10 USC 2373 AGREEIVIENT
BETWEEN

Ology Bioservices, Inc. (Awardee or Contractor)
13200 NW Nano Court
Alachua, FL 32615
And
NATICK CONTRACTING DIVISION (Government)
110 Thomas Johnson Dr.
Frederick, MD 21702

Effective Date: 21 Feb 2020

Agreement No.: VV911QY-20-9-0003

Total Amount of the Agreement: 

Ology Bioservices, Inc. Government - 
.. ?22m

 

 

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Senior VP. Government Contracts Agreements Of?cer
Title Title
21 Februaly 2020 21 Feb 2020
Date Date

ARTICLE 1. Scope.
A. This 10 U.S.C. § 2373 Agreement (the “Agreement”) is entered 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. § 2373 and is not a
procurement contract governed by the Federal Acquisition Regulation (FAR), a grant,
cooperative agreement, or 10 U.S.C. § 2371(b) other transaction agreement. The FAR and
the Defense Federal Acquisition Regulation Supplement (DFARS) apply only as
specifically referenced herein. This Agreement is not intended to be, nor will it be
construed as, forming, by implication or otherwise, a partnership, a corporation, or other
business organization. This Agreement is not subject to the Bayh-Dole Act, 35 U.S.C.
§§ 200-212.
B. The 2018 National Defense Authorization Act (NDAA) amended 10 U.S.C. § 2358 to
add 10 U.S.C. § 2373 as “authorized means” of Defense contracting for research and
development projects (Pub. L. 115–91, div. A, title VIII, § 862, Dec. 12, 2017, 131 Stat.
1495) and expressed a preference for use of 10 U.S.C. § 2373 for certain contracting
actions: “In the execution of science and technology and prototyping programs” (Pub. L.
115–91, div. A, title VIII, § 867, Dec. 12, 2017, codified at 10 U.S.C. § 2371 note).
C. This Agreement meets all criteria necessary for 10 U.S.C. § 2373 contracting actions.
Consistent with the stated purpose of the statute, the Parties agree that scope and the
ultimate purpose of this Agreement is to acquire chemical activity and medical supplies
and designs thereof necessary for experimental or test purposes in the development of the
best supplies needed for national defense. Examples of supplies for purposes of this
Agreement include manufacturing platforms, compounds, drug product, drug substance,
conformance lots, optimized products, shakedown/engineering/ development runs,
equipment, and materials. All supplies purchased for testing and experimental purposes
under this Agreement are necessary to develop the best supplies for national defense, such
as Food and Drug Administration (FDA) licensed vaccines and therapeutics.
D. This Agreement will facilitate multiple projects for development of specific supplies
required by the Government within the scope of the Agreement as described herein, each of
which will be described in a Statement of Work (SOW).
E. Each project facilitated by this Agreement, will produce quantities of supplies that are
necessary for experimentation and technical evaluation of those supplies only. Any project
with multiple SOWs shall not, in the aggregate, exceed the quantity necessary for
experimentation and technical evaluation. All SOWs executed under this Agreement shall
be within the scope of the Agreement as described herein. The Parties agree that this
Agreement is not intended to, and does not authorize purchase of chemical activity and
medical supplies and designs thereof in quantities greater than those necessary for
experimental or test purposes in the development of the best supplies needed for national
defense. Accordingly, the requirements of 10 USC Chapter 137 are not applicable to this
Agreement or any SOW issued hereunder.

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The ADMF was built to the
speci?cation of the Department of Defense to be biosafety level 3. who continue to own the
Government Equipment within the ADMF that is critical for the safety of the employees.
functionality of the building and success of the govermnent projects.

   

G. In consideration of the guaranteed minimum amormt established under this Agreement. the
Awardee will provide research and development to complete the deliverables described in each
order?s Statements of Work up to the stated maximum. The minimum amormt of this

Agreement shall be $1,000,000.00 for the Term and the maximum amormt of this Agreement
shall be $90.000.000.00 for the Term.

ARTICLE 2. Term and Termination.

A. Term: The Term of this Agreement cormnences upon the Effective Date and extends
for a period of six (6) years (the Term). SOWs may be incorporated at any time dru?ing the
Term and the delivery date of any such SOW may extend beyond the end of the Term.

B. Termination for Convenience: The Goverrnnent may terminate this Agreement for any
or no reason by providing at least one eighty (180) calendar days? prior written
notice to the Awardee. The Govenmlent and Awardee will negotiate in good faith a
reasonable and timely adjustment of all outstanding issues between the Parties as a result
of termination by the Govermnent for convenience. consistent with the tenns of this
Agreement. Termination of this Agreement will not impact ongoing projects which were
awarded prior to the notice of termination under this Agreement.

C. Termination for Cause: If the Awardee materially fails to comply with the provisions of
this Agreement. the Agreement Officer (AO). after issuance of a Clue notice and faihu?e of
the Awardee to crue the defect within thirty (30) calendar days or the time allowed by the
AO after Awardee?s receipt of the cure notice. whichever is longer. may take one or more
of the following actions as appropriate:

temporarily withhold payments pending correction of the de?ciency.
(ii) disallow all or part of the cost of the activity or action not in compliance.
wholly or partly suspend or terminate this Agreement. including the
termination of one or more SOWs issued rmder this Agreement.
(iv) withhold fmther ?mding.
require Awardee to pay reprn?chase costs as defined in Article 2C 1. Repurchase
Against Contractors Account. or
(Vi) take any other legally available remedies.

Repm?chase Against Contractors Accormt.
a. When the supplies are still required after termination. the AO shall repm?chase the
same or similar supplies against the ontractor?s accormt as soon as practicable. The
A0 shall repru?chase at as reasonable a price as practicable. considering the quality

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and delivery requirements. The AO may repurchase a quantity in excess of the
undelivered quantity terminated for cause when the excess quantity is needed, but
excess cost may not be charged against the Contractor for more than the undelivered
quantity terminated for cause (including variations in quantity). The AO will make a
decision whether or not to repurchase before issuing the termination notice.
b. If repurchase is made at a price over the price of the supplies terminated, the AO
shall, after completion and final payment of the repurchase contract or agreement,
make written demand on the Contractor for the total amount of the excess, giving
consideration to any increases or decreases in other costs such as transportation,
discounts, etc. If the Contractor fails to make payment, the AO shall follow the
procedures in FAR subpart 32.6 for collecting contract debts due the Government.
2. Termination for Cause Procedures.
If this Agreement is terminated for Cause in whole or in part, Awardee will grant the
Government a non-exclusive, paid up, perpetual license to the patents and documentation
necessary for the purpose of continuing development of all deliverables that were subject
to the termination. Additionally, the Awardee shall provide the U.S. Government or its
designee with a non-exclusive, paid up, license to any patent, copyright, technical data or
regulatory information directly related to those terminated deliverables to permit the U.S.
Government to pursue commercialization of the technology with a third party, on terms to
be agreed between the Parties and subject to rights granted or held by third parties. The
terms of this section and the obligations herein will be included in any exclusive license
given by the Awardee to a third party for any intellectual property covered by this
Agreement, on terms to be agreed between Awardee and such third party. This clause will
survive the acquisition or merger of the Awardee by or with a third party.
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 materially comply with the terms of this
Agreement.
D. Survival: Except as noted in Article 2.C., 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 of
Intellectual 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 concerning SOW’s directly associated with this
Agreement. The Awardee shall provide access to project results in accordance with the
Awardee’s Project Timeline located in Appendix A.

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 B. Project Managers: The Awardee and the Governnrent will each designate a Project
Manager responsible for facilitating the commrmications. reporting and meetings between
the Parties. Each Party will also designate an alternate to the Project Manager. in case the
primary Project Manager is unavailable. See Project Manager/Alternate Project Manager
point of contact information for each respective party below:

Awardee Pro'ect Maria ers:
Pro'ect Mana er: Alternate Pro'ect Mana er:

 

Govermnent Pro'ect Mana ers GP
Pro'ect Mana er: Alternate Pro'ect Mana er:

 

C. Key Personnel: The ontactor's organization shall be established with authority to
effectively complete the deliverables. This organization shall become effective upon
execution of this Agreement and its integrity shall be maintained until the deliverable(s)
is/are accepted by the Government. The key personnel listed in the applicable SOW are
considered to be critical to the successful performance of this Agreement. Prior to
replacing these key personnel. the Awardee shall provide written noti?cation to the A0.
The Awardee shall demonstrate that the quali?cations of the proposed substitute persormel
are generally equivalent to or better than the quali?cations of the personnel being
replaced.

D. Subcontract Approval: Modi?cations to subcontracts and/or new subcontracts under
this Agreement that could reasonably impact the technical approach proposed and
accepted by the Government require the approval of the AO prior to being executed.

ARTICLE 4. Agreement Administration.

In no event shall any understanding or agreement, modi?cation, change order. or other
matter in deviation ??om the terms of this agreement between the Awardee and a person
other than the Agreement Of?cer be effective or binding upon the Govermnent. All such
actions must be fornralized by a proper written contractual document executed by the
Agreement Of?cer and Awardee Representative.

Government Representatives:
Agreements Of?cer (AO)

    

A eementS ialists AS
Primary Alternate

 

Awardee Representatives:

 

ARTICLE 5. Performance Objectives and Changes.

A. Statement of Work (SOW): The SOW. Appendix A. describes the scope ofactivities
that will be undertaken by the Awardee pursuant to separately issued orders issued for
speci?c requirements within the Scope of the Agreement (the ?Orders?). Orders shall be
issued as modi?cations to this Agreement. Each Order shall inc01porate additional SOWs.
In consideration of Govenmient funding under this Agreement. the Awardee will provide
research and development to complete the deliverables described in each SOW. which are
inc01porated herein and attached hereto as Appendix A. The ?rst SOW shall be Appendix
A-l. the next Appendix A-2. the next Appendix etc.

B. Recommendations for h-?Iodi?cations: At any time during the term of this Agreement.
progress or results may indicate that a change in the SOW would be bene?cial to the
project objectives. Reconmrendations for modi?cations. including justi?cations to
support any changes to the SOW. will be documented in a letter and submitted by
Awardee to the GPM with a copy to the AO. This letter will detail the technical.
chronological and ?nancial impact. if any. of the proposed modi?cation to the project.
Any resultant modi?cation is subject to the mutual agreement of the Palties. The
is not obligated to pay for additional or revised costs unless and until this

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Agreement is formally revised by the AO and made part of this Agreement. 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 AO will be responsible for the review and
verification of any recommendations to revise or otherwise modify the Agreement, the
SOW, or other proposed changes to the terms and conditions of this Agreement.
D. Government Changes. The Government may issue unilateral, within scope changes to the
work called for under this Agreement, which the Awardee shall perform pending finalization
of the Agreement’s modification reflecting the change and associated costs. The Awardee will
be reimbursed for costs incurred that are reasonable, allowable and allocable to the work
performed as required by the Government’s mandated change. In addition, the Government
may unilaterally make minor or administrative no-cost agreement modifications (e.g., changes
in the paying office or appropriation data, changes to Contractor personnel proposed by
Contractor, etc.).
E. Amending the Agreement: The Government will be responsible for effecting all
modifications to this Agreement, with the concurrence of the Awardee for modifications
that are not minor or administrative. Administrative and material matters under this
Agreement will be referred to the AO.
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 C.
H. Disputes: For any disagreement, claim, or dispute arising under this Agreement, the
parties shall communicate with one another in good faith and in a timely and cooperative
manner. Whenever disputes, disagreements, or misunderstandings arise, the parties shall
attempt to resolve the issue by discussion and mutual agreement as soon as practicable.
Failing resolution by mutual agreement, the aggrieved party shall request a resolution in
writing from the AO. The AO will review the matter and render a decision in writing. Any
such decision is final and binding. In the event of a decision, within (60) calendar days of
the referral for review (or such other period as agreed upon by the parties), either party
may pursue any right or remedy provided by law in a court of competent jurisdiction as
authorized by 28 U.S.C. 1491. Alternately, the parties may agree to explore and establish
and Alternate Disputes Resolution procedure to resolve this dispute.
I. Quality Agreement. A Quality Agreement will be developed separately for each Order
exercised under this Agreement.
ARTICLE 6. INSPECTION/ACCEPTANCE
A. Inspection: The Government has the right to inspect and test all work called for by the
applicable SOW during the period of performance. The Government or its designee, including
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 employees and contractors of the FDA, may inspect the areas of premises of the Awardee or
any subawardee that are specifically designated to the performance of the work under the
applicable SOW. Inspections and testing will be requested and scheduled between the
Government Project Manager (or its designee) and Awardee Project Manager. The
Government shall perform inspections and tests in a manner that will not unduly delay the
work, and during an agreeable time and date for both the Government and Awardee
(subawardee). If the Government performs any required inspection or test on the premises of
the Awardee or a subawardee, the Awardee shall furnish and shall require subawardees to
furnish, at no increase in price, all reasonable facilities 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 after completion/delivery, unless
otherwise specified in the Agreement. 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 reject nonconforming work. Inspection/Acceptance of the
deliverable(s) performed at Awardee's facility shall not exceed 120 days after completion The
Government waives the right to reject nonconforming work should it fail to notify the
Awardee within the 120 days of delivery, unless otherwise specified in the applicable SOW.
Acceptance of the work shall be conclusive. The Government shall notify the Awardee, and
separately negotiate storage of a deliverable, if storage of the work is anticipated to exceed 120
days.
ARTICLE 7. Financial Matters
This is an expenditure-based agreement. The payments provided under this Agreement are
intended to compensate the Awardee on a cost basis for performance under this
Agreement. The Awardee shall provide its best efforts to complete a project based on the
estimated cost.
A. Payment. Payments are based on amounts generated from the Awardee’s financial or
cost records. The Awardee shall be reimbursed for each element identified in the awarded
cost proposal as set forth in Appendix B. The schedule is predicated upon the
Government’s fiscal year, which begins on October 1 of each calendar year, and ends on
September 30 of the subsequent calendar year.
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
Government may incrementally fund this agreement. The amount of Government funds
obligated by this Agreement and available for payment is set forth in the Line of
Accounting and Appropriation, or subsequent amendments providing incremental funding.
C. The Government is not obligated to provide payment to the Awardee for amounts in
excess of the amount of obligated funds allotted by the Government.
D. The Government shall pay the Awardee, upon submission of proper invoices, the prices
stipulated in this Agreement for work delivered or rendered and accepted, less any
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 deductions provided in this Agreement. Unless otherwise specified, payment shall be
made upon acceptance of any portion of the work delivered or rendered for which a price
is separately stated in the Agreement. Payments processed in WAWF and should be made
within thirty (30) calendar days of receipt of a request for payment.
E. WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS
(a) Definitions.
Department of Defense Activity Address Code (DoDAAC) is a six-position
code that uniquely identifies a unit, activity, or organization.
Document type means the type of payment request or receiving report available
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 designated
electronic 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://wawf.eb.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 this
contract/order:
(1) Document type. The Awardee shall use the following document type:
Invoice and Receiving Report (Combo)
(2) Inspection/acceptance location. The Awardee shall select the following
inspection/acceptance location(s) in WAWF, as specified by the contracting
officer.

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 (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

(b) (4)

Issue By DoDAAC
Admin DoDAAC
Inspect By DoDAAC
Ship To Code

(b) (4)
(b) (4)
(b) (4)

(4) Payment request and supporting documentation. The Awardee shall ensure a
payment request includes appropriate contract line item and subline item
descriptions of the work performed or supplies delivered, unit price/cost per
unit, 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.
(b) (6)

(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.
F. 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 the
Agreement or any entity that participates in the performance of this Agreement that
directly pertain to, and involve transactions relating to, the Agreement for a period of three
(3) years after final payment is made. This requirement shall not apply with respect to any
Party to this Agreement or any entity that participates in the performance 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
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 provides for audit access by a government entity in the year prior to the date of this
Agreement. This paragraph only applies to any 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. Reserved
ARTICLE 9. Intellectual Property Rights
The Parties agree that the terms in this Article apply generally to this Agreement, and that
the terms may be modified in any SOW issued under this Agreement by mutual agreement
of the Parties. If a SOW does not address intellectual property rights, the terms of this
Article will govern intellectual property rights related to that SOW. To the extent there is
any conflict between this Article and the intellectual property rights provision contained in
a SOW, the terms of the SOW shall control.
A. Background Intellectual Property 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 this Agreement
(“Background IP”). Additionally, no party to this Agreement will enter into an agreement
with any manufacturer or other third party whereby the third party will obtain rights in
Agreement Inventions or Study Data, as those terms are defined in this Agreement, absent
the mutual consent of the parties to the awarded contract.
B. Definitions. For purposes of this agreement, an “Agreement Invention” is any
invention, regardless of whether it is not patentable, or is patentable under U.S. patent law
that is conceived or first reduced to practice under this Agreement.
C. Awardee’s Background IP. Prior to the issuance of any SOW, Awardee shall disclose
Background IP which contain claims that are related to research contemplated under the
SOW, and shall provide identifying information to the Government. No license(s) to any
patent applications, issued patents, or Background IP shall be granted under this
Agreement, and are specifically excluded from the definitions of "Agreement Invention"
contained in this Agreement.
D. 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 or foreign
patent, trademark or copyright, arising out of this Agreement, provided the Awardee is
notified of such claims and proceedings as soon as practicable by the Government of the
suit or action alleging such infringement and shall have been given such opportunity as is
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 afforded by applicable laws, rules, or regulations to participate in its defense. Further, this
indemnity shall not apply toAn infringement resulting from compliance with specific written instructions of the AO
directing a change in the supplies to be delivered or in the materials or equipment to be
used, or directing a manner of performance of the contract not normally used by the
Contractor; An infringement resulting from addition to or change in supplies or
components furnished subsequent to delivery or performance; or a claimed infringement
that is unreasonably settled without the consent of the Contractor, unless required by final
decree of a court of competent jurisdiction.
E. 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 work performed under this Agreement.
Awardee shall keep the Government reasonably advised on the status of 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 in any country a patent or
patent application covering an Agreement Invention, which is defined below, Awardee
shall so inform the Government in a timely manner to allow Awardee to thoughtfully
consider the Government's comments regarding such a proposed decision. Nothing in this
Article 10 shall restrict the Government in its preparation, filing, prosecution and
maintenance of a patent or patent application covering an Agreement Invention.
F. Patent Enforcement. Awardee will have the first option to enforce any patent rights
covering an Agreement Invention owned jointly by the Parties or solely by Awardee, at
Awardee’s expense. If Awardee chooses not to exercise this option, the Government may
enforce patent rights covering a joint Agreement Invention only with Awardee’s prior
written approval.
G. Ownership. Ownership of any invention, regardless of whether it is not patentable, or
is patentable under U.S. patent law that is conceived or first reduced to practice under this
Agreement (Agreement 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 Agreement Inventions will accrue to the inventor or inventor-organization.
The Parties represent and warrant that each inventor will assign his or her rights in any
such inventions to his or her employing organization. If either an Awardee employee or a
Government employee makes a sole Agreement Invention, the entire rights to that
Agreement Invention will be respectively assigned to the Awardee or the Government. If
an Awardee employee and a Government employee jointly make an Agreement Invention,
it will be owned jointly by the Awardee and the Government. Ownership of Agreement
Inventions made in whole or in part with subawardee employees, including employees of
other components of the Government, will be determined solely pursuant to an agreement
between the Awardee and the applicable subawardee.
H. Patent Applications. The Parties will respectively have the option to file a patent
application claiming any Agreement Invention made solely by their respective employees.
The Parties will consult with each other regarding the options for filing a patent
application claiming a joint Agreement Invention. Within thirty (30) calendar days of
being notified of the discovery of an Agreement Invention or filing a patent application
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 covering an Agreement Invention, each Party will provide notice of such discovery or
filing to the other Party. The Parties will reasonably cooperate with each other in the
preparation, filing, and prosecution of any patent application claiming an Agreement
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 by the Parties.
I. Licenses. For each Agreement Invention made solely by the Awardee, the Government
will receive a non-exclusive, worldwide, transferable, paid-up, royalty-free, irrevocable
license to practice the invention and the right to sublicense same to third parties to practice
the invention for any Government purpose, including but not limited to continuing
research and development related to the Agreement Invention, and eventual regulatory
approval and commercialization thereof. The Government will receive a right of first
refusal for an exclusive license to the Agreement Invention, subject to no less than a (b)
(b) (4) royalty rate based on gross royalty revenue received by the Government. For(4)
any
Agreement Invention made solely by the Government, the Awardee will receive a nonexclusive, worldwide, transferable, paid-up, royalty-free, irrevocable license to practice
the Agreement Invention or allow a third party to practice the invention for any purpose.
The Awardee will receive a right of first refusal for an exclusive license to the Agreement
Invention for purposes of FDA licensure of the technology described herein for the
indication described herein, subject to a termination terms substantially similar to the
events described in Section 11(e) below.
J. Awardee shall report any Agreement Inventions to the Government within 60 days of
the time it was conceived or first reduced to practice under this Agreement. Executive
Order No. 9424 of 18 February 1944 requires all executive Departments and agencies of
the Government to forward through appropriate channels to the Commissioner of Patents
and Trademarks, for recording, all Government interests in patents or applications for
patents.
ARTICLE 10. Data Rights.
The Parties agree that the terms in this Article 10 apply generally to this Agreement, and
that the terms may be modified in any SOW issued under this Agreement by mutual
agreement of the Parties. If a SOW does not address data rights, the terms of this Article
10 will govern data rights related to that SOW. To the extent there is any conflict between
this Article 11 and the data rights provision contained in a SOW, the terms of the SOW
shall control.
A. For purposes of this Agreement, “Study Data” is all data generated in connection with
the performance of the studies under this Agreement. Study Data shall be owned by the
Awardee. The U.S. Government shall have the right to use, modify, reproduce, release,
perform, display, or disclose data first produced in the performance of this Agreement
within the Government and otherwise for "Unlimited Rights," as this term is defined in
DFARS 252.227-7013(a)(16). The Government may, under a separate agreement or by
modification to this Agreement, obtain any rights to use or disclose the Awardee's
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 material or data to the extent that such material or data was produced outside the scope of
this Agreement.
Notwithstanding the above, as a result of this Agreement, the Government shall obtain
"Unlimited rights," as this term is defined in DFARS 252.227-7013(a)(16) specific to any
Study Data generated under, and as a result of this Agreement.
B. The Awardee agrees to retain and maintain in good condition until five (5) years after
completion or termination of this Agreement, all Study Data generated under this
Agreement. In the event of exercise of the Government's rights as potentially granted
under paragraph 2.C, the Awardee agrees to deliver at no additional cost to the
Government, all Study Data, in Awardee's possession and developed under this
Agreement, necessary to deliver the supplies identified on the particular SOW within sixty
(60) calendar days from the date of the written request.
C. Marking of Data: The Awardee will mark any Study Data delivered under this
Agreement with the following legend:
"Use, duplication, or disclosure is subject to the restrictions as stated in Agreement No.
W911QY-20-9-XXXX between the Government and the Awardee."
Any rights that the Awardee or the Government may have in Study Data delivered under
this Agreement, whether arising under this Agreement or otherwise, will not be affected
by Awardee's failure to mark data pursuant to this Article.
D. All Technical Data and Software (each term as defined under DFARS 252.227-7013)
which shall be delivered under this Agreement with less than unlimited rights shall be
identified with reasonable specificity and particular rights granted (Government Purpose,
Limited or Restricted (all as defined in DFARS 252.227-7013)) in a data rights assertions
list supplied to the Government, for review and evaluation, prior to entering into the
agreement for the applicable SOW. All other Technical Data and Software developed
under funding of this Agreement shall be delivered with unlimited rights as provided for
within this Article.
ARTICLE 11. Regulatory Rights.
The Parties agree that the terms in this Article 11 apply generally to this Agreement, and
that the terms may be modified in any SOW issued under this Agreement by mutual
agreement of the Parties. If a SOW does not address regulatory rights, the terms of this
Article 11 will govern regulatory rights related to that SOW. To the extent there is any
conflict between this Article 11 and the data rights provision contained in a SOW, the
terms of the SOW shall control.
This Agreement may include research with one or more investigational drug, biologic or medical
device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA
pre-market approval or clearance before commercial marketing may begin. Subject to further
negotiation between the parties and set forth in the SOW, the Contractor may serve as the
14

 Sponsor of the Regulatory Application (an Investigational New Drug Application (IND),
Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License
Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification
Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under this
agreement. The Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and
“applicant” are defined or used 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 it to exclusive communications
related to the Regulatory Application.
With respect to any products regulated by the FDA, the Contractor agrees to the following:
a. The Contractor shall provide to the Government all data, including top-line summaries
and key conclusions from all studies, supporting the regulatory filing and commercial
approval to the extent that such data, summaries, and conclusions are funded under this
Agreement. In addition, the Contractor will offer the Government the opportunity to
review and provide comments on a final draft of regulatory submissions which include
data funded under this Agreement. The Government will review any such submissions
promptly upon receipt. The Contractor shall reasonably consider any comments
provided by the Government, and prior to submission shall provide notification to the
Government of any additional edits or revisions. The Contractor shall keep the
Government reasonably apprised of planned FDA meetings and post-meeting outcomes
relating to activities funded under this Agreement.
b. Communications. The Contractor shall provide the Government with all
communications and summaries thereof, both formal and informal, to or from FDA
regarding the regulatory submissions subject to this Agreement and ensure that the
Government representatives are invited to participate in any formal Sponsor meetings
with the FDA. The Contractor shall use its best efforts to ensure that the Government
representatives are invited to participate in any informal Sponsor meetings with the
FDA so long as the Contractor has 48 hour advance notice of such Sponsor meeting
from the FDA prior to the scheduled meeting time.
c. Non-compliance with section (b) may result in termination of the agreement.
d. Product Development Failure. Certain product development failures may trigger certain
remedies in Section “e.” below for the Government advanced developer funding the
development of the work contemplated in the applicable SOW. This remedy is not
available to the Government for any cause outside of the following:
(i) if this agreement is terminated for nonperformance; or
(ii) the Contractor gives notice, required to be submitted to the Government no later
than 30 business days, of any formal management decision to terminate this
product development effort pre-market or to file for Federal bankruptcy
protection.
e. If any of the product development failures listed in section “d” occur, the Contractor,
upon the request 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 or award), regulatory
correspondence, and supporting regulatory information related to the Technology
to the Government or its designee;
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 (ii) shall inform FDA of the transfer of sponsorship or holdership of the Regulatory
Application transferred under section (e)(i) above; and
(iii) shall negotiate in good faith a non-exclusive license, at customary industry rates
and under reasonable terms and conditions, to any patent, copyright or other
intellectual property owned or controlled by the Contractor, developed prior to or
outside the scope of this agreement, or any technical data that is necessary for the
Government to pursue commercialization of this technology with a third party for
sale to the Government or otherwise.
f. This clause will survive the acquisition or merger of the Contractor by or with a third
party. This clause will also be included in any subcontracts/sub agreements relating to
the development of the Technology. This clause will survive the expiration of this
agreement.
ARTICLE 12. Foreign Access to Data.
Export Compliance: The Parties will comply with any applicable U.S. export control
statutes or regulations in performing this Agreement.
ARTICLE 13. Scientific Publications and Press Releases.
A. The Parties shall jointly agree on a publication plan for the data derived from studies
executed under this Agreement (such data to be considered New Data). This publication
plan will identify key New Data to be disclosed or presented and the target date for
finalizing any related scientific abstract or manuscript. As part of its Monthly Progress
Reports, the Awardee will share the publication plan with the Government.
B. The Parties will jointly develop each abstract or manuscript and agree on the authorship
and the content of the final draft to be submitted; provided that authorship for 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://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guide
lines-conduct_research.pdf.
C. Prior to submission for publication, the Parties shall provide drafts of proposed
publications to the authors of such publications for review and comment, and shall provide
copies to non-authors for viewing purposes. Review periods are ten (10) business days for
abstracts, or less than ten (10) business days if agreed by Project Managers and in order to
meet publication submission deadlines. Review periods are twenty (20) calendar days for
manuscripts. Contributing parties shall be appropriately accredited in any publication.
D. The Parties will jointly agree on whether to issue one or more press releases related to
the resulting New 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 in advance
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 data generated in studies
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 executed by Awardee outside the scope of this Agreement, the Awardee, at its sole
discretion, may issue a press release related to such data.
ARTICLE 14. 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 practice inventions covered by United States or foreign patents in the
performance of work under this Agreement.
B. Patent Infringement. Each Party will advise the other Party promptly and in reasonable
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. 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 for lost 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 such damages.
D. Disclosure of Information. Subject to Articles 10 and 11, the Awardee shall not release
to anyone outside the Awardee’s organization any unclassified information, regardless of
medium (e.g., film, tape, document), pertaining to any part of this Agreement or any
program related to this Agreement, unless (i) the Agreements Officer has given prior
written approval or (ii) the information is otherwise in the public domain before the date
of release.
E. Force Majeure. Neither Party will be liable to the other Party for failure or delay in
performing its obligations hereunder if such failure or delay arises from circumstances
beyond the control and without the fault or negligence of the Party (a Force Majeure
event). Examples of such circumstances are: authorized acts of the government in either
its sovereign or contractual capacity, war, insurrection, freight embargos, fire, flood, 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 such
provision to any person or set of circumstances, is determined to be invalid, unlawful, void
or unenforceable to any extent, the remainder of this Agreement, and the application of
such provision to persons or circumstances other than those as to which 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 the fullest extent permitted by law.
G. Priority Access.
1) Defense Priority and Allocations Requirements. This Agreement, and each Order placed
under this Agreement may be a rated order certified for national defense and emergency
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 preparedness, and the Contractor shall follow all requirements of the Defense Priorities and
Allocations System (DPAS) regulation (15 700).

2) Reserved.

H. Assigrnnent. Awardee shall not engage in any sale. transfer. merger or acquisition that
would require novation in accordance with FAR 42.1204(a) without the prior written consent of
the AO. which shall not be unreasonably withheld. Once the transfer is complete. novation
shall be governed by FAR 42.1204. which is hereby incorporated by reference. Awardee may
engage in a sale. transfer. merger or acquisition that does not require a novation in accordance
with FAR 42.1204(b) without the written consent of the Govenmrent. provided that the
Awardee provides a written agreement evidencing the assignee?s intent to continue work within
the Agreement Scope and obligate itself to the terms and conditions of this Agreement.

I. Foreign Investment. In addition to the requirements above in subsection (H). prior to the
close of any "covered transaction." as that term is defined by 50 U.S.C. 4565(a)(4). Contractor
shall make a voluntary submission of information related to the covered transaction to the
Committee 011 Foreign Investment in the United States The FIUS package shall
be submitted to the A0 for review and comment 10 business days in advance of ontractor?s
voluntary submission to FIUS. For the purposes of determining whether a transaction is a
"covered transaction." the parties acknowledge that the ADM Facility is "critical infrastructure"
that. during the term of this Agreement. may be used to produce "critical technologies" in
support of "national security." as those terms are defined in 50 U.S.C . 4565(a). Contractor
agrees to follow any issued throughout the FIUS process. including any
determinations with respect to permissibility of the transaction.

J.

 

K. Choice ofLaw. This Agreement and the resolution of disputes hereunder will be
governed. construed. and interpreted by the statutes. regulations. and/or legal precedent
applicable to the Govermnent of the United States of America. Unless explicitly stated.
the Parties do not intend that this Agreement be subject to the Federal Acquisition
Regulation either directly or indirectly or by operation of law. When a speci?c FAR
requirement is incorporated by reference in this Agreement. the text of the clause alone
will apply without application or incorporation of other provisions of these regulations.

L. Order of Precedence. In the event of a con?ict between the terms of this Agreement
and the attaclmrents incorporated herein. the con?ict shall be resolved by giving

18

precedence in descending order as follows: (i) each SOW as included in Appendix A, (ii)
the Articles of this Agreement, and (iii) other Appendices to the Agreement.

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Ology Bioservices, Inc. NATICK CONTRACTING DIVISION

BY: 9* BY: 

TITLE: Senior VP, Government Contracts TITLE: Agreements Officer

 

 

DATE: 21 February 2020 DATE: 21 Feb 2020

 

 

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Appendix B
Project Schedule Payment Schedule
The Government shall pay the Contractor, upon the submission of proper invoices or vouchers
Expenditures shall be submitted based on the awarded budget. Federal funds are to be used only
for costs that a reasonable and prudent person would incur in carrying out the work. The
Awardee must maintain a financial system capable of identifying costs applicable to this
Agreement, compliant with Cost Principles (48 CFR Part 31). An invoice will be submitted
through Wide Area Work Flow (WAWF) in accordance with agreement requirements. Final
payment of the Agreement shall be determined upon mutual agreement and settlement of any
outstanding indirect costs.
The Awardee shall proceed with the performance in accordance with the terms and conditions of this
Agreement and its Appendices. However, the Government may require the Awardee to cease
performance at any time prior to the commencement of 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.

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 Appendix 
Government Property

Govermnent Property: ?Government Property? means any property furnished by the
Govermnent and facilitating performance of this Agreement, (ii) acquired by the Awardee under
cost reimbursement terms of this Agreement, or acquired by the Awardee at the
Government?s cost imder ?xed price terms of this Agreement (FP-GP) and speci?cally identi?ed
in this Government Property Appendix. Except for commercial off the shelf software and
licenses thereto, Govermnent Property does not include intellectual property and software. The
Govermnent owns and holds title to all Government Property.

The Govermnent shall deliver to the Awardee any Government Property required to be furnished
as described in this Agreement together with related data and information needed for its intended
use. The delivery and/or performance dates speci?ed in this Agreement are based upon the
expectation that the Government-flunished property will be suitable for performance and will be
delivered to the Awardee by the dates stated in the Agreement. If not so suitable, the Awardee
shall give timely written request to the AO who will advise the Awardee on a course of action to
remedy the problem.

FPGP includes: [Mark if none]:
Use Description Make/NIodel Est. Cost

Project Speci?c Equipment Requirements

 

 

 

 

 

 

 

The Awardee shall have, initiate and maintain a system of internal controls to manage, control,
use, preserve, protect, repair, accormt for and maintain Government Property in its possession
and shall initiate and maintain the processes, systems, procedures, records required control and
maintain accormtability of Government Property. The Awardee shall include this clause in all
subcontracts imder which Government Property comes into the possession of any subawardee.
Unless otherwise provided for in this Agreement or approved by the AD, the Awardee shall not:
use Government Property for any pmpose other than to ful?ll the requirements of this
Agreement, or (ii) alter the Government Property.

The Awardee shall establish and implement property management plans, systems, and
procedures regarding its acquisition of Government Property, its receipt of Government
Property, in addition to, the status, dates ?unished or acquired, identi?cation, quantity, cost,
marking, date placed in service, location, inventory and disposition of Govermnent Property, to
include a reporting process for all discrepancies, loss of Government Property, physical

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inventory results, audits and self-assessments, corrective actions, and other property related
reports as directed by the AO.
Upon conclusion or termination of the Agreement, the Awardee shall submit a request in writing
to the AO, for disposition/disposal instructions and shall store Government Property not to
exceed 120 days pending receipt of such instructions. Storage shall be at no additional cost to the
Government unless otherwise noted in the Agreement. The Government, upon written notice to
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 and purposeful destructive testing, obsolescence, normal 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) AO 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; OR (III)
GOVERNMENT PROPERTY IS DISPOSED OF IN ACCORDANCE WITH THE
GOVERNMENT’S DIRECTIONS.

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