Xcellerex Related Inventions ” means any Invention that relates directly to the design or modification of the Xcellerex Systems. For the purposes of this definition, “directly” means “in a direct manner” and/or “immediately applicable.”
 
(c) “ Xcellerex Systems ” means (i) Xcellerex bioreactors and mixers known as XDR™ and XDM™, (ii) FlexFactory systems and methods, (iii) bags and other consumables, (iv) downstream purification systems and methods that are proprietary to Xcellerex, (v) the Xcellerex product and process control systems and methods and electronic batch record technology, (vi) PDMax ® , in each case for (i) through (vi) developed or obtained by or on behalf of Xcellerex, and (vii) integrated product and process controls for systems provided by Third Party vendors to Xcellerex.
 
(d) “ Xcellerex Technology ” means “any Technology developed or obtained by or on behalf of Xcellerex that relates to Xcellerex SOPs, including mammalian and microbial cell culture in disposable bioreactors and downstream purification systems and methods that are proprietary to Xcellerex, Xcellerex bioreactors and mixers known as XDR™ and XDM™, FlexFactory systems and methods, bags and other consumables, the Xcellerex process control systems and methods and electronic batch record technology, PDMax ®  and integrated product and/or process controls for systems provided by Third Party vendors to Xcellerex.
 
21
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit 10.7
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXCLUSIVE LICENSE AGREEMENT
 
for SKI’s technology
 
“Polyvalent Conjugate Vaccines for Cancer”
(SK#14491)
 
TABLE OF CONTENTS
 
         
PREAMBLE
   
  
 
ARTICLES:
   
  
 
I
 
DEFINITIONS
II
 
GRANT; IP OWNERSHIP
III
 
DUE DILIGENCE
IV
 
DEVELOPMENT COLLABORATION
V
 
PAYMENTS
VI
 
REPORTS AND RECORDS
VII
 
CONFIDENTIALITY
VIII
 
PATENT PROSECUTION
IX
 
INFRINGEMENT
X
 
INDEMNIFICATION, PRODUCT LIABILITY; REPRESENTATIONS
XI
 
EXPORT CONTROLS
XII
 
NON-USE OF NAMES
XIII
 
ASSIGNMENT
XIV
 
TERM; TERMINATION
XV
 
PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
XVI
 
MISCELLANEOUS PROVISIONS
Exhibit A
  
PATENT RIGHTS
Exhibit B
  
CLINICAL TRIALS
Exhibit C
  
DEVELOPMENT PLAN
Exhibit D
  
MATERIALS TRANSFER AGREEMENT
 
June 20th, 2008
 
1
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
This Exclusive License Agreement (the “Agreement”) is effective on the date last subscribed below (the “Effective Date”), and is by and between  Sloan-Kettering Institute for Cancer Research  (hereinafter referred to as “SKI”), a New York membership corporation with principal offices at 1275 York Avenue, New York, New York 10065, and  MabVax Therapeutics, Inc ., a Delaware corporation with principal offices located at 11588 Sorrento Valley Road, Suite 20, San Diego, CA 92121 (“LICENSEE”).
 
WITNESSETH
 
WHEREAS, SKI is the sole owner of certain Patent Rights and Know How (each as later defined herein) and has the right to grant licenses under said Patent Rights and Know How; and
 
WHEREAS, SKI desires to have the Patent Rights and Know How utilized in the public interest and is willing to grant a license to its interest thereunder; and
 
WHEREAS, LICENSEE seeks to commercially develop the Patent Rights through a program of exploiting the Patent Rights whereby it expects public utilization shall result therefrom; and
 
NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto agree as follows:
 
ARTICLE I - DEFINITIONS
 
For the purpose of this Agreement, the following words and phrases shall have the following meanings:
 
1.1
“Affiliates” shall mean any person, firm, corporation or other entity controlling, controlled by, or under common control with a party hereto. For the purpose of the preceding sentence, the term “control” shall mean ownership, directly or indirectly, of more than 50% of the equity capital or the authority, directly or indirectly, to appoint a majority of the directors of another entity. With regard to SKI, “Affiliate” shall mean the Memorial Sloan-Kettering Cancer Center and the Memorial Hospital for Cancer and Allied Diseases.
 
1.2
“Biological Materials” shall mean materials controlled by SKI necessary or useful to develop the Licensed Process or Licensed Product, including (a) serum samples from patients in Phase I Clinical Trials or Phase II Clinical Trials conducted by SKI; (b) frozen and stored serum samples from patients in previous clinical trials; (c) antigens for flow cytometry and ELISA; (d) complement lysis assay materials; (e) sample vaccines used in the Phase I Clinical Trials or Phase II Clinical Trials conducted by SKI; (f) conjugates for mouse testing; (g) mouse antibodies; (h) cell lines; and (i) any other materials requested by LICENSEE and actually agreed in writing to be provided by SKI under a Materials Transfer Agreement in the form attached hereto as Exhibit D.
 
2
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.3
“Clinical Data” shall mean all preclinical, clinical, pharmacology, toxicology, safety, and efficacy data, and similar information of SKI, in the form of case reports in the case of data from clinical trials, as well as any summary and analytical information produced by SKI in the normal course of conduct of the clinical trials, relating solely to the Licensed Product or Licensed Processes, whether existing as of the Effective Date or acquired thereafter by SKI, including such data and information obtained in connection with the Phase I Clinical Trials and Phase II Clinical Trials conducted by SKI pursuant to Sections 4.2(a) and (b), respectively or pursuant to any other clinical trials conducted by SKI, as provided in Section 4.6.
 
1.4
“Commercially Reasonable Efforts” shall mean the reasonable efforts and resources of similarly situated companies, or in the case of SKI shall mean similarly situated research institutions, that are consistent with sound business judgment taking into consideration stage of development or product life, product labeling, the development potential, regulatory environment, market potential, safety and efficacy, patent or other proprietary position, economic return, and competitive market conditions, all measured by the facts and circumstances at the time such efforts are due.
 
1.5
“Confidential Information” shall mean all proprietary materials or other information (whether or not patentable) disclosed by one party to the other that is identified as proprietary or confidential by the disclosing party or that would be reasonably understood to be the type of information that should be treated as proprietary or confidential. The terms of this Agreement shall be considered the Confidential Information of both parties. “Confidential Information” will not include any information that the receiving party can demonstrate by competent evidence that the information disclosed:
 
 
(a)
was in the public domain prior to the date of the disclosure; or
 
 
(b)
enters the public domain through no breach of this Agreement by the receiving party;
 
 
(c)
was already known to the receiving party at the time of disclosure;
 
 
(d)
is subsequently received by the receiving party on a nonconfidential basis in good faith from a third party without breaching any confidential obligation between the third party and the disclosing party; or
 
 
(e)
is independently developed by the receiving party without reference to or any other use of the disclosing party’s Confidential Information.
 
1.6
“Development Plan” means the description of the activities to be conducted by SKI with respect to the Phase I Clinical Trials and the Phase II Clinical Trials pursuant to Section 4.2(a) and (b), respectively, and any assistance to be provided by LICENSEE with respect to such clinical trials. The Development Plan is attached hereto as Exhibit C.
 
3
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.7
“FDA” shall mean the United States Food and Drug Administration, its equivalent in another country, or successor agencies thereto.
 
1.8
“Field of Use” shall mean monovalent and multi-molecular polyvalent cancer vaccines, except that, for the Globo H antigen, “Field of Use” shall mean multi-molecular polyvalent cancer vaccines. Multi-molecular polyvalent cancer vaccine means a cancer vaccine containing more that one type of antigen but not in the same molecule.
 
1.9
“GAAP” shall mean generally accepted accounting principles as applicable in the United States, consistently applied.
 
1.10
“IND” shall mean an Investigational New Drug Application filed with the FDA with respect to a pharmaceutical product (or Biological IND or similar application for regulatory approval to use a molecule(s) for investigational purposes in the U.S.) and any similar foreign application, registration or certification submitted to the FDA.
 
1.11
“Know How” shall mean ideas, inventions, discoveries, trade secrets, know how, improvements, data, and information (which as of the Effective Date are not subject to a patent or patent application), together with all experience, data, formulas, procedures, and results, and improvements thereon, that (a) exist as of the Effective Date, (b) are under the ownership and control of SKI, and (c) directly relate to the Patent Rights in the Field of Use.
 
1.12
1.12 A “Licensed Process” shall mean any process which either (a) is covered in whole or in part by the Patent Rights, (b) would infringe a Valid Claim but for this Agreement, or (c) uses Know-How, in each case, in any country in which such process is practiced.
 
1.13
A “Licensed Product” shall mean any product or part thereof which:
 
 
(a)
either (i) is covered in whole or in part by the Patent Rights; (ii) would infringe a Valid Claim but for this Agreement; or (iii) uses Know-How, in each case, in the country in which any product or part thereof is made, leased, used or sold; or
 
 
(b)
is manufactured using a Licensed Process.
 
1.14
“NDA” shall mean a New Drug Application filed with the FDA with respect to a pharmaceutical product (or a Biological License Application or similar application for regulatory approval to sell a Licensed Product in the U.S.) and any similar foreign application, registration or certification submitted to the FDA.
 
1.15
“Net Sales” shall mean LICENSEE’s and its Affiliates and sublicensees’ gross invoiced sales of Licensed Products or Licensed Processes in the country of, and at the time of, sale less the sum of the following:
 
 
(a)
Discounts actually allowed and granted (including cash discounts and quantity discounts), retroactive price reductions, charge-back payments and rebates
 
4
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
granted to managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to trade customers (a “Discount”);  provided however , that, where any such Discount is based on sales of a Combination Product (as defined below), the Discount shall be allocated to such Licensed Product in the same manner as the purchase price is allocated for Combination Products, as described below;
 
 
(b)
Credits or allowances actually granted upon claims, damaged goods, rejections or returns of such Licensed Product, including such Licensed Product returned in connection with recalls or withdrawals;
 
 
(c)
Freight out, postage, shipping and insurance charges for delivery of such Licensed Product;
 
 
(d)
Taxes, tariffs, excise, sales, duties, or other taxes levied on, absorbed or otherwise imposed on the sale of such Licensed Product or Licensed Process, including value-added taxes, or other governmental charges otherwise imposed upon the billed amount, as adjusted for rebates and refunds, to the extent not paid by a third party; and
 
 
(e)
Bad debts and uncollectible receivables;  provided  that, in any calendar year, such deduction for bad debts and uncollectible receivables will not exceed 4% of the total billings for sales of Licensed Products and Licensed Processes sold in that year.
 
No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by LICENSEE and on its payroll, or for cost of collections. In the event (x) a drug product in a finished dosage form contains a Licensed Product in combination with one or more other therapeutically active ingredients or with a carrier molecule or an immunological adjuvant or (y) the Licensed Product is sold as part of a bundled set of products (in each case, a “Combination Product”), the Net Sales of the Licensed Product, for the purposes of calculating royalty payments of this Agreement, shall be determined by multiplying the Net Sales of the Combination Product by the fraction MA+B), where A is the weighted (by sales volume) average invoice price in a particular country of the Licensed Product when sold separately in finished form and B is the weighted average invoice price in that country of the other active ingredient(s) in finished form or other constituent products in the bundled set sold separately. In the event that such average invoice price cannot be determined for each of the Licensed Product and the other active ingredient(s) or other products in the Combination Product, Net Sales for purposes of determining royalty payments shall be agreed by the parties in writing based on the relative value contributed by each component.
 
For purposes of calculating Net Sales, sales between or among LICENSEE or its Affiliates or sublicensees shall be excluded from the computation of Net Sales, but sales by LICENSEE or its Affiliates or sublicensees to third parties shall be included in the computation of Net Sales.
 
5
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
Licensed Products shall be considered “sold” when billed or invoiced. In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time of shipment or when the Licensed Product is paid for, if paid for before shipment or invoice.
 
In the case of any sale or other disposal for value, such as barter or counter-trade, of the Licensed Product, or part thereof, other than in an arm’s-length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Licensed Product in the country of sale or disposal.
 
Net Sales shall be determined in accordance with GAAP.
 
Notwithstanding the foregoing or any other provision of this Agreement to the contrary, Licensed Products distributed for free or at cost and not in exchange of any non-monetary consideration, (i) for promotional or sampling purposes, (ii) for research or testing or in preclinical studies or clinical trials, or (iii) in compassionate or humanitarian use programs, shall not be considered in determining Net Sales.
 
1.16
“Non-Royalty Sublicense Revenue” shall mean the amount actually received by LICENSEE from sublicensees arising from the grant of a sublicense of the right to make or sell Licensed Products or practice Licensed Processes, including up-front license fees, license issue fees, maintenance fees and milestone payments paid by a sublicensee to LICENSEE in consideration for the grant by LICENSEE of a sublicense of the right to make or sell Licensed Products or practice Licensed Processes; provided, however, that “Non-Royalty Sublicense Revenue” shall in any event exclude: (a) royalties paid to LICENSEE by a sublicensee based on such sublicensee’s sale of Licensed Products or practice of Licensed Processes; (b) any payments by a sublicensee to LICENSEE that are tied directly to the provision of goods and services by LICENSEE to such sublicensee (including research and development funding) to compensate LICENSEE for the fair market value of the provision of such goods and services; (c) payments for equity or debt securities of LICENSEE (except to the extent such payments exceed the fair market value of such securities on the date of issuance); (d) annual minimum royalties, milestone payments, or similar payments to the extent such payments, on an aggregate basis for each specific type of payment (i.e., milestone, annual minimum royalties, etc.) received from all sublicensees in a certain year, do not exceed each such fees and payments owed in a certain year by LICENSEE to SKI hereunder; and (e) reimbursement of patent costs actually incurred by LICENSEE.
 
1.17
“Past Patent Costs” shall mean (a) [*****] of SKI’s unreimbursed costs of preparation, prosecution, and maintenance of the patents and patent applications relating to [*****], [*****] and [*****] of the Patent Rights and (b) [*****] of SKI’s unreimbursed costs of preparation, prosecution, and maintenance of the patents and patent applications relating to [*****] and [*****] of the Patent Rights, in each case, that SKI incurred before the Effective Date.
 
6
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.18
“Patent Rights” shall mean all of the following SKI intellectual property (anywhere in the world):
 
 
(a)
The United States and foreign patents and patent applications listed in Exhibit A;
 
 
(b)
United States and foreign patents issued from the applications listed in Exhibit A, and from divisionals and continuations of these applications;
 
 
(c)
claims of U.S. and foreign continuation-in-part applications, and of the resulting patents, which are directed to subject matter specifically described in or entitled to or claim priority on the U.S. and foreign patent applications listed in Exhibit A; and
 
 
(d)
any reissues, extensions, substitutions, re-examinations, supplementary protection certificates, and patents of addition of patents and patent applications described in (a), (b), or (c) above.
 
1.19
“Phase I Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase I study as defined in 21 CFR § 312.21(a) (or its successor regulation).
 
1.20
“Phase II Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase II study as defined in 21 CFR § 312.21(b) (or its successor regulation).
 
1.21
“Phase Ill Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase III study as defined in 21 CFR § 312.21(c) (or its successor regulation).
 
1.22
“Preferred Indication” shall have the meaning set forth in Section 32(c).
 
1.23
“Regulatory Approval” shall mean all authorizations by the FDA or other appropriate governmental entity or entities necessary for commercial sale of a Licensed Product or Licensed Process in that country including, where applicable, approval of labeling, price, reimbursement and manufacturing.
 
1.24
“Royalty Year” shall mean each twelve-month period commencing January 1 and ending December 31 during the term of this Agreement. For the first Royalty Year of this Agreement, the Royalty Year shall be the period of time between the signing of the Agreement and December 31.
 
1.25
“Vaccine” shall mean a vaccine used by SKI in connection with the clinical trials of this Agreement which would infringe in whole or in part the Patent Rights but for this Agreement. The forms of the Vaccines (with the underlying antigen components) contemplated as of the Effective Date are set forth in Exhibit B, which antigen components may be modified from time to time by SKI or the parties.
 
7
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.26
“Valid Claim” shall mean a claim within the Patent Rights of (i) any granted, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, and that has not been lost through interference proceedings or by intentional or unintentional abandonment, or (ii) a pending patent application; provided,  however , that if a claim of a pending patent application shall not have issued within six years, or seven years in the case of a Japanese patent application, after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for purposes of Article V of this Agreement during the period of time starting after the sixth, or seventh for a Japanese patent application, anniversary of the earliest filing date from which such claim takes priority and unless and until a patent issues with such claim.
 
ARTICLE II - GRANT; LP OWNERSHIP
 
2.1
SKI hereby grants to LICENSEE and its Affiliates an exclusive worldwide right and license under the Patent Rights, including the right to sublicense, to make, offer for sale, import, have made, use, lease and sell Licensed Products and to practice Licensed Processes in the Field of Use, during the term of the Agreement, subject, in each case, to the rights reserved or observed in Section 2.4 below.
 
2.2
SKI hereby grants to LICENSEE and its Affiliates an exclusive, as it relates to commercial purposes, and not exclusive as it relates to non-commercial purposes, worldwide right and license under the Clinical Data, including the right to sublicense, to make, offer for sale, import, have made, use, lease and sell Licensed Products and to practice the Licensed Processes in the Field of Use, during the term of the Agreement, subject to the rights reserved or observed in Section 2.4 below. Notwithstanding the above, LICENSEE allows for the clinical data developed by SKI in the performance of Clinical Trials for neuroblastoma in which beta-glucan is used to be shared with the third party providing SKI with the beta-glucan for such Clinical Trials. Such third party shall have non-exclusive rights to the commercial use of such clinical trial data.
 
2.3
SKI hereby grants to LICENSEE and its Affiliates a non-exclusive worldwide right and license under the Know How, including the right to sublicense, to make, offer for sale, import, have made, use, lease and sell Licensed Products and to practice the Licensed Processes in the Field of Use, during the term of the Agreement, subject to the rights reserved or observed in Section 2.4 below.
 
2.4
Notwithstanding any other provisions of this Agreement, it is agreed that SKI and its Affiliates shall retain the right to practice the licensed Patent Rights for non commercial teaching and research activities, including clinical trials to the extent provided in Section 4.6. All rights reserved to the United States Government and others under 35 USC §§200-212, as amended, shall remain and shall in no way be affected by this Agreement.
 
8
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
2.5
With respect to sublicenses, the following shall apply:
 
 
(a)
LICENSEE agrees that any sublicenses granted by it shall provide that the obligations to SKI of Articles III (to the extent applicable to the rights sublicensed to the sublicensee), VI (as provided in such Article), IX (to the extent such sublicensee is granted any enforcement rights), XI, XII, XIII and XIV of this Agreement shall be binding upon the sublicensee as if it were a party to this Agreement. LICENSEE further agrees to attach copies of these Articles to sublicense agreements.
 
 
(b)
LICENSEE agrees to forward to SKI a copy of any and all fully executed sublicense agreements, which copy may be redacted solely to remove any confidential, proprietary or competitive information of LICENSEE or such sublicensee.
 
2.6
The license granted hereunder shall not be construed to confer any rights upon LICENSEE by implication, estoppel or otherwise as to any technology not included in the Patent Rights or Know How.
 
2.7
The parties agree as follows:
 
 
(a)
SKI understands and agrees that, as between the parties, SKI will not own any right, title, and interest in any technology, inventions, improvements, or data that LICENSEE creates by itself or together with third parties (including all clinical data from clinical trials conducted solely by LICENSEE or together with third parties), including all patent rights with respect thereto. SKI shall not claim ownership of any right, title, and interest in and to such technology, inventions, improvements, or data.
 
 
(b)
Within 45 days after the Effective Date, SKI shall disclose and deliver to LICENSEE copies of the patents and patent applications within the Patent Rights, as well as supporting documentation, such as file wrappers and correspondence between the United States Patent Office or foreign patent offices and SKI, that are not already in LICENSEE’s possession.
 
 
(c)
Any technology, inventions, improvements, or data that is created jointly by one or more employees or consultants of SKI and one or more employees or consultants of LICENSEE during the performance of this Agreement and that directly relate to this Agreement (collectively, the “Joint Inventions”), including any patent rights claiming the Joint Inventions (the “Joint Patent Rights”), shall be jointly owned by SKI and LICENSEE. The parties agree that (i) subject to any rights granted to LICENSEE hereunder, each party shall have the right to practice and exploit the Joint Inventions and Joint Patent Rights in accordance with the United States and other applicable patent laws without any obligation to account to the other for profits with respect to, or to obtain any approval of the other, by
 
9
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
reason of their joint ownership thereof; and (ii) each party waives any such right of accounting or approval it may have under applicable laws in any country, and to the extent there are any applicable laws that prohibit such a waiver, each party will be deemed to so consent. Each party agrees to be named as a party, if necessary, to bring or maintain a lawsuit involving any Joint Technology or Joint Patent Right.
 
 
(d)
If LICENSEE desires to include SKI as an investigational site in a LICENSEE sponsored clinical trial of the Licensed Product or Licensed Processes, such a relationship, including rights, obligations, and payments, will be governed by a separate clinical trial agreement to be negotiated separately between the parties.
 
2.8
The parties agree to the following provisions regarding the Joint Patent Rights:
 
 
(a)
During the term of this Agreement, LICENSEE shall have the first right to control prosecution and maintenance of Joint Patent Rights.
 
 
(b)
If LICENSEE elects not to pursue the prosecution or maintenance of a Joint Patent Right in a particular country, then LICENSEE shall so notify SKI promptly in writing and in reasonable time to enable SKI to meet any deadlines by which an action must be taken to establish or preserve any such rights in such Joint Patent Right in such country. Upon receipt of each such notice from LICENSEE, SKI shall have the right, but not the obligation, to pursue the filing or support the continued prosecution or maintenance of such Joint Patent Right at its expense in such country. If SKI elects to pursue such filing or continue such support, then SKI shall notify LICENSEE of such election and LICENSEE will not have further rights to such Joint Patent Rights in that particular country.
 
 
(c)
Each party shall, at the other party’s request, assist and cooperate in the filing and prosecution of any application, amendment, submission, response or correspondence with respect to any Joint Patent Right in accordance with this Agreement, including execution and delivery of all necessary documents. Each party shall provide the other party, sufficiently in advance for the other party to comment, with copies of all patent applications and other material submissions and correspondence with any patent counsel or patent authorities pertaining to the Joint Patent Rights and shall give due consideration to the comments of the other party.
 
 
(d)
For so long as SKI has not granted any rights or licenses to any third party under the Joint Patent Rights, all costs and expenses associated with the prosecution and maintenance of the Joint Patent Rights shall be borne by LICENSEE, unless agreed otherwise in writing;  provided  that, if SKI grants any third party any rights or licenses under, all costs and expenses associated with the prosecution and maintenance of the Joint Patent Rights shall be shared equally by LICENSEE and SKI.
 
10
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE III - DUE DILIGENCE
 
3.1
LICENSEE (itself or through its sublicensees) shall use Commercially Reasonable Efforts to bring Licensed Products or Licensed Processes to market and to continue marketing efforts for one or more Licensed Products or Licensed Processes throughout the life of this Agreement. Accomplishment of any of the milestones or diligence obligations hereunder by any sublicensee of LICENSEE or by SKI shall be deemed accomplishment by LICENSEE.
 
3.2
LICENSEE’s adherence to the following milestones shall be deemed to be satisfaction of LICENSEE’s obligation to use Commercially Reasonable Efforts:
 
 
(a)
LICENSEE has delivered to SKI prior to the execution of this Agreement, LICENSEE’s detailed business, research and development plan. Reports shall be provided to SKI annually to relay update and status information on LICENSEE’s business, research and development progress, including projections of activity anticipated for the next reporting year.
 
 
(b)
LICENSEE or its sublicensees shall be responsible for using Commercially Reasonable Efforts to secure all required and/or necessary Regulatory Approvals to sell, exploit, or market any and all Licensed Products. LICENSEE shall advise SKI, through annual reports described in Section 3.2(a) above, of its, or its sublicensees, program of development for obtaining said approvals.
 
 
(c)
LICENSEE hereby agrees to use its Commercially Reasonable Efforts to develop or to sublicense Licensed Products and/or Licensed Processes for the treatment of [*****] (“Preferred Indications”) and for additional indications as LICENSEE and SKI may agree from time to time. Three years from the date the IND for an applicable Licensed Product or Licensed Process for an applicable Preferred Indication is transferred from SKI to LICENSEE, or [*****], whichever is earlier, or [*****].
 
 
(d)
If LICENSEE fails to perform in accordance with Sections 3.1, 3.2(b), and 3.2(c) above, then SKI shall provide LICENSEE with written notice of such failure and shall negotiate in good faith with LICENSEE regarding either (i) implementing a new plan within 4 months for the development of Licensed Products or Licensed Processes or (ii) in LICENSEE’ s discretion, modifying the Field of Use. If a new plan is agreed to and LICENSEE fails to use Commercially Reasonable Efforts to implement the plan, then SKI may treat such failure as a default and may terminate this Agreement pursuant to Section 14.2(iv) below but only with respect to the Preferred Indication to which such failure relates.
 
ARTICLE IV - DEVELOPMENT COLLABORATION
 
4.1
Steering Committee .
 
11
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(a)
The Parties shall establish a joint steering committee (each, a “Steering Committee”) for each Phase II Clinical Trial to be conducted pursuant to Section 4.2 and listed in Exhibit B to oversee, review, manage and direct activities described herein, which committee shall be established within 30 days after the Effective Date (or such later time agreed upon by the parties). Each Steering Committee shall be comprised of 2 representatives of each party (or their designees), each with appropriate decision-making authority. Each Steering Committee shall meet periodically as needed during the term of this Agreement, but in no event less than once during each calendar quarter, in person (with locations to alternate between the parties) or by teleconference or other electronic means as mutually agreed, to discuss matters within its jurisdiction. Each Steering Committee shall adopt such procedural rules as shall be necessary or convenient for its work, including procedures for taking minutes of meetings.
 
 
(b)
The Steering Committees shall be responsible for: (i) approving the design of all Phase II Clinical Trials to be conducted by SKI and all related protocols; (ii) oversight of the activities associated with such Phase II Clinical Trials to be conducted by SKI; (iii) approving any amendments to such Phase II Clinical Trials or related protocols; (iv) approving amendments to the Development Plan; (v) consulting with LICENSEE regarding (but not approval over) the protocol and conduct of Phase II Clinical Trials conducted by LICENSEE and any subsequent breast and ovarian Phase II Clinical Trial or Phase III Clinical Trials conducted by LICENSEE; (vi) establishing a method for the exchange of information between SKI and LICENSEE such that LICENSEE will have access to Clinical Data as soon as it is developed, which method may include, upon the request of LICENSEE, the creation of an internal Web site (the creation of which shall be the responsibility of LICENSEE), for the posting of Clinical Data for easy access by both parties; and (vii) otherwise serving as a forum for exchanging information related to the Phase II Clinical Trials.
 
 
(c)
The members of the Steering Committees shall seek to make all determinations to be made by them unanimously following full discussion thereof (with each party’s representatives having, collectively, one vote). If any Steering Committee is unable to reach a unanimous decision on any matter within its jurisdiction, then (i) SKI shall cast the deciding vote with regard to Phase II Clinical Trials conducted by SKI, and (ii) LICENSEE shall cast the deciding vote with regard to any other Steering Committee matter not ascribed to SKI pursuant to clause (i).
 
 
(d)
SKI shall keep the applicable Steering Committee fully informed about the status of the activities performed by it pursuant to this Article W, including providing such Steering Committee with copies of the final form of all written reports that relate to such activities.
 
 
(e)
Notwithstanding anything herein to the contrary, upon SKI’s completion of all activities to be conducted by SKI pursuant to this Article IV, LICENSEE, in its
 
12
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
sole discretion, may disband the applicable Steering Committee(s) upon written notice to SKI.
 
4.2
SKI Phase I Clinical Trials and SKI Phase II Clinical Trials . SKI will use its Commercially Reasonable Efforts to conduct the Phase I Clinical Trials and the Phase II Clinical Trials described in this Section 4.2 in accordance with the Development Plan unless prevented to do so by reasons beyond SKI’s reasonable control, including fire, explosion, flood, war, terrorist act, strike, riot, funding unavailability, principal investigator unavailability or insufficient patient accrual or unless prevented to do so by institutional policy.
 
 
(a)
[*****] thereon, unless prevented to do so by reasons beyond SKI’s reasonable control, including fire, explosion, flood, war, terrorist act, strike, riot, funding unavailability, principal investigator unavailability or insufficient patient accrual, or as otherwise agreed to by LICENSEE. [*****]. SKI will keep LICENSEE fully informed of the progress of the Phase I Clinical Trials conducted by SKI, including any amendments to the protocols or INDs related thereto. At the conclusion of the Phase I Clinical Trials conducted by SKI (except with respect to the Phase I Clinical Trials conducted by SKI for breast and ovarian cancer) or at any earlier time agreed to by LICENSEE and SKI, all further development responsibility shall be transferred to LICENSEE, subject to Section 4.6.
 
 
(b)
[*****], unless prevented to do so by reasons beyond SKI’s reasonable control, including fire, explosion, flood, war, terrorist act, strike, riot, funding unavailability, principal investigator unavailability or insufficient patient accrual, or as otherwise agreed to by LICENSEE. [*****]. SKI will keep the applicable Steering Committee fully informed of the progress of the Phase II Clinical Trials conducted by SKI, including any amendments to the protocols or INDs related thereto. At the conclusion of the Phase II Clinical Trials listed on Exhibit B conducted by SKI, or at any earlier time agreed to by LICENSEE and SKI, all further development responsibility shall be transferred to LICENSEE, subject to Section 4.6.
 
 
(c)
LICENSEE shall use its Commercially Reasonable Efforts to provide the assistance described in the Development Plan to SKI with respect to the Phase I Clinical Trials and Phase II Clinical Trials conducted by SKI pursuant to this Section 4.2.
 
4.3
Decision to Proceed. In the event that LICENSEE determines that the results of a specific Phase I Clinical Trial conducted by SKI or [*****] conducted by SKI warrant continued development, LICENSEE shall consult with the applicable Steering Committee on the protocol and conduct of a Phase II Clinical Trial [*****]. SKI and LICENSEE will share equally the costs of [*****] used as the placebo in each such Phase II Clinical Trial. Notwithstanding the foregoing, [*****]. Any further supply of Vaccine by SKI to LICENSEE will be made according to the provisions of Section 4.9 and payment by
 
13
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
LICENSEE to SKI to cover the costs associated with creating the Vaccine plus reasonable and appropriate fringe and overhead costs.
 
4.4
Decision Not to Proceed . In the event that LICENSEE determines that the results of a specific Phase I Clinical Trial conducted by SKI or breast or ovarian Phase II Clinical Trial conducted by SKI do not warrant continued development, LICENSEE will be entitled to continue development with respect to such Vaccine and component antigens as LICENSEE determines, subject to Section 4.6 and the other terms of this Agreement.
 
4.5
Funding . In the event that SKI obtains funding for the Phase II Clinical Trials that are to be conducted by LICENSEE and are listed in Exhibit B, such additional funding shall first go to offset SKI’s costs of conducting a specific Phase II Clinical Trial and then to offset LICENSEE’s expenses for the same trial to the extent allowed by the funding source. For any such Phase II Clinical Trials, Licensee retains the right to cast the deciding vote on the Steering Committee pursuant to Section 4.1(c) as if Licensee fully funded the clinical trial.
 
4.6
Additional Clinical Trials . SKI acknowledges and agrees that, except for the Phase I Clinical Trials and the Phase II Clinical Trials to be conducted by SKI pursuant to Section 4.2, SKI shall have no right to conduct any further clinical trials with respect to the Licensed Products and Licensed Process based on an IND held by LICENSEE, except with LICENSEE’s prior written consent. SKI acknowledges and agrees that any data or information obtained in connection with any clinical trial conducted by SKI with respect to solely a Licensed Product or Licensed Process shall be deemed “Clinical Data” hereunder.
 
4.7
Biological Materials Transfer . In addition to the provisions of Section 4.3 above, upon LICENSEE’s request and SKI’s agreement, SKI will supply to LICENSEE a reasonable supply of Biological Materials which may be used for purposes of developing the Licensed Products and Licensed Processes hereunder and for general research purposes. SKI will supply the Biological Materials after execution of a Materials Transfer Agreement between LICENSEE and SKI in the form attached hereto as Exhibit D (or in substantially similar form), at no cost to LICENSEE unless the Biological Material has been obtained at considerable cost to SKI, in which case the parties will meet to discuss supply alternatives.
 
4.8
Tech Transfer .
 
 
(a)
Within 30 days of LICENSEE’s request, SKI shall commence the transfer to LICENSEE (or a Third Party selected by LICENSEE to manufacture) of relevant data and information used by SKI in the manufacture of the Vaccines or otherwise necessary for LICENSEE to manufacture the Licensed Product (including all applicable chemistry, manufacturing, and controls (CMC) information) and will complete such transfer in the time frame reasonably requested by LICENSEE. Within 60 days of the Effective Date, SKI shall commence the transfer to
 
14
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
LICENSEE of all Know How and will complete such transfer in the time frame reasonably requested by LICENSEE. Within 30 days of the completion of any Phase I Clinical Trial or Phase II Clinical Trial conducted by SKI or upon LICENSEE’s earlier request, SKI shall commence the transfer to LICENSEE of all Clinical Data and complete such transfer in the time frame reasonably requested by LICENSEE. All tech transfers shall be made subject to LICENSEE making payment of the costs associated with the copying and transferring of such data, Know How, and Clinical Data according to Section 5.4.
 
 
(b)
Furthermore, at any time during the term of this Agreement, LICENSEE (or its representative) shall be entitled to audit SKI’s records with respect to the Clinical Data. LICENSEE shall also be entitled to audit SKI’s records with respect to Know How, which means being granted access to original data to the extent related to Licensed Products and Licensed Processes contained in notebooks used and in other records generated in Dr. Livingston’s and Dr. Ragupathi’s laboratories or under either of their supervision.
 
4.9
[*****]
 
4.10
Ownership of Regulatory Approvals . LICENSEE shall have sole responsibility to oversee, monitor, coordinate, file and hold in its name all NDAs, INDs, all other communications with and submissions to the FDA and all such Regulatory Approvals with respect to Licensed Products; except that SKI shall file in its name all INDs with respect to the Phase I Clinical Trials and Phase II Clinical Trials conducted by SKI. At the end of each such Phase I Clinical Trial or Phase II Clinical Trial conducted by SKI, as applicable, or earlier if necessary for a smooth transition of responsibilities to LICENSEE or otherwise requested by LICENSEE, SKI will transfer to LICENSEE the IND related to such Phase I Clinical Trial or Phase II Clinical Trial, as applicable.
 
4.11
Regulatory . SKI, in consultation with LICENSEE, shall have primary responsibility for communications with and submissions to the FDA with respect to Phase I Clinical Trials and Phase II Clinical Trials conducted by SKI. With respect to clinical trials conducted by SKI, SKI shall have responsibility for interfacing, corresponding and meeting with the FDA with respect to Licensed Products; however, LICENSEE shall be entitled to participate in all such meetings and telephonic discussions between representatives of SKI and the FDA with respect to Licensed Products. SKI agrees to and shall notify LICENSEE of planned meetings and telephonic discussions with the FDA and to use Commercially Reasonable Efforts to accommodate the schedule of LICENSEE’s attendees at such meetings or discussions. LICENSEE shall be entitled to have a representative at all such meetings and discussions. SKI shall provide LICENSEE with drafts of any documents or other correspondence to be submitted to the FDA pertaining to Licensed Products, sufficiently in advance of submission for LICENSEE to review any such submission, and LICENSEE may comment on such documents, in which case SKI will consider and in good faith adopt all reasonable comments of LICENSEE. SKI shall provide to LICENSEE, as soon as reasonably practicable, copies of any documents or
 
15
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
other correspondence received from the FDA pertaining to Licensed Products (including any meeting minutes). LICENSEE shall have sole responsibility for communications with and submissions to the FDA with respect to all other clinical trials for Licensed Products and Licensed Processes and otherwise.
 
4.12
Consulting Agreement . SKI acknowledges that LICENSEE intends to enter into consulting agreements with Dr. Philip 0. Livingston and Dr. Govind Ragupathi. On the Effective Date, there is no conflict of interest for Dr. Philip 0. Livingston and Dr. Govind Ragupathi to enter into such consulting agreements.
 
ARTICLE V - PAYMENTS
 
5.1
For the rights, privileges and licenses granted hereunder, LICENSEE shall pay to SKI the following:
 
 
(a)
A license issue fee of $50,000, payable immediately upon signing this Agreement.
 
 
(b)
Royalties as follows:
 
 
(i)
A royalty, on a Licensed Product-by-Licensed Product basis, in an amount equal to (A) [*****] of the Net Sales of such Licensed Product until the total accumulated Net Sales of such Licensed Product reach [*****]; (B) [*****] of all subsequent Net Sales of such Licensed Product until the total accumulated Net Sales of such Licensed Product reach [*****]; and (C) [*****] of all subsequent Net Sales of such Licensed Product after the total accumulated Net Sales of such Licensed Product reach [*****].
 
 
(ii)
Notwithstanding the amounts set forth in Section 5.1(b)(i), (x) with respect to the Licensed Product for [*****], if no Valid Claim set forth on Exhibit A under the heading [*****] has issued, or (y) with respect to the Licensed Product for [*****], if no Valid Claim set forth on Exhibit A under the heading [*****] has issued (in each case, a “Specific Valid Claim,” as applicable), but, in each case, the applicable Licensed Product is otherwise covered by a Valid Claim, then the royalties for such Licensed Product, as applicable, until the issuance of any such Specific Valid Claim, shall be reduced to (A) [*****] of the Net Sales of such Licensed Product until the total accumulated Net Sales of such Licensed Product reach [*****]; (B) [*****] of all subsequent Net Sales of such Licensed Product until the total accumulated Net Sales of such Licensed Product reach [*****]; and (C) [*****] of all subsequent Net Sales of such Licensed Product after the total accumulated Net Sales of such Licensed Product reach [*****];
 
 
(iii)
If LICENSEE, its Affiliates or its sublicensees pay third party royalties on the sales of a Licensed Product or practice of a Licensed Process in any
 
16
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
country in consideration for third party patent rights (a “Third Party Payment”), the royalties payable under this Section 5.1(b) on such Licensed Product or Licensed Process in such country, shall be decreased by [*****] of the amount of such Third Party Royalty Payment attributable to sales of the applicable Licensed Product or Licensed Process; provided, however, that in no case shall such reduction lower the amount of royalties otherwise payable under this Section 5.1(b) by more than [*****].
 
 
(iv)
Notwithstanding the foregoing, in any country where the sale of the Licensed Product or practice of the Licensed Process would not infringe any Valid Claim, then the royalties payable under this Section 5.1(b) on such Licensed Product or Licensed Process in such country shall be decreased to [*****] of what would otherwise be paid pursuant to Section 5.1(b)(i) and 5.1(b)(iii), and milestones reached in any such countries shall not be subject to milestones payments under Section 5.1(d) and shall not count as milestones reached under Section 5.1(d).
 
 
(v)
The determination of what constitutes a “different” Licensed Product for the purposes of this Section 5.1(b) will be made pursuant to the same criteria set forth in Section 5.1(d)(ii).
 
 
(vi)
Royalties under this Section 5.1(b) shall be payable in respect of the Net Sales of the Licensed Product in each country in the Territory until the later of: (A) the expiry of ten years from the first commercial sale of the Licensed Product in that country; or (B) the expiration of the last-to-expire Valid Claim covering such Licensed Product Rights at the time of and in the country of sale.
 
 
(c)
For Non-Royalty Sublicense Revenue actually received, LICENSEE shall pay SKI the following amounts based on the execution date of the sublicense agreement with respect to which such amounts are owed: (i) [*****] from sublicenses granted in a certain field of use before the filing of an IND for that field of use; (ii) [*****] from sublicenses granted in a certain field of use after the filing of an IND but before the first patient enrollment in a Phase III Clinical Trial for that field of use; (iii) [*****] from sublicenses granted in a certain field of use after fast patient enrollment in a Phase III Clinical Trial but before approval of the NDA for that field of use; and (iv) [*****] from sublicenses granted in a certain field of use for which a Licensed Product has received an NDA approval. For each sublicense granted in more than one field of use in which each field of use is in a different development stage, such percentages shall be calculated according to a proportional allocation. Payments to SKI under this Section 5.1(c) shall be made within 30 days of LICENSEE’s receipt of Non-Royalty Sublicensee Revenue from the applicable sublicensee.
 
17
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(d)
Milestones as follows:
 
 
(i)
Milestone payments, irrespective of whether LICENSEE or sublicensee attains such milestone, as follows: for the first Licensed Product to meet each milestone set forth below when such milestone is achieved after the Effective Date:
 
 
(A)
[*****] upon the dosing of the first patient in a Phase III Clinical Trial, which [*****] payment will consist of the following:
 
 
(1)
$50,000 (or such lesser amount necessary to fully pay then-outstanding Past Patent Costs) towards the reimbursement of Past Patent Costs, and
 
 
(2)
the remainder as a payment for the achievement of such milestone; and
 
 
(B)
[*****] upon receipt of an NDA approval, which [*****] payment will consist of the following:
 
 
(1)
$100,000 (or such lesser amount necessary to fully pay then-outstanding Past Patent Costs) towards the reimbursement of Past Patent Costs, and
 
 
(2)
the remainder as a payment for the achievement of such milestone;
 
provided  that, if the Licensed Product at the time of the milestone event would be subject to the lower royalty rates described in Section 5.1(b)(ii), then the applicable milestone above will be reduced by [*****]. The foregoing milestone payments are paid only once regardless of the number of Licensed Products or additional indications such a product may obtain.
 
 
(ii)
For each subsequent NDA approval of an additional and different Licensed Product, milestone payments as follows: (A) [*****] or (B) [*****] if the Licensed Product at the time of issuance of the NDA would be subject to the lower royalty rates described in Section 5.1(b)(ii). The foregoing payment shall be payable only once for a single Licensed Product regardless of the number of additional indications, such product may obtain. For clarity as to what constitutes a “different” Licensed Product, (x) two dosage forms of a product would constitute the same Licensed Product; (y) any derivative or modification of a Licensed Product that contains only the same antigens, or contains only a subset of the original set of antigens, and has the same indication would constitute the same Licensed Product; and (z) any derivative or modification of a
 
18
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
Licensed Product that carries a separate indication is considered a different Licensed Product, other than a modification that is limited to a change in the formulation of a Licensed Product (which formulation modifications would constitute the same Licensed Product).
 
 
(e)
Annual minimum royalty payments as follows:
 
 
(i)
[*****] after transfer of the first IND to LICENSEE in accordance with Section 4.10 but prior to the approval of the first NDA for a Licensed Product, which [*****] payment will consist of the following:
 
 
(A)
$10,000 (or such lesser amount necessary to fully pay then-outstanding Past Patent Costs) towards the reimbursement of Past Patent Costs, and
 
 
(B)
the remainder as an annual minimum royalty payment;
 
 
(ii)
[*****]:
 
 
(A)
$20,000 (or such lesser amount necessary to fully pay then-outstanding Past Patent Costs) towards the reimbursement of Past Patent Costs, and
 
 
(B)
the remainder as an annual minimum royalty payment; and
 
 
(iii)
[*****]:
 
 
(A)
$40,000 (or such lesser amount necessary to fully pay then-outstanding Past Patent Costs) towards the reimbursement of Past Patent Costs, and
 
 
(B)
the remainder as an annual minimum royalty payment.
 
Such minimum royalty payments and Past Patent Cost reimbursement payments shall be prorated for the year of issuance of an NDA. The minimum royalty payments shall be credited against the earned royalty payments required in Section 5.1(b)(i) or 5.1(b)(ii), as applicable, above for the same Royalty Year.
 
 
(f)
Patent expenses according to the terms of Article VIII, to be paid within 30 days after receipt of an invoice.
 
5.2
If LICENSEE receives Non-Royalty Sublicense Revenue from sublicensees under this Agreement in the form of non-cash consideration, LICENSEE shall pay SKI payments as required by Section 5.1(c), based on the fair market value of such payment, unless SKI waives in writing such payment obligation.
 
19
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
5.3
No multiple royalties shall be payable because any Licensed Product, its manufacture, use, sale, offer for sale, or importation is or shall be covered by more than one Valid Claim licensed under this Agreement.
 
5.4
Unless otherwise agreed by the parties, LICENSEE shall pay SKI SKI’ s actual, reasonable costs for (a) the preparation and delivery of Clinical Data and other reports LICENSEE may reasonably request under this Agreement (such as case report forms), and (b) the transfer of the Know How from SKI to LICENSEE, including reprographic services. All such costs will be agreed upon in writing by the parties prior to commencement of such information preparation or transfer process.
 
5.5
Payments shall be paid in United States dollars in New York, NY, or at such other place as SKI may reasonably designate consistent with the laws and regulations controlling in any foreign country, but not in any other currency. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at the JP Morgan Chase Bank (N.A.) on the last business day of the calendar quarterly reporting period to which such royalty payments relate. If at any time legal restrictions prevent the prompt remittance of royalties or other payments owed to SKI by LICENSEE with respect to any country where a sublicense is issued or a Licensed Product is sold, LICENSEE shall provide prompt written notice to SKI, and payment of the royalty shall be made by the deposit thereof in local currency to the credit of SKI in a recognized banking institution designated by SKI by written notice to LICENSEE. When in any country the law or regulations prohibit both the transmittal and the deposit of royalties on sales in such country, royalty payments shall be suspended for as long as such prohibition is in effect, and, as soon as such prohibition ceases to be in effect, all royalties that LICENSEE would have been under an obligation to transmit or deposit but for the prohibition shall forthwith be deposited or transmitted, to the extent allowable.
 
5.6
The following shall apply to payments hereunder:
 
 
(a)
LICENSEE shall pay to SKI interest on any amounts not paid when due (which are not subject to a bona fide dispute). Such interest will accrue from the 15 th  day after the payment was due at prime interest rate, as determined by the JP Morgan Chase Bank (N.A.) or its successor entity, on each day the payment is delinquent, and the interest payment will be due and payable on the first day of each month after interest begins to accrue, until full payment of all amounts due SKI is made.
 
 
(b)
SKI’ s rights to receive such interest payments shall be in addition to any other rights and remedies available to SKI.
 
 
(c)
If the interest rate required in this Subsection exceeds the legal rate in a jurisdiction where a claim for such interest is being asserted, the required interest rate shall be reduced, for such claim only, to the maximum interest rate allowable in the jurisdiction.
 
20
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE VI - REPORTS AND RECORDS
 
6.1
LICENSEE shall keep, and shall require its Affiliates and sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to SKI hereunder. Said books and records shall be maintained for a period of no less than four years following the period to which they pertain. For the term of this Agreement, upon reasonable written notice (not less than four weeks), LICENSEE shall grant SKI the right to cause an independent, certified public accountant reasonably acceptable to LICENSEE to audit such records to confirm payments due hereunder for a period covering not more than the preceding four years. Such audits may be exercised no more than once per year during normal business hours at the location where LICENSEE maintains its books and records. No accounting period of LICENSEE shall be subject to audit more than one time for the same purpose. SKI shall bear the full cost of such audit unless such audit discloses an underpayment by LICENSEE of more than 10% or $50,000 for any 12-month period, in which case, LICENSEE shall bear the full cost of such audit and shall promptly remit to SKI the amount of any underpayment, plus interest as stipulated in Section 5.6.
 
6.2
LICENSEE, within 60 days after each December 31 for Royalty Years for which there are no Net Sales, and within each 60 days after March 31, June 30, September 30 and December 31 for Royalty Years for which there are Net Sales, shall deliver to SKI true and accurate reports, giving such particulars of the business conducted by LICENSEE and its sublicensees during the preceding reporting period under this Agreement as shall be pertinent to a royalty accounting hereunder. LICENSEE shall use Commercially Reasonable Efforts to obtain such reports from sublicensees as are necessary to fulfill its reporting requirements under this Section 6.2 (including by providing for such an obligation in any sublicense agreement), but it shall not be deemed a material breach of this Agreement by LICENSEE if, notwithstanding LICENSEE’s Commercially Reasonable Efforts, LICENSEE is unable to timely report regarding its sublicensees’ activities as a result of such sublicensees’ failure to timely provide the requisite information to LICENSEE. These reports shall include at least the following, to be itemized per Licensed Product and Licensed Process:
 
 
(a)
Number of Licensed Products and Licensed Processes commercially used, manufactured and sold, rented or leased;
 
 
(b)
Total billings for Licensed Products and Licensed Processes commercially used, sold, rented or leased;
 
 
(c)
Deductions applicable as provided in the definition of Net Sales;
 
 
(d)
Total royalties due;
 
 
(e)
Names and addresses of all sublicensees of LICENSEE;
 
21
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(f)
Total royalty income from all revenues subject to sublicensees’ royalties; and
 
 
(g)
Total Non-Royalty Sublicense Revenue.
 
6.3
With each such report submitted, LICENSEE shall pay to SKI the royalties due and payable under this Agreement. If no royalties shall be due, LICENSEE shall so report.
 
6.4
Milestone payments shall be reported and paid when due.
 
6.5
LICENSEE agrees to forward to SKI a copy of such reports received by LICENSEE from its sublicensees during the preceding reporting period. Such reports may exclude, or have redacted, any Confidential Information of the sublicensee.
 
ARTICLE VII - CONFIDENTIALITY
 
7.1
Beginning on the Effective Date and continuing throughout the term of this Agreement and thereafter for a period of 5 years, LICENSEE agrees to keep any and all non-published information and correspondence relating to the Patent Rights and Know How received from SKI or its patent counsel as SKI’s Confidential Information.
 
7.2
Beginning on the Effective Date and continuing throughout the term of this Agreement and thereafter for a period of 5 years, neither party will at any time, without the express prior written consent of the disclosing party, disclose or otherwise make known or available to any third party any Confidential Information of such disclosing party. The receiving party will utilize reasonable procedures to safeguard the Confidential Information of the disclosing party, including releasing such Confidential Information only on a “need-to-know” basis. LICENSEE is hereby authorized to release Confidential Information to Affiliates, employees, agents, shareholders and members, consultants, contractors, manufacturers, service providers, bankers, securities advisors, investors and potential investors, legal advisors, and the like who are under an obligation of confidentiality and require the information to perform their duties. LICENSEE is hereby authorized to release Confidential Information to its potential sublicensees for the purpose of negotiating and granting sublicenses;  provided  that LICENSEE takes reasonable precautions to safeguard such Confidential Information of SKI.
 
7.3
Beginning on the Effective Date and continuing throughout the term of this Agreement and thereafter for a period of 5 years, except as otherwise expressly set forth herein, Confidential Information shall be used only in connection with the legitimate purposes of this Agreement.
 
7.4
Notwithstanding the provisions of Sections 7.1 through 7.4, each party may disclose Confidential Information belonging to the other party to the extent such disclosure is reasonably necessary:
 
22
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(a)
to comply with applicable laws (including to comply with any applicable securities regulation, stock exchange or NASDAQ disclosure requirements) or to defend or prosecute litigation in accordance with this Agreement; provided  that the receiving party provides prior written notice of such disclosure to the disclosing party and takes reasonable and lawful actions to avoid or minimize the degree of such disclosure;
 
 
(b)
to prosecute patent applications as contemplated by this Agreement;
 
 
(c)
to make filings and submissions to, or correspond or communicate with, the FDA or any clinical registry, including for purposes of obtaining authorizations to conduct clinical trials of, and to commercialize, Licensed Products or Licensed Processes pursuant to this Agreement; and
 
 
(d)
to exercise its rights hereunder;  provided  such disclosure is covered by terms of confidentiality similar to those set forth herein.
 
7.5
For the first 8 years following the Effective Date, SKI agrees to the following provisions:
 
 
(a)
SKI shall provide to LICENSEE copies of any proposed presentation or publication or abstract pertaining to the Patent Rights, Know How or Clinical Data prior to the submission of such documents for presentation or publication. Such proposed presentations or publications shall be supplied to LICENSEE at least 30 days in advance of submission to a journal, editor, or other third party; abstracts shall be supplied at least 10 business days in advance of such submission.
 
 
(b)
LICENSEE may request that changes or deletions be made in any proposed publication solely in order to prevent public disclosure of LICENSEE Confidential Information. SKI agrees that it will honor LICENSEE’s requests to remove any such Confidential Information included in any such proposed public disclosure.
 
 
(c)
If LICENSEE believes that the subject matter to be disclosed or published warrants patent protection, LICENSEE will identify the subject matter requiring protection and notify SKI within the 30-day or 10 business-day review period required according to Section 7.5(a) above, and SKI shall delay the proposed public disclosure for no more than an additional 60-day period in order to allow LICENSEE to file patent applications thereon according to the provisions of Article VIII.
 
7.6
Each party acknowledges that improper use or disclosure of information of the other party that must be kept in confidence under this Article VII would cause substantial harm to the other party and that such harm would not be remedied by the payment of damages alone. Accordingly, each party shall be entitled to preliminary and permanent injunctive
 
23
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
relief and other equitable relief for any breach of this Article VII by the other party, without prejudice to all other remedies available at law or in equity.
 
7.7
SKI and LICENSEE agree that, in performing under this Agreement, each party shall adhere to all applicable government laws, rules, regulations and guidelines, including, to the extent applicable, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its regulations and official guidance promulgated thereunder, and those regulations and guidances of the FDA, including among others the Generic Drug Enforcement Act of 1992 (21 USC §§ 305,306). Certifications and other documents required by these statutes and regulations, such as those relating to financial conflicts of interest and debarment from performing clinical trials, shall be provided as necessary.
 
ARTICLE VIII - PATENT PROSECUTION
 
8.1
After the Effective Date, subject to Section 8.5, LICENSEE shall be responsible for future costs of preparation, prosecution, and maintenance of the Patent Rights during the term of this Agreement and for Past Patent Costs as follows:
 
 
(a)
[*****].
 
 
(b)
Any other remaining Past Patent Costs will be paid pursuant Sections 5.1(d)(i) and 5.1(e) until all Past Patent Costs are paid to SKI.
 
8.2
SKI will remain responsible for the preparation, prosecution, and maintenance of the Patent Rights during the term of this Agreement and will be the client of the patent counsel preparing, prosecuting and maintaining the Patent Rights. SKI will identify any deadlines for such cases that are within the first 45 days following the Effective Date. SKI shall use Commercially Reasonable Efforts to prosecute and maintain the Patent Rights in the United States and in such countries as are determined by SKI, after consultation with LICENSEE, using counsel of SKI’s choice, which choice will take into account LICENSEE’s suggestions for counsel and counsel must be acceptable to LICENSEE.
 
8.3
Notwithstanding the foregoing, SKI agrees that LICENSEE may, upon notice and approval by SKI, assume the day-to-day activities related to such preparation, prosecution, and maintenance, subject to the supervision of SKI, and that LICENSEE will have the right to discuss and instruct patent counsel with respect to the Patent Rights;  provided  that SKI must be copied on all communications between LICENSEE and the patent counsel and that SKI will be consulted on all significant decisions with respect to the prosecution and maintenance of the Patent Rights;  provided further  that SKI, upon written notice to LICENSEE, may withdraw its approval of LICENSEE conducting day-to-day activities if the parties have had at least one significant unresolved disagreement regarding the prosecution of the Patent Rights or if LICENSEE has not kept SKI informed of all significant decisions as required in this Section 8.3. If SKI withdraws its approval, SKI shall continue to use the same patent counsel previously used for the
 
24
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
Patent Rights unless and until SKI has taken reasonable efforts to reduce any costs associated with changing patent counsel. In the event that SKI and LICENSEE cannot agree on any decisions with respect to the prosecution and maintenance of the Patent Rights, including the actions to be taken and the claims to be filed SKI will have the final decision. If SKI fails to respond in a timely manner to LICENSEE or LICENSEE’s patent counsel in providing input and instruction on the prosecution and maintenance of the Patent Rights, then LICENSEE may instruct patent counsel without benefit of SKI’s consultation. SKI may not consider such failure to respond a reason for withdrawal of its approval for LICENSEE to continue to conduct day-to-day activities regarding prosecution of the Patent Rights.
 
8.4
Each party agrees to keep the other party reasonably informed of its activities pertaining to the preparation, prosecution, and maintenance of the Patent Rights and to provide the other party with copies of all relevant correspondence with the national patent offices in which the Patent Rights are being prosecuted. To the extent practicable, each party may comment on and give suggestions to the prosecution led by the other party, and the prosecuting party shall give due consideration to such comments when filing responses to office actions on any pending patent applications within the Patent Rights;  provided  that, if one party has not provided comments prior to the deadline for filing a response or otherwise filing a document (and with sufficient time for the prosecuting party to give due consideration to such comments), the prosecuting party may make such filing without waiting for or addressing such comments of the other party. Upon reasonable request and to the extent practicable, SKI shall provide LICENSEE with any additional information LICENSEE desires with regard to preparation, prosecution, and maintenance of the Patent Rights.
 
8.5
In the event that LICENSEE desires to abandon any patent within the Patent Rights, LICENSEE shall so communicate to SKI with reasonable prior written notice of such intended abandonment or decline of responsibility to maintain the relevant Patent Rights, and SKI shall have the opportunity to continue such patent prosecution or maintenance at its own expense, and LICENSEE’s rights in the abandoned patent(s) shall terminate, and LICENSEE will have no further obligation to SKI with regard to such patents.
 
8.6
For so long as LICENSEE continues to be responsible for all costs of preparation, prosecution, and maintenance of a Patent Right, SKI shall not abandon such Patent Right or subject matter disclosed or claimed therein, without the prior written consent of LICENSEE.
 
8.7
Neither party shall be liable if it is not successful in having a particular patent claim within the Patent Rights issued.
 
ARTICLE IX - INFRINGEMENT
 
9.1
LICENSEE as the exclusive commercial user of the Patent Rights shall have the first right, but not the obligation, to enforce the Patent Rights within the Field of Use and to
 
25
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
initiate and prosecute an infringement action. As such, LICENSEE may take, among other things, any of the following actions: (a) enter into a sublicense agreement with a company suspected of infringement, (b) bring and control any action or proceeding with respect to infringement of any Patent Rights at LICENSEE’ s own expense and by counsel of its own choice, and SKI shall have the right, at its own expense, to be represented in any such action by counsel of its own choice, or (c) determine that no action is required. In each case, LICENSEE shall consult with (but not obtain the approval of) SKI with respect to the actions LICENSEE is considering taking. If LICENSEE fails to bring and control any action or proceeding with respect to infringement of any Patent Rights within (i) 120 days following notice from SKI of alleged infringement or misappropriation, or (ii) 30 days before the time limit, if any, set forth in the applicable laws and regulations for the filing of such actions, whichever comes first, then SKI, following written notice to LICENSEE, shall have the right to bring and control any such action at its own expense and by counsel of its own choice, and LICENSEE shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
 
9.2
Each party shall notify the other of each instance of alleged infringement and shall keep the other reasonably informed of all stages of Patent Rights enforcement. Each party may join the other as party plaintiff if required by applicable law. All costs of any action to enforce the Patent Rights taken by LICENSEE shall be borne by LICENSEE and any awarded damages derived therefrom shall be shared as described in Section 9.6. No settlement, consent judgment or other voluntary final disposition of any suit by SKI may be entered into without the prior written consent of LICENSEE, which consent shall not be unreasonably withheld;  provided that, pursuant to the terms of this Agreement, LICENSEE shall have the sole right (in its sole discretion) to grant a sublicense to any alleged infringer. No settlement, consent judgment or other voluntary final disposition of any suit by LICENSEE that admits or concedes that any of the Patent Rights is invalid or unenforceable or otherwise adversely affects the rights of SKI in the Patent Rights may be entered into without the prior written consent of SKI, which consent shall not be unreasonably withheld.
 
9.3
Each party shall promptly notify the other in writing in the event that a third party shall bring a claim of infringement against SKI or LICENSEE, either in the United States or in any foreign country in which there are Patent Rights.
 
9.4
In the event LICENSEE is sued for patent infringement, threatened with such suit, or enjoined from exercising its license rights granted hereunder, LICENSEE may terminate this Agreement according to Article XIII or contest the action against it. In any such action, LICENSEE shall be fully responsible for all its costs, including expenses, judgments and settlements, and all proceeds that it may recover, including judgments, settlements and awards, shall be shared as described in Section 9.7. SKI shall not be liable for any losses incurred as the result of an action for infringement brought against LICENSEE as the result of LICENSEE’s exercise of any rights granted under this
 
26
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
Agreement. LICENSEE’s may not deduct, from payments due to SKI, any portion of its costs related to any judgment or settlement of such actions.
 
9.5
In any infringement suit as either party may institute to enforce the Patent Rights against third parties pursuant to this Agreement, or in any infringement action brought against either party by a third party, each party hereto shall, at the request and expense of the other party, cooperate in all respects and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like.
 
9.6
LICENSEE will provide written notice to SKI at least 30 days prior to bringing a challenge to invalidate any of the patents included in the Patent Rights.
 
9.7
Except as otherwise agreed by the parties, any recovery realized as a result of any litigation described in this Article LX (whether by way of settlement or otherwise) will be allocated as follows: (a) first allocated to reimbursement of documented, unreimbursed legal fees and expenses incurred by the party initiating the proceeding for such litigation, (b) then allocated toward reimbursement of any of documented, unreimbursed legal fees and expenses of the other party for such litigation, and (c) then the remainder will be retained by the party that brought such proceedings, except that, if LICENSEE is the party that brought such proceedings, any portion of such remainder that was awarded to LICENSEE on the basis of lost sales, lost profits or a reasonable royalty with respect to Licensed Products or Licensed Processes shall be treated as Net Sales for purposes of this Agreement, and any portion of such remainder that was awarded to Company as punitive or other extraordinary damages for the applicable infringement or misappropriation shall be treated as Non-Royalty Sublicense Revenue for purposes of this Agreement.
 
ARTICLE X - INDEMNIFICATION, PRODUCT LIABILITY; REPRESENTATIONS
 
10.1
LICENSEE shall, at all times during the term of this Agreement and thereafter, indemnify, defend and hold harmless SKI and its Affiliates, their Board of Managers, officers, employees and affiliates, against any and all third party losses, damages, liabilities, costs, and expenses, including legal expenses and reasonable attorneys’ fees and including to the extent arising out of the death of or injury to any person or persons or out of any damage to property (collectively, “Indemnified Losses”), to the extent arising out of or resulting from (a) the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Product(s) and/or Licensed Process(es) and or Clinical Data and Know How by LICENSEE, or (b) any material obligation of LICENSEE hereunder or material breach thereof;  provided  that LICENSEE shall have no obligation to indemnify SKI or any such person to the extent of any Indemnified Loss (i) for which SKI has an obligation to indemnify LICENSEE pursuant to Section 10.2, as to which Indemnified Losses each party shall indemnify the other to the extent of their respective liability for such Indemnified Losses, or (ii) that arises out of or results from the negligence or willful misconduct by or of SKI or any indemnified person under this
 
27
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
Section 10.1 or SKI’s retention of rights pursuant to Section 2.4 or SKI’s (or any indemnified person’s) exercise of such rights.
 
10.2
SKI shall, at all times during the term of this Agreement and thereafter, indemnify, defend and hold harmless LICENSEE and its Affiliates, their Board of Managers, officers, employees and affiliates, against any and all Indemnified Losses to the extent arising out of or resulting from (a) any material breach of any representations or warranties by SKI hereunder; (b) any material obligation of SKI hereunder or material breach thereof; (c) SKI’s conduct of Phase I Clinical Trials and Phase II Clinical Trials; or (d) SKI’s retention of rights pursuant to Section 2.4 or SKI’s exercise of such rights (including in the conduct of any additional clinical trials);  provided  that SKI shall have no obligation to indemnify LICENSEE to the extent of any Indemnified Loss that arises out of or results from the negligence or willful misconduct of LICENSEE under this Section 10.2.
 
10.3
For the term of this Agreement, upon the commencement of clinical use, production, sale, or transfer by LICENSEE, whichever occurs first (but no earlier than within 90 days of the Effective Date), of any Licensed Product or Licensed Process, LICENSEE shall obtain and carry in full force and effect general liability insurance which shall protect LICENSEE and SKI in regard to events covered by Section 10.1 above. Such insurance shall be written by a reputable insurance company, shall list SKI as an additional named insured thereunder, shall be endorsed to include liability coverage, and shall require 30 days written notice to be given to SKI prior to any cancellation or material change thereof that would violate the foregoing. The limits of such insurance shall not be less than $2,000,000 per occurrence with an annual aggregate of $5,000,000 for personal injury, death or property damage. LICENSEE shall provide SKI with Certificates of Insurance evidencing the same.
 
10.4
Each party represents and warrants to the other party that it has the right to enter into this Agreement and perform its obligations contained herein.
 
10.5
SKI represents and warrants that:
 
 
(a)
it is the owner of the Patent Rights and Know How;
 
 
(b)
to the best of its knowledge, there is no infringement of the Patent Rights or Know How;
 
 
(c)
it has the right to grant the licenses herein to LICENSEE;
 
 
(d)
there are no agreements in conflict with this Agreement; and
 
 
(e)
none of SKI’s employees conducting or overseeing the clinical trials to be conducted by SKI pursuant hereto and, to the best of its knowledge, neither SKI nor any of its agents, in their capacity as such, have been disqualified or debarred
 
28
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
by the FDA, pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted under United States law for conduct relating to the development or approval, or otherwise relating to the regulation of any Licensed Product under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation or been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation.
 
10.6
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS AND NEITHER EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND INCLUDING ANY WARRANTIES WITH RESPECT TO COMPLETION OF CLINICAL TRIALS OR THE RESULTS NOT PRODUCING CERTAIN OUTCOMES.
 
10.7
EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS UNDER THIS ARTICLE X, IN NO EVENT SHALL EITHER PARTY, THEIR TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGES OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
 
ARTICLE XI - EXPORT CONTROLS
 
It is understood that SKI is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (including the Arms Export Control Act, as amended and the Export Administration Act of 1979), and that its obligations hereunder are contingent on compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the applicable agency of the United States Government and/or written assurances by LICENSEE that LICENSEE shall not export data or commodities to certain foreign countries without prior approval of such agency. SKI neither represents that a license shall not be required nor that, if required, it shall be issued.
 
ARTICLE XII - NON-USE OF NAMES
 
LICENSEE shall not use the names of SKI or its Affiliates, nor any of their employees (except for the founders of LICENSEE who are employees of SKI and may refer to their status as such), nor any adaptation thereof, in any advertising, promotional or sales literature without prior written consent obtained from SKI in each case. The foregoing notwithstanding, without the consent of SKI, LICENSEE may state that it has licensed from SKI one or more of the patents and patent applications comprising the Patent Rights.
 
29
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE XIII - ASSIGNMENT
 
Except as otherwise provided herein, neither party may assign its rights or delegate its duties under this Agreement without the prior written consent of the other party, such consent not to be unreasonably withheld;  provided however , LICENSEE may assign this Agreement to any Affiliate or to any successor in connection with the merger of LICENSEE, the sale or transfer of all or substantially all of LICENSEE’ s assets in a manner such that the assignee agrees in writing to remain liable and responsible for the performance and observance of all its duties and obligations hereunder. Subject to the restrictions contained in the preceding sentence, this Agreement shall be binding upon the successors and assigns of the parties. Any attempted delegation or assignment not in accordance with this Section shall be of no force or effect.
 
ARTICLE XIV - TERM; TERMINATION
 
14.1
The term of this Agreement shall commence on the Effective Date and, unless this Agreement is earlier terminated in accordance with the provisions herein, shall continue in full force and effect, on a country-by-country basis, until there is no remaining royalty obligation in such country pursuant to Section 5.1(b)(vii), at which time this Agreement shall expire in its entirety in such country.
 
14.2
SKI may terminate this Agreement as follows:
 
 
(i)
SKI may terminate this Agreement upon written notice to LICENSEE, if LICENSEE is declared insolvent by a court of competent jurisdiction and does not return to solvency before the expiration of a 30-day period; or, a petition in bankruptcy is filed against LICENSEE and is consented to, acquiesced in or remains undismissed for 90 days; or LICENSEE makes a general assignment for the benefit of creditors, or a receiver is appointed for LICENSEE and does not return to solvency before the expiration of a 30-day period;
 
 
(ii)
If LICENSEE fails to pay SKI undisputed license fees, royalties and patent expenses due and payable hereunder for more than 30 days, SKI shall have the right to terminate this Agreement on 30 days written notice, unless LICENSEE shall pay SKI within the 30-day period, all such license fees, royalties and patent expenses and interest due and payable. Upon the expiration of the 30-day period, if LICENSEE shall not have paid all such royalties, patent expenses and interest due and payable, the rights, privileges and license granted hereunder shall terminate. However, in the case of disputed license fees, royalties, and patent expenses, LICENSEE shall notify SKI in writing within 30 days of receiving written notice from SKI that LICENSEE disputes such payment. The parties will negotiate in good faith to resolve the dispute. If, within 45 days of LICENSEE’s request to resolve the dispute, the parties are unable to agree on a resolution to the dispute, then such matter shall be resolved by binding
 
30
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
arbitration in accordance with the Commercial Arbitration Rules of the AAA and the same procedures as set forth in Section 14.6.
 
 
(iii)
If LICENSEE defaults in its obligations under Section 10.3 to procure and maintain insurance, which default is not cured within 30 days of receipt of written notice from SKI;
 
 
(iv)
If LICENSEE breaches a material obligation of this Agreement, other than those occurrences set out in Sections 14.2(i), 14.2(ii) or 14.2(iii) hereinabove, which shall always take precedence in that order over any material breach or default referred to in this Section 14.2(iv), SKI shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder if LICENSEE has not cured such breach within 90 days after written notice from SKI;  provided  that, notwithstanding the foregoing, in the event of a breach of a material obligation that is capable of being cured, but is not reasonably capable of being cured within the 90-day cure period, if LICENSEE (i) proposes within such 90-day period a written plan to cure such breach within a defined time frame, and (ii) makes good faith efforts to cure such default and to implement such written cure plan, then SKI may not terminate this Agreement for so long as LICENSEE is diligently pursuing such cure in accordance with such plan.
 
14.3
LICENSEE shall be entitled to terminate this Agreement upon 90 days advance written notice to SKI either at will (without penalty of any kind) or in the event of SKI’s breach of a material obligation of this Agreement, which breach is not cured (if capable of being cured) within this 90-day period. Such termination may be in whole or on an indication-by-indication basis.
 
14.4
Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination. Upon termination of this Agreement by SKI under Section 14.2 or at will by LICENSEE pursuant to Section 14.3, LICENSEE must return to SKI all Confidential Information of SKI;  provided  that LICENSEE shall have the right for six months thereafter to dispose of all Licensed Products then in its inventory, and shall pay royalties thereon, in accordance with the provisions of Article V and shall submit the related reports as required by Article VI, as though this Agreement had not terminated.
 
14.5
Upon termination of this Agreement for any reason,  provided  that the applicable sublicensee is in material compliance with its sublicense agreement, all sublicenses shall be assumed by SKI on the terms negotiated in the sublicense agreement, except that SKI shall not be liable to such sublicensee with respect to any obligations of LICENSEE to the sublicensee that exceed the obligations of SKI to LICENSEE hereunder.
 
31
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
14.6
Upon SKI’s material breach of this Agreement, which breach has not been cured (if capable of being cured) within a 90-day period after LICENSEE’s written notice to SKI, LICENSEE may elect to pursue the following remedy:
 
 
(a)
Upon LICENSEE’s request, the parties will negotiate in good faith to determine the extent of the commercial and monetary damages suffered by LICENSEE due to the material breach by SKI. If the parties are able to agree upon the amount of the damages, future milestone payments under Section 5.1(e) and royalty obligations on future Net Sales under Section 5.1(b) shall be reduced proportionally to offset the monetary damage to LICENSEE;  provided  that such payments will not be reduced by more than 50% but any damages that are not offset in one year shall be carried forward from year to year until the entire amount of the damages are offset in full.
 
 
(b)
If, within 45 days of LICENSEE’s request to negotiate under clause (a) above, the parties are unable to agree on the amount of damages, or how those damages should be offset against future milestone and royalty payments, then such matter shall be resolved by binding arbitration in accordance with the Commercial Arbitration Rules of the AAA and the provisions of this Section 14.6. The party desiring to initiate an arbitration proceeding will send a written notice to the other party requesting the commencement of the arbitration proceeding and specifying the issue to be resolved. Within 15 days from the date such notice is sent, each party will designate one neutral arbitrator. Within 15 days thereafter, the first two arbitrators will designate a third. Each arbitrator will by training, education, or experience have knowledge of the subject matter of the dispute. If either party fails to choose an arbitrator within the foregoing time period, the AAA will choose an arbitrator on behalf of that party. Disputes about arbitration procedure will be resolved by the arbitrators or, failing agreement, by the AAA in New York, New York. Unless otherwise agreed by the parties, the arbitration proceedings will be conducted in New York, New York. The decision of the arbitrators shall be final and shall be fully and irrevocably accepted by the parties. The arbitrators will have the authority to grant specific performance and allocate costs between the parties (including attorneys’ fees); provided that the arbitrators will have no authority to award damages in contravention of this Agreement. The parties shall use their reasonable efforts to conduct all dispute resolution procedures under this Section 14.6 as expeditiously, efficiently, and cost-effectively as possible. Notwithstanding anything herein to the contrary, nothing in this Agreement shall restrict either party at any time from seeking equitable relief to prevent irreparable harm that may be caused by the other party’s actual or threatened breach of this Agreement.
 
14.7
Upon the expiration of the obligations of LICENSEE to make the royalty payments required by Article V in any country, LICENSEE shall have a fully paid-up, royalty-free, non-exclusive, sublicensable license under the Know How, Clinical Data, and the subject
 
32
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
matter described in the Patent Rights to make, offer for sale, import, have made, use, lease, and sell Licensed Products and to practice Licensed Processes in that country in the Field of Use.
 
14.8
Articles VII, XII, XIV, and XVI, and Sections 2.7, 2.8, 4.12, 8.7, 10.1, 10.2, 10.5, 10.6, and 10.7 of this Agreement shall survive termination.
 
ARTICLE XV - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
 
Any payment, notice or other communication pursuant to this Agreement shall be sufficiently made or given when delivered by courier, by facsimile (followed by hard copy sent by mail) or other means providing proof of delivery to such party at its address below or as it shall designate by written notice given to the other party:
 
In the case of SKI:
 
Sloan-Kettering Institute for Cancer Research
1275 York Avenue
New York, New York 10065
Attention:
  
Eric M. Cottington
 
  
Vice President
 
  
Research Resources Management
   
Telephone:
  
646 227 2065
Facsimile:
  
212 717 3080
 
In the case of LICENSEE:
 
MabVax Therapeutics, Inc.
11588 Sorrento Valley Rd., Suite 20
San Diego, CA 92121
   
Attention:
  
David Hansen
 
  
President and CEO
Telephone:
  
(858) 259-9405
Facsimile:
  
None
 
Checks shall be made payable to Sloan-Kettering Institute for Cancer Research (Tax I.D. No. 13-1624182) shall contain an accompanying letter indicated the Agreement Section to which the payment pertains, shall contain the Agreement SK number and shall be forwarded to:
 
Memorial Sloan-Kettering Cancer Center
General Post Office Box
P.O. Box 27718
 
33
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
New York, New York 10087-27718
 
ARTICLE XVI - MISCELLANEOUS PROVISIONS
 
16.1
This Agreement (together with that certain Research and License Agreement between the parties dated April 7, 2008) constitutes the entire agreement between the parties with respect to its subject matter and supersedes all prior agreements or understandings between the parties relating to its subject matter. This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both parties.
 
16.2
This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of the State of New York, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted.
 
16.3
The parties agree that any dispute relating to this Agreement, to any rights or licenses granted hereunder and to any patents licensed hereunder, shall be resolved in the Supreme Court of the State of New York, New York County, or in the United States District Court for the Southern District of New York. Each party hereby submits itself to the jurisdiction of those courts for the purpose of resolving any such disputes.
 
16.4
The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
 
16.5
All Licensed Products shipped to or sold shall be marked in such a manner as to conform with the patent laws and practice of the country of manufacture or sale.
 
16.6
The failure of either 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.
 
16.7
This Agreement may be executed in any number of counterparts and each of such counterparts shall for all purposes be an original and all such counterparts shall together constitute but one and the same agreement.
 
16.8
Neither party will be responsible for delays resulting from causes beyond the reasonable control of such party, including fire, explosion, flood, war, terrorist act, strike, or riot;  provided  that the nonperforming party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.
 
34
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
16.9
Each party hereto agrees to execute, acknowledge and deliver such further instruments, and to do all other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
 
16.10
Except as otherwise explicitly specified to the contrary, (a) references to a Section, Article, Exhibit or Schedule means a Section or Article of, or Schedule or Exhibit to this Agreement, unless another agreement is specified, (b) the word “including” will be construed as “including without limitation,” (c) references to a particular statute or regulation include all rules and regulations thereunder and any predecessor or successor statute, rules or regulations, in each case, as amended or otherwise modified from time to time, (d) words in the singular or plural form include the plural and singular form, respectively, (e) words of any gender include each other gender, (0 “or” is disjunctive but not necessarily exclusive, (g) the word “will” shall be construed to have the same meaning and effect as the word “shall,” (h) whenever this Agreement refers to a number of days, such number shall refer to calendar days unless business days are specified, and (i) references to a particular person include such person’s successors and assigns to the extent not prohibited by this Agreement.
 
IN WITNESS WHEREOF, authorized representatives of the parties have signed and dated this Agreement below.
 
       
Sloan-Kettering Institute for Cancer Research
     
MabVax Therapeutics, Inc.
   
           
By:
 
/s/ Eric M. Cottington
     
By:
 
/s/ J. David Hansen
   
   
Eric M. Cottington, PhD
         
Name:
 
J. David Hansen
   
   
Vice President
         
Title:
 
President and CEO
   
   
Research Resources Management
         
Date:
 
6-23-08
   
   
Date:
 
6-30-08
               
 
 
35
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT A
 
Patent Rights
 
[*****]
 
 
36
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT B
 
Clinical Trials
 
[*****]
 
 
37
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT C
 
Development Plan
 
MabVax,Therapeutics, Inc. Vaccine Development Plan
 
Section 1: Development Plan Overview
 
MabVax will engage in the discovery and identification of therapeutic antibodies as well as the clinical development of multiple cancer vaccines for the following anti-cancer indications; sarcoma, melanoma, neuroblastoma, ovarian, breast, and small cell lung cancer. The vaccines for the treatment of sarcoma and small cell lung cancer vaccines will be the initial focus of the company’s clinical development efforts. The objectives of the plan are the following:
 
 
 
Antibody Program
 
 
 
Discover, evaluate, and identify lead antibody development candidates to each of the antigens contained in the multivalent vaccines developed by Drs. Livingston and Ragupathi of SKI. Each antibody candidate for each antigen will be selected from the serum of six to fifteen patients participating in the Phase I clinical trials planned at SKI for 2008 through 2009. The Antibody Development Plan incorporated into the Research and License Agreement dated April 7, 2008 between SKI and MabVax contains the additional details regarding antibody discovery and development.
 
 
 
Vaccine Program
 
 
 
SKI will initiate Phase I clinical trials of the monovalent cancer vaccine comprising the sialyl Le a  antigen for the treatment of breast cancer and six additional polyvalent vaccines for the treatment of sarcoma, melanoma, neuroblastoma, small cell lung cancer, breast and ovarian cancer. All of these Phase I trials will be funded and executed by SKI.
 
 
 
At the conclusion of all Phase I trials, except for the Phase I trials in breast and ovarian cancer, SKI will transfer to MabVax the IND and all development responsibility for all of the remaining cancer vaccines. If, during the development program by either SKI or MabVax, there are any additional anti-cancer indications for the same vaccines that will be transferred to MabVax, then MabVax can assume responsibility for the development of that vaccine for the new indication.
 
 
 
Provided that the results of the Phase I trials justify continued clinical development, SKI will initiate two Phase II clinical trials for the polyvalent vaccines for breast and ovarian cancer. These two trials will be funded and executed by SKI and are expected to last from 4 to 5 years. At the conclusion of the Phase II breast and ovarian cancer trials, the IND and all development responsibility for these vaccines will be transferred to MabVax.
 
 
 
Provided that the results of the Phase I trials justify continued clinical development, MabVax will initiate Phase II clinical trials for the polyvalent vaccines for sarcoma and small cell lung cancer. The trials will be multi-center,
 
38
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
randomized, controlled trials that would be a part of the clinical program necessary to support filing a New Drug Application with FDA under Accelerated Approval or Fast Track review designations. These two clinical trials will be funded and executed by MabVax and are expected to last 4 years.
 
 
 
SKI and MabVax will establish a Steering Committee to guide the management of the Phase II clinical trials by both organizations.
 
 
 
MabVax will fund and execute a complete validation of all preclinical and clinical development and manufacturing steps and processes implemented to date to assure compliance with all regulatory requirements.
 
 
 
SKI will be responsible for manufacturing all Phase I clinical trial materials as well as all Phase II clinical trial materials for small cell lung cancer, sarcoma, breast and ovarian cancer. MabVax will be responsible for all additional vaccine manufacturing.
 
 
 
SKI will transfer the know-how and technology for manufacturing of all vaccines to a MabVax designated cGMP qualified third party beginning in 2008.
 
 
 
Additional clinical trials supporting the melanoma and neuroblastoma vaccine products are scheduled to begin pending positive early results from the Phase II sarcoma trial.
 
Section 2: Vaccine Development Program Overview
 
MabVax Funding and Near Term Activities
 
MabVax has raised $8M in a Series A financing to support both the early antibody rescue and evaluation effort as well as the development of cancer vaccines licensed from SKI. Our funding is sufficient for MabVax accomplish the following tasks relative to the development of the licensed cancer vaccines:
 
   
Activity
 
  
[*****]
   
Finalize protocol development for the sarcoma and small cell lung cancer trials and have the protocols reviewed by external FDA experts
 
  
[*****]
   
Complete a clinical, manufacturing and regulatory gap analysis to determine if the work done by SKI to date is sufficient to meet all FDA requirements.
 
  
[*****]
   
Begin systematic effort to bring all preclinical, clinical, manufacturing processes and procedures into FDA compliance.
 
  
[*****]
   
Transition cGMP vaccine manufacturing from SKI to MabVax and MabVax designated qualified third-parties
 
  
[*****]
   
Hire one or more appropriate contract research organizations to; 1.) Help recruit additional institutions and investigators, 2.) Initiate and
 
  
[*****]
 
39
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
   
manage the Phase II trials, 3.) Help analyze the data that emerges from the trials.
 
  
 
   
Initiate Phase II clinical trial in Sarcoma
 
  
[*****]
   
Initiate Phase II clinical trial in small cell lung cancer
 
  
[*****]
   
Manage and fund all aspects of the Phase II clinical trials for a minimum of 24 months
 
  
[*****]
   
Evaluate data from melanoma and neuroblastoma Phase I clinical trials to determine the optimal clinical development pathway for either or both
 
  
[*****]
   
Evaluate data from the Phase II breast and ovarian cancer trials and determine whether either or both warrant further clinical development and construct the optimal clinical development pathway
 
  
[*****]
 
Sarcoma and Small Cell Lung Cancer Initial Focus
 
Dr. Livingston’s, and therefore MabVax’s initial focus will be on the continued clinical development of the sarcoma and small cell lung cancer vaccines. Dr. Livingston’s experience and prior Phase I trials have indicated that the antigens in the sarcoma and small cell lung cancer vaccines have demonstrated significant immunogenicity and have elicited protective responses in clinical trial participants. There are also animal models and cell based assays that have been developed for these cancer types and results from those tests have given additional support to the idea that these vaccines have a higher likelihood of success. Both of these vaccines are for cancer types with a high unmet medical need. Relapse rates are extremely high and 5-year survival is very low. Additionally, these products could receive Accelerated Approval, Fast Track, or Early Access designations from FDA.
 
The sarcoma/melanoma Phase I trial is scheduled to begin in July of this year. This is a Phase I trial in Melanoma that is expected to be sufficient to allow initiation of a Phase II trial in Sarcoma. SKI is responsible for funding and conducting the Phase I clinical trials for these two vaccines. The IND will then be transferred to MabVax and MabVax will have responsibility for funding and conducting the follow-on Phase II trials. We expect that it will take eight months to accumulate enough safety data to support the initiation of a Phase II clinical trial. The Phase II trial will start sometime between December of 2008 and May of 2009 depending on the number of changes to the Phase II protocol that has been already drafted, the timing of a pre-Phase II meeting with FDA, and the amount of work required to validate the cGMP manufacturing of the current clinical supply. The Sarcoma Phase II trial will require a minimum of 48 months to complete. The Sarcoma trial could be delayed if SKI or the FDA decides that the Melanoma Phase I trial is not sufficient to allow the transition to a Sarcoma trial and a separate Phase I trial in Sarcoma must be completed before the Phase II trial can begin.
 
40
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
The small cell lung cancer Phase I trial will begin in October of this year. We expect that it will take eight months to accumulate enough safety data to support the initiation of a Phase II clinical trial. The Phase II trial will start sometime between May and September of 2009 depending on the number of changes to the Phase II protocol that has been already drafted, the timing of a pre-Phase II meeting with FDA, and the amount of work required to validate the cGMP manufacturing of the current clinical supply. The small cell lung cancer Phase II trial will require 42 months to complete.
 
If the early results from the sarcoma vaccine Phase II trial can demonstrate efficacy, then either the same vaccine or a derivative of the vaccine could be utilized in the treatment of melanoma and neuroblastoma. MabVax would be able to leverage the manufacturing, preclinical, and safety data derived from the sarcoma vaccine development effort to facilitate product development for these follow-on indications.
 
Additional Activities
 
The company will retain expert consultants with specific experience in regulatory affairs, cancer trial design and execution. Key issues that must be resolved prior to the initiation of the Phase II trials concern assessment of all preclinical development to determine if all FDA required activities have been completed, finalization of the Phase II protocols and review by FDA trained experts, validation of the GMP manufacturing process at SKI and determining if they meet FDA requirements for commercial development of biologic products. Up to this point in time, synthesis and extraction/purification of antigens for vaccine manufacture occurred at third-party facilities or at SKI. Conjugation of the antigens to KLH and vialing of the multivalent product is done under contract and under cGMP conditions by a San Diego based company. While much of this work is conducted under cGMP conditions and has received previous FDA review and approval, it has been intended for institutional based Phase I trials. As we move toward supporting both a Phase II trial and commercial production, each of the processes of manufacture of the final product will have to verified, validated, and documented. In addition, the adjuvant QS-21 is being synthesized at SKI and equivalency to the original formulation will have to be demonstrated prior to the initiation of the Phase II trial. These activities are crucial to validating the Phase I and Phase II clinical supply of the multivalent sarcoma and SCLC vaccines that has already been produced and is intended to support both the planned Phase I and Phase II trials. The company will put in place a technology transfer program to transfer vaccine manufacture from SKI to a qualified third party capable of commercial production. The company will engage a qualified contract research organization to provide input into all licensed vaccine trial design as well as manage the multi-center Phase II clinical trials for sarcoma and small cell lung cancer.
 
The current Phase II clinical protocols were written from the perspective of an institutional IND. It has been constructed with significant expert input but without the benefit of a pre-Phase IUIII meeting with FDA. To assure ourselves that our revised development plan will satisfy all regulatory requirements, we plan to discuss with the FDA the utility of a Special Protocol Assessment which would allow MabVax to confirm the clinical development pathway and required CMC activities required to move the programs forward successfully.
 
41
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
Summary
 
We have provided a detailed overview of our development plan for both the antibody and vaccine programs. Both programs represent significant commercial opportunity either as stand alone products or more likely as complementary products. The vaccine program begins in 2008 with the SKI sponsored Phase I trials of the multivalent vaccines. The Phase H trials for sarcoma and small cell lung cancer could start eight months after the Phase I trials begin provided that the Phase I trials demonstrate adequate immunogenicity and tolerability. The Phase II trials will take between approximately 48 months to complete. We have budgeted substantial expenses for the clinical development of the sarcoma and small cell lung cancer vaccines along with validation and gap analysis activities for all preclinical, clinical, regulatory, and manufacturing activities. Sufficient funding for two and one half years of operations supporting all programs outlined in this plan has already by raised from a Series A venture capital investment. Additional funding is available pending reasonable achievement of development milestones and early signs of clinical success.
 
42
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT D
 
Materials Transfer Agreement
 
TINS MATERIALS TRANSFER AGREEMENT (“Agreement”), made by and between  MABVAX THERAPEUTICS, INC ., a Delaware corporation with principal offices located at 11588 Sorrento Valley Rd., Suite 20, San Diego, CA 92121 (“MABVAX”), and  SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH , a New York membership corporation with principal offices located at 1275 York Avenue, New York, NY 10065 (“SKI”), shall govern the terms and conditions of the transfer of materials by SKI to MABVAX. This Agreement is being made effective as of          (the “ Effective Date ”). This Agreement, in its non executed form, is Exhibit D of a certain Exclusive License Agreement between SKI and MABVAX dated          (the “ License Agreement ”).
 
1.  Project . This Agreement and the provision of materials hereunder is generally for the research and development of monovalent and polyvalent cancer vaccines pursuant to the License Agreement and for MABVAX’s use of such materials for its own research purposes (the “Pr o ject”).
 
2.  Biological Materials . SKI shall transfer to MABVAX, to the extent that SKI has the right to transfer, certain “Biological Materials” (as defined in the License Agreement) owned by, or licensed to SKI, which Biological Materials are listed on Schedule A attached hereto and made a part hereof, which Exhibit may be amended from time-to-time as additional Biological Materials are transferred to MABVAX hereunder.
 
3.  Limitation of Use . SKI hereby grants MABVAX the right to use the Biological Materials only for the purposes of the Project and for no other purpose whatsoever without SKI’s prior written consent. MABVAX shall not use the Biological Materials in humans except for vaccines or other material approved for use in clinical trials.
 
4.  Confidentiality . The confidentiality obligations of Article VII of the License Agreement are hereby incorporated by reference.
 
5.  Control of Biological Materials . MABVAX shall retain control over the Biological Materials and shall not transfer the Biological Materials to any third party without prior written approval of SKI. For the purposes hereof, “third parties” shall not include those employees, consultants, agents, contractors, sublicensees and partners of MABVAX who will be involved in the handling, testing and/or evaluation of Biological Materials in carrying out the Project. Upon termination of this Agreement, unless otherwise agreed by the parties, MABVAX shall discontinue its use of the Biological Materials and shall, upon the written request of SKI, destroy or return any unused Biological Materials to SKI.
 
6.  Biological Materials . Biological Materials shall remain the property of, and title to all Biological Materials shall remain in, SKI.
 
43
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
(a) Other than as provided in Section 5, MABVAX shall not sell, or otherwise transfer to any other party, the Biological Materials, or SKI’S method(s) of using the Biological Materials, whether with, or without consideration, for any purpose, or use.
 
(b) No right or license to use the Biological Materials other than as specifically provided by this Agreement and the License Agreement is granted by SKI to MABVAX.
 
(c) MABVAX shall not obtain, and shall not attempt to obtain, patent coverage on the Biological Materials in the form provided by SKI without the express written consent of SKI. All inventions developed solely by SKI and related to the Biological Materials, their properties, compositions, and structures, as well as know-how, methods, procedures, processes, and screening methods SKI uses to identify the Biological Materials shall be solely owned by SKI.
 
7. Developments.
 
(a)  Developments . “ Developments ” means: (i) any inventions, improvement, discovery, development, or novel combination resulting from or created during the Project by MABVAX or the parties jointly; and (ii) any new materials, test results or data resulting from the Project or developed by MABVAX or the parties jointly during and in connection with the Project.
 
(b)  Ownership . Ownership of Developments will follow inventorship. SKI hereby grants MABVAX a royalty-free, non-exclusive license to Biological Materials or derivatives of Biological Materials that are required for the use of MABVAX or joint Developments.
 
(c)  Use and Disclosure of Jointly-Owned Developments . Each party will promptly and fully disclose to the other party any Developments which any employee of such party may make, whether alone or jointly. Jointly-owned Developments are subject to Sections 2.7 and 2.8 of the License Agreement.
 
(d)  Inventors and Authors . Inventorship of any Development will be in accordance with United States patent laws.
 
(e) MABVAX Methods and Procedures. All know-how, methods, procedures, processes, technology, and screening methods owned by MABVAX and utilized in the Project by MABVAX pursuant to this Agreement will remain owned by MABVAX.
 
8.  No Warranty . The Biological Materials are being made available only for the limited purposes of the Project. THE BIOLOGICAL MATERIALS AND DEVELOPMENTS ARE BEING SUPPLIED WITH NO WARRANTIES, EXPRESS OR IMPLIED, AND SKI EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT.
 
44
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
9.  Care of Use of Biological Materials . MABVAX acknowledges that the Biological Materials are experimental in nature and may have unknown characteristics and, therefore, agrees to use prudence and reasonable care in the use, handling, storage, transportation and disposition and containment of the Biological Materials. Notwithstanding the foregoing, MABVAX shall be entitled to rely on the written representations and instructions (if any) of SKI regarding the use, handling, storage, transportation, or other disposition, or containment of the Biological Materials.
 
10.  Limitation of Liability . In no event shall SKI be liable for any use of the Biological Material by MABVAX except to the extent such liability arises from the gross negligence or willful misconduct of SKI. To the extent permitted by federal and state laws, MABVAX hereby agrees to defend, indemnify and hold SKI harmless from any third party loss, claim, damage or liability, of whatsoever kind or nature, to the extent arising from MABVAX’s acts in connection with this Agreement or MABVAX’s use, handling or storage of the Biological Material, except to the extent such liability of claim arises from the gross negligence or willful misconduct of SKI. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES ARISING OUT OF, OR IN CONNECTION WITH THIS AGREEMENT WHETHER OR NOT THAT PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF, OR IS OTHERWISE ON NOTICE OF, SUCH POSSIBILITY.
 
11.  Compliance With Laws . MABVAX shall use, handle, store, transport, dispose of and contain the Biological Materials in compliance with all applicable laws.
 
12.  No Conflict . SKI and MABVAX each represent, to the other, that this Agreement does not and will not conflict with any other right, or obligation provided under any other agreement, or obligation that it has with any third party.
 
13.  Term of Agreement . This Agreement shall terminate upon the expiration or earlier termination of the License Agreement. This Agreement shall be effective as of the Effective Date. Sections 4, 6, 7, 10, 13 & 17 of this Agreement, and applicable provisions intended by their nature to survive, shall survive the expiration or termination of this Agreement and remain in full force and effect.
 
14.  Independent Contractors; Use of Names . The parties shall perform this Agreement in the capacity of independent contractors. Neither party, nor their respective employees, consultants, or representatives, shall be considered employees, partners, or agents of the other party. Neither party may make any representations, or commitments on the other party’s behalf, nor may one party use the other party’s name or trademarks in public disclosure without the named party’s prior written consent.
 
15.  General . This Agreement and the License Agreement contain the entire agreement between the parties with respect to the subject matter hereof, and supersede any prior agreements, negotiations, or representations between the parties with respect to the subject matter hereof, whether written or oral, except that if any provision of this Agreement is found to
 
45
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
be in conflict with the License Agreement, then the terms and provisions of the License Agreement shall control. This Agreement may be modified only by a subsequent written agreement signed by the parties. If any provision of this Agreement is held to be unenforceable, the remaining provisions shall continue unaffected.
 
16.  Assignment . Neither party shall assign this Agreement without the prior written consent of the other party, except in connection with the assignment of the License Agreement.
 
17.  Law . This Agreement shall be governed by and construed in accordance with the laws of the State of New York.
 
18.  Notices . Any notice required or permitted hereunder shall be in writing and shall be deemed effectively given upon delivery by facsimile (followed by hard copy sent by mail) or personal delivery, or the day after delivery to a recognized overnight courier, to the following addresses:
 
If to MABVAX:
 
MabVax Therapeutics, Inc.
11588 Sorrento Valley Rd., Suite 20
San Diego, CA 92121
 
Attention: David Hansen, President and CEO
  
 
  
If to SKI
 
Sloan-Kettering Institute for Cancer Research
1275 York Avenue
New York, New York 10021
Attention: Andrew D. Maslow
Director, Office of Industrial Affairs
Telephone: (858) 259-9405
  
 
  
Telephone:
  
 
Facsimile:
   
  
 
  
Facsimile:
  
 
 
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed below, effective as of the date written above.
 
MabVax Therapeutics, Inc.
     
Sloan-Kettering Institute for Cancer Research
         
By:
         
By:
   
   
(Signature)
         
(Signature)
   
J. David Hansen
         
Andrew D. Maslow
   
President and CEO
         
Director, Office of Industrial Affairs
 
46
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
Exhibit 10.8
 
CONFIDENTIAL TREATMENT REQUESTED
 
SK#13624
 
RESEARCH AND LICENSE AGREEMENT
 
BETWEEN
 
SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH
 
AND
 
MABVAX THERAPEUTICS, INC.
 
TABLE OF CONTENTS
 
PREAMBLE
ARTICLES:
   
  
   
     
1
 
DEFINITIONS
  
 
2
  
     
2
 
RESEARCH COLLABORATION AND TRANSFER OF BIOLOGICAL MATERIAL
  
 
7
  
     
3
 
OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY
  
 
8
  
     
4
 
GRANT
  
 
10
  
     
5
 
DUE DILIGENCE
  
 
11
  
     
6
 
PAYMENTS
  
 
12
  
     
7
 
CONFIDENTIAL INFORMATION
  
 
14
  
     
8
 
REPORTS AND RECORDS
  
 
16
  
     
9
 
INFRINGEMENT
  
 
17
  
     
10
 
INDEMNIFICATION, PRODUCT LIABILITY
  
 
19
  
     
11
 
EXPORT CONTROLS
  
 
20
  
     
12
 
NON-USE OF NAMES
  
 
21
  
     
13
 
ASSIGNMENT
  
 
21
  
     
14
 
TERMINATION
  
 
21
  
     
15
 
PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
  
 
22
  
     
16
 
MISCELLANEOUS PROVISIONS
  
 
23
  
     
Exhibits
   
  
     
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
This Agreement is effective on the date last subscribed below (the “Effective Date”), and is by and between  Sloan-Kettering Institute for Cancer Research  (hereinafter referred to as “SKI”), a New York membership corporation with principal offices at 1275 York Avenue, New York, New York 10065,  and MabVax Therapeutics, Inc. , a corporation with principal offices located at 11588 Sorrento Valley Road, Suite 20, San Diego, CA 92121 (“Company”).
 
WITNESSETH
 
WHEREAS, SKI has been engaged in research efforts focused on the development of conjugated tumor antigens as cancer vaccines; and
 
WHEREAS, SKI plans to conduct human clinical trials on such cancer vaccines which are expected to generate antisera against tumor antigens; and
 
WHEREAS, Company has expertise in the discovery, development and production of monoclonal antibodies using the lymphocytes of naturally exposed or vaccinated donors; and
 
WHEREAS, Company seeks to commercially develop monoclonal antibodies derived from the SKI human clinical trials for therapeutic and diagnostic uses through a vigorous and diligent program whereby public utilization shall result therefrom;
 
NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, the parties hereto agree as follows:
 
ARTICLE 1
 
DEFINITIONS
 
For the purpose of this Agreement, the following words and phrases shall have the following meanings:
 
1.1 “Affiliate” shall mean any person, firm, corporation or other entity controlling, controlled by, or under common control with a party hereto. For the purpose of the preceding sentence, the term “control” shall mean ownership, directly or indirectly, of more than 50% of the equity capital or the authority, directly or indirectly, to appoint a majority of the directors of another entity. With regard to SKI, “Affiliate” shall mean the Memorial Sloan-Kettering Cancer Center and the Memorial Hospital for Cancer and Allied Diseases.
 
1.2 “Biological Material” shall mean human blood and lymphocytes obtained from patients enrolled in the Participating SKI Clinical Trials.
 
1.3 “Collaboration Materials” shall mean (i) any and all materials (including without limitation monoclonal antibodies) developed in the course of the Development Program using the Biological Material and (ii) any derivatives of the foregoing materials.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
1.4 “Commercially Reasonable Efforts” shall mean the efforts and resources of similarly situated companies that are consistent with sound business judgment taking into consideration product labeling, the development potential, regulatory environment, market potential, economic return, and competitive market conditions, all measured by the facts and circumstances at the time such efforts are due.
 
1.5 “Development Program” shall mean the research to be conducted by Company as described in Exhibit B.
 
1.6 “Development Technology” shall mean (i) any and all Collaboration Materials, and (ii) any and all intellectual property rights in and to any Program Inventions (including, without limitation, Program Patent Rights).
 
1.7 “FDA” shall mean the United States Food and Drug Administration, its equivalent in another country, or successor agencies thereto.
 
1.8 “First Commercial Sale” means, in each country, the first commercial sale, where sale means delivery, billing out or invoicing, whichever comes first, of a Licensed Product by Company, its Affiliates or sublicensees to any person or entity other than Company, its Affiliates or sublicensees following Regulatory Approval in the country in which the sale is made.
 
1.9 A “Licensed Process” shall mean any process which is covered in whole or in part by a Valid Claim of the SKI Program Patent Rights or Joint Program Patent Rights in any country in which such process is practiced.
 
1.10 A “Licensed Product” shall mean any product or part thereof made, leased, used or sold by or on behalf of Company which:
 
(a) is or contains a Collaboration Material; or
 
(b) is covered in whole or in part by a Valid Claim of SKI Program Patent Rights or Joint Program Patent Rights in the country in which any product or part thereof is made, leased, used or sold; or
 
(c) is manufactured by using a Licensed Process.
 
1.11 “Net Sales” shall mean Company’s and its Affiliates and sublicensees’ gross invoiced sales of Licensed Products or Licensed Processes less the sum of the following:
 
(a) Discounts actually allowed and granted (including, without limitation, cash discounts and quantity discounts), retroactive price reductions, charge-back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to trade customers (a “ Discount ”);  provided however , that where any such Discount is based on sales of a bundled set of products in which such Licensed Product is included, the Discount shall be allocated to such Licensed Product on a
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
pro rata basis based on the sales value (i.e., the unit average selling price multiplied by the unit volume) of the Licensed Product relative to the sales value contributed by the other constituent products in the bundled set, with respect to such sale;
 
(b) Credits or allowances actually granted upon claims, damaged goods, rejections or returns of such Licensed Product, including such Licensed Product returned in connection with recalls or withdrawals;
 
(c) Freight out, postage, shipping and insurance charges for delivery of such Licensed Product;
 
(d) Taxes, tariffs, excise, sales, duties, or other taxes levied on, absorbed or otherwise imposed on the sale of such Licensed Product or Licensed Process, including, without limitation, value-added taxes, or other governmental charges otherwise imposed upon the billed amount, as adjusted for rebates and refunds, to the extent not paid by a third party; and
 
(e) Bad debts and uncollectible receivables provided that, in any calendar year, such deduction for bad debts and uncollectible receivables will not exceed four percent (4%) of the total billings for sales of Licensed Products and Licensed Processes sold in that year.
 
In the event a drug product in a finished dosage form contains a Licensed Product in combination with one or more other therapeutically active ingredients or with a carrier molecule or an immunological adjuvant (in each case, a “ Combination Product ”), the Net Sales of the Licensed Product, for the purposes of calculating royalty payments of this Agreement, shall be determined by multiplying the Net Sales (as defined above in this Section) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average invoice price in a particular country of the Licensed Product when sold separately in finished form and B is the weighted average invoice price in that country of the other active ingredient(s) sold separately in finished form. In the event that such average invoice price cannot be determined for both the Licensed Product and the other active ingredient(s) in the Combination Product, Net Sales for purposes of determining royalty payments shall be agreed by the parties based on the relative value contributed by each component. In the case of a Combination Product that contains one or more other therapeutically active ingredients, in no event shall Net Sales for purposes of determining royalty payments be less than fifty percent (50%) of the Net Sales of the Combination Product. In the case of a Combination Product that contains a carrier molecule or adjuvant but does not contain another therapeutically active ingredient, in no event shall Net Sales for purposes of determining royalty payments be less than seventy five percent (75%) of the Net Sales of the Combination Product.
 
For purposes of calculating Net Sales, sales between or among Company or its Affiliates or sublicensees shall be excluded from the computation of Net Sales, but sales by Company or its Affiliates or sublicensees to third parties shall be included in the computation of Net Sales.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
Licensed Products shall be considered “sold” when billed or invoiced. In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time of shipment or when the Licensed Product is paid for, if paid for before shipment or invoice.
 
In the case of any sale or other disposal for value, such as barter or counter-trade, of the Licensed Product, or part thereof, other than in an arm’s-length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Licensed Product in the country of sale or disposal.
 
No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by Company and on its payroll, or for cost of collections.
 
Net Sales shall be determined in accordance with GAAP.
 
Notwithstanding the foregoing or any other provision of this Agreement to the contrary, Licensed Products for which Company receives no consideration used (i) for promotional or sampling purposes and (ii) in preclinical studies or clinical trials or in compassionate use programs, shall not be considered in determining Net Sales.
 
1.12 “Non-Royalty Sublicense Revenue” shall mean the amount actually received by Company from sublicensees arising from the grant of a sublicense of the right to make or sell Licensed Products or Licensed Processes, including, but not limited to, up-front license fees, license issue fees, maintenance fees and milestone payments paid by a sublicensee to Company in consideration for the grant by Company of a sublicense of the right to make or sell Licensed Products or Licensed Processes;  provided however , that “Non-Royalty Sublicense Revenue” shall in any event exclude: (A) royalties paid to Company by a sublicensee based on such sublicensee’s sale of Licensed Products or Licensed Processes; (B) any payments by a sublicensee to Company that are tied directly to the provision of goods and services by Company to such sublicensee (including, without limitation, research and development funding) to compensate Company for the fair market value of the provision of such goods and services; (C) payments for equity or debt securities of Company (except to the extent such payments exceed the fair market value of such securities on the date of issuance); and (D) reimbursement of patent costs actually incurred by Company.
 
1.13 “Participating SKI Clinical Trials” shall mean those human clinical trials listed in Exhibit A, which are to be conducted at Memorial Sloan-Kettering Cancer Center, and from which Biological Material is planned to be obtained.
 
1.14 “Patent Rights” shall mean all patent filings, utility model filings and design filings, whether granted (issued), or not and all foreign counterparts of any of the foregoing, including but not limited to patent applications, continuations, continuations-in-part, additions, divisionals, provisionals or any substitute applications, black box applications, registration applications, supplementary protection certificate applications, and including granted (issued)
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
patents with respect to any of such application, including reissue patents, re-examination patents, renewal patents, extensions including supplementary protection certificates, confirmation patents or registration patents and patents of addition.
 
1.15 “Phase 1 Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 1 study as defined in 21 CFR § 312.21(a) (or its successor regulation).
 
1.16 “Phase 2 Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or its successor regulation).
 
1.17 “Phase 3 Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) (or its successor regulation).
 
1.18 “Program Inventions” shall mean new and useful processes, machines, manufactures or compositions of matter that a) Are conceived either prior to or during the performance of the Development Program and are first reduced to practice during the performance of the Development Program and b) Relate to the Biological Material or the Collaboration Material or claim in whole or in part the Collaboration Materials.
 
1.19 “Program Patent Rights” shall mean Patent Rights claiming Program Inventions.
 
1.20 “Regulatory Approval” shall mean all authorizations by the appropriate governmental entity or entities necessary for commercial sale of a Licensed Product or Licensed Process in that country including, without limitation and where mandatory, approval of labeling, price, reimbursement and manufacturing.
 
1.21 “Royalty Term” shall mean, in the case of any Licensed Product or Licensed Process in any country, the period of time commencing on the First Commercial Sale of such Licensed Product or Licensed Process in such country and ending upon the later of (a) the expiration of the last-to-expire Valid Claim within the SKI Program Patent Rights and SKI’s Interest in Joint Program Patents which the Licensed Product or Licensed Process would infringe in such country but for this Agreement, or (b) twelve (12) years after the date of First Commercial Sale of such Licensed Product or Licensed Process in such country.
 
1.22 “Royalty Year” shall mean each twelve (12) month period commencing January 1 and ending December 31 during the term of this Agreement. For the first year of this Agreement, the Royalty Year shall be the period of time between the signing of the Agreement and December 31.
 
1.23 “SKI Patents” means the patents listed in Exhibit E and any additional patent rights controlled by SKI that SKI agrees dominate the Licensed Products or the Licensed Processes and for which SKI has the unencumbered right to give to Company a nonexclusive research and development license, as long as such additional patent rights are added to Exhibit E through an amendment of the Agreement.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
1.24 “Valid Claim” shall mean a claim of (i) any granted, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, and that has not been lost through interference proceedings or by intentional or unintentional abandonment, or (ii) a pending patent application;  provided however , that if a claim of a pending patent application shall not have issued within five (5) years after the earliest filing date from which such claim takes priority, such claim shall not constitute a Valid Claim for purposes of this Agreement unless and until a patent issues with such claim.
 
ARTICLE 2
 
RESEARCH COLLABORATION AND TRANSFER OF BIOLOGICAL MATERIAL
 
2.1 SKI shall use its best efforts to initiate the Participating SKI Clinical Trials listed in Exhibit A on a timely basis, subject to Institutional Review Board (“IRB”) and FDA approvals.
 
2.2 SKI makes no warranty that (a) any of the Participating SKI Clinical Trials will be initiated, (b) any of the Participating SKI Clinical Trials will commence at a specific time, or (c) any of the Participating SKI Clinical Trials will yield Biological Materials. SKI shall not be liable to Company if any of the Participating SKI Clinical Trials are not carried out, not commenced when expected, or do not yield Biological Materials.
 
2.3 Subsequent to the commencement of a Participating SKI Clinical Trial and subject to the detection of appropriate immune responses to the administered cancer vaccine or vaccines from patients enrolled therein, SKI will make available to Company, on an exclusive (as to any other commercial or non-commercial entity except for SKI and its affiliates) basis the Biological Material for use in the Development Program according to the quantities and schedule in Exhibit C. Exhibit C may be revised when agreed upon in writing by SKI and the Company or as required by an IRB or the FDA.
 
2.4 Company shall pay to SKI the sum of [*****] per patient as cost reimbursement (provided that such Biological Material sample meets the criteria specified in Exhibit C, as such exhibit may be amended from time to time).
 
2.5 Company agrees that its use of the Biological Material shall be for the performance of the Development Program only
 
2.6 Company may not transfer the Biological Material to a third party without the prior written permission of SKI except that Company may transfer the Biological Material to a third party that is specifically engaged by agreement to perform Development Program activities
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
on Company’s behalf. All third party uses and users of the Biological Material shall comply with the relevant terms of this Agreement.
 
2.7 SKI represents and warrants that, prior to initiating any Participating SKI Clinical Trial, SKI will have obtained from an IRB, in accordance with all applicable federal, state and local laws and regulations (including 45 C.F.R. part 46), appropriate assurance that such Participating SKI Clinical Trial is designed in a manner appropriate to ensure that the participating subjects are protected. Such assurance shall include, without limitation, IRB approval of the form of informed consent agreement to be signed by each human subject participating in such Participating SKI Clinical Trial or his or her legal representative (the “Consent”), which Consent shall (i) comply with all applicable federal and state laws and regulations, (ii) expressly include the subject’s consent to the collection of Biological Material, the donation of the Biological Material to SKI, the transfer of the Biological Material to Company, and the use of Biological Material to conduct the Development Program; and (iii) contain an express acknowledgment by or on behalf of the subject that he or she is relinquishing any right or claim to any inventions, new techniques, technology, product or other economic opportunity that may result from the use of the Biological Material.
 
2.8 Company agrees to comply with all governmental and National Institutes of Health regulations and guidelines which are applicable to the Company’s use of the Biological Materials. Since not all of the Biological Materials’ characteristics are known, they should be used with caution and prudence.
 
2.9 SKI will make available to the Company sufficient quantities, to be mutually agreed by the parties in writing, of the polyvalent vaccines used in the clinical trials listed in Exhibit A, and the monovalent components of those vaccines, for use in the Development Program. The use of the supplied vaccines will be limited to the Development Program and subject to the provisions of Section 4.2.
 
ARTICLE 3
 
OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY
 
3.1 SKI retains title and all rights to the Biological Material subject to the rights granted herein.
 
3.2 SKI understands and agrees that Company will have ownership claims of any right, title, and interest over the Collaboration Materials that Company creates by itself or together with third parties. SKI shall not claim ownership of any right, title, and interest in and to the Collaboration Materials
 
3.3 Inventorship of Program Inventions shall be determined in accordance with U.S. patent laws. Any Program Invention that is invented solely by one or more employees or consultants of Company (each, a “Company Program Invention”), and Program Patent Rights
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
claiming such Company Program Invention (“Company Program Patents”), shall be solely owned by Company. Any Program Invention that is invented solely by one or more employees or consultants of SKI (each, a “SKI Program Invention”), and Program Patent Rights claiming such SKI Program Invention (“SKI Program Patents”) shall be solely owned by SKI. “SKI Program Patents” shall not include the Patent Rights listed in Exhibit E hereto. Any Program Invention that is invented jointly by one or more employees or consultants of SKI and one or more employees or consultants of Company (each, a “Joint Program Invention”), and Program Patent Rights claiming such Joint Program Invention (“Joint Program Patents”), shall be jointly owned by SKI and Company.
 
3.4 Company shall have the sole right to control prosecution and maintenance of Company Program Patents, at Company’s sole expense.
 
3.5 SKI shall diligently prosecute and maintain the SKI Program Patents in the United States and in such countries as are determined by SKI and agreed to by Company, using counsel of its choice. Company shall be responsible for and pay all future costs and expenses incurred by SKI for the preparation, filing, prosecution, issuance, and maintenance of the SKI Program Patents. If Company does not agree to bear the expense of filing patent applications in any foreign countries in which SKI wishes to obtain patent protection, then SKI may file and prosecute such applications at its own expense and any license granted hereunder shall exclude such countries. SKI shall provide Company with copies of all relevant documentation so that Company may be informed and to give Company reasonable opportunity to advise SKI of the continuing prosecution, and Company agrees to keep this documentation confidential.
 
3.6 During the term of this Agreement, Company shall have the first right to control prosecution and maintenance of Joint Program Patents, at Company’s sole expense. If Company elects not to pursue the prosecution or maintenance of a Joint Program Patent in a particular country, then Company shall so notify SKI promptly in writing and in reasonable time to enable SKI to meet any deadlines by which an action must be taken to establish or preserve any such rights in such Joint Program Patent in such country. Upon receipt of each such notice from Company or if, at any time, Company fails to initiate any such action after a request by SKI that Company do so, SKI shall have the right, but not the obligation, to pursue the filing or support the continued prosecution or maintenance of such Joint Program Patent at its expense in such country. If SKI elects to pursue such filing or continue such support, then SKI shall notify Company of such election and Company agrees to give up ownership of such Joint Program Patent. Each party shall, at the other party’s request, assist and cooperate in the filing and prosecution of any application, amendment, submission, response or correspondence with respect to any Joint Program Patent in accordance with this Agreement, including but not limited to, execution and delivery of all necessary documents. Each party shall provide the other party, sufficiently in advance for the other party to comment, with copies of all patent applications and other material submissions and correspondence with any patent counsel or patent authorities pertaining to the Joint Program Patents, and shall give due consideration to the comments of the other party.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE 4
 
GRANT
 
4.1 SKI hereby grants to Company an exclusive, worldwide right and license, including the right to sublicense, to the Biological Materials and the SKI Program Patents and SKI’s interest in Joint Program Patents to discover, develop, make, have made, use, sell, have sold, offer for sale and import Collaboration Materials and Licensed Products and to practice Licensed Processes, during the term of this Agreement, subject to the rights reserved or observed in Sections 4.3.
 
4.2 SKI hereby grants to Company a nonexclusive research and development license for Company to practice the use of SKI’s cancer vaccines identified in the SKI Patents and the antigens which they contain (to the extent that SKI has a Valid Claim on any antigens included in any or all vaccines) for the purpose of discovering, developing, making, having made, and commercializing Collaboration Materials, Licensed Products and Licensed Processes, and not for human use.
 
4.3 Notwithstanding any other provisions of this Agreement, it is agreed that SKI and its Affiliates shall retain the right to utilize all SKI Program Inventions, SKI’s Interest in Joint Program Inventions, Biological Materials and Development Technology for internal non-commercial teaching and research activities. Upon SKI’s request and upon execution of the Material Transfer Agreement between the Company and SKI attached as Exhibit G, Company will reasonably supply Collaboration Materials to SKI for these purposes. These research activities shall be under the direction of Dr. Philip Livingston and are subject to such Material Transfer Agreement. All rights reserved to the United States Government under 35 USC §§ 200-212, as amended, shall remain and shall in no way be affected by this Agreement.
 
4.4 Company hereby agrees that every sublicensing agreement to which it shall be party and which shall relate to the rights, privileges and license granted hereunder shall contain an acknowledgment by the sublicensee of the duration of the Royalty Term.
 
4.5 Company agrees that any sublicenses granted by it shall provide that the obligations to SKI of Article 5, Sections 5.1 and 5.2, and Articles 7, 8, 9, 10, 11, 12, 13, 14 and 16 of this Agreement shall be binding upon the sublicensee as if it were a party to this Agreement.
 
4.6 Each Party agrees to be named as a party, if necessary, to bring or maintain a lawsuit involving a Joint Program Patent.
 
The license granted hereunder shall not be construed to confer any rights upon Company by implication, estoppel or otherwise, except as expressly set forth herein.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE 5
 
DUE DILIGENCE
 
5.1 Company and its sublicensees shall use Commercially Reasonable Efforts to bring Licensed Products or Licensed Processes to market through a thorough, vigorous and diligent program for exploitation of the Development Technology and to continue active, diligent marketing efforts for one or more Licensed Products or Licensed Processes which have received Regulatory Approval throughout the life of this Agreement. Notwithstanding Company’s intentions and obligations, Company expressly disclaims any representation or warranty that any development or marketing activities will be successfully completed, and SKI expressly acknowledges the possibility that, despite Company’s use of Commercially Reasonable Efforts, any or all development and marketing activities with respect to Licensed Products and Licensed Processes may be unsuccessful.
 
5.2 In addition, Company shall adhere to the following milestones:
 
(a) Company has delivered to SKI prior to the execution of this Agreement, its Development Plan as Exhibit F which shall include a business, research and development plan including, for example, time planned for each phase of development of the Development Technology for a three (3) year period. Similar reports shall be provided to SKI annually within sixty (60) days of the anniversary of the Effective Date to relay update and status information on Company’s business, research and development progress, including projections of activity anticipated for the next reporting year.
 
(b) Company shall be solely responsible for diligently and promptly taking all reasonable steps to secure all required and/or necessary governmental approvals to sell, exploit, or market any and all Licensed Products. Company shall advise SKI, through annual reports described in Section 5.2(a) above, of its program of development for obtaining said approvals.
 
5.3 Company’s material breach of section 5.1 shall entitle SKI to terminate the rights granted to Company under section 4.2 of this Agreement, subject to Company’s right to cure thereunder. Termination of the rights granted to Company under Section 4.2 of this Agreement as per this Section shall not affect all other rights granted to Company in this Agreement.
 
5.4 Company warrants that it has raised sufficient funds in a Series A investment to fully fund the Development Program in Exhibit B as evidenced by the letter outlining the commitment from the Company’s investor, attached as Exhibit D.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE 6
 
PAYMENTS
 
6.1 For the rights and the privileges and licenses granted in Sections 4.1 and 4.2 hereunder, Company shall pay to SKI, in the manner hereinafter provided, during the Royalty Term of this Agreement or until this Agreement shall be terminated as hereinafter provided, whichever occurs first:
 
(a) A license issue fee of five thousand dollars ($5,000), payable within forty-five (45) days of the Effective Date.
 
(b) A fee of five thousand dollars ($5,000), payable within forty-five (45) days of the start of the third clinical trial of any of the clinical trials listed in Exhibit A.
 
(c) Royalties as follows:
 
(i) A royalty in an amount equal to [*****] of the Net Sales by Company, Affiliate or any sublicensee, of the Licensed Products or Licensed Processes. Royalties under this Section 6.1(b)(i) shall be payable on a country-by-country and Licensed Product-by-Licensed Product or Licensed Process-by-Licensed Process basis for the period equal to the Royalty Term for such Licensed Product or Licensed Process in such country.
 
(ii) If one or more follow-on protein products or a biosimilar product that is a generic equivalent product or considered a bio-similar product (the “Biosimilar”) and is marketed for the same indication and in the same Territory as a Licensed Product (the “Non-exclusive Licensed Product”), [*****], provided however that in no case shall such reduction lower the amount of royalties otherwise payable for that Non-exclusive Licensed Product by more than [*****].
 
(iii) If Company, its Affiliates or its Sublicensees pay third party royalties on the sales of a Licensed Product or the practice of a Licensed Process, in any country in the Territory in consideration for third party patent rights (the “Third Party Royalty Payment”), the royalties payable under this Article 6.1(c) on such Licensed Product or Licensed Process in such country in the Territory, [*****]; provided, however, that in no case shall such reduction lower the amount of royalties otherwise payable under this Article 6.1(c) by more than [*****];
 
(iv) The Company shall have the right to reduce its royalty payments to SKI if after using Commercially Reasonable Efforts a Licensed Product is sublicensed to a third-party and the resulting sublicense royalty does not allow the Company to receive a royalty amount at least equal to the royalty amount due SKI. In such a case, the sublicense royalty will be divided equally between the Company and SKI.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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(v) [*****] of Non-Royalty Sublicense Revenue.
 
(d) Milestone payments as follows for each Licensed Product to achieve the milestone:
 
(i) in the event such milestone is achieved by Company:
 
 
(1)
[*****] upon the initiation of the first Phase 1 Clinical Trial;
 
 
(2)
[*****] upon the initiation of a Phase 3 Clinical Trial;
 
 
(3)
[*****] upon filing of an NDA;
 
 
(4)
[*****] upon First Commercial Sale in the United States; and
 
 
(5)
[*****] upon First Commercial Sale in each of the following four countries: Japan, Germany, United Kingdom, and France.
 
For the avoidance of doubt, if a particular Licensed Product contains or comprises two or more distinct Collaboration Materials, each of the foregoing milestone payments shall be payable only one time for such Licensed Product, notwithstanding the fact that such Licensed Product contains or comprises two or more distinct Collaboration Materials.
 
(ii) in the event a milestone is achieved by a sublicensee, the amount due under 6.1(c)(i) above plus [*****] of any amount in excess of such amount paid by a sublicensee to Company.
 
For the avoidance of doubt, the payments specified in this Section 6.1 are payable regardless of the ownership of the Development Technology on which the applicable Licensed Product is based.
 
6.2 If Company receives from sublicensees anything of value in lieu of cash payments based upon payment obligations of any sublicense under this Agreement, Company shall pay SKI royalty or other payments as required by Section 6.1(b), based on the fair market value of such payment, unless SKI waives in writing such payment obligation.
 
6.3 Company is not obligated to pay multiple royalties if any Licensed Product or Licensed Process is covered by more than one Valid Claim of the Program Patent Rights or the same Licensed Product or Licensed Process is covered by Valid Claims in two or more countries.
 
6.4 Payments shall be paid in United States dollars in New York, NY, or at such other place as SKI may reasonably designate consistent with the laws and regulations controlling in
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
13
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
any foreign country, but not in any other currency. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate prevailing at the JP Morgan Chase Bank (N.A.) on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
 
6.5 Interest
 
(a) Company shall pay to SKI interest on any amounts not paid when due. Such interest will accrue from the fifteenth (15th) day after the payment was due at an annual rate two percent (2%) above the daily prime interest rate, as determined by The JP Morgan Chase Bank (N.A.) or its successor entity, on each day the payment is delinquent, and the interest payment will be due and payable on the first day of each month after interest begins to accrue, until full payment of all amounts due SKI is made.
 
(b) SKI’s rights to receive such interest payments shall be in addition to any other rights and remedies available to SKI.
 
(c) If the interest rate required in this Subsection exceeds the legal rate in a jurisdiction where a claim for such interest is being asserted, the required interest rate shall be reduced, for such claim only, to the maximum interest rate allowable in the jurisdiction.
 
ARTICLE 7
 
CONFIDENTIAL INFORMATION
 
7.1 It may be necessary or desirable for the parties to disclose proprietary, trade secret and/or information relating to patients, Participating SKI Clinical Trials, Collaboration Materials, the Development Program, Licensed Products and/or Licensed Processes (hereinafter “Confidential Information”) to one another.
 
7.2 All medical records (or other patient information) are Confidential Information of SKI, and do not need to be marked “Confidential.” SKI will make all attempts to ensure that any information revealing patient identifiable health information of the patients contributing Biological Material will be removed. Company agrees to make best efforts to erase and remove any such identifying information that may remain despite SKI’s precautions. There shall be no time limit on the parties’ obligation to maintain the confidentiality of patient identifiable health information, including information whose identifiers may be ascertained by the exercise of reasonable effort through investigation.
 
7.3 Any other Confidential Information shall be marked as “Confidential” or, if provided to the other party orally, shall be reduced to writing marked as “Confidential” and sent to the other party within thirty (30) days of the oral disclosure, except that this requirement shall not apply to patient information, which is always Confidential Information. Each party agrees that Confidential Information of the other party disclosed to it or to its employees shall remain
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
14
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
confidential during the term of this Agreement and for five (5) years after expiration or termination hereof. Notwithstanding the foregoing, in the event of termination of this Agreement, upon Company’s prior written consent, not to be unreasonably withheld, SKI may disclose to third parties such Confidential Information pertaining to Joint Program Inventions and Program Patent Rights claiming such Joint Program Inventions as is reasonably necessary for SKI to identify other potential licensee’s of SKI’s technology. Except as otherwise expressly set forth herein, Confidential Information shall:
 
(a) be used only in connection with the legitimate purposes of this Agreement;
 
(b) be disclosed only to those who have a need to know it; and
 
(c) be safeguarded with the same care normally afforded confidential information in the possession, custody or control of the party holding the Confidential Information.
 
The foregoing shall not apply when, after and to the extent the receiving party can demonstrate by competent evidence that the Confidential Information disclosed:
 
(i) was in the public domain prior to the date of the disclosure; or
 
(ii) enters the public domain through no breach of this Agreement by the receiving party; or
 
(iii) was already known to the receiving party at the time of disclosure; or
 
(iv) is subsequently received by the receiving party on a non-confidential basis in good faith from a third party without breaching any confidential obligation between the third party and the disclosing party; or
 
(v) was independently developed, as established by tangible evidence, by the receiving party without reference to information or material provided by the disclosing party; or
 
(vi) is required to be disclosed for minimal compliance with court orders, statutes or regulations or SKI/MEMORIAL audits for compliance with such regulatory requirements, provided that prior to any such disclosure to the extent reasonably practicable, the party from whom disclosure is sought shall promptly notify the other party and shall afford such other party the opportunity to challenge or otherwise lawfully seek limits upon such disclosure of Confidential Information.
 
(vii) Company is hereby authorized to release Confidential Information to employees, agents, consultants, contractors, manufacturers, service providers, bankers,
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
15
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
securities advisors and the like who are under an obligation of confidentiality and require the information to perform their duties. Company is hereby authorized to release Confidential Information to its potential Sublicensees for the purpose of negotiating and granting of Sublicenses thereof, provided that Company takes reasonable precautions to safeguard such Confidential Information of SKI. Company is authorized to release Confidential Information for the purpose of prosecuting and enforcing Program Patents, obtaining marketing approvals, and making regulatory submissions.
 
ARTICLE 8
 
REPORTS AND RECORDS
 
8.1 Company shall keep, and shall require its Affiliates and sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to SKI hereunder. Said books and records shall be maintained for a period of no less than four (4) years following the period to which they pertain. SKI shall have the right to cause an independent, certified public accountant reasonably acceptable to Company to audit such records to confirm payments due hereunder for a period covering not more than the preceding four (4) years. Such audits may be exercised no more than once per year during normal business hours upon reasonable prior written notice to Company. No accounting period of Company shall be subject to audit more than one time for the same purpose. SKI shall bear the full cost of such audit unless such audit discloses an underpayment by Company of more than ten percent (10%) or $50,000, for any twelve (12) month period, in which case, Company shall bear the full cost of such audit and shall promptly remit to SKI the amount of any underpayment, plus interest as stipulated in Section 6.5.
 
8.2 Company, within sixty (60) days after June 30 and December 31 of each year, shall deliver to SKI true and accurate reports, giving such particulars of the business conducted by Company and its sublicensees during the preceding six-month period under this Agreement as shall be pertinent to a royalty accounting hereunder. Company shall use commercially reasonable efforts to obtain such reports from sublicensees as are necessary to fulfill its reporting requirements under this Section 8.2, but it shall not be deemed a material breach of this Agreement by Company if, notwithstanding Company’s commercially reasonable efforts, Company is unable to timely report regarding its sublicensees’ activities as a result of such sublicensees’ failure to timely provide the requisite information to Company. These shall include at least the following, to be itemized per Licensed Product and Licensed Process:
 
(a) Number of Licensed Products and Licensed Processes commercially used, manufactured and sold, rented or leased.
 
(b) Total billings for Licensed Products and Licensed Processes commercially used, sold, rented or leased.
 
(c) Deductions applicable as provided in the definition of Net Sales.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
(d) Total royalties due.
 
(e) Names and addresses of all sublicensees of Company.
 
(f) Total royalty income from all revenues subject to sublicensees’ royalties.
 
(g) Total Non-Royalty Sublicense Revenue.
 
8.3 With each such report submitted, Company shall pay to SKI the royalties due and payable under this Agreement. If no royalties shall be due, Company shall so report.
 
8.4 Each milestone payment shall be reported and paid within thirty (30) days after achievement of the corresponding milestone.
 
8.5 Company agrees to forward to SKI a copy of any and all fully executed sublicense agreements, provided that Company shall have the right to redact from such copy any financial or other terms that Company deems confidential and that are not necessary for SKI to ascertain Company’s compliance with this Agreement, and further agrees to timely forward to SKI a copy of payment reports received by Company from its sublicensees during the preceding Royalty Year.
 
ARTICLE 9
 
INFRINGEMENT
 
9.1 Each party shall promptly notify the other in writing of any alleged or threatened infringement of any Program Patent or any alleged or threatened misappropriation of any Program Invention of which it becomes aware.
 
9.2 Company shall have the obligation to address a potential infringement of any SKI Program Patent by taking one of the following actions: (a) entering into a sublicense agreement with a company suspected of infringement, (b) bring and control any action or proceeding with respect to infringement of any SKI Program Patents at Company’s own expense and by counsel of its own choice, and SKI shall have the right, at its own expense, to be represented in any such action by counsel of its own choice, or (c) determining that no action is required. In each case, Company shall consult with SKI to seek the written consent of SKI for a particular action. Such consent of SKI shall not be unreasonably withheld. If Company fails to bring any such action or proceeding within (a) one hundred twenty (120) days following the notice of alleged infringement or misappropriation, or (b) thirty (30) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, and the Company and SKI cannot agree on a course of action to address the potential infringement, then SKI shall have the right to bring and control any such action at its own expense and by counsel of its own choice, and Company shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
17
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
9.3 In the event a party brings an action for infringement of any SKI Program Patents and Joint Program Patents in accordance with this Article 9, such party shall keep the other party fully informed of the status and results of such action, and the other party shall cooperate fully, including, if required to bring such action, the furnishing of a power of attorney, and, to the extent possible, having its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like. The party bringing an action shall have the right to join the other party as a party plaintiff if such action is necessary to bring or maintain the action and all costs of that action shall be borne by the party bringing the action.
 
9.4 Neither party shall have the right to settle any patent infringement litigation under this Article 9 with respect to SKI Program Patents and SKI Joint Program Patents without the prior written consent of the other party, which shall not be unreasonably withheld, delayed, or conditioned.
 
9.5 Except as otherwise agreed by the parties in connection with a cost-sharing arrangement, any recovery realized as a result of litigation described in this Article 9 (whether by way of settlement or otherwise) will be first allocated to reimbursement of unreimbursed legal fees and expenses incurred by the party initiating the proceeding, then toward reimbursement of any of unreimbursed legal fees and expenses of the other party, and then the remainder will be retained by the party that brought such proceedings, except that, if Company is the party that brought such proceedings, any portion of such remainder that was awarded to Company on the basis of lost sales, lost profits or a reasonable royalty with respect to Licensed Products or Licensed Processes shall be treated as Net Sales for purposes of this Agreement, and any portion of such remainder that was awarded to Company as punitive or other extraordinary damages for the applicable infringement or misappropriation shall be treated as Non-Royalty Sublicense Revenue.
 
9.6 In the event Company is sued for infringement or misappropriation of a third party’s intellectual property rights in connection with the exercise of its license rights hereunder, or threatened with such suit, or is enjoined from exercising such license rights, Company will use Commercially Reasonable Efforts to determine how and whether to defend against such charges of infringement or misappropriation. Company shall be solely responsible for its costs, including expenses, judgments and settlements, in connection with the foregoing. Company may not deduct from payments due to SKI hereunder any portion of its costs related to any defense, judgment or settlement of such action.
 
9.7 Company or its Affiliates will be responsible for, and shall have sole discretion in, selecting trademarks for the use on or in connection with Licensed Products and Licensed Processes throughout the world. Company or its Affiliate will be responsible for registration of such trademarks, in its discretion, and will be the sole owner of such trademarks, including all goodwill related thereto.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
18
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE 10
 
INDEMNIFICATION, PRODUCT LIABILITY
 
10.1 Company shall at all times during the term of this Agreement and thereafter, indemnify, defend and hold harmless SKI and its Affiliates, their Board of Managers, officers, employees and affiliates (“SKI Indemnitees”) from and against any and all losses, damages, liabilities, expenses and costs, including legal expense and reasonable attorneys’ fees (“Indemnified Losses”), arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever resulting from the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Product(s) and/or Licensed Process(es), from Company’s use, handling or storage of the Biological Materials, or arising from any breach of any representation or warranty of Company hereunder, except to the extent such Indemnified Losses result from the gross negligence or willful misconduct of SKI or SKI’s breach of this Agreement.
 
10.2 SKI shall at all times during the term of this Agreement and thereafter, indemnify, defend and hold harmless Company and its Affiliates, their Board of Directors, officers, employees and affiliates (“Company Indemnitees”), from and against any and all Indemnified Losses to which any such Company Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any third party to the extent such Indemnified Losses arise out of SKI’s or its Affiliate’s use, handling or storage of any Biological Material, SKI Program Invention or Joint Program Invention or any breach of any representation or warranty of SKI.
 
10.3 For the term of this Agreement, upon the commencement of clinical use, production, sale, or transfer, whichever occurs first, of any Licensed Product or Licensed Process, Company shall obtain and carry in full force and effect general liability insurance which shall protect Company and SKI in regard to events covered by Section 10.1 above. Such insurance shall be written by a reputable insurance company, shall list SKI as an additional named insured thereunder, shall be endorsed to include liability coverage, and shall require thirty (30) days written notice to be given to SKI prior to any cancellation or material change thereof. The limits of such insurance shall not be less than two million dollars ($2,000,000) per occurrence with an annual aggregate of five million dollars ($5,000,000) for personal injury, death or property damage. Company shall provide SKI with Certificates of Insurance evidencing the same.
 
10.4 Each party represents and warrants to the other that, as of the Effective Date: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its terms, and does
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
19
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.
 
10.5 SKI represents that to the best of its knowledge owns the SKI Patents, and has the right to grant to Company the rights and licenses provided for herein. SKI represents and warrants that it owns the Biological Materials and has obtained or will obtain all fully informed consents required by applicable law with respect to the Biological Materials and the rights granted to company here under.
 
10.6 Except as otherwise expressly set forth in this Agreement, SKI MAKES NO REPRESENTATIONS, AND COMPANY ACKNOWLEDGES THAT, SINCE THE BIOLOGICAL MATERIALS ARE EXPERIMENTAL IN NATURE, THEY ARE PROVIDED WITH NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING. Moreover, except as expressly set forth herein, THE TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES.
 
ARTICLE 11
 
EXPORT CONTROLS
 
It is understood that SKI is subject to United States Laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (including the Arms Export Control Act, as amended and the Export Administration Act of 1979), and that its obligations hereunder are contingent on compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Company that Company shall not export data or commodities to certain foreign countries without prior approval of such agency. SKI neither represents that a license shall not be required nor that, if required, it shall be issued.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
20
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE 12
 
NON-USE OF NAMES
 
No party shall use the name of the other party, nor any of their employees, nor any adaptation thereof, in any advertising, promotional or sales literature or for whatever purpose whatsoever without prior written consent.
 
ARTICLE 13
 
ASSIGNMENT
 
Except as otherwise provided herein, neither party may assign its rights or delegate its duties under this Agreement without the prior written consent of the other party, such consent not to be unreasonably withheld; provided, however, the Company may assign this Agreement to any Affiliate or to any successor of substantially all of the Company’s assets in a manner such that the assignee agrees in writing to remain liable and responsible for the performance and observance of all its duties and obligations hereunder. References to a party shall include any Affiliate of that party to whom such an assignment or delegation has been made or ratified. Subject to the restrictions contained in the preceding sentence, this Agreement shall be binding upon the successors and assigns of the parties. Any attempted delegation or assignment not in accordance with this Article shall be of no force or effect.
 
ARTICLE 14
 
TERMINATION
 
14.1 The term of this Agreement shall begin on the Effective Date and, unless this Agreement is earlier terminated in accordance with this Section 14.1, shall expire upon expiration of the last-to-expire Royalty Term for any Licensed Product or Licensed Process. SKI may terminate this Agreement prior to its expiration:
 
(a) if (i) Company is declared insolvent by a court of competent jurisdiction and does not return to solvency before the expiration of a thirty (30) day period, or (ii) a petition in bankruptcy is filed against Company and is consented to, acquiesced in or remains undismissed for thirty (30) days, or (iii) Company makes a general assignment for the benefit of creditors, or (iv) a receiver is appointed for Company;
 
(b) if Company fails to pay SKI license fees and royalties due and payable hereunder for more than thirty (30) days past the date such payments are due, SKI shall have the right to terminate this Agreement on thirty (30) days written notice, unless Company shall pay SKI within the thirty (30) day period, all such license fees, royalties and patent expenses and interest due and payable. Upon the expiration of the thirty (30) day period, if Company shall not
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
21
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
have paid all such royalties, patent expenses and interest due and payable, the rights, privileges and license granted hereunder shall terminate;
 
(c) if Company materially breaches a provision of this Agreement, such as Company defaults in its obligations under Section 10.3 to procure and maintain insurance or if an examination pursuant to Section 8.1 shows an underreporting or underpayment by Company in excess of 20% for any twelve (12) month period, other than those occurrences set out in Sections 14.1(a) and 14.1(c), hereinabove, which shall always take precedence in that order over any material breach or default referred to in this Section 14.1(D), SKI shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder by sixty (60) days’ notice to Company. Such termination shall become effective unless Company shall have cured any such breach prior to the expiration of the sixty (60) day period.
 
(d) if Company is convicted of a felony relating to the manufacture, use, or sale of Licensed Products;
 
14.2 Company shall be entitled to terminate this Agreement upon sixty (60) days advance written notice to SKI, either at will (without penalty of any kind) or in the event of SKI’s material breach of any of the provisions of this Agreement, which breach is not cured (if capable of being cured) within this sixty (60) day period.
 
14.3 Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination.
 
14.4 If this Agreement is terminated, or if Company suspends Development Program for six (6) months or more, or does not intend to use specific Biological Materials, and upon the request of SKI, Company shall promptly return any unused Biological Materials to SKI or dispose of them in an approved manner, at SKI’s discretion.
 
14.5 On a country-by-country and Licensed Product-by-Licensed Product or Licensed Process-by-Licensed Process basis, at the end of the Royalty Term for a Licensed Product or Licensed Process in a country, the licenses granted to Company under this Agreement shall become perpetual, irrevocable, non-exclusive, transferable, paid-up, and royalty-free.
 
14.6 Articles 7, 10, 12, 15 and 16 and Sections 8.1, 14.3, and 14.4 of this Agreement shall survive termination or expiration.
 
ARTICLE 15
 
PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
 
Any payment, notice or other communication pursuant to this Agreement shall be sufficiently made or given when delivered by courier or other means providing proof of delivery
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
22
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
to such party at its address below or as it shall designate by written notice given to the other party:
 
In the case of SKI:
 
Sloan-Kettering Institute for Cancer Research
1275 York Avenue
New York, New York 10021
Attention: Eric M. Cottington
Vice President
Research Resources Management
 
In the case of Company:
 
MabVax Therapeutics, Inc.
David Hansen
President and CEO
11588 Sorrento Valley Road, Suite 20
San Diego, CA 92121
 
Checks shall be made payable to Sloan-Kettering Institute for Cancer Research (Tax I.D. No. 13-1624182) and shall be forwarded to:
 
Memorial Sloan-Kettering Cancer Center
Office of Industrial Affairs
General Post Office Box
P. O. Box 27718
New York, New York 10087-27718
 
ARTICLE 16
 
MISCELLANEOUS PROVISIONS
 
16.1 This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of the State of New York, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted.
 
16.2 The parties agree that any dispute relating to this Agreement, to any rights or licenses granted hereunder and to any patents licensed hereunder, shall be resolved in the Supreme Court of the State of New York, New York County, or in the United States District Court for the Southern District of New York. Each party hereby submits itself to the jurisdiction of those courts for the purpose of resolving any such disputes.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
23
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
16.3 The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
 
16.4 The relationship between the parties under this Agreement shall be that of independent contractors and not as an agent, joint venturer, or partner. Nothing in this Agreement gives either party the right to act on behalf of the other or incur any obligation or liability on behalf of the other party without its prior written consent.
 
16.5 Company agrees to mark the Licensed Products sold in the United States with all applicable United States patent numbers. All Licensed Products shipped to or sold in other countries shall be marked in such a manner as to conform with the patent laws and practice of the country of manufacture or sale.
 
16.6 The failure of either 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.
 
16.7 This Agreement may be executed in any number of counterparts and each of such counterparts shall for all purposes be an original and all such counterparts shall together constitute but one and the same agreement.
 
16.8 Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, other than an obligation to make a payment, when such failure or delay is caused by or results from fire, floods, embargoes, government regulations, prohibitions or interventions, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts, acts of God, or any other cause beyond the reasonable control of the affected Party.
 
IN WITNESS WHEREOF, authorized representatives of the parties have signed and dated this Agreement below.
 
Sloan-Kettering Institute for Cancer Research
     
MabVax Therapeutics, Inc.
         
By:
 
/s/ Erin M. Cottington
     
By:
 
/s/ David Hansen
   
Eric M. Cottington
Vice President
Research Resources Management
         
David Hansen
President and CEO
MabVax Therapeutics, Inc.
             
   
Date:
 
04/07/2008
         
Date:
 
03/25/2008
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
24
 
 
 

 
CONFIDENTIAL TREATMENT REQUESTED
 
Read and Understood:
 
   
/s/ Philip O. Livingston
 
Philip O. Livingston
 
   
/s/ Govind Ragupathi
 
Govind Ragupathi
 
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
25
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT A
 
Planned SKI Clinical Trials Utilizing Licensed Vaccines
 
[*****]
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
26
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
SK#13624
 
EXHIBIT B
 
Development Program
 
1.1
Collection of Lymphocytes from Target Donors and Incorporation into the MabVax Antibody Generation Process
 
MabVax will coordinate the initial antibody generation efforts with the currently planned Phase I and 11 clinical trial program scheduled to begin in the first quarter of 2008 at MSKCC.
 
MabVax will make reasonable efforts to rescue human monoclonal antibodies derived from SKI Biological Materials using established MabVax know-how and technology that has been used successfully in the past. SKI will provide the respective antigens and cell lines in sufficient amount and quality to enable screening for antibody producing cells and evaluation of antibody binding (ELISA and other assays). The initial goal is to generate antibody producing hybridoma cells that are specific for the antigens used for vaccination. Multiple sequential antibody generation efforts will be initiated as lymphocytes become available from individuals with a demonstrated immune response to at least one of the antigens.
 
1.2
Generation of Primary Panel of Antibodies to Each Cancer Antigen
 
Cells that produce specific antibodies of interest will be expanded and subcloned, if possible, and the variable sequence of the antibodies will be cloned and rescued by Molecular Biology technology (PCR). The variable sequence will be inserted into a full length human IgG antibody and expressed in mammalian cells to generate recombinant human antibodies. MabVax intends to generate a panel of 10 or more distinct antibodies specific for each of the antigens used in the vaccines. The isolated antibodies will be sequenced and classified according to the current antibody nomenclature.
 
1.3
Evaluation of Each Panel of Antibodies to Select Lead Antibody for In Vitro Testing
 
The human antibodies will initially be selected based on binding to the specific antigen as measured by ELISA. Subsequent testing will establish antigen specificity and reactivity with the native antigen expressed on cells by flow cytometry. More stringent functional assays will also be used to probe the utility of antibodies. For example, the ability of the antibody candidates to mediate complement mediated lysis utilizing human complement will be evaluated. In addition, the antibodies will be tested for in vitro activity in complement dependent and complement independent cell mediated lysis assays (ADCC assays). Small scale production (1-10 mg amounts) and purification will be done to obtain sufficient material to perform these in vitro assays.
 
1.4
Selection of Lead Antibody Candidates for Each Antigen
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
27
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
SK#13624
 
The next goal is to select the most promising candidates for further development. Antibody candidates with promising specificity, affinity and effector function activity in vitro will be scaled up further to produce antibodies at the several 100 mg scale. Selection of a high producing cell line(s) and adaptation to serum-free media will be performed. Once sufficient antibody is generated, the efficacy of the selected candidates will be determined in suitable murine cancer models. Initially it is planned to focus on [*****] which is expressed on an available syngeneic murine malignancy (the EL4 lymphoma). Xenogenic models involving subcutaneous or intravenous administration of human cancer cells lines into nude mice or, as recently described for a series of SCLC cell lines, NK depleted SCID mice will also be pursued.
 
The efficacy of selected, most promising lead candidate antibodies may be further evaluated to compare stand alone or combination treatment. It is anticipated that the proposed in vivo studies will lead to the selection of antibody lead candidates that merit further preclinical and clinical development efforts.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
28
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
SK#13624
 
EXHIBIT C
 
Amounts and schedule of Biological Materials to be delivered
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
29
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT D
 
Funding
 
 
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
30
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT E
 
SKI Patents
 
[*****]
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
31
 
Exhibit 10.9
 
CONFIDENTIAL TREATMENT REQUESTED
 
SK2O11-1138
 
EXCLUSIVE LICENSE TO UNIMOLECULAR VACCINE ANTIBODIES
(“AGREEMENT”)
 
TABLE OF CONTENTS
 
ARTICLE I - DEFINITIONS
  
 
   
ARTICLE II - GRANT
  
 
   
ARTICLE III - DUE DILIGENCE
  
 
   
ARTICLE IV - PAYMENTS
  
 
   
ARTICLE V - REPORTS AND RECORDS
  
 
   
ARTICLE VI - INDEMNIFICATION, PRODUCT LIABILITY
  
 
   
ARTICLE VII - EXPORT CONTROLS
  
 
   
ARTICLE VIII - NON-USE OF NAMES
  
 
   
ARTICLE IX - CONFIDENTIAL INFORMATION
  
 
   
ARTICLE X - ASSIGNMENT
  
 
   
ARTICLE XI - TERMINATION
  
 
   
ARTICLE XII - TRANSFER OF BIOLOGICAL MATERIALS
  
 
   
ARTICLE XIII - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
  
 
   
ARTICLE XIV - MISCELLANEOUS PROVISIONS
  
 

Exhibit A
  
Developmental Plan
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
This Agreement is effective on the date last subscribed below (“Effective Date”), and is by and between  Sloan-Kettering Institute for Cancer Research  (“SKI”), a New York membership corporation with principal offices at 1275 York Avenue, New York, NY 10065, and  MabVax, Inc . a Delaware corporation with principal offices located at 11588 Sorrento Valley Road, Suite 20, San Diego CA 92121 (“LICENSEE”).
 
WITNESSETH
 
WHEREAS, SKI is the sole owner of Biological Material (as later defined herein) and has the right to grant licenses to Biological Material; and
 
WHEREAS, SKI desires to have certain Antibody-based products resulting from the Biological Material utilized in the public interest and is willing to grant a license to its interest thereunder; and
 
WHEREAS, LICENSEE seeks to commercially develop Licensed Products and Processes through a Development Plan whereby public utilization shall result therefrom.
 
NOW, THEREFORE, in consideration of the promises and the mutual covenants contained herein, the parties hereto agree as follows:
 
ARTICLE I - DEFINITIONS
 
For the purpose of this Agreement, the following words and phrases shall have the following meanings:
 
1.1 “Antibody(ies)” means an immunoglobin (Ig)molecule, generally comprising four polypeptide chains, two heavy chains (H) and two light (L) chains or an equivalent homologue thereof (e.g. a camelid nanobody, which comprises only a H chain, single domain antibodies (dAbs) which can be either H or L chains); including full length functional mutants, variants, or derivatives thereof (including but not limited to chimeric antibodies, which retain the essential epitope binding features of an Ig molecule and including dual specific, bispecific, multispecific, and dual variable domain Igs; Igs (e.g. IgG, IgE, IgM)of any class or subclass (e.g. IgG1) and allotype. Also included within the term Antibody is an Antibody fragment, which is a molecule comprising at least one polypeptide chain that is not full length.
 
1.2 “Biological Material” means human blood and lymphocytes obtained from patients enrolled in the SKI Clinical Trial and transferred to LICENSEE as detailed in Article XII, titled ‘Transfer of Biological Materials.’
 
1.3 “Biological Materials Derived Antibody(ies)” will mean the specific Antibodies that LICENSEE has Derived from Biological Material generated from the SKI Clinical Trial.
 
1.4 “Development Plan” means the LICENSEE’s outline of a program aimed at advancing one or more Licensed Product or Licensed Process for commercialization as described in Exhibit A, attached and herein made part of this Agreement.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.5 “Derived” means in whole or in part, obtained, developed, created, designed, derived, resulting from, based upon, containing or incorporating.
 
1.6 “Field of Use” means all human preventative, therapeutic, prognostic, diagnostic and drug discovery applications for Biological Materials Derived Antibodies.
 
1.7 A “Licensed Process(es)” means any process or method which utilizes Biological Materials Derived Antibodies.
 
1.8 A “Licensed Product(s)” means any product comprising or containing in whole or in part Biological Materials Derived Antibodies.
 
1.9 “LICENSEE” shall include affiliates, that is, any person, firm, corporation or other entity controlling, controlled by, or under common control with a party hereto. The term “control” wherever used throughout this Agreement shall mean ownership, directly or indirectly, of more than 50% of the equity capital or the ability to effect the election of a majority of the directors. With regard to SKI, affiliate shall mean the Memorial Sloan-Kettering Cancer Center and the Memorial Hospital for Cancer and Allied Diseases.
 
1.10 “Net Sales” shall mean LICENSEE’s, and/or its subLICENSEEs’ billings for sales of Licensed Products and Licensed Processes less the sum of the following (“Qualifying Costs”):
 
 
(a)
Discounts actually allowed and granted (including, without limitation, cash discounts and quantity discounts), retroactive price reductions, charge-back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to trade customers (a “ Discount ”);  provided however , that where any such Discount is based on sales of a bundled set of products in which such Licensed Product is included, the Discount shall be allocated to such Licensed Product on a pro rata basis based on the sales value (i.e., the unit average selling price multiplied by the unit volume) of the Licensed Product relative to the sales value contributed by the other constituent products in the bundled set, with respect to such sale;
 
 
(b)
Credits or allowances actually granted upon claims, damaged goods, rejections or returns of such Licensed Product and Licensed Processes, including such Licensed Product and Licensed Processes returned in connection with recalls or withdrawals;
 
 
(c)
Freight out, postage, shipping and insurance charges for delivery of such Licensed Product and Licensed Processes;
 
 
(d)
Taxes or duties levied on, absorbed or otherwise imposed on the sale of such Licensed Product and Licensed Processes, including, without
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
2
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
limitation, value-added taxes, or other governmental charges otherwise imposed upon the billed amount, as adjusted for rebates and refunds, to the extent not paid by a third party.
 
 
(e)
Bad debts and uncollectible receivables provided that, in any calendar year, such deduction will not exceed four percent (4%) of the total billings for sales of Licensed Products and Licensed Processes sold in that year.
 
 
(f)
In the event a drug product in a finished dosage form contains a Licensed Product in combination with one or more other therapeutically active ingredients or with a carrier molecule or an immunological adjuvant (in each case, a “Combination Product”), the Net Sales of the Licensed Product, for the purposes of calculating royalty payments of this Agreement, shall be determined by multiplying the Net Sales (as defined above in this Section) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average invoice price in a particular country of the Licensed Product when sold separately in finished form and B is the weighted average invoice price in that country of the other active ingredient(s) sold separately in finished form. In the event that such average invoice price cannot be determined for both the Licensed Product and the other active ingredient(s) in the Combination Product, Net Sales for purposes of determining royalty payments shall be agreed by the parties based on the relative value contributed by each component. In the case of a Combination Product that contains one or more other therapeutically active ingredients, in no event shall Net Sales for purposes of determining royalty payments be less than fifty percent (50%) of the Net Sales of the Combination Product. In the case of a Combination Product that contains a carrier molecule or adjuvant but does not contain another therapeutically active ingredient, in no event shall Net Sales for purposes of determining royalty payments be less than seventy five percent (75%) of the Net Sales of the Combination Product.
 
 
(g)
For purposes of calculating Net Sales, sales between or among Company or its Affiliates or sublicensees shall be excluded from the computation of Net Sales, but sales by Company or its Affiliates or sublicensees to third parties shall be included in the computation of Net Sales.
 
No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by LICENSEE and on its payroll, or for cost of collections.
 
Licensed Products and Licensed Processes shall be considered “sold” when billed or invoiced. Licensed Product Net Sales shall be determined in accordance with GAAP. The Qualifying Costs shall not exceed five percent (5%) of the gross proceeds or exceed 5% of the fair market value,
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
3
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
attributable to Net Sales unless requested by LICENSEE in writing, whose request shall not be unreasonably denied.
 
Notwithstanding the foregoing or any other provision of this Agreement to the contrary, Licensed Products for which Company receives no consideration used (i) for promotional or sampling purposes and (ii) in preclinical studies or clinical trials or in compassionate use programs, shall not be considered in determining Net Sales.
 
1.11 “Non-Royalty Sublicense Revenue” shall mean the amount actually received by Company from sub-LICENSEE arising from the grant of a sublicense of the right to make or sell Licensed Products or Licensed Processes, including, but not limited to, up-front license fees, license issue fees, maintenance fees and milestone payments paid by a sub-LICENSEE to Company in consideration for the grant by Company of a sublicense of the right to make or sell Licensed Products or Licensed Processes;  provided however , that “Non-Royalty Sublicense Revenue” shall in any event exclude: (A) royalties paid to Company by a sub-LICENSEE based on such sub-LICENSEE’s sale of Licensed Products or Licensed Processes; (B) any payments by a sub-LICENSEE to Company that are tied directly to the provision of goods and services by Company to such sub-LICENSEE (including, without limitation, research and development funding) to compensate Company for the fair market value of the provision of such goods and services; (C) payments for equity or debt securities of Company (except to the extent such payments exceed the fair market value of such securities on the date of issuance).
 
1.12 A “Phase I Trial” shall mean a clinical study involving the initial introduction of an investigational new drug into humans, typically designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, that provides data capable of meeting statutory standards for marketing approval. For example, in the United States, “Phase 1 Trial” means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(a).
 
1.13 A “Phase II Trial” shall mean a human clinical study conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and, possibly, to determine the common short-term side effects and risks associated with the drug, that provides data capable of meeting statutory standards for marketing approval. For example, in the United States, “Phase 2 Trial” means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (b).
 
1.14 “Pivotal and/or Phase III Trial” shall mean a controlled human clinical study, that is performed after preliminary evidence suggesting effectiveness of the drug under evaluation has been obtained, and intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling, that provides data capable of meeting statutory standards for marketing approval. For example, in the United States, “Phase 3 Trial” or “Pivotal Trial” means a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21 (c).
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
4
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.15 “Royalty Year” shall mean each twelve month period commencing January 1 and ending December 31 during the term of this Agreement. For the first year of this Agreement, the Royalty Year shall be the period of time between the signing of the Agreement and December 31.
 
1.16 The “SKI Clinical Trial” means the Phase I Ovarian Vaccine Trial with the Unimolecular Vaccine composed of the unimolecular backbone to which the antigens GM2, Globo-H, MUC1, Tn and TF are attached, conjugated to KLH (IRB 09-184).
 
1.17 The “Term” shall mean from the Effective Date to 12 years from first (1st) commercial sale of a Licensed Product or Licensed Process in such country unless this Agreement is terminated before that time according to the terms hereof.
 
1.18 “Territory” means the entire world.
 
1.19 “Unimolecular Vaccine Patent Rights” shall mean all SKI patents that cover A cancer vaccine comprising two or more carbohydrate-based or MUC-1 antigens linked to a single molecular backbone.
 
ARTICLE II - GRANT
 
2.1 SKI hereby grants to LICENSEE, an exclusive (except as set forth below), sublicenseable, worldwide, royalty-bearing license to the Biological Materials Derived Antibodies (a) to develop, have developed, make, have made, use, have used, offer for sale, have offered for sale, sell, have sold, import, have imported, commercialize and have commercialized Licensed Products for use in the Field of Use and (b) to perform Licensed Processes in the Field of Use.
 
2.2 SKI hereby grants to LICENSEE, a non-exclusive, worldwide, license, explicitly excluding the right to sublicense, to use the Biological Material to develop Licensed Products and Licensed Processes in the Field of Use
 
2.3 LICENSEE may sublicense its rights under the exclusive license granted in the Agreement, subject to limitations agreed upon in the Agreement and that will ensure SKI’s ability to protect its rights under the Agreement. Company hereby agrees that every sublicensing agreement to which it shall be party and which shall relate to the rights, privileges and license granted hereunder shall contain an acknowledgment by the sublicensee of the duration of the Royalty Term.
 
2.4 LICENSEE hereby agrees that any sublicenses granted by it shall provide that the obligations to SKI of Article III, Sections 3.1 and 3.2, V, VI, VII, VIII, X, XI, and XIV, of this Agreement shall be binding upon the subLICENSEE as if it were a party to this Agreement.
 
2.5 The license granted hereunder shall not be construed to confer any rights upon LICENSEE by implication, estoppel or otherwise as to any technology not included in this agreement.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
5
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
2.6 SKI may not grant similar rights to Biological Materials generated from the same or similar Phase I clinical trials as defined in Section 1.16 to any other company unless that company receives from SKI a license to the Unimolecular Vaccine Patent Rights.
 
2.7 SKI retains title and all rights to the Biological Material subject to the rights granted herein.
 
2.8 SKI understands and agrees that Company will have ownership of any right, title, and interest over the Biological Material Derived Antibodies that Company creates by itself or together with third parties. SKI shall not claim ownership of any right, title, and interest in and to the Biological Material Derived Antibodies.
 
ARTICLE III - DUE DILIGENCE
 
3.1 LICENSEE will undertake to use commercially reasonable efforts to develop and commercialize Licensed Products.
 
3.2 In addition, LICENSEE shall adhere to the following commercialization milestones for each Licensed Product:
 
 
(a)
The LICENSEE’s commercial efforts will include using commercially reasonable efforts to perform LICENSEE’s obligations under the Development Plan in Exhibit A.
 
3.3 LICENSEE shall be responsible for diligently and promptly taking all reasonable steps to secure all required and/or necessary governmental approvals to sell, exploit, or market any and all Licensed Products and/or Licensed Processes. LICENSEE shall advise SKI, through annual reports described in Section 5.2 herein of its program of development for obtaining said approvals.
 
ARTICLE IV - PAYMENTS
 
4.1 In consideration for the license to be granted to LICENSEE under the Agreement, LICENSEE shall pay SKI the following amounts:
 
 
(a)
In exchange for the substantial investment of time, resources and money expended by LICENSEE to perform the serological analyses of patients vaccinated with the unimolecular vaccine construct in the Phase I trial specified in Section 1.16, LICENSEE will not pay an initial license fee to SKI.
 
 
(b)
LICENSEE will pay the following milestone payments upon the achievement by LICENSEE, its affiliates and/or subLICENSEEs of the following milestones with respect to Licensed Products:
 
 
(i)
[*****].
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
6
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(ii)
[*****] due upon first patient enrolled in a Phase III Clinical Trial for each Licensed Product.
 
 
(iii)
[*****].
 
 
(iv)
[*****] upon regulatory approval for the each Licensed Product in the United States; [*****] in each of the following countries; Japan, Germany, United Kingdom, France, and China; and [*****] for any other country.
 
 
(v)
Each milestone payment is payable with thirty (30) days of the occurrence of each applicable milestone event. Each milestone payment will be payable only one time.
 
 
(c)
LICENSEE will pay an amount equal to [*****] of all per annum on Net Sales of Licensed Products or Licensed Processes by LICENSEE, its affiliates and/or its subLICENSEEs: Royalties shall be payable on a Licensed Product-by-Licensed Product and Licensed Process-by-Licensed Process and country-by-country basis until twelve (12) years from the first (18) commercial sale of such Licensed Product or Licensed Process in such country on a product by product basis.
 
 
(i)
If Company, its Affiliates or its Sublicensees pay third party royalties on the sales of a Licensed Product or the practice of a Licensed Process, in any country in the Territory in consideration for third party patent rights (the “Third Party Royalty Payment”), the royalties payable under this Article 4.1(c) on such Licensed Product or Licensed Process in such country in the Territory, shall be decreased by [*****] of the amount of such Third Party Royalty Payment attributable to sales of the applicable Licensed Product or Licensed Process; provided, however, that in no case shall such reduction lower the amount of royalties otherwise payable under this Article 4.1(c) by more than [*****];
 
 
(ii)
The Company shall have the right to reduce its royalty payments to SKI if after using Commercially Reasonable Efforts a Licensed Product is sublicensed to a third-party and the resulting sublicense royalty does not allow the Company to receive a royalty amount at least equal to the royalty amount due SKI. In such a case, the sublicense royalty will be divided equally between the Company and SKI.
 
 
(iii)
If one or more follow-on protein products or a biosimilar product that is a generic equivalent product or considered a bio-similar product (the “Biosimilar”) and is marketed for the same indication and in the same Territory as a Licensed Product (the “Non-
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
7
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
exclusive Licensed Product”), then the Royalty rate for that Nonexclusive Licensed Product for a specific territory shall be [*****], provided however that in no case shall such reduction lower the amount of royalties otherwise payable for that Non-exclusive Licensed Product by more than [*****].
 
 
(iv)
For the avoidance of doubt, if a particular Licensed Product contains or comprises two or more distinct Biological Material Derived Antibodies each of the foregoing milestone payments shall be payable only one time for such Licensed Product, notwithstanding the fact that such Licensed Product contains or comprises two or more distinct Biological Material Derived Antibodies.
 
 
(v)
[*****] of all Non-Royalty Sublicense Revenue.
 
 
(vi)
The Company shall have the right to reduce its royalty payments to SKI if after using Commercially Reasonable Efforts a Licensed Product is sublicensed to a third-party and the resulting sublicense royalty does not allow the Company to receive a royalty amount at least equal to the royalty amount due SKI. In such a case, the sublicense royalty will be divided equally between the Company and SKI.
 
 
(vii)
In no case shall LICENSEE pay less than [*****] of all amounts received by LICENSEE or its affiliates in connection with any sublicense.
 
4.2 If LICENSEE receives from subLICENSEEs anything of value in lieu of cash payments based upon payment obligations of any sublicense under this Agreement, LICENSEE shall pay SKI royalty for other such payments as required by Clause 4.1(c), based on the fair market value of such payment, unless SKI waives in writing such payment obligation.
 
4.3 Payments shall be paid in United States dollars in New York, NY, or at such other place as SKI may reasonably designate consistent with the laws and regulations controlling in any foreign country, but not in any other currency. If any currency conversion shall be required in connection with the payment hereunder, such conversion shall be made by using the exchange rate prevailing at the Chase Manhattan Bank on the last business day of the calendar quarterly reporting period to which such payments relate.
 
4.4  Interest
 
 
(a)
LICENSEE shall pay to SKI interest on any amounts not paid when due. Such interest will accrue from the forty-fifth (451h) day after the payment was due at a rate two percent (2%) above the daily prime interest rate, as determined by the Chase Manhattan Bank or its successor entity, on each
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
8
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
day the payment is delinquent, and the interest payment will be due and payable on the first day of each month after interest begins to accrue, until full payment of all amounts due SKI is made.
 
 
(b)
SKI’s rights to receive such interest payments shall be in addition to any other rights and remedies available to SKI.
 
 
(c)
If the interest rate required in this subsection exceeds the legal rate in a jurisdiction where a claim for such interest is being asserted, the required interest rate shall be reduced, for such claim only, to the maximum interest rate allowable in the jurisdiction.
 
ARTICLE V - REPORTS AND RECORDS
 
5.1 LICENSEE shall keep, and shall require its Affiliates and subLICENSEEs to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to SKI hereunder. Said books and records shall be maintained for a period of no less than five (5) years following the period to which they pertain. SKI shall have the right to cause an independent, certified public accountant reasonably acceptable to Company to audit such records to confirm payments due hereunder for a period covering not more than the preceding four (4) years. Such audits may be exercised no more than once per year during normal business hours upon reasonable prior written notice to Company. No accounting period of Company shall be subject to audit more than one time for the same purpose. SKI shall bear the full cost of such audit unless such audit discloses an underpayment by Company of more than ten percent (10%) or $50,000, for any twelve (12) month period, in which case, Company shall bear the full cost of such audit and shall promptly remit to SKI the amount of any underpayment, plus interest as stipulated in Section 4.4.
 
5.2 LICENSEE, prior to or on January 1 of each year, shall deliver to SKI reports relaying update and status information on LICENSEE’s business, research and development progress relating to the Biological Material Derived Antibodies, including projections of activity or milestones anticipated for the next reporting year.
 
5.3 LICENSEE, prior to or on January 1 of each year, beginning in the year following receipt of any Net Sales Revenues or milestone or royalty payments, shall deliver to SKI true and accurate reports, giving such particulars of the business conducted by LICENSEE and its subLICENSEEs during the preceding twelve-month period under this Agreement as shall be pertinent to a royalty accounting hereunder. These shall include at least the following, to be itemized per Licensed Product and Licensed Process:
 
 
(a)
Number of Licensed Products and Licensed Processes commercially used, manufactured and sold, rented or leased.
 
 
(b)
Total billings for Licensed Products and Licensed Processes commercially used, sold, rented or leased.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
9
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(c)
Deductions applicable as provided in Section 1.10.
 
 
(d)
Total royalties due.
 
 
(e)
Names and addresses of all subLICENSEEs of LICENSEE.
 
 
(f)
Total royalty income from all revenues subject to subLICENSEEs’ royalties.
 
 
(g)
Total sublicensing fee income.
 
5.4 With each such report submitted, LICENSEE shall pay to SKI the royalties due and payable under this Agreement. If no royalties shall be due, LICENSEE shall so report.
 
5.5 Milestone payments shall be reported and paid when due.
 
5.6 LICENSEE agrees to forward to SKI a copy of any and all fully executed sublicense agreements, and further agrees to timely forward to SKI a copy of such reports received by LICENSEE from its subLICENSEEs relating to Licensed Products during the preceding Royalty Year.
 
ARTICLE VI - INDEMNIFICATION, PRODUCT LIABILITY
 
6.1 LICENSEE shall at all times during the term of this Agreement and thereafter, indemnify, defend and hold SKI and its Affiliates, their Board of Managers, officers, employees and affiliates, harmless against all claims and expenses, including legal expenses and reasonable attorneys’ fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever resulting from the production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Product(s) and/or Licensed Process(es) or arising from any obligation of LICENSEE hereunder.
 
6.2 SKI shall at all times during the term of this Agreement and thereafter, hold harmless Company and its Affiliates, their Board of Directors, officers, employees and affiliates (“Company Indemnitees”), from and against any and all Indemnified Losses to which any such Company Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any third party to the extent such Indemnified Losses arise out of SKI’s or its Affiliate’s use, handling or storage of any Biological Material or any breach of any representation or warranty of SKI.
 
6.3 LICENSEE shall obtain and carry in full force and effect general liability insurance which shall protect LICENSEE and SKI in regard to events covered by Section 6.1 above. Such insurance shall be written by a reputable insurance company, shall list SKI as an additional named insured thereunder, shall be endorsed to include liability coverage, and shall require thirty (30) days written notice to be given to SKI prior to any cancellation or material change thereof. The limits of such insurance shall not be less than two million dollars ($2,000,000) per occurrence with an annual aggregate of five million dollars ($5,000,000) for
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
personal injury, death or property damage. LICENSEE shall provide SKI with Certificates of Insurance evidencing the same.
 
6.4 Each party represents to the other that, as of the Effective Date: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.
 
6.5 SKI represents that to the best of its knowledge that it owns the Biological Materials and has obtained or will obtain all fully informed consents required by applicable law with respect to the Biological Materials and the rights granted to company here under.
 
6.6 Except as otherwise expressly set forth in this Agreement, SKI MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND VALIDITY OF, THE CONFIDENTIAL INFORMATION IT PROVIDES, THE BIOLOGICAL MATERIAL, OR RELATING TO THE BIOLOGICAL MATERIALS DERIVED ANTIBODIES.
 
ARTICLE VII - EXPORT CONTROLS
 
It is understood that SKI is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (including the Arms Export Control Act, as amended and the Export Administration Act of 1979), and that its obligations hereunder are contingent on compliance with applicable United States export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by LICENSEE that LICENSEE shall not export data or commodities to certain foreign countries without prior approval of such agency. SKI neither represents that a license shall not be required nor that, if required, it shall be issued.
 
ARTICLE VIII - NON-USE OF NAMES
 
LICENSEE shall not use the names of SKI or its Affiliates, nor any of their employees, nor any adaptation thereof, in any advertising, promotional or sales literature without prior written consent obtained from SKI in each case.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
ARTICLE IX - CONFIDENTIAL INFORMATION
 
9.1 It may be necessary or desirable for the parties to disclose proprietary, trade secret and/or information relating to patients, SKI Clinical Trial, Biological Materials, Biological Materials Derived Antibodies, the Development Program, Licensed Products and/or Licensed Processes (hereinafter “Confidential Information”) to one another.
 
9.2 Any other Confidential Information shall be marked as “Confidential” or, if provided to the other party orally, shall be reduced to writing marked as “Confidential” and sent to the other party within thirty (30) days of the oral disclosure, except that this requirement shall not apply to patient information, which is always Confidential Information. Each party agrees that Confidential Information of the other party disclosed to it or to its employees shall remain confidential during the term of this Agreement and for five (5) years after expiration or termination hereof. Except as otherwise expressly set forth herein, Confidential Information shall:
 
 
(a)
be used only in connection with the legitimate purposes of this Agreement;
 
 
(b)
be disclosed only to those who have a need to know it; and
 
 
(c)
be safeguarded with the same care normally afforded confidential information in the possession, custody or control of the party holding the Confidential Information.
 
The foregoing shall not apply when, after and to the extent the receiving party can demonstrate by competent evidence that the Confidential Information disclosed:
 
 
(i)
was in the public domain prior to the date of the disclosure; or
 
 
(ii)
enters the public domain through no breach of this Agreement by the receiving party; or
 
 
(iii)
was already known to the receiving party at the time of disclosure; or
 
 
(iv)
is subsequently received by the receiving party on a non-confidential basis in good faith from a third party without breaching any confidential obligation between the third party and the disclosing party; or
 
 
(v)
was independently developed, as established by tangible evidence, by the receiving party without reference to Confidential Information or Biological Material or other materials provided by the disclosing party; or
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
12
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
(vi)
is required to be disclosed for minimal compliance with court orders, statutes or regulations or SKI audits for compliance with such regulatory requirements, provided that prior to any such disclosure to the extent reasonably practicable, the party from whom disclosure is sought shall promptly notify the other party and shall afford such other party the opportunity to challenge or otherwise lawfully seek limits upon such disclosure of Confidential Information.
 
 
(vii)
LICENSEE is hereby authorized to release Confidential Information to employees, agents, consultants, contractors, manufacturers, service providers, bankers, securities advisors and the like who are under an obligation of confidentiality and require the information to perform their duties. LICENSEE is hereby authorized to release Confidential Information to its potential SubLICENSEEs for the purpose of negotiating and granting of Sublicenses thereof, provided that LICENSEE takes reasonable precautions to safeguard such Confidential Information of SKI. Company is authorized to release Confidential Information for the purpose of prosecuting and enforcing patents, obtaining marketing approvals, and making regulatory submissions.
 
ARTICLE X - ASSIGNMENT
 
This Agreement shall be binding upon the respective successors, legal representatives and assignees of SKI and LICENSEE. Neither this Agreement nor the rights granted hereunder shall be transferred or assigned in whole or in part by either Party without prior written approval from the other Party.
 
ARTICLE XI - TERMINATION
 
11.1 SKI may terminate this Agreement if:
 
 
(a)
LICENSEE is declared insolvent by a court of competent jurisdiction and does not return to solvency before the expiration of a sixty day period, or, a petition in bankruptcy is filed against LICENSEE and is consented to, acquiesced in or remains undismissed for sixty (60) days; or makes a general assignment for the benefit of creditors, or a receiver is appointed for LICENSEE, and LICENSEE does not return to solvency before the expiration of a sixty (60) day period;
 
 
(b)
LICENSEE fails to pay SKI license fees, or royalties and payable hereunder for more than sixty (60) days, SKI shall have the right to terminate this Agreement on thirty (30) days written notice, unless LICENSEE shall pay SKI within the thirty (30) day period, all such license fees, royalties and patent expenses and interest due and payable.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
13
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
 
Upon the expiration of the thirty (30) day period, if LICENSEE shall not have paid all such royalties, patent expenses and interest due and payable, the rights, privileges and license granted hereunder shall terminate;
 
 
(c)
LICENSEE defaults in its obligations under Section 6.3 to procure and maintain insurance;
 
 
(d)
An examination pursuant to Section 5.1 shows an underreporting or underpayment by LICENSEE in excess of 15% for any twelve (12) month period, SKI shall have the right to terminate this Agreement on sixty (60) days written notice, unless LICENSEE shall pay SKI within the sixty (60) day period, all such underpayment of license fees, royalties and patent expenses and interest due and payable;
 
 
(e)
LICENSEE is convicted of a felony relating to the manufacture, use, or sale of Licensed Products or Licensed Processes;
 
 
(f)
LICENSEE materially breaches a provision of this Agreement, other than those occurrences set out in Sections 11.2.a, 11,2.b and 11.2d, hereinabove, which shall always take precedence in that order over any material breach or default referred to in this Section 11.11, SKI shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder by thirty (30) days’ notice to LICENSEE. Such termination shall become effective unless LICENSEE shall have cured any such breach prior to the expiration of the thirty (30) day period.
 
 
(g)
LICENSEE does not dose a first patient in a Phase I Trial with a Licensed Product or Licensed Product within five (5) years of the Effective Date of this Agreement unless an extension for additional time requested by LICENSEE in writing, whose request shall not be unreasonably denied.
 
11.2 LICENSEE shall be entitled to terminate this Agreement upon thirty (30) days advance written notice to SKI. Should LICENSEE terminate this Agreement, however, LICENSEE agrees not to develop, have developed, make, have made, use, have used, offer for sale, have offered for sale, sell, have sold, import, have imported, commercialize and/or have commercialized Licensed Products and (b) to not perform Licensed Processes.
 
11.3 Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination. LICENSEE must return to SKI all Biological Materials not consumed in the execution of the Development Plan or destroy the Biological Material in an approved manner; provided, however, that, unless terminated under Sections 11.1, LICENSEE shall have the right for six (6) months thereafter to dispose of all Licensed Products then in its inventory, and shall pay royalties thereon, in accordance with the provisions of Article IV and shall submit the related reports as required by Article V, as though this Agreement had not terminated,
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
11.4 Upon termination of this Agreement for any reason any subLICENSEEs not then in default shall have all sublicenses assumed by SKI on the same terms and conditions as the license agreement in place between the LICENSEE and a subLICENSEE,
 
11.5 Upon termination of this Agreement for any reason LICENSEE shall cease development, have developed, make, have made, use, have used, offer for sale, have offered for sale, sell, have sold, import, have imported, commercialize and have commercialized Licensed Products or Licensed Processes developed from Biological Materials Derived Antibodies.
 
11.6 Article VI, Article VIII, Section 11.3 and Section 11.5 of this Agreement shall survive termination.
 
ARTICLE XII - TRANSFER OF BIOLOGICAL MATERIALS
 
12.1 SKI shall transfer to LICENSEE two sets of samples from patients participating in the SKI Clinical Trial. The first set of samples will be serum drawn at multiple designated time points and transferred to LICENSEE for determination of antibody titers to each of the five antigens in the vaccine. The second set of samples will be 100 ml’s of blood drawn at one designated time point from each eligible patient participating in the SKI Clinical Trial and transferred to LICENSEE according to LICENSEE’s instructions. LICENSEE agrees to perform serology on each of these blood draws and provide SKI a copy of its serology results, which SKI can use for any purpose.
 
12.2 SKI makes no warranty that the SKI Clinical Trial will yield Biological Material Derived Antibodies. SKI shall not liable to LICENSEE if SKI Clinical Trial does not yield Biological Material Derived Antibodies.
 
12.3 LICENSEE agrees that its use of the Biological Material shall be for the performance of the Development Program only.
 
12.4 LICENSEE may not transfer the Biological Material to a third party without the prior written permission of SKI except that LICENSEE may transfer the Biological Material to a third party that is specifically engaged by agreement to perform Development Program activities on LICENSEE’s behalf. All third party uses and users of the Biological Material shall comply with the relevant terms of this agreement.
 
12.5 LICENSEE agrees to comply with all governmental and National Institutes of Health regulations and guidelines which are applicable to the LICENSEE’s use of the Biological Materials, Since not all of the Biological Materials’ characteristics are known, they should be used with caution and prudence.
 
12.6 SKI will make all attempts to ensure that any information revealing the identity of the patients contributing the samples sent as Biological Material will be removed. LICENSEE agrees to make best efforts to erase and remove any such identifying information that may remain despite SKI’s precautions.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
12.7 A summary of results obtained by LICENSEE from the Development Plan research will be shared with SKI, and copies of such results will be sent as soon as feasible.
 
12.8 Upon termination or expiration of this Agreement, or if LICENSEE does not intend to use the Biological Material, LICENSEE shall promptly destroy the Biological Material in an approved manner,
 
12.9 If a publication results from work using the Material, Company agrees to acknowledge SKI and/or give appropriate credit to SKI.
 
12.10 Prior to the filing of any patent application for any Licensed Product or Licensed Process, LICENSEE will disclose to SKI the sequence of the antibody upon which the Licensed Product or Process is based, or other such unique identifying information, to enable SKI to identify a Licensed Product or Process for tracking and enforcement of payment obligations. Any information disclosed under this provision shall not be shared with any persons outside of the SKI Office of Technology Development, except SKI personnel whose function is the tracking of revenue from Biological Materials Derived Antibodies, internal counsel and external counsel. To be clear this prohibition includes any researcher at SKI or SKI Affiliated Institution.
 
12.11 If the Development which involves the Biological Material results in an invention, improvement or substance, whether or not patentable that is not a Biological Materials Derived Antibody, Company agrees to disclose promptly to SKI all such Inventions in order that the parties can negotiate, when appropriate and in good faith, suitable agreements which shall provide for the further development of said Inventions. Such agreements may include arrangements to determine potential commercial utility. LICENSEE has the right, however, to utilize Biological Material only as needed to develop Biological Materials Derived Antibodies
 
ARTICLE XIII - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
 
Any payment, notice or other communication pursuant to this Agreement shall be sufficiently made or given when delivered by courier or other means providing proof of delivery to such party at its address below or as it shall designate by written notice given to the other party:
 
In the case of SKI:
 
Sloan-Kettering Institute for Cancer Research
1275 York Avenue
New York, NY 10065
     
Attention:
  
Andrew D. Maslow
 
  
Director
 
  
Office of Technology Development
 
In the case of LICENSEE:
 
MabVax Therapeutics, Inc.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
16
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
11588 Sorrento Valley Road, Suite 20
San Diego, CA 92121
     
Attention:
  
J. David Hansen
 
  
President and CEO
 
All payments due hereunder shall be made payable to Sloan-Kettering Institute for Cancer Research (Tax I.D. No. 13-1624182), shall have a note on the check stub or on its transmittal letter that the payment relates to the Agreement SK2011-1138, shall note the applicable invoice number, and shall be forwarded to SK1’s lock-box:
 
Memorial Sloan-Kettering Cancer Center
P. O. Box 29035
New York, NY 10087-29035
 
All invoices due under this Agreement shall be sent to:
 
MabVax Therapeutics, Inc.
11588 Sorrento Valley Road, Suite 20
San Diego, CA 92121
     
Attention:
  
J. David Hansen
 
  
President and CEO
 
ARTICLE XIV - MISCELLANEOUS PROVISIONS
 
14.1 This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of the State of New York, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted.
 
14.2 The parties agree that any dispute relating to this Agreement, to any rights or licenses granted hereunder shall be resolved in the Supreme Court of the State of New York, New York County, or in the United States District Court for the Southern District of New York. Each party hereby submits itself to the jurisdiction of those courts for the purpose of resolving any such disputes.
 
14.3 The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
 
14.4 LICENSEE agrees to mark the Licensed Products sold in the United States with all applicable United States patent numbers. All Licensed Products shipped to or sold in other countries shall be marked in such a manner as to conform to the patent laws and practice of the country of manufacture or sale.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
14.5 The failure of either 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.
 
14.6 This Agreement may be executed in any number of counterparts and each of such counterparts shall for all purposes be an original and all such counterparts shall together constitute but one and the same agreement.
 
14.7 This Agreement may be amended only by prior written agreement signed by the parties.
 
14.8 It is expressly agreed by the parties hereto that SKI and LICENSEE are independent contractors and nothing in this Agreement is intended to create an employer relationship, joint venture, or partnership between the parties. No party has the authority to bind the other.
 
[Signature Page to Follow]
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
18
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
MABVAX, INC.
     
SLOAN-KETTERING INSTITUTE FOR
CANCER RESEARCH
         
By:
 
/s/ J. David Hansen
     
By:
 
/s/ Andrew D. Maslow
   
J. David Hansen
         
Andrew D. Maslow
   
President and CEO
         
Director
   
MabVax Therapeutics, Inc.
         
Office of Technology Development
     
Date: October 13, 2011
     
Date: October 13, 2011
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
19
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
EXHIBIT A
 
(Developmental Plan)
 
MabVax will engage in the discovery and identification of therapeutic antibody development candidates as well as the clinical development of multiple antibodies recovered from the blood of vaccinated patients. The objectives of the plan are the following:
 
 
1.
Discover, evaluate, and identify lead antibody development candidates to each of the antigens contained in the multivalent vaccines developed by Dr. Danishefsky and identified as a unimolecular vaccine.
 
 
2.
Each antibody candidate for each antigen will be selected from the serum of patients participating in the Phase I clinical trials currently underway at SKI.
 
 
3.
The antibody candidates will be selected based on extensive in vitro and in vivo testing detailed in the plan.
 
 
4.
For each viable antibody development candidate MabVax will perform all preclinical development work and will use commercially reasonable efforts to file INDs and conduct clinical testing.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
20
 
Exhibit 10.10
 
CONFIDENTIAL TREATMENT REQUESTED
 
OPTION AGREEMENT
 
This Option Agreement (the “ Agreement ”), effective as of August 29, 2014 (the “ Effective Date ”), is entered by and between MabVax Therapeutics, Inc., with a principal place of business at 11588 Sorrento Valley Road, Suite 20, San Diego, CA 92121 (“ MabVax ”), and Juno Therapeutics, Inc., with a principal place of business at 307 Westlake Avenue North, Suite 300, Seattle, WA 98109 (“ Juno ”).
 
BACKGROUND
 
A.
MabVax owns certain Patent Rights (as defined below) relating to certain antibody binding domains;
 
B.
MabVax has isolated Domains (as defined herein) with binding specificity for human GD2 or sialyl Lewis A antigens, and Controls certain patents and patent applications with respect to such Domains;
 
C.
MabVax represents that it will, on or about the Effective Date, enter into an agreement with Memorial Sloan-Kettering Cancer Center (“ MSKCC ”) under which MabVax will deliver certain Biological Materials (defined below) to MSKCC for research purposes (“ MSKCC Agreement ”). MabVax represents that, under the MSKCC Agreement, MSKCC has no right to transfer Domains provided by MabVax under the MSKCC Agreement, or CARs that contain such Domains, or the sequences of any such Domains, to any person or entity (including Juno) without MabVax’s consent; and
 
D.
Juno desires to obtain an exclusive option to obtain from MabVax a license under the Patent Rights (as defined herein), and MabVax desires to grant such an option to Juno, on the terms and conditions herein.
 
NOW, THEREFORE, in consideration of the premises and mutual promises set forth in this Agreement, and other good and valuable consideration, the exchange, receipt and sufficiency of which are acknowledged, MabVax and Juno agree as follows:
 
1.
DEFINITIONS
 
1.1 “ Affiliate ” means, with respect to a party, any person or entity, which controls, is controlled by or is under common control with such party, and only for the duration of such control. For the purpose of this definition, “control” means: (a) direct or indirect ownership of fifty percent (50%) or more (or, if fifty percent (50%) or less, the maximum ownership interest permitted by applicable law) of the stock or shares having the right to vote for the election of directors of such corporate entity; or (b) the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise. For avoidance of doubt, Telik, Inc., a Delaware corporation, will constitute an “Affiliate” of MabVax.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
1
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
1.2 “ Biological Materials ” means any genetic sequences (such as cDNA and genes), vectors, constructs, cells, plasmids and/or other biological materials containing a Domain, or a portion thereof.
 
1.3 “ CAR Product ” means any T-cell based product containing a CAR where the CAR includes a Domain, and where such product is under development, developed, made or sold by Juno or its Affiliates or sublicensees.
 
1.4 “ CAR T-Cell Product ” means any T-cell based product containing a CAR.
 
1.5 “ Chimeric Antigen Receptor ” or “ CAR ” means chimeric antigen receptor.
 
1.6 “ Confidential Information ” means: (a) the terms and conditions of this Agreement; (b) any information disclosed or made available by a party to the other party in connection with this Agreement that is in written, graphic, machine readable or other tangible form and, in each case, is marked “Confidential” or in some other manner to indicate its confidential nature; (c) information disclosed orally hereunder which is identified as confidential when disclosed and such disclosure of confidential information is confirmed in writing within thirty (30) days by the disclosing party; and (d) any other information of the type or nature that should reasonably be understood by a reasonable business person, in the context of the disclosure, to be confidential.
 
1.7 “ Change of Control ” means with respect to MabVax: (a) the sale of all or substantially all of its assets; (b) any issuance, sale, or transfer of the outstanding shares of capital stock or equity of MabVax (whether in a single transaction or in a series of related transactions) as a result of which the holders of the voting power of the outstanding capital stock or equity of MabVax immediately prior to such transaction, own less than fifty percent (50%) of the then outstanding capital shares of securities entitled to vote generally in the election of the directors (or other managing authority) of MabVax or the surviving or resulting corporation or acquirer, as the case may be, immediately following such transaction; or (c) the merger or consolidation of MabVax with another entity (whether in a single transaction or in a series of transactions) as a result of which the holders of the voting power of the outstanding capital stock of MabVax immediately prior to such transaction, own less than fifty percent (50%) of the then outstanding capital shares of securities or equity entitled to vote generally in the election of the directors (or other managing authority) of MabVax or the surviving or resulting corporation or acquirer, as the case may be, immediately following such transaction.
 
1.8 “ Control ” or “ Controlled ” means possession of the ability to grant the license provided for herein at any time during the term of this Agreement without violating the terms of any agreement or other arrangement with a third party.
 
1.9 “ Cover ” (in all its verb and adjectival forms, such as “Covered” and “Covers”) means (a) with respect to a Valid Claim in an issued patent, that, in the absence of a license, the use, offer for sale, sale, importation or manufacture of the product in question would infringe such Valid Claim or (b) with respect to a Valid Claim in a pending application, that, in the absence of a license, the use,
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
2
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
offer for sale, sale, importation or manufacture of the product in question would infringe such Valid Claim, should such a claim issue.
 
1.10 “ Domain ” means [*****].
 
1.11 “ Field ” means the detection, diagnosis and/or treatment of cancer in humans and/or animals.
 
1.12 “ Licensed Product ” means any CAR Product that is Covered by a Valid Claim.
 
1.13 “ Option Period ” means the period from the Effective Date until the earlier of either (i) June 30, 2016; or (ii) ninety (90) days from the date that MSKCC completes its research under the MSKCC Agreement.
 
1.14 “ Patent Rights ” means: (a) the patent applications and patents listed on  Exhibit A  hereto; (b) any patent applications and patents owned or Controlled by MabVax or its Affiliates disclosing or claiming any Domain, provided, however, that upon a Change of Control of MabVax during the term of this Agreement, the foregoing is limited to those patent applications and patents that were Controlled by MabVax and its Affiliates prior to the Change of Control (but, with respect to Affiliates, only those Affiliates that qualified as Affiliates of MabVax immediately prior to such Change of Control); (c) all divisionals, continuations, and continuations-in-part of the foregoing patents and/or patent applications, and all foreign counterparts thereof; (d) any patents in any jurisdiction hereafter issuing on any of the foregoing applications; and (e) any renewals, reissues, re-examinations or extensions (such as supplementary protection certificates) of or for any of the preceding. The list of Patent Rights on  Exhibit A  will be updated annually by MabVax pursuant to Section 5.2.
 
1.15 “ Target(s) ” means (i) GD2 and/or (ii) sialyl Lewis A antigen, as the context may dictate.
 
1.16 “ Territory ” means all countries, jurisdictions and territories.
 
1.17 “ Third Party ” means any person or entity other than the parties hereto and their respective Affiliates.
 
1.18 “ Valid Claim ” means a claim: (a) of an issued and unexpired patent included within the Patent Rights, unless the claim has been held unenforceable or invalid by a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, or has otherwise been finally admitted or determined to be invalid, unpatentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise, provided that if the holding of such court or governmental body is later reversed by a court or agency with overriding authority, the claim shall be reinstated as a Valid Claim with respect to sales made after the date of such reversal; (b) of a pending patent application within the Patent Rights to the extent the claim continues to be prosecuted in good faith for a period of time not to exceed [*****] from its earliest priority filing date in the applicable country; or (c) under any
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
3
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications described in this Section 1.18.
 
2.
OPTION
 
2.1  Grant to Juno . MabVax hereby grants to Juno an exclusive option to obtain an exclusive, royalty-bearing license (which license would include the right to grant and authorize sublicenses through multiple tiers) under the Patent Rights and under MabVax’s right, title and interest in and to Biological Materials to develop, make, have made, use, import, have imported, sell, have sold, offer for sale and otherwise exploit Licensed Products within the Territory for use in the Field.
 
2.2  Option Period; Exercise . Juno may exercise its option at any time during the Option Period upon written notice to MabVax.
 
2.3  Further Agreement; Financial Terms . During the ninety (90) day period immediately following the Effective Date, MabVax and Juno will negotiate in good faith with respect to the terms (other than financial terms) of the license agreement that would be used by the parties to document the license granted pursuant to any exercise of the option described in Sections 2.1 and 2.2 (“ License Agreement ”). Upon agreement, MabVax and Juno will amend this Agreement to add such license agreement as  Exhibit B  to this Agreement. [*****]. Upon agreement, the parties will enter into a definitive agreement in substantially the form attached hereto as  Exhibit B . In the event the parties are unable to agree on the financial terms within 90 days from Juno’s exercise of the Option, [*****].
 
2.4  Exclusivity . During the Option Period, MabVax will not: (a) use, or permit any Third Party other than MSKCC to use any Domain to generate any CAR T-Cell Product; (b) engage in partnership, collaboration, licensing or similar discussions or negotiations with any Third Party other than MSKCC with regard to such Third Party’s use of the Patent Rights and/or any Domain(s) to generate any CAR T-Cell Product; or (c) enter into any agreement with any Third Party other than MSKCC for any of the foregoing.
 
2.5  Biological Materials . During the Option Period, MabVax will not transfer any Biological Materials to Juno or its Affiliates or any Third Party other than MSKCC for the purpose of generating any CAR or any product containing any CAR.
 
2.6  Option Fee . In consideration for the option and other rights granted herein, Juno will pay to MabVax an option fee of [*****] within five (5) days of the Effective Date.
 
2.7  Juno Obligations . Juno will review data provided by MSKCC to Juno regarding the Domains in a similar manner to its review of data provided by MSKCC to Juno for other domains at a similar stage of research and development. In all instances, Juno will retain the right in its sole discretion to determine whether to exercise the option hereunder during the Option Period.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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CONFIDENTIAL TREATMENT REQUESTED
 
3.
CONFIDENTIAL INFORMATION
 
3.1  Non-Disclosure and Non-Use . Except as expressly provided in this Article 3, the parties agree that, during the term of this Agreement and for [*****] thereafter, the receiving party (a) will not publish or otherwise disclose to any third party, and (b) will not use for any purpose except for the purposes contemplated by this Agreement any Confidential Information furnished to it by the other party pursuant to this Agreement. Each party will take reasonable measures to protect the secrecy of and avoid disclosure and unauthorized use of the Confidential Information of the other party. Without limiting the foregoing, each party, as a receiving party, will take at least those measures that it takes to protect its own confidential information of a similar nature. The obligations under this Article 3 will not apply to any information to the extent that it can be established by the receiving party by competent proof that such information:
 
(i) was already known to the receiving party, other than under an obligation of confidentiality, at the time of disclosure by the disclosing party under this Article 3;
 
(ii) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving party by the disclosing party under this Article 3;
 
(iii) became generally available to the public or otherwise part of the public domain after its disclosure by the disclosing party under this Article 3 other than through any act or omission of the receiving party in breach of this Agreement;
 
(iv) was independently developed by the receiving party without use of or reference to the disclosing party’s Confidential Information, as such development is shown by the receiving party’s records (however such records do not need to document that the development was independent); or
 
(v) was subsequently lawfully disclosed, without any non-use or non-disclosure obligations for the benefit of the disclosing party, to the receiving party by a person other than the disclosing party.
 
Juno acknowledges that it has no right to receive, and MabVax shall not provide the Domains, or the genetic sequences of any antibody or antibody fragment therein, or any binding domain therein, under this Agreement. In any event, however, the Domains constitute MabVax Confidential Information (subject to the provisions of Section 3.1).
 
3.2  Permitted Use and Disclosures . Each party may use or disclose Confidential Information disclosed to it by the other party to the extent such use or disclosure is reasonably necessary in complying with any applicable law, order, rule or regulation of any court or governmental body or governmental agency or otherwise submitting information to tax or other governmental authorities, provided that such party will provide the other party with prompt written notice of such planned disclosure prior to such disclosure (only to the extent prior notice is allowed under applicable laws, orders, rules or regulations) so that the other party may seek a protective order or other
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
5
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
appropriate relief. Subject to the foregoing sentence and the disclosing party’s compliance with its obligations thereunder, such party may furnish the portion of the documents and information that it is legally compelled or it is otherwise required to disclose in connection therewith. Each party may disclose the terms of this Agreement to the extent such disclosure is reasonably necessary in: (i) filings under applicable securities laws or regulations or per the rules of any securities exchange or similar organization; (ii) to potential and actual acquirers, and to investors, underwriters and lenders, subject to reasonable non-use and non-disclosure requirements; and (iii) to their and their Affiliates’ respective employees, directors, contractors, legal advisors, accountants, and financial advisors, subject to reasonable non-use and non-disclosure requirements. The receiving party will be responsible for the compliance of such directors, officers, employees, contractors, legal advisors, accountants and financial advisors with this Article 3.
 
4.
REPRESENTATIONS AND WARRANTIES
 
4.1  MabVax . MabVax represents and warrants that: (a) it is a corporation duly organized validly existing and in good standing under the laws of Delaware; (b) the execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on the part of MabVax; (c) as of the Effective Date and to MabVax’s actual knowledge, there are no threatened or pending actions, lawsuits, claims or arbitration proceedings brought against MabVax in any way relating to the Domains and/or Patent Rights; (d) it will provide written notice to Juno of any threatened or pending actions, lawsuits, claims or arbitration proceedings brought against MabVax in any way relating to the Domains and/or Patent Rights of which MabVax becomes aware; (e) it has not entered into on or prior to the Effective Date, and will not enter into any agreement during the term of this Agreement, with any third party which is in conflict with the rights granted to Juno under this Agreement, and has not taken, and will not take during the term of this Agreement, any action that is inconsistent with the rights granted to Juno under this Agreement; (f) as of the Effective Date, to MabVax’s actual knowledge, the manufacture, use and sale of Domains does not infringe or misappropriate any intellectual property rights of any third party; (g) this Agreement is a legal and valid obligation binding upon MabVax and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by the parties does not conflict with any agreement, instrument or understanding to which MabVax is a party or by which it is bound; and (h) except for the option granted to Juno hereunder, it owns all right, title and interest in and to the Patent Rights.
 
4.2  Juno . Juno represents and warrants that: (a) it is a corporation duly organized validly existing and in good standing under the laws of the State of Delaware; (b) the execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on the part of Juno; and (c) this Agreement is a legal and valid obligation binding upon Juno and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by the parties does not conflict with any agreement, instrument or understanding to which Juno is a party or by which it is bound.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
6
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
4.3  Disclaimer . EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 4, NEITHER PARTY MAKES ANY REPRESENTATIONS NOR EXTENDS ANY WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO ANY INTELLECTUAL PROPERTY RIGHTS OR THE PATENT RIGHTS OR ANY OTHER MATTER, AND DISCLAIMS ALL SUCH REPRESENTATIONS AND WARRANTIES. Nothing contained in this Agreement shall be construed as a warranty or representation by MabVax as to the validity or scope of any of the Patent Rights, or that any patent will issue within the Patent Rights, or that the Patent Rights include or will include Valid Claims, or, except as expressly set forth in Section 4.1 or Article 5, that anything made, used, sold or otherwise disposed of under any license granted by MabVax is or will be free from infringement of patents, copyrights, and other rights of Third Parties.
 
5.
INTELLECTUAL PROPERTY MATTERS
 
5.1  Ownership . As between the parties, MabVax will remain the sole and exclusive owner of the Patent Rights, and reserves all right, title and interest therein and thereto, and no license is granted under the Patent Rights or any other intellectual property rights to Juno pursuant to this Agreement by implication or estoppel; except, in each case, for the option therein and thereto granted to Juno hereunder.
 
5.2  MabVax’s Responsibilities . MabVax will have the sole right, at its expense, to control the preparation, filing, prosecution and maintenance of the Patent Rights, and any interference or opposition proceeding relating thereto, using patent counsel of its choice and at its sole expense. During the term of this Agreement, MabVax will provide to Juno an updated  Exhibit A  from time to time, but MabVax will provide such an update on at least an annual basis during the thirty (30) days immediately preceding each anniversary of the Effective Date. MabVax agrees that it will not file or assist any third party to file any patent application disclosing or claiming any materials containing a CAR directed against any Domain, and/or their use.
 
5.3  Enforcement . If either party hereto becomes aware that any Patent Rights are being or have been infringed by any third party, such party will promptly notify the other party hereto in writing describing the facts relating thereto in reasonable detail (subject to any obligations of confidentiality restricting such notice). MabVax will have the sole and exclusive right, but not the obligation, to prosecute and control any action, suit or proceeding with respect to such infringement, including any declaratory judgment action (each an “ Action ”), at its expense; such control to include using counsel of its choice and may retain any recovery attained in such an Action.
 
6.
TERM AND TERMINATION
 
6.1  Term . The term of this Agreement will commence on the Effective Date, and unless earlier terminated as provided in this Article 6, will continue in full force and effect until the earlier of (i) Juno’s exercise of the option pursuant to Section 2.2; or (ii) expiration of the Option Period.
 
6.2  Termination for Cause . If either party materially breaches this Agreement, the other party may elect to give the breaching party written notice describing the alleged breach. If the
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
7
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
breaching party has not cured or discontinued such breach within thirty (30) days after receipt of such notice, the notifying party will be entitled, in addition to any other rights it may have under this Agreement, to terminate this Agreement effective immediately upon written notice.
 
6.3  Termination by MabVax . If Juno, its Affiliates, or their employees, directors or officers is party to any action or proceeding, whether filed by it or under its authority, or in which it joins, in which a determination is sought that any of the Patent Rights are invalid or unenforceable, or which constitutes an opposition to any of the Patent Rights, MabVax may elect to give Juno written notice describing such action or proceeding and the alleged involvement therein. If Juno has not cured or discontinued the alleged involvement in such action or proceeding within ten (10) business days after receipt of such notice specifying such ten (10) business day cure period, MabVax will be entitled to terminate this Agreement effective immediately upon written notice.
 
6.4  Termination for Insolvency . Either party may terminate this Agreement if the other becomes the subject of a voluntary or involuntary petition in bankruptcy or any proceeding relating to insolvency, receivership, liquidation, or composition or the benefit of creditors, if that petition or proceeding is not dismissed with prejudice within sixty (60) days after filing.
 
6.5  Permissive Termination . Juno may terminate this Agreement at any time with thirty (30) days prior written notice to MabVax.
 
6.6  Effect of Termination .
 
(a)  Accrued Rights and Obligations . Termination rights are cumulative and without prejudice to either party’s other available rights and remedies. Termination of this Agreement for any reason will not release any party hereto from any liability which, at the time of such termination, has already accrued to the other party or which is attributable to a period prior to such termination, nor preclude either party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to such termination.
 
(b)  Return of Confidential Information . All documents and other tangible objects containing or representing Confidential Information that have been disclosed by either party to the other party, and all copies or extracts thereof that are in the possession or control of the other party, will be destroyed or returned to the disclosing party within thirty (30) days after the disclosing party’s written request (“ Return Request ”). Notwithstanding the foregoing provisions of this Section 6.6(b), each party acknowledges that the receiving party will not be required to return to the disclosing party or destroy those copies of the disclosing party’s Confidential Information that: (i) were stored on the receiving party’s backup, disaster recovery or business continuity systems in the ordinary course of the receiving party’s business; or (ii) the receiving party retains to comply with legal or regulatory obligations or to protect or exercise its rights under this Agreement. For clarification, following the termination of this Agreement, the receiving party will neither retrieve nor use such disclosing party’s Confidential Information for any purpose other than the intended use of the systems in subsection (i) above or for the limited purposes under subsection (ii) above.
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
8
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
6.7  Survival . Sections 4.3, 6.6 and 6.7 and Article 1, 3 and 7 of this Agreement will survive expiration or termination of this Agreement for any reason.
 
7.
MISCELLANEOUS
 
7.1  Independent Contractors . The relationship of the parties under this Agreement is that of independent contractors. Neither party will be deemed to be an employee, agent, partner, franchisor, franchisee, joint venture or legal representative of the other for any purpose as a result of this Agreement or the transactions contemplated thereby, and neither will have the right, power or authority to create any obligation or responsibility on behalf of the other.
 
7.2  Assignment . The parties agree that neither this Agreement nor their rights and obligations under this Agreement will be delegated, assigned or otherwise transferred to a third party, in whole or part, whether voluntarily or by operation of law, including by way of sale of assets, merger or consolidation, without prior written consent of the other party. Notwithstanding the foregoing, each party may, without such consent, assign this Agreement and its rights and obligations hereunder in their entirety: (a) to an Affiliate of such party; or (b) in connection with the transfer or sale of all or substantially all of its assets to which this Agreement relates, or in the event of its merger, consolidation, change in control or similar transaction. Subject to the foregoing, this Agreement will be binding on and inure to the benefit of the parties and their permitted successors and assigns. Any attempted delegation, assignment or transfer in violation of the foregoing will be null and void.
 
7.3  Governing Law . This Agreement will be governed by, interpreted and enforced in accordance with the laws of the State of Delaware, without regard to principles of conflicts of laws. All disputes arising out of this Agreement will be subject to the exclusive jurisdiction and venue of the state and federal courts located in New Castle County, Delaware (and the appellate courts thereof), and each party hereby irrevocably consents to the personal and exclusive jurisdiction and venue thereof.
 
7.4  Notices . Any notices required or permitted under this Agreement or required by law must be in writing by first class certified mail or international express delivery service (such as DHL), in each case properly posted and fully prepaid to the applicable address below, or to such other address as either party may substitute by written notice under this Section 7.4. Notice will be deemed to have been given when delivered or, if delivery is not accomplished by reason or some fault of the addressee, when tendered.
 
If to MabVax:        
  
MabVax Therapeutics, Inc.
 
  
11588 Sorrento Valley Road, Suite 20
 
  
San Diego, CA 92121
 
  
Attention: J. David Hansen, President and CEO
   
If to Juno:
  
Juno Therapeutics, Inc.
 
  
307 Westlake Avenue North, Suite 300
 
  
Seattle, WA 98109
 
  
Attention: General Counsel
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
9
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
7.5  Construction . Whenever the words “include,” “includes” or “including” are used in this Agreement they will be deemed to be followed by the words “without limitation”. A reference to any legislation or to any provision of any legislation will include any modification, amendment, re-enactment thereof, any legislative provision substituted therefore and all rules, regulations and statutory instruments issued or related to such legislation. The parties and their respective counsel have had an opportunity to fully negotiate this Agreement. If any ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the parties, and no presumption or burden of proof will arise favoring or disfavoring any party by virtue of the authorship of any provision of this Agreement. No prior draft of this Agreement will be used in the interpretation or construction of this Agreement. Headings are used for convenience only and will not in any way affect the construction or interpretation of this Agreement.
 
7.6  Severability . If any provision, or portion thereof, in this Agreement is held to be invalid or unenforceable to any extent, such provision of this Agreement will be enforced to the maximum extent permissible by applicable law so as to effect the intent of the parties, and the remainder of the Agreement will remain in full force and effect. The parties will negotiate in good faith a valid and enforceable substitute provision for any invalid or unenforceable provision that most nearly achieves the intent and economic effect of such invalid or unenforceable provision as if it were enforceable.
 
7.7  Waiver . Any waiver of any provision of this Agreement or of a party’s rights or remedies under this Agreement must be in writing to be effective. Failure, neglect, or delay by a party to enforce the provisions of this Agreement or its rights or remedies at any time, will not be construed as a waiver of such party’s rights under this Agreement and will not in any way affect the validity of the whole or any part of this Agreement or prejudice such party’s right to take subsequent action. No exercise or enforcement by either party of any right or remedy under this Agreement will preclude the enforcement by such party of any other right or remedy under this Agreement or that such party is entitled by law to enforce.
 
7.8  Entire Agreement; Modification . This Agreement (including the Exhibits and any amendments hereto signed by both parties) sets forth the entire agreement and understanding of the parties with respect to the subject matter of this Agreement, and supersedes all prior oral and written, and contemporaneous oral, communications, representations, understandings, and agreements between the parties with respect to such subject matter. This Agreement may not be altered, amended or modified in any way except by a writing (excluding email or similar electronic transmissions) signed by the authorized representatives of both parties.
 
7.9  Counterparts . This Agreement may be executed in two or more counterparts, each of which will be deemed an original and all of which together will constitute one and the same Agreement.
 
[Signature Page to Option Agreement Follows]
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
10
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
IN WITNESS WHEREOF, MabVax and Juno have executed this Agreement by their respective duly authorized representatives.
 
MABVAX THERAPEUTICS, INC.
     
JUNO THERAPEUTICS, INC.
         
By:
 
/s/ J. David Hansen
     
By:
 
/s/ Kendall M. Mohler
Print Name:
 
J. David Hansen
     
Print Name:
 
Kendall M. Mohler
Title:
 
President and CEO
     
Title:
 
CSO
 
[Signature Page to Option Agreement]
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
11
 
 
 

 
 
CONFIDENTIAL TREATMENT REQUESTED
 
Exhibit A
 
Patent Rights
 
[*****]
 
Portions of this Exhibit, indicated by [*****], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
12
 
Exhibit 10.11
 
BEGINNING WITH THE EFFECTIVE DATE OF THIS SUPPLEMENTAL AGREEMENT, THE CONTRACT IS AMENDED AS FOLLOWS:
 
Pursuant to FAR 52.217-9, Option to Extend the Term of the Contract, the Government hereby exercises its option to fund the contract term  from August 15, 2014 through August 15, 2016 (Option Period 1) , this contract is hereby changed as follows:
 
ARTICLE B.2 PRICES – PHASE I
 
The total fixed price of this contract is $249,965.
 
Upon delivery and acceptance of the item(s) described in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below:
 
Description
  
 
Invoice #
  
 
Period Covered
 
  
 
Amount
PDF Kick-Off Presentation
  
HHSN2611201300060C-01
  
 
Month 1
  
  
$62,492; 1/4 of total
negotiated amount
Quarterly Report 1
  
HHSN2611201300060C-02
  
 
Month 2-3
  
  
$62,492; 1/4 of total
negotiated amount
Quarterly Report 2
  
HHSN2611201300060C-03
  
 
Month 4-6
  
  
$62,492; 1/4 of total
negotiated amount
Draft Commercialization Plan, Summary of Salient Results, Draft Final Report
  
HHSN2611201300060C-04
  
 
Month 1-8
  
  
$31,244.50; 1/8 of total
negotiated amount
PDF of Final Presentation, Final Report, Final Summary of Salient Results, Final Commercialization Plan
  
HHSN2611201300060C-05
  
 
Month 1-9
  
  
$31,344.50; 1/8 of
total negotiated
amount
 
  
 
  
     
  
 
Total Fixed Price
  
 
  
$
249,965
  
  
 
 
  
 
  
     
  
 
 
ARTICLE B.2 OPTION FOR PHASE II – is added to read as follows:
 
 
a.
Unless the Government exercises its option pursuant to the option clause referenced in ARTICLEI.3.ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.
 
 
b.
Pursuant to FAR Clause 52.217-9 set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The fixed price of this contract will be increased as set forth in paragraph c., below.
 
     
MabVax Therapeutics, Inc.
  
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Contract No. HHSN261201300060C
  
 
NCI Control No. N43CO-2013-00060
  
 
Modification No. 4
  
 
 
 
 

 
 
 
c.
The total estimated cost of the contract (Base Year and exercised options) is  Increased by $1,470,034 from $229,536 to $1,699,570.
 
 
d.
The fixed fee for the exercised Option of this contract  is increased by $29,400, from $20,429 to $49,829 . The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE 1.I. of this contract.
 
 
e.
The total estimated amount of the contract, represented by the sum of the estimated cost plus fixed fee for the Base Period and Exercised Options  is increased by $1,499,434 from $249,965 to $1,749,399 .
 
 
f.
Upon the delivery and acceptance of the Option Service described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below:
 
Phase I
 
  
Estimated Cost
 
  
Fixed Fee
 
  
Firm Fixed Price
 
 
Base Period (Phase I) 09/20/2013 – 08/15/2014 (Completed)
  
$
229,536
  
  
$
20,429
  
  
$
249,965
  
 
Phase II
 
  
Estimated Cost
 
  
Fixed Fee
 
  
Cost Plus Fixed Fee
 
 
Option Period: (Phase II): 08/16/2014-08/15/2016)
  
$
1,470,034
  
  
$
29,400
  
  
$
1,499,434
  
Total
 
  
$
1,470,034
  
  
$
29,400
  
  
$
1,749,399
  
 
ARTICLE B.3 ADVANCE UNDERSTANDINGS –  is revised to read as follows :
 
Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.
 
 
a.
Certification of Small Business Eligibility
 
The Contractor is required to certify their eligibility as a Small Business prior to receipt of final payment for the Phase I portion of the contract. Therefore, the Contractor shall certify their eligibility as a small business for research and development purposes under the SBIR program in their final invoice submission under the contract.
 
     
MabVax Therapeutics, Inc.
  
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NCI Control No. N43CO-2013-00060
  
 
Modification No. 4
  
 
 
 
 

 
 
If the Option for Phase II is exercised, the Contractor shall certify their eligibility prior to receiving 50% of the total award amount on the Phase II award, and prior to final payment on the Phase II award. The eligibility requirements are:
 
Phase I
 
 
 
A minimum of two-thirds of the research or analytical effort shall be performed by the Contractor.
 
 
 
The Principal Investigator shall be primarily employed with the Contractor. Primary employment means that more than one half (50%) of the employee’s time is spent with the Contractor. Primary employment with the Contractor precludes full-time employment at another organization.
 
 
 
All research or research and development work shall be performed by the Contractor and its subcontractors in the United States.
 
Phase II
 
 
 
A minimum of one-half of the research or analytical effort shall be performed by the Contractor. The percentage of work shall be measured by labor hours.
 
 
 
The Principal Investigator shall be primarily employed with the Contractor. Primary employment means that more than one half (50%) of the employee’s time is spent with the Contractor. Primary employment with the Contractor precludes full-time employment at another organization.
 
 
 
All research or research and development work shall be performed by the Contractor and its subcontractors in the United States.
 
 
b.
Subcontract – Phase I
 
To negotiate a fixed price type subcontract with Charles River Laboratories for Pharmacological, toxicity, work in non-human primates for an amount not to exceed $45,285 for the period September 20, 2013 - August 15, 2014. Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.
 
To negotiate a fixed price type subcontract with Memorial Sloan Kettering Cancer Center for an amount not to exceed $0.00 as an in kind contribution contract for all animal work involving mice the period September 20, 2013 - August 15, 2014.
 
     
MabVax Therapeutics, Inc.
  
Page 4
Contract No. HHSN261201300060C
  
 
NCI Control No. N43CO-2013-00060
  
 
Modification No. 4
  
 
 
 
 

 
 
Subcontract - Phase II
 
To negotiate a fixed price type subcontract with  Memorial Sloan Kettering Cancer Center  for an amount not to exceed  $444,424  for the period  August 16, 2014 - August 15, 2016 . Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.
 
To negotiate a fixed price type subcontract with  Bioreliance, Inc.  for an amount not to exceed  $101,021  for the period  August 16, 2014 - August 15, 2016 . Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.
 
 
c.
Consultants – Phase II
 
Consultant fee(s) to be paid to the following individual(s):
 
 
Name
  
Rate Per Hour
 
  
Number of Hours
 
  
Total Cost Including
Travel Not to Exceed
 
BioPharma Consulting
  
$
400
  
  
 
50
  
  
$
20,000
  
Ridge Biotechnology
  
$
300
  
  
 
40
  
  
$
12,000
  
Pacific BioDevelopment
  
$
375
  
  
 
10
  
  
$
3,750
  
ProPharmaCon
  
$
225
  
  
 
180
  
  
$
40,500
  
 
 
d.
Contractor/Subcontractor Travel
 
 
1.
Expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall be unallowable without the prior written approval of the Contracting Officer. No retroactive approvals will be issued, and no travel costs incurred without prior Contracting Officer approval will be paid.
 
 
2.
All travel requests shall be sent to both the Contracting Officer and the Contracting Officer’s Representative (COR) 90 calendar days prior to the planned start date of the travel. If it is determined that the travel is allowable, then the Contracting Officer will issue written approval.
 
 
e.
Contract Number Designation
 
On all correspondence submitted under this contract, the Contractor agrees to clearly identify the two contract numbers that appear on the face page of the contract as follows:
 
Contract No. HHSN261201300060C
NCI Control No. N43CO201300060
 
     
MabVax Therapeutics, Inc.
  
Page 5
Contract No. HHSN261201300060C
  
 
NCI Control No. N43CO-2013-00060
  
 
Modification No. 4
  
 
 
 
 

 
 
 
f.
SBIR Funding Agreement Certification
 
The SBIR Funding Agreement Certification form, located in SECTION J, must be completed at the time of award prior to the performance of work under this contract, in accordance with the SBIR Policy Directive issued by SBA(October 18, 2012).
 
For additional information, see NIH Policy Notice NOT-OD-13-116, entitled, “New Program Certifications Required for SBIR and STTR Awards,” located at:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-116.html .
 
 
g.
SBIR Fast Track Recertification Requirement
 
Phase I and Phase II SBIR awards are considered separate funding agreements under the Fast-Track Initiative. Therefore, Phase I Fast-Track awardees must recertify that they meet all of the eligibility criteria for an SBIR or STTR award prior to issuance of the Phase II award.
 
ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS –  is revised to read as follows :
 
Items Unallowable Unless Otherwise Provided
 
Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:
 
 
1.
Conferences and Meetings
 
 
2.
Food for Meals, Light Refreshments, and Beverages
 
 
3.
Promotional Items  [includes, but is not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees.]
 
 
4.
Acquisition, by purchase or lease, of any interest in real property;
 
 
5.
Special rearrangement or alteration of facilities;
 
 
6.
Purchase or lease of  any  item of general purpose office furniture or office equipment regard less of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);
 
     
MabVax Therapeutics, Inc.
  
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NCI Control No. N43CO-2013-00060
  
 
Modification No. 4
  
 
 
 
 

 
 
 
7.
Travel to attend general scientific meetings;
 
 
8.
Foreign travel;
 
 
9.
Consultant costs;
 
 
10.
Subcontracts;
 
 
11.
Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more and “sensitive items” (defined as items of personal property (supplies and equipment that are highly desirable and easily converted to person use), regardless of acquisition value.
 
 
12.
Printing Costs (as defined in the Government Printing and Binding Regulations).
 
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
 
ARTICLE C.1. STATEMENT OF WORK
 
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work described below, set forth in SECTION J-List of Attachments, attached here to and made a part of this contract.
 
Document Title
  
 
Date
Statement of Work - Phase I
  
August 23, 2013
Statement of Work - Phase II
  
August 23, 2013
 
ARTICLE C.2. REPORTING REQUIREMENTS –  is revised to read as follows:
 
All reports required herein shall be submitted in an electronic format via email as attachments to the following designated NCI Branch Distribution Mailbox.:
 
ncibranchcinvoices@mail.nih.gov
 
NOTE: Hard copies of reports are no longer required and shall no longer be mailed in to NCI OA. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the contractor shall divide the deliverable into files of 50 MB each. All deliverables should be limited to five file attachments or less. We understand that in some cases more than five attachments will be necessary.
 
The subject line of the email shall read as follows: Deliverable_Contract Number_Vendor’s Name_Deliverable Description_Due Date
 
See ARTICLE F.2., DELIVERIES, for additional instructions.
 
     
MabVax Therapeutics, Inc.
  
Page 7
Contract No. HHSN261201300060C
  
 
NCI Control No. N43CO-2013-00060
  
 
Modification No. 4
  
 
 
 
 

 
 
All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508compliance, including guidance and specific checklists, by application, can be found at:  http://www.hhs.gov/web/508/index.html  under “Making Files Accessible.”
 
 
a.
Technical Reports
 
In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports during the period of performance of this contract:
 
[Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]
 
1.
Kick-off Presentation
 
The Contractor shall prepare and submit a kick-off presentation. Presentation of the slides will occur either in-person, through Webinar, or teleconference. The presentation shall cover the following:
 
 
a.
Discussion of the Contractor’s organization/project status, particularly changes that occurred since the proposal submission.
 
 
b.
The Contractor’s recent achievements (patents, publications, sales, regulatory approvals, partnerships, awards, etc.).
 
 
c.
Status of the field.
 
 
d.
Status of commercial and academic competitors.
 
 
e.
Where the proposed project is positioned against the state of the art.
 
 
f.
Intellectual property landscape.
 
 
g.
Refresher on the proposed technology/ R&D.
 
 
h.
Detailed plan for the first budget period of the contract.
 
 
i.
Milestones (technical and commercial) to be achieved by the end of the first budget period of the contract.
 
 
j.
Discussion of anticipated technical risks and alternative approaches.
 
 
k.
Questions to the National Cancer Institute (NCI).
 
     
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2.
Quarterly Report – Phase I
 
The Contractor shall submit two (2) Quarterly Reports which shall include:
 
 
a.
Summary of technical objectives with status of each objective clearly marked (e.g. previously complete, complete during the reporting period, not started, etc.)
 
 
b.
Clear description of activities accomplished in the quarter.
 
 
c.
Analysis of experimental data and presentation of selected date.
 
 
d.
Comments regarding the timeliness of performance.
 
 
e.
Brief explanation of objectives/activities to be pursued in the next reporting period.
 
The report shall generally be no longer than five (5) pages excluding tables presenting the data, figures, images and graphs.
 
Quarterly Report - Phase II
 
The Contractor shall submit Quarterly Reports which shall include the same information as required for the Phase I Quarterly Reports. The first reporting period in Phase II consists of the first full three (3) months of performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of three (3) full calendar months.
 
The first Phase II Quarterly Report shall be due 15 calendar days after the first complete reporting period. Thereafter, report shall be due on or before the 15th calendar day following each reporting period.
 
3.
Draft Updated Commercialization Plan
 
The Contractor shall submit an updated commercialization plan which shall include:
 
 
a.
Value of the SBIR Project, Expected Outcomes, and Impact
 
Describe, in layperson’s terms, the proposed value of the SBIR project and its key technology objectives. State the product, process, or service to be developed in Phase III. Clarify the need addressed, specifying weaknesses in the current approaches to meet this need. In addition, describe the commercial applications of the research and the innovation inherent in this application. Be sure to also specify the potential societal, educational, and scientific benefits of this work. Explain the non-commercial impacts to the overall significance of the project. Explain how the SBIR contract integrates with the overall business plan of the Contractor.
 
     
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b.
Organization
 
Give a brief description of the Contractor’s organization including corporate objectives, core competencies, present size (annual sales level and number and types of employees), history of previous Federal and non-Federal funding, regulatory experience, and subsequent commercialization, and any current products/services that have significant sales. Include a short description of the origins of the Contractor’s organization. Indicate the Contractor’s vision for the future, how the Contractor will grow/maintain a sustainable business entity, and how the Contractor will meet critical management functions as the Contractor’s organization evolves from a small technology R&D business to a successful commercial entity.
 
 
c.
Market, Customer, and Competition
 
Describe the market and/or market segments being targeted and provide a brief profile of the potential customer. Tell what significant advantages the Contractor’s innovation will bring to the market, e.g., better performance, lower cost, faster, more efficient or effective, new capability. Explain the hurdles the Contractor will have to overcome in order to gain market/customer acceptance of the Contractor’s innovation. Describe any strategic alliances, partnerships, or licensing agreements the Contractor has in place to get FDA approval (if required) and to market and sell the Contractor’s product. Briefly describe the Contractor’s marketing and sales strategy. Give an overview of the current competitive and scape and any potential competitors over the next several years.
 
 
d.
Intellectual Property (IP) Protection
 
Describe how the Contractor is going to protect the IP that results from the Contractor’s innovation. Also note other actions the Contractor may consider taking that will constitute at least a temporal barrier to others aiming to provide a solution similar to the Contractor’s.
 
 
e.
Finance Plan
 
Describe the necessary financing the Contractor will require to commercialize the product, process, or service, and when it will be required. Describe the Contractor’s plans to raise the requisite financing to launch the Contractor’s innovation into Phase III and begin the revenue stream. Plans for this financing stage may be demonstrated in one or more of the following ways:
 
 
 
Letter of commitment of funding.
 
 
 
Letter of intent or evidence of negotiations to provide funding, should the Phase II project be successful and the market need still exist.
 
 
 
Letter of support for the project and/or some in-kind commitment, e.g., to test or evaluate the innovation.
 
 
 
Specific steps the Contractor is going to take to secure Phase III funding.
 
     
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f.
Production and Marketing Plan
 
Describe how the production of the Contractor’s product/process/service will occur (e.g., in-house manufacturing, contract manufacturing). Describe the steps the Contractor will take to market and sell the Contractor’s product/process/service. For example, explain plans for licensing, Internet sales, etc.
 
 
g.
Revenue Stream
 
Explain how the Contractor plans to generate a revenue stream for the Contractor’s organization should this project be a success. Examples of revenue stream generation include, but are not limited to, manufacture and direct sales, sales through value added resellers or other distributors, joint venture, licensing, service. Describe how the Contractor’s staffing will change to meet the Contractor’s revenue expectations.
 
The Contracting Officer’s Representative (COR) will provide comments regarding the Draft Updated Commercialization Plan within two (2) weeks from the receipt date of the document.
 
4.
Final Commercialization Plan
 
The Contractor shall provide the Final Commercialization Plan by the completion date of the Phase I portion of the contract. This document shall include the changes required in the Draft Updated Commercialization Plan as well as the comments provided by the COR.
 
5.
Draft Final Report and Draft Summary of Salient Results - Phase I
 
The Draft Final Report for Phase I shall consist of the work performed and results obtained for the entire contract period of performance of Phase I as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Summary of Salient Results for Phase I shall be consist of a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. Both the Draft Final Report and Draft Summary of Salient Results for Phase I shall be submitted within 15calendar days of completing month 8 of contract performance. A Quarterly Report shall not be required for the period when the Phase I Final Report is due. The COR will provide comments regarding the Draft Final Report and Draft Summary of Salient Results for Phase I within two (2) weeks from the receipt date of the document.
 
Draft Final Report and Draft Summary of Salient Results - Phase II
 
The Draft Final Report for Phase II shall consist of the work performed and results obtained for the entire contract period of performance of Phase II as stated in SECTION F of this contract. This report shall be insufficient detail to describe comprehensively the results achieved. The Draft Summary of Salient Results for Phase II shall consist of a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.
 
     
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Both the Draft Final Report and Draft Summary of Salient Results for Phase II shall be submitted within one (1) month of the Phase II contract completion date. A Quarterly Report shall not be required for the period when the Phase II Final Report is due. The COR will provide comments regarding the Draft Final Report and Draft Summary of Salient Results for Phase II within two (2) weeks from the receipt date of the document.
 
6.
Final Report - Phase I
 
The Contractor shall provide the Phase I Final Report by the completion date of the Phase I portion of the contract. This document shall include the changes required in the Phase I Draft Final Report as well as the comments provided by the COR.
 
Final Report - Phase II
 
The Contractor shall provide the Phase II Final Report by the completion date of the Phase II portion of the contract. This document shall include the changes required in the Phase II Draft Final Report as well as the comments provided by the COR.
 
7.
Final Presentation - Phase I
 
The Contractor shall prepare and submit a final presentation which shall be due on or before the completion date of Phase I portion of the contract. Presentation of the slides shall occur either in-person, through Webinar, or teleconference. The presentation shall cover the following:
 
 
a.
Discussion of the Contractor’s/project status.
 
 
b.
The Contractor’s achievements during the Phase l performance period (patents, publications, sales, regulatory approvals, partnerships, awards, etc.).
 
 
c.
Detailed technical results of the performed research and development.
 
 
d.
Discussion of proposed milestones and whether they were achieved during the contract performance.
 
 
e.
Summary of submitted commercialization plan.
 
 
f.
If the Contractor is interested in pursuing Phase II research, detailed discussion of the anticipated Phase II technical activities with emphasis on how they fit in the commercialization plan. The Phase II research plan and commercialization plan shall be included in the final presentation for Phase I.
 
 
g.
Questions to the NCI.
 
     
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Final Presentation - Phase II
 
The Contractor shall prepare and submit a final presentation which shall be due on the completion date of Phase II portion of the contract. Presentation of the slides shall occur either in-person, through webinar, or teleconference. The presentation shall cover the following:
 
 
a.
Discussion of the Contractor’s/project status.
 
 
b.
The Contractor’s achievements during the performance period (patents, publications, sales, regulatory approvals, partnerships, awards, etc.).
 
 
c.
Detailed technical results of the performed research and development.
 
 
d.
Discussion of proposed milestones and whether they were achieved during the contract performance.
 
 
e.
Summary of submitted commercialization plan.
 
 
f.
Questions to the NCI.
 
8.
Final Summary of Salient Results - Phase I
 
The Contractor shall submit, with the Phase I Final Report, a final summary (not to exceed 200 words) of salient results achieved during the performance of the contract.
 
Final Summary of Salient Results - Phase II
 
The Contractor shall submit, with the Phase II Final Report, a final summary (not to exceed 200 words) of salient results achieved during the performance of the contract.
 
9.
Section 508 Annual Report - Phase I
 
The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under “Vendor Information and Documents.”
 
Section 508 Annual Report - Phase II
 
The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under “Vendor Information and Documents.”
 
     
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b.
Other Reports/Deliverables
 
1.
Reporting of Financial Conflict of Interest (FCOI) - Phase II
 
All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.
 
45 CFR Part 94 is available at:  http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 . See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.
 
(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDINGINVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)
 
2.
NIH Small Business Innovation Research (SBIR) Program Life Cycle Certification
 
In accordance with the SBIR/STTR Reauthorization Act of 2011, the contractor shall complete and submit the NIH Small Business Innovation Research (SBIR) Life Cycle Certification form, located in SECTION J, of the contract to the Contracting Officer. This certification is required to ensure the contractor is meeting the program’s requirements during the life cycle of the contract.
 
The Life Cycle Certification form shall be submitted as follows:
 
Phase I SBIR Contractors shall submit the Certification at the time of receiving final payment or disbursement.
 
Phase II SBIR Contractors shall submit the Certification prior to receiving more than 50% of the total contract amount  AND  prior to final payment or disbursement.
 
The Contracting Officer, may, at any time after ward request further clarifications and supporting documentation in order to assist in the verification of any information provided by the contractor. For additional information, see NIH Policy Notice NOT-OD-13-116, entitled, “New Program Certifications Required for SBIR and STTR Awards, “located at:  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-116.html .
 
     
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ARTICLE C.3. INVENTION REPORTING REQUIREMENT
 
All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources(DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.
 
The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:
 
Contracting Officer
National Institutes of Health
Brenda Oberholzer
Office of Acquisitions
8490 Progress Drive
Riverside Five, Suite 400, Room 4031
Frederick, MD 21701- 4998
 
If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above. To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed “Interagency Edison,” an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.
 
SECTION D - PACKAGING, MARKING AND SHIPPING
 
All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.
 
     
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SECTION E - INSPECTION AND ACCEPTANCE
 
The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.
 
For the purpose of this SECTION, the Contracting Officer’s Representative is the authorized representative of the Contracting Officer.
 
 
c.
Inspection and acceptance will be performed at:
 
National Cancer Institute
National Institutes of Health
9609 Medical Center Drive Room 1W558, MSC 9706
Rockville, MD 20850
 
Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.
 
 
d.
This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.
 
FAR Clause  52.246-7, Inspection of Research and Development - Fixed Price  (August 1996).
 
FAR Clause  52.246-16, Responsibility for Supplies  (April 1984).
 
SECTION F - DELIVERIES OR PERFORMANCE
 
ARTICLE F.1. PERIOD OF PERFORMANCE –  is revised to read as follows:
 
The period of performance of this contract shall be from 09/20/2013 through  08/15/2016 .
 
If the Government exercises its option pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:
 
Option
  
 
Option Period
Option for Phase II
  
August 16, 2014 - August 15, 2016
 
ARTICLE F.2. DELIVERIES – IS REVISED TO READ AS FOLLOWS:
 
All deliveries shall be submitted in electronic format to the following designated NCI Branch Distribution Mailbox:ncibranchcinvoices@mail.nih.gov.
 
NOTE: Hard copies of reports are no longer required and shall no longer be mailed in to NCI OA. A hard copy is required for the Invention Report. Please refer to ARTICLE F.2 DELIVERIES, paragraph b.
 
     
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The subject line of the email shall read as follows: Deliverable_Contract Number_Vendor’s Name_Deliverable Description_Due Date
 
Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:
 
The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:
 
Item
No.
  
 
Description
  
 
Quantity
  
 
Delivery Schedule
1.
  
Kick Off Presentation
  
2
  
Due at the conclusion of the Kick-Off presentation which shall be completed within 30 calendar days of contract award.
       
2.
  
Quarterly Report One -  Phase I
  
2
  
Due within 15 calendar days of completion of month 3 of performance.
       
3.
  
Quarterly Report Two -  Phase I
  
2
  
Due within 15 calendar days of completion of month 6 of performance.
       
4.
  
Draft Updated Commercialization Plan, Draft Summary of Salient Results, and Draft Final Report and Draft Final Report -  Phase I
  
2
  
Due within 15 calendar days of completion of month 8 of performance.
       
5.
  
Final Presentation, Final Summary of Salient Results, Final Report and Final Presentation -  Phase I
  
2
  
Due on or before Phase I completion date.
       
6.
  
Quarterly Reports - Phase II
  
2
  
Within 15 calendar days after each reporting period.
       
7.
  
Draft Summary of Salient Results, and Draft Final Report and Draft Final Report - Phase II
  
2
  
One month prior to the Phase II completion date.
       
8.
  
Final Summary of Salient Results, Final Report and Final Presentation - Phase II
  
2
  
Due on or before the Phase II completion date.
       
9.
  
Annual Utilization Report
  
2
  
Due one year after the start of Phase II.
       
10.
  
Final Invention Statement
  
2
  
Due on or before contract completion date.
 
     
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Item
No.
  
 
Description
  
 
Quantity
  
 
Delivery Schedule
11.
  
Invention Disclosure Report
  
2
  
Due on or before contract completion date.
       
12.
  
Section 508 Annual Report
  
2
  
Due one year after the start of Phase II.
       
13.
  
Section 508 Conformance Certification
  
2
  
Due on or before Phase I completion date.
       
14.
  
Final Presentation- Phase II
  
2
  
Due on or before the completion of Phase II.
       
15.
  
New or Revised Financial Conflict of Interest (FCOI) Report and Mitigation Report
  
1
  
Due as FCOI arises.
 
 
b.
The above items shall be addressed and delivered to:
 
 
Addressee
  
 
Deliverable Item No
  
 
Quantity
Brenda Oberholzer
National Cancer Institute
Office of Acquisitions
8490 Progress Drive
Riverside Five, Suite 400, Room 4031
Frederick, MD 21701
Email:  oberholzerb@mail.nih.gov
  
1-15
  
(1) Electronic Copy
Ming Zhao, COR
National Cancer Institute
NCI SBIR & STTR Programs, Room 1W534
9609 Medical Center Drive, MSC9705
Bethesda, MD 20892-9705
Email:  zhaoming3@mail.nih.gov
  
1-8 and 14
  
(1) Electronic Copy
OPERA, OEH, NIH
6705 Rockledge Drive Suite 310, MSC 7980
Bethesda, Maryland 20892-7980
  
10-11
  
(1) hard copy to OPERA; (1) electronic copy to CO
 
ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
 
This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:  http://www.acquisition.gov/far .
 
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:  52.242-15, Stop Work Order  (August 1989)
 
Alternate I  (April 1984) is applicable to this contract.
 
52.242-17, Government Delay of Work  (April 1984).
 
     
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SECTION G - CONTRACT ADMINISTRATION DATA
 
ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)
 
The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:
 
Ming Zhao, Ph.D.
 
The COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract The Government may unilaterally change its COR designation.
 
ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (JANUARY 2006)
 
The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.
 
(End of Clause)
 
The following individual(s) is/are considered to be essential to the work being performed hereunder:
 
Name
  
 
Title
Wolfgang Scholz, Ph.D.
  
Principal Investigator
 
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ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT –  is revised to read as follows:
 
 
a.
Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH Cost-Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.
 
 
1.
Payment requests shall be submitted to the offices identified below.  Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.
 
 
a.
The original invoice shall be submitted to the following designated billing office:
 
National Institutes of Health
Office of Financial Management
Commercial Accounts
2115 East Jefferson Street, Room 4B-432, MSC 8500
Bethesda, MD 20892-8500
 
 
b.
One courtesy copy of the original invoice shall be submitted electronically as follows:
 
 
1.
The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary supporting documentation as one single attachment.
 
 
2.
Save  the single attachment (scanned invoice along with any supporting documentation) in the following format: YourVendorName_Invoice number (e.g., if you are submitting Invoice123456, save the single attachment as “MabVax Therapeutics_Invoice HHSN261201300060C-01”) [Note: Please do not use special characters such as (#, $, %,*, &, !) when saving your attachment. Only the underscore symbol (    ) is permitted.]
 
 
3.
Transmit  the saved single attachment via e-mail to the appropriate branch’s Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCIOA Branch C - ncibranchcinvoices@mail.nih.gov. Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contract
 
     
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Number_Contract Title_ Contractor’s Name_ unique Invoice number (e.g, HHSN261201300060C_Development of an Imaging Agent Targeting Sialyl Lewis A_Support_MabVax Therapeutics_Invoice HHSN261201300060C-01)  [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office listed in subparagraph a, above, to meet the requirements of a “proper invoice.” Also, The Contractor must certify on the payment request that the electronic courtesy copy is a duplicate of the original invoice mailed to NIH’s Office of Financial Management.]
 
 
2.
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:
 
 
a.
Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute.
 
 
b.
Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NCI OA Branch C - ncibranchcinvoices@mail.nih.gov.
 
 
c.
Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract.  [Note: AVIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.]  If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
 
 
d.
DUNS or DUNS+4 Number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract and as registered in the Central Contractor Registration(CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract.  [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.]  If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
 
 
e.
Invoice Matching Option. This contract requires a two-way match.
 
     
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f.
Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.
 
 
g.
The Contract Title is:
 
Development of an Imaging Agent Targeting Sialyl Lewis A
 
 
h.
Contract Line Items as follows:
 
Line Item #
  
 
Line Item Description
1
  
Development of an Imaging Agent Targeting Sialyl Lewis A, Period of Performance: September 20, 2013 - August 15, 2014. (Phase I)
5
  
Development of an Imaging Agent Targeting Sialyl Lewis A, Period of Performance: August 16, 2014 - August 15, 2016. (Phase II)
 
 
b.
Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.
 
 
c.
The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:
 
“I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract.”
 
ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (DECEMBER 2013)
 
 
a.
Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.
 
 
b.
The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.
 
 
c.
Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.
 
     
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(End of Clause)
 
ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
 
 
a.
Contractor Performance Evaluations
 
Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared as determined by the Contracting Officer.
 
Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.
 
Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.
 
 
b.
Electronic Access to Contractor Performance Evaluations
 
Contractors may access evaluations through a secure Web site for review and comment at the following address:
 
http://www.cpars.gov
 
SECTION H - SPECIAL CONTRACT REQUIREMENTS – is revised to read as follows:
 
ARTICLE H.1. HUMAN SUBJECTS
 
It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans without the prior written approval of the Contracting Officer.
 
ARTICLE H.2. NEEDLE DISTRIBUTION
 
The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.
 
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ARTICLE H.3. ACKNOWLEDGEMENT OF FEDERAL FUNDING
 
The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.
 
ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
 
The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.
 
ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(B) (OCTOBER 2009)
 
Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.
 
The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.
 
The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.
 
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of
 
     
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time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Assurances.  Note : The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; Web site: ( http://www.aphis.usda.gov/animal_welfare ).
 
(End of Clause)
 
ARTICLE H.6. ANIMAL WELFARE
 
All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm.  In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the Contractor’s technical proposal, as modified in the Final Proposal Revision (FPR), dated 08/23/2013, which is incorporated by reference.
 
ARTICLE H.7. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES
 
All Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with Nonhuman Primates,” located at the following URL:
 
http://oma.od1.nih.gov/manualchapters/intramural/3044-2/
 
ARTICLE H.8. OPTION PROVISION
 
Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the [ Use for Cost-Reimbursement Contracts : estimated cost [plus fixed fee] of the contract will be increased as set forth in the ESTIMATED COST [PLUS FIXED FEE]/  Use for Fixed-Price Contracts : price of the contract will be increased asset forth in the OPTION PRICES] Article in SECTION B of this contract.
 
     
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ARTICLE H.9. LIMITATIONS ON SUBCONTRACTING - SBIR
 
Phase I - The Contractor shall perform a minimum of two-thirds of the research and/or analytical effort (total contract price less profit/fee) conducted under this contract. Any deviation from this requirement must be approved in writing by the Contracting Officer.
 
Phase II - The Contractor shall perform a minimum of one-half of the research and/or analytical effort (total contract price less profit/fee) conducted under this contract. Any deviation from this requirement must be approved in writing by the Contracting Officer.
 
ARTICLE H.10. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(B) (JANUARY 2010)
 
 
a.
Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 provisions is available at  http://www.section508.gov/ . The complete text of Section 508 Final provisions can be accessed at  http://www.access-board.gov/guidelines-and-standards .
 
 
b.
The Section 508 standards applicable to this contract/order are identified in the Statement of Work. The contractor must provide a written Section 508 conformance certification due at the end of each contract/order exceeding $100,000 when the contract/order duration is one year or less. If it is determined by the Government that EIT products and services provided by the Contractor do not conform to the described accessibility standards in the Product Assessment Template, remediation of the products or services to the level of conformance specified in the Contractor’s Product Assessment Template will be the responsibility of the Contractor at its own expense.
 
 
c.
In the event of a modification(s) to this contract/order, which adds new EIT products or services or revises the type of, or specifications for, products or services the Contractor is to provide, including EIT deliverables such as electronic documents and reports, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template to assist the Government in determining that the EIT products or services support Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found on the HHS Web site ( http://www.hhs.gov/web/508/contracting/technology/vendors.html ). [(End of HHSAR 352.239-73(b)]
 
     
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d.
Prior to the Contracting Officer exercising an option for a subsequent performance period/additional quantity or adding funding for a subsequent performance period under this contract, as applicable, the Contractor must provide a Section 508 Annual Report to the Contracting Officer and Project Officer. Unless otherwise directed by the Contracting Officer in writing, the Contractor shall provide the cited report in accordance with the followings schedule. Instructions for completing the report are available in the Section 508 policy on the HHS Office on Disability Web site under the heading Vendor Information and Documents. The Contractor’s failure to submit a timely and properly completed report may jeopardize the Contracting Officer’s exercising an option or adding funding, as applicable.
 
Schedule for Contractor Submission of Section 508 Annual Report :
 
Refer to ARTICLE F.2 DELIVERIES
 
[End of HHSAR 352.239-73(c)]
 
ARTICLE H.12. PUBLICATION AND PUBLICITY
 
In addition to the requirements set forth in HHSAR Clause  352.227-70, Publications and Publicity  incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:
 
“This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201300060C”
 
The following ARTICLES are hereby added as follows:
 
ARTICLE H.13. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
 
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is  1-800-HHS-TIPS (1-800-447-8477) . All telephone calls with be handled confidentially. The website to file a complaint on-line is  http://oig.hhs.gov/fraud/hotline/and  the mailing address is:
 
US Department of Health and Human Services
Office of Inspector General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489
Washington, D.C. 20026
 
     
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ARTICLE H.14. YEAR 2000 COMPLIANCE
 
In accordance with FAR 39.106, Information Technology acquired under this contract must be Year 2000 compliant asset forth in the following clause(s):
 
 
1.
Service Involving the Use of Information Technology YEAR 2000 COMPLIANCE—SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY
 
The Contractor agrees that each item of hardware, software, and firmware used under this contract shall be able to accurately process date data (including, but not limited to, calculating, comparing and sequencing) from, into and between the twentieth and twenty-first centuries and the Year 1999 and the Year 2000 and leap year calculations.
 
ARTICLE H.15. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS
 
The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.
 
ARTICLE H.16. GUN CONTROL
 
The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.
 
ARTICLE H.17 NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH FUNDED RESEARCH
 
NIH-funded investigators shall submit to the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) an electronic version of the author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC:  http://www.pubmedcentral.nih.gov .
 
Additional information is available at  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html .
 
ARTICLE H.18. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
 
The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.
 
     
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ARTICLE H.19. CONFIDENTIALITY OF INFORMATION
 
 
a.
Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.
 
 
b.
The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the “Disputes” clause.
 
 
c.
If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.
 
 
d.
Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.
 
 
e.
Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
 
 
f.
Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.
 
 
g.
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
 
The following information is covered by this article:
 
All data on participants in the clinical trial(s) performed under this contract.
 
ARTICLE H.20 INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST – PHASE II
 
The Institution (includes any contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under NIH contracts,
 
     
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or proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site:  http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno= 45As  required by 45 CFR Part 94, the Institution shall, at a minimum:
 
 
a.
Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator’s reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
 
 
1.
With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
 
 
2.
With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest; or
 
 
3.
Intellectual property rights and interests, upon receipt of income related to such rights and interest.
 
Significant financial interests do not include the following:
 
 
1.
Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and
 
 
2.
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
 
 
b.
Require each Investigator to complete training regarding the Institution’s financial conflicts of interest policy prior to engaging in research related to any NIH-funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.
 
     
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c.
Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the NIH-funded research.
 
 
d.
Require that each Investigator who is planning to participate in the NIH-funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interest (and those of the Investigator’s spouse and dependent children) no later than the date of submission of the Institution’s proposal for NIH-funded research. Require that each Investigator who is participating in the NIH-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.
 
 
e.
Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator’s significant financial interest is related to NIH-funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to NIH-funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the NIH-funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.
 
 
f.
Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).
 
 
g.
Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).
 
 
h.
Maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures, and all actions under the Institution’s policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48CFR Part 4, subpart 4.7, Contract Records Retention.
 
 
i.
Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.
 
 
j.
Complete the certification in Section K - Representations, Certifications, and Other Statements of Offerors titled “Certification of Institutional Policy on Financial Conflicts of Interest”.
 
     
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If the failure of an Institution to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the NIH-funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the NIH-funded research project.
 
The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Institution’s review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of a financial conflict of interests. The Contracting Officer may require submission of the records or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer may decide that a particular financial conflict of interest will bias the objectivity of the NIH-funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.
 
     
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PART II - CONTRACT CLAUSES
 
SECTION I - CONTRACT CLAUSES –  is revised to read as follows:
 
ARTICLE I.1. GENERAL CLAUSES FOR A FIXED-PRICE RESEARCH AND DEVELOPMENTSBIR PHASE I CONTRACT
 
This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause maybe accessed electronically as follows: FAR Clauses at:  http://www.acquisition.gov/far/ . HHSAR Clauses at:  http://www.hhs.gov/policies/hhsar/subpart352.html.
 
 
a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
 
:FARCLAUSE NO.
  
 
DATE
  
 
TITLE
52.202-1
  
Nov 2013
  
Definitions (Over the Simplified Acquisition Threshold)
52.203-12
  
Oct 2010
  
Limitation on Payments to Influence Certain Federal Transactions (Over$150,000)
52.203-17
  
Apr 2014
  
Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
52.204-10
  
Jul 2013
  
Reporting Executive Compensation and First-Tier Subcontract Awards($25,000 or more)
52.204-13
  
Jul 2013
  
System for Award Management Maintenance
52.209-6
  
Aug 2013
  
Protecting the Government’s Interest When Subcontracting WithContractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
52.215-8
  
Oct 1997
  
Order of Precedence - Uniform Contract Format
52.219-6
  
Jul 1996
  
Notice of Total Small Business Set-Aside
52.222-3
  
Jun 2003
  
Convict Labor
52.222-21
  
Feb 1999
  
Prohibition of Segregated Facilities
52.222-26
  
Mar 2007
  
Equal Opportunity
52.222-35
  
Jul 2014
  
Equal Opportunity for Veterans ($100,000 or more)
52.222-36
  
Jul 2014
  
Equal Opportunity for Workers with Disabilities
52.222-37
  
Jul 2014
  
Employment Reports on Veterans ($100,000 or more)
52.222-50
  
Feb 2009
  
Combating Trafficking in Persons
52.222-54
  
Aug 2013
  
Employment Eligibility Verification (Over the Simplified Acquisition Threshold)
52.223-6
  
May 2001
  
Drug-Free Workplace
52.223-18
  
Aug 2011
  
Encouraging Contractor Policies to Ban Text Messaging While Driving
52.225-1
  
May 2014
  
Buy American - Supplies
52.225-13
  
Jun 2008
  
Restrictions on Certain Foreign Purchases
52.227-1
  
Dec 2007
  
Authorization and Consent, Alternate I (Apr 1984)
52.227-2
  
Dec 2007
  
Notice and Assistance Regarding Patent and Copyright Infringement
52.227-11
  
Dec 2007
  
Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements
 
     
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FARCLAUSE NO.
  
 
DATE
  
 
TITLE
in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
52.227-20
  
May 2014
  
Rights in Data - SBIR Program
52.232-9
  
Apr 1984
  
Limitation on Withholding of Payments
52.232-23
  
May 2014
  
Assignment of Claims
52.232-25
  
Jul 2013
  
Prompt Payment
52.232-33
  
Jul 2013
  
Payment by Electronic Funds Transfer—System for Award Management
52.232-39
  
Jun 2013
  
Unenforceability of Unauthorized Obligations
52.233-1
  
May 2014
  
Disputes
52.233-3
  
Aug 1996
  
Protest After Award
52.233-4
  
Oct 2004
  
Applicable Law for Breach of Contract Claim
52.243-1
  
Aug 1987
  
Changes - Fixed Price, Alternate V (Apr 1984)
52.244-6
  
Jul 2014
  
Subcontracts for Commercial Items
52.249-1
  
Apr 1984
  
Termination for the Convenience of the Government (Fixed-Price) (Short Form)
52.249-9
  
Apr 1984
  
Default (Fixed-Price Research and Development)(Over the Simplified Acquisition Threshold)
52.253-1
  
Jan 1991
  
Computer Generated Forms
 
 
b.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFRCHAPTER 3) CLAUSES:
 
HHSARCLAUSE NO.
  
 
DATE
  
 
TITLE
352.202-1
  
Jan 2006
  
Definitions
352.203-70
  
Mar 2012
  
Anti-Lobbying
352.222-70
  
Jan 2010
  
Contractor Cooperation in Equal Employment Opportunity Investigations
352.227-70
  
Jan 2006
  
Publications and Publicity
352.231-71
  
Jan 2001
  
Pricing of Adjustments
352.242-70
  
Jan 2006
  
Key Personnel
352.242-73
  
Jan 2006
  
Withholding of Contract Payments
 
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SBIR PHASE II CONTRACT
 
This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at:  http://www.acquisition.gov/far/ . HHSAR Clauses at:  http://www.hhs.gov/policies/hhsar/subpart352.html .
 
     
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a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
 
FARCLAUSE NO.
  
 
DATE
  
 
TITLE
52.202-1
  
Nov 2013
  
Definitions (Over the Simplified Acquisition Threshold)
52.203-3
  
Apr 1984
  
Gratuities (Over the Simplified Acquisition Threshold)
52.203-5
  
May 2014
  
Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)
52.203-6
  
Sep 2006
  
Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)
52.203-7
  
May 2014
  
Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)
52.203-8
  
May 2014
  
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
52.203-10
  
May 2014
  
Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
52.203-12
  
Oct 2010
  
Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)
52.203-17
  
Apr 2014
  
Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
52.204-4
  
May 2011
  
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (Over the Simplified Acquisition Threshold)
52.204-10
  
Jul 2013
  
Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)
52.204-13
  
Jul 2013
  
System for Award Management Maintenance
52.209-6
  
Aug 2013
  
Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
52.215-2
  
Oct 2010
  
Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]
52.215-8
  
Oct 1997
  
Order of Precedence - Uniform Contract Format
52.215-10
  
Aug 2011
  
Price Reduction for Defective Certified Cost or Pricing Data (Over $700,000)
52.215-12
  
Oct 2010
  
Subcontractor Cost or Pricing Data (Over $700,000)
52.215-14
  
Oct 2010
  
Integrity of Unit Prices (Over the Simplified Acquisition Threshold)
52.215-15
  
Oct 2010
  
Pension Adjustments and Asset Reversions (Over $700,000)
52.215-18
  
Jul 2005
  
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
52.215-19
  
Oct 1997
  
Notification of Ownership Changes
 
 
b.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
 
HHSARCLAUSE NO.
  
 
DATE
  
 
TITLE
352.202-1
  
Jan 2006
  
Definitions - with Alternate paragraph (h) (Jan 2006)
352.203-70
  
Mar 2012
  
Anti-Lobbying
352.216-70
  
Jan 2006
  
Additional Cost Principles
352.222-70
  
Jan 2010
  
Contractor Cooperation in Equal Employment Opportunity Investigations
352.227-70
  
Jan 2006
  
Publications and Publicity
352.228-7
  
Dec 1991
  
Insurance - Liability to Third Persons
352.233-71
  
Jan 2006
  
Litigation and Claims
352.242-70
  
Jan 2006
  
Key Personnel
352.242-73
  
Jan 2006
  
Withholding of Contract Payments
352.242-74
  
Apr 1984
  
Final Decisions on Audit Findings
 
     
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[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SBIR PHASE II CONTRACT- Rev. 07/2014].
 
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES
 
ARTICLE 1.1. of this SECTION is hereby modified as follows:
 
Alternate I  (October 1997) of FAR Clause  52.215-14, Integrity of Unit Prices  (October 2010) is added.
 
Alternate I V (October 2010) of FAR Clause  52.215-21, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data—Modifications  (October 2010) is added.
 
 
c.
The following clause(s) are added to this contract:
 
FAR Clause  52.203-3, Gratuities  (April 1984)
 
FAR Clause  52.203-5, Covenant Against Contingent Fees  (April 1984)
 
FAR Clause  52.203-6, Restrictions on Subcontractor Sales to the Government  (September 2006)
 
FAR Clause  52.203-7, Anti-Kickback Procedures  (October 2010)
 
FAR Clause  52.203-8, Cancellation, Recission, and Recovery of Funds for Illegal or Improper Activity  (January 1997)
 
FAR Clause  52.203-10, Price or Fee Adjustment for Illegal or Improper Activity  (January 1997)
 
FAR Clause  52.204-4, Printed or copied Double-Sided on Postconsumer Fiber Content Paper  (May 2011)
 
FAR Clause  52.215-2, Audit and Records Negotiation  (October 2010)
 
FAR Clauses  52.215-15, Pension Adjustments and Asset Reversions  (October 2010);  52.215-18, Reversion or Adjustment of Plans for Post Retirement Benefits (PRB) Other Than Pensions  (July 2005); and,  52.215-19, Notification of Ownership Changes  (October 1997), are deleted in their entirety.
 
     
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FAR Clause  52.215-14, Integrity of Unit Prices  (October 2010)
 
FAR Clause  52.219-8, Utilization of Small Business Concerns  (July 2013)
 
FAR Clause  52.219-14, Limitations on Subcontracting  (December 1996)
 
FAR Clause  52.222-40, Notification of Employee Rights Under the National Labor Relations Act  (December 2010)
 
FAR Clause  52.229-3, Federal, State and Local Taxes  (February 2013)
 
FAR Clause  52.232-1, Payments (Phase I)
 
FAR Clause  52.232-2, Payments under Fixed-Price Research and Development Contracts  (April 1984)
 
FAR Clause  52.232-17, Interest  (October 2010)
 
FAR Clause  52.242-13, Bankruptcy  (July 1995)
 
FAR Clause  52.244-5, Competition in Subcontracting  (December 2010)
 
The following clause(s) is substituted as follows:
 
FAR Clause  52.249-1, Termination for the Convenience of the Government (Fixed-Price)(Short Form) (April 1984) is deleted in its entirety and  FAR Clause 52.249-2, Termination for the Convenience of the Government (Fixed Price)  (April 2012) is substituted therefor.
 
FAR Clause  52.229-3, Federal, State and Local Taxes  (February 2013) is deleted in its entirety, and FAR Clause  52.229-4, Federal, State and Local Taxes (State and Local Adjustments)  (February 2013) is substituted therefor.
 
FAR Clause  52.232-1, Payments  (April 1984) is deleted in its entirety and  FAR Clause 52.232-16, Progress Payments  (April 2012) is substituted therefor.
 
Alternate I (March 2000) is not applicable to this contract.
 
Alternate II (August 1987) is not is applicable to this contract.
 
Alternate III (March 2000) is not is applicable to this contract.
 
Alternate IV (October 2010) of FAR Clause 52.215-21, Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data—Modifications (October 2010) is added.
 
     
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Modification No. 4
  
 
 
 
 

 
 
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
 
This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
 
 
a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
 
 
1.
FAR Clause  52.215-17, Waiver of Facilities Capital Cost of Money  (October 1997).
 
 
2.
FAR Clause  52.217-8, Option to Extend Services  (November 1999).
 
“..The Contracting Officer may exercise the option by written notice to the Contractor within 60calendar days prior to the expiration date of this contract.”
 
 
3.
FAR Clause  52.219-28, Post-Award Small Business Program Representation  (July 2013).
 
 
4.
FAR Clause  52.242-3, Penalties for Unallowable Costs  (May 2001).
 
 
5.
FAR Clause  52.244-5, Competition in Subcontracting  (December 1996).
 
 
6.
FAR Clause  52.245-1, Government Property  (April 2012).
 
 
7.
FAR Clause  52.245-9, Use and Charges  (April 2012).
 
 
8.
FAR Clause  52.246-23, Limitation of Liability  (February 1997).
 
 
b.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:
 
 
1.
HHSAR Clause  352.231-70, Salary Rate Limitation  (August 2012).
 
Note : P.L. 112-74 sets forth the Salary Rate Limitation at the Executive Level II Rate, effective December 23, 2011.
 
See the following Web site for Executive Schedule rates of pay:  http://www.opm.gov/oca/
 
( For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive
 
     
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Modification No. 4
  
 
 
 
 

 
 
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
 
This contract incorporates the following clauses in full text.
 
 
a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
 
52.232-99 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS(DEVIATION) (AUG 2013)
 
 
1.
This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012, and the extension to that policy provided by OMB Policy Memorandum M-13-15, Extension of Policy to Provide Accelerated Payment to Small Business Subcontractors, dated July 11, 2013.
 
 
2.
Upon receipt of accelerated payments from the Government, the Contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.
 
 
3.
Include the substance of this clause, including this paragraph (b), in all subcontracts with small business concerns.
 
 
4.
The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.
 
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
 
SECTION J - LIST OF ATTACHMENTS
 
The following documents that are highlighted and attached are incorporated in this contract:
 
1.
Statement of Work
 
Statement of Work - Phase I, dated August 23, 2013, 2 pages.
Statement of Work - Phase II, dated August 23, 2013, 2 pages.
 
2.
Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2 – Phase I
 
Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2, (7/13), 3 pages.
 
3.
Invoice Instruction for NIH Cost-Reimbursement Contract, NIH(RC)-4 – Phase II
 
Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-4, (7/13), 6 pages.
 
4.
Disclosure of Lobbying Activities, SF-LLL
 
Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages.
 
     
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5.
SBIR Funding Agreement
 
Small Business Certification, 3 pages.
 
END OF MODIFICATION - ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED ARE IN FULL EFFECT.
 
     
MabVax Therapeutics, Inc.
  
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Modification No. 4
  
 
 
 
 

 
 
Statement of Work (Phase II) Dated 08/23/2013
Contract No. HHSN261201300060C
 
STATEMENT OF WORK (Phase II)
 
     
TITLE:
  
Development of an imaging agent targeting sialyl Lewis A
PRINCIPAL INVESTIGATOR(S):
  
Wolfgang W Scholz, PhD
PROJECT DURATION :
  
24 months
COMPANY:
  
MabVax Therapeutics
SUBCONTRACTORS:
  
MSKCC, BioReliance
 
I.
Background Information and Objectives
 
A.
Background Information
 
Pancreatic cancer is a highly lethal disease with a 5 year survival rate for all stages combined of only ~4%. Ductal adenocarcinomas account for the majority of those tumors (~95%) and over 80% of individuals are diagnosed late during disease. The outlook for individuals with advanced and metastatic disease is very grim with median survival times of 10 and 6 months, respectively. There is a clear need for new diagnostic tools that allow earlier detection and for improved therapy regiments. We have developed 5B1, a fully human antibody that targets sialyl Lewis A, which is highly expressed on adenocarcinomas, including pancreatic ductal adenocarcinoma. 5B1 showed promising activity as therapeutic agent in xenografts models, and 89Zr-hu5B1 demonstrated remarkable tumor accumulation and sensitivity in preclinical imaging models. This new agent might detect primary tumors and metastases earlier and have a significant impact on treatment of disease.
 
B.
Technical Objectives
 
Proof of concept preclinical studies and preliminary toxicological studies will be completed during the Phase I efforts. The objective of the proposed Phase II efforts has the overall goal to file an exploratory IND (eIND) for a Phase 0/1 clinical study. Several specific objectives must be met to reach the overall goal to file an eIND.
 
         
Objective 1: Manufacture and test clinical grade material
 
  
Milestone 1.1:
  
Demonstrate tumor accumulation, high reproducibility and accuracy in two additional animal models.
 
  
Milestone 1.2:
  
Generate and characterize a MCB for manufacturing of the imaging agent.
 
  
Milestone 1.3:
  
Manufacture clinical grade imaging agent.
 
Objective 2: Complete dosimetry and toxicology studies. Milestone 2.1: Generate report for CMC section.
 
  
Milestone 2.2:
  
Generate report for pharmacology section.
 
  
Milestone 2.3:
  
Generate report for toxicology section.
 
Objective 3: Generate the documentation required for the filing of an eIND
 
  
Milestone 3.1:
  
Prepare eIND package and submit investigator brochure for IRB review
 
II.
Services to be Performed
 
A.
General Requirements
 
 
1.
The contractor shall independently perform all work and furnish all labor, materials, supplies, equipment, and services (except as otherwise specified in the contract).
 
 
2.
All work will be monitored by the Government Project Officer identified in Section G of the contract.
 
     
MabVax Therapeutics, Inc.
  
Attachment 1
 
 
 

 
 
Statement of Work (Phase II) Dated 08/23/2013
Contract No. HHSN261201300060C
 
B.
Specific Requirements
 
Phase II Milestones and Timeline
(Please feel free to use format appropriate for your project)
 
  
 
  
 
Months
1-9
 
  
 
Months
10-18
 
  
 
Months
19-24
 
Objective 1
  
 
  
 
******
  
  
 
***
  
  
     
 
  
Milestone 1.1
  
 
X
  
  
     
  
     
 
  
Milestone 1.2
  
 
X
  
  
     
  
     
 
  
Milestone 1.3
  
     
  
 
X
  
  
     
Objective 2
  
 
  
     
  
 
***
  
  
 
*****
  
 
  
Milestone 2.1
  
     
  
 
X
  
  
     
 
  
Milestone 2.2
  
     
  
     
  
 
X
  
 
  
Milestone 2.3
  
     
  
     
  
 
X
  
Objective 3
  
 
  
     
  
     
  
 
**
  
 
  
Milestone 3.1
  
     
  
     
  
 
X
  
 
     
MabVax Therapeutics, Inc.
  
Attachment 1
 
 
 

 
 
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING INSTRUCTIONS
FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4
 
Format : Submit payment requests on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.
 
Number of Copies : Submit payment requests in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.
 
Frequency : Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks.
 
Cost Incurrence Period : Costs incurred must be within the contract performance period or covered by precontract cost provisions.
 
Billing of Costs Incurred : If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall cite the amount(s) and month(s) in which the costs were incurred.
 
Contractor’s Fiscal Year : Prepare payment requests in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.
 
Currency : All NIH contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract shall not exceed the United States dollars authorized.
 
Costs Requiring Advance Approval : Costs requiring advance approval by the Contracting Officer, which are not set forth in the Contract Schedule shall be identified by the Contracting Officer’s Authorization (COA) Number as a separate expenditure category on the payment request. In addition, the Contractor shall show any cost limitation or ceiling set forth in the Contract Schedule, i.e. an Advance Understanding, as a separate expenditure category on the payment request.
 
Invoice/Financing Request Identification : Identify each payment as either:
 
 
(a)
Interim Invoice/Contract Financing Request : These are interim payment requests submitted during the contract performance period.
 
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
 
(b)
Completion Invoice : Submit the completion invoice promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and all performance provisions have been completed.
 
 
(c)
Final Invoice : A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).
 
Preparation and Itemization of the Invoice/Financing Request:
 
The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.  All information must be legible or the invoice will be considered improper and returned to the Contractor .
 
 
(a)
Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
 
 
(b)
Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract. Any invoice identified as improper will be sent to this address. Also include the name, title, phone number, and e-mail address of the Point of Contact in case of questions. If the remittance name differs from the legal business name, both names must appear on the invoice. Provide the Contractor’s Federal Taxpayer Identification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4 number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract, and as registered in the System for Award Management (SAM) database.
 
When an approved assignment of claims has been executed, the Contractor shall provide the same information for the assignee as is required for the Contractor (i.e., name, address, point of contact, TIN, and DUNS number), with the remittance information clearly identified as such.
 
 
(c)
Invoice/Financing Request Number : Identify each payment request by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization. For example, if a contractor has already submitted invoice number 05 on one of its contracts or orders, it cannot use that same invoice number on any other contract or order. Payment requests with duplicate invoice numbers will be considered improper and returned to the contractor.
 
The NIH does not prescribe a particular numbering format but suggests using a job or account number for each contract and order followed by a sequential
 
     
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
invoice number (example: 8675309-05). Invoice numbers are limited to 30 characters. There are no restrictions on the use of special characters, such as colons, dashes, forward slashes, or parentheses.
 
If all or part of an invoice is suspended and the contractor chooses to reclaim those costs on a supplemental invoice, the contractor may use the same unique invoice number followed by an alpha character, such as “R” for revised (example: 8675309-05R).
 
 
(d)
Date Invoice/Financing Request Prepared : Insert the date the payment request is prepared.
 
 
(e)
Contract Number and Order Number (if applicable) : Insert the contract number and order number (as applicable).
 
 
(f)
Contract Title : Insert the contract title exactly as it appears on the cover page of the contract and/or Section G of the Contract Schedule.
 
 
(g)
Current Contract Period of Performance : Insert the contract start date/effective date through the current completion date of the contract.
 
 
(h)
Total Estimated Cost of Contract/Order : Insert the total estimated cost of the contract, exclusive of fee. If billing under an order, insert the total estimated cost of the order, exclusive of fee. For contracts/orders with options or incremental funding provisions, enter the amount currently obligated and available for payment.
 
 
(i)
Total Fixed-Fee : Insert the total fixed-fee (where applicable). For contracts/orders with options or incremental funding provisions, enter the amount currently obligated and available for payment (where applicable).  Note If the contract provides for another type of Fee, i.e. Award or Incentive Fee, insert the amount available to be earned as identified in the contract and indicate the type of fee to be billed on the payment request.
 
 
(j)
Two-Way/Three-Way Match : Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.
 
 
(k)
Office of Acquisitions : Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
 
 
(l)
Central Point of Distribution : Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
 
     
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
 
(m)
Billing Period : Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
 
 
(n)
Amount Billed - Current Period : Insert the amount claimed for the current billing period by major cost element, including any adjustments and fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
 
 
(o)
Amount Billed - Cumulative : Insert the cumulative amounts claimed by major cost element, including any adjustments and fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
 
 
(p)
Direct Costs : Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.
 
 
1)
Direct Labor : Include salaries and wages paid (or accrued) for direct performance of the contract.
 
For Level of Effort contracts only, the Contractor shall provide the following information on a separate sheet of paper attached to the payment request:
 
 
 
hours or percentage of effort and cost by labor category (as specified in the Level of Effort Article in Section F of the Contract Schedule) for the current billing period, and
 
 
 
hours or percentage of effort and cost by labor category from contract inception through the current billing period. (NOTE: The Contracting Officer may require the Contractor to provide additional breakdown for direct labor, such as position title, employee name, and salary or hourly rate.)
 
 
2)
Fringe Benefits : List any fringe benefits applicable to direct labor and billed as a direct cost. Cite the rate(s) used to calculate fringe benefit costs, if applicable.
 
 
3)
Accountable Personal Property : Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS  Contractor’s Guide for Contract of Government Property ). Show permanent research equipment separate from general purpose equipment.
 
     
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. Precede the item with an asterisk (*) if the equipment is below the $1,000 approval level. Include reference to the following (as applicable):
 
 
 
item number for the specific piece of equipment listed in the Property Schedule, and,
 
 
 
Contracting Officer Authorization (COA) number, if the equipment is not covered by the Property Schedule.
 
The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract.
 
 
4)
Materials and Supplies : Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.
 
 
5)
Premium Pay : List remuneration in excess of the basic hourly rate.
 
 
6)
Consultant Fee : List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.
 
 
7)
Travel : Include domestic and foreign travel. Foreign travel is travel outside of the United States and its territories and possessions. However, for an organization located outside the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.
 
 
8)
Subcontract Costs : List subcontractor(s) by name and amount billed.
 
 
9)
Other : List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.
 
 
(q)
Cost of Money (COM) : Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed.
 
 
(r)
Indirect Costs : Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
 
 
(s)
Fixed-Fee : Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.  Note : If the contract provides for another type of Fee, i.e. Award or Incentive Fee, provide the same documentation for the amount claimed.
 
     
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
 
(t)
Total Amounts Claimed : Insert the total amounts claimed for the current and cumulative periods.
 
 
(u)
Adjustments : Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.
 
 
(v)
Grand Totals
 
 
(w)
Certification : The Contractor shall include the following certification at the bottom of each payment request:
 
“Pursuant to authority vested in me, I certify that this voucher is correct and proper for payment.”
 
Note The contract may require additional certifications (See Invoice Submission Instructions in Section G of the Contract Schedule)
 
The Contracting Officer may require the Contractor to submit detailed support for costs claimed on one or more interim payment requests.
 
FINANCIAL REPORTING INSTRUCTIONS:
 
These instructions correspond to the Columns on the Sample Invoice/Financing Request.
 
Column A - Expenditure Category : Enter the expenditure categories required by the contract.
 
Column B - Cumulative Percentage of Effort/Hrs. - Negotiated: Enter the percentage of effort or number of hours agreed to for each employee or labor category listed in Column A.
 
Column C - Cumulative Percentage of Effort/Hrs . - Actual: Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.
 
Column D - Amount Billed - Current : Enter amounts billed during the current period. Column E - Amount Billed - Cumulative: Enter the cumulative amounts to date.
 
Column F - Cost at Completion : Enter data only when the Contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates are essential.
 
Column G - Contract Amount : Enter the costs agreed to for all expenditure categories listed in Column A.
 
Column H - Variance (Over or Under) : Show the difference between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made in Column F. This column need not be filled in when Column F is blank. When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column F by Column G, an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost Clause in the contract.
 
     
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
Modifications : List all new modification(s) (not previously reported) in the amount negotiated for an item in the appropriate cost category.
 
Expenditures Not Negotiated : An expenditure for an item for which no amount was negotiated (e.g., at the discretion of the Contractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in, except for G. Column H will of course show a 100 percent variance and will be explained along with those identified under H above.
 
     
NIH(RC-4
  
Attachment 3
Revised 7/2013
  
 
 
 
 

 
 
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
 
                             
(a) Designated Billing Office Name and Address:
National Institutes of Health
Office of Financial Management
Commerical Accounts
2115 East Jefferson Street, Room 4B4, MSC
8500
Bethesda, MD 20892-8500
 
(b) Contractor’s Name, Address, Point of Contact,
TIN, and DUNS or DUNS+4 Number:
ABC Corporation
Anywhere, U.S.A. Zip+4
Name, Title, Phone Number, and E-mail
Address of Contractor’s Point of Contact.
DUNS or DUNS+4:                     
TIN:                     
  
(c) Invoice/Financing Request No.:                      
 
(d) Date Invoice/Financing Request Prepared:                     
 
(e) Contract No. and Order No. (if applicable):
 
(f) Contract Title:
 
(g) Current Contract Period of Performance:
 
(h) Total Estimated Cost of Contract/Order:
 
(i) Total Fixed Fee (if applicable):
 
(j) Two-Way Match:
 Three-Way Match:
 
(k) Office of Acquisitions:
 
(l) Cental Point of Distribution:
 
(m) This invoice/financing request represents reimbursable costs for the period from              to             .
   
  
 
Cumulative %
of Effort/Hrs
  
 
Amount Billed
  
 
  
 
  
 
Expenditure Category*
                A
 
  
Neg.
B
  
Actual
C
  
(n)
Current
D
  
(o)
Cum
E
  
Cost at
Comp
F
  
Contract
Value
G
  
Variance
H
(p) Direct Costs:
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(1) Direct Labor
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(2) Fringe Benefits     %
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(3) Accountable Property
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(4) Materials & Supplies
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(5) Premium Pay
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(6) Consultant Fees
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(7) Travel
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(8) Subcontracts
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(9) Other
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(q) Cost of Money     %
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(r) Indirect Costs     %
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(s) Fixed Fee     %
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(t) Total Amount Claimed
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(u) Adjustments
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
(v) Grand Totals
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
“Pursuant to authority vested in me, I certify that this voucher is correct and proper for payment.”
 
         
         
(Name of Official)
     
(Title)
 
*
Attached details as specified in the contract or requested by the Contracting Officer
 
 
 

 
 
SBIR Funding Agreement Certification
 
All small businesses that are selected for award of an SBIR funding agreement must complete this certification at the time of award and any other time set forth in the funding agreement that is prior to performance of work under this award. This includes checking all of the boxes and having an authorized officer of the awardee sign and date the certification each time it is requested.
 
Please read carefully the following certification statements. The Federal government relies on the information to determine whether the business is eligible for a Small Business Innovation Research (SBIR) Program award. A similar certification will be used to ensure continued compliance with specific program requirements during the life of the funding agreement. The definitions for the terms used in this certification are set forth in the Small Business Act, SBA regulations (13 C.F.R. Part 121), the SBIR Policy Directive and also any statutory and regulatory provisions referenced in those authorities.
 
If the funding agreement officer believes that the business may not meet certain eligibility requirements at the time of award, they are required to file a size protest with the U.S. Small Business Administration (SBA), who will determine eligibility. At that time, SBA will request further clarification and supporting documentation in order to assist in the verification of any of the information provided as part of a protest. If the funding agreement officer believes, after award, that the business is not meeting certain funding agreement requirements, the agency may request further clarification and supporting documentation in order to assist in the verification of any of the information provided.
 
Even if correct information has been included in other materials submitted to the Federal government, any action taken with respect to this certification does not affect the Government’s right to pursue criminal, civil or administrative remedies for incorrect or incomplete information given in the certification. Each person signing this certification may be prosecuted if they have provided false information.
 
The undersigned has reviewed, verified and certifies that ( all boxes must be checked ):
 
(1) The business concern meets the ownership and control requirements set forth in 13 C.F.R, §121.702.
 
         
x   Yes
  
¨   No
  
 
 
(2) If a corporation, all corporate documents (articles of incorporation and any amendments, articles of conversion, by-laws and amendments, shareholder meeting minutes showing director elections, shareholder meeting minutes showing officer elections, organizational meeting minutes, all issued stock certificates, stock ledger, buy-sell agreements, stock transfer agreements, voting agreements, and documents relating to stock options, including the right to convert non-voting stock or debentures into voting stock) evidence that it meets the ownership and control requirements set forth in 13 C.F.R. §121.702.
 
         
x   Yes
  
¨   No
  
                    N/A Explain why N/A:                     
 
 
 

 
 
(3) If a partnership, the partnership agreement evidences that it meets the ownership and control requirements set forth in 13 C.F.R. §121.702.
 
         
Yes   ¨         No   x
  
               N/A Explain why N/A:
  
C-Corp. Public Company
 
(4) If a limited liability company, the articles of organization and any amendments. and operating agreement and amendments, evidence that it meets the ownership and control requirements set forth in 13 C.F.R. §121.702.
 
         
Yes   ¨         No   x
  
               N/A Explain why N/A:
  
C-Corp. Public Company
 
(5) The birth certificates, naturalization papers, or passports show that any individuals it relies upon to meet the eligibility requirements are U.S. citizens or permanent resident aliens in the United States.
 
         
x   Yes         ¨   No
  
            N/A Explain why N/A:                    
  
 
 
(6) It has no more than 500 employees, including the employees of its affiliates.
 
         
x   Yes         ¨   No
  
            For clarity – 12 employees
  
 
 
(7) SBA has not issued a size determination currently in effect finding that this business concern exceeds the 500 employee size standard.
 
         
¨   Yes         x   No
  
            No determination
  
 
 
(8) During the performance of the award, the principal investigator will spend more than one half of his/her time as an employee of the awardee or has requested and received a written deviation from this requirement from the funding agreement officer.
 
     
x   Yes         ¨   No
  
             Deviation approved in writing by funding agreement officer:     %
 
(9) All, essentially equivalent work, or a portion of the work proposed under this project (check the applicable line):
 
x
Has not been submitted for funding by another Federal agency.
 
¨
Has been submitted for funding by another Federal agency but has not been funded under any other Federal grant, contract, subcontract or other transaction.
 
¨
A portion has been funded by another grant, contract, or subcontract as described in detail in the proposal and approved in writing by the funding agreement officer.
 
(10) During the performance of award, it will perform the applicable percentage of work unless a deviation from this requirement is approved in writing by the funding agreement officer (check the applicable line and fill in if needed):
 
SBIR Phase I: at least two-thirds (66 2/3%) of the research.
 
SBIR Phase II: at least half (50%) of the research.
 
Deviation approved in writing by the funding agreement officer:     %
 
(11) During performance of award, the research/research and development will be performed in the United States unless a deviation is approved in writing by the funding agreement officer.
 
         
x   Yes         ¨   No
  
           Waiver has been granted
  
 
 
 
 

 
 
(12) During performance of award, the research/research and development will be performed at my facilities with my employees, except as otherwise indicated in the SBIR application and approved in the funding agreement.
 
     
x   Yes         ¨   No
  
 
 
(13) It has registered itself on SBA’s database as majority-owned by venture capital operating companies, hedge funds or private equity firms.
 
         
¨   Yes         x   No
  
     N/A Explain why N/A:
  
 
 
(14) It is a Covered Small Business Concern (a small business concern that: (a) was not majority-owned by multiple venture capital operating companies (VCOC’s), hedge funds, or private equity firms on the date on which it submitted an application in response to an SBIR solicitation; and (b) on the date of the SBIR award, which is made more than 9 months after the closing date of the solicitation, is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms).
 
     
¨   Yes         x   No
  
 
 
x   It will notify the Federal agency immediately if all or a portion of the work proposed is subsequently funded by another Federal agency. Yes
 
I understand that the information submitted may be given to Federal, State and local agencies for determining violations of law and other purposes.
 
I am an  officer  of the business concern authorized to represent it and sign this certification on its behalf. By signing this certification, I am representing on my own behalf, and on behalf of the business concern that the information provided in this certification, the application, and all other information submitted in connection with this application, is true and correct as of the date of submission. I acknowledge that any international or negligent misrepresentation of the information contained in this certification may result in criminal, civil or administrative sanctions, including but not limited to: (1) fines, restitution and/or imprisonment under 18 U.S.C. §1001; (2) treble damages and civil penalties under the False Claims Act (31 U.S.C. §3729  et seq .); (3) double damages and civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C. §3801  et seq .); (4) civil recovery of award funds, (5) suspension and/or debarment from all Federal procurement and nonprocurement transactions (FAR Subpart 9.4 or 2 C.F.R. part 180); and (6) other administrative penalties including termination of SBIR/STTR award.
 
         
   
Signature
/s/ J. David Hansen
 
Date
7/30/14
   
Print Name (First, Middle, Last)
J. David Hansen
   
Title  President & CEO
   
Business Name  MabVax Therapeutics, Inc.
 
Exhibit 31.1
 
Certification Under Section 302
 
I, J. David Hansen, certify that:
 
1. I have reviewed this quarterly report on Form 10-Q/A of MabVax Therapeutics Holdings, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
 
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
Date: August 12, 2015
 
By:
 
    /s/  J. David Hansen
       
    J. David Hansen
       
    Chief Executive Officer


Exhibit 31.2
 
Certification Under Section 302
 
I, Gregory P. Hanson, certify that:
 
1. I have reviewed this quarterly report on Form 10-Q/A of MabVax Therapeutics Holdings, Inc.;
 
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:
 
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
Date: August 12, 2015
 
By:
 
    /s/  Gregory P. Hanson
       
    Gregory P. Hanson
       
    Chief Financial Officer
 
Exhibit 32
 
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of MabVax Therapeutics Holdings, Inc. (the “Company”), does hereby certify, to such officer’s knowledge, that:
 
The Quarterly Report on Form 10-Q/A for the three months ended June 30, 2015 (the “Form 10-Q/A”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q/A fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: August 12, 2015
 
By:
 
    /s/  J. David Hansen
       
    J. David Hansen
       
    Chief Executive Officer
     
Date: August 12, 2015
 
By:
 
    /s/  Gregory P. Hanson
       
    Gregory P. Hanson
       
    Chief Financial Officer
 
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
  August 12, 2015
 

Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner
MabVax Therapeutics, Inc.
Owned Patents
1. US
14/468,827
26-Aug-2014
   
Pending
26-Aug-2034
NUCLEIC ACIDS ENCODING HUMAN ANTIBODIES TO SIALYL-LEWIS A
MabVax Therapeutics, Inc.
2. PCT
PCT/US2014/052631
26-Aug-2014
   
Pending
26-Aug-2034
NUCLEIC ACIDS ENCODING HUMAN ANTIBODIES TO SIALYL-LEWIS A
MabVax Therapeutics, Inc.
3. US
14/730,036
03-Jun-2015
   
Pending
03-Jun-2035
HUMAN MONOCLONAL ANTIBODIES TO GANGLIOSIDE GD2
MabVax Therapeutics, Inc.
4. PCT
PCT/US2015/033954
03-Jun-2015
   
Pending
03-Jun-2035
HUMAN MONOCLONAL ANTIBODIES TO GANGLIOSIDE GD2
MabVax Therapeutics, Inc.


 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer


--
 
 

 
Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
August 12, 2015



 
 
Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner
MabVax Therapeutics, Inc.
Sloan-Kettering Institute for Cancer Research (SKI)
Licensed Applications and Patents
a)   AU
67792/98
25-Mar-1998
750701
14-Nov-2002
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
b)   CA
2,286,798
25-Mar-1998
228798
07-Jan-2014
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI

c)   CH
98913180
25-Mar-1998
0996455
16-Dec-2009
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
d)   DE
69841385.7
25-Mar-1998
   
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
e)   EP
98913180
25-Mar-1998
0996455
16-Dec-2009
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI


 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer


--
 
 

 
Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
August 12, 2015



Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner
f)   FR
98913180
25-Mar-1998
0996455
16-Dec-2009
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI

g)   GB
98913180
25-Mar-1998
0996455
16-Dec-2009
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
h)   JP
10-543934
25-Mar-1998
4308918
15-May-2009
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
i)   US
09/083,776
25-Mar-1998
6,660,714
9-Dec-2003
Granted
25-Mar-2018
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
j)   US
10/205,021
25-Jul-2002
7,160,856
9-Jan-2007
Granted
7-Oct-2019
ALPHA-O-LINKED GLYCOCONJUGATES, METHODS OF PREPARATION AND USES THEREOF
SKI
k)   US
10/898,410
23-Jul-2004
7,550,146
23-Jun-2009
Granted
1-Mar-2019
GLYCOPEPTIDE CONJUGATES AND USES THEREOF
SKI


 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer


--
 
 

 
Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
August 12, 2015



Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner

l)   US
08/196,154
21-Jan-1994
7,014,856
21-Mar-2006
Granted
30-Aug-2022 (Date of Expiration is 21-Mar-2023 but TD to
US 08/477,097 sets to this date)
GANGLIOSIDE-KLH CONJUGATE VACCINES PLUS QS-21
SKI
m)   US
08/475,784
07-Jun-1995
6,967,022
22-Nov-2005
Granted
30-Aug-2022 (Date of Expiration is 22-Nov-2022 but TD to US 08/477,097 sets to this date)
GANGLIOSIDE-KLH CONJUGATE VACCINES PLUS QS-21
SKI
n)   US
08/477,097
07-Jun-1995
6,936,253
30-Aug-2005
Granted
30-Aug-2022
GANGLIOSIDE-KLH CONJUGATE VACCINES PLUS QS-21
SKI
o)   US
08/477,147
07-Jun-1995
7,001,601
21-Feb-2006
Granted
30-Aug-2022 (Date of Expiration is 21-Feb-2023 but TD to
US 08/477,097 sets to this date)
GANGLIOSIDE-KLH CONJUGATE VACCINES PLUS QS-21
SKI
p)   US
08/481,809
12-Jul-2005
6,916,476
12-Jul-2005
Granted
12-Jul-2022
GANGLIOSIDE-KLH CONJUGATE VACCINES PLUS QS-21
SKI

q)   EP
10184649.1
5-Jul-2002
   
Pending
5-Jul-2022
POLYVALENT CONJUGATE VACCINE FOR CANCER
SKI


 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer


--
 
 

 
Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
August 12, 2015



Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner
r)   US
10/752,945
6-Jan-2004
7,479,266
20-Jan-2009
Granted
23-Mar-2024
POLYVALENT CONJUGATE VACCINE FOR CANCER
SKI
s)   US
12/262,729
31-Oct-2008
8,092,780
10-Jan-2012
Granted
16-Apr-2023
POLYVALENT CONJUGATE VACCINE FOR CANCER
SKI
t)   US
13/314,521
8-Dec-2011
8,540,964
9/24/2013
Granted
5-Jul-2022
POLYVALENT CONJUGATE VACCINE FOR CANCER
SKI
u)   US
13/951,795
26-Jul-2013
   
Allowed
5-Jul-2022
POLYVALENT CONJUGATE VACCINE FOR CANCER
SKI
v)   AU
716699
26-Apr-1996
716699
1-Jun-2000
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
                 


 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer


--
 
 

 
Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
August 12, 2015



Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner
w)   CA
2,218,884
26-Apr-1996
2,218,884
8-Jul-2008
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
x)   DE
96913895.7
26-Apr-1996
69635730
11-Jan-2006
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
y)   EP
96913895.7
26-Apr-1996
0823913
11-Jan-2006
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
z)   ES
96913895.7
26-Apr-1996
0823913
11-Jan-2006
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI


 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer


--
 
 

 
Exhibit 99.1:  MabVax Therapeutics, Inc. – Granted and Pending Patents and Applications
August 12, 2015




Country
Application
No.
Filing
Date
Patent
No.
Issued
Date
Status
Estimated Expiration Date *
Title
Owner
aa)   FR
96913895.7
26-Apr-1996
0823913
11-Jan-2006
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
bb)   GB
96913895.7
26-Apr-1996
0823913
11-Jan-2006
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
cc)   IT
96913895.7
26-Apr-1996
0823913
11-Jan-2006
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI
dd)   JP
1996-532802
26-Apr-1996
4166273
8-Aug-2008
Granted
26-Apr-2016
SYNTHESIS OF THE BREAST TUMOR-ASSOCIATED ANTIGEN DEFINED BY MONOCLONAL ANTIBODY MBr1 AND USES THEREOF
SKI



 
* Expiration dates may be increased or decreased by additions of time under Patent Term Adjustment (PTA), Patent Term Extension (PTE) and/or filing of a Terminal Disclaimer