[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.

Exhibit 10.45

PUBLIC HEALTH SERVICE

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
FOR EXTRAMURAL-PHS CLINICAL RESEARCH

This Agreement is based on the model Cooperative Research and Development
Agreement (“CRADA”) adopted by the U.S. Public Health Service (“PHS”) Technology
Transfer Policy Board for use by components of the National Institutes of Health
(“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food
and Drug Administration (“FDA”), which are agencies of the PHS within the
Department of Health and Human Services (“HHS”).

This Cover Page identifies the Parties to this CRADA:

The U.S. Department of Health and Human Services, as represented by
National Cancer Institute
an Institute, Center, or Division (hereinafter referred to as the “IC”) of the
National Institutes of Health

and

Exelixis, Inc.,
hereinafter referred to as the “Collaborator,”
having offices at 210 East Grand Avenue, South San Francisco, CA 94080,
created and operating under the laws of Delaware.

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COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
FOR EXTRAMURAL-PHS CLINICAL RESEARCH

Article 1.     Introduction

This CRADA between IC and Collaborator will be effective when signed by the
Parties, which are identified on both the Cover Page and the Signature Page
(page 34). The official contacts for the Parties are identified on the Contacts
Information Page (page 35). Publicly available information regarding this CRADA
appears on the Summary Page (page 36). The research and development activities
that will be undertaken by IC, NCI Investigators, and Collaborator in the course
of this CRADA are detailed in the Research Plan, attached as Appendix A. The
staffing, funding, and materials contributions of the Parties are set forth in
Appendix B. An example of typical terms for a Material Transfer Agreement
(“MTA”) for the transfer of Investigational Agent from NCI to NCI Extramural
Investigators is attached as Appendix C. For this Agreement, IC means National
Cancer Institute (NCI). Since CTEP and DCTD (defined below) within the NCI are
responsible for the Research Plan, IC, NCI, DCTD and CTEP may be used
interchangeably in this Agreement when a specific program is responsible for an
activity.

Article 2.     Definitions

The terms listed in this Article will carry the meanings indicated throughout
the CRADA. To the extent a definition of a term as provided in this Article is
inconsistent with a corresponding definition in the applicable sections of
either the United States Code (U.S.C.) or the Code of Federal Regulations
(C.F.R.), the definition in the U.S.C. or C.F.R. will control.

“Adverse Event” or “AE” means any untoward medical occurrence associated with
the use of a drug in humans, whether or not considered drug related, as defined
under 21 C.F.R §312.32. See also FDA Good Clinical Practice Guideline
(International Conference on Harmonisation (ICH) E6: “Good Clinical Practice:
Consolidated Guidance, 62 Federal Register 25, 691 (1997)).

“Affiliate” means any corporation or other business entity controlled by,
controlling, or under common control with Collaborator at any time during the
term of the CRADA. For this purpose, “control” means direct or indirect
beneficial ownership of at least fifty percent (50%) of the voting stock or at
least fifty percent (50%) interest in the income of the corporation or other
business entity.

“Annual Report” means the report of progress of an IND-associated investigation
that the Sponsor must submit to the FDA within sixty (60) days of the
anniversary of the effective date of the IND (pursuant to 21 C.F.R. § 312.33).

“Background Invention” means an Invention conceived and first actually reduced
to practice before the Effective Date.

“Clinical Investigator” means, in accordance with 21 C.F.R. § 312.3, an
individual who actually conducts a clinical investigation, that is, who directs
the administration or dispensation of Test Article to a Human Subject, and who
assumes responsibility for studying Human Subjects, for recording and ensuring
the integrity of research data, and for protecting the welfare and safety of
Human Subjects. For clarity, all Clinical Investigators will either be NCI
Extramural Investigators or NCI Intramural Investigators.

“Clinical Research Site(s)” means the site(s) at which the Protocol(s) described
in the Research Plan will be performed.

"Collaborator Confidential Information" means scientific, business and financial
information disclosed by or on behalf of Collaborator in writing and marked or
otherwise identified as confidential. Collaborator

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Confidential Information does not include CRADA Data, descriptions of CRADA
Materials, and Raw Data.

“Collaborator Materials” means all tangible materials not first produced in the
performance of this CRADA that are owned or controlled by Collaborator and used
in the performance of the Research Plan. The term “Collaborator Materials” does
not include Test Article (defined below).

“Confidential Information” means Collaborator Confidential Information, IC
Confidential Information, Protocols, the Research Plan, or Identifiable Private
Information, provided that Confidential Information does not include:

(a)    information that is publicly known or that is available from public
sources;
(b)
information that has been made available by the disclosing Party to others
without a confidentiality obligation;

(c)
information that is already known by the receiving Party without obligations of
confidentiality, or information that is independently created or compiled by the
receiving Party without reference to or use of the information provided under
this CRADA; or

(d)
information that is subsequently disclosed to the receiving Party by a third
party without obligations of confidentiality.

“Contract” means a Funding Agreement that is a research and development
mechanism that provides that the contractor perform for the benefit of the
Government, with an expectation of completion of the stated research goals and
the delivery of a report, data, materials or other product. Generally, Contracts
are administered under the Federal Acquisition Regulations (FAR) codified at
Title 48 C.F.R., Chapter 1 or the Health Services Acquisition Regulations (HSAR)
codified at Title 48 C.F.R., Chapter 3.

“Cooperative Agreement” means a Funding Agreement that is a species of a Grant,
whereby the funding Federal agency intends to be substantially involved in
carrying out the research program.

“Cooperative Research and Development Agreement” or “CRADA” means an agreement,
entered into pursuant to the Federal Technology Transfer Act of 1986, as amended
(15 U.S.C. §§ 3710a et seq.), and Executive Order 12591 of April 10, 1987.

“CRADA Collaborator Principal Investigator(s)” or “CRADA Collaborator PI(s)”
means the person(s) who will be responsible for the scientific and technical
conduct of the Research Plan on behalf of the CRADA Collaborator.

“CRADA Data” means information developed by or on behalf of either or both
Parties (including by NCI Investigators) in the performance of the Research
Plan, excluding Raw Data.

“CRADA Materials” means all tangible materials first produced in the performance
of the Research Plan other than CRADA Data, Raw Data, Collaborator Materials or
Test Article. CRADA Materials do not include specimens collected from Human
Subjects.
    
“CRADA Subject Invention” means any Invention that is conceived or first
actually reduced to practice in the performance of the Research Plan by or on
behalf of either or both Parties.

“CTA” means Clinical Trial Agreement.

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“CTEP” means the Cancer Therapy Evaluation Program, DCTD, NCI, a program within
NCI which plans, assesses and coordinates all aspects of clinical trials
including extramural clinical research programs, internal resources, treatment
methods and effectiveness, and compilation and exchange of data.

“DCTD” means Division of Cancer Treatment and Diagnosis, NCI.

“DCTD Clinical Support Assays” means [ * ]. DCTD’s work may include such
activities as [ * ]. These studies will be performed by DCTD employees and
contractors who are obligated to assign any and all intellectual property to
PHS. Although DCTD Clinical Support Assays are non-clinical in nature, for the
purpose of this CRADA they are treated separately from Non-Clinical Studies
(defined below) as the approval process and oversight for DCTD Clinical Support
Assays and Non-Clinical Studies are different.

“DTP” means Developmental Therapeutics Program, DCTD, NCI, the program within
the NCI which coordinates pre-clinical development of agents to be evaluated in
DCTD-sponsored clinical trials.

“Effective Date” means the date of the last signature of the Parties executing
this Agreement.

“Funding Agreement” means a Contract, Grant, or Cooperative Agreement entered
into between a Federal agency and another party for the performance of
experimental, developmental or research work funded in whole or in part by the
Federal Government.

“Government” means the Government of the United States of America.

“Grant” means a Funding Agreement that is an award of financial assistance which
may be provided for support of basic research in a specific field of interest to
the funding Federal agency.

“Human Subject” means, in accordance with the definition in 45 C.F.R. §
46.102(f), a living individual about whom an investigator conducting research
obtains:

(a)    data through intervention or interaction with the individual; or
(b)    Identifiable Private Information.

"IC Confidential Information" means scientific information disclosed by or on
behalf of IC in writing and marked or otherwise identified as confidential. IC
Confidential Information does not include CRADA Data, descriptions of CRADA
Materials, and Raw Data.

“IC Materials” means all tangible materials not first produced in the
performance of this CRADA that are owned or controlled by IC and used in the
performance of the Research Plan.

“Identifiable Private Information” or “IPI” about a Human Subject means private
information from which the identity of the subject is or may readily be
ascertained. Regulations defining and governing this information include 45
C.F.R. Part 46 and 21 C.F.R. Part 50.

“IND” means an “Investigational New Drug Application,” filed in accordance with
21 C.F.R. Part 312 under which clinical investigation of an experimental drug or
biologic (Test Article) is performed in Human Subjects in the United States or
intended to support a United States licensing action.

“Institutional Review Board” or “IRB” means, in accordance with 45 C.F.R. Part
46, 21 C.F.R. part 56, and other applicable regulations, an independent body
comprising medical, scientific, and nonscientific members, whose responsibility
is to ensure the protection of the rights, safety, and well-being of the Human
Subjects involved in a study.

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“Invention” means any invention or discovery that is or may be patentable or
otherwise protected under Title 35 of the United States Code, or any novel
variety of plant which is or may be protectable under the Plant Variety
Protection Act, 7 U.S.C. §§ 2321 et seq.

“Investigator’s Brochure” means, in accordance with the definition in 21 C.F.R.
§ 312.23(a)(5), a document containing information about the Test Article,
including animal screening, preclinical toxicology, and detailed pharmaceutical
data, including a description of possible risks and side effects to be
anticipated on the basis of prior experience with the drug or related drugs, and
precautions, such as additional monitoring, to be taken as part of the
investigational use of the drug.

“Joint CRADA Subject Inventions” means all CRADA Subject Inventions invented
jointly by IC employees together with employees, contractors or agents of
Collaborator.

“Multi-Party Data” means data from studies sponsored by NCI pursuant to CTAs or
CRADAs, where such data are collected under Protocols and Non-Clinical Studies
involving combinations of investigational agents supplied from more than one CTA
or CRADA collaborator.

“NCI Extramural Investigator” means an investigator who is not an NCI employee
and who is supported by NCI Funding Agreements, together with all personnel
assisting the investigator in the performance of research under this CRADA.

“NCI Intramural Investigator” means an investigator who is an NCI employee, as
well as all personnel assisting the investigator in the performance of research
under this CRADA.

“NCI Investigator” means any NCI Intramural Investigator, NCI Extramural
Investigator, Non-Clinical Investigator or an investigator who conducts the DCTD
Clinical Support Assays, together with all personnel assisting an investigator
with the conduct of DCTD Clinical Support Assays.

“NIH CRADA Extramural Investigator/Officer(s)” means the IC extramural staff who
are responsible for the conduct and/or management of the CRADA on behalf of the
NIH IC. All NIH CRADA Extramural Investigator/Officer(s) are employees of IC. In
the case of this CRADA, the NIH CRADA Extramural Investigator is [ * ] and the
NIH CRADA Extramural Officer is [ * ].

“Non-Clinical Investigator” means any individual who conducts, directs, or
assumes responsibility for Non-Clinical Studies, together with all personnel
assisting such individual in the performance of Non-Clinical Studies.
Non-Clinical Investigators will be either NCI Intramural Investigators or NCI
Extramural Investigators.

“Non-Clinical Studies” means exploratory in vitro, in vivo, and ex vivo studies
using defined biological models including [ * ]. Non-Clinical Studies may
include [ * ]. This defined term shall be limited to studies under this CRADA.
Non-Clinical Studies can be performed by Clinical Investigators or Non-Clinical
Investigators. Non-Clinical Studies under this CRADA shall not include DCTD
Clinical Support Assays.

“Patent” means any issued United States patent, any international
counterpart(s), and any corresponding grant(s) by a non-U.S. government in place
of a patent.

“Patent Application” means an application for patent protection for a CRADA
Subject Invention with the United States Patent and Trademark Office
(“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

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“Placebo” means an inactive substance identical in appearance to the material
being tested that is used to distinguish between drug action and suggestive
effect of the material under study.
  
“Protocol” means the formal, detailed description of a clinical study involving
Human Subjects to be performed as provided for in the Research Plan. It
describes the objective(s), design, methodology, statistical considerations, and
organization of a clinical study involving Human Subjects. For the purposes of
this CRADA, the term Protocol includes any and all associated documents,
including informed consent forms, to be provided to Human Subjects and potential
participants in the study.

“Protocol Review Committee” (or “PRC”) means the CTEP/DCTD committee that
reviews and approves studies involving NCI investigational agents and/or
activities supported by NCI.

“Raw Data” means the primary quantitative and empirical data first collected
from experiments and clinical trials conducted within the scope of this CRADA.
Raw Data includes case report forms.

“Research Plan” means the statement in Appendix A of the respective research and
development commitments of the Parties. The Research Plan should describe the
provisions for sponsoring the IND, clinical and safety monitoring, and data
management.

“Secondary Data” means data that is generated through research utilizing
non-publicly available CRADA Data, de-identified Raw Data and/or human
biological specimens from Protocols conducted under the CRADA Research Plan.
    
“Sponsor” means, in accordance with the definition in 21 C.F.R. § 312.3, an
organization or individual who assumes legal responsibility for supervising or
overseeing clinical trials with Test Articles, and is sometimes referred to as
the IND holder.

“Steering Committee” means the research and development team whose composition
and responsibilities with regard to the research performed under this CRADA are
described in Appendix A.

“Summary Data” means any extract or summary of the Raw Data generated either by,
or on behalf of, IC or by, or on behalf of, Collaborator. Summary Data may
include extracts or summaries that incorporate IPI.

“Test Article” means, in accordance with 21 C.F.R. § 50.3(j), any drug
(including a biological product), medical device, food additive, color additive,
electronic product, or any other article subject to regulation under the Federal
Food, Drug, and Cosmetic Act that is intended for administration to humans or
animals, including a drug or biologic as identified in the Research Plan, that
is used within the scope of the Research Plan. The Test Article may also be
referred to as Investigational Agent, Study Material, or Study Product. For this
Agreement, Test Article, Investigational Agent, Study Material or Study Product
means XL184 (cabozantinib) provided by or on behalf of Collaborator.

Article 3.     Cooperative Research and Development

3.1
Performance of Research and Development. The research and development activities
to be carried out under this CRADA will be performed solely by the Parties
identified on the Cover Page, as well as by NCI Investigators as described in
the Research Plan. However, NCI Extramural Investigators are not Parties to the
CRADA, and this CRADA does not grant to Collaborator any rights to Inventions
made by NCI Extramural Investigators. The NIH CRADA Extramural
Investigator/Officers and CRADA Collaborator PIs will be responsible for
coordinating the scientific and technical conduct of this project on behalf of
their employers. Any Collaborator employees who will work at IC facilities will
be required to sign a Guest Researcher or Special Volunteer Agreement
appropriately modified in view of the terms of this CRADA.

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3.2
Research Plan. The Parties recognize that the Research Plan describes the
collaborative research and development activities they will undertake and that
interim research goals set forth in the Research Plan are good faith guidelines.
Should events occur that require modification of these goals, then by mutual
agreement the Parties can modify them through an amendment, according to
Paragraph 13.6.

3.3
Use and Disposition of Collaborator Materials and IC Materials. The Parties
agree to use Collaborator Materials and IC Materials only in accordance with the
Research Plan and Protocol(s), not to transfer these materials to third parties
except in accordance with the Research Plan and Protocol(s) or as approved by
the owning or providing Party, and, upon expiration or termination of the CRADA,
to dispose of these materials as directed by the owning or providing Party.

3.4
Third-Party Rights in Collaborator’s CRADA Subject Inventions. If Collaborator
has received (or will receive) support of any kind from a third party in
exchange for rights in any of Collaborator’s CRADA Subject Inventions,
Collaborator agrees to ensure that its obligations to the third party are both
consistent with Articles 6 through 8 and subordinate to Article 7 of this CRADA.

3.5
Disclosures to IC. Prior to execution of this CRADA, Collaborator agrees to
disclose to IC all instances in which outstanding royalties are due under a PHS
license agreement and in which Collaborator had a PHS license terminated in
accordance with 37 C.F.R. § 404.10. These disclosures will be treated as
Collaborator Confidential Information upon request by Collaborator in accordance
with the definition in Article 2 and Paragraphs 8.3 and 8.4.

3.6
Clinical Investigator Responsibilities. The Clinical Investigator will be
required to submit, or to arrange for submission of, each Protocol associated
with this CRADA to all appropriate IRBs, and for ensuring that the IRBs are
notified of the role of Collaborator in the research. In addition to the
Protocol, all associated documents, including informational documents and
advertisements, must be reviewed and approved by the appropriate IRB(s) before
starting the research at each Clinical Research Site. The research will be done
in strict accordance with the Protocol(s) and no substantive changes in a
finalized Protocol will be made unless mutually agreed upon, in writing, by the
Parties. Research will not commence (or will continue unchanged, if already in
progress) until each substantive change to a Protocol, including those required
by either the FDA or the IRB, has been integrated in a way acceptable to the
Parties, submitted to the FDA (if applicable) and approved by the appropriate
IRBs.

3.7    Investigational New Drug Applications.

3.7.1    DCTD, NCI, as indicated in the Research Plan, will prepare and submit
all IND(s), and all Clinical Investigators participating in DCTD-sponsored
clinical trials must have completed registration documents on file (1572 forms)
with CTEP.

3.7.2    To support the DCTD IND(s), Collaborator agrees to provide to DCTD
background data and information necessary to support the IND(s). Collaborator
further agrees to provide a letter of cross-reference to all pertinent
regulatory filings, including an IND sponsored by Collaborator, as necessary to
support the DCTD IND(s). Collaborator’s employees will be reasonably available
to respond to inquiries from the FDA regarding information and data contained in
the Collaborator’s IND, or other information and data provided to DCTD by the
Collaborator pursuant to this Article 3. If DCTD has provided information or
data to assist Collaborator in any of Collaborator’s IND filings, DCTD will
provide a letter of cross-reference to its IND(s) and respond to inquiries
related to information provided by DCTD, as applicable.

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3.7.3    If Collaborator supplies Collaborator Confidential Information to DCTD
in support of an IND filed by DCTD, this information will be protected in
accordance with the corresponding confidentiality provisions of Article 8.
 
3.7.4
During the term of this CRADA, Collaborator may sponsor its own clinical trials
and hold its own IND for studies performed outside the scope of this CRADA.
These studies, however, should not adversely affect the ability to accomplish
the goal of the Research Plan, for example, by competing for the same study
population. All data from those clinical trials are proprietary to Collaborator
for purposes of this CRADA. Collaborator will permit DCTD to review and use the
summary and safety data from any such trials in its possession solely as
necessary for regulatory purposes for DCTD-sponsored clinical trials which are
conducted under this CRADA. For clarity, Collaborator is not required to
generate any data summaries to provide to DCTD, and is only obligated to provide
those summaries that have already been created by or on behalf of Collaborator.

3.7.5 In the event that Canadian Clinical Research Sites are participating in
DCTD-sponsored clinical trials, Collaborator will need to assist in the
submission of the regulatory documents to the Canadian Health Products and Food
Branch to allow for such participation. This may include providing a letter of
cross-reference to an existing Clinical Trials Application, including supporting
documentation on the production of the Investigational Agent. The forms and
procedures for preparing Canadian Clinical Trials Application are available at
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/index-eng.php.
Notwithstanding the foregoing, no Canadian Clinical Research Sites may
participate in any DCTD-sponsored clinical trials without the mutual agreement
of the Parties.

3.7.6
In the event that other international Clinical Research Sites are participating
in DCTD-sponsored Protocols, Collaborator will assist such international
Clinical Research Sites in the submission of necessary regulatory documents to
allow for such participation. The international participant will work directly
with the Collaborator to obtain the necessary regulatory documents other than
the IB (as defined in Paragraph 3.8.7) or Certificate of Analysis of the
Investigational Agent, which may be provided by DCTD with Collaborator’s
approval. Notwithstanding the foregoing, no international Clinical Research
Sites may participate in any DCTD-sponsored clinical trials without the
Collaborator’s consent, which consent may be withheld at Collaborator’s
discretion.

3.8    Investigational Agent Information and Supply.
3.8.1
Collaborator agrees to provide DCTD without charge and on a schedule that will
ensure adequate and timely performance of the research, a sufficient quantity of
formulated and acceptably labeled, clinical-grade Investigational Agent (and, if
required by the Protocol(s), Placebo) to complete clinical trial(s) under
Protocol(s) mutually agreed to and approved under this CRADA. Investigational
Agent should be suitable for shipment to all countries and sites participating
in DCTD-sponsored clinical trials approved under this CRADA. DCTD does not
maintain country-specific Investigational Agent supplies. Collaborator will
provide a Certificate of Analysis to DCTD for each lot of the Investigational
Agent provided. It is understood that DCTD shall take responsibility for and
reasonable steps to maintain appropriate records and assure appropriate supply,
handling, storage, distribution and usage of these materials in accordance with
the terms of this Agreement, the Protocol(s), the Material Safety Data Sheet
provided by Collaborator, and any applicable laws and regulations relating
thereto.

3.8.2
DCTD will provide updated forecasts of amounts of Investigational Agent
anticipated for ongoing and anticipated clinical studies under mutually agreed
upon Protocol(s) and, in any event, will notify Collaborator of the quantity of
Investigational Agent required to maintain adequate supply for each

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clinical study to be conducted under such Protocol(s) at least [ * ] before the
date on which Collaborator is required to supply such Investigational Agent for
use in such studies. Collaborator further agrees to provide draft
Investigational Agent labels to the NCI Pharmaceutical Management Branch (PMB)
for review and agrees to reasonable labeling revisions to comply with DCTD label
guidelines. NCI NSC (National Service Center) numbers will be required to be on
the label of Investigational Agent for all DCTD-sponsored clinical trials.

3.8.3
Collaborator agrees to provide without charge Investigational Agent or
unformulated analytical grade Investigational Agent or metabolites, if
available, to DCTD to supply to NCI Investigators for the performance of
mutually agreed upon Non-Clinical Studies, such as [ * ]. These studies will be
approved by the PRC and conducted according to Protocols approved by both
Parties.

3.8.4
Collaborator agrees to allow Investigational Agent to be distributed to NCI
Investigators for mutually agreeable Non-Clinical Studies [ * ]. These may
include non-clinical studies [ * ]. Each such Non-Clinical Study will be
proposed by the NCI Investigator and, in order to proceed, must be approved by
both NCI and Collaborator. These studies will be conducted according to
Non-Clinical Study proposals approved by both Parties.

3.8.5
All NCI Extramural Investigators who will receive Investigational Agent for
Non-Clinical Studies as provided in Paragraph 3.8.3 as necessary and appropriate
or Paragraph 3.8.4 above must first sign Material Transfer Agreements (MTAs)
substantially in the form attached hereto as Appendix C that acknowledge the
proprietary nature of the Investigational Agent to Collaborator and include
intellectual property and publication provisions. Collaborator acknowledges that
the MTA attached hereto as Appendix C is acceptable to Collaborator. NCI will
notify Collaborator if an NCI Extramural Investigator wants to make any material
changes to such MTA (e.g., modifications to the confidentiality, publication,
indemnification or intellectual property provisions), and Collaborator will have
the right to approve or reject such changes. Investigational Agent will not be
distributed to an NCI Extramural Investigator for Non-Clinical Studies unless
and until such investigator signs an MTA that is acceptable to Collaborator.

3.8.6
Collaborator agrees to provide Investigational Agent to DCTD for DCTD to conduct
DCTD Clinical Support Assays [ * ]; provided, however, that the total amount of
Investigational Agent required to be provided by Collaborator to DCTD and used
to conduct DCTD Clinical Support Assays under this Paragraph 3.8.6 will [ * ].

3.8.7
Collaborator agrees to provide to the PMB the Investigator's Brochure (IB) for
Investigational Agent and all subsequent revisions/editions. In addition to
being filed with the CTEP IND, the IB will be on file in the PMB and will be
distributed to all NCI Investigators participating in a clinical trial using the
Investigational Agent under this CRADA. Distribution will be accompanied by a
statement about the confidentiality of the document and it is anticipated that
distribution will be electronic. All electronic distribution will be done using
Adobe Acrobat PDF. Any IB received by the PMB that is not in this format will be
converted before distribution. Hard copy IBs should be sent to IB Coordinator,
Pharmaceutical Management Branch, CTEP, DCTD, NCI, 6130 Executive Blvd, Room
7149, Rockville, MD 20852. Electronic versions should be emailed to the IB
Coordinator at IBCoordinator@mail.nih.gov.

3.9
Investigational Agent Delivery and Usage. Collaborator will ship the
Investigational Agent and, if required, Placebo for use in mutually agreed
Protocol(s) under the Research Plan to NCI or its designee in containers marked
in accordance with 21 C.F.R. § 312.6. NCI agrees that the Clinical Investigators
will keep appropriate records and take reasonable steps to ensure that the
Investigational Agent is used in accordance with the Protocol(s) and applicable
FDA regulations. In addition, NCI agrees that the

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amended.

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Investigational Agent (and all Collaborator Confidential Information relating to
the Investigational Agent) will be used solely for the conduct of the CRADA
research and development activities. Furthermore, NCI agrees that no analysis or
modification of the Investigational Agent will be performed without
Collaborator’s prior written consent. Upon the completion of the Research Plan
or termination of this Agreement, any unused quantity of Investigational Agent
will be returned to Collaborator or disposed as directed by Collaborator at
Collaborator’s expense. [ * ].

3.10    Auditing and Monitoring.

3.10.1    DCTD, NCI will be primarily responsible for monitoring Clinical
Research Sites and for assuring the quality of all clinical data, unless
otherwise stated in the Research Plan. Auditing will comply with the DCTD
guidelines as described on the CTEP website at:
http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring.htm. NCI clinical
trials must be conducted in accordance with Good Clinical Practices promulgated
by the FDA (“FDA GCP”).

3.10.2    Subject to the restrictions in Paragraph 8.10 concerning IPI, and with
reasonable advance notice and at reasonable times, IC will seek permission for
Collaborator or its designee(s) to access Clinical Research Sites to audit the
conduct of the research at times convenient to Clinical Research Sites, and to
obtain updates on ongoing clinical trials. Collaborator may also make
arrangements with IC to audit Raw Data and source documents, at the completion
of a Protocol and at Collaborator’s expense, to the extent necessary to verify
compliance with FDA GCP and the Protocol(s).

3.11
FDA Meetings/Communications. All formal meetings with the FDA concerning any
clinical trial within the scope of the Research Plan will be discussed by
Collaborator and IC in advance. The Parties acknowledge that day-to-day DCTD
communications with the FDA regarding clinical Protocols under the CRADA may not
be considered as formal meetings with the FDA. However, DCTD will inform and
discuss with Collaborator the outcome of informal communications. Each Party
reserves the right to take part in setting the agenda for, to attend, and to
participate in these meetings. The Sponsor of a clinical trial conducted under
this CRADA will provide the other Party with copies of FDA meeting minutes, all
transmittal letters for IND submissions, IND safety reports, formal questions
and responses that have been submitted to the FDA, Annual Reports, and official
FDA correspondence, pertaining either to the INDs for such clinical trial
conducted under this CRADA or to the Clinical Investigators on Protocols
performed in accordance with the Research Plan, except to the extent that those
documents contain the proprietary information of a third party or dissemination
is prohibited by law.

3.12
Steering Committee and CRADA Research. The Parties agree to establish a Steering
Committee comprising at least the NIH CRADA Extramural Investigator/Officers and
CRADA Collaborator PIs to conduct and monitor the proposed and ongoing clinical
studies and non-clinical research of the Investigational Agent in accordance
with the CRADA Research Plan. Members of the Steering Committee shall continue
to remain employed by their respective employers under their respective terms of
employment and, if a member ceases to be employed by a Party, such member shall
be replaced with a new member that is an employee of such Party.

In addition to the Steering Committee, a Project Team comprising NCI and
Collaborator scientific members for the purpose of discussing the DCTD Clinical
Support Assays will be assembled. This Project Team will be a collaborative body
responsible for reviewing and approving projects described under “Respective
Contributions of the Parties” of Appendix A of this CRADA, which outlines the
DCTD Clinical Support Assays. Manuscripts and presentations related to these
studies will be handled in accordance with Paragraph 8.7 of this CRADA.

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Additional CRADA information, including [ * ] shall remain on file with NCI.

Article 4.     Reports

4.1
Interim Research and Development Reports. The NIH CRADA Extramural
Investigator/Officers and CRADA Collaborator PIs should exchange information
regularly (e.g., at least [ * ], or as appropriate for the stage of the research
being conducted under the CRADA), in writing. This exchange may be accomplished
through meeting minutes, detailed correspondence, circulation of draft
manuscripts, Steering Committee reports, copies of Annual Reports and any other
reports updating the progress of the CRADA research. However, the Parties must
exchange updated Investigator’s Brochure, safety, formulation and preclinical
data, and toxicology findings related to the Investigational Agent as they
become available.

4.2
Final Research and Development Reports. IC will provide to Collaborator final
reports of the results of all studies conducted under the Research Plan as they
become available and, for those final reports that have not been provided by IC
during the term of the CRADA, within six (6) months after the expiration or
termination of this CRADA. These reports will set forth the technical progress
made; any publications arising from the research; and the existence of invention
disclosures of potential CRADA Subject Inventions and/or any corresponding
Patent Applications. [ * ].

4.3
Fiscal Reports. If Collaborator has agreed to provide funding to IC under this
CRADA and upon the request of Collaborator, then concurrent with the provision
of final research and development reports according to Paragraph 4.2, IC will
submit to Collaborator a statement of all costs incurred by IC for the CRADA. If
the CRADA has been terminated, IC will specify any costs incurred before the
date of termination for which IC has not received funds from Collaborator in
accordance with Paragraph 5.3, as well as for all reasonable termination costs
including the cost of returning Collaborator property or removal of abandoned
Collaborator property, for which Collaborator will be responsible.

4.4
Safety Reports. DCTD shall report all serious and unexpected possible, probable
and definite Adverse Events to the FDA in accordance with the reporting
obligations of 21 CFR 312.32 and will, within 24 hours of notification to the
FDA, forward a copy of all such reports to Collaborator. All other Adverse Event
reports received by DCTD shall be reported to the FDA consistent with 21 CFR
312.32 and 312.33. DCTD will forward a copy of such reports to Collaborator
(drugsafety@exelixis.com) within 24 hours of providing such reports to the FDA.
In the event that Collaborator informs the FDA or any other regulatory authority
of any serious and unexpected Adverse Events, Collaborator must notify the NCI
within 24 hours of informing the FDA or any other regulatory authority of such
Adverse Events by sending the reports to CTEPSupportAE@tech-res.com. NCI will
then notify the Clinical Investigator(s) conducting studies under DCTD-sponsored
Protocols, if appropriate.

4.5
Annual Reports. DCTD will provide to Collaborator a copy of the Annual Report
concurrently with the submission of the Annual Report to the FDA. Such Annual
Reports will be CRADA Data, and will be kept confidential by the Parties in
accordance with Article 8. Collaborator will provide DCTD with a copy of its
Annual Report to the FDA if Collaborator is sponsoring studies of
Investigational Agent under its own IND outside the scope of the Research Plan,
which Annual Report will be Collaborator Confidential Information.

Article 5.     Staffing, Financial, and Materials Obligations

5.1
IC and Collaborator Contributions. The contributions of any staff, funds,
materials, and equipment by the Parties are set forth in Appendix B. The Federal
Technology Transfer Act of 1986, 15 U.S.C. § 3710a(d)(1) prohibits IC from
providing funds to Collaborator for any research and development activities
under this CRADA.

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5.2
IC Staffing. No IC employees will devote 100% of their effort or time to the
research and development activities under this CRADA. IC will not use funds
provided by Collaborator under this CRADA for IC personnel to pay the salary of
any permanent IC employee. Although personnel hired by IC using CRADA funds will
focus principally on CRADA research and development activities, Collaborator
acknowledges that these personnel may nonetheless make contributions to other
research and development activities, and the activities will be outside the
scope of this CRADA. IC personnel will not use the Investigational Agent to
perform any research and development activities outside the scope of this CRADA.

5.3
Collaborator Funding. Collaborator acknowledges that Government funds received
by Collaborator from an agency of the Department of Health and Human Services
may not be used to fund IC under this CRADA. If Collaborator has agreed to
provide funds to IC then the payment schedule appears in Appendix B and
Collaborator will make payments according to that schedule. If Collaborator
fails to make any scheduled payment, IC will not be obligated to perform any of
the research and development activities specified herein or to take any other
action required by this CRADA until the funds are received. IC will use these
funds exclusively for the purposes of this CRADA. IC will maintain separate and
distinct current accounts, records, and other evidence supporting its financial
obligations under this CRADA and, upon written request, will provide to the
Collaborator a Fiscal Report according to Paragraph 4.3, which delineates all
payments made and all obligated expenses, along with the Final Research Report
described in Paragraph 4.2.

5.4
Capital Equipment. Collaborator’s commitment, if any, to provide IC with capital
equipment to enable the research and development activities under the Research
Plan appears in Appendix B. If Collaborator transfers to IC the capital
equipment or provides funds for IC to purchase it, then IC will own the
equipment. If Collaborator loans capital equipment to IC for use during the
CRADA, Collaborator will be responsible for paying all costs and fees associated
with the transport, installation, maintenance, repair, removal, or disposal of
the equipment, and IC will not be liable for any damage to the equipment.

Article 6.     Intellectual Property

6.1
Ownership of CRADA Subject Inventions, CRADA Data, and CRADA Materials. Subject
to the Collaborator option described in Paragraph 7.2, the Government license
described in Paragraph 7.5, the sharing requirements and the regulatory filing
requirements of Paragraphs 8.1 and 8.2, the producing Party will retain sole
ownership of and title to all CRADA Subject Inventions, all copies of CRADA
Data, Raw Data and all CRADA Materials, in each case produced solely by its
employee(s) or, in the case of Collaborator, produced solely by Collaborator’s
employees, contractors or agents. The Parties will own jointly (with each owning
an undivided interest) all CRADA Subject Inventions invented jointly by IC
employees together with employees, contractors or agents of Collaborator (“Joint
CRADA Subject Inventions”) and all CRADA Materials developed jointly by one or
more IC employees and one or more of Collaborator’s employees, contractors or
agents. The rights of any NCI Extramural Investigator in data it generates will
not be affected by this CRADA. The Parties acknowledge that the individuals
performing DCTD Clinical Support Assays will be NCI Intramural Investigators or
will be IC contractors who are obligated to assign any and all CRADA Subject
Inventions and related intellectual property to NIH, in which case such CRADA
Subject Inventions and related intellectual property are subject to the
Collaborator option described in Paragraph 7.2.

6.2
Reporting. The Parties will promptly report to each other in writing each CRADA
Subject Invention reported by their respective personnel, and any Patent
Applications filed thereon, resulting from the research and development
activities conducted under this CRADA. Each Party will report all CRADA Subject
Inventions to the other Party in sufficient detail to determine inventorship,
which will be determined in accordance with U.S. patent law. These reports will
be treated as Confidential Information in

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accordance with Article 8. Formal reports will be made by and to the Patenting
and Licensing Offices identified on the Contacts Information Page herein.

6.3
Filing of Patent Applications. Each Party will make timely decisions regarding
the filing of Patent Applications on the CRADA Subject Inventions made solely by
its employee(s), and will notify the other Party in advance of filing.
Collaborator will have the first opportunity to file a Patent Application on
Joint CRADA Subject Inventions and will notify PHS of its decision whether to
file within [ * ] of the applicable Invention being reported or at least thirty
(30) days before any patent filing deadline, whichever occurs sooner. If
Collaborator fails to notify PHS of its decision within that time period or
notifies PHS of its decision not to file a Patent Application, then PHS has the
right to file a Patent Application on the Joint CRADA Subject Invention. Neither
Party will be obligated to file a Patent Application. However, if PHS elects not
to file a Patent Application on a CRADA Subject Invention made solely by IC
employees, PHS may agree to permit Collaborator, at Collaborator’s election and
expense, to undertake the preparation, filing, prosecution, and maintenance of
such Patent Application and PHS will execute all documents and take such other
acts reasonably necessary to enable Collaborator to assume responsibility for
filing, prosecuting, and maintaining such Patent Application and any resulting
Patents. Such permissions will be at the discretion of the NIH OTT and will not
be unreasonably withheld. In the event that PHS elects to file a Patent
Application on a CRADA Subject Invention made solely by IC employees, PHS agrees
to use reasonable efforts to discuss a patent filing strategy with Collaborator
reasonably in advance of filing such Patent Application. Collaborator will place
the following statement in any Patent Application it files on a CRADA Subject
Invention: “This invention was created in the performance of a Cooperative
Research and Development Agreement with the National Institutes of Health, an
Agency of the Department of Health and Human Services. The Government of the
United States has certain rights in this invention.” If either Party files a
Patent Application on a Joint CRADA Subject Invention, then the filing Party
will include a statement within the Patent Application that clearly identifies
the Parties and states that the Joint CRADA Subject Invention was made under
this CRADA.

6.4
Patent Expenses. Unless agreed otherwise, the Party filing a Patent Application
will pay all preparation and filing expenses, prosecution fees, issuance fees,
post issuance fees, patent maintenance fees, annuities, interference expenses,
and attorneys’ fees for that Patent Application and any resulting Patent(s).
However, a Party will have the right to elect to cease prosecuting a Patent
Application or maintaining any resulting Patent(s) directed to a Joint CRADA
Subject Invention, provided that such Party provides at least[ * ] notice to the
other Party of such election and, if requested by the other Party, executes all
documents and takes such other acts reasonably necessary (e.g., assign its
interest) to enable the other Party to assume, at the other Party’s expense, the
responsibility for filing, prosecuting, and maintaining the Patent Application
and any resulting Patent(s). If a license to any CRADA Subject Invention is
granted to Collaborator pursuant to Paragraph 7.2(a)(i), 7.2(a)(ii) or Paragraph
7.2(c), then Collaborator will be responsible for all out-of-pocket expenses and
fees, past and future, in connection with the preparation, filing, prosecution,
and maintenance of any Patent Applications and Patents claiming exclusively
licensed CRADA Subject Inventions and will be responsible for a pro-rated share,
divided equally among all licensees, of those out-of-pocket expenses and fees
for non-exclusively licensed CRADA Subject Inventions. Collaborator may waive
its non-exclusive or exclusive option rights or disclaim its exclusive or
non-exclusive license for Patent Application(s) or Patent(s) at any time with
respect to one or more countries, and incur no subsequent financial obligation
for those Patent Application(s) or Patent(s).

6.5
Prosecution of Patent Applications. Except with respect to CRADA Subject
Inventions conceived and reduced to practice solely by Collaborator’s employees,
contractors or agents, the Party filing a Patent Application for a CRADA Subject
Invention will provide the non-filing Party with a copy of any official
communication relating to prosecution of the Patent Application within [ * ] of
transmission of the communication. Each Party will also provide the other Party,
at the other Party’s request, with copies of material documents retained in the
applicable Patent Application or Patent file for such Invention. The

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Parties agree to consult with each other regarding the prosecution of Patent
Applications directed to CRADA Subject Inventions made solely by IC employees
and CRADA Subject Inventions made jointly by IC employees together with
employees, contractors or agents of the Collaborator. If Collaborator elects to
file and prosecute Patent Applications on Joint CRADA Subject Inventions, then
Collaborator agrees to use the U.S.P.T.O. Customer Number Practice and/or grant
PHS a power(s) of attorney (or equivalent) necessary to assure PHS access to its
intellectual property rights in these Patent Applications. PHS and Collaborator
will cooperate with each other to obtain necessary signatures on Patent
Applications, assignments, or other documents.

Article 7.     Licensing

7.1
Background Inventions. Other than as specifically stated in this Article 7,
nothing in this CRADA will be construed to grant any rights in one Party’s
Background Invention(s) to the other Party, except to the extent necessary for
the Parties to conduct the research and development activities described in the
Research Plan during the term of the CRADA.

7.2
Collaborator’s License Option to CRADA Subject Inventions. With respect to
Government rights to any CRADA Subject Invention made solely by an IC
employee(s) or a Joint CRADA Subject Invention for which a Patent Application
has been filed, PHS hereby offers to the Collaborator the following options and
grants:

7.2(a). For CRADA Subject Inventions that would be described in Patent
Applications that claim the use and/or the composition of the Investigational
Agent(s): PHS hereby grants to Collaborator: (i) an option to elect a
royalty-free (except for patent prosecution and maintenance fees for Patent
Applications and Patents claiming such Inventions, which will be pro-rated and
divided equally among all licensees), world-wide, non-exclusive license for
commercial purposes with the right to sublicense to Affiliates or collaborators
working on behalf of Collaborator for Collaborator’s development purposes; (ii)
a time limited option to negotiate an exclusive, or co-exclusive, if applicable,
world-wide, royalty bearing license for commercial purposes, including the right
to grant sublicenses, on terms to be negotiated in good faith by the
Collaborator(s) and PHS; and (iii) at Collaborator’s request, a paid-up,
nonexclusive, royalty-free, world-wide license for research purposes only. NIH
retains the right to make and use any Inventions covered by this Paragraph
7.2(a) for all non-profit research, including for educational purposes and to
permit other educational and non-profit institutions to do so.

7.2(b). For CRADA Subject Inventions pursuant to research under this CRADA not
covered under Paragraph 7.2(a), including those that use non-publicly available
CRADA Data or specimens from patients treated with Investigational Agent under
the CRADA, (including specimens obtained from NCI CTEP-funded tissue banks) PHS
hereby grants to Collaborator: (i) a paid-up nonexclusive, nontransferable,
royalty-free, world-wide license for research purposes only; and (ii) a
nonexclusive, royalty-free, world-wide license to (a) disclose such Inventions
to a regulatory authority when seeking marketing authorization of the
Investigational Agent, and (b) disclose such Inventions on a product insert or
other promotional material regarding the Investigational Agent after having
obtained marketing authorization from a regulatory authority. Notwithstanding
the above, PHS is under no obligation to file a Patent Application or maintain
patent prosecution for any such Inventions.

7.2(c). In addition, for Inventions made by NIH’s Intramural Investigator(s) or
any other employees or agents of IC, which are or may be patentable or otherwise
protectable, as a result of research utilizing the Investigational Agent(s),
unreleased or non-publicly available CRADA Data or Investigational Agent-treated
specimens outside the scope of approval granted by the NCI CTEP (Unauthorized
Inventions): PHS agrees, at Collaborator's request, to grant to Collaborator a
royalty-free (except for all out of pocket Patent prosecution and maintenance
costs for Patent Applications and Patents claiming such inventions, which

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will be pro-rated and divided equally among all licensees) exclusive or
co-exclusive commercial license to Unauthorized Inventions. NIH will retain a
non-exclusive, sublicensable royalty free license to practice such Inventions
for Government purposes.

7.2(d). In addition to the license options to CRADA Subject Invention(s)
contained in Paragraphs 7.2(b) and 7.2(c) above, PHS hereby grants to
Collaborator an exclusive option to CRADA Subject Inventions to elect an
exclusive or nonexclusive commercialization license to such Inventions. The
field of use of this license option will not exceed the scope of the Research
Plan.
  
7.3
Exercise of Collaborator’s License Option. To exercise the option(s) or grant(s)
set forth in Paragraph 7.2, Collaborator must submit a written notice to the PHS
Patenting and Licensing Contact identified on the Contacts Information Page (and
provide a copy to the IC Contact for CRADA Notices) within three (3) months
after either (i) Collaborator receives written notice from PHS that a Patent
Application has been filed or (ii) the date on which Collaborator files a Patent
Application. The written notice exercising the option(s) will include a
completed “Application for License to Public Health Service Inventions” and will
initiate a negotiation period that expires [ * ] after the date of exercise of
the option. If PHS has not responded in writing to the last proposal by
Collaborator within this [ * ] period, the negotiation period will be extended
to expire one (1) month after PHS so responds, during which month Collaborator
may accept in writing the final license proposal of PHS. If PHS and Collaborator
fail to reach agreement within [ * ], (or such additional period as described
above) on the terms for an exclusive license for a particular Paragraph 7.2(a)
Invention, then for a period of [ * ] thereafter PHS agrees not to offer to
license the Paragraph 7.2(a) Invention to any third party on materially better
terms than those last offered to Collaborator without first offering such terms
to Collaborator, in which case Collaborator will have a period of [ * ] in which
to accept or reject the offer. In the absence of Collaborator’s exercise of the
option with respect to a CRADA Subject Invention, or upon election of a
nonexclusive license to such Invention, PHS will be free to license the CRADA
Subject Invention to others. These time periods may be extended at the sole
discretion of PHS upon good cause shown in writing by Collaborator, provided
that [ * ].

7.4
Government License in IC Sole CRADA Subject Inventions and Joint CRADA Subject
Inventions. Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions
owned solely by IC or Joint CRADA Subject Inventions and licensed pursuant to an
option in Paragraph 7.2, Collaborator grants to the Government a nonexclusive,
nontransferable, irrevocable, paid-up license to practice the CRADA Subject
Invention or have the CRADA Subject Invention practiced throughout the world by
or on behalf of the Government for research or other Government purposes. In the
exercise of this license, the Government will not publicly disclose trade
secrets or commercial or financial information that is privileged or
confidential within the meaning of 5 U.S.C. § 552(b)(4) or which would be
considered privileged or confidential if it had been obtained from a non-federal
party.

7.5
Government License in Collaborator Sole CRADA Subject Inventions. Pursuant to 15
U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made solely by an employee of
Collaborator, Collaborator grants to the Government a nonexclusive,
nontransferable, irrevocable, paid-up license to practice the CRADA Subject
Invention or have the CRADA Subject Invention practiced throughout the world by
or on behalf of the Government for research or other Government purposes. In the
exercise of this license, the Government will not publicly disclose trade
secrets or commercial or financial information that is privileged or
confidential within the meaning of 5 U.S.C. § 552(b)(4) or which would be
considered privileged or confidential if it had been obtained from a non-federal
party.

7.6
Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants
Collaborator an exclusive, or co-exclusive, license to a CRADA Subject Invention
made solely by an IC employee or a Joint CRADA Subject Invention, the Government
will retain the right to require Collaborator to grant to a responsible
applicant a nonexclusive, partially exclusive, or exclusive sublicense to use
the CRADA Subject Invention

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in Collaborator’s licensed field of use on terms that are reasonable under the
circumstances; or, if Collaborator fails to grant a license, to grant a license
itself. The exercise of these rights by the Government will only be in
exceptional circumstances and only if the Government determines (i) the action
is necessary to meet health or safety needs that are not reasonably satisfied by
Collaborator, (ii) the action is necessary to meet requirements for public use
specified by federal regulations, and such requirements are not reasonably
satisfied by Collaborator; or (iii) Collaborator has failed to comply with an
agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The
determination made by the Government under this Paragraph is subject to
administrative appeal and judicial review under 35 U.S.C. § 203(2).

7.7
Third-Party Rights In IC Sole CRADA Subject Inventions. For a CRADA Subject
Invention conceived prior to the Effective Date solely by an IC employee that is
first actually reduced to practice after the Effective Date in the performance
of the Research Plan, the option offered to Collaborator in Paragraph 7.2 may be
restricted if, prior to the Effective Date, PHS filed a Patent Application and
has either offered or granted a license in the CRADA Subject Invention to a
third party. Collaborator nonetheless retains the right to apply for a license
to any such CRADA Subject Invention in accordance with the terms and procedures
of 35 U.S.C. § 209 and 37 C.F.R. Part 404.

7.8
Joint CRADA Subject Inventions Not Exclusively Licensed by Collaborator. If
Collaborator does not acquire an exclusive commercialization license to a Joint
CRADA Subject Invention in all fields of use then, for those fields of use not
exclusively licensed to Collaborator, each Party will have the right to use the
Joint CRADA Subject Invention and to license its use to others, and each Party
will cooperate with the other, as necessary, to fulfill international licensing
requirements. The Parties may agree to a joint licensing approach for any
remaining fields of use.

Article 8.    Rights of Access and Publication

8.1
Right of Access to CRADA Data and CRADA Materials. IC and Collaborator agree to
exchange all CRADA Data and to share all CRADA Materials. Both Parties agree
that they will not disclose CRADA Data to third parties until it is published in
accordance with Paragraph 8.7, except as necessary to perform its obligations
under this CRADA or as expressly permitted in Paragraph 8.2. In addition, IC
represents that NCI Extramural Investigators are subject to obligations to keep
CRADA Data confidential until it is published in accordance with Paragraph 8.7.
If the CRADA is terminated, each Party agrees to provide CRADA Materials in
quantities needed to complete all active Protocols or Protocols that have
commenced or been approved by the PRC and Collaborator in accordance with the
procedures set forth in the Research Plan prior to such termination. Such
provision will occur before the termination date of the CRADA or sooner, if
required by the Research Plan. However, if a Party terminates the CRADA in
accordance with Paragraph 10.3 because of the other Party’s material breach, the
terminating Party will have no obligation to provide CRADA Materials for the
completion of the Research Plan. If Collaborator possesses any human biological
specimens from clinical trials under the CRADA, the specimens must be handled as
described in the Protocol or as otherwise directed by IC before the termination
date of the CRADA.

8.2
Use of CRADA Data and CRADA Materials. The Parties will be free to utilize CRADA
Data and CRADA Materials internally for their own purposes, consistent with
their obligations under this CRADA. IC may share CRADA Data or CRADA Materials
with any NCI Extramural Investigators it has engaged to conduct the CRADA
research and development activities, provided the obligations of this Paragraph
8.2 are simultaneously conveyed and such NCI Extramural Investigators agree to
comply with such obligations. Collaborator may share CRADA Data or CRADA
Materials with any contractors, Affiliates, collaboration/development partners
or agents it has engaged to conduct the CRADA research and development
activities, as well as with Collaborator’s licensees and contractors, provided
the obligations of this Paragraph 8.2 are simultaneously conveyed and such third
parties agree to comply with such obligations. In addition,

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Collaborator may share CRADA Data or CRADA Materials with governmental
regulatory authorities (including the FDA) for the purpose of developing,
seeking regulatory approval for and commercializing the Investigational Agent or
pharmaceutical products containing the Investigational Agent, including in
connection with regulatory filings. Collaborator shall not transfer CRADA Data
to any third party other than those set forth in this Paragraph without the
written permission of the NCI. Following NCI’s permission, Collaborator and such
third party shall enter into a Confidential Disclosure Agreement with
confidentiality terms at least as stringent as those set forth herein, and
Collaborator can then transfer the data to such third party.

8.2.1    CRADA Data, Raw Data and Secondary Data.
Collaborator and IC will use reasonable efforts to keep CRADA Data and Secondary
Data confidential until published as permitted under this CRADA or until
corresponding Patent Applications are filed. To the extent permitted by law,
each Party will have the right to use any and all CRADA Data in and for any
regulatory filing by or on behalf of the Party. NCI will make CRADA Data, Raw
Data and Secondary Data in NCI’s possession and control available to
Collaborator for its own use and for Collaborator’s use for seeking regulatory
approval to market and for commercialization of Investigational Agent and
pharmaceutical products containing Investigational Agent.

8.2.2    CRADA Materials.
Collaborator and IC will use reasonable efforts to keep descriptions of CRADA
Materials confidential until published as permitted under this CRADA or until
corresponding Patent Applications are filed and published. Collaborator
acknowledges that the basic research mission of PHS includes sharing with third
parties for further research those research resources made in whole or in part
with NIH funding. Consistent with this mission and the tenets articulated in
“Sharing of Biomedical Research Resources: Principles and Guidelines for
Recipients of NIH Research Grants and Contracts,” December 1999, available at
http://ott.od.nih.gov/NewPages/RTguide_final.html, following publication either
Party may make available to third parties for further research those CRADA
Materials made jointly by both PHS and Collaborator. Notwithstanding the above,
if those joint CRADA Materials are the subject of a pending Patent Application
or a Patent, or were created using a patent-pending or patented material or
technology, the Parties may agree to restrict distribution or freely distribute
them. Each Party may distribute those CRADA Materials made solely by the other
Party only upon written consent from that other Party or that other Party’s
designee.

8.3
Confidential Information. Each Party agrees to limit its disclosure of
Confidential Information to the amount necessary to carry out the Research Plan,
and will place a confidentiality notice on all this information. A Party orally
disclosing Confidential Information to the other Party will identify the
disclosure as confidential at the time of oral disclosure and summarize the
disclosure in writing and provide it to the other Party. Each Party receiving
Confidential Information agrees to use it only for the purposes described in the
Research Plan or as otherwise permitted in this Agreement. Either Party may
object to the designation of information as Confidential Information by the
other Party. Notwithstanding anything to the contrary in this CRADA, the
restrictions on use and disclosure of Confidential Information under this CRADA
shall not apply to Collaborator’s use and disclosure of Collaborator
Confidential Information or to IC’s use and disclosure of IC Confidential
Information.

8.4
Protection of Confidential Information. Confidential Information will not be
disclosed, copied, reproduced or otherwise made available by a Party to any
other person or entity without the other Party’s consent or as permitted under
this CRADA except as required by a court or administrative body of competent
jurisdiction, by federal or other applicable law or regulation, or as necessary
for Patent filings and/or prosecution in accordance with Article 6. A Party
shall be permitted to disclose Confidential

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Information consisting of information necessary for the safe handling, potential
hazards or cautionary warnings of Investigational Agent, and/or use of the
Investigational Agent or materials related to the Investigational Agent to those
individuals who have a need to know such information in connection with the
performance of the Research Plan. Each Party agrees to use reasonable efforts to
maintain the confidentiality of Confidential Information, which will in no
instance be less effort than the Party uses to protect its own Confidential
Information. Each Party agrees that a Party will not be liable for the
disclosure of that portion of the Confidential Information which, after notice
to and consultation with the other Party, such Party determines may not be
lawfully withheld, provided the other Party has been given a reasonable
opportunity to seek a court order to enjoin disclosure. Each Party will use
reasonable efforts to limit the disclosure and maintain confidentiality of
Confidential Information disclosed as permitted in this Paragraph 8.4 to the
extent possible. Disclosure of Confidential Information in accordance with this
Paragraph 8.4 will not otherwise affect the confidential nature of the
information.

8.5
Human Subject Protection. The research to be conducted under this CRADA involves
Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all
research to be performed under this CRADA will conform to applicable federal
laws and regulations. Additional information is available from the HHS Office
for Human Research Protections (http://www.hhs.gov/ohrp/).

8.6
Duration of Confidentiality Obligation. Collaborator Confidential Information
that is a trade secret, or commercial or financial information under the meaning
of 5 U.S.C. Section 552(b)(4), shall not be disclosed by IC. The obligation to
maintain the confidentiality of all Confidential Information will expire at the
earlier of the date when the information is no longer Confidential Information
as defined in Article 2 or [ * ] years after the expiration or termination date
of this CRADA, except for IPI, for which the obligation to maintain
confidentiality will extend indefinitely. Collaborator may request an extension
to this term when necessary to protect Confidential Information relating to
products not yet commercialized.

8.7
Publication. The Parties are encouraged to make publicly available the results
of their research and development activities. [ * ]. Before Collaborator or NCI
(including an NCI Investigator) submits a paper or abstract for publication
about a CRADA Subject Invention, CRADA Data, or CRADA Materials, the other Party
will have thirty (30) days to review proposed manuscripts and three (3) days to
review proposed abstracts to assure that Confidential Information is protected.
NCI will ensure that Collaborator Confidential Information identified by
Collaborator is excised from a proposed publication. Either Party may request in
writing that a proposed publication be delayed for up to thirty (30) additional
days as necessary to file a Patent Application. If a CRADA Subject Invention
disclosed in a proposed publication is solely owned by IC pursuant to Paragraph
6.1, NCI will refrain from publication of such proposed manuscript or
presentation until such time as PHS has filed a Patent Application covering such
invention. Manuscripts to be submitted for publication by NCI Investigators will
be sent to NCI’s Regulatory Affairs Branch NCICTEPpubs@mail.nih.gov for
forwarding to Collaborator for review as soon as they are received and in
compliance with the timelines outlined above. Abstracts to be presented by NCI
Investigators will be sent to NCI’s Regulatory Affairs Branch
NCICTEPpubs@mail.nih.gov for forwarding to Collaborator as soon as they are
received, preferably no less than [ * ] prior to submission, but prior to
presentation or publication, to allow for preservation of U.S. or foreign patent
rights. All publications made under this Paragraph 8.7 will contain an
appropriate acknowledgement of each Party’s contributions under this CRADA.

8.8
Clinical Investigators’ Research and Non-Clinical Investigators’ Development
Activities. In pursuing the development of Investigational Agent pursuant to
this CRADA, NCI may utilize NCI Extramural Investigators for part or all of the
completion of the Research Plan, which may cover Non-Clinical Studies and
clinical studies, through Funding Agreements and MTAs. Participation in
DCTD-sponsored clinical trials by NCI Extramural Investigators shall be
determined after competitive solicitation and review of Protocol Letters of
Intent (LOIs) and Protocols by CTEP, NCI and Collaborator. All Funding
Agreements

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and MTAs for the conduct of extramural Non-Clinical Studies and clinical trials
will include the Intellectual Property Option to Collaborator (including any
updates) (web site:
http://ctep.cancer.gov/industryCollaborations2/intellectual_property.htm).
Although this CRADA does not grant to Collaborator any rights to Inventions made
or Raw Data generated by NCI Extramural Investigators, as they are not parties
to this CRADA, NCI agrees that:

8.8.1
With regard to Collaborator Confidential Information, NCI will require the NCI
Investigators to agree to confidentiality provisions at least as restrictive as
those provided in this CRADA, and to Collaborator’s use of CRADA Data for
obtaining regulatory approval for marketing Investigational Agent or
pharmaceutical products containing Investigational Agent. In addition, NCI will
assure that the NCI Extramural Investigators are aware of their obligations to
provide to Collaborator Raw Data or any other data in the possession of NCI
Extramural Investigators working with Investigational Agent under a Funding
Agreement or MTA as requested by Collaborator in accordance with Paragraph
8.8.2.

8.8.2
If Collaborator wants access to Raw Data or any other data in the possession of
the NCI Investigators working with Investigational Agent under a Funding
Agreement or other agreements, Collaborator must first contact the Regulatory
Affairs Branch (RAB), CTEP, NCI Telephone 301-496-7912; anshers@mail.nih.gov.
Subsequent to authorization by RAB, which authorization will not be unreasonably
withheld, Collaborator may directly contact the NCI Investigators. Collaborator
will bear any costs associated with providing the Raw Data in formats customized
for Collaborator, which costs will be paid by Collaborator directly to the NCI
Investigators.

8.8.3
If Collaborator abandons development or commercialization of Investigational
Agent without the transfer of its development or commercialization efforts to
another party within [ * ] of abandonment, NCI has the right to make CRADA Data
and Raw Data available to a third party. NCI will notify Collaborator of its
intention to provide such data to a third party. For purposes of this Paragraph
8.8.3, Collaborator shall not be deemed to have abandoned development or
commercialization of Investigational Agent so long as either (a) Collaborator
devotes at least [ * ] to the development or commercialization of
Investigational Agent during [ * ], or (b) a third party is actively conducting
research relating to Investigational Agent under an agreement with Collaborator.

8.8.4
IC will promptly provide to Collaborator a copy of all Invention disclosures IC
receives from NCI Extramural Investigators.

8.8.5
If NCI discovers that an NCI Extramural Investigator that is conducting any
portion of the Research Plan breaches any of the provisions of its Funding
Agreement or MTA regarding its work with Investigational Agent, NCI will discuss
with Collaborator an appropriate resolution to such breach and shall take
appropriate action as necessary to rectify such breach.

8.9
Multi-Party Data Rights. For clinical Protocol(s) or Non-Clinical Study(ies)
under the Research Plan where Investigational Agent is used in combination with
another investigational agent supplied to NCI pursuant to a CTA or CRADA between
NCI and an entity not a Party to this CRADA (such entity, hereinafter referred
to as a “Third Party”) the access and use of Multi-Party Data by the
Collaborator and the Third Party shall be co-exclusive as follows:

8.9.1
NCI will provide both Collaborator and the Third Party with notice regarding the
existence and nature of the agreements governing their collaborations with NIH,
the design of the proposed combination Protocol(s) or Non-Clinical Study(ies),
and the existence of any obligations that

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might restrict NCI's participation in the proposed combination Protocols or
Non-Clinical Study(ies).

8.9.2
Collaborator shall agree to permit use of the Multi-Party Data from these trials
by the Third Party to the extent necessary to allow the Third Party to develop,
obtain regulatory approval for, or commercialize its own investigational
agent(s). However, this provision will not apply unless the Third Party also
agrees to Collaborator’s reciprocal use of Multi-Party Data.

8.9.3
Collaborator and the Third Party must agree in writing prior to the commencement
of the combination Protocol(s) by signing the drug approval form for clinical
studies or Non-Clinical Study(ies) that each will use the Multi-Party Data
solely for the development, regulatory approval, and commercialization of its
own investigational agent(s).

8.10
Access, review and receipt of Identifiable Private Information. Collaborator
access to and review of Identifiable Private Information shall be only for
on-site quality auditing, or as necessary for purposes of satisfying FDA or
other health authorities' reporting requirements, and for internal research
purposes, directly related to obtaining regulatory approval of Investigational
Agent. Collaborator is prohibited from access, review, receipt, or use of such
information for other purposes. All IRB approved Protocols and informed consent
documents related to this research project will clearly describe this practice.
The Protocol and the informed consent must clearly state (i) the existence of
the Collaborator; (ii) the Collaborator's access to and permitted uses of
Identifiable Private Information; and (iii) the extent to which confidentiality
will be maintained. For clinical Protocol(s) involving a Third Party, the other
party's access, review, receipt, or use of Identifiable Private Information
shall be subject to the same limitations as described in this Paragraph 8.10.

Article 9.     Representations and Warranties

9.1
Representations of IC. IC hereby represents to Collaborator that:

9.1.1
IC has the requisite power and authority to enter into this CRADA and to perform
according to its terms, and that IC’s official signing this CRADA has authority
to do so.

9.1.2
To the best of its knowledge and belief, neither IC nor any of its personnel
involved in this CRADA is presently subject to debarment or suspension by any
agency of the Government. Should IC or any of its personnel involved in this
CRADA be debarred or suspended during the term of this CRADA, IC will notify
Collaborator within thirty (30) days of receipt of final notice. IC requires all
NCI Extramural Investigators performing any part of the Research Plan to assure
that they and their respective personnel involved in the performance of the
Research Plan are not subject to debarment or suspension by any agency of the
Government, and to notify IC if they or any of their personnel involved in the
performance of the Research Plan are debarred or suspended during the term of
the CRADA. IC will notify Collaborator promptly if it receives notice that any
NCI Extramural Investigators performing any part of the Research Plan are
debarred or suspended.

9.2
Representations and Warranties of Collaborator. Collaborator hereby represents
and warrants to IC that:

9.2.1
Collaborator has the requisite power and authority to enter into this CRADA and
to perform according to its terms, and that Collaborator’s official signing this
CRADA has authority to do so.

  
9.2.2
Neither Collaborator nor any of its personnel involved in this CRADA, including
Affiliates, agents, and contractors, are presently subject to debarment or
suspension by any agency of the

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Government. Should Collaborator or any of its personnel involved in this CRADA
be debarred or suspended during the term of this CRADA, Collaborator will notify
IC within thirty (30) days of receipt of final notice.

9.2.3
Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to
provide funding under Appendix B, Collaborator is financially able to satisfy
these obligations in a timely manner.

9.2.4
The Investigational Agent provided for use in clinical studies under the
Research Plan has been produced in accordance with the FDA’s current Good
Manufacturing Practices set out in 21 C.F.R. §§ 210-211, and ICH Q7, and meets
the specifications cited in the Certificate of Analysis and Investigator’s
Brochure provided.

Article 10.     Expiration and Termination

10.1
Expiration. Unless terminated earlier as permitted in this CRADA, this CRADA
will expire on the last date of the term set forth on the Summary Page. In no
case will the term of this CRADA extend beyond the term indicated on the Summary
Page unless it is extended in writing in accordance with Paragraph 13.6.

10.2
Termination by Mutual Consent. IC and Collaborator may terminate this CRADA at
any time by mutual written consent.

10.3
Unilateral Termination. Either IC or Collaborator may unilaterally terminate
this CRADA (a) at any time by providing written notice at least sixty (60) days
before the desired termination date; or (b) upon written notice in the event of
a material breach by the other Party that has not been cured within [ * ] after
the breaching Party’s receipt of a written notice of such breach provided in
accordance with Paragraph 13.8; or (c) immediately upon written notice for Human
Subject safety concerns. IC may, at its option, retain funds transferred to IC
before unilateral termination by Collaborator for use in completing the Research
Plan. If Collaborator terminates this Agreement under subclause (a) of this
Paragraph before the completion of all active Protocol(s) or Protocol(s) that
have been approved by the PRC and Collaborator in accordance with the procedures
set forth in the Research Plan, then Collaborator will supply enough
Investigational Agent (and Placebo, if applicable) to complete these
Protocol(s).

10.4
Funding for IC Personnel. If Collaborator has agreed to provide funding for IC
personnel and this CRADA is unilaterally terminated by Collaborator before its
expiration for any reason other than for an uncured material breach or Human
Subject safety concerns, then Collaborator agrees that funds for that purpose
will be available to IC for a period of six (6) months after the termination
date or until the expiration date of the CRADA, whichever occurs sooner. If
there are insufficient funds to cover this expense, Collaborator agrees to pay
the difference.

10.5
New Commitments. Neither Party will incur new expenses related to this CRADA
after expiration, or mutual termination, or a notice of a unilateral termination
and will, to the extent feasible, cancel all outstanding commitments and
contracts by the termination date. Collaborator acknowledges that IC will have
the authority to retain and expend any funds previously paid by Collaborator for
up to two and one-half (2.5) years subsequent to the expiration or termination
date to cover any unpaid costs obligated during the term of the CRADA in
undertaking the research and development activities set forth in the Research
Plan.

 
Article 11.     Disputes

11.1
Settlement. Any dispute arising under this CRADA which is not disposed of by
agreement of the NIH CRADA Extramural Investigator/Officers and CRADA
Collaborator PIs will be submitted jointly to the

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signatories of this CRADA. If the signatories, or their designees, are unable to
jointly resolve the dispute within thirty (30) days after notification thereof,
the Assistant Secretary for Health (or his/her designee or successor) will
propose a resolution. Nothing in this Paragraph will prevent any Party from
pursuing any additional administrative remedies that may be available and, after
exhaustion of such administrative remedies, pursuing all available judicial
remedies.

11.2
Continuation of Work. Pending the resolution of any dispute or claim pursuant to
this Article 11, the Parties agree that performance of all obligations will be
pursued diligently.

Article 12.     Liability

12.1
NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO
EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING THE
CONDITIONS OF THE RESEARCH OR ANY INVENTION OR MATERIAL, WHETHER TANGIBLE OR
INTANGIBLE, MADE OR DEVELOPED UNDER OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE
OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH
OR ANY INVENTION, MATERIAL OR INVESTIGATIONAL AGENT, OR THAT A TECHNOLOGY OR
INVESTIGATIONAL AGENT UTILIZED BY A PARTY IN THE PERFORMANCE OF THE RESEARCH
PLAN DOES NOT INFRINGE ANY THIRD-PARTY PATENT RIGHTS.

12.2
Indemnification and Liability. No indemnification for any loss, claim, damage,
or liability is intended or provided by any Party under this Agreement. Each
Party will be liable for any loss, claim, damage or liability that said Party
incurs in connection with or as a result of its activities under this CRADA,
except that IC, as an agency of the Government, assumes liability only to the
extent provided under the Federal Tort Claims Act , 28 U.S.C. Chapter 171.

12.3
Force Majeure. Neither Party will be liable for any unforeseeable event beyond
its reasonable control and not caused by its own fault or negligence, which
causes the Party to be unable to perform its obligations under this CRADA, and
which it has been unable to overcome by the exercise of due diligence. If a
force majeure event occurs, the Party unable to perform will promptly notify the
other Party. It will use its diligent efforts to resume performance as quickly
as possible and will suspend performance only for such period of time as is
necessary as a result of the force majeure event.

Article 13.     Miscellaneous

13.1
Governing Law. The construction, validity, performance and effect of this CRADA
will be governed by U.S. federal law, as applied by the federal courts in the
District of Columbia. If any provision in this CRADA conflicts with or is
inconsistent with any U.S. federal law or regulation, then the U.S. federal law
or regulation will preempt that provision.

13.2
Compliance with Law. IC and Collaborator agree that they will comply with, and
advise any individuals they have engaged to conduct the CRADA research and
development activities to comply with, all applicable Executive Orders,
statutes, and HHS regulations relating to research on human subjects (45 C.F.R.
Part 46, 21 C.F.R. Parts 50 and 56) and relating to the appropriate care and use
of laboratory animals (7 U.S.C. §§ 2131 et seq.; 9 C.F.R. Part 1, Subchapter A),
including all applicable federal regulations for the protection of Human
Subjects, which may include the Standards for Privacy of Individually
Identifiable Health Information set forth in 45 C.F.R. Part 164. Collaborator
agrees to ensure that its employees, contractors, and agents who might have
access to a “select agent or toxin” (as that term is defined in 42 C.F.R. §§
73.4-73.5) transferred from IC is properly licensed to receive the “select agent
or toxin.”

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13.3
Waivers. None of the provisions of this CRADA will be considered waived by any
Party unless a waiver is given in writing to the other Party. The failure of a
Party to insist upon strict performance of any of the terms and conditions
hereof, or failure or delay to exercise any rights provided herein or by law,
will not be deemed a waiver of any rights of any Party.

13.4
Headings. Titles and headings of the articles and paragraphs of this CRADA are
for convenient reference only, do not form a part of this CRADA, and will in no
way affect its interpretation.

13.5
Severability. The illegality or invalidity of any provisions of this CRADA will
not impair, affect, or invalidate the other provisions of this CRADA.

13.6
Amendments. Minor modifications to the Research Plan may be made by the mutual
written consent of the NIH CRADA Extramural Investigator/Officers and CRADA
Collaborator PIs. Substantial changes to the CRADA Research Plan, changes to the
CRADA including extensions of the term, or any changes to the model template MTA
will become effective only upon a written amendment signed by the signatories to
this CRADA or by their representatives duly authorized to execute an amendment.
A change will be considered substantial if it directly expands the range of the
potential CRADA Subject Inventions, alters the scope or field of any license
option governed by Article 7, or requires a significant increase in the
contribution of resources by either Party.

13.7
Assignment. Neither this CRADA nor any rights or obligations of any Party
hereunder shall be assigned or otherwise transferred by either Party without
written notification of the other Party in accordance with Paragraph 13.8. The
Collaborator acknowledges the applicability of 41 U.S.C. § 15, the Anti
Assignment Act, to this Agreement.  The Parties agree that the identity of
the Collaborator is material to the performance of this CRADA and that the
duties under this CRADA are nondelegable.

13.8
Notices. All notices pertaining to or required by this CRADA will be in writing,
signed by an authorized representative of the notifying Party, and delivered by
first class registered or certified mail by U.S. Postal Service with return
receipt, or by an express/overnight commercial delivery service, prepaid and
properly addressed to the other Party at the address designated on the Contacts
Information Page, or to any other address designated in writing by the other
Party. Notices will be considered timely if received on or before the
established deadline date or sent on or before the deadline date as verifiable
by U.S. Postal Service postmark or dated receipt from a commercial carrier.
Notices regarding the exercise of license options will be made pursuant to
Paragraph 7.3. Either Party may change its address by notice given to the other
Party in the manner set forth above. All notices will be deemed to have been
given on the date received, as evidenced by return receipt of the records of the
U.S. Postal Service or other delivery service, as applicable.

13.9
Independent Contractors. The relationship of the Parties to this CRADA is that
of independent contractors and not agents of each other or joint venturers or
partners. Each Party will maintain sole and exclusive control over its personnel
and operations. If Collaborator elects to perform any portion of the Research
Plan through contractors or consultants, Collaborator agrees to incorporate into
such contract all provisions necessary to ensure that the work of such
contractor(s) or consultant(s) is governed by the terms of the CRADA, including,
but not limited to a provision for the assignment of inventions of the
contractor(s) or consultant(s) to the Collaborator.

In conducting a portion of the CRADA research, it may be necessary for NCI to
utilize the services of NCI Extramural Investigators. As described in Paragraph
8.8, these NCI Extramural Investigators perform under Funding Agreements or
MTAs, which include an Intellectual Property Option to Collaborator (web site:
http://ctep.cancer.gov/industryCollaborations2/default.htm#guidelines_for_collaborations).
The other NCI contractors performing the DCTD Clinical Support Assays, are
subject to a Determination of Exceptional Circumstances (35 U.S.C. §
202(a)(ii)), through which their rights in Inventions made using

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the Investigational Agent are assigned to the Government. Such Inventions are
then subject to the terms of this CRADA as if they were conceived and reduced to
practice by IC employees.

13.10
Use of Name; Press Releases. By entering into this CRADA, the Government does
not directly or indirectly endorse any product or service that is or will be
provided, whether directly or indirectly related to either this CRADA or to any
patent or other intellectual-property license or agreement that implements this
CRADA by Collaborator, its successors, assignees, or licensees. Collaborator
will not in any way state or imply that the Government or any of its
organizational units or employees endorses any product or services. Each Party
agrees to provide proposed press releases that reference or rely upon the work
under this CRADA to the other Party for review and comment at least five (5)
business days before publication. Either Party may disclose the Title and
Abstract of the CRADA to the public without the approval of the other Party.

13.11
Reasonable Consent. Unless otherwise expressly provided in this CRADA, whenever
a Party’s consent or permission is required under this CRADA, its consent or
permission will not be unreasonably withheld or delayed.

13.12
Export Controls. Collaborator agrees to comply with U.S. export law and
regulations, including 21 U.S.C. 382 and 21 CFR Part 312.110. If Collaborator
has a need to transfer any CRADA Materials made in whole or in part by IC, or IC
Materials, or IC Confidential Information to a person located in a country other
than the United States, to an Affiliate organized under the laws of a country
other than the United States, or to an employee of Collaborator in the United
States who is not a citizen or permanent resident of the United States,
Collaborator will acquire any and all necessary export licenses and other
appropriate authorizations.

13.13
Entire Agreement. This CRADA constitutes the entire agreement between the
Parties concerning the subject matter of this CRADA and supersedes any prior
understanding or written or oral agreement with respect thereto, including the
Confidential Disclosure Agreement entered into between Exelixis and The National
Cancer Institute effective March 19, 2010 (the “CDA”). For clarity, this CRADA
only supersedes the CDA with respect to Confidential Information (as such term
is defined in Section 1 of the CDA) disclosed by or on behalf of Collaborator
related to the Investigational Agent and/or drug development programs for
Investigational Agent, such that all such Confidential Information disclosed
under the CDA shall be deemed Collaborator Confidential Information under this
CRADA. The CDA shall remain in effect with respect to all Confidential
Information disclosed or to be disclosed by or on behalf of Collaborator related
to other Collaborator drug development candidates and/or programs.

13.14
Survivability. The provisions of Paragraphs 3.3, 3.4, 3.7.3, 3.9, 3.10, 3.11,
4.2, 4.3, 4.4, 4.5 (for so long as IC is sponsoring clinical studies of the
Investigational Agent under the CRADA), 5.3, 5.4, 6.1-8.10, 10.3-10.5, 11.1,
11.2, 12.1-12.3, 13.1-13.3, 13.5, 13.6, 13.8, 13.9, 13.10 and 13.14 will survive
the expiration or early termination of this CRADA.

SIGNATURES BEGIN ON THE NEXT PAGE

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SIGNATURE PAGE

ACCEPTED AND AGREED

BY EXECUTING THIS AGREEMENT, EACH PARTY REPRESENTS THAT ALL STATEMENTS MADE
HEREIN ARE TRUE, COMPLETE, AND ACCURATE TO THE BEST OF ITS KNOWLEDGE.
COLLABORATOR ACKNOWLEDGES THAT IT MAY BE SUBJECT TO CRIMINAL, CIVIL, OR
ADMINISTRATIVE PENALTIES FOR KNOWINGLY MAKING A FALSE, FICTITIOUS, OR FRAUDULENT
STATEMENT OR CLAIM.

FOR IC:

/s/ JAMES H. DOROSHOW, M.D.
 
9/29/2011
James H. Doroshow, M.D.
Deputy Director, National Cancer Institute
 
Date

FOR COLLABORATOR:

/s/ MICHAEL M. MORRISSEY, Ph.D
 
10/5/2011
Signature
 
Date
 
 
 
Typed Name: Michael M. Morrissey, Ph.D
Title: President & CEO
 
 

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CONTACTS INFORMATION PAGE

CRADA Notices

For IC:
For Collaborator:

[ * ]

[ * ]

Patenting and Licensing

For IC:
For Collaborator (if separate from above):

[ * ]

[ * ]

Delivery of Materials Identified In Appendix B (if any)

For IC:
For Collaborator:

N/A

N/A

    

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SUMMARY PAGE

EITHER PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION,
RELEASE THIS SUMMARY PAGE TO THE PUBLIC.

TITLE OF CRADA:    Clinical Development of Exelixis, Inc.’s Proprietary
Cabozantinib (XL184), a MET and Vascular Endothelial Growth Factor Receptor 2
(VEGFR2)/(Kinase Insert Domain Receptor (KDR) inhibitor, as an Anti-Cancer
Agent.

PHS [ * ] Component:
National Cancer Institute

NIH CRADA Extramural Investigator/ [ * ]
Officer(s):

Collaborator:
Exelixis, Inc.

CRADA Collaborator Principal Investigator:
[ * ]

            
Term of CRADA:
five (5) years from the Effective Date

ABSTRACT OF THE RESEARCH PLAN:
Exelixis, Inc. and the National Cancer Institute have entered into a Cooperative
Research and Development Agreement (“CRADA”) under which they will collaborate
on the non-clinical and clinical development of Exelixis Inc.’s proprietary
Cabozantinib (XL184), a MET and VEGFR2/KDR inhibitor, as an anti-cancer
agent.            
                                                    
                                                    
                                                    

                                      

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APPENDIX A: RESEARCH PLAN

Title of CRADA
Clinical Development of Exelixis Inc.’s Proprietary Cabozantinib (XL184), a MET
and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2)/Kinase Insert Domain
Receptor (KDR) inhibitor, as an Anti-Cancer Agent

[ * ]
{Redacted content comprises approximately 9 pages}

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APPENDIX B

Financial and Staffing Contributions of the Parties

For NIH:

[ * ]

For Collaborator:

[ * ] {Redacted content comprises approximately 2 pages}

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APPENDIX C
MATERIAL TRANSFER AGREEMENT

Provider:     Division of Cancer Treatment and Diagnosis, National Cancer
Institute

Recipient:
University School of Medicine

Recipient’s Investigator: Dr. John Doe, Ph.D., as an employee of the University
School of Medicine

1. Provider agrees to transfer to Recipient's Investigator the following
Research Material:

xxxxx mg of XL184 (cabozantinib), an agent proprietary to Exelixis, Inc.
(Collaborator)

2. THIS RESEARCH MATERIAL MAY NOT BE USED IN HUMANS. The Research Material will
only be used for research purposes by Recipient's Investigator in his/her
laboratory, for the Research Project described below, under suitable containment
conditions. This Research Material will not be used by for-profit recipients for
screening, production or sale, for which a commercialization license may be
required. Recipient agrees to comply with all Federal rules and regulations
applicable to the Research Project and the handling of the Research Material.

2(a). Is Research Material of human origin?

Yes
No

2(b). If yes in 2(a), was Research Material collected according to 45 CFR Part
46, "Protection of Human Subjects"?

Yes (Please provide Assurance Number: )
No
Not Applicable

3. This Research Material will be used by Recipient's Investigator solely in
connection with the following research project ("Research Project") described
with specificity as follows (use an attachment page if necessary):

This Research Material will be used for preclinical studies investigating the
effects of the Research Material in a cancer cell line.

3(a). Are any materials used in the Research Project of human origin?

Yes
No

3(b). If yes in 3(a), were human-origin materials collected according to 45 CFR
Part 46, "Protection of Human Subjects"?

Yes (Please provide Assurance Number: )
No
Not Applicable

4. (a). To the extent permitted by law, Recipient agrees to treat in confidence,
for a period of five (5) years from the date of its disclosure, any of
Provider's or Collaborator’s written information about this Research Material

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amended.

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that is stamped "CONFIDENTIAL" (the “Confidential Information”) except for
information that was previously known to Recipient or that is or becomes
publicly available or which is disclosed to Recipient without a confidentiality
obligation. Any oral disclosures to Recipient shall be identified as being
CONFIDENTIAL by written notice delivered to Recipient within thirty (30) days
after the date of the oral disclosure, and shall be Confidential Information
hereunder.

4. (b). Recipient may publish or otherwise publicly disclose the results of the
Research Project, however Collaborator will have thirty (30) days to review
proposed manuscripts and three (3) days to review proposed abstracts to assure
that Confidential Information is protected, except when a shortened time period
under court order or the Freedom of Information Act pertains. Collaborator may
request in writing that a proposed publication be delayed for up to thirty (30)
additional days as necessary to file a Patent Application. Manuscripts to be
submitted for publication by Recipient’s Investigator will be sent to NCI’s
Regulatory Affairs Branch [NCICTEPpubs@mail.nih.gov] for forwarding to
Collaborator for review as soon as they are received and in compliance with the
timelines outlined above. Abstracts to be presented by Recipient’s Investigator
will be sent to NCI’s Regulatory Affairs Branch [NCICTEPpubs@mail.nih.gov] for
forwarding to Collaborator as soon as they are received, preferably no less than
three days prior to submission, but prior to presentation or publication, to
allow for preservation of U.S. or foreign patent rights. In all oral
presentations or written publications concerning the Research Project, Recipient
will acknowledge Provider's or Collaborator’s contribution of this Research
Material unless requested otherwise.

5. This Research Material is proprietary to Collaborator. Collaborator has
agreed to allow NCI to make its proprietary compound available for this Research
Project. Recipient's Investigator agrees to retain control over this Research
Material and further agrees not to transfer the Research Material to other
people not under her or his direct supervision without advance written approval
of Provider. When the Research Project is completed or terminated, the Research
Material will be disposed of, if directed by Provider.

6. This Research Material is provided as a service to the research community. IT
IS BEING SUPPLIED TO RECIPIENT WITH NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Provider
and Collaborator make no representations that the use of the Research Material
will not infringe any patent or proprietary rights of third parties.

7. Recipient shall retain title to any patent or other intellectual property
rights in inventions made by its employees in the course of the Research
Project. Recipient agrees not to claim, infer, or imply endorsement by the
Government of the United States of America (hereinafter referred to as
"Government") of the Research Project, the institution or personnel conducting
the Research Project or any resulting product(s). Unless prohibited by law from
doing so, Recipient agrees to hold the Government and Collaborator harmless and
to indemnify the Government and Collaborator for all liabilities, demands,
damages, expenses and losses arising out of Recipient's use for any purpose of
the Research Material.

8. The undersigned Provider and Recipient expressly certify and affirm that the
contents of any statements made herein are truthful and accurate.    

9. This MTA shall be construed in accordance with Federal law as applied by the
Federal courts in the District of Columbia.

10. Results of the Research Project shall be provided to the Provider and
Collaborator. Publications shall be provided to Provider and Collaborator as
described in Article 4(b).

11. Recipient (“Institution”) agrees to notify Provider and Collaborator upon
the filing of any patent applications related to research with this Research
Material under this Agreement and abide by the following terms of the
Intellectual Property Option to Collaborator:

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Institution agrees to promptly notify the Provider (NCI) and Collaborator in
writing of any inventions, discoveries or innovations made by the Recipient’s
Investigator or any other employees or agents of Institution, whether patentable
or not, which are conceived or first actually reduced to practice pursuant to
the Research Project.

For inventions described in patent disclosures that claim the use and/or the
composition of the Research Material(s) (Section A Inventions), Institution
hereby grants to Collaborator(s): (i) a royalty-free, worldwide, non-exclusive
license for commercial purposes with the right to sublicense to affiliates,
contractors, licensees or collaborators working on behalf of Collaborator for
Collaborator’s or Collaborator’s licensees’ development or commercialization
purposes; and (ii) a time limited first option to negotiate an exclusive, or
co-exclusive, if applicable, world-wide, royalty bearing license for commercial
purposes, including the right to grant sublicenses, subject to any rights of the
Government of the United States of America, on terms to be negotiated in good
faith by the Collaborator(s) and Institution. If Collaborator accepts the
non-exclusive commercial license, the Collaborator agrees to pay all out of
pocket patent prosecution and maintenance costs which will be pro-rated and
divided equally among all licensees. If Collaborator obtains an exclusive
commercial license, in addition to any other agreed upon licensing arrangements
such as royalties and due diligence requirements, the Collaborator agrees to pay
all out of pocket patent prosecution and maintenance costs. Collaborator(s) will
notify Institution, in writing, if it is interested in obtaining a commercial
license to any Section A Invention within three (3) months of Collaborator’s
receipt of a patent application or six (6) months of receipt of an invention
report notification of such a Section A Invention. In the event that
Collaborator fails to so notify Institution, or elects not to obtain an
exclusive license, then Collaborator’s option expires with respect to that
Section A Invention, and Institution will be free to dispose of its interests in
accordance with its policies. If Institution and Collaborator fail to reach
agreement within ninety (90) days, (or such additional period as Collaborator
and Institution may agree) on the terms for an exclusive license for a
particular Section A Invention, then for a period of three (3) months thereafter
Institution agrees not to offer to license the Section A Invention to any third
party on materially better terms than those last offered to Collaborator without
first offering such terms to Collaborator, in which case Collaborator will have
a period of thirty (30) days in which to accept or reject the offer. If
Collaborator elects to negotiate an exclusive commercial license to a Section A
Invention, then Institution agrees to file and prosecute patent application(s)
diligently and in a timely manner and to give Collaborator an opportunity to
comment on the preparation and filing of any such patent application(s).
Notwithstanding the above, Institution is under no obligation to file or
maintain patent prosecution for any Section A Invention.

For those inventions not covered by Section A, but are nevertheless conceived or
first actually reduced to practice pursuant to the Research Project and to those
inventions that are conceived or first actually reduced to practice pursuant to
the Research Project that use non-publicly available clinical data or specimens
from patients treated with the NCI-provided Research Material (including
specimens obtained from NCI DCTD-funded tissue banks) (Section B Inventions),
Institution agrees to grant the following to the collaborator: (i) a paid-up
nonexclusive nontransferable, royalty-free, world-wide license to all Section B
Inventions for research purposes only; and (ii) a nonexclusive, royalty-free,
world-wide license to (a) disclose Section B Inventions to a regulatory
authority when seeking marketing authorization of the Research Material and (b)
disclose Section B Inventions on a product insert or other promotional material
regarding the Research Material after having obtained marketing authorization
from a regulatory authority. Notwithstanding the above, Institution is under no
obligation to file or maintain patent prosecution for any Section B Invention.

For all Section A and Section B Inventions, regardless of Collaborator’s
decision to seek a commercial license, Institution agrees to grant Collaborator
a paid-up, nonexclusive, royalty-free, world-wide license for research purposes
only. Institution retains the right to make and use any Section A Invention for
all non-profit research, including for educational purposes and to permit other
educational and non-profit institutions to do so.

Institution agrees, at Collaborator's request and expense, to grant to
Collaborator a royalty-free exclusive or co-exclusive license to inventions made
by Institution’s Investigator(s) or any other employees or agents of
Institution, which are or may be patentable or otherwise protectable, as a
result of research utilizing the Research Material(s) outside

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the scope of the NCI DCTD Research Project (Unauthorized Inventions).
Institution will retain a non-exclusive, non-sub-licensable royalty free license
to practice the invention for research use purposes.

Institution agrees to promptly notify NCI DCTD (NCICTEPpubs@mail.nih.gov) and
Collaborator(s) in writing of any Section A Inventions, Section B Inventions,
and Unauthorized Inventions upon the earlier of: (i) any submission of any
invention disclosure to Institution of a Section A, Section B, or Unauthorized
Invention, or (ii) the filing of any patent applications of a Section A, Section
B, or Unauthorized Invention. Institution agrees to provide a copy of either the
invention disclosure or the patent application to the Collaborator and to NCI
DCTD, which will treat it in accordance with 37 CFR Part 401. These requirements
do not replace any applicable reporting requirements under the Bayh-Dole Act, 35
USC 200-212, and implementing regulations at 37 CFR Part 401.

12. This Agreement shall terminate two (2) years from the date of the last
signature below. However, this Agreement may be terminated upon written notice
to Institution if the Institution materially breaches any of its obligations
hereunder and fails to cure such breach within thirty (30) days after receiving
written notice of such breach. The provisions of Sections 4, 5, 7, 9, 10, 11, 12
and 13 will survive the termination of this Agreement.

13. Collaborator is a third party beneficiary under this Agreement and has the
right, but is not required, to enforce the provisions of this Agreement.

Signatures Begin on Next Page

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SIGNATURES

RECIPIENT

________________     _________________________________________
Date
John Doe, Ph.D.        

    

________________     _________________________________________
Date
Authorized Signature for Recipient and Title

Recipient's Official and Mailing Address:

John Doe, Ph.D.
Associate Professor
Department of Biochemistry
University School of Medicine
City, State, Zip
Phone:

NATIONAL CANCER INSTITUTE
                                        

________________     _________________________________________     
Date
Sherry Ansher, Ph.D.

Associate Chief, Agreement Coordination Group    

________________
_________________________________________

Date                Jason Cristofaro, J.D., Ph.D.
CTEP Alternate Technology Development Coordinator

Please address all correspondence related to this agreement to Sally Hausman at
the following address by express mail:

Sally Hausman
Senior Specialist, Research and Development Agreements
Regulatory Affairs Branch
Cancer Therapy Evaluation Program
Executive Plaza North, Suite 7111
6130 Executive Blvd.
Rockville, MD 20852-7181

Any false or misleading statements made, presented, or submitted to the
Government, including any relevant omissions, under this Agreement and during
the course of negotiation of this Agreement are subject to all applicable civil
and criminal statutes including Federal statutes 31 U.S.C. '' 3801‑3812 (civil
liability) and 18 U.S.C. ' 1001 (criminal liability including fine(s) and/or
imprisonment).

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.