Exhibit 10.15

 

Confidential Treatment Requested by ITUS Corporation,

IRS Employer Identification No. 11-2622630

 

***CONFIDENTIAL TREATMENT REQUESTED***

 

Note: Confidential treatment requested with respect to certain portions hereof
denoted with “[***]”

COLLABORATION AGREEMENT

THIS AGREEMENT is entered into on November 17, 2017 (hereinafter “Effective
Date) by and between H. Lee Moffitt Cancer Center and Research Institute, Inc. a
non-profit Florida corporation organized pursuant to Section 1004.43, Florida
Statutes, whose address is 12902 Magnolia Drive Tampa, Florida 33612 (“Moffitt”)
and Certainty Therapeutics, Inc., a corporation duly organized under the laws
of  Delaware  whose address is 3150 Almaden Expressway, Suite 250, San Jose,
California 95118 (hereinafter "Company"). Moffitt and Company are hereinafter
referred to individually as “Party” and collectively as “Parties.”

 

WHEREAS, the Company has been formed to exploit certain Intellectual Property
obtained in a license from The Wistar Institue of Anatomy and Biology pursuant
to a License Agreement between The Wistar Institute of Anatomy and Biology
(“Wistar”) and Company, dated November 13, 2017;

WHEREAS, Moffitt is a National Cancer Institute designated comprehensive cancer
center, a statewide research institute, and a national resource for basic
science, clinical research, and interdisciplinary approaches to research and
patient treatment;

 

WHEREAS, Moffitt and Company through their respective scientists and
investigators wish to jointly engage in the basic and/or translational research
project set forth in the Research Plan (defined below) to perform preclinical
testing necessary to support clinical testing in accordance with Good Laboratory
Practices (GLP) and FDA requirements. 

NOW THEREFORE, IN CONSIDERATION OF THE FOREGOING AND FOR OTHER GOOD AND VALUABLE
CONSIDERATION, THE RECEIPT AND SUFFICIENCY OF WHICH ARE HEREBY ACKNOWLEDGED, THE
PARTIES HEREBY AGREE AS FOLLOWS:

ARTICLE 1                           DEFINITIONS.

1.1.            THE FOREGOING RECITALS ARE HEREBY INCORPORATED HEREIN BY
REFERENCE AND ACKNOWLEDGED AS TRUE AND CORRECT.  UNLESS SPECIFICALLY SET FORTH
TO THE CONTRARY IN THIS AGREEMENT, THE FOLLOWING TERMS, WHETHER USE IN THE
SINGULAR OR PLURAL, SHALL HAVE THE RESPECTIVE MEANINGS SET FORTH BELOW. 

(A)                “ANTI-CORRUPTION LAWS” SHALL MEAN ANY ANTI-BRIBERY AND
ANTI-CORRUPTION LAWS, RULES, REGULATIONS APPLICABLE TO A PARTY UNDER THIS
AGREEMENT (EACH AS AMENDED FROM TIME TO TIME) INCLUDING THE PREVENTION OF
CORRUPTION ACT (CAP.241) OF SINGAPORE, THE U.S. ANTI-KICKBACK LAW, U.S. FOREIGN
CORRUPT PRACTICES ACT, THE UK BRIBERY ACT 2010 AND THE OECD CONVENTION AGAINST
THE BRIBERY OF FOREIGN GOVERNMENT OFFICIALS IN INTERNATIONAL BUSINESS
TRANSACTIONS, TOGETHER WITH ANY APPLICABLE IMPLEMENTING LEGISLATION, INCLUDING
ANY APPLICABLE LOCAL LAW ADDRESSING BRIBERY OR CORRUPTION.

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(B)               “BUDGET” SHALL MEAN THE BUDGET THAT WAS AGREED TO BY THE
PARTIES TO BE USED FOR THE PURPOSE OF PERFORMING THE RESEARCH PLAN, ATTACHED
HERETO AS EXHIBIT C, WHICH IS INCORPORATED HEREIN IN ITS ENTIRETY.  IN THE EVENT
EXHIBIT C IS BLANK OR IS NOT ATTACHED HERETO, THEN THE PARTIES UNDERSTAND AND
AGREE THAT COMPANY WILL NOT BE PROVIDING FUNDING FOR THE RESEARCH PLAN. 

(C)                “CONFIDENTIAL INFORMATION” SHALL MEAN ALL INFORMATION AND
MATERIALS, INCLUDING BUT NOT LIMITED TO INVENTION DISCLOSURES, PROPRIETARY
TECHNOLOGIES, ECONOMIC INFORMATION, BUSINESS OR RESEARCH STRATEGIES, TRADE
SECRETS AND MATERIAL EMBODIMENTS THEREOF, FURNISHED BY OR ON BEHALF OF SUCH
PARTY WHICH WOULD REASONABLY BE CONSIDERED TO BE PROPRIETARY OR CONFIDENTIAL, OR
THAT IS MARKED “CONFIDENTIAL” (OR IF PROVIDED IN ORAL, VISUAL OR NON-TANGIBLE
FORM, MADE KNOWN AT THE TIME OF DISCLOSURE TO BE CONFIDENTIAL, BUT SHALL NOT
INCLUDE DATA.

(D)                “DATA” SHALL MEAN MOFFITT DATA AND COMPANY DATA. 

(E)                “INVENTION” SHALL MEAN ANY AND ALL DISCOVERIES, DEVELOPMENTS,
IMPROVEMENTS, MODIFICATIONS, FORMULATIONS, ANALOGS OR HOMOLOGS, MATERIALS,
COMPOSITIONS OF MATTER, CELL LINES, PROCESSES, MACHINES, MANUFACTURES AND OTHER
INVENTIONS (WHETHER OR NOT PATENTABLE) CONCEIVED, DISCOVERED, OR OTHERWISE MADE
UNDER OR ARISES FROM THE RESEARCH PLAN.  

(F)                "JOINT INVENTIONS" SHALL MEAN INVENTIONS ARISING FROM THE
RESEARCH PLAN AND INVENTED JOINTLY ON ONE HAND BY COMPANY EMPLOYEES OR PERSONS
OBLIGATED TO ASSIGN INVENTIONS TO COMPANY AND ON THE OTHER HAND BY MOFFITT
EMPLOYEES. MOFFITT AND COMPANY SHALL JOINTLY OWN ALL JOINT INVENTIONS.

(G)               “COMPANY DATA” SHALL HAVE THE MEANING SET FORTH IN SECTION
4.1. 

(H)               "COMPANY INVENTIONS" SHALL MEAN INVENTIONS ARISING FROM THE
RESEARCH PLAN AND INVENTED SOLELY BY COMPANY EMPLOYEES OR PERSONS OBLIGATED TO
ASSIGN THEIR INVENTIONS TO COMPANY. COMPANY RETAINS ALL RIGHT, TITLE, AND
INTEREST IN AND TO ALL COMPANY INVENTIONS.

(I)                 “COMPANY RESEARCH MATERIALS” SHALL MEAN (I) COMPOUND, CELL
LINE, MOUSE, VECTOR, ANTIBODY, TISSUE, OR ANY MATERIAL TRANSFERRED FROM COMPANY
TO MOFFITT WHILE THIS AGREEMENT IS IN FULL FORCE AND EFFECT AND (II) IS FULLY
IDENTIFIED AND DESCRIBED IN EXHIBIT A, WHICH IS INCORPORATED HEREIN IN ITS
ENTIRETY.  IF COMPANY RESEARCH MATERIALS ARE NOT LISTED ON OR IDENTIFIED IN
EXHIBIT A, THEN THE PARTIES UNDERSTAND AND AGREE THAT COMPANY WILL NOT BE
PROVIDING ANY COMPANY RESEARCH MATERIALS UNDER THIS AGREEMENT. 

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(J)                 “MOFFITT DATA” SHALL HAVE THE MEANING SET FORTH IN SECTION
4.1 OF THIS AGREEMENT. 

(K)               "MOFFITT INVENTIONS" SHALL MEAN INVENTIONS ARISING FROM THE
RESEARCH PLAN AND INVENTED SOLELY BY ITS EMPLOYEES, INCLUDING FROM ITS EMPLOYEES
USE OF THIRD PARTY RESEARCH MATERIALS.  MOFFITT HAS THE FULL RIGHT AND AUTHORITY
TO PROTECT AND COMMERCIALIZE MOFFITT INVENTIONS.

(L)                  “MOFFITT RESEARCH MATERIALS” SHALL MEAN (I) COMPOUND, CELL
LINE, MOUSE, VECTOR, ANTIBODY, TISSUE, OR ANY MATERIAL GENERATED OR CREATED
UNDER THE RESEARCH PLAN AND TRANSFERRED FROM MOFFITT TO COMPANY WHILE THIS
AGREEMENT IS IN FULL FORCE AND EFFECT AND (II) IS FULLY IDENTIFIED AND DESCRIBED
IN EXHIBIT A.  MOFFITT RESEARCH MATERIALS INCLUDES PROGENY AND DERIVATIVES OF
MOFFITT RESEARCH MATERIALS.  IF MOFFITT RESEARCH MATERIALS ARE NOT LISTED ON OR
IDENTIFIED IN EXHIBIT A, THEN THE PARTIES UNDERSTAND AND AGREE THAT MOFFITT WILL
NOT BE PROVIDING ANY MOFFITT RESEARCH MATERIALS UNDER THIS AGREEMENT. 

(M)             “THIRD PARTY RESEARCH MATERIALS”  SHALL MEAN MEAN ANY THIRD
PARTY OWNED (I) COMPOUND, CELL LINE, MOUSE, VECTOR, ANTIBODY, TISSUE, OR ANY
MATERIAL GENERATED, CREATED THAT MOFFITT IS REQUIRED TO USE TO CONDUCT THE
RESEARCH PLAN WHILE THIS AGREEMENT IS IN FULL FORCE AND EFFECT AND (II) ARE
IDENTIFIED AND DESCRIBED IN EXHIBIT A.

(N)               “OPTION PERIOD” SHALL HAVE THE MEANING SET FORTH IN SECTION
6.5.

(O)               “NEGOTIATION PERIOD” SHALL HAVE THE MEANING SET FORTH IN
SECTION 6.5.

(P)                “RESEARCH PLAN” SHALL MEAN THE RESEARCH DESCRIBED IN EXHIBIT
B, WHICH IS INCORPORATED HEREIN IN ITS ENTIRETY.  THE RESEARCH PLAN MAY ONLY BE
CHANGED OR AMENDED BY PRIOR WRITTEN AGREEMENT BY THE PARTIES.

(Q)               “TERM” SHALL HAVE THE MEANING SET FORTH IN SECTION 7.1 OF THIS
AGREEMENT.

ARTICLE 2                           SUPPLY OF RESEARCH MATERIALS. 

2.1.            COMPANY AGREES TO PROVIDE MOFFITT WITH THE COMPANY RESEARCH
MATERIALS TO THE EXTENT SET FORTH IN EXHIBIT A.  COMPANY ALSO MAY, AT ITS
DISCRETION, PROVIDE MOFFITT WITH CERTAIN INFORMATION RELATING TO THE RESEARCH
MATERIALS.  MOFFITT AGREES TO PROVIDE COMPANY WITH MOFFITT RESEARCH MATERIALS TO
THE EXTENT SET FORTH IN EXHIBIT A. 

ARTICLE 3                           RESEARCH ACTIVITIES. 

3.1.            MOFFITT AND COMPANY SHALL AND USE COMMERCIALLY REASONABLE
EFFORTS TO UNDERTAKE THE RESEARCH PLAN AS SET FORTH IN EXHIBIT B.  THE RESEARCH
PLAN MAY BE MODIFIED, SUPPLEMENTED, OR AMENDED, BUT ONLY AS AGREED TO IN WRITING
BY BOTH PARTIES.

3.2.            MOFFITT WILL USE ANY COMPANY RESEARCH MATERIALS PROVIDED TO
MOFFITT SOLELY FOR RESEARCH PURPOSES IN ACCORDANCE WITH THE RESEARCH PLAN. 
MOFFITT WILL OBTAIN WRITTEN PERMISSION TO USE ANY THIRD PARTY RESEARCH MATERIALS
REQUIRED TO CONDUCT THE RESEARCH PLAN.  MOFFITT WILL NOT USE COMPANY RESEARCH
MATERIALS, MOFFITT RESEARCH MATERIALS, OR THIRD PARTY RESEARCH MATERIALS TO
CONDUCT STUDIES OR TRIALS IN HUMAN SUBJECTS, IN CLINICAL TRIALS, OR FOR IN VITRO
OR IN VIVO DIAGNOSTIC PURPOSES INVOLVING HUMAN SUBJECTS WITHOUT THE PRIOR
WRITTEN CONSENT OF COMPANY.  MOFFITT WILL NOT TRANSFER ANY COMPANY RESEARCH
MATERIALS TO A THIRD PARTY.    

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3.3.            COMPANY WILL USE MOFFITT RESEARCH MATERIALS AND THIRD PARTY
RESEARCH MATERIALS SOLELY FOR RESEARCH PURPOSES IN ACCORDANCE WITH THE RESEARCH
PLAN. COMPANY WILL NOT USE MOFFITT RESEARCH MATERIALS OR CONDUCT STUDIES OR
TRIALS IN HUMAN SUBJECTS, IN CLINICAL TRIALS, OR FOR IN VITRO OR IN VIVO
DIAGNOSTIC PURPOSES INVOLVING HUMAN SUBJECTS WITHOUT THE PRIOR WRITTEN CONSENT
OF MOFFITT. COMPANY WILL NOT TRANSFER MOFFITT RESEARCH MATERIALS TO A THIRD
PARTY.  COMPANY SHALL NOT USE THE MOFFITT RESEARCH MATERIAL, COMPANY RESEARCH
MATERIAL, OR THIRD PARTY RESEARCH MATERIAL TO PRODUCE OR MANUFACTURE PRODUCTS
THAT WILL BE SOLD, LEASED, LICENSED OR TRANSFERRED TO ANY THIRD PARTY.

ARTICLE 4                           DATA AND REPORTING.

4.1.            “MOFFITT DATA” SHALL MEAN ANY DATA, RESULTS, ANALYSIS (INCLUDING
BIOINFORMATIC ANALYSIS), OR OTHER INFORMATION GENERATED BY OR IN COLLABORATION
WITH MOFFITT IN ITS PERFORMANCE OF THE RESEARCH PLAN OR USE OF COMPANY RESEARCH
MATERIALS OR THIRD PARTY RESEARCH MATERIALS.  “COMPANY DATA” SHALL MEAN ANY
DATA, RESULTS, ANALYSIS (INCLUDING BIOINFORMATIC ANALYSIS), OR OTHER INFORMATION
GENERATED BY COMPANY IN ITS PERFORMANCE OF THE RESEARCH PLAN OR USE OF THE
MOFFITT RESEARCH MATERIALS.  THE MOFFITT DATA AND COMPANY DATA SHALL BE JOINTLY
OWNED BY THE PARTIES.    THE RESEARCH PLAN AND ALL MOFFITT DATA AND COMPANY DATA
GENERATED FROM CONDUCTING THE RESEARCH PLAN SHALL BE CONDUCTED AND RECORDED IN
ACCORDANCE WITH GOOD LABORATORY PRACTICES (GLP) AND IN A MANNER TO SUPPORT AN
INVESTIGATIONAL NEW DRUG APPLICATION WITH THE FDA.  FROM TIME TO TIME, THE
COMPANY AND ITS AUTHORIZED AGENTS, MAY MONITOR THE CONDUCT OF THE RESEARCH PLAN,
AND GENERATION OF MOFFITT DATA IN ACCORDANCE WITH THESE REQUIREMENTS AND MAY
VISIT MOFFITT AND MEET WITH THE MOFFITT PRINCIPAL INVESTIGATOR(S) RESPONSIBLE
FOR THE PERFORMANCE OF THE RESEARCH PLAN FOR THE PURPOSE OF SUCH MONITORING. 
ANY SUCH MONITORING OR VISITS SHALL BE SCHEDULED WITH REASONABLE ADVANCE NOTICE
IN COORDINATION WITH MOFFITT DURING NORMAL BUSINESS HOURS AND UNDER MOFFITT’S
SUPERVISION.  TO THE EXTENT REQUIRED BY LAW, MOFFITT SHALL ALSO PERMIT
INSPECTION BY RESPONSIBLE LEGAL AND REGULATORY AUTHORITIES WITH RESPECT TO THE
RESEARCH PLAN AND PRECLINICAL STUDIES TO BE CONDUCTED IN ACCORDANCE WITH THE
RESEARCH PLAN OR AS OTHERWISE REASONABLY NECESSARY TO SATISFY THE REQUEST OF
SUCH AUTHORITIES RELATED TO THIS RESEARCH PLAN.  TO THE EXTENT PERMITTED BY LAW
AND PRACTICABLE, MOFFITT SHALL NOTIFY COMPANY OF ANY SUCH INSPECTIONS.
 THROUGHOUT THE TERM, MOFFITT SHALL MAINTAIN COMPLETE AND ACCURATE RECORDS OF
ALL MOFFITT DATA AND PROVIDE COMPANY A COPY OF SUCH MOFFITT DATA AT LEAST
QUARTERLY AND UPON REASONABLE REQUEST BY COMPANY AND ITS AUTHORIZED AGENTS AT
TIME INTERVALS OTHER THAN QUARTERLY.  THROUGHOUT THE TERM, COMPANY SHALL
MAINTAIN COMPLETE AND ACCURATE RECORDS OF ALL COMPANY DATA AND PROVIDE MOFFITT A
COPY OF SUCH COMPANY DATA AT LEAST QUARTERLY AND UPON REASONABLE REQUEST BY
MOFFITT AT TIME INTERVALS OTHER THAN QUARTERLY.  WITHIN SIXTY DAYS AFTER THE
EXPIRATION OR TERMINATION OF THIS AGREEMENT OR COMPLETION OF THE RESEARCH PLAN,
WHICHEVER IS EARLIER, MOFFITT SHALL PROMPTLY PROVIDE A WRITTEN REPORT, AND COPY,
OF ANY AND ALL OF THE MOFFITT DATA TO COMPANY. WITHIN SIXTY DAYS AFTER THE
EXPIRATION OR TERMINATION OF THIS AGREEMENT OR COMPLETION OF THE RESEARCH PLAN,
WHICHEVER IS EARLIER, COMPANY SHALL PROMPTLY PROVIDE A WRITTEN REPORT, AND COPY,
OF ANY AND ALL OF THE COMPANY DATA TO MOFFITT.

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4.2.            COMPANY RECOGNIZES THAT MOFFITT AND ANY THIRD PARTY THAT MAY OWN
RIGHTS IN THE MOFFITT DATA) MAY WISH TO PUBLISH THE DATA IN SCIENTIFIC JOURNALS
OR PRESENT THE DATA AT SYMPOSIA OR OTHER ACADEMIC MEETINGS, AND COMPANY AGREES
THAT MOFFITT (AND ANY THIRD PARTY HAVING RIGHTS IN THE MOFFITT DATA) WILL HAVE
THE RIGHT TO DO SO, SOLELY IN ACCORDANCE WITH THE FOLLOWING PROVISIONS.  MOFFITT
WILL SUBMIT TO COMPANY ANY SUCH PROPOSED PUBLICATION OR PRESENTATION OF THE DATA
AT LEAST THIRTY (30) DAYS PRIOR TO THE SUBMISSION FOR PUBLICATION OR
PRESENTATION.  IF COMPANY DETERMINES THAT THE PROPOSED PUBLICATION OR
PRESENTATION CONTAINS PATENTABLE SUBJECT MATTER THAT REQUIRES PROTECTION,
COMPANY MAY REQUIRE THE DELAY OF PUBLICATION OR PRESENTATION FOR AN ADDITIONAL
PERIOD OF NOT MORE THAN THIRTY (30) DAYS TO PERMIT THE PREPARATION AND FILING OF
A PATENT APPLICATION.  IF COMPANY, ON ITS OWN, OR AFTER CONSULTATION WITH
WISTAR, DETERMINES THAT THE PROPOSED PUBLICATION OR PRESENTATION INCLUDES
COMPANY CONFIDENTIAL INFORMATION, IT WILL SO INFORM MOFFITT, AND MOFFITT WILL
DELETE SUCH COMPANY CONFIDENTIAL INFORMATION FROM ANY PROPOSED DISCLOSURE AS
DIRECTED BY COMPANY.  NOTWITHSTANDING THE FOREGOING, ONCE COMPANY HAS REVIEWED A
PUBLICATION OR PRESENTATION FOR WRITTEN OR ORAL DISCLOSURE AND THE ADDITIONAL
PERIOD OF 30 DAYS TO PERMIT FILING OF A PATENT APPLICATION HAS EXPIRED, MOFFITT
(AND THIRD PARTIES) SHALL BE ALLOWED TO FREELY DISCLOSE SUCH PUBLICATION OR
PRESENTATION IN THE FUTURE.   IF MOFFITT MAKES ANY MATERIAL CHANGES TO A
PUBLICATION OR PRESENTATION, SUCH PUBLICATION OR PRESENTATION MUST BE
RE-SUBMITTED TO COMPANY FOR REVIEW IN ACCORDANCE WITH THIS SECTION 4.2.   

4.3.            THE PARTIES MAY ELECT TO COLLABORATE TOGETHER IN WRITING A
MANUSCRIPT TO BE PUBLISHED IN A RESPECTED SCIENTIFIC JOURNAL. FOR SUCH JOINTLY
WRITTEN MANUSCRIPT, AUTHORSHIP SHALL BE BASED ON CONTRIBUTIONS TO THE RESEARCH
PLAN, IN ACCORDANCE WITH ACADEMIC STANDARDS AND CUSTOM. 

ARTICLE 5                           OWNERSHIP; NO IMPLIED LICENSE.

5.1.            MOFFITT ACKNOWLEDGES AND AGREES THAT, NOTWITHSTANDING ANY OTHER
PROVISIONS OF THIS AGREEMENT, (I) COMPANY HOLDS ALL RIGHT, TITLE, AND INTEREST
IN AND TO THE COMPANY RESEARCH MATERIALS AND COMPANY CONFIDENTIAL INFORMATION,
AND (II) COMPANY HAS THE RIGHT TO USE OR PERMIT OTHERS TO USE THE COMPANY
RESEARCH MATERIALS AND COMPANY CONFIDENTIAL INFORMATION AT ANY TIME FOR ANY
LAWFUL PURPOSE.  NO OPTION, LICENSE, OR CONVEYANCE OF RIGHTS, EXPRESS OR
IMPLIED, IS GRANTED BY COMPANY TO MOFFITT IN CONNECTION WITH ANY COMPANY
RESEARCH MATERIALS OR COMPANY CONFIDENTIAL INFORMATION, EXCEPT THE RIGHT TO USE
THE COMPANY RESEARCH MATERIALS AND COMPANY CONFIDENTIAL INFORMATION IN
ACCORDANCE WITH THE TERMS OF THIS AGREEMENT.

5.2.            COMPANY ACKNOWLEDGES AND AGREES THAT, NOTWITHSTANDING ANY OTHER
PROVISIONS OF THIS AGREEMENT, (I) MOFFITT HOLDS ALL RIGHT, TITLE, AND INTEREST
IN AND TO THE MOFFITT RESEARCH MATERIALS AND MOFFITT CONFIDENTIAL INFORMATION,
AND (II) MOFFITT HAS THE RIGHT TO USE OR PERMIT OTHERS TO USE THE MOFFITT
RESEARCH MATERIALS AND MOFFITT CONFIDENTIAL INFORMATION AT ANY TIME FOR ANY
LAWFUL PURPOSE.  NO OPTION, LICENSE, OR CONVEYANCE OF RIGHTS, EXPRESS OR
IMPLIED, IS GRANTED BY MOFFITT TO COMPANY IN CONNECTION WITH ANY MOFFITT
RESEARCH MATERIALS OR MOFFITT CONFIDENTIAL INFORMATION, EXCEPT THE RIGHT TO USE
THE MOFFITT RESEARCH MATERIALS AND MOFFITT CONFIDENTIAL INFORMATION IN
ACCORDANCE WITH THE TERMS OF THIS AGREEMENT.  FOR THE AVOIDANCE OF DOUBT, THIS
DOES NOT AFFECT THE COMPANY’S JOINT OWNERSHIP OF THE MOFFITT DATA AS SET FORTH
IN SECTION 4.1.

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ARTICLE 6                           INVENTIONS.

6.1.            INVENTORSHIP SHALL BE DETERMINED BY THE PATENT LAWS OF THE
UNITED STATES AND INITIAL OWNERSHIP SHALL FOLLOW INVENTORSHIP.  EACH PARTY SHALL
RETAIN ALL OF ITS RIGHT, TITLE AND INTEREST IN AND TO ANY AND ALL INVENTIONS
MADE PRIOR TO, OR OUTSIDE THE ACTIVITIES OF, THIS AGREEMENT. EXCEPT AS EXPRESSLY
SET FORTH HEREIN, NO LICENSE, EXPRESS OR IMPLIED, IS GRANTED WITH RESPECT TO ANY
PATENTS, PATENT APPLICATIONS, KNOW-HOW (WHETHER PATENTABLE OR UNPATENTABLE) OR
OTHER INTELLECTUAL PROPERTY RIGHTS OF THE OTHER PARTY.

6.2.            MOFFITT SHALL HAVE THE SOLE RIGHT TO FILE, PROSECUTE AND
MAINTAIN PATENT APPLICATIONS AND PATENTS WITH RESPECT TO MOFFITT INVENTIONS.
 COMPANY SHALL HAVE THE SOLE RIGHT TO FILE, PROSECUTE AND MAINTAIN PATENT
APPLICATIONS AND PATENTS WITH RESPECT TO COMPANY INVENTIONS. 

6.3.            WITH RESPECT TO JOINT INVENTIONS, COMPANY SHALL FILE, PROSECUTE,
AND MAINTAIN PATENT APPLICATIONS ON BEHALF OF THE PARTIES, AT COMPANY’S SOLE
EXPENSE.  WITH RESPECT TO ANY JOINT INVENTION, COMPANY SHALL (A) CONSULT WITH
MOFFITT AND KEEP MOFFITT FULLY INFORMED OF THE PROGRESS OF ALL PATENT
APPLICATIONS AND PATENTS, INCLUDING ALL ISSUES RELATING TO THE PREPARATION,
FILING, PROSECUTION AND MAINTENANCE OF PATENT APPLICATIONS AND PATENTS THAT
CLAIM JOINT INVENTIONS, (B) CONSULT WITH MOFFITT AND KEEP THE MOFFITT FULLY
INFORMED ABOUT COMPANY’S PATENT STRATEGY WITH RESPECT TO PATENT APPLICATIONS
THAT CLAIM JOINT INVENTIONS, (C) PROVIDE TO MOFFITT ADVANCE COPIES OF DOCUMENTS
RELEVANT TO PREPARATION, FILING, PROSECUTION AND MAINTENANCE OF THE PATENT
APPLICATIONS AND PATENTS THAT CLAIM JOINT INVENTIONS SUFFICIENTLY IN ADVANCE OF
FILING TO ALLOW MOFFITT A REASONABLE OPPORTUNITY TO REVIEW AND COMMENT ON SUCH
DOCUMENTS, (D) CONSIDER AND IMPLEMENT ALL MOFFITT COMMENTS ON SUCH PATENT
FILINGS, AND (E) PROVIDE MOFFITT WITH FINAL COPIES OF SUCH DOCUMENTS. 

6.4.            COMPANY HEREBY GRANTS MOFFITT A ROYALTY FREE, NON SUBLICENSABLE,
NON TRANSFERABLE, PERPETUAL, NON EXCLUSIVE LICENSE TO USE AND PRACTICE ANY
COMPANY INVENTION FOR ITS INTERNAL NON-COMMERCIAL RESEARCH PURPOSES.  MOFFITT
HEREBY GRANTS COMPANY A ROYALTY FREE, NON SUBLICENSABLE, NON TRANSFERABLE,
PERPETUAL, NON EXCLUSIVE LICENSE TO USE AND PRACTICE ANY MOFFITT INVENTION FOR
ITS INTERNAL, NON-COMMERCIAL RESEARCH PURPOSES. 

6.5.            MOFFITT HEREBY GRANTS COMPANY AN OPTION TO A ROYALTY-BEARING,
SUBLICENSABLE, EXCLUSIVE LICENSE IN MOFFITT INVENTIONS AND MOFFITT’S INTEREST IN
JOINT INVENTIONS FOR SUCH TERRITORIES AS COMPANY MAY REQUEST.  COMPANY MAY
EXERCISE ITS OPTION TO SUCH EXCLUSIVE LICENSE AT ANY TIME WITHIN SIX (6) MONTHS
AFTER MOFFITT NOTIFIES COMPANY OF A NEW INVENTION.  ("OPTION PERIOD").  IN THE
EVENT COMPANY NOTIFIES MOFFITT IN WRITING THAT IT WISHES TO EXERCISE ITS OPTION
TO AN EXCLUSIVE LICENSE DURING THE OPTION PERIOD, THE PARTIES SHALL HAVE SIX (6)
MONTHS ("NEGOTIATION PERIOD") TO AGREE ON THE TERMS OF SUCH LICENSE, WHICH SHALL
BE NEGOTIATED IN GOOD FAITH UNDER COMMERCIALLY REASONABLE TERMS.  IN THE EVENT
THAT (A) COMPANY FAILS TO NOTIFY MOFFITT OF ITS DESIRE TO EXERCISE ITS OPTION TO
AN EXCLUSIVE LICENSE DURING THE OPTION PERIOD, OR (B) COMPANY NOTIFIES MOFFITT
THAT IT DOES NOT WISH TO EXERCISE ITS OPTION TO AN EXCLUSIVE LICENSE, OR (C) THE
PARTIES ARE UNABLE TO AGREE ON THE TERMS OF SUCH LICENSE BY THE END OF THE
NEGOTIATION PERIOD, THEN MOFFITT SHALL HAVE NO FURTHER OBLIGATION TO COMPANY
WITH RESPECT TO SUCH INVENTION EXCEPT THAT COMPANY ’S INTERNAL RESEARCH USE
LICENSE SHALL CONTINUE IN EFFECT.

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6.6.            MOFFITT SHALL OBTAIN ALL INTELLECTUAL PROPERTY RIGHTS IN ALL
DATA AND INTELLECTUAL PROPERTY THAT ANY VENDOR OR SUBCONTRACTOR MOFFITT ENGAGES
IN PERFORMING THE RESEARCH PLAN.  ANY DATA THAT A VENDOR OR SUBCONTRACTOR THAT
MOFFITT ENGAGES IN PERFORMING THE DEVELOPMENT PLAN GENERATES OR CREATES SHALL BE
TREATED AS MOFFITT DATA JOINTLY OWNED BY MOFFITT AND THE COMPANY AND ANY SUCH
SUBCONTRACTOR OR VENDOR THAT MOFFITT ENGAGES SHALL HAVE NO RIGHTS IN AND TO SUCH
DATA, MOFFITT ALSO SHALL OBTAIN ALL INTELLECTUAL PROPERTY RIGHTS IN ANY NEW
INVENTIONS THAT ANY VENDOR OR SUBCONTRACTOR MOFFITT ENGAGES DEVELOPS IN
PERFORMING THE DEVELOPMENT PLAN. TO THE EXTENT THAT THEY ARE NOT JOINT
INVENTIONS, ANY SUCH INVENTIONS GENERATED OR CREATED BY A VENDOR OR
SUBCONTRACTOR THAT MOFFITT ENGAGES IN PERFORMING THE DEVELOPMENT PLAN SHALL BE
TREATED AS MOFFITT INVENTIONS, SUBJECT TO SECTION 6.5.  IN THE EVENT THAT
MOFFITT ENGAGES A THIRD PARTY ACADEMIC ORGANIZATION TO PERFORM ANY OF THE
ACTIVITIES UNDER THE RESEARCH PLAN, MOFFITT SHALL USE COMMERCIALLY REASONABLE
EFFORTS TO OBTAIN THE GREATEST AMOUNT OF DATA AND INTELLECTUAL PROPERTY RIGHTS
FROM SUCH RELATIONSHIP.  IN ANY EVENT, MOFFITT SHALL ENSURE AT A MINIMUM, THAT
ANY INTELLECTUAL PROPERTY THAT A THIRD PARTY ACADEMIC ORGANIZATION CREATES OR
DEVELOPS IN THE COURSE OF PERFORMING THE RESEARCH PLAN THAT IS NECESSARY FOR
COMMERCIALIZATION, SHALL BE MADE AVAILABLE FOR LICENSE TO COMPANY ON FAIR,
REASONABLE, AND NON-DISCRIMINATORY TERMS. 

 

ARTICLE 7                           TERM AND TERMINATION.

7.1.            THIS AGREEMENT WILL COMMENCE AS OF THE EFFECTIVE DATE SET FORTH
IN THE FIRST PARAGRAPH OF THIS AGREEMENT AND UNLESS TERMINATED OTHERWISE AS
PROVIDED HEREIN, THIS AGREEMENT WILL EXPIRE TWENTY-FOUR (24) MONTHS FROM SUCH
DATE, UNLESS EXTENDED UPON MUTUAL WRITTEN AGREEMENT OF THE PARTIES (“TERM”).

7.2.            EITHER PARTY MAY TERMINATE THIS AGREEMENT (I) UPON ANY BREACH BY
THE OTHER PARTY OF THE TERMS OR CONDITIONS OF THIS AGREEMENT, WHICH BREACH
CANNOT BE, OR IS NOT, CURED WITHIN THIRTY (30) DAYS AFTER THE BREACHING PARTY
RECEIVES WRITTEN NOTICE BY THE NON-BREACHING PARTY REGARDING SUCH BREACH OR (II)
UPON THE OTHER PARTY BECOMING BANKRUPT OR MAKING AN ASSIGNMENT FOR THE BENEFIT
OF ITS CREDITORS, UPON APPOINTMENT OF A TRUSTEE OR RECEIVER FOR THE OTHER PARTY
OF ALL OR SUBSTANTIALLY ALL OF ITS PROPERTY, OR UPON THE FILING OF A VOLUNTARY
OR INVOLUNTARY PETITION BY OR AGAINST THE OTHER PARTY UNDER ANY BANKRUPTCY OR
INSOLVENCY LAW, THE REORGANIZATION OR REARRANGEMENT PROVISIONS OF THE UNITED
STATES BANKRUPTCY CODE, OR ANY SIMILAR LAW, (III) OR UPON THE TERMINATION,
DEATH, OR OTHER NONAVAILABILITY OF THE MOFFITT PRINCIPAL INVESTIGATOR(S)
RESPONSIBLE FOR CONDUCTING THE RESEARCH PLAN AND THE PARTIES CANNOT REACH
AGREEMENT ON NEW PRINCIPAL INVESTIGATORS.  THE RIGHTS OF TERMINATION UNDER THIS
SECTION 7 WILL NOT BE AFFECTED IN ANY WAY BY A PARTY'S WAIVER OR FAILURE TO TAKE
ACTION WITH RESPECT TO ANY PREVIOUS BREACH OR OTHER CIRCUMSTANCE GIVING RISE TO
THE RIGHTS OF TERMINATION HEREUNDER.

7.3.            TERMINATION OF THIS AGREEMENT FOR ANY REASON WILL BE WITHOUT
PREJUDICE TO ANY RIGHTS THAT WILL HAVE ACCRUED TO THE BENEFIT OF EITHER PARTY
PRIOR TO SUCH TERMINATION.  SECTIONS 3-6, 8, AND 10-13 SHALL SURVIVE TERMINATION
OR EXPIRATION OF THIS AGREEMENT.  UPON EXPIRATION OR TERMINATION OF THIS
AGREEMENT, MOFFITT (I) WILL IMMEDIATELY TERMINATE THE RESEARCH PLAN, INCLUDING
WITHOUT LIMITATION CEASING ALL USES OF THE COMPANY RESEARCH MATERIALS AND
COMPANY CONFIDENTIAL INFORMATION, AND (II) WILL, AT THE DIRECTION OF COMPANY,
WITHIN THIRTY DAYS AFTER TERMINATION, DESTROY OR RETURN (A) ALL COMPANY RESEARCH
MATERIALS SUPPLIED TO IT AND (B) ALL COPIES OF THE COMPANY CONFIDENTIAL
INFORMATION (EXCEPT THAT MOFFITT MAY RETAIN ONE COPY OF THE COMPANY CONFIDENTIAL
INFORMATION SOLELY FOR ARCHIVAL PURPOSES, SUBJECT TO THE OBLIGATIONS OF SECTION
8 BELOW).  UPON EXPIRATION OR TERMINATION OF THIS AGREEMENT, COMPANY (I) WILL
IMMEDIATELY TERMINATE THE RESEARCH PLAN, INCLUDING WITHOUT LIMITATION CEASING
ALL USES OF THE MOFFITT RESEARCH MATERIALS AND MOFFITT CONFIDENTIAL INFORMATION,
AND (II) WILL, AT THE DIRECTION OF MOFFITT, WITHIN THIRTY DAYS AFTER
TERMINATION, DESTROY OR RETURN (A) ALL MOFFITT RESEARCH MATERIALS SUPPLIED TO IT
AND (B) ALL COPIES OF THE MOFFITT CONFIDENTIAL INFORMATION (EXCEPT THAT COMPANY
MAY RETAIN ONE COPY OF THE MOFFITT CONFIDENTIAL INFORMATION SOLELY FOR ARCHIVAL
PURPOSES, SUBJECT TO THE OBLIGATIONS OF SECTION 8 BELOW). 

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ARTICLE 8                           CONFIDENTIALITY AND USE.

8.1.            TO THE EXTENT PERMITTED BY LAW, THE PARTIES SHALL SAFEGUARD THE
OTHER PARTY’S CONFIDENTIAL INFORMATION AGAINST DISCLOSURE TO THIRD PARTIES WITH
THE SAME DEGREE OF CARE AS IT EXERCISES WITH ITS OWN DATA OF A SIMILAR NATURE.
MOFFITT AND COMPANY AGREE NOT TO DISCLOSE CONFIDENTIAL INFORMATION TO OTHERS
(EXCEPT TO THEIR EMPLOYEES, AGENTS, INDEPENDENT CONTRACTORS, CONSULTANTS, OR
AFFILIATES WHO ARE BOUND BY A LIKE OBLIGATION OF CONFIDENTIALITY). THE PARTIES
SHALL USE THE CONFIDENTIAL INFORMATION OF THE OTHER PARTY IN FURTHERANCE OF
PERFORMING OR CARRYING OUT THEIR RESPECTIVE OBLIGATIONS AND DUTIES UNDER THIS
AGREEMENT. CONFIDENTIAL INFORMATION DOES NOT INCLUDE INFORMATION WHICH:

(A)                IS PUBLICLY AVAILABLE PRIOR TO THE DATE OF THIS AGREEMENT OR
BECOMES PUBLICLY AVAILABLE THEREAFTER THROUGH NO WRONGFUL ACT OF THE RECEIVING
PARTY;

(B)               WAS KNOWN TO THE RECEIVING PARTY PRIOR TO THE DATE OF
DISCLOSURE OR BECOMES KNOWN TO THE RECEIVING PARTY THEREAFTER FROM A THIRD PARTY
HAVING A BONA FIDE RIGHT TO DISCLOSE THE INFORMATION;

(C)                THE RECEIVING PARTY CAN DEMONSTRATE, THROUGH WRITTEN
DOCUMENTATION, WAS IN THE RECEIVING PARTY’S RIGHTFUL POSSESSION ON A
NON-CONFIDENTIAL BASIS PRIOR TO DISCLOSURE BY THE PROVIDING PARTY HEREUNDER;

(D)               THE RECEIVING PARTY CAN DEMONSTRATE, THROUGH WRITTEN
DOCUMENTATION, IS DISCLOSED TO THE RECEIVING PARTY WITHOUT RESTRICTION ON
FURTHER DISCLOSURE;

(E)                THE RECEIVING PARTY CAN DEMONSTRATE, THROUGH WRITTEN
DOCUMENTATION, IS INDEPENDENTLY DEVELOPED WITHOUT THE USE OF THE PROVIDING
PARTY’S CONFIDENTIAL INFORMATION;

(F)                MUST REASONABLY BE DISCLOSED TO REGULATORY AUTHORITIES,
PROVIDED THAT THE RECEIVING PARTY PROMPTLY NOTIFIES THE PROVIDING PARTY TO GIVE
THE PROVIDING PARTY THE OPPORTUNITY TO CONTEST OR LIMIT THE SCOPE OF SUCH
DISCLOSURE; OR

(G)               IS OBLIGATED TO PRODUCE PURSUANT TO AN ORDER OF A COURT OF
COMPETENT JURISDICTION OR A FACIALLY VALID ADMINISTRATIVE, LEGISLATIVE OR OTHER
SUBPOENA OR PURSUANT TO APPLICABLE LAW, PROVIDED THAT THE RECEIVING PARTY
PROMPTLY NOTIFIES THE PROVIDING PARTY TO GIVE THE PROVIDING PARTY THE
OPPORTUNITY TO CONTEST OR LIMIT THE SCOPE OF SUCH ORDER.

8

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8.2.            THE OBLIGATIONS OF CONFIDENTIALITY AND NON USE UNDER THIS
SECTION 8 SHALL CONTINUE FOR FIVE (5) YEARS AFTER THE EFFECTIVE DATE.

8.3.            USE OF NAME; PUBLICITY.  THE PARTIES MAY MAKE THE FACTUAL
STATEMENT THAT COMPANY HAS ENTERED INTO THIS COLLABORATION AGREEMENT WITH
MOFFITT AND MAY DISCUSS THE TERMS OF THIS AGREEMENT, THE RESEARCH PLAN, AND
PROGRESS AND STATUS OF THE COMPLETION OF THE RESEARCH PLAN, IN FILINGS OF THE
COMPANY OR ITUS MADE WITH THE SECURITIES EXCHANGE COMMISSION (SEC) AND IN
INVESTOR OR ROAD SHOW PRESENTATIONS.

 

ARTICLE 9                           NOTICES. 

9.1.            ANY REQUEST, NOTICE, REPORT, PAYMENT, APPROVAL OR OTHER
COMMUNICATION REQUIRED OR PERMITTED UNDER THIS AGREEMENT WILL BE IN WRITING, AND
WILL BE DEEMED DELIVERED (I) ON THE DATE OF DELIVERY WHEN DELIVERED PERSONALLY;
(II) ON THE DATE SENT BY CONFIRMED FACSIMILE (FOLLOWED BY THE ACTUAL DOCUMENT
SENT BY COMMERCIAL EXPRESS COURIER SPECIFYING NEXT DAY DELIVERY, WITH WRITTEN
VERIFICATION OF RECEIPT); (III) ONE BUSINESS DAY AFTER DEPOSIT WITH A COMMERCIAL
OVERNIGHT COURIER SPECIFYING NEXT DAY DELIVERY, WITH WRITTEN VERIFICATION OF
RECEIPT; OR (IV) ON THE DATE RECEIVED WHEN SENT BY REGISTERED OR CERTIFIED MAIL,
RETURN RECEIPT REQUESTED, POSTAGE PREPAID; AND (V) ON THE DATE RECEIVED WHEN
SENT BY ELECTRONIC MAIL.  ALL COMMUNICATIONS WILL BE SENT TO THE ADDRESS SET
FORTH BELOW OR SUCH OTHER ADDRESS AS EITHER PARTY MAY DESIGNATE FROM TIME TO
TIME IN ACCORDANCE WITH THIS SECTION 9.1.

To Company :

Certainty Therapeutics, Inc.

3150 Almaden Expressway,

Suite 250, San Jose, California 95118

Attn:  Amit Kumar, Chief Executive Officer

Email:  ak@ITUScorp.com

 

To Moffitt:

H. Lee Moffitt Cancer Center and Research Institute, Inc.

Attention: Director, Office of Sponsored Research

12902 Magnolia Drive, MBC-OSR

Tampa, FL  33612

Fax:  (813) 745-6804

awards@moffitt.org

 

With courtesy copies to: 

 

H. Lee Moffitt Cancer Center and Research Institute, Inc.

Attention: Vice President for Research Administration

12902 Magnolia Drive, SRB-3

Tampa, FL  33612

Fax:  (813) 745-8709

 

H. Lee Moffitt Cancer Center and Research Institute, Inc.

Attn: L. David de la Parte, General Counsel

12902 Magnolia Drive

Tampa, Florida 33612-9497

 

 

9

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ARTICLE 10                       GOVERNING LAW.

10.1.        THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED
IN ACCORDANCE WITH, THE LAWS OF THE STATE OF FLORIDA WITHOUT REFERENCE TO
CONFLICT OF LAWS PRINCIPLES OR STATUTORY RULES OF ARBITRATION INCLUDED THEREIN.
ANY DISPUTE OR PROCEEDING UNDER THIS AGREEMENT SHALL BE SUBJECT TO THE EXCLUSIVE
JURISDICTION AND VENUE OF THE 13TH JUDICIAL CIRCUIT IN AND FOR HILLSBOROUGH
COUNTY, FLORIDA AND THE PARTIES HEREBY CONSENT TO THE EXCLUSIVE PERSONAL
JURISDICTION AND VENUE OF THESE COURTS.

ARTICLE 11                       WARRANTIES AND INDEMNIFICATION.

11.1.        MOFFITT ACCEPTS ANY COMPANY RESEARCH MATERIALS WITH THE KNOWLEDGE
THAT THEY ARE EXPERIMENTAL IN NATURE AND AGREE TO COMPLY WITH ALL LAWS AND
REGULATIONS FOR THE SHIPPING, HANDLING AND USE THEREOF. COMPANY RESEARCH
MATERIALS ARE BEING SUPPLIED “AS IS” WITH NO WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR
WARRANTY AGAINST INFRINGEMENT.  COMPANY ACCEPTS THE MOFFITT RESEARCH MATERIALS
WITH THE KNOWLEDGE THAT THEY ARE EXPERIMENTAL IN NATURE AND AGREE TO COMPLY WITH
ALL LAWS AND REGULATIONS FOR THE SHIPPING, HANDLING AND USE THEREOF. MOFFITT
RESEARCH MATERIALS ARE BEING SUPPLIED “AS IS” WITH NO WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR WARRANTY AGAINST INFRINGEMENT. 

11.2.        NO INDEMNIFICATION FOR ANY LOSS, CLAIM, DAMAGE, OR LIABILITY IS
INTENDED OR PROVIDED BY EITHER PARTY UNDER THIS AGREEMENT.  EACH PARTY SHALL BE
LIABLE FOR ANY LOSS, CLAIM, DAMAGE OR LIABILITY THAT SAID PARTY INCURS AS A
RESULT OF SAID PARTY’S ACTIVITIES UNDER THIS AGREEMENT.

ARTICLE 12                       PAYMENT SCHEDULE. 

12.1.        MOFFITT SHALL BE COMPENSATED BY COMPANY FOR ITS CONDUCT OF THE
RESEARCH PLAN IN ACCORDANCE WITH THE BUDGET AS OUTLINED IN EXHIBIT C OF THIS
AGREEMENT.  THE BUDGET SETS FORTH THE DOLLAR AMOUNT AND SCHEDULE FOR ALL
PAYMENTS OWED TO MOFFITT UNDER THIS AGREEMENT.  UNLESS OTHERWISE AGREED IN
WRITING BY THE PARTIES, SUCH PAYMENT AMOUNT IS INCLUSIVE OF ANY AND ALL
APPLICABLE FEES, PERSONNEL COSTS, AND OVERHEAD.

ARTICLE 13                       MISCELLANEOUS.

13.1.        THE PARTIES SHALL HAVE SEPARATE AGREEMENTS WITH THEIR EMPLOYEES
WHEREBY THE EMPLOYEES ARE OBLIGATED TO ASSIGN ALL RIGHT, TITLE, AND INTEREST IN
ANY INVENTION GENERATED IN THE COURSE OF THE RESEARCH PLAN TO SUCH PARTY.

13.2.        COMPANY SHALL PERFORM THE RESEARCH PLAN AND ITS OTHER OBLIGATIONS
HEREUNDER, AND USE THE MOFFITT RESEARCH MATERIALS IN COMPLIANCE WITH ALL
APPLICABLE LAWS, REGULATIONS AND LEGAL REQUIREMENTS, INCLUDING BUT NOT LIMITED
TO THOSE RELATING TO BIOTECHNOLOGICAL RESEARCH, HANDLING AND CONTAINMENT OF
BIOHAZARDOUS MATERIALS, AND USE OR DISCLOSURE OF PATIENT INFORMATION OR
MATERIALS.

10

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13.3.        MOFFITT SHALL PERFORM THE RESEARCH PLAN AND ITS OTHER OBLIGATIONS
HEREUNDER, AND USE THE COMPANY RESEARCH MATERIALS IN COMPLIANCE WITH ALL
APPLICABLE LAWS, REGULATIONS AND LEGAL REQUIREMENTS, INCLUDING BUT NOT LIMITED
TO THOSE RELATING TO BIOTECHNOLOGICAL RESEARCH, HANDLING AND CONTAINMENT OF
BIOHAZARDOUS MATERIALS, AND USE OR DISCLOSURE OF PATIENT INFORMATION OR
MATERIALS.

13.4.        MOFFITT SHALL (A) COMPLY WITH ALL APPLICABLE LAWS, RULES AND
REGULATIONS PERTAINING TO THE DEVELOPMENT, TESTING, MANUFACTURE, MARKETING,
IMPORT OR EXPORT OF ANY LICENSED PRODUCTS; AND (B) NOT EMPLOY, CONTRACT WITH OR
RETAIN ANY PERSON DIRECTLY OR INDIRECTLY IN THE PERFORMANCE OF THE RESEARCH PLAN
IF SUCH PERSON IS: (I) EXCLUDED FROM A FEDERAL HEALTH CARE PROGRAM AS OUTLINED
IN SECTIONS 1128 AND 1156 OF THE SOCIAL SECURITY ACT (SEE THE OFFICE OF
INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES LIST OF
EXCLUDED INDIVIDUALS/ENTITIES AT
HTTP://WWW.OIG.HHS.GOV/FRAUD/EXCLUSIONS/EXCLUSIONS_LIST.ASP), (II) DEBARRED BY
ANY HEALTH AUTHORITY, INCLUDING (BUT NOT LIMITED TO) BY THE FDA UNDER 21 U.S.C.
335A (SEE THE FDA OFFICE OF REGULATORY AFFAIRS DEBARMENT LIST AT
HTTP://WWW.FDA.GOV/ICECI/ENFORCEMENTACTIONS/FDADEBARMENTLIST/DEFAULT.HTM), OR
(III) EXCLUDED FROM CONTRACTING WITH THE FEDERAL GOVERNMENT (SEE THE EXCLUDED
PARTIES LISTING SYSTEM AT WWW.SAM.GOV).

13.5.        MOFFITT ACKNOWLEDGES THAT THE TRANSFER AND USE BY FOREIGN NATIONALS
OF CERTAIN COMMODITIES AND TECHNICAL DATA IS SUBJECT TO U.S. LAWS AND
REGULATIONS CONTROLLING THE EXPORT AND USE BY FOREIGN NATIONALS OF SUCH
COMMODITIES AND TECHNICAL DATA, INCLUDING THE ARMS EXPORT CONTROL ACT, THE
INTERNATIONAL TRAFFIC IN ARMS REGULATIONS (“ITAR”), THE EXPORT ADMINISTRATION
REGULATIONS (“EAR”) AND THE LAWS AND REGULATIONS IMPLEMENTED BY THE OFFICE OF
FOREIGN ASSETS CONTROL, U.S. DEPARTMENT OF THE TREASURY (“OFAC”).  THESE LAWS
AND REGULATIONS, AMONG OTHER THINGS, PROHIBIT OR REQUIRE A LICENSE FOR THE
EXPORT OR USE BY FOREIGN NATIONALS OF CERTAIN TYPES OF TECHNICAL DATA TO
SPECIFIED COUNTRIES.  MOFFITT SHALL COMPLY WITH ALL SUCH APPLICABLE U.S. LAWS
AND REGULATIONS IN THE PERFORMANCE OF THE RESEARCH PLAN.

13.6.        MOFFITT AGREES THAT IT HAS NOT AND WILL NOT, EITHER DIRECTLY OR
INDIRECTLY, ENGAGE IN BRIBERY, OR OFFER, OR PROMISE, OR AUTHORIZE TO PAY OR MAKE
ANY IMPROPER PAYMENT OF ANY MONIES OR FINANCIAL OR OTHER ADVANTAGE, INCLUDING
CASH, LOAN, GIFT, TRAVEL, ENTERTAINMENT, HOSPITALITY, FACILITATION PAYMENT,
KICKBACK, POLITICAL OR PHILANTHROPIC CONTRIBUTION, ANYTHING OF VALUE, OR ANY
OTHER PERCEIVED BENEFIT TO IMPROPERLY OBTAIN OR RETAIN A BUSINESS ADVANTAGE IN
VIOLATION OF ANY ANTI-CORRUPTION LAWS AND FURTHER, EACH PARTY HEREUNDER AGREES
THAT IT SHALL NOT TAKE ANY ACTION THAT WOULD CAUSE THE OTHER PARTIES TO BE IN
VIOLATION OF SUCH ANTI-CORRUPTION LAWS IN THE PERFORMANCE OF THE RESEARCH PLAN.

13.7.        THE PARTIES REPRESENT AND WARRANT THAT THEY HAVE THE RIGHT AND
AUTHORITY TO ENTER INTO THIS AGREEMENT AND PERFORM ITS OBLIGATIONS AND GRANT THE
RIGHTS GRANTED HEREUNDER AND THAT NO PRE-EXISTING OR FUTURE OBLIGATION, THROUGH
CONTRACT OR OTHERWISE, WILL SUBSTANTIALLY INTERFERE WITH OR PREVENT THEM FROM
PERFORMING ITS OBLIGATIONS OR SUBSTANTIALLY INTERFERE WITH OR PREVENT THEM FROM
EXERCISING ITS RIGHTS HEREUNDER.

11

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13.8.        EACH PARTY SHALL NOT ASSIGN OR TRANSFER ANY RIGHTS, OBLIGATIONS OR
DUTIES UNDER THIS AGREEMENT WITHOUT THE PRIOR WRITTEN CONSENT OF THE OTHER
PARTY.

13.9.        THIS AGREEMENT SHALL CONSTITUTE THE ENTIRE UNDERSTANDING BETWEEN
THE PARTIES AND SUPERSEDES ANY AND ALL PRIOR OR CONTEMPORANEOUS REPRESENTATIONS,
AGREEMENTS AND PROMISES, WRITTEN OR ORAL, BETWEEN THE PARTIES REGARDING THE
SUBJECT MATTER OF THIS AGREEMENT. NO MODIFICATION, AMENDMENT, OR WAIVER MAY BE
ACCOMPLISHED TO THE TERMS OF THE AGREEMENT WITHOUT THE WRITTEN CONSENT OF BOTH
PARTIES.

13.10.    THIS AGREEMENT MAY BE EXECUTED IN ONE OR MORE COUNTERPART COPIES
(INCLUDING BY FACSIMILE, PDF, OR OTHER ELECTRONIC DELIVERY), WHICH WHEN JOINED,
SHALL TOGETHER CONSTITUTE ONE AGREEMENT. 

13.11.    IN THE EVENT THAT ANY PROVISION OF THIS AGREEMENT SHALL BE FOUND
INVALID, ILLEGAL OR UNENFORCEABLE, THE VALIDITY, LEGALITY AND ENFORCEABILITY OF
THE REMAINING PROVISIONS SHALL NOT IN ANY WAY BE AFFECTED OR IMPAIRED.

13.12.    IT IS UNDERSTOOD THAT THIS AGREEMENT IN NO WAY ALTERS ANY RIGHTS THAT
THE U.S. GOVERNMENT MIGHT HAVE.

13.13.    THE HEADINGS PRECEDING THE TEXT OF EACH SECTION OF THIS AGREEMENT ARE
FOR CONVENIENCE ONLY AND SHALL NOT BE CONSTRUED TO DEFINE, MODIFY, EXPAND,
LIMIT, OR AFFECT THE CONSTRUCTION OF OR TO BE TAKEN INTO ACCOUNT IN INTERPRETING
THE SUBSTANCE OF THIS AGREEMENT. 

13.14.    THE FAILURE OF ANY PARTY HERETO TO ENFORCE AT ANY TIME, OR FOR ANY
PERIOD OF TIME, ANY PROVISION OF THIS AGREEMENT SHALL NOT BE CONSTRUED AS A
WAIVER OF EITHER SUCH PROVISION OR OF THE RIGHT OF SUCH PARTY THEREAFTER TO
ENFORCE EACH AND EVERY PROVISION OF THIS AGREEMENT.

13.15.    COMPANY SHALL COMPLY WITH ALL APPLICABLE UNITED STATES LAW AND
REGULATIONS CONTROLLING THE EXPORT OF CERTAIN COMMODITIES AND TECHNICAL DATA,
INCLUDING WITHOUT LIMITATION ALL EXPORT ADMINISTRATION REGULATIONS OF THE UNITED
STATES DEPARTMENT OF COMMERCE.  AMONG OTHER THINGS, THESE LAWS AND REGULATIONS
PROHIBIT OR REQUIRE A LICENSE FOR THE EXPORT OF CERTAIN TYPES OF COMMODITIES AND
TECHNICAL DATA TO SPECIFIED COUNTRIES.  COMPANY HEREBY GIVES WRITTEN ASSURANCE
THAT IT WILL COMPLY WITH ALL APPLICABLE UNITED STATES EXPORT CONTROL LAWS AND
REGULATIONS, THAT IT BEARS SOLE RESPONSIBILITY FOR ANY VIOLATION OF SUCH LAWS
AND REGULATIONS BY ITSELF. 

13.16.    ITUS CORPORATION HEREBY ABSOLUTELY, UNCONDITIONALLY AND IRREVOCABLY
GUARANTEES TO MOFFITT THE COMPANY’S TIMELY AND FAITHFUL PAYMENT OF ALL FINANCIAL
OBLIGATIONS TO MOFFITT AS SET FORTH IN SECTION 12 AND THE BUDGET IN EXHIBIT C OF
THIS AGREEMENT.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.

12

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CERTAINTY THERAPEUTICS, INC.

H. LEE MOFFITT CANCER CENTER AND

RESEARCH INSTITUTE, INC.

By:

/s/Amit Kumar

By:

/s/Margaret J. Fonner

Name:

Amit Kumar

Name:

Margaret J. Fonner, CRA

Title:

Chief Executive Officer (CEO)

Title:

 Director, Office of Sponsored Research

ITUS CORPORATION

By:

/s/Michael J. Catelani

Name:

Michael Catelani

Title:

Chief Operating Officer (COO)   

 

13

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EXHIBIT A

 

DESCRIPTION AND QUANTITY OF MOFFITT RESEARCH MATERIALS, COMPANY RESEARCH
MATERIALS AND THIRD PARTY RESEARCH MATERIALS

 

Moffitt Research Material

Description of Material

Quantity

***

***

***

Company Research Material

Description of Material

Quantity

***

***

***

 

 

 

 

 

Third Party Research Material

Description of Material

Quantity

Master Cell Bank

***

Quantity will be agreed upon by both Parties during the term of the Agreement

 

14

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EXHIBIT B

RESEARCH PLAN

The goal of this project is to develop a new Chimeric Endocrine Receptor T cell
(CERTcell™) therapy against ovarian and prostate cancer, which is similar to
chimeric antigen receptors (CARs) T cell therapy but instead using the natural
receptor-ligand interactions between follicle-stimulating hormone (FSH) and its
receptor (FSHR) expressed on ovarian tumor cells. Upon ligand:receptor
interactions, these modified T cells are activated via signaling domains
converting these T cells into potent and selective tumor cell killers.
Specifically, this proposal will address the necessary preclinical optimization
for subsequent clinical testing.

 

 A. BACKGROUND AND SUMMARY OF PUBLISHED RESULTS (PMID: 27435394)

 

[exhibitimage.jpg]

Fig.1. Schematic depiction of FSHR-targeting CER constructs. To target FSHR, we
synthetized a construct expressing a signal peptide, followed by the two
subunits of FSH (FSHb and CGa the latter common to LH and TSH), separated by a
linker. This targeting motif was cloned in frame with a hinge domain from CD8a,
followed by the transmembrane domain of CD8a, the intracellular domain of a
co-stimulatory mediator (4-1BB and CD28 will be tested) and, finally, the
activating CD3z domain.

 

 

1-In an effort to overcome the paucity of surface (targetable) antigens
selectively expressed by tumor cells and not by healthy tissues, we identified
FSHR as a targetable (cell surface) antigen present on >50 of ovarian carcinomas
of different histological types, including serous malignancies1-3.

2-We demonstrated that in healthy adult women, the FSHR is only expressed in the
ovary (granulosa cells4 and at low levels in the ovarian endothelium5), but NOT
in any other healthy tissue, including the brain3. Given that oophorectomy is a
standard procedure in the treatment of ovarian cancer, targeting the FSHR will
not damage healthy tissues.

3-Human T cells expressing full-length FSH-redirected chimeric receptors (FSHCER
T cells; Fig.1) mediate significant therapeutic effects (including tumor
rejection) against 3 of 4 patient-derived tumors in vivo, compared to
mock-transduced T cells. Consistently, the growth of established FSHR+ human
ovarian cancer CaOV3 tumors was significantly delayed in mice receiving a single
injection of 6 million CERT cells, while administration of mock-transduced T
cells allows tumor progression.

4-In immunocompetent mice growing syngeneic, orthotopic, and aggressive ovarian
tumors, fully murine FSH-targeted T cells (carrying mouse FSH as a targeting
motif for mouse FSHR) also increased survival without any measurable toxicity.

 

 

B. APPROACH

 

PHASE I. Milestone: Define the Maximum Tolerated Dose for FSHCER T cells and
show safety in vivo   .

 

We demonstrated that the administration of 2 doses of 1.5 million FSHCER T cells
targeting murine FSHR into peritoneal ovarian cancer (ID8-Vegf/Defb29)-bearing
immunocompetent mice delayed malignant progression without any alterations in
hepatic enzymes, creatinine or any other obvious sign of toxicity3. These
experiments will define the maximum tolerated dose for a single infusion of
CERTcells. Here, Moffitt will infuse tumor-free C57BL/6 mice (5/group) with 106,
107, or 2 X 107 mouse FSHCERTcells or HBSS (4 groups), and follow them for 5
months. Doses have been selected based on 5 years of experience with adoptive
transfer of T cells in various preclinical models3,6-10. T cells will be
initially infused i.p., because this is the route endorsed by the NCI for
targeting ovarian cancer in the clinic11). In complementary experiments, Moffitt
will also challenge NSG mice (5/group) with flank OVCAR3 cells (106) and also
treat them at day 14 with 106, 107, or 2 X 107 human FSHCERTcells or HBSS. These
mice will be followed until tumors reach 2 cm in any dimension or signs of GVHD
(general health deterioration; see below) become obvious.

 

15

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Readouts of potential toxicity. In all mice, the following readouts will be
monitored:

General health status: The health status of mice will be monitored closely over
the first 24 h period, and daily thereafter for one week, then once weekly for
the duration of the study. Euthanasia by CO2 will be performed when the
following clinical signs associated with pain/distress are observed: Difficult
breathing increased respiratory rate, decreased movements or reduced grooming
and feeding. Alternatively, mice appearing significantly comprised (e.g.
dehydrated, anorexic, dyspnic) will be immediately removed from the study and
euthanized by CO2.

Body weight: Moffitt will measure and record body weight daily for the first
week, and once per week until the conclusion of the study. If mice experience
>10% body weight loss in 24 h they will be euthanized. Otherwise, recorded body
weight will be compared to control mice.

IL-6: Serum will be collected through retroorbital bleeding daily for the first
3 days after FSHCER T cell administration, and circulating levels of IL-6
(responsible for the cytokine release syndrome observed in some patients12) will
be quantified. Differences between treatment and control groups will be
recorded.

Liver and kidney function: Serum will be also collected by Moffitt through
retroorbital bleeding at days 10, 20 and 30 after FSHCERT cell administration,
and at the end of the study. AST, ALT and creatinine will be quantified as
markers of liver and hepatic function. Differences between treatment and control
groups will be recorded.

Cytokines in peritoneal fluid: In different groups of mice treated with the
maximum tolerated dose vs. HBSS (5/group), we will also collect peritoneal wash
by perfusing the peritoneal cavity with 1 mL of saline at day 3 after FSHCER T
cell administration. IL-6 and TNF-a will be determined through ELISA.

Histology: The liver, pancreas, intestine, heart, kidney, brain, and lung will
be examined by Moffittfor evidence of tissue damage in H&E staining as well as
the presence of (CD45+) inflammatory infiltrates by IHC at the completion of the
study. Leukocyte accumulation in healthy tissues will be compared.

 

Phase I will be completed during year 1.

 

 

PHASE II. Milestone: Manufacturing of clinical grade materials for clinical
use                                           .

Generation of clinical grade vectors for clinical use. Moffitt will work with
***. In collaboration with them, Moffitt will produce a master cell bank using
retro-viral vectors encoding the FSH-targeted construct and the proper packaging
cells (e.g., pSFG retroviruses packaged in PG13 cells). Moffitt will sequence
the vector containing the FSHCERT from 5’LTR to the 3’LTR to ensure that the
construct is inserted without alterations to its sequence. We will then test the
product to assure the safety of biological products, including: (1) sterility,
(2) mycoplasma, and (3) adventitious viral agents, following FDA guidelines.
Alternatively, we will consider the production of enough clinical grade CERTcell
viral supernatant for a phase I trial through another third party vendor subject
to Company approval.

 

16

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Production of clinical grade materials for clinical use. Moffitt will also
optimize protocols for the production of human FSHCERT cells using reagents that
will be used in the clinical trial and samples from the aphaeresis of 2 healthy
donors. Moffitt will perform these experiments at the Cell Therapies Core of
Moffitt Cancer Center, which has cutting-edge GMP facilities and experienced
personnel for translation of cellular therapies.

FSHCER constructs will be transduced by spinoculation on CD3/CD28-activated CD3+
T cells enriched from minileukapheresis products and exposed to viral
supernatant on retronectin coated plates in the presence of cytokines. Using
FSHCERT cells generated in this manner, Moffitt will design a Q-PCR assay for
determining the trafficking and persistence of adoptively transferred CERTcells
in vivo in peripheral blood in our future clinical trial. In addition, Moffitt
will optimize a flow cytometry analysis of transferred CERTcells based on the
detection of FSHb on transduced (CD3+) T cells, by fluorescently labeling
available anti-human FSH antibodies, or using a primary anti-FSH antibody and a
fluorescently labeled secondary antibody.

Studies including cryopreservation and storage at 4°C will be performed in
transduced CERTcells at the end of cell processing. CERTcells cryopreserved for
1, 3 and 6 months, or stored at 4°C for 24, 48 and 72 hours, will be evaluated
for cell viability, CERT expression and functional activity against
FSHR-expressing (OVCAR3) tumor cells.

 

Phase II will be completed between months 3 and 20.

 

 

Subsequent goals(outside scope of the Agreement that the parties may
pursue)                                                                                                                  
                      .

The ultimate goal of this research collaboration is to move these interventions
to a clinical trial. Our current expectations for clinical protocol planning and
drafting, to be modified depending on the FDA’s feedback, are outlined below:

-The initial trial should be designed as an open-label, single-arm pilot
clinical trial of autologous FSHR redirected T cells administered
intraperitoneally in patients with recurrent, chemoresistant FSHR+ ovarian
carcinoma that expresses FSHR, as determined in previous biopsies or the
original tumor by western-blot analysis.

-Clinical SOPs should be designed based on Moffitt’spreclinical results and
other ongoing trials using different CART cell formulations (e.g.,
https://clinicaltrials.gov/ct2/show/NCT02498912?term=muc+ovarian+cancer&rank=6
).

-As for other ongoing CAR T cell trials, in some patients a lymphodepleting
cyclophosphamide dose of 750 mg/m2 will be administered 2-4 days prior to
starting the T cell infusion.

-The primary toxicity that is anticipated is inflammation caused by killing of
tumor cells that express the target, which will be preclinically addressed in
Phase I.

-After setting the starting dose, a conventional dose escalation should be based
on log (or, if required by FDA, half-log) increments. It is important to note
that, because Moffitt will use endogenous FSH, the risk of anaphylaxis or immune
targeting of CART cells previously described for xenogeneic (murine) scFvs is
negligible. Equally important, the expression of the FSH receptor is limited to
the ovary, which is routinely resected in ovarian cancer patients.

 

17

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-Under the scientific direction and oversight of Drs. Marco Davila and Daniel
Abate-Daga, Moffitt will  assist Certainty Therapeutics, Inc.  with submission
of the IB, IC, protocol, and other necessary documents to the Recombinant DNA
Advisory Committee (RAC), the institutional biosafety committee (IBC), the IRB,
the DSMB, the local Phase I committee for the trial site, and the FDA for
approval. We anticipate that these necessary regulatory submissions could be
completed by the end of the second year of this collaboration.

 

 

BIBLIOGRAPHY AND REFERENCES CITED

 

1.         Zhang, X.Y., et al. Follicle-stimulating hormone peptide can
facilitate paclitaxel nanoparticles to target ovarian carcinoma in vivo. Cancer
Res 69, 6506-6514 (2009).

2.         Al-Timimi, A., Buckley, C.H. & Fox, H. An immunohistochemical study
of the incidence and significance of human gonadotrophin and prolactin binding
sites in normal and neoplastic human ovarian tissue. Br J Cancer 53, 321-329
(1986).

3.         Perales-Puchalt, A., et al. Follicle-Stimulating Hormone Receptor Is
Expressed by Most Ovarian Cancer Subtypes and Is a Safe and Effective
Immunotherapeutic Target. Clin Cancer Res 23, 441-453 (2017).

4.         Simoni, M., Gromoll, J. & Nieschlag, E. The follicle-stimulating
hormone receptor: biochemistry, molecular biology, physiology, and
pathophysiology. Endocr Rev 18, 739-773 (1997).

5.         Vannier, B., Loosfelt, H., Meduri, G., Pichon, C. & Milgrom, E.
Anti-human FSH receptor monoclonal antibodies: immunochemical and
immunocytochemical characterization of the receptor. Biochemistry 35, 1358-1366
(1996).

6.         Amatangelo, M.D., et al. Three-dimensional culture sensitizes
epithelial ovarian cancer cells to EZH2 methyltransferase inhibition. Cell Cycle
12, 2113-2119 (2013).

7.         Nesbeth, Y. & Conejo-Garcia, J.R. Harnessing the effect of adoptively
transferred tumor-reactive T cells on endogenous (host-derived) antitumor
immunity. Clin Dev Immunol 2010, 139304 (2010).

8.         Nesbeth, Y., et al. CCL5-mediated endogenous antitumor immunity
elicited by adoptively transferred lymphocytes and dendritic cell depletion.
Cancer Res 69, 6331-6338 (2009).

9.         Nesbeth, Y.C., et al. CD4+ T cells elicit host immune responses to
MHC class II- ovarian cancer through CCL5 secretion and CD40-mediated licensing
of dendritic cells. J Immunol 184, 5654-5662 (2010).

10.       Stephen, T.L., et al. Transforming Growth Factor beta-Mediated
Suppression of Antitumor T Cells Requires FoxP1 Transcription Factor Expression.
Immunity 41, 427-439 (2014).

11.       Walker, J.L., et al. Intraperitoneal catheter outcomes in a phase III
trial of intravenous versus intraperitoneal chemotherapy in optimal stage III
ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study.
Gynecol Oncol 100, 27-32 (2006).

12.       Lee, D.W., et al. T cells expressing CD19 chimeric antigen receptors
for acute lymphoblastic leukaemia in children and young adults: a phase 1
dose-escalation trial. Lancet (2014).

18

--------------------------------------------------------------------------------

EXHIBIT C

BUDGET

 

 

Principal Investigator: Conejo-Garcia, Jose

BUDGET -YEARS 1 AND 2

PERSONNEL

 

 

YEAR 1

YEAR 2

 

TOTAL

NAME

 

ROLE ON

PROJECT

Percent

Effort

Devoted

Calendar

Months

Devoted

 

 

 

Salary and

Fringe

Benefits

 

Salary and Fringe

Benefits

 

 

 

KEY PERSONNEL (MCC A)

Dr. Conejo-Garcia

PI

***

***

Dr. Davila

Co-I

***

***

Dr. Abate-Daga

Co-I

***

***

Dr. Kelley

Co-I

***

***

TECHNICAL STAFF (MCC B)

 

 

 

 

 

 

 

 

TBN

Post Doc

***

***

SUBTOTALS     →  

$                         ***

$                  ***

$                    ***

Materials and Supplies

 

 

 

 

 

Glassware and Plasticware

$

*** 

$

***

Beads for lmmunopurification and T cell expansion

$

***

$

***

Antbodies (FACS, T cell expansion)

$

***

$

***

Reagents for Q-PCR

 

$

***

ELISAS, immunological analysis

$

***

cell culture

$

***

$

***

Other Expenses

 

 

 

 

    Comparative Medicine

$

***

    FACS sorting

$

***

$

***

    Human Cells Procurement

$

***

$

***

    Generation and testing of a master cell bank (retrovirus)(Rimedion)

$

***

    Clinical supernatant production and testing (Rimedion)

 

 

$

***

    Cell Therapy Core (4 tech transfer runs)

 

 

$

***

    Alliance Management Fee

$

***

$

***

 

 

 

 

 

 

 

 

 

 

 

$

***

SUBTOTAL DIRECT COSTS

 

$

***

$

***

$

***

FACILITIES AND ADMINISTRATIVE COSTS
@                                                                                                                                ***

 

$

***

$

***

$

***

TOTAL COSTS FOR TOTAL PERIOD

 

$

458,684

$

701,671

$

1,160,355

 

Moffitt may amend and re-allocate funds within the Budget from time to time at
its sole discretion, as long as the total dollar amount of all payments owed to
Moffitt under this Agreement are not changed as a result of the re-allocation.

 

19

--------------------------------------------------------------------------------

 

Payment Schedule: $250,003 shall be invoiced upon execution of the Agreement

$227,588 shall be invoiced at 6, 12, 18, and 24 months post-Effective Date of
the Agreement

 

Payment is due within 45 days after receipt of invoice.

 

Invoice:

Moffitt shall submit invoices to:

 

Name: Dr. Amit Kumar

Email: ak@ituscorp.com

CC: mcatelani@ituscorp.com

 

20