OTHER TRANSACTION AUTHORITY
FOR PROTOTYPE
AGREEMENTBETWEEN

Rigel Pharmaceuticals Inc. (Awardee)1180 Veterans Blvd.,
South San Francisco, CA 94080
DUNS: 967965468
CAGE: 60TS7And
NATICK CONTRACTING DIVISION (Government)
110 Thomas Johnson Dr.
Frederick, MD 21702
Effective Date: 29 January 2021
Agreement No.: W911QY-21-9-0018
Total Amount of the Agreement: $16,500,000.00

Awardee

Signature

Printed Name(b) (6)
Printed Name
Agreements Officer

Title

January 28. 2021

Date

Title

29 January 2021

Date

This Other Transaction Authority for Prototype Agreement is entered into between the
United States of America, hereinafter called the "Government", pursuant to and under U.S.
Federal law and Rigel Pharmaceuticals Inc., a non-traditional defense contractor,
hereinafter called the "Awardee". The United States of America and Awardee aresometimes referred to herein individually as a "Party" and collectively as the "Parties."
WHEREAS, the Awardee is eligible for an Other Transaction Authority for Prototype
Agreement in accordance with 10 USC § 2371b(d)(1)(A) as amended by the National
Defense Authorization Act for Fiscal Year 2018 as they are non-traditional defense
contractor, attesting to "An entity that is not currently performing and has not performed,
for at least the one-year period preceding the solicitation of sources by the Department of
Defense for the procurement or transaction, any contract or subcontract for the Departmentof Defense that is subject to the full coverage under the cost accounting standards
prescribed pursuant to Section 1502 of title 41 and the regulations implementing suchsection.";
WHEREAS, the DoD currently has authority under 10 U.S.C. § 2371b to award "othertransactions" (0Ts) in certain circumstances for prototype projects that are directly relevant
to enhancing the mission effectiveness of military personnel and the supporting platforms,
systems, components, or materials proposed to be acquired or developed by the DoD, or to
improve platforms, systems, components, or materials in use by the Armed Forces;
WHEREAS, a prototype can generally be described as a physical or virtual model used
to evaluate the technical or manufacturing feasibility or military utility of a particulartechnology or process, concept, end item, or system;
WHEREAS, Awardee currently markets TAVALISSE (fostamatinib disodium
hexahydrate) tablets, which is approved in the U.S. and Europe as a treatment for adultchronic immune thrombocytopenia (ITP), a rare autoimmune disorder;
WHEREAS, this Agreement meets the criteria for a prototype project;
NOW THEREFORE, the Parties have agreed as follows:

ARTICLE 1. Scope.
A. This Other Transaction Authority for Prototypes Agreement (the "Agreement") isentered into between the Government and the Awardee on the Effective Date set
forth above. For the avoidance of doubt, this Agreement is entered into pursuant to
10 U.S.C. § 2371b and is not a procurement contract governed by the Federal
Acquisition Regulation (FAR), a grant, or cooperative agreement. The FAR and the2Defense Federal Acquisition Regulation Supplement (DFARS) apply only as
specifically referenced herein. This Agreement is not intended to be, nor will it beconstrued as, forming, by implication or otherwise, a partnership, a corporation, orother business organization. This Agreement is not subject to the Bayh-Dole Act,
35 U.S.C. §§ 200- 12.
B. The Parties agree that the ultimate purpose of this Agreement is the development ofa countermeasure against COVID-19 by rapidly obtaining safety and efficacy datathat will facilitate approval by the FDA for Emergency Use Authorization (EUA) ofa repurposed FDA-approved oral SYK inhibitor (fostamatinib), (hereinafter referred
to as the "Prototype Project" or "Prototype"). A Prototype may be a clinical trial, ademonstration of efficacy or safety, or other process, or a combination of theforegoing in defense of SARS-CoV-2/COVID-19. This Prototype Project is acombination of an agile development activity, design, and demonstration of thetechnical and operational utility of a product to move forward as an FDA-approved
therapeutic against COVID-19. The Awardee shall develop the Prototype(s) as
described in the Awardee's Statement of Work (SOW), which is incorporated
herein and attached hereto as Appendix A.
C. The prototype will be deemed successful upon the Government's determination that
the Awardee's efforts meet the key technical requirements of the SOW and are
sufficient to meet an FDA compliant final report(s) that supports the completion ofa human clinical trial(s). In accordance with 10 U.S.C. 2371b(f), this competitively
awarded prototype OTA may result in the award of a follow-on production contract
or transaction for a quantity not to exceed 10 million treatment courses.
ARTICLE 2. Term and Termination.

A. Term: The Term of this Agreement commences upon the Effective Date and extends
through final payment. This Agreement is anticipated to end 14 months after the
Effective Date, subject to completion of the project(s). A transaction for a prototype
project is complete upon the written determination of the appropriate official for thematter in question that efforts conducted under a Prototype OT: (1) met the key
technical goals of a project, or (2) accomplished a particularly favorable or
unexpected result that justifies the completion of the prototype.
B. Termination for Convenience: The Government may terminate this Agreement for
any or no reason by providing at least thirty (30) calendar days' prior written noticeto the Awardee. The Government and Awardee will negotiate in good faith areasonable and timely adjustment of all outstanding issues between the Parties as aresult of termination by the Govenunent for convenience, consistent with the termsof this Agreement.
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Following notice of termination, Awardee shall use commercially reasonable efforts toterminate ongoing performance costs. The parties recognize that vendor agreements
may include termination clauses and that not all costs may be terminable in full.
Awardee shall not be paid for any post-termination work performed or costs incurred
which reasonably could have been avoided.
The Government and the Awardee will negotiate in good faith a reasonable and timely
adjustment of all outstanding issues between the Parties as a result of termination,
consistent with the terms of this Agreement. Failure of the Parties to agree to areasonable adjustment will be resolved pursuant to Article 5.H (Disputes). In the eventof termination, the Parties shall negotiate in good faith a reasonable wind-down planand neither Party shall have any continuing obligations to perform under the
Agreement except as otherwise specified herein.
C. Termination for Cause: If the Awardee materially fails to comply with theprovisions of this Agreement, the Other Transaction Agreement Officer (OTA0),
after issuance of a cure notice and failure of the Awardee to cure the defect withinten (10) business days or the time allowed by the °TAO after Awardee's receipt of
the cure notice, whichever is longer, may take one or more of the following actions
as appropriate:(i) temporarily withhold payments pending correction of the deficiency,(ii)disallow all or part of the cost of the activity or action not in compliance,(iii) wholly or partly suspend or terminate this Agreement,(iv) withhold further funding, or(v)take any other legally available remedies.
Notwithstanding this Article 2.C, the Government's rights and Awardee's
obligations under this paragraph will cease to exist if the Government terminates
this Agreement for any reason other than for Awardee's failure to materiallycomply with the terms of this Agreement.
D. Survival: In the event of Termination, all rights, obligations, and duties hereunder,
which by their nature or by their express terms extend beyond the expiration or
termination of this Agreement, including but not limited to warranties,
indemnifications, intellectual property (including rights to and protection ofIntellectual Property and proprietary information), and product support obligations
shall survive the expiration or termination of this Agreement.
ARTICLE 3. Project Management.
A. Program Governance: The Awardee is responsible for the overall management of
the project development program and related program decisions. The Government
will have continuous involvement with the Awardee. The Awardee shall provide
access to project results in accordance with the Awardee's Project Timeline locatedin Appendix A.
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B. Project Managers: The Awardee and the Government will each designate a ProjectManager responsible for facilitating the communications, reporting, and meetings
between the Parties. Each Party will also designate an alternate to the ProjectManager, in case the primary Project Manager is unavailable. See ProjectManager/Alternate Project Manager point of contact information for each respective
party below:
Awardee Project Managers(b) (6)(b) (6)
C. Key Personnel: Any key personnel specified in this agreement are considered to be
essential to work performance. At least thirty (30) calendar days prior to theAwardee voluntarily diverting any of the specified individuals to other programs orcontracts the Awardee shall notify the Agreements Officer and shall submit ajustification for the diversion or replacement and a request to replace the individual.
The request must identify the proposed replacement and provide an explanation of
how the replacement's skills, experience, and credentials meet or exceed therequirements of the Agreement (including, when applicable, Human Subjects
Testing requirements). If the employee of the Awardee is terminated for cause or
separates from the Awardee voluntarily with less than thirty (30) calendar-day
notice, the Awardee shall provide the maximum notice practicable under thecircumstances. The Awardee shall not divert, replace, or announce any such change
to key personnel without the written consent of the Agreements Officer. The
Agreement will be modified to add or delete key personnel as necessary to reflect theagreement of the parties. The key personnel are listed in Appendix C. The
requirements of this Article 3.0 are intended to be read in combination with therequirements of the immediately following Article 3.D, and with Appendix C.
D. Substitution of Key Personnel
The Contractor agrees to assign the Key Personnel listed in Appendix C to theAgreement as those persons whose resumes/CVs were submitted with the proposal
who are necessary to fill the requirements of the Agreement. No substitutions shall5

be made except in accordance with this clause.
All requests for substitution must provide a detailed explanation of the circumstancenecessitating the proposed substitution, a complete resume for the proposed
substitute and any other information requested by the Agreements officer to approveor disapprove the proposed substitution. All proposed substitutes must havequalifications that are equal to or higher than the qualifications of the person to be
replaced. The Agreements officer or authorized representative will evaluate such
requests and promptly notify the contractor of his approval or disapproval thereof.
The contractor further agrees to include the substance of this clause in any relevant
subcontract, which may be awarded under this Agreement.
E. Subaward Approval: Modifications to subawards and/or new subcontracts under thisAgreement that could reasonably impact the technical approach proposed andaccepted by the Government require the approval of the OTAO prior to being
executed.
F. The OTAO has assigned an Agreements Officer's Representative (AOR) for thisagreement. The Awardee will receive a copy of the written designation outlining theroles and responsibilities of the AOR and specifying the extent of the AOR's
authority to act on behalf of the OTAO. The AOR is not authorized to make any
commitments or changes that will affect price, quality, quantity, delivery, or any
other term or condition of the Agreement.
ARTICLE 4. Agreement Administration.
In no event shall any understanding or agreement, modification, change order, or othermatter in deviation from the terms of this Agreement between the Awardee and a person
other than the OTAO be effective or binding upon the Government. All such actions
must be formalized by a proper contractual document executed by the OTAO.

Government Representatives:
Other Transaction Agreements Officer (OTAO)(b) (4), (b) (6)ACC-APG-Fort Detrick 110 Thomas Johnson
Dr. Frederick, MD 21702(b) (4), (b) (6)Other Transaction Agreement Specialist (OTAS)
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(b) (6)ACC-APG-Fort Detrick
110 Thomas Johnson Dr.
Frederick, MD 21702(b) (6)
Agreements Officer Representative (AOR):(b) (6)1564 Freedman Drive
Fort Detrick, MD 21702(b) (6)
Awardee Representatives:(b) (6)1180 Veterans Blvd.
South San Francisco, CA 94080(b) (6)
Awardee Administrative Contact:(b) (6)1180 Veterans Blvd.
South Ran Francisco, CA 94080(b) (6)ARTICLE 5. Performance Objectives and Changes.
A. Statement of Work (SOW): The SOW, Appendix A, describes the scope of activities
that will be undertaken by the Awardee to achieve the objective.
B. Recommendations for Modifications: At any time during the term of this Agreement,
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progress or results may indicate that a change in the SOW would be beneficial to theproject objectives. Recommendations for modifications, including justifications to
support any changes to the SOW, will be documented in a letter and submitted byAwardee to the GPM with a copy to the OTAO. This letter will detail the technical,
chronological and financial impact, if any, of the proposed modification to theproject. Any resultant modification is subject to the mutual agreement of the Parties.
The Government is not obligated to pay for additional or revised amounts unless anduntil this Agreement is formally revised by the OTAO and made part of thisAgreement. Any modification to this Agreement to account for recommended
changes in the SOW or Payable Milestones will be considered a supplemental
agreement.
C.Review of Recommendations: The OTAO will be responsible for the review andverification of any recommendations to revise or otherwise modify the Agreement,
the SOW, the milestone payments, or other proposed changes to the terms andconditions of this Agreement.
D.Minor Modifications: The Government may make minor or administrative
Agreement modifications unilaterally (e.g., changes in the paying office orappropriation data, changes to Awardee personnel proposed by Awardee, etc.).
E. Amending the Agreement: The Government will be responsible for effecting all
modifications to this Agreement, with the concurrence of the Awardee formodifications that are not minor or administrative. Administrative and material
matters under this Agreement will be referred to OTAO.
F. Modification Communications: No other communications, whether oral or in writing,that purport to change this Agreement are valid.
G.Government Property: If applicable, terms and conditions applicable to Government
Property shall be incorporated through Appendix D.
H.Disputes: For any disagreement, claim, or dispute arising under this Agreement, theparties shall communicate with one another in good faith and in a timely andcooperative manner. Whenever disputes, disagreements, or misunderstandings arise,
the parties shall attempt to resolve the issue by discussion and mutual agreement assoon as practicable. Failing resolution by mutual agreement, the aggrieved party shallrequest a resolution in writing from the OTAO. The OTAO will review the matterand render a decision in writing within sixty (60) calendar days. Thereafter, either
party may pursue any right or remedy provided by law in a court of competentjurisdiction as authorized by 28 U.S.C. 1491. Alternately, the parties may agree by
mutual consent to explore and establish and Alternate Disputes Resolution procedure
to resolve this dispute. The Awardee shall proceed diligently with performance under8

this agreement pending resolution of the dispute.
ARTICLE 6. Inspection/Acceptance
A.Inspection: The Govermnent has the right to inspect and test all work called for by thisAgreement, to the extent practicable at all places and times, including the period of
performance, and in any event before acceptance. The Government may also inspect thepremises of the Awardee or any subawardee engaged in performance, with seven (7)calendar days advance notice to the Awardee, or fourteen (14) calendar days advancenotice to any such subawardee. The scope and duration of any such Government
inspection will be mutually agreed between the Parties in writing in advance, suchagreement not to be unreasonably withheld. The Government shall perform inspections
and tests in a manner that will not unduly delay the work. If the Government performs
any inspection or test on the premises of the Awardee or a subawardee, the Awardee shallfurnish and shall require subawardees to furnish, at no increase in price, all reasonablefacilities and assistance for the safe and convenient performance of these duties. Except
as otherwise provided in the Agreement, the Government shall bear the expense of
Government inspections or tests made at other than the Awardee's or subawardee's
premises.
B. The Government shall inspect/accept or reject the work as promptly as practicable after
completion/delivery, unless otherwise specified in the Agreement. Government failure toinspect and accept or reject the work shall not relieve the Awardee from responsibility,
nor impose liability on the Government, for nonconforming work. Work is
nonconforming when it is defective in material or workmanship or is otherwise not in
conformity with Agreement requirements. The Government has the right to rejectnonconforming work. Inspection/Acceptance of the Prototype performed should notexceed 90 days after completion.
ARTICLE 7. Financial Matters
This Agreement is a fixed milestone Other Transaction Authority agreement. The
payments provided under this Agreement are intended to compensate the Awardee
upon completion of milestones of performance under this Agreement.
A. Payment. The Awardee shall be paid for each milestone executed and accomplishedin accordance with the performance schedule set forth in Appendix B. The schedule
is predicated upon the Government's fiscal year, which begins on October 1 of eachyear, and ends on September 30 of the subsequent calendar year.
The Awardee will provide AOR, °TAO and OTAS notification of milestone successand any documentation that supports successful completion of the milestone. Within
9ten (10) business days of receipt, the OTAO will either, 1) confirm milestonecompletion and authorize the Awardee to invoice against the completed milestone or,2) notify the Awardee of any deficiencies, additional documentation or clarifications
reasonably needed by the Government to complete its review of the milestone. The
Parties agree that payments will be made upon the OTAO's acceptance of completed
milestones.
B. Obligation. Under no circumstances shall the Government's financial obligation
exceed the amount obligated in this Agreement or by amendment to the Agreement.
The amount of Government funds obligated by this Agreement and available forpayment is set forth in the administrative document generated from PD2,
demonstrating the appropriate Contract Line Item Number, and Accounting andAppropriation information. The Government may incrementally fund this agreement.
C. The Government is not obligated to provide payment to the Awardee for amounts inexcess of the amount of obligated funds allotted by the Government.
D. After accomplishment of each milestone, the Awardee will submit the corresponding
invoice through a Government provided invoicing and payment system, as detailed in
Section 7.G. The Government shall pay the Awardee, upon submission of proper
invoices, the amounts stipulated in this Agreement for work delivered or rendered andaccepted, less any deductions provided in this Agreement. Unless otherwise specified,payment shall be made upon acceptance of any portion of the work delivered orrendered for which a price is separately stated in the Agreement. Payments will bemade within thirty (30) calendar days of receipt of a request for payment.
E. Subject to paragraph H of this clause, the Awardee shall maintain adequate records toaccount for all funding under this Agreement. Neither the Cost Accounting Standards
nor any other aspect of the Federal Acquisition Regulation or its supplements apply toAwardee's accounting of costs under this Agreement. Costs shall be accounted for inaccordance with Awardee's established commercial accounting practices and therequirements of this Agreement, with appropriate arrangements for receipt,
distribution and accounting for Federal funds.
F. Prior written approval by the OTAO, or the AOR, is required for all travel directly
and identifiably funded by the Government under this agreement. The Awardee shallpresent to the OTAO or AOR, an itinerary for each planned trip, showing the name of
the traveler, purpose of the trip, origin/destination, dates of travel, and estimated cost
broken down by line item as far in advanced of the proposed travel as possible, but noless than two weeks before travel is planned to commence. In the event thatemergency travel is required (e.g., in the event of an outbreak) that would make two
weeks' notice impractical, travel requests may be submitted to the Government for an
expedited review. Emergency travel requests shall be labelled as such and shall10

include a brief summary of the emergency situation and rationale for expedited
review.
G. WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)(a) Definitions. As used in this clause—
Department of Defense Activity Address Code (DoDAAC) is a six positioncode that uniquely identifies a unit, activity, or organization.
Document type means the type of payment request or receiving reportavailable for creation in Wide Area WorkFlow (WAWF).
Local processing office (LPO) is the office responsible for payment
certification when payment certification is done external to the entitlement
system.
(b) Electronic invoicing. The WAWF system is the method to electronically process
vendor payment requests and receiving reports, as authorized by DFARS 252.2327003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Awardee shall (i) have a designatedelectronic business point of contact in the System for Award Management at
https://www.acquisition.gov; and (ii) be registered to use WAWF at
https://wawf.eb.mil/ following the step-by-step procedures for self-registration
available at this website.
(d) WAWF training. The Awardee should follow the training instructions of the
WAWF Web-Based Training Course and use the Practice Training Site before
submitting payment requests through WAWF. Both can be accessed by selecting the"Web Based Training" link on the WAWF home page at https://wawfleb.mil/.
(e) WAWF methods of document submission. Document submissions may be via
Web entry, Electronic Data Interchange, or File Transfer Protocol.
(f) WAWF payment instructions. The Awardee must use the following information
when submitting payment requests and receiving reports in WAWF for thisAgreement:(1) Document type. The Awardee shall use the following document type:
2 in 1 combo.
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(2) Inspection/acceptance location. The Awardee shall select the following
inspection/acceptance location(s) in WAWF, as specified by the contracting
officer.
(3) Document routing. The Awardee shall use the information in the Routing
Data Table below only to fill in applicable fields in WAWF when creating
payment requests and receiving reports in the system.
Routing Data Table
Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC

11Q0490
W911QY
W911QYW56XNH

Issue By DoDAAC
Admin DoDAAC
Inspect By DoDAAC(4) Payment request and supporting documentation. The Awardee
shall ensure a payment request includes appropriate contract line itemand subline item descriptions of the work performed or supplies
delivered, costs, fee (if applicable), and all relevant back-up
documentation in support of each payment request.
(5) WAWF email notifications. The Awardee shall enter the email address
identified below in the "Send Additional Email Notifications" field of
WAWF once a document is submitted in the system.

(g) WAWF point of contact.
(1) The Awardee may obtain clarification regarding invoicing in WAWF
from the following contracting activity's WAWF point of contact.
(2) For technical WAWF help, contact the WAWF helpdesk at
866-618-5988.
(End of Clause)
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H. Comptroller General Access to Records: To the extent that the total Government
payments under this Agreement exceed $5,000,000, the Comptroller General, at its
discretion, shall have access to and the right to examine records of any Party to theAgreement or any entity that participates in the performance of this Agreement that
directly pertain to, and involve transactions relating to, the Agreement for a periodof three (3) years after final payment is made. This requirement shall not apply withrespect to any Party to this Agreement or any entity that participates in theperformance of the Agreement, or any subordinate element of such Party or entity,that has not entered into any other agreement (contract, grant, cooperative
agreement, or "other transaction") that provides for audit access by a government
entity in the year prior to the date of this Agreement. This paragraph only applies toany record that is created or maintained in the ordinary course of business or
pursuant to a provision of law. The terms of this paragraph shall be included in all
sub-agreements to the Agreement other than sub-agreements with a component of
the U.S. Government. The Comptroller General may not examine records pursuant
to a clause included in an agreement more than three years after the final payment
is made by the United States under the agreement.
ARTICLE 8. Report and Data Requirements
A. Weekly Teleconferences and Communication
Awardee shall conduct weekly teleconferences with the Government throughout
the performance of the Agreement to discuss tasks accomplished and direction
for the upcoming tasks. The Government anticipates reducing theteleconferences once enrollment executes and again after completion of the trial.
Awardee shall provide agendas and read-ahead material as required two days
prior to the meetings and shall provide minutes of each meeting to theGovernment. Awardee shall include key subawardees as attendees at theseteleconferences when applicable. The Awardee shall provide meeting minutes
within three (3) business days after each formal scheduled
meeting/teleconference conducted with JPEO JPM CBRN Medical.
B. Quarterly Progress Reports
The Awardee shall submit a Quarterly Progress report within twenty (20) calendar
days after the end of each quarter of performance. The Quarterly Progress reportshall contain the technical progress made during the previous quarter and the
updated resource loaded Integrated Master Schedule (IMS) in Microsoft Project
format. The schedule update shall include the explanation for any changes in theschedule, and drivers for the changes, as applicable. The report should also address
any concerns that would impact the performance, schedule, or cost planned for the13

effort. The Awardee shall report risk matrix format to include risk mitigation
strategies. Note: Any identified changes require formal notification to the °TAO in
accordance with the Agreement provisions.
In addition, the Quarterly Progress Report shall contain regular status updates of
all Intellectual Property (IP) license(s) related to the effort to ensure that all
license(s) are in good standing as the project progresses. In the event of any
change in IP license(s) status or potentially imminent change in status, theAwardee shall immediately contact the OTA and GPM in writing.
The Government will have ten (10) calendar days to respond to the report with any
comments and the Awardee will have an additional five (5) calendar days to revise
the deliverable or respond to those comments.
C. Monthly Financial Status Report
The Awardee shall submit a Monthly Financial Status Report no later than twenty(20) calendar days after the end of each month of performance. The Government
will have ten (10) calendar days to respond to the report with any comments and theAwardee will have an additional ten (10) calendar days to revise the deliverable or
respond to those comments. Reports will cover milestones accomplished monthly
for the duration of the Period of Performance (PoP), in addition to a monthly
milestone forecast. The Awardee shall provide all submissions in Excel format,
including all formulas.
D. Final report
A Final Report shall be prepared at the end of the effort by the Awardee. The Final
Report shall narrate a complete summary of the project execution and associatedresults obtained. The narration will include outstanding problems and their potential
solutions, problems solved during the course of the agreement, and the solutions tothe solved problems. The Final Report shall demonstrate how the prototype wasdeveloped and advanced.
The Awardee shall submit a Draft Final Report by the forty-fifth (45th) calendar day
following the end of the project. The Government shall provide comments to theAwardee by the thirtieth (30th) calendar day following receipt of the Awardee's
Draft Final Report. The Awardee shall submit the Final Report on the thirtieth (30th)
calendar day after receipt.
E. Ad Hoc Meetings
In addition to the monthly meetings and written quarterly program updates,
14

additional ad hoc meetings to address specific issues or to convey time-sensitive
updates or scientific data related to the program will be held. The Awardee shallprovide meeting minutes within three (3) business days after each ad hoc
meeting/teleconference conducted with JPEO JPM CBRN Medical.
F. Patents — Reporting of Inventions
The Awardee shall report any OTA Inventions (as defined in Article 10 hereof) inaccordance with the terms and conditions of this Other Transaction Agreement(OTA).
G. Miscellaneous Data Submissions
If applicable, the Awardee must submit to the Government all briefings, regulatory
strategy, United States Army Medical Research and Development Command Human
Research Protection Office (HRPO) Approvals, technical presentations and publications,and any formal technical reports that have been prepared for eventual submission to
FDA or other regulatory agencies. Examples include the following reports related to:completed batch records, certificates of analysis, drug substance and product stability,
and clinical testing. Examples include clinical performance and clinical quality
documentation.
H. Work Breakdown Structure
Three-level WBS with costs and schedule (top level is program, level two (2) isphase, level three (3) are major tasks). For WBS level two (2), show breakdown
for labor, material, and other indirect costs.
WBS shall be updated annually or thirty (30) calendar days after a Statement ofWork modification. Government review/approval is fifteen (15) calendar days after
receipt of first submittal. Provide changes to draft within ten (10) calendar days ofsuch request. Provide final document within ten (10) calendar days after approvalof changes is received.
I. Integrated Master Schedule
The Awardee shall provide within thirty (30) calendar days after project award an
IMS in Microsoft Project format. Any updates to the IMS shall be included in thequarterly progress reports.
Submission shall be thirty (30) calendar days after the end of each month of
performance. The Government will have ten (10) calendar days to respond to thereport with any comments and the performer will have an additional five (5)calendar days to revise the deliverable or respond to those comments.
15

J. Incident Report.
The Awardee shall report any incident to the Government that could result in any
delay in schedule from the most recent IMS critical path delivered to theGovernment. Telephonically contact the GPM within one day of incident. A writtensummary report shall be submitted within three (3) business days of an incident, toinclude, what happened, what was the impact, if there are any available corrective
actions and a time line for when the corrective actions would be in place.
K. Source Material Reports
The Awardee shall submit a detailed spreadsheet regarding critical project materials
that are sourced from a location other than the United States, sources, including but
not limited to: physical locations of sources material by type of material (e.g.,
software, testing, analytical and environmental componentry, reagents) and locationand nature of clinical study sites.
L. Awardee Locations
The Awardee shall submit detailed data regarding locations where work will be
performed under this Agreement, including addresses, points of contact, and work
performed per location, to include sub-awardees.
Awardee will submit Work Locations Report:•••

Within 5 business days of Agreement award
Within 30 business days after a substantive location or capabilities change
Within 2 business days of a substantive change if the work performed supports
medical countermeasure development that addresses a threat that has been
declared a Public Health Emergency by the HHS Secretary or a Public Health
Emergency of International Concern (PHEIC) by the WHO

ARTICLE 9. Confidential Information
A. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining toan institution or organization.
B. The Agreements Officer and the Awardee may, by mutual consent, identify elsewhere inthis Agreement specific information and/or categories of information which theGovernment will furnish to the Awardee or that the Awardee is expected to generate whichis confidential. Similarly, the Agreements Officer and the Awardee may, by mutual16

consent, identify such confidential information from time to time during the performance of
the Agreement. Failure to agree will be settled pursuant to the "Disputes" clause.
C. If it is established elsewhere in this Agreement that information to be utilized under thisAgreement, or a portion thereof, is subject to the Privacy Act, the Awardee will follow therules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, andimplementing regulations and policies, with respect to systems of records determined to be
subject to the Privacy Act.
D. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed
without the prior written consent of the individual, institution, or organization.
E. Whenever the Awardee is uncertain with regard to the proper handling of material underthe Agreement, or if the material in question is subject to the Privacy Act or is confidential
information subject to the provisions of this article, the Awardee shall obtain a written
determination from the Agreements Officer prior to any release, disclosure, dissemination,or publication.
F. Agreements Officer Determinations will reflect the result of internal coordination withappropriate program and legal officials.
G. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
H. Awardee acknowledges that Government-provided confidential information will not beprovided to sub-agreement holders unless or until Article 9 flows down to the relevant subagreement, and such entity agrees to be in substantial compliance with this Article 9.
ARTICLE 10. Intellectual Property Rights

A. Awardee represents that the rights held by or granted to Awardee, including all
intellectual property licenses, are sufficient to enable Awardee to perform its
obligations under this Agreement.
B. Background IP and Materials. The Awardee and the Government each retain any
intellectual property (IP) rights to their own materials, data, technology,
information, documents, or know-how—or potential rights, such as issued patents,
patent applications, invention disclosures, or other written documentation—that
exist prior to execution of this Agreement or are developed outside the scope of thisAgreement ("Background IP").
C. Awardee's Background IP. Awardee warrants that it has filed patent application(s)or is the assignee of issued patent(s) listed below which contain claims that are17related to research contemplated under this Agreement. No Government funding
was used to fmance, develop, or acquire the background IP. No license(s) to any
patent applications or issued patents shall be granted under this Agreement, and theapplication(s) and any continuing applications (except for continuing applications
pursuant to this agreement) are specifically excluded from the definitions of "OTA
Invention" contained in this Agreement: See Appendix F.
D. Government's Background IP. The government warrants that it has no BackgroundIP and therefore lists "None".
E. Patent Indemnity. The Awardee shall indemnify the Government and its officers,
employees and agents against liability, including costs, for actual or alleged direct
or contributory infringement of, or inducement to infringe, any United States orforeign patent, trademark or copyright, resulting from Awardees performance of
the SOW under this Agreement, provided the Awardee is reasonably notified ofsuch claims and proceedings.
F. Patent Prosecution. Awardee agrees to take responsibility for the preparation,filing, prosecution, and maintenance of any and all patents and patent applications
listed as Awardee Background IP that are relevant to the work performed under thisAgreement. Awardee shall keep the Government reasonably advised on the statusof Awardee Background IP by providing an annual report on the status of Awardee
Background IP. Prior to acting on a decision by Awardee to abandon or not file inany country a patent or patent application covering an OTA Invention, which isdefined below, Awardee shall so inform the Government in a timely manner toallow Awardee to thoughtfully consider the Government's comments regarding
such a proposed decision. Nothing in this ARTICLE shall restrict the Government
in its preparation, filing, prosecution and maintenance of a patent or patentapplication covering an OTA Invention.
G. Patent Applications. Each Party shall report any OTA Inventions to the other Party
within 60 days of the time the inventor discloses it in writing to its personnel
responsible for patent matters. The Parties will respectively have the option to file apatent application claiming any OTA Invention made solely by their respective
employees. The Parties will consult with each other regarding the options for filinga patent application claiming a joint OTA Invention. Within forty-five (45)calendar days of being notified of the discovery of an OTA Invention or filing apatent application covering an OTA Invention, each Party will provide notice ofsuch discovery or filing to the other Party. The Parties will reasonably cooperatewith each other in the preparation, filing, and prosecution of any patent application
claiming an OTA Invention. Any Party filing a patent application will bear
expenses associated with filing and prosecuting the application, as well as
maintaining any patents that issue from the application, unless otherwise agreed by18

the Parties.
H. Patent Enforcement. Awardee will have the first option to enforce any patent rights
covering an OTA Invention owned jointly by the Parties or solely by Awardee, atAwardee's expense. If Awardee chooses not to exercise this option, theGovernment may enforce patent rights covering a joint OTA Invention only withAwardee's prior written approval.
I.

OTA Inventions. Ownership of any invention, regardless of whether it is notpatentable, or is patentable under U.S. patent law that is conceived or first reduced
to practice under this Agreement ("OTA Invention") will follow inventorship in
accordance with U.S. patent law. The Bayh-Dole Act, 35 U.S.C. §§ 200-212 does
not apply to this Agreement and, as such, title to inventions will accrue to theinventor or inventor-organization. In the event an OTA Invention exists, the Parties
represent and warrant that each inventor will assign his or her rights in any suchinventions to his or her employing organization. Notwithstanding the foregoing,
neither the Government nor Awardee anticipate the Government making a Sole
Government OTA Invention, nor the Parties jointly making a Joint OTA Invention,
as Awardee employees are solely responsible, as between the Parties, forperforming the Prototype Project under this Agreement. Any OTA Invention madesolely by an Awardee employee is subject to a nonexclusive, nontransferable, irrevocable,
worldwide paid-up license for the Government to practice and have practiced the OTA
Invention on behalf of the Government.

J.

Licenses. Upon the Awardee's request, the Government agrees to enter into goodfaith negotiations with the Awardee regarding the Awardee's receipt of anonexclusive commercialization license covering the Government's interest in any
OTA Invention made in whole by a Government employee.

K. Executive Order No. 9424 of 18 February 1944 requires all executive Departments
and agencies of the Government to forward through appropriate channels to theCommissioner of Patents and Trademarks, for recording, all Government interestsin patents or applications for patents.
L. The Government shall flow down the requirements of this Article 10 to theirrespective personnel, member entities, agents, and Awardees (including
employees) at all levels, under this Agreement.

ARTICLE 11. Data Rights
A. Background Data. "Background Data" shall mean all technical data, as defined in
DFARS 252.227-7013 that exists prior to execution of this Agreement, or are19

developed outside the scope of this Agreement. The Awardee's Background Data
includes, but is not limited to, the following technical data, to the extent such data
exists prior to execution of this Agreement or is developed outside the scope of thisAgreement: See Appendix G. The Awardee retains all of its right, title and interest
in and to its Background Data, and the Government receives no rights or licenses toany such Background Data hereunder. The Government may, under a separate
agreement or by modification to this agreement, obtain any rights to use or disclose
the Awardee's Background Data to the extent that such material or data wasproduced outside the scope of this Agreement.
B. Subject Data. All data generated in connection with the performance of thisAgreement, or that arises out of the use of any materials or enabling technology
provided or used by the Awardee in the performance of this Agreement, otherAwardee materials or Awardee confidential information, whether conducted by theGovernment or the Awardee (collectively, the "Subject Data"), shall be owned by
the Awardee.
Subject Data in any document that would disclose an enabling disclosure of an OTA
Invention will be subject to Limited Rights until publication of patent application inaccordance with Article 10 of this Agreement, and such Subject Data will beidentified accordingly with reasonable specificity. Once publicized, the USG shallreceive Government Purpose Rights to all such Subject Data.
All other Subject Data shall be delivered with Government Purpose Rights.
As used herein, "Limited Rights" means the rights to use, modify, reproduce,
perform, display, or disclose data, in whole or in part, within the Government solely
for research purposes in respect of the prophylaxis and treatment of COVID-19. The
Government will ensure that disclosed information is safeguarded in accordance withthe restrictions of this Agreement. The Government may not, without the prior written
permission of the Awardee, release or disclose the data outside the Government, use
the data for competitive procurement or manufacture, release or disclose the data forcommercial purposes, or authorize the data to be used by another party. The Parties
shall maintain the confidentiality of all data subject to or designated as falling within
Limited Rights.
As used herein, "Government Purpose Rights" means the rights to (i) use, modify,
reproduce, release, perform, display, or disclose data solely within the Government,(ii) release or disclose data outside the Government, and (iii) authorize persons towhom release or disclosure has been made to use, modify, reproduce, release,perform, display, or disclose that data; in each case (i)-(iii) solely as required for
Government purposes. Government purposes do not include the rights to use, modify,
reproduce, release, perform, display, or disclose data for commercial or competitive20

purposes or to authorize others to do so. Even where disclosure is made forGovernment purposes, such disclosure will be governed by a contractual terminology
or a non-disclosure agreement restricting further dissemination of the information andotherwise ensuring compliance with the government's rights and obligations in thedisclosed data.
C. The Awardee agrees to retain and maintain in good condition until seven (7) years
after completion or termination of this Agreement, all data generated under thisAgreement. In the event of exercise of the Government's rights as potentiallygranted under paragraph 2.C, the Awardee agrees to deliver at no additional cost to
the Government, all data, in Awardee's possession and developed under thisAgreement, necessary to develop the Prototype within sixty (60) calendar days
from the date of the written request.
D. Marking of Data: The Awardee will mark any data delivered under this Agreementwith the following legend:"Use, duplication, or disclosure is subject to the restrictions as stated in Agreement
No. W911QY-21-9-0018 between the Government and the Awardee."
Any rights that the Awardee or the Government may have in data delivered under
this Agreement, whether arising under this Agreement or otherwise, will not beaffected by Awardee's failure to mark data pursuant to this Article.
E. All Subject Data which shall be delivered under this Agreement with less thanunlimited rights shall be identified in reasonable specificity and particular rights
granted (Government Purpose or Limited (all as defined in this Agreement) prior
to delivery under the Agreement. All other Subject Data developed under fundingof this agreement shall be delivered with Government Purpose Rights.
ARTICLE 12. Regulatory Rights
This Agreement includes research with drugs that are regulated by the FDA andrequire FDA clearance before commercial marketing may begin for the COVID-19
indication. The Parties anticipate that for the Prototype Project(s) contemplated under
this Agreement, the Awardee or its designated subawardee will serve as the Sponsor of
the Regulatory Application (an investigational new drug application (IND), or anotherregulatory filing submitted to FDA) that will permit commercial marketing of
fostamatinib for a COVID-19 indication. The Sponsor of the Regulatory Application
to FDA (as the terms "sponsor", "sponsor-investigator", and "applicant" are defined orused in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), has
certain standing before the FDA that entitles him to exclusive communications related21

to the Regulatory Application.
Regarding any technology developed under this agreement for which Awardee or its
designated subawardee serves as regulatory Sponsor, the Awardee agrees to thefollowing, which will flow down to appropriate subawardees performing regulatory
functions:a. Government Regulatory Representatives: The Senior Director Medical Regulatory(SDMR) is the JPEO-CBRND representative for all regulatory and quality
activities. The Awardee shall coordinate with the SDMR prior to communicating
or meeting with the FDA, or other regulatory authorities, as appropriate. The
Awardee shall invite the SDMR to all FDA meetings if applicable and related
preparatory regulatory discussions.
1. The regulatory Sponsor shall submit a letter to FDA indicating the SDMR as a
co-contact and that FDA is authorized to contact SDMR for DoD
regulatory/policy input, as needed for this development effort. This notice
could be part of the PL 115-92 authorization letter described below. In thiscircumstance and to the maximum extent practicable, the Government will
include the Sponsor in any and all meetings and correspondence with the
FDA. If it is not practicable to include the Sponsor in any interaction with the
FDA, the Government will provide a summary of the interaction to theSponsor within ten (10) business days.
2. Non-compliance with section (a) may result in termination of the Agreement.
b.

Regulatory Submissions. The Awardee will provide to the Government all data,
including top-line summaries and key conclusions from all studies supporting theregulatory filing and commercial approval to the extent that such data, summaries,
and conclusions are funded by this Agreement. In addition, the Awardee will offer theGovernment the opportunity to review and provide comments on a final draft ofregulatory submissions, which include data funded by this Agreement. The
Government will review any such submissions (i.e., the IND) promptly upon receipt.
The Awardee will reasonably consider any comments provided by the Government,
and prior to submission will provide notification to the Government of any additional
edits or revisions. The Awardee will keep the Government apprised of planned FDA
meetings and post-meeting outcomes relating to activities funded by this Agreement.

c.

Communications. The Awardee shall provide the Government with all material
communications and summaries thereof, both formal and informal, to or from FDA,
regarding the technology within 48 hours, and ensure that the Government
representatives are invited to participate in any formal or informal Sponsor meetings
with FDA. Awardee shall (1) ensure that the Government representatives are
consulted and are invited to participate in any formal or informal Sponsor meetings
22with FDA related to the technology; and (2) notify the FDA that the Government has
the right to discuss with FDA any development efforts regarding the technology.
d.

Rights of Reference. Awardee hereby grants to the Government and its permitted
sublicensees a limited "right of reference or use" (as that term is defined in 21 C.F.R.
§ 314.3(b), as amended from time to time) to Awardee's filings to the FDA inconnection with the Regulatory Application strictly for COVID-19 purposes. The
Awardee shall provide appropriate notification of the Government's access andreference rights to the applicable regulatory authorities requested by the Government
for the limited purposes described above. Awardee agrees to provide a letter of crossreference to the Government and file such letter with the appropriate FDA office.
The Government will agree to any reasonable request for information connected to its
reliance on the right of reference provided under this Section. This provision is inaddition to any rights in technical data described earlier in this document.

e.

Product Development Failure. Certain product development failures may trigger certain
remedies in this section for the Government advanced developer funding the developmentof this Prototype.
1. This remedy is only available to the Government if and when any of the following
conditions occur during the Term of this Agreement:i. this Agreement is terminated for nonperformance; orii. the Awardee gives notice, required to be submitted to the Government no later
than 30 business days, of any formal management decision to terminate theprototype project;iii. the Awardee gives written notice, required to be submitted to the Government
no later than 30 business days, of any filing that anticipates Federal bankruptcy
protection.
2. If any of the product development failures listed above occur, the Awardee, upon therequest of the Government:i. Shall transfer possession, ownership and sponsorship or holdership of any
Regulatory Application (including any associated expedited review
designation, priority review voucher, or marketing exclusivity eligibility oraward), regulatory correspondence, and supporting regulatory information
related to the Prototype to the Government or its designee;ii. Shall inform FDA of the transfer of sponsorship or holdership of the Regulatory
Application transferred under section (2)(i) above; andshall negotiate in good faith and upon fair and reasonable terms a non-exclusive
license to any patent, copyright, Technical Data or other intellectual property
owned or controlled by the Awardee, developed prior to or outside the scope of
this Agreement that is necessary for the Government to pursue
23

commercialization of the Prototype, with a third party for sale to theGovernment or otherwise.
3. This clause will survive the acquisition or merger of the Awardee by or with a third
party. This clause will also be included in any subcontracts/subawards relating to thedevelopment of the Prototype entered into following execution of this Agreement.
This clause will survive the expiration of this Agreement.
f. Public Law 115-92 Sponsor Authorization Letter/ DoD Medical Product Priority: Public
Law 115-92 allows the DoD to request, and FDA to provide, assistance to expedite
development of products to diagnose, treat, or prevent serious or life-threatening diseases
or conditions facing American military personnel. The Awardee recognizes that only the
DoD can utilize Public Law 115-92. As such, the Awardee will work proactively with the
SDMR to leverage this law to its maximum potential under this Agreement.
1. The Awardee shall submit to the Government, within thirty (30) days of project award,
a fully executed sponsor authorization letter enabling FDA to disclose information to
JPEO-CBRND and its Government support contractors related to the proposed productunder Public Law 115-92. A template for the sponsor authorization letter was includedin Appendix E.
2. JPEO-CBRND shall formally submit the executed letter to the FDA under the
Regulatory Application, only if the proposed product becomes a DoD medical productpriority under Public Law 115-92.
3. If the product becomes a DoD medical product priority, to the maximum extent
practicable, JPEO-CBRND will include the Awardee in any and all meetings andcorrespondence conducted with the FDA under Public Law 115-92. If it is notpracticable to include the Awardee in any Public Law 115-92 interaction with the FDA
regarding the product (for example, discussions conducted at quarterly or semi-annual
DoD-FDA meetings mandated by the Public Law), JPEO-CBRND will provide asummary of the interaction to the Awardee within ten (10) business days.

g.

Regulatory Compliance:
1. cGCP Compliance. Awardee shall maintain clinical development and operations as
required to ensure proper clinical testing, operations, data management, biostatisticalevaluation, clinical supply, and other capabilities required to ensure full compliancewith Good Clinical Practices (GCP).
2. Drug Supply Chain Security Act. The provision of doses of the Protoype Projectwill be compliant with applicable provisions of the Drug Supply Chain Security Act(DSCSA) Sections 581-585 of PL 113-54 (Nov 27, 2013), taking into account FDA's
regular guidance for the public health response.

h. Flow Down: The Awardee shall flow down the requirements of this Article 12 to any
24subawardee funded under this agreement.
ARTICLE 13. Foreign Access to Data.
A. Export Compliance: The Parties will comply with any applicable U.S. export control
statutes or regulations in performing this Agreement.
ARTICLE 14. Disclosure of Information
A. Performance under this Agreement may require the Awardee to access non-public dataand information proprietary to a Government agency, another Government Awardee or ofsuch nature that its dissemination or use other than as specified in the work statement
would be adverse to the interests of the Government or others. Neither the Awardee, norAwardee personnel, shall divulge nor release data nor information obtained underperformance of this Agreement, except authorized by Government personnel or upon
written approval of the OTAO in accordance with OWS or other Government policies
and/or guidance. The Awardee shall not use, disclose, or reproduce proprietary data thatbears a restrictive legend, other than as specified in this Agreement, or any information at
all regarding this agency.
B. The Awardee shall comply with all Government requirements for protection of nonpublic information. Unauthorized disclosure of nonpublic information is prohibited by
the Government's rules. Unauthorized disclosure may result in termination of theAgreement, replacement of an Awardee employee, or other appropriate redress. Neither
the Awardee nor the Awardee's employees shall disclose or cause to be disseminated,
any information concerning the operations of the activity, which could result in, or
increase the likelihood of, the possibility of a breach of the activity's security or interrupt
the continuity of its operations.
C. No information related to data obtained under this Agreement shall be released or
publicized without the prior written consent of the AOR, whose approval shall not be
unreasonably withheld, conditioned, or delayed, provided that no such consent is required
to comply with any law, rule, regulation, court ruling or similar order; for submission to
any government entity for submission to any securities exchange on which the Awardee's(or its parent corporation's) securities may be listed for trading; or to third parties relating
to securing, seeking, establishing or maintaining regulatory or other legal approvals orcompliance, financing and capital raising activities, or mergers, acquisitions, or otherbusiness transactions.
ARTICLE 15. Scientific Publications and Press Releases.
A. Public Affairs and Operational Security Review: All manuscripts, press releases,
presentations and other publications will be provided to the JPEO-CBRND Public25

Affairs Office (PAO) allowing for review/approval in accordance with Article 16
prior to use or release. Per JPEO-CBRND regulation the PAO review will include
Operational Security (OPSEC) review.
B.The Parties shall jointly agree on a publication plan for the Study Data derived fromstudies executed under this Agreement. This publication plan will identify key new
Data to be disclosed or presented and the target date for finalizing any relatedscientific abstract or manuscript. As part of its Quarterly Program Reviews, theAwardee will share the publication plan with the Government.
C. Scientific publication regarding Study results in any form, including, without
limitation, manuscript(s), abstracts, posters, slides, or other materials used forpresentations ("Scientific Publication"): Prior to either Party submitting a
Scientific Publication for publication which contains the results of the Study under
this Agreement, each Party shall notify the other Party in writing of the proposed
Scientific Publication, offer ample opportunity to review proposed Scientific
Publication, and to file patent applications in a timely manner (if applicable),
provided that the review period is at least thirty (30) days from receipt of the draft
Scientific Publication and the filing period is at least an additional sixty (60) days
from the end of the review period. The Parties agree that authorship related to
Scientific Publications shall be determined in accordance with and governed by thecriteria defmed by the International Committee of Medical Journal Editors(ICMJE) "Recommendations for the Conduct, Reporting, Editing, and Publicationof Scholarly Work in Medical Journals." The Parties also agree to give appropriate
credit to the entity responsible for the Study performed. The publishing Party shallkeep the proposed Scientific Publication confidential for the entire review period
and, if applicable, the patent filing period, and shall delete the other Party's
proprietary information (other than the results of the Study generated hereunder)from the Scientific Publication upon request.
D.The Parties may jointly develop each abstract or manuscript and agree on theauthorship and the content of the final draft to be submitted; provided that authorshipfor each abstract and manuscript will be determined based on whether a particular
individual made a significant contribution to the conceptualization, design,
execution, or interpretation of a research study, as authorship is defined in the fifth
edition of the Guidelines and Policies for the Conduct of Research in the Intramural
Research Program at NIH, available at:https://oirmih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/g
ui delines-conduct_research.pdf.
E. Prior to submission for publication, the Parties shall provide drafts of proposed
publications to the authors of such publications for review and comment, andshall provide copies to non-authors for viewing purposes. Review periods are ten
26

(10) business days for abstracts, or less than ten (10) business days if agreed by ProjectManagers and in order to meet publication submission deadlines. Review periods aretwenty (20) calendar days for manuscripts. Contributing parties shall be appropriately
accredited in any publication.
F. The Parties will jointly agree on whether to issue one or more press releases related
to the resulting Data. If all Parties agree that one or both Parties will issue a press
release, each Party will also have the right to review and agree on the content inadvance of its publication. Other parties, if any, contributing to the studies, will
have review rights and will be appropriately accredited in the press release. For
clarity, for data generated in studies executed by Awardee outside the scope of thisAgreement, the Awardee, at its sole discretion, may issue a press release related tosuch data.
G.Press releases: Prior to any such release containing the Study results or otherinformation about the Study performed under this Agreement, Parties agree toprovide written notification and ample opportunity (at least five business days) for
review to the other Party; provided that each Party will use best efforts to complete
its review of proposed press releases in a shorter period of time if the Party
initiating the press release identifies the need for an urgent review. Comments andapproval by each Party shall be prior to release.

ARTICLE 16. Publications and Publicity.
The Awardee shall not release any reports, manuscripts, press releases, orabstracts about the work being performed under this Agreement without written
notice in advance to the Government.
A. Unless otherwise specified in this Agreement, the Awardee may publish theresults of its work under this Agreement. The Awardee shall promptly send a
copy of each submission to the AOR for security review prior to submission.
The Awardee shall also inform the AOR when the abstract article or otherpublication is published, and furnish a copy of it as finally published.
B. Unless authorized in writing by the AO, the Awardee shall not display
Government logos including Operating Division or Staff Division logos on
any publications.
C. The Awardee shall not reference the products(s) or services(s) awarded under
this Agreement in commercial advertising, as defined in FAR 31.205-1, in any
manner which states or implies Government approval or endorsement of the
product(s) or service(s) provided.
27

D. The Awardee shall include this clause, including this section (d) in all
subAwards where the subAwardee may propose publishing the results of its
work under the subAward. The Awardee shall acknowledge the support of theGovernment whenever publicizing the work under this Agreement in any
media by including an acknowledgement substantially as follows:"This project has been funded in part by the U.S. Government under
Agreement W911QY-21-9-0018. The US Government is authorized toreproduce and distribute reprints for Governmental purposes notwithstanding
any copyright notation thereon."
ARTICLE 17. Human Subjects.
A. Definitions. As used in this clause —(1)Assurance of compliance means a written assurance that an institution will comply
with requirements of 32 CFR Part 219, as well as the terms of the assurance, which
the Human Research Protection Official determines to be appropriate for the
research supported by the Department of Defense (DoD) component (32 CFR
219.103).
(2)Human Research Protection Official (HRPO) means the individual designated by thehead of the applicable DoD component and identified in the component's Human
Research Protection Management Plan as the official who is responsible for theoversight and execution of the requirements of this clause, although some DoD
components may use a different title for this position.
(3)Human subject means a living individual about whom an investigator (whether
professional or student) conducting research (i) Obtains information or biospecimens
through intervention or interaction with the individual, and uses, studies, or analyzes
the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates
identifiable private information or identifiable biospecimens. (32 CFR 219.102(e)).
For example, this could include the use of human organs, tissue, and body fluids
from individually identifiable living human subjects as well as graphic, written, or
recorded information derived from individually identifiable living human subjects.
(4)Institution means any public or private entity, or department or agency (including
federal, state, and other agencies). (32 CFR 219.102(f)).
(5)Institutional Review Board (IRB) means a board established in accord with and forthe purposes expressed in 32 CFR Part 219 (32 CFR 219.102(g)).
28

(6)IRB approval means the determination of the IRB that the research has been reviewed
and may be conducted at an institution within the constraints set forth by the IRB
and by other institutional and Federal requirements (32 CFR 219.102(h)).
(7)Research means a systematic investigation, including research, development, testing,and evaluation, designed to develop or contribute to generalizable knowledge.
Activities that meet this defmition constitute research for purposes of 32 CFR Part
219, whether or not they are conducted or supported under a program that is
considered research for other purposes. For example, some demonstration andservice programs may include research activities (32 CFR 219.102(1)).
B. The Awardee shall oversee the execution of the research to ensure compliance withthis clause. The Awardee shall comply fully with 32 CFR Part 219 and DoD
Instruction 3216.02, applicable DoD component policies, 10 U.S.C. 980, and,
when applicable, Food and Drug Administration policies and regulations.
C. The clinical trial described in the Statement of Work will comply with ICH Good
Clinical Practices (GCP) regulations.:
D. All clinical sites and IRBs utilized in the clinical trial described in the Statement ofWork are required to register with the Office for Human Research Protections(OHRP) and receive Federal Wide Assurance (FWA) numbers in accordance withhuman subject protections regulations 45 C.F.R 46.103.
E. The Awardee shall include the substance of this clause, including this paragraph(f), in related subcontracts that may include research involving human subjects inaccordance with 32 CFR Part 219, DoD Instruction 3216.02, and 10 U.S.C. 980,
including research that meets exemption criteria under 32 CFR 219.104. Thisclause does not apply to subcontracts that involve only the use of cadavermaterials.

ARTICLE 20. Most Favored Customer.
A. In the event that the Parties agree to a follow-on production agreement pursuant to 10
U.S.C. 2371b Awardee agrees that it shall sell to the U.S. Government up totreatment courses of TAVALISSE at a rice not greater anill. Any additiona
treatment course will e sold to the U.S. Government at a price to be negotiated andagreed by the Parties.
B. If Awardee develops a like product (commercialized version or derivative of the
production model of the Prototype) with similar capability and intended application,29

but at a lower unit price ("Like Product") regardless of quantity, Awardee shall makethe DoD aware of that similar product and the technical and price differences between
that product and the Prototype. Such notification shall be made to the °TAO in writing,of which email is an acceptable form, within thirty (30) days of such offering.
ARTICLE 21. Immunity from Liability.
In accordance with the Public Readiness and Emergency Preparedness Act ("PREP Act"), Pub.
L. No. 109148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42
U.S.C. § 247d-6e), as well as the Secretary of HHS's Declaration Under the Public Readinessand Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed.
Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), and amended on April 15, 2020, 85 Fed.
Reg. 21012 (together, the "PREP Act Declaration"):This Agreement is being entered into for purposes of facilitating the manufacture,(i)
testing, development, distribution, administration, and use of "Covered Countermeasures" forresponding to the COVID-19 public health emergency, in accordance with Section VI of the
PREP Act Declaration;(ii)
Awardee's performance of this Agreement falls within the scope of the"Recommended Activities" for responding to the COVID-19 public health emergency, to theextent it is in accordance with Section III of the PREP Act Declaration; and(iii) Awardee is a "Covered Person" to the extent it is a person defined in Section V of the
PREP Act Declaration.
Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the
PREP Act (42 U.S.C. § 247d-6d), the Department of Defense contracting via assisted
acquisition on behalf of the HHS, expressly acknowledges and agrees that the HHS
Declaration cited above, specifically its language providing immunity from suit and liability isapplicable to this acquisition as long as Awardee's activities fall within the terms andconditions of the PREP Act and the PREP Act Declaration.
The Government may not use, or authorize the use of, any products or materials provided
under this Agreement, unless such use occurs in the United States (or a U.S. territory where
U.S. law applies including, but not limited to, embassies, military installations and NATOinstallations) and is protected from liability under a declaration issued under the PREP Act, ora successor COVID-19 PREP Act Declaration of equal or greater scope. Any use where theapplication of the PREP Act is in question will be discussed with Awardee prior to use and, if
the Parties disagree on such use, the dispute will be resolved according to Article 5(H).
ARTICLE 22. Miscellaneous Clauses.
A. No Consent. Nothing in the terms of this Agreement constitutes express or implied Government
authorization and consent for Awardee or its subawardee(s) to utilize, manufacture or practiceinventions covered by United States or foreign patents in the performance of work under this30

Agreement.
B. Patent Infringement. Each Party will advise the other Party promptly and inreasonable written detail, of each claim or lawsuit of patent infringement based on
the performance of this Agreement. When requested by either Party, all evidence
and information in possession of the Party pertaining to such claim or lawsuit will
be provided to the other at no cost to the requesting Party.
C. Limitation of Liability. Except for claims of non-payment of amounts due under
Article 7, any claims for damages of any nature whatsoever pursued under thisAgreement shall be limited to direct damages only up to the aggregate amount ofGovernment funding disbursed as of the time the dispute arises. In no event will
either Party be liable to the other Party or any third party claiming through such
Party for any indirect, incidental, consequential or punitive damages, or claims forlost profits, arising under or relating to this Agreement, whether based in contract,
tort or otherwise, even if the other Party has been advised of the possibility of suchdamages.
D. Disclosure of Information. Subject to Article 10, the Awardee shall not release toanyone outside the Awardee's organization any unclassified non-public
information, regardless of medium (e.g., film, tape, document), pertaining to theclinical trial that is subject of this Agreement, unless (i) the °TAO has given priorwritten approval or (ii) the information is otherwise in the public domain before thedate of release or (iii) such disclosure would be made by Awardee normally as partof such a trial in the regular course of its business. For purposes of this clause,Awardee's Organization includes entities identified as subawards..
E. Force Majeure. Neither Party will be liable to the other Party for failure or delay inperforming its obligations hereunder if such failure or delay arises fromcircumstances beyond the control and without the fault or negligence of the Party(a Force Majeure event). Examples of such circumstances are: authorized acts ofthe government in either its sovereign or contractual capacity, war, insurrection,
freight embargos, fire, flood, pandemic, or strikes. The Party asserting Force
Majeure as an excuse must take reasonable steps to minimize delay or damages
caused by unforeseeable events.
F. Severability. If any provision of this Agreement, or the application of any suchprovision to any person or set of circumstances, is determined to be invalid,
unlawful, void or unenforceable to any extent, the remainder of this Agreement, andthe application of such provision to persons or circumstances other than those as towhich it is determined to be invalid, unlawful, void or unenforceable, will not be
impaired or otherwise affected and will continue to be valid and enforceable to the31fullest extent permitted by law.
G. Choice of Law. This Agreement and the resolution of disputes hereunder will begoverned, construed, and interpreted by the statutes, regulations, and/or legal
precedent applicable to the Government of the United States of America. Unlessexplicitly stated, the Parties do not intend that this Agreement be subject to theFederal Acquisition Regulation either directly or indirectly or by operation of law.
When a specific FAR requirement is incorporated by reference in this Agreement,
the text of the clause alone will apply without application or incorporation of otherprovisions of these regulations.
H. Order of Precedence. In the event of a conflict between the terms of this Agreement
and the attachments incorporated herein, the conflict shall be resolved by giving
precedence in descending order as follows:(i) the Articles of this Agreement, and(ii) the Appendices to the Agreement.
I. Conflicts of Interest.
The Awardee does and shall comply with the requirements of 21 CFR Part 54,
Financial Disclosure by Clinical Investigators
J. Organizational Conflicts of Interest.
Performance under this Agreement may create an actual or potential organizational
conflict of interest such as are contemplated by FAR Part 9.505-General Rules. The
Awardee shall not engage in any other contractual or other activities which could
create an organizational conflict of interest (OCI). This provision shall apply to theAwardee and all sub-recipients. This provision shall have effect throughout theperiod of performance of this Agreement, any extensions thereto by change order or
supplemental agreement, and for two (2) years thereafter. The Government may
pursue such remedies as may be permitted by law or this Agreement, upondetermination that an OCI has occurred.
The work performed under this Agreement may create a significant potential for
certain conflicts of interest, as set forth in FAR Parts 9.505-1, 9.505-2, 9.505-3, and9.505-4. It is the intention of the parties hereto to prevent both the potential for bias
in connection with the Awardee's performance of this Agreement, as well as thecreation of any unfair competitive advantage as a result of knowledge gained
through access to any non-public data or third party proprietary information.
The Awardee shall notify the Agreements Officer immediately whenever it
32becomes aware that such access or participation may result in any actual or
potential OCI. Furthermore, the Awardee shall promptly submit a plan to theAgreements Officer to either avoid or mitigate any such OCI. The Agreements
Officer will have sole discretion in accepting the Awardee's mitigation plan. In theevent the Agreements Officer unilaterally determines that any such OCI cannot besatisfactorily avoided or mitigated, other remedies may be taken to prohibit theAwardee from participating in Agreement requirements related to OCI.
Whenever performance of this Agreement provides access to another Awardee's
proprietary information, the Awardee shall enter into a written agreement with theother entities involved, as appropriate, in order to protect such proprietary
information from unauthorized use or disclosure for as long as it remains
proprietary; and refrain from using such proprietary information other than as
agreed to, for example to provide assistance during technical evaluation of otherAwardees' offers or products under this Agreement. An executed copy of all
proprietary information agreements by individual personnel or on a corporate basis
shall be furnished to the ()TAO within fifteen (15) calendar days of execution.
K. Telecommunications and Video Surveillance. FAR 52.204-25 Prohibition on
Contracting for Certain Telecommunications and Video Surveillance Services orEquipment incorporated by reference.
L. Data Privacy. The Parties will comply with all applicable Laws regarding Study
participant confidentiality and data protection, including, without limitation,
HIPAA, HITECH, and applicable state privacy Laws, in the collection, use, storage
and disclosure of protected health information (as defined under HIPAA or the
relevant Law) ("PHI"). Awardee shall, or shall direct its representatives to, collect,use, store, access and disclose PHI collected from Study participants only inaccordance with applicable ICFs or with applicable Laws. Awardee shall also
obtain in the ICF or separate authorization document, permission for USG/USG
representatives involved with or evaluating the Study to access and obtain copies of
the Subject Data to the same extent as Awardee and to otherwise exercise its rights
under this Agreement, including, without limitation, its audit rights.

33

Appendix A
Statement of Work
The Awardee plans to execute the program in accordance with the statement of work provided below.
The plan is to accomplish the entire project based on the schedule prescribed in this agreement.
Completion dates are expressed in Appendix B. The numbering scheme below is adopted from theAwardee's Statement of Work as included in its proposal. Only the sections of the proposal included inthis Appendix A are made a part of this Agreement.
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

1.1

Introduction

Coronavirus Disease 2019 (COVID-19) is the disease caused by Severe Acute Respiratory
Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower
respiratory tract and can lead to acute respiratory distress syndrome (ARDS) in a subset ofpatients with a known high mortality rate. Additionally, some patients develop other organ
dysfunction including myocardial injury, acute kidney injury, shock along with endothelial
dysfunction and subsequently micro and macrovascular thrombosis. Accordingly, there is anurgent and unmet medical need to find treatments that can effectively reduce the risk of
ARDS, organ damage, thrombosis or the mortality rate in COVID-19 subjects.
Fostamatinib is unique among FDA approved products being evaluated for the treatment of
COVID-19 disease because it targets both the cytokine storm associated with SAR-CoV2
infection as well as the thrombotic effects of COVID-19 disease. The active metabolite of
fostamatinib, R406, is a potent and selective inhibitor of SYK which can decrease stimulation of
Fc receptor (FcR) by the SARS-CoV2- antibody immune complexes while also decreasing Ctype lectin receptor mediated coagulopathy disorders by inhibiting immune cell activation caused
by COVID-19 related tissue damage or pathogen signals.
Fostamatinib is marketed in the U.S. as TAVALISSE (fostamatinib disodium hexahydrate)tablets. The product is approved in the U.S. and Europe as a treatment for adult chronic
immune thrombocytopenia (ITP)-- a rare autoimmune disorder. Fostamatinib is a tablet thatis administered orally.
Rigel has initiated a Phase 3 clinical trial entitled Double-Blind, Randomized, PlaceboControlled, Adaptive Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safetyof Fostamatinib in COVID-19 Subjects. This trial is evaluating the safety and efficacy of
Fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain
high-risk prognostic factors. This multi- center, double-blind, placebo-controlled, adaptive
design study is expected to enroll over 300 evaluable patients that will be randomly assigned
34

to either fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1).
Treatment will be administered orally twice daily for 14 days. For subjects who aredischarged from the hospital before completing 14 days of study treatment, subjects will selfadminister in an out-patient setting. There will be a follow-up period to day 60. The primary
endpoint of this study is the proportion of subjects who progress to severe/critical disease
within 29 days.
1.2

Scope

Ri el will com lete the on-• om Phase 3 trial.

1.3

Objective

The program is designed to provide the following end products:••

Application for an EUA supporting the use of Fostamatinib for the prevention ofprogression to severe/critical COVID-19 Disease in hospitalized and out-patient
populations, as appropriate.
Final Clinical Study Reports (CSR) for the Phase 3 study, conducted under Good Clinical
Practice (GCP) on the benefit and safety of Fostamatinib in COVID-19 patients, delivered
to the FDA and JPEO-CBRND, JPM-Medical under eCTD standards.

The Rigel development plan provides a complete solution to the US Government's
requirement, with an estimated period of performance of twelve months.
This is a prototype project because Rigel will develop Fostamatinib by conducting randomized
placebo- controlled clinical study(s) and filing for an EUA, in order to evaluate the technical35

feasibility of using Fostamatinib for the prevention of progression to severe/critical COVED-19
Disease in hospitalized patients, and if appropriate an out-patient population, an indication(s) not
currently approved by the FDA.
2.0 APPLICABLE DOCUMENTS
NA
3.0 REQUIREMENTS
Overall Scope & Objectives of the Prototype Project
Rigel will conduct a randomized controlled clinical trial of Fostamatinib in COVID-19
patients and provide an option to support other clinical trials as well as support DoD efforts
to obtain an EUA for Fostamatinib for the prevention of progression to severe/critical
COVID-19 Disease in hospitalized and out-patient populations as appropriate.
WBS 1

BASE PERIOD

Ri• el will corns lete the on-

Phase 3 trial.

WBS 1.1
CLINICAL STUDIESWBS 1.1.1 INPATIENT STUDIESWBS 1.1.1.1 COMPLETE PHASE 3 EFFICACY STUDY — DOUBLE-BLIND,RANDOMIZED, PLACEBO-CONTROLLED, ADAPTIVE DESIGN,MULTI-CENTER PHASE 3 STUDY TO EVALUATE THE EFFICACYAND SAFETY OF FOSTAMATIMB IN COVID-19 SUBJECTSThis study is a double-blind, randomized, placebo-controlled, adaptive design, multi-center,
Phase 3 study to evaluate the efficacy and safety of fostamatinib in COVID-19 subjects. It isestimated that approximately 300 hospitalized COVBD-19 subjects without respiratory failure
and with certain high-risk factors will be evaluated. Subjects will be randomized 1:1 to either
SOC plus fostamatinib or SOC plus placebo. In addition to SOC, fostamatinib or placebo will
be administered orally for 14 days at a dose of 150 mg twice daily. If patients are discharged,
36

treatment will be self-administered. The primary efficacy endpoint of the study is: Progression
to severe/critical disease within 29 days of first dose of study treatment, defined as proportionof subjects with a change of clinical status score from 3, 4, or 5 to a clinical status score of 6, 7,
or 8 on the 8-point ordinal scale. A number of other secondary, efficacy, and safety endpoints
are included in the study.
WBS 1.1.2 OUTPATIENT STUDIESWBS 1.1.2.1 OUTPATIENT STUDY SUPPORT
Rigel will provide technical, regulatory and clinical trial planning expertise to support thedevelopment and planning of a Phase 2 clinical trial designed to evaluate the safety andefficacy of fostamatinib in preventing the progression to severe/critical COVID-19 diseasein out-patient populations.
WBS 1.2
REGULATORY ACTIVITIESWBS 1.2.1 FDA FILINGS, CORRESPONDENCE & EUA SUBMISSIONSWBS 1.2.1.1 ROUTINE FDA CORRESPONDENCES
The trial defined in SOW# 1.1.1.1 will be conducted under ND #151287 which was
opened for the development of fostamatinib in COVID-19 patients. Study safety clearance
letter to proceed with the phase 3 clinical study outlined in SOW #1.1.1.1 was received
from the FDA on November 5th, 2020.
Rigel will complete all filings and correspondences required as part of this clinical trial.
Rigel will participate in all filings and correspondences with the FDA as required to support
the development and planning of the Phase 2 outpatient study.
WBS 1.2.1.2 EMERGENCY USE AUTHORIZATIONWBS 1.3
CONTRACT ADMINISTRATION & PROJECT MANAGEMENTWBS 1.3.1 PROJECT MANAGEMENTWBS 1.3.1.1 BASE PERIOD (CLIN 0001) PROJECT MANAGEMENT
37

Rigel will provide the NHLBI Phase 2 clinical study and its Phase 3 clinical study with highlevel project management support including the potential Pre-EUA and EUA applications with
the US FDA.
BASE PERIOD (CL1N
0001)

1. 1
1 . .1.1
1. .2
1 .2.11.2
1.2.1
1.2.1.1
1.2.1.2
1.3
1.3.1
1.3.1.1

mica tu lesClinical Study — In Patient
Complete Phase 3 - Double-Blind, Randomized, Placebo-Controlled, Adaptive
Design, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of
Fostamatinib in COVID-19 Subjects
Clinical Study — Outpatient
Provide Outpatient Study Support — Planning
Regulatory Activities
FDA Filings and Corresylondence
Routine FDA Communications
Submit Emergency Use Authorization Package
Contract Administration & Pro ect Malta. ement
Project Management
Base Penod (CL1N 0001) Project Management

COVID-19: Program Timeline'Timing dependent upon on-going discussions with NHLBI

38

Appendix B
Project Schedule/Milestone Payment Schedule
The Government shall pay the Awardee, upon the submission of proper invoices orvouchers, the prices stipulated in this Agreement for supplies delivered and acceptedor services rendered and accepted, less any deductions provided in this Agreement.
Invoices shall be submitted based on the awarded milestones. The below payment
schedule is traceable to applicable task(s)/deliverable(s) identified within thestatement of work. Payments are due upon completion and acceptance of alldeliverables within each phase. An invoice will be submitted through Wide Area
Work Flow (WAWF) in accordance with agreement requirements within ten (10) daysof the deliverable being submitted.
Event

Month

Year

Total

Amount$16,500,000

The Awardee shall proceed with the performance in accordance with the terms andconditions of this Agreement and its Appendices. However, the Government may
require the Awardee to cease performance at any time prior to the commencementof any milestone or task. Such notice to cease performance must be from the AO
and be in writing, of which email is an acceptable form.
The Parties acknowledge that the nature of this Prototype Project requires flexibility
and the ability to react to changing circumstances. Although the Statement of Work39

sets the scope for activities the Government may require under this Agreement, it is
not intended to, and does not, prescribe with specificity each task that Awardee will
perform.

Appendix C
Key Personnel
1. Awardee's Organization and Key Personnel.
a. The Awardee's organization shall be established with authority to effectively
accomplish the objectives of the Statement of Work. This organization shallbecome effective upon award of the Agreement and its integrity shall bemaintained for the duration of the effort.
b. Any key personnel specified in this agreement are considered to be essential towork performance. At least thirty (30) calendar days prior to the Awardee voluntarily
diverting any of the specified individuals to other programs or contracts the Awardee
shall notify the Agreements Officer and shall submit a justification for the diversion
or replacement and a request to replace the individual. The request must identify the
proposed replacement and provide an explanation of how the replacement's skills,
experience, and credentials meet or exceed the requirements of the Agreement(including, when applicable, Human Subjects Testing requirements). If the employeeof the Awardee is terminated for cause or separates from the Awardee voluntarily
with less than thirty (30) calendar-day notice, the Awardee shall provide themaximum notice practicable under the circumstances. The Awardee shall not divert,
replace, or announce any such change to key personnel without the written consent of
the Agreements Officer. The Agreement will be modified to add or delete key
personnel as necessary to reflect the agreement of the parties. The key personnel are
listed in Appendix C. The requirements of this Appendix C are intended to be read in
combination with the requirements of Article 3, Sections C and D.

Table 2: Key Personnel
SummaryAppendix D
Government Property
Government Property: "Government Property" means any property (i) furnished by theGovernment and facilitating performance of this Agreement, (ii) acquired by the Awardee
under cost reimbursement terms of this Agreement, or (iii) acquired by the Awardee under
fixed price terms of this Agreement (FP-GP) if specifically identified in this Government
Property Appendix. Except for commercial off the shelf software and licenses thereto,
Government Property does not include intellectual property and software. The Government
owns and holds title to all Government Property.
The Government shall deliver to the Awardee any Government Property required to be furnishedas described in this Agreement together with related data and information needed for its intended
use. The delivery and/or performance dates specified in this Agreement are based upon the
expectation that the Government-furnished property will be suitable for performance and will bedelivered to the Awardee by the dates stated in the Agreement. If not so suitable, the Awardee
shall give timely written request to the OTAO who will advise the Awardee on a course of action
to remedy the problem.
FPGP includes: [Mark N/A if none]:
Reference Government provided spreadsheet maintained by the Awardee and incorporated
into the agreement upon approval by the OTAO.

The Awardee shall have, initiate and maintain a system of internal controls to manage, control,use, preserve, protect, repair, account for and maintain Government Property in its possession
and shall initiate and maintain the processes, systems, procedures, records required control andmaintain accountability of Government Property. The Awardee shall include this clause in all
subAwards under which Government Property comes into the possession of any subawardee.
Unless otherwise provided for in this Agreement or approved by the OTAO, the Awardee shallnot: (i) use Government Property for any purpose other than to fulfill the requirements of thisAgreement, or (ii) alter the Government Property.
The Awardee shall establish and implement property management plans, systems, andprocedures regarding its acquisition of Government Property, its receipt of Government
Property, in addition to, the status, dates furnished or acquired, identification, quantity, cost,marking, date placed in service, location, inventory and disposition of Government Property, toinclude a reporting process for all discrepancies, loss of Government Property, physicalinventory results, audits and self-assessments, corrective actions, and other property related
reports as directed by the OTAO.
Upon conclusion or termination of the Agreement, the Awardee shall submit a request in writing
to the OTAO, for disposition/disposal instructions and shall store Government Property not toexceed 120 days pending receipt of such instructions. Storage shall be at no additional cost to theGovernment unless otherwise noted in the Agreement. The Government, upon written notice to42the Awardee, may abandon any Government Property in place, at which time all obligations of
the Government regarding such Government Property shall cease.
Awardee Liability for Government Property. "Loss of Government Property" means the loss,
damage or destruction to Government Property reducing the Government's expected economic
benefits of the property and includes loss of accountability but does not include planned andpurposeful destructive testing, obsolescence, reasonable wear and tear or manufacturing defects.
THE AWARDEE SHALL BE LIABLE FOR LOSS OF GOVERNMENT PROPERTY IN
AWARDEE'S POSSESSION, EXCEPT WHEN ANY ONE OF THE FOLLOWING APPLIES:(I) OTAO GRANTS RELIEF OF RESPONSIBILITY AND LIABILITY FOR LOSS OF THE
PARTICULAR GOVERNMENT PROPERTY; (II) GOVERNMENT PROPERTY IS
DELIVERED OR SHIPPED UNDER THE GOVERNMENT'S INSTRUCTIONS AND
SHIPPERS; OR (III) GOVERNMENT PROPERTY IS DISPOSED OF IN ACCORDANCEWITH THE GOVERNMENT'S DIRECTIONS.

Appendix E
43

MODEL AUTHORIZATION FOR FDA TO SHARE NON-PUBLIC INFORMATION WITH THE
DEPARTMENT OF DEFENSE[To be completed on applicant/sponsor/information-owner letterhead][FDA Official — e.g., Center or Office Director]
United States Food and Drug Administration
10903 New Hampshire Avenue
Building, RoomSilver Spring, MD 20993[Identify relevant FDA Tracking number — e.g., NDA/ANDA/BLA, EUA/Pre-EUA, master file, etc.)]
Re: FDA Sharing of Non-Public Information Concerning [insert name of regulated product(s)] with Departmentof Defense (DoD) Partners'
On behalf of [insert name of information owner], I authorize the United States Food and Drug
Administration (FDA) to share with DoD Partners, and with contractors to those Partners, all information
concerning the above described product(s) that [insert name of information owner] has provided or will provide
to FDA or to any other DoD Partner. I understand that those Partners have committed to use such information
only for the purposes of the DoD and have committed or are otherwise legally required to maintain theconfidentiality of such information (or both), and that contractors to DoD are bound by their contracts tomaintain the confidentiality of the information. I understand that the information may contain confidentialcommercial or fmancial information or trade secrets within the meaning of 18 USC § 1905, 21 USC § 331(j),and 5 USC § 552(b)(4), that is exempt from public disclosure.
Authorization is given to FDA to share this information without deleting confidential commercial or
financial or trade secret information. This authorization shall remain valid unless revoked in writing. As
indicated by my signature, I am authorized to provide this consent on behalf of [insert name of information
owner] and my full name, title, address, telephone number, and facsimile number are set out below for
verification.
Sincerely,'DoD Partners include the U.S. Army Medical Research and Materiel Command (USAMRMC), the Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Science and Technology Office (JSTO) of the Defense
Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and other DoD entities.

44

(Signature)(Printed name)(Title)(Address)(Telephone & Facsimile Numbers)
cc:
Office of Counterterrorism and Emerging Threats (OCET), Office of the Chief Scientist, FDA(EUA.00ET@fda.hhs.gov)
The primary MCM Center, as follows:
For CBER, (Counterterrorism and Medical Countermeasures Staff or CBEREUA@fda.hhs.gov)
For CDER, (Counter-Terrorism and Emergency Coordination Staff or CDEREUA@fda.hhs.gov)
For CDRH, for IVD medical devices, (device@fda.hhs.gov) and for non-IVD medical devices(cdrhemcm@fda.hhs.gov)

45

Appendix F
Rigel Pharmaceuticals, Inc. is the sole owner of intellectual property rights, as described below, covering the drug substancefostamatinib, drug products comprising fostamatinib, and methods of making and using such drug substance and drug product.
The drug product is currently marketed in the US by Rigel, and in Europe and Canada under license from Rigel, for the treatmentof immune thrombocytopenia.
Patent Properties Owned by Rigel Pharmaceuticals
Patent Family 1: US Patents 7,060,827, 7,803,393, 7,906,644, 10,682,350

Owner

Rigel Pharmaceuticals, Inc.

Inventors

R. Singh, A. Argade, D. Payan, S.
Molineaux, S. Holland, J. Clough,H. Keim, S. Bhamidipati, C.
Sylvain, H. Li, A. Rossi
Continuations from US Patent
7,557,210, claiming priority to
60/353,267, 60/353,333,
60/399,673, 60/434,277
February 1, 2002

Priority Data

Earliest Priority Date
International Application PCT No[Publication Number]International Application Filing
Date

PCT/US03/03022.
[WO/2003/063794]
January 31, 2003

Ownership
This patent family is owned by Rigel Pharmaceuticals.

Brief Summary of the Invention
Covers intermediates of Fostamatinib Drug Substance and processes for making such intermediates
StatusThe Table below summarizes the status of this patent family.

46

Country

Official No.

Status

Predicted Expiry

Austria

EP1471915

Issued1/31/2023

Austria

EP2281563

Issued1/31/2023

Australia

3208931

Issued1/31/2023

Belgium

EP1471915

Issued1/31/2023

Belgium

EP2281563

Issued1/31/2023

Bulgaria

EP1471915

Issued1/31/2023

Bulgaria

EP2281563

Issued1/31/2023

Brazil

PI0307355-6

Issued

11/13/2028

Belarus

12599

Issued1/31/2023

Canada2,474,277

Issued1/31/2023

China

ZL03803180.9

Issued1/31/2023

China

ZL201110056352.5

Issued1/31/2023

Cyprus

EP1471915

Issued1/31/2023

CyprusEP2281563

Issued1/31/2023

Croatia

P20040684

Issued1/31/2023

Czech Republic

EP1471915

Issued1/31/2023

Czech Republic

EP2281563

Issued1/31/2023

Denmark

EP1471915

Issued1/31/2023

Denmark

EP2281563

Issued1/31/2023

Estonia

EP1471915

Issued1/31/2023

Estonia

EP2281563

Issued1/31/2023

47

ountry

Official No.

Status

Predicted Expiry
1/31/2023

EP147101';

Granted(validated in
AT,BE,BG,CH,C
Y,CZ,DE,DK,EE,
ES,FI,FR,GB,GR,
HU,IE,IT,LT,LU,
LV,MC,NL,PT,R
0,SE,SI,SK,TR

EuropeEP2281563

Granted
1/31/2023(validated in
AT,BE,BG,CH,C
Y,CZ,DE,DK,EE,
ES,FI,FR,GB,GR,
HU,IE,IT',LT,LU,
LV,MC,NL,PT,R
0,SE,SI,SK,TR

Finland

EP1471915

Issued1/31/2023

Finland

EP2281563

Issued1/31/2023

FranceEP1471915

Issued1/31/2023

FranceEP2281563

Issued1/31/2023

Germany

EP1471915

Issued1/31/2023

Germany

EP2281563

Issued1/31/2023

GreeceEP1471915

Issued1/31/2023

GreeceEP2281563

Issued1/31/2023

Hong Kong

HK 1069538

Issued1/31/2023

Hong Kong

HK1154216

Issued1/31/2023

Hungary

EP1471915

Issued1/31/2023

Hungary

EP2281563

Issued1/31/2023

India

239514

Issued1/31/2023

Europe48

Wfficial No.

StatusIreland

EP1471915

Issued1/31/2023

Ireland

EP2281563

Issued1/31/2023

Israel163206

Issued1/31/2023

Israel221381

Issued1/31/2023

Italy

EP1471915

Issued1/31/2023

Italy

EP2281563

Issued1/31/2023

Japan

4658477

Issued1/31/2023

Japan

5357116

Issued1/31/2023

LatviaEP1471915

Issued1/31/2023

LatviaEP2281563

Issued1/31/2023

Lithuania

EP1471915

Issued1/31/2023

Lithuania

EP2281563

Issued1/31/2023

Luxembourg

EP1471915

Issued1/31/2023

Luxembourg

EP2281563

Issued1/31/2023

MonacoEP1471915

Issued1/31/2023

MonacoEP2281563

Issued1/31/2023

Mexico334572

Issued1/31/2023

Mexico341239Issued1/31/2023

Netherlands

EP1471915

Issued1/31/2023

Netherlands

EP2281563

Issued1/31/2023

New Zealand

534361

Issued1/31/2023

Norway328071

Issued1/31/2023

Poland214 988

Issued1/31/2023

Portugal

EP1471915

Issued1/31/2023

49.

Predicted Expiry

.Licr ,Official No.

Status

Predicted Expiry

Portugal

EP2281563

Issued1/31/2023

Romania

EP1471915

Issued1/31/2023

Romania

EP2281563

Issued1/31/2023

Russia2343148

Issued1/31/2023

Russia2493150

Issued1/31/2023

Serbia53367

Issued1/31/2023

Serbia54105

Issued1/31/2023

Singapore

105788Issued1/31/2023

Singapore

167664

Issued1/31/2023

Slovenia

EP1471915

Issued1/31/2023

Slovenia

EP2281563

Issued1/31/2023

Slovak Republic

EP1471915

Issued1/31/2023

Slovak Republic

EP2281563

Issued1/31/2023

South Africa

2004/05979

Issued1/31/2023

South Korea

10-1037856

Issued1/31/2023

Spain

EP1471915

Issued1/31/2023

Spain

EP2281563

Issued1/31/2023

SwedenEP1471915

Issued1/31/2023

SwedenEP2281563

Issued1/31/2023

Switzerland

EP1471915

Issued1/31/2023

Switzerland

EP2281563

Issued1/31/2023

TurkeyEP1471915

Issued1/31/2023

TurkeyEP2281563

Issued1/31/2023

Ukraine81758

Issued1/31/2023

United Kingdom

EP1471915

Issued1/31/2023

50

Country

edicted Expiry

United Kingdom

EP2281563:PIM—
IssuedUnited States of America

7,060,827

Issued

4/20/2023

United States of America

7,906,644

Issued

11/21/2024

United States of America

7,803,939

Issued3/25/2023

United States of America

10,682,350

Issued

11/21/2024

1/31/2023

Patent Family 2: US Patent 7,122,542 & 7,560,466
Owner

Rigel Pharmaceuticals, Inc.

Inventors

Earliest Priority Date

R. Singh, A. Argade, H. Li, S.
Bhamidipati, D. Carroll, C. Sylvain,
J. Clough, H. Keim
60/572,256, 60/531,598, and60/491,641
July 30, 2003

International Application PCT No

WO 2005/016893

Priority Data

[Publication Number]International Application Filing
Date

July 30, 2004

Ownership
This patent family is owned by Rigel Pharmaceuticals.

Brief Summary of the Invention
Covers intermediates useful for making, and the active metabolite of, Fostamatinib Drug Substance
StatusThe Table below summarizes the status of this patent family.

Official No.
Australia

2011200367

Pending51

7/30/2024

,! ••Austria

EP1656372

Issued7/30/2024

Belarus

18495

Issued7/30/2024

Belgium

EP1656372

Issued7/30/2024

Bulgaria

EP1656372

Issued7/30/2024

Brazil0413018-9

Issued7/30/2024

Canada2533377

Issued7/30/2024

China

ZL200480022235.5

Issued7/30/2024

Croatia

EP1656372

Issued7/30/2024

Cyprus

EP1656372

Issued7/30/2024

Czech Republic

EP1656372

Issued7/30/2024

Denmark

EP1656372

Issued7/30/2024

Estonia

EP1656372

Issued7/30/2024

EuropeEP1656372

Granted7/30/2024(validated in
AT,BE,BG,C
H,CY,CZ,D
E,DK,EE,ES,
FI,FR,GB,G
R,HR,HU,IE,
LU,MC,NL,
PO,PT,RO,S
I,SK,TRFinland

EP1656372

Issued7/30/2024

FranceEP1656372

Issued7/30/2024

Germany

EP1656372

Issued7/30/2024

GreeceEP1656372

Issued7/30/2024

Hong Kong

HK1091209

Issued7/30/2024fficial No.

•

• ,,

Hungary

EP1656372

Issued7/30/2024

India

259745

Issued7/30/2024

Ireland

EP1656372

Issued7/30/2024

Israel173299Issued7/30/2024

Italy

EP1656372

Issued7/30/2024

Japan

4886511

Issued7/30/2024

Luxembourg

EP1656372

Issued7/30/2024

MonacoEP1656372

Issued7/30/2024

Mexico307152

Issued7/30/2024

Netherlands

EP1656372

Issued7/30/2024

New Zealand

545270Issued7/30/2024

Norway333771

Issued7/30/2024

PolandEP1656372

Issued7/30/2024

Portugal

EP1656372

Issued7/30/2024

Romania

EP1656372

Issued7/30/2024

Russia2356901

Issued7/30/2024

Serbia53109

Issued7/30/2024

Singapore

118995

Issued7/30/2024

Singapore

145698Issued7/30/2024

Slovak Republic

EP1656372

Issued7/30/2024

Slovenia

EP1656372

Issued7/30/2024

South Korea

10-1201603

Issued7/30/2024

Spain

EP1656372

Issued7/30/2024

Sweden

EP1656372

Issued7/30/2024

Switzerland

EP1656372

Issued7/30/2024

53

piry

t,ITPTErrrniFla
I

TurkeyEP1656372

Issued7/30/2024

Ukraine91000

Issued7/30/2024

United Kingdom

EP1656372

Issued7/30/2024

United States of America

7,122,542

Issued

2/12/2025

United States of America

7,560,466

Issued7/30/2024

South Africa

2006/01460

Issued7/30/2024

Patent Family 3: Stemming from US Patent 7,449,458
Owner
Inventors

Rigel Pharmaceuticals, Inc.

Priority Data

S. Bhamidipati, R. Singh, V. Stella,
T.Sun
60/645,424 and 60/654,620

Earliest Priority Date

January 19, 2005

International Application PCT No

PCT/U506/01945 [W02006078846][Publication Number]International Application Filing
Date

January 19, 2006

Ownership
This patent family is owned by Rigel Pharmaceuticals.
Brief Summary of the Invention
Covers Fostamatinib Drug Substance, specifically and generically, as well as methods of making and using.
StatusThe Table below summarizes the status of this patent family.

Australia

Official No.

his2006206458

Issued54

1/19/2026

Official No.

Predicted expiry

Austria

EP 1856135

Issued

1/19/2026

Belarus

17180

Issued

1/19/2026

Belgium

EP 1856135

Issued

1/19/2026

Bermuda

448EP

Registered

1/19/2026

British Virgin Islands

EP 1856135

Registered

1/19/2026

Bulgaria

EP 1856135

Issued

1/19/2026

Brazil

PI0606318-7

Published

1/19/2026 (10years from grant)

Canada2,591,948

Issued

1/19/2026

Cayman Islands

EP 1856135

Registered

1/19/2026

China

ZL200680002643.3

Issued

1/19/2026

CyprusEP 1856135

Issued

1/19/2026

Czech Republic

EP 1856135

Issued

1/19/2026

Denmark

EP 1856135

Issued

1/19/2026

Estonia

EP 1856135

Issued

1/19/2026

EuropeEP 1856135

Granted1/19/2026(validated in
AT,BE,BG,C
H,CY,CZ,D
E,DK,EE,ES,
FI,FR,GB,G
R,HR,HU,IE.
IS,LU,MC,N
L,LT,LV,P0.
PT,RO,SI,S
K,TR

Fiji

EP 1856135

Registered

1/19/2026

Finland

EP 1856135

Issued

1/19/2026

55

Country

Official No.

'Predicted expiry

FranceEP 1856135

Issued

1/19/2026

Germany

EP 1856135

Issued

1/19/2026

Gibraltar

673

Registered

1/19/2026

GreeceEP 1856135

Issued

1/19/2026

GrenadaEP 1856135

Registered

1/19/2026

Hong Kong

11K1108896

Issued

1/19/2026

Hungary

EP 1856135

Issued

1/19/2026

Iceland

EP 1856135

Issued

1/19/2026

India

262177

Issued

1/19/2026

Ireland

EP 1856135

Issued

1/19/2026

Israel183890Issued

1/19/2026

Italy

EP 1856135

Issued

1/19/2026

Japan

4,801,096

Issued

1/19/2026

JerseyEP 1856135

Registered

1/19/2026

Kiribati

EP 1856135

Registered

1/19/2026

LatviaEP 1856135

Issued

1/19/2026

Lithuania

EP 1856135

Issued

1/19/2026

Luxembourg

EP 1856135

Issued

1/19/2026

MonacoEP 1856135

Issued

1/19/2026

Mexico297057

Issued

1/19/2026

Mexico346822

Issued

1/19/2026

Netherlands

EP 1856135

Issued

1/19/2026

New Zealand

555947

Issued

1/19/2026

Norway339146

Issued

1/19/2026

PolandEP 1856135

Issued

1/19/2026

56

, , I

fficial No.

WM'

Predicted expiry

Portugal

EP 1856135

Issued

1/19/2026

Romania

EP 1856135

Issued

1/19/2026

Russia2416616

Issued

1/19/2026

Singapore

133812

Issued

1/19/2026

Singapore

167710Issued

1/19/2026

Slovak Republic

EP 1856135

Issued

1/19/2026

Slovenia

EP 1856135

Issued

1/19/2026

South Africa

2007/05410

Issued

1/19/2026

South Korea

10-1278397

Issued

1/19/2026

Spain

EP 1856135

Issued

1/19/2026

Sweden

EP 1856135

Issued

1/19/2026

Switzerland

EP 1856135

Issued

1/19/2026

TurkeyEP 1856135

Issued

1/19/2026

Turks & Caicos

EP 1856135

Registered

1/19/2026

Ukraine91210

Issued

1/19/2026

United Kingdom

EP 1856135

Issued

1/19/2026

United States of America

7,449,458

Issued

9/4/2026

United States of America

7,538,108

Issued3/28/2026

United States of America

7,563,892

Issued

6/17/2026

United States of America

7,989,448

Issued6/12/2026

United States of America

8,211,889

Issued

1/19/2026

United States of America

10.577.381

Issued

1/19/2026

United States of America

US-2020-0270271-Al

Published

1/19/2026

57

Patent Family 4: Stemming from US Patent 8,163,902

Owner
Inventors

Rigel Pharmaceuticals, Inc.

Priority Data

S. Bhamidipati, R. Singh, T. Sun, E.
Masuda60/866,722

Earliest Priority Date

November 21,2006

International Application PCT No

PCT/US2007/085313[WO/2008/064274][Publication Number]International Application Fffing
Date

November 20, 2007

Ownership
This patent family is owned by Rigel Pharmaceuticals.
Brief Summary of the Invention
Covers Fostamatinib Drug Substance crystal and oral dosage forms..
StatusThe Table below summarizes the status of this patent family.
Country

Status1 icted expiry

Canada2673137

Issued

11/20/2027

Denmark

EP2078026

Issued

11/20/2027

EuropeEP2078026

Granted(validated in
CH,DE,DK,
ES,FR,GB,I
E,LU,NL

11/20/2027

FranceEP2078026

Issued

11/20/2027

Germany

EP2078026

Issued

11/20/2027

Hong Kong1133257B

Issued

11/20/2027

Ireland

EP2078026

Issued

11/20/2027

58

•Country' •edicted expiry

Italy

EP2078026

Issued

11/20/2027

Japan

5264759

Issued

11/20/2027

Luxembourg

EP2078026

Issued

11/20/2027

Netherlands

EP2078026

Issued

11/20/2027

Spain

EP2078026

Issued

11/20/2027

SwedenEP2078026

Issued

11/20/2027

Switzerland

EP2078026

Issued

11/20/2027

United Kingdom

EP2078026

Issued

11/20/2027

United States of America

8,163,902

Issued

6/17/2026

United States of America

8,445,485

Issued

6/17/2026

United States of America

7,563,892

Issued

6/17/2026

United States of America

9,737,554

Issued

6/17/2026

Patent Family 5: Stemming from US Patent 8.263.112

Owner

Rigel Pharmaceuticals, Inc.

Inventors
Priority Data

T. Sun and R. Lo
60/986,237

Earliest Priority Date

November 7, 2007

International Application PCT No

PCT/US08/082618[W02009/061909][Publication Number]International Application Fffing
Date

November 6, 2008

Ownership
This patent family is owned by Rigel Pharmaceuticals.

59

Brief Summary of the Invention
Covers Fostamatinib Drug Substance formulations and methods of formulating.
StatusThe Table below summarizes the status of this patent family.
Metal No.

Status

Predicted expiry

Albania

EP2217241

Issued11/6/2028

Australia

2008323938

Issued11/6/2028

Austria

EP2217241

Issued11/6/2028

Barbados

2001/1533

pending

11/6/2028

Belgium

EP2217241

Issued11/6/2028

Bermuda

448EP

Registered

1/19/2026

BosniaEP2217241

Issued11/6/2028

Bulgaria

EP2217241

Issued11/6/2028

Brazil

PI0820389A2

Publilled

11/6/2028 (10years from grant)

Canada2,704,474

Issued11/6/2028

Croatia

EP2217241

Itied

11/6/2028

Cyprus

EP2217241

Issued11/6/2028

Czech Republic

EP2217241

Issued11/6/2028

Denmark

EP2217241

Issued11/6/2028

Estonia

EP2217241

Issued11/6/2028

Eurasian Patent

020210Issued11/6/2028

EuropeEP2217241

Granted(validated in
AL,AT,BA.
BE,BG,CH.
CY,CZ,DE.
DK,EE,ES.F
LFR,GB,GR,

11/6/2028

60

Official No.

StatusLPredicted expiry

ITR,HU,IE,IS,IT,LU,MC,
MK,MT,NL,
LT,LV,PO,P
T,RO,SI,SK,TR
Finland

EP2217241

Issued11/6/2028

FranceEP2217241

Issued11/6/2028

Germany

EP2217241

Issued11/6/2028

GreeceEP2217241

Issued11/6/2028

GuatemalaA-2010-000135

Published

11/6/2028

Hong Kong

11K10110227.2

Issued11/6/2028

Hungary

EP2217241

Issued11/6/2028

Iceland

EP2217241

Issued11/6/2028

India

278101

Issued11/6/2028

Indonesia

DP000048679

Issued11/6/2028

Ireland

EP2217241

Issued11/6/2028

Israel205204

Issued11/6/2028

Italy

EP2217241

Issued11/6/2028

Japan

5567487

Issued11/6/2028

LatviaEP2217241

Issued11/6/2028

Liechtenstein

EP2217241

Issued11/6/2028

Lithuania

EP2217241

Issued11/6/2028

Luxembourg

EP2217241

Issued11/6/2028

Malaysia

MY-169761-A

Issued11/6/2028

Malta

EP2217241

Issued11/6/2028

61

Official No.

' • • dicted expiry

MonacoEP2217241

Issued11/6/2028

North Macedonia

EP2217241

Issued11/6/2028

Mexico309713Issued11/6/2028

Netherlands

EP2217241

Issued11/6/2028

New Zealand

585913Issued11/6/2028

NorwayEP2217241

Issued11/6/2028

PolandEP2217241

Issued11/6/2028

Portugal

EP2217241

Issued11/6/2028

Romania

EP2217241

Issued11/6/2028

Russia2416616

Issued

1/19/2026

SerbiaEP2217241

Issued11/6/2028

Singapore

185961

Issued11/6/2028

Slovak Republic

EP2217241

Issued11/6/2028

Slovenia

EP2217241

Issued11/6/2028

South Africa

2010/02918

Issued11/6/2028

South Korea

10-1663838

Issued11/6/2028

Spain

EP2217241

Issued11/6/2028

SwedenEP2217241

Issued11/6/2028

Switzerland

EP2217241

Issued11/6/2028

TurkeyEP2217241

Issued11/6/2028

Trinidad & Tobago

TT/A/2010/00075

Pending

11/6/2028

Ukraine102825

Issued11/6/2028

United Kingdom

EP2217241

Issued11/6/2028

United States of America

8.263.122

Issued

11/24/2030

United States of America

8,372,415

Issued11/6/2028

62

Country
United States of America

8,652,492

Issued11/6/2028

Vietnam

14296

Issued11/6/2028

Patent Family 6: Stemming from US Patent 8,299,242
Owner
Inventors

Rigel Pharmaceuticals, Inc.

Priority Data

U. Felfer, K-H. Giselbrecht and M.
Wolberg
61/270,073

Earliest Priority Date

July 2, 2009

International Application PCT No

PCT/US2010/040792[W02011/002999A1][Publication Number]International Application Filing
Date

July 1, 2010

Ownership
This patent family is owned by Rigel Pharmaceuticals.
Brief Summary of the Invention
Covers Fostamatinib Drug Substance processes for preparing and formulations.
StatusThe Table below summarizes the status of this patent family.

redicted expiry
Albania

EP2448950

Issued- 1 2030

Australia

2010266213

Issued

7/1/2030

Austria

EP2448950

Issued

7/1/2030

Belgium

EP2448950

Issued

7/1/2030

BosniaEP2448950

Issued

7/1/2030

63

Country•atus

Bulgaria

EP2448950

Issued

7/1/2030

BrazilBRPI1011888A2

Published

7/1/2030 (10 years
from grant)

Canada2,766,801

Issued

7/1/2030

China

ZL 201080039108.1

Issued

7/1/2030

Croatia

EP2448950

Issued

7/1/2030

CyprusEP2448950

Issued

7/1/2030

Czech Republic

EP2448950

Issued

7/1/2030

Denmark

EP2448950

Issued

7/1/2030

Estonia

EP2448950

Issued

7/1/2030

Eurasian Patent

021657

Issued

7/1/2030

EuropeEP2448950

Granted(validated in
AL,AT,BA,
BE,BG,CH,CY,CZ,DE,
DK,EE,ES,F
I,FR,GB,GR,
HR,HU,IE,IS,IT,LU,MC,
MK,MT,NL,
LT,LV,PO,P
T,RO,SI,SK,TR

7/1/2030

Finland

EP2448950

Issued

7/1/2030

FranceEP2448950

Issued

7/1/2030

Germany

EP2448950

Issued

7/1/2030

GreeceEP2448950

Issued

7/1/2030

Hong Kong

1169996B

Issued

7/1/2030

64I

Predicted expiry

•Predicted expiry

Hungary

EP2448950

Issued

7/1/2030

Iceland

EP2448950

Issued

7/1/2030

India

296496

Issued

7/1/2030

Ireland

EP2448950

Issued

7/1/2030

Italy

EP2448950

Issued

7/1/2030

Japan

5739882

Issued

7/1/2030

LatviaEP2448950

Issued

7/1/2030

Lithuania

EP2448950

Issued

7/1/2030

Luxembourg

EP2448950

Issued

7/1/2030

Macedonia

EP2448950

Issued

7/1/2030

Malta

EP2448950

Issued

7/1/2030

MonacoEP2448950

Issued

7/1/2030

Montenegro

EP2448950

Issued

7/1/2030

North Macedonia

EP2448950

Issued

7/1/2030

Netherlands

EP2448950

Issued

7/1/2030

NorwayEP2448950

Issued

7/1/2030

PolandEP2448950

Issued

7/1/2030

Portugal

EP2448950

Issued

7/1/2030

Romania

EP2448950

Issued

7/1/2030

San Marino

EP2448950

Issued

7/1/2030

SerbiaEP2448950

Issued

7/1/2030

Singapore

176799Issued

7/1/2030

Slovak Republic

EP2448950

Issued

7/1/2030

Slovenia

EP2448950

Issued

7/1/2030

Spain

EP2448950

Issued

7/1/2030

65

IMPIrIMMI

Country
SwedenEP2448950

Issued

7/1/2030

Switzerland

EP2448950

Issued

7/1/2030

TurkeyEP2448950

Issued

7/1/2030

Ukraine108077

Issued

7/1/2030

United Kingdom

EP2448950

Issued

7/1/2030

United States of America

8,299,242

Issued

7/1/2030

United States of America

8,481,724

Issued

7/1/2030

United States of America

8,691,798

Issued

7/1/2030

Patent Family 7: Stemming from US Patent 8,771,648

Owner
Inventors

Rigel Pharmaceuticals, Inc.

Priority Data

B. Gururajan, F.A.K Alhusban, I.P
Gabbott, D. Bradley, B. Simpson and
D. Sievwright
61/512,621

Earliest Priority Date

July 28, 2011

International Application PCT No

PCT/GB2012/051791[W02013/014454 Al][Publication Number]International Application Filing
Date

July 26, 2012

Ownership
This patent family is owned by Rigel Pharmaceuticals.

Brief Summary of the Invention
Covers Fostamatinib Drug Product unit dosage formulations.
StatusThe Table below summarizes the status of this patent family.

66

a4 t11 itfficial No.

• :piry

Albania

EP2736487

Issued7/26/2032

Australia

2012288632

Issued7/26/2032

Austria

EP2736487

Issued7/26/2032

Belgium

EP2736487

Issued7/26/2032

Bulgaria

EP2736487

Issued7/26/2032

BrazilBR112014001999A2

Published

7/26/2032 (10years from grant)

Canada2,843,138

Issued7/26/2032

China

ZL 201280046605.3

Issued7/26/2032

Croatia

EP2736487

Issued7/26/2032

CyprusEP2736487

Issued7/26/2032

Czech Republic

EP2736487

Issued7/26/2032

Denmark

EP2736487

Issued7/26/2032

Estonia

EP2736487

Issued7/26/2032

Eurasian Patent

0028432

Issued7/26/2032

EuropeEP2736487

Granted(validated in
AL,AT,BA.
BE,BG,CH.
CY,CZ,DE.
DK,EE,ES,F
I,FR,GB,GR,
HR,HU,IE,IS,IT,LU,MC,
MK,MT,NL,
LT,LV,PO,P
T,RO,SI,SK,TR

7/26/2032

Finland

EP2736487

Issued7/26/2032

67

Country•

FranceEP2736487

Issued7/26/2032

Germany

EP2736487

Issued7/26/2032

GreeceEP2736487

Issued7/26/2032

Hong Kong

1198741B

Issued7/26/2032

Hungary

EP2736487

Issued7/26/2032

Iceland

EP2736487

Issued7/26/2032

Ireland

EP2736487

Issued7/26/2032

Italy

EP2736487

Issued7/26/2032

Jamaica

18/1/5318

Pending

7/26/2032

Japan

6019116

Issued7/26/2032

LatviaEP2736487

Issued7/26/2032

Liechtenstein

EP2736487

Issued7/26/2032

Lithuania

EP2736487

Issued7/26/2032

Luxembourg

EP2736487

Issued7/26/2032

Malta

EP2736487

Issued7/26/2032

Mexico339685

Issued7/26/2032

MonacoEP2736487

Issued7/26/2032

Montenegro

EP2736487

Issued7/26/2032

North Macedonia

EP2736487

Issued7/26/2032

Netherlands

EP2736487

Issued7/26/2032

NorwayEP2736487

Issued7/26/2032

Pakistan

490/2012

Pending

7/26/2032

Panama89809-01

Issued7/26/2032

PolandEP2736487

Issued7/26/2032

Portugal

EP2736487

Issued7/26/2032

68

'

•

•

• ,!

Romania

EP2736487

Issued7/26/2032

San Marino

EP2736487

Issued7/26/2032

SerbiaEP2736487

Issued7/26/2032

Slovak Republic

EP2736487

Issued7/26/2032

Slovenia

EP2736487

Issued7/26/2032

South Korea

10-2024120

Issued7/26/2032

South Korea

10-2090440

Issued7/26/2032

Spain

EP2736487

Issued7/26/2032

SwedenEP2736487

Issued7/26/2032

Switzerland

EP2736487

Issued7/26/2032

TurkeyEP2736487

Issued7/26/2032

Ukraine108077

Issued

7/1/2030

United Kingdom

EP2736487

Issued7/26/2032

United States of America

8,771,648

Issued7/27/2032

United States of America

8,951,504

Issued7/27/2032

Uruguay

UY34223A

Published

7/26/2032

Venezuela

931-12

Pending

7/26/2032

69

piry

Patent Family 8: Stemming from US Patent 9,388,203

Owner
Inventors

Rigel Pharmaceuticals, Inc.

Priority Data

B. McKeever, L.J. Diorazio, M.F>
Jones, L. Ferris, S.L.M. Janbon, S.
Siedlecki, G.H. Churchill and P.A.
Crafts61/919,671

Earliest Priority Date

December 20, 2013

International Application PCT No

PCT/US2014/071613[W02015/095765][Publication Number]International Application Filing
Date

December 19, 2014

Ownership
This patent family is owned by Rigel Pharmaceuticals.
Brief Summary of the Invention
Covers process for making Fostamatinib Drug Substance.
StatusThe Table below sununarizes the status of this patent family.
IOfficial No.
Albania

EP3083648

1 1"1
- '
IssuedAustralia

2012288632

Issued7/26/2032

Austria

EP3083648

Issued

12/19/2034

Belgium

EP3083648

Issued

12/19/2034

BosniaEP3083648

Issued

12/19/2034

Bulgaria

EP3083648

Issued

12/19/2034

CanadaCA2898644A1

Published

12/19/2034

China

ZL201480069979.6

Issued

12/19/2034

Croatia

EP3083648

Issued

12/19/2034

70

1
12/19/2034

CountryIMP'

VW

IIPPIRMI,

CyprusEP3083648

Issued

12/19/2034

Czech Republic

EP3083648

Issued

12/19/2034

Denmark

EP3083648

Issued

12/19/2034

Estonia

EP3083648

Issued

12/19/2034

EuropeEP3083648

Granted(validated in
AL,AT,BA.
BE,BG,CH.
CY,CZ,DE.
DK,EE,ES,F
I,FR,GB,GR,
HR,HUJEJS,IT,LU,MC,
MX,MT,NL,
LT,LV,PO,P
T,RO,SI,SK,TR

12/19/2034

Finland

EP3083648

Issued

12/19/2034

FranceEP3083648

Issued

12/19/2034

Germany

EP3083648

Issued

12/19/2034

GreeceEP3083648

Issued

12/19/2034

Hong Kong

1229336B

Issued

12/19/2034

Hungary

EP3083648

Issued

12/19/2034

Iceland

EP3083648

Issued

12/19/2034

Ireland

EP3083648

Issued

12/19/2034

Italy

EP3083648

Issued

12/19/2034

Japan6522005

Issued

12/19/2034

LatviaEP3083648

Issued

12/19/2034

71

Liechtenstein

EP3083648

Issued

12/19/2034

Lithuania

EP3083648

Issued

12/19/2034

Luxembourg

EP3083648

Issued

12/19/2034

Malta

EP3083648

Issued

12/19/2034

MonacoEP3083648

Issued

12/19/2034

Montenegro

EP3083648

Issued

12/19/2034

North Macedonia

EP3083648

Issued

12/19/2034

Netherlands

EP3083648

Issued

12/19/2034

NorwayEP3083648

Issued

12/19/2034

PolandEP3083648

Issued

12/19/2034

Portugal

EP3083648

Issued

12/19/2034

Romania

EP3083648

Issued

12/19/2034

San Marino

EP3083648

Issued

12/19/2034

SerbiaEP3083648

Issued

12/19/2034

Slovak Republic

EP3083648

Issued

12/19/2034

Slovenia

EP3083648

Issued

12/19/2034

Spain

EP3083648

Issued

12/19/2034

SwedenEP3083648

Issued

12/19/2034

Switzerland

EP3083648

Issued

12/19/2034

TurkeyEP3083648

Issued

12/19/2034

United Kingdom

EP3083648

Issued

12/19/2034

United States of America

9,388,203

Issued

12/19/2034

United States of America

9.695.204

Issued

12/19/2034

72

Patent Family 9: Stemming from US Patent Application US-2020-0377518-A
Owner

Rigel Pharmaceuticals, Inc.

Inventors
Priority Data

E. Masuda
62/853,937

Earliest Priority Date

May 29, 2019

International Application PCT No

PCTUS2020/035383 [not yet
published][Publication Number]International Application Filing
Date

May 29, 2020

Ownership
This patent family is owned by Rigel Pharmaceuticals.
Brief Summary of the Invention
Covers method for using Fostamatinib Drug Product to prevent thrombosis.
StatusThe Table below summarizes the status of this patent family.

Official No.
United States of America

US-2020-0377518-A1

Predicted expiry
Published

Patent Family 10: Stemming from PCT Patent Application PCT/US2020/046060A
73

05/29/2040

OwnerRigel Pharmaceuticals, Inc.

Inventors
Priority Data

V. Taylor, S. Issakani and C. Young
62/886,806

Earliest Priority Date

August 14, 2019

International Application PCT No

PCT/US2020/046060 [not yet
published][Publication Number]International Application Filing
Date

August 13, 2020

Ownership
This patent family is owned by Rigel Pharmaceuticals.
Brief Summary of the Invention
Covers method for using Fostamatinib Drug Product genus to prevent or treat cytokine release syndrome.
StatusThe Table below sununarizes the status of this patent family.

Inn
PCT

Official No.

Status

Predicted expiry

IPCT/US2020/046060

I Pending

I August 13, 2040

I

75

Appendix G

Data Rights:
Technical Data or Computer
Software to be Furnished with
Restrictions
Know-how anddocumentation associatedwith the manufacturing of
Fostamatinib Drug
Substance
Know-how anddocumentation associatedwith the manufacturing of
Fostamatinib Drug Product
Documents related tocommunication with FDA on
non-COVID-19 related
indications
Documents related tocommunication with FDA on
COVID-19 generated prior tocontract award.

Name of Organization Asserting
Restrictions

Basis for
Assertion

Asserted
RightsDeveloped
exclusively at
privateexpenseLimited Rights

Rigel Pharmaceuticals

Developed
exclusively at
privateexpenseDeveloped
exclusively at
privateexpenseDeveloped
exclusively at
privateexpenseLimited Rights

Rigel Pharmaceuticals

Limited Rights

Rigel Pharmaceuticals

Limited Rights

Rigel Pharmaceuticals