Document:

Exhibit 10.15 

 

 

EXECUTION COPY

 

***Text Omitted and Filed Separately 

with the Securities and Exchange Commission.

Confidential Treatment Requested 

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

COLLABORATION AND

EXCLUSIVE LICENSE AGREEMENT

 

by and between

 

MERCK SHARP & DOHME CORP.

 

and

 

CHIMERIX, INC.

 

    	 

    	 

    

 

Table
of Contents

 

 

	 	 	 	Page
	 	 	 	 
	Article 1	 	DEFINITIONS	1
	 	 	 	 
	Article 2	 	LICENSE GRANTS; GOVERNANCE	13
	 	 	 	 
	2.1	 	Exclusive License Grant	13
	 	 	 	 
	2.2	 	Non-Exclusive License Grant	13
	 	 	 	 
	2.3	 	No Implied Licenses	14
	 	 	 	 
	2.4	 	No Grant of Inconsistent Rights by Chimerix	14
	 	 	 	 
	2.5	 	Covenant Not to Sue	15
	 	 	 	 
	2.6	 	Joint Steering Committee	15
	 	 	 	 
	2.7	 	Alliance Managers	16
	 	 	 	 
	2.8	 	Compliance with Law	16
	 	 	 	 
	Article 3	 	DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION	17
	 	 	 	 
	3.1	 	Technology Transfer; Transition of Activities	17
	 	 	 	 
	3.2	 	Inventory Transfer and Manufacturing Technology Transfer	17
	 	 	 	 
	3.3	 	Development, Manufacture and Commercialization	18
	 	 	 	 
	3.4	 	Records and Reports	20
	 	 	 	 
	3.5	 	Excused Performance	21
	 	 	 	 
	Article 4	 	CONFIDENTIALITY AND PUBLICATION	21
	 	 	 	 
	4.1	 	Nondisclosure Obligation	21
	 	 	 	 
	4.2	 	Chimerix Know-How	23
	 	 	 	 
	4.3	 	Publication	23
	 	 	 	 
	4.4	 	Publicity/Use of Names	24
	 	 	 	 
	4.5	 	Remedies	24
	 	 	 	 
	Article 5	 	PAYMENTS; ROYALTIES AND REPORTS	25
	 	 	 	 
	5.1	 	Upfront Payment	25
	 	 	 	 
	5.2	 	Milestone Payments	25
	 	 	 	 
	5.3	 	Royalties	27
	 	 	 	 
	5.4	 	Reports; Payment of Royalty	30
	 	 	 	 
	5.5	 	Audits	30
	 	 	 	 
	5.6	 	Payment; Exchange Rate	31

 

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Table
of Contents

(continued)

 

	 	 	 	Page
	 	 	 	 
	5.7	 	Income Tax Withholding	31
	 	 	 	 
	5.8	 	Chimerix Third Party Licenses	32
	 	 	 	 
	Article 6	 	REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS	32
	 	 	 	 
	6.1	 	Mutual Representations and Warranties	32
	 	 	 	 
	6.2	 	Representations and Warranties	33
	 	 	 	 
	6.3	 	Chimerix Further Representations, Warranties and Covenants	36
	 	 	 	 
	6.4	 	Disclaimer	37
	 	 	 	 
	Article 7	 	IP OWNERSHIP; PATENT PROVISIONS	37
	 	 	 	 
	7.1	 	Ownership of Collaboration Inventions; Know-How	37
	 	 	 	 
	7.2	 	Filing, Prosecution and Maintenance of Patents for Collaboration Inventions	38
	 	 	 	 
	7.3	 	Filing, Prosecution and Maintenance of Other Chimerix Patents; Option of Merck to Prosecute and Maintain Other Chimerix Patents	39
	 	 	 	 
	7.4	 	Interference, Opposition, Invalidation, Reexamination and Reissue	40
	 	 	 	 
	7.5	 	Enforcement and Defense	41
	 	 	 	 
	7.6	 	Patent Term Extensions	45
	 	 	 	 
	7.7	 	Third Party Infringement Suits	45
	 	 	 	 
	7.8	 	UC License	45
	 	 	 	 
	Article 8	 	TERM AND TERMINATION	45
	 	 	 	 
	8.1	 	Term and Expiration	45
	 	 	 	 
	8.2	 	Termination by Merck	46
	 	 	 	 
	8.3	 	Termination for Cause	46
	 	 	 	 
	8.4	 	Effect of Early Termination	47
	 	 	 	 
	8.5	 	Effect of Expiration or Termination; Survival	52
	 	 	 	 
	Article 9	 	INDEMNIFICATION; LIMITATION ON LIABILITY	53
	 	 	 	 
	9.1	 	Indemnification by Merck	53
	 	 	 	 
	9.2	 	Indemnification by Chimerix	53
	 	 	 	 
	9.3	 	Procedure	53
	 	 	 	 
	9.4	 	Limitation of Liability	54
	 	 	 	 
	9.5	 	Insurance	54
	 	 	 	 
	Article 10	 	MISCELLANEOUS	55

 

    	-ii-

    	 

    

 

Table
of Contents

(continued)

 

	 	 	 	Page
	 	 	 	 
	10.1	 	Force Majeure	55
	 	 	 	 
	10.2	 	Assignment/Change of Control	55
	 	 	 	 
	10.3	 	Severability	56
	 	 	 	 
	10.4	 	Notices	56
	 	 	 	 
	10.5	 	Applicable Law	57
	 	 	 	 
	10.6	 	Dispute Resolution	57
	 	 	 	 
	10.7	 	Entire Agreement; Amendments	58
	 	 	 	 
	10.8	 	Headings and Interpretation	58
	 	 	 	 
	10.9	 	Business Day Requirements	59
	 	 	 	 
	10.10	 	Independent Contractors	59
	 	 	 	 
	10.11	 	Waiver	59
	 	 	 	 
	10.12	 	Cumulative Remedies	59
	 	 	 	 
	10.13	 	Waiver of Rule of Construction	59
	 	 	 	 
	10.14	 	Counterparts	59
	 	 	 	 
	10.15	 	Further Actions	60
	 	 	 	 
	10.16	 	No Third Party Rights	60
	 	 	 	 
	10.17	 	Expenses	60
	 	 	 	 
	10.18	 	Extension to Affiliates	60

 

    	-iii-

    	 

    

 

 

COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT

 

THIS COLLABORATION
AND EXCLUSIVE LICENSE AGREEMENT (“Agreement”), effective as of July 23, 2012 (the “Effective Date”),
is made by and between MERCK SHARP & DOHME CORP., a corporation organized and existing under the laws of New Jersey, (“Merck”)
and CHIMERIX, INC., a corporation organized and existing under the laws of the State of Delaware (“Chimerix”).

 

RECITALS:

 

WHEREAS, Chimerix
owns or otherwise controls patents, patent applications, know-how and other information relating to the compound known as CMX157;

 

WHEREAS, Merck
has experience in the development and commercialization of pharmaceutical products; and

 

WHEREAS, Merck
desires to obtain an exclusive license under the Chimerix Patent Rights (as hereinafter defined) and Chimerix Know-How (as hereinafter
defined) upon the terms and conditions set forth herein, and Chimerix desires to grant such a license, in order to Research (as
hereinafter defined), and to develop, make, have made, use, sell, offer for sale, export and import Compounds (as hereinafter defined)
and Products (as hereinafter defined) for use in the Field (as hereinafter defined) in the Territory (as hereinafter defined);

 

NOW, THEREFORE,
in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are
hereby acknowledged, the Parties hereby agree as follows:

 

Article
1

DEFINITIONS

 

Unless specifically
set forth to the contrary herein, the following terms shall have the respective meanings set forth below:

 

		1.1	“Act” shall mean, as applicable, the United States Federal Food, Drug and Cosmetic
Act, 21 U.S.C. §§ 301 et seq., and/or the Public Health Service Act, 42 U.S.C. §§ 262 et seq., as such may
be amended from time to time.

 

		1.2	“Affiliate” shall mean, with respect to any Person, any other Person that directly
or indirectly controls, is controlled by or is under common control with such Person. A Person shall be deemed to control another
Person if such Person possesses the power to direct or cause the direction of the management, business and policies of such Person,
whether through the ownership of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise.

 

		1.3	“Agreement” shall have the meaning set forth in the introductory paragraph to
this Agreement.

 

    	 

    	 

    

 

		1.4	“Applicable Laws” shall mean the applicable laws of any jurisdiction
which are applicable to any of the Parties or their respective Affiliates in carrying out activities hereunder or to which any
of the Parties or their respective Affiliates in carrying out the activities hereunder is subject, and shall include all statutes,
enactments, acts of legislature, laws, ordinances, rules, regulations, notifications, guidelines, policies, directions, directives
and orders of any statutory authority, tribunal, board, or court or any central or state government or local authority or other
governmental entity in such jurisdictions.

 

		1.5	“Calendar Quarter” shall mean the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31.

 

		1.6	“Calendar Year” shall mean each successive period of twelve (12) months commencing
on January 1 and ending on December 31.

 

		1.7	“Change of Control” shall mean with respect to a Party: (i) the sale of all
or substantially all of such Party’s assets or business relating to this Agreement; (ii) a merger, reorganization or consolidation
involving such Party in which the voting securities of such Party outstanding immediately prior thereto cease to represent at least
fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation;
or (iii) a person or entity, or group of persons or entities, acting in concert (other than financial investment groups that do
not have as a primary business the development and/or commercialization of pharmaceutical products or companion diagnostics)
acquire more than fifty percent (50%) of the voting equity securities or management control of such Party.

 

		1.8	“Chimerix” shall have the meaning set forth in the introductory paragraph to
this Agreement.

 

		1.9	“Chimerix Collaboration Inventions” shall mean all Collaboration Inventions,
patentable or otherwise, that are conceived, discovered, developed, invented, reduced to practice and/or otherwise made in the
course of conducting activities under this Agreement during the Initial Development Period, solely by employees of Chimerix (or
any of its Affiliates) or other persons (not employed by Merck (or any of its Affiliates)) acting on behalf of Chimerix (or any
of its Affiliates). Chimerix Collaboration Inventions shall not include Chimerix’s interest in any Joint Collaboration Inventions.

 

		1.10	“Chimerix Know-How” shall mean all Know-How which is Controlled by Chimerix
or any of its Affiliates as of the Effective Date or at any time during the Initial Development Period, including (i) the Lipid-Antiviral-Conjugate
Technology but only to the extent the same is incorporated in the Compound or Product, and (ii) any Know-How within the Chimerix
Collaboration Inventions and Chimerix’s (and its Affiliates’) rights to Know-How within the Joint Collaboration Inventions.
For purposes of this definition of “Chimerix Know-How”, “Affiliates” shall exclude a Third Party that becomes
an Affiliate of Chimerix after the Effective Date as a result of a Change of Control of

 

    	-2-

    	 

    

 

			Chimerix in which Chimerix is acquired
by such Third Party; provided that in all cases, all Know-How within the “Chimerix Know-How” prior to the time that
such Change of Control occurs shall continue to be included in “Chimerix Know-How” following such Change of Control.
Notwithstanding the foregoing, to the extent any employee of an Affiliate having control (as defined in Section 1.2) over Chimerix
after a Change of Control of Chimerix (i) participates in the Committee (to the extent it continues in existence after such Change
of Control), or (ii) serves as an Alliance Manager, all Know-How provided by such employee(s) of such controlling Affiliate during
the Initial Development Period shall be included in “Chimerix Know-How”, subject in all cases to Article 7 (including
Section 7.1.1).

 

		1.11	“Chimerix Patent Rights” shall mean any and all Patent Rights which are
                                                                   Controlled by Chimerix or any of its Affiliates as of the Effective Date or at any time during the Term and which (i) claim
                                                                   or cover any Compound and/or Product (but excluding claims solely and specifically claiming an Other Active in a given
                                                                   Combination Product as an individual separate component), or the development, manufacture, commercialization, use or sale
                                                                   thereof or the Research, or (ii) claim or cover any Chimerix Know-How. The Chimerix Patent Rights shall
                                                                   include Chimerix’s (and its Affiliates’) rights in Joint Patent Rights. The Chimerix Patent Rights shall include
                                                                   those listed on Schedule 1.11. For purposes of this definition of “Chimerix Patent Rights”,
                                                                   “Affiliates” shall exclude a Third Party that becomes an Affiliate of Chimerix after the Effective Date as a
                                                                   result of a Change of Control of Chimerix in which Chimerix is acquired by such Third Party; provided that in all cases, all
                                                                   Patent Rights within the “Chimerix Patent Rights” prior to the time that such Change of Control occurs shall
                                                                   continue to be included in “Chimerix Patent Rights” following such Change of Control. Notwithstanding the
                                                                   foregoing, to the extent any employee of an Affiliate having control (as defined in Section 1.2) over Chimerix after a
                                                                   Change of Control of Chimerix (i) participates in the Committee (to the extent it continues in existence after such Change of
                                                                   Control), or (ii) serves as an Alliance Manager, all Patent Rights Controlled by such Affiliate which cover or claim
                                                                   inventions provided by such employee(s) of such controlling Affiliate shall be included in “Chimerix Patent
                                                                   Rights”, subject in all cases to Article 7 (including Section 7.1.1).

 

		1.12	“Chimerix Third Party License Agreements” shall mean the UC License.

 

		1.13	“Clinical Trial” shall mean a Phase I Clinical Trial, Phase II Clinical Trial,
or Phase III Clinical Trial, as applicable.

 

		1.14	“Collaboration Invention” shall mean any protocol, formula, data, know-how,
information, trade secret, process, method, composition of matter, compound, material, article of manufacture, discovery, invention
or finding, patentable or otherwise, that is conceived, discovered, developed, invented, reduced to practice and/or otherwise made
(as would be necessary to establish inventorship under United States patent law (regardless of where the applicable activities
occurred)) in the course of performing activities under this Agreement during the Initial Development Period. For clarity,
“Collaboration Invention” shall exclude Patent Rights.

 

    	-3-

    	 

    

 

		1.15	“Combination Product” shall mean a Product which includes any Other Actives
in combination with a Compound, including a fixed-dose combination product. All references to Product in this Agreement shall be
deemed to include Combination Product. For clarity, the definition of “Combination Product” shall not be interpreted
as a grant of a license by Chimerix to Merck to any proprietary Other Actives of Chimerix for use in a Combination Product as an
individual separate component.

 

		1.16	“Commercially Reasonable Efforts” shall mean, with respect to the efforts to
be expended by a Party with respect to any objective, reasonable, diligent, good faith efforts to accomplish such objective as
such Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that
with respect to the Research, or the development, seeking Marketing Authorization for or commercialization of any Product (or Compound,
as applicable), such efforts shall be [...***...].Commercially
Reasonable Efforts shall be determined on a market-by-market, indication-by-indication and product-by-product basis, and it is
anticipated that the level of effort will be different for different markets, and will change over time, reflecting changes in
the status of the Product and the market(s) involved.

 

		1.17	“Committee” shall mean the joint steering committee established to facilitate
the collaboration hereunder, as more fully described in Section 2.6.1.

 

		1.18	“Compound” shall mean:

 

		(i)	the (3-(hexadecyloxy)propyl hydrogen ((R)-1-(6-amino-9H-purin 9-yl)propan-2-yloxy) methyl phosphonate,
known as “CMX157”;

 

		(ii)	any and all Tenofovir Diphosphate Converting Compounds (other than CMX157) Controlled by Chimerix
or any of its Affiliates existing as of the Effective Date, including those set forth on Schedule 1.18;

 

		(iii)	any and all Tenofovir Diphosphate Converting Compounds Controlled by Chimerix or any of its Affiliates
and synthesized or generated after the Effective Date and during the Term; but excluding those Tenofovir Diphosphate Converting
Compounds owned or otherwise controlled by a Third Party that becomes an Affiliate of Chimerix as a result of a Change of Control
of Chimerix in which Chimerix is acquired by such Third Party, which Tenofovir Diphosphate Converting Compounds are (x) 

 

***Confidential
Treatment Requested

  

    	-4-

    	 

    

 

			owned or
otherwise controlled by such Third Party immediately prior to such Change of Control, or (y) owned or controlled by such Third
Party following such Change of Control, provided that such Tenofovir Diphosphate Converting Compounds were invented or reduced
to practice without use of any Chimerix Know-How Controlled by Chimerix as of the time of such Change of Control and are not claimed
by any of the Chimerix Patent Rights set forth in Schedule 1.11. For clarity, in all cases, all Tenofovir Diphosphate Converting
Compounds described in the first sentence of this clause (iii) or within clauses (i) and (ii) prior to the time that such Change
of Control occurs shall continue to be included in “Compounds” following such Change of Control;

 

		(iv)	any and all metabolites of any of the compounds described in the foregoing clauses (i), (ii) or
(iii);

 

		(v)	any and all prodrugs of any of the compounds described in the foregoing clause (i), (ii), (iii)
or (iv), as well as conjugates and complexes of the compounds described in the foregoing clauses (i), (ii), (iii) or (iv); and/or

 

		(vi)	any and all analogs, salts, free acids/bases, solvates, enantiomers, isomers, hydrates, esters,
racemates, poylmorphic forms and/or other derivatives of any of the compounds described in the foregoing clauses (i), (ii), (iii),
(iv) or (v).

 

		1.19	“Confidential Information” shall mean any and all proprietary and/or confidential
information and data, including all scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and
commercial information or data, whether communicated in writing or orally or by any other method, which is provided by or on behalf
of one Party to the other Party in connection with this Agreement.

 

		1.20	“Control”, “Controls” or “Controlled
by” shall mean with respect to any Patent Rights, Know-How or other intellectual property assets or rights, as applicable,
the possession of (whether by ownership or license or other right, other than pursuant to a license under this Agreement) or the
ability of a Party to grant access to, or a license or sublicense of, such item or right as provided for herein without violating
the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder
to grant the other Party such access or license or sublicense.

 

		1.21	“Development Plan” shall have the meaning set forth in Section 3.3.2, as such
plan may be amended or updated from time to time in accordance with this Agreement.

 

		1.22	“Excepted Licensor” means any licensor under any of the Chimerix Third Party
License Agreements.

 

    	-5-

    	 

    

 

		1.23	“Field” shall mean the use of Compound and/or Product for any and all purposes
in humans, including all therapeutic and prophylactic uses.

 

		1.24	“Filing” of an NDA shall mean the acceptance by the applicable Regulatory Authority
of an NDA for filing; provided that such Regulatory Authority has not issued a refusal to file letter or a letter identifying deficiencies
for which the Regulatory Authority will suspend its review following submission of the filing.

 

		1.25	“First Commercial Sale” shall mean, with respect to a given Product in a given
country in the Territory, the first shipment to a Third Party of commercial quantities of such Product sold in such country to
a Third Party on arm’s length terms by Merck (or its Affiliate or sublicensee) for end use or consumption of such Product
in the Field in such country in the Territory (following, in all cases, receipt of Marketing Authorization for such Product in
such country), excluding, however, any sale or other distribution for use in a Clinical Trial or for compassionate or similar use,
or for test marketing, sampling or promotional uses. For clarity, First Commercial Sale shall be determined on a Product-by-Product
and country-by-country basis.

 

		1.26	“Generic Product” shall mean with respect to a Product, any pharmaceutical product
(other than those Products commercialized by Merck or its Related Parties hereunder under the trademark designated by Merck or
such Related Party), including any combination product, that contains an active ingredient which is a Compound.

 

		1.27	“Good Clinical Practices” or “GCPs” shall mean, as applicable,
the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration
(“FDA”) or other relevant governmental authority having jurisdiction over the development, manufacture or sale
of Product in the Territory pursuant to its regulations, guidelines or otherwise, as applicable.

 

		1.28	“Good Laboratory Practices” or “GLPs” shall mean, as applicable,
the then current good laboratory practice regulations of the FDA as described in the United States Code of Federal Regulations
(“CFR”) or any comparable corresponding foreign regulations or their respective successor regulations, as applicable.

 

		1.29	“Good Manufacturing Practices” or “GMPs” shall mean, as applicable,
the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant governmental
authority having jurisdiction over the development, manufacture or sale of Product in the Territory pursuant to its regulations,
guidelines or otherwise, as applicable.

 

		1.30	“HBV Indication” shall mean an Indication for the treatment of HBV (hepatitis
B virus).

 

		1.31	“HIV Indication” shall mean an Indication for the treatment of HIV (human immunodeficiency
virus).

 

    	-6-

    	 

    

 

		1.32	“IND” shall mean an Investigational New Drug application, Clinical Study Application,
Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with
or submitted to the applicable Regulatory Authority in conformance with the requirements of such Regulatory Authority.

 

		1.33	“Indication” shall mean a separate and distinct disease or medical condition
in humans for which (i) a Product that is in Clinical Trials is intended to treat, prevent and/or diagnose and/or (ii) a Product
has received Marketing Authorization (as indicated on the approved labeling for such Product), as applicable.

 

		1.34	“Initiates” or “Initiation” shall mean, with respect to a
Clinical Trial, the administration of the first dose to a properly enrolled patient in such Clinical Trial.

 

		1.35	“Initial Development Period” shall mean the period commencing on the Effective
Date and ending on the Initiation of the first Phase II Clinical Trial for the first Product.

 

		1.36	“Joint Collaboration Inventions” shall mean all Collaboration Inventions, patentable
or otherwise, that are conceived, discovered, developed, invented, reduced to practice and/or otherwise made in the course of conducting
activities under this Agreement during the Initial Development Period, jointly by employee(s) of Merck and/or its Affiliate and/or
a Third Party acting on behalf of Merck or its Affiliate, on the one hand, and employee(s) of Chimerix and/or its Affiliate and/or
a Third Party acting on behalf of Chimerix or its Affiliate, on the other hand.

 

		1.37	“Joint Patent Rights” shall mean all Patent Rights to the extent claiming patentable
Joint Collaboration Inventions.

 

		1.38	“Know-How” shall mean any and all proprietary data, information, materials and
know-how (whether patentable or not) necessary, useful or otherwise related to a Compound and/or Product (including any Combination
Product), or any formulation, product improvement and/or indication thereof, or the research, discovery, development, manufacture,
commercialization or use of any of the foregoing, that are not in the public domain, including, (a) ideas, discoveries, inventions,
improvements, technology or trade secrets, (b) pharmaceutical, chemical and biological materials, products, components or compositions,
(c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological,
chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality
control data and information related thereto, (e) technical and non-technical data and other information related to the foregoing,
and (f) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information
or materials. “Know-How” shall exclude proprietary data, information, materials and know-how solely and specifically
related to an Other Active in a given Combination Product as an individual separate component.

 

    	-7-

    	 

    

 

		1.39	“Lipid-Antiviral-Conjugate Technology” shall mean all Chimerix proprietary technology,
data, information, and know-how related generally to the lipid modification of anti-viral compounds, but not specifically related
to a Compound or Product, and all Patent Rights and other intellectual property in connection therewith, but expressly excluding
inventions claimed in the Chimerix Patent Rights.

 

		1.40	“Major Markets in the EU” shall mean any one of the following countries: the
United Kingdom, France, Germany, Italy or Spain.

 

		1.41	“Marketing Authorization” shall mean all approvals from the relevant Regulatory
Authority necessary to market and sell a Product in a given country in the Territory (including all applicable pricing and governmental
reimbursement approvals even if not legally required to sell Product in a country).

 

		1.42	“Merck” shall have the meaning set forth in the introductory paragraph to this
Agreement.

 

		1.43	“Merck Collaboration Invention” shall mean all Collaboration Inventions, patentable
or otherwise, that are conceived, discovered, developed, invented, reduced to practice and/or otherwise made in the course of conducting
activities under this Agreement during the Initial Development Term, by employees of Merck (or any of its Affiliates) or other
persons (not employed by Chimerix (or any of its Affiliates)) acting on behalf of Merck (or any of its Affiliates). Merck Collaboration
Inventions shall not include Merck’s interest in any Joint Collaboration Inventions.

 

		1.44	“NDA” shall mean a New Drug Application, Worldwide Marketing Application, Marketing
Authorization Application, or similar application or submission for Marketing Authorization of a Product filed with a Regulatory
Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in a given country or group of countries.

 

		1.45	“Net Sales” shall mean:

 

		1.45.1	the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Product
in the Territory for use in the Field sold by Merck or its Related Parties to the first Third Party after deducting, if not previously
deducted, from the amount invoiced or received:

 

		(a)	trade and quantity discounts other than early payment cash discounts;

 

		(b)	returns, rebates, chargebacks and other allowances;

 

		(c)	retroactive price reductions that are actually allowed or granted;

 

		(d)	deductions to gross invoice price of Product imposed by Regulatory Authorities or other governmental
entities;

 

    	-8-

    	 

    

 

		(e)	sales commissions, distribution fees and other similar fees paid to Third Party distributors and/or
selling agents;

 

		(f)	a fixed amount equal to [...***...]
of the amount invoiced to cover bad debt, early payment cash discounts, transportation and insurance and custom duties; and

 

		(g)	the standard inventory cost of devices or delivery systems used for dispensing or administering
or delivering Product.

 

		1.45.2	With respect to sales of Combination Products (including fixed-dose combination products), Net
Sales for any such Combination Product in a particular country in the applicable Calendar Quarter shall be calculated as follows:

 

		(a)	Where all active ingredients in such Combination Product are sold separately in such country, Net
Sales shall be calculated by multiplying [...***...] by [...***...], and [...***...].

 

		(b)	If the Compound component of the Combination Product is sold separately in such country, but none
of the Other Actives is sold separately in such country, Net Sales for the purpose of determining royalties due hereunder for the
Combination Product will be calculated by multiplying [...***...] by [...***...], and [...***...].

 

		(c)	If the Compound component of the Combination Product is not sold separately in such country, but
the Other Active(s) are sold separately in such country, Net Sales for the purpose of determining royalties due hereunder for the
Combination Product will be calculated by multiplying [...***...] by [...***...], and [...***...].

 

		(d)	If neither the Compound component nor the Other Actives are sold separately in such country, Net
Sales for the purposes of determining royalties due hereunder for the Combination Product will be [...***...], and [...***...],

 

***Confidential
Treatment Requested

 

    	-9-

    	 

    

 

and [...***...].

 

In applying
the foregoing formulas for purposes of Section 1.45.2, Merck shall act in good faith and make determinations in accordance with
Merck’s regular accounting methods, consistently applied. In the event either Party reasonably believes that the calculation
set forth in Section 1.45.2 does not fairly reflect the value of the Compound relative to the Other Actives in the Combination
Product, the Parties shall negotiate, in good faith, other means of calculating Net Sales with respect to Combination Products
to so reflect such value.

 

		1.46	“Other Actives” shall mean, with respect to a given Combination Product, one
or more active pharmaceutical ingredients contained in such Combination Product, other than a Compound.

 

		1.47	“Party” shall mean Merck and Chimerix, individually, and “Parties”
shall mean Merck and Chimerix, collectively.

 

		1.48	“Patent Rights” shall mean (i) patents and patent applications in the Territory
(which for the purposes of this Agreement shall be deemed to include certificates of invention and applications for certificates
of invention) and (ii) any and all divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations,
re-examinations, revalidations, extensions, supplementary protection certificates and the like of any such patents and patent applications,
and (iii) any and all foreign equivalents of the foregoing in the Territory.

 

		1.49	“Person” means any individual, partnership, joint venture, limited liability
company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity
not specifically listed herein.

 

		1.50	“Phase I Clinical Trial” shall mean a human clinical trial in any country that
would satisfy the requirements of 21 CFR 312.21(a).

 

		1.51	“Phase II Clinical Trial” shall mean a human clinical trial in any country that
would satisfy the requirements of 21 CFR 312.21(b).

 

		1.52	“Phase III Clinical Trial” shall mean a human clinical trial in any country
that would satisfy the requirements of 21 CFR 312.21(c).

 

		1.53	“Proof of Concept” shall mean that a given Compound has completed the [...***...]
with respect to the Compound, as defined in and in accordance with the Development Plan, and has met the success criteria set forth
in Schedule 1.53 in connection therewith (as such success criteria may be updated in accordance with Section 3.3.3), as
reasonably determined by Merck.

 

***Confidential
Treatment Requested

 

    	-10-

    	 

    

 

 

		1.54	“Product” shall mean any pharmaceutical composition or preparation (in any and
all dosage forms) in final form containing a Compound, including any Combination Product. For clarity, different formulations or
dosage strengths of a given Product shall be considered the same Product for purposes of this Agreement.

 

		1.55	“Region” means the group of countries in the Territory as set forth in one of
the following clauses: [...***...].

 

		1.56	“Regulatory Authority” shall mean any applicable government regulatory authority
involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a Product in the Territory, including,
in the United States, the United States Food and Drug Administration and any successor governmental authority having substantially
the same function.

 

		1.57	“Regulatory Documentation” shall mean all regulatory applications, registrations,
licenses, authorizations and approvals (including all Marketing Authorizations), all correspondence submitted to or received from
Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority),
and all reports and documentation in connection with clinical studies and tests (including study reports and study protocols, and
copies of all interim study analysis), and all data contained in any of the foregoing, including all INDs, NDAs, advertising and
promotion documents, manufacturing data, drug master files, clinical data, adverse event files and complaint files, in each case
related to a Compound and/or Product.

 

		1.58	“Related Party” shall mean each of Merck, its Affiliates, and their respective
sublicensees hereunder (which term does not include distributors), as applicable.

 

		1.59	“Research” shall mean to conduct research and discovery, including in vitro
and in vivo experiments, necessary or useful for the development of, or otherwise in connection with, a Compound or
Product. For clarity, Research expressly excludes any making of, or discovery of, compounds that are other than Compounds and/or
Products.

 

		1.60	“Tenofovir Diphosphate Converting Compound” shall mean a pharmaceutically active
compound that is converted in vivo into the active moiety tenofovir diphosphate. It is understood that CMX157 is a Tenofovir
Diphosphate Converting Compound.

 

		1.61	“Territory” shall mean all of the countries in the world, and their territories
and possessions.

 

		1.62	“Third Party” shall mean an entity other than Merck and its Affiliates, and
Chimerix and its Affiliates.

 

***Confidential Treatment Requested

 

    	-11-

    	 

    

 

		1.63	“UC License” shall mean that certain License Agreement dated as of May 13, 2002,
by and between Chimerix and the Regents of the University of California (“UC”) as amended on September 11, 2002,
December 17, 2010, September 14, 2011 and July 19, 2012.

 

		1.64	“Valid Patent Claim” shall mean, with respect to a given Compound, a claim of
an issued and unexpired patent included within the Chimerix Patent Rights that [...***...].

 

		1.65	“Violation” shall mean that Chimerix or any of its officers or directors or
any other Chimerix personnel (or other permitted agents of Chimerix performing activities hereunder) has been: (1) convicted of
any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office
of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (2) identified
in the OIG List of Excluded Individuals/Entities (LEIE) database (http://exclusions.oig.hhs.gov/) or the U.S. General Services
Administration’s list of Parties Excluded from Federal Programs (http://www.epls.gov); or (3) listed by any US Federal agency
as being suspended, debarred, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs,
including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/) (each of (1), (2) and (3) collectively the “Exclusions
Lists”).

 

		1.66	Additional Definitions. The following terms have the meanings set forth in the corresponding
Sections of this Agreement:

 

	Term	 	Section
	 	 	 
	“AAA”	 	10.6.1
	“Additional Tax”	 	5.7
	“Additional Third Party Licenses”	 	5.3.7
	“Alliance Manager”	 	2.7
	“Approval Milestones”	 	5.2.1
	“Chimerix Indemnified Parties”	 	9.1
	“Chimerix/UC Patent Rights”	 	7.3
	“Code”	 	8.4(d)

 

***Confidential Treatment Requested

 

    	-12-

    	 

    

 

	“EU Approval Milestone”	 	5.2.1
	“Excluded Claim”	 	10.6.6
	“Exclusion List”	 	1.65
	“Executives”	 	2.6.1
	“Indemnified Party”	 	9.3
	“Indemnifying Party”	 	9.3
	“Inventory”	 	3.2.1
	“License Payments”	 	5.7
	“Manufacturing Consultants”	 	3.2.2
	“Merck Indemnified Parties”	 	9.2
	“Merck Patent Rights”	 	7.2.4
	“Merck Withholding Tax Action”	 	5.7
	“Product Infringement Action”	 	7.5.2
	“Relevant Chimerix Patent Claims”	 	7.5.2
	“Royalty Period”	 	5.3.4
	“Safety Termination”	 	8.2
	“Sensitive Information”	 	10.2
	“Taxes”	 	5.7
	“Term”	 	8.1
	“Transfer Period”	 	3.1
	“US Approval Milestone”	 	5.2.1

 

Article
2

LICENSE GRANTS; GOVERNANCE

 

		2.1	Exclusive License Grant

 

Subject to the terms and conditions
of this Agreement, Chimerix hereby grants to Merck an exclusive (even as to Chimerix and its Affiliates) royalty bearing license
under the Chimerix Patent Rights and the Chimerix Know-How, with the right to sublicense (subject to the restriction set forth
below), to conduct Research, and to develop, make, have made, use, offer to sell, sell, export and/or import Compounds and Products,
in the Territory for use in the Field. Merck may grant sublicenses (through multiple tiers of sublicenses) of the rights granted
to it under this Section 2.1 without Chimerix’s consent; provided, however, that promptly following the execution of any
such sublicense with a Third Party, Merck shall provide written notice to Chimerix of the name of the sublicensee.

 

	2.2	Non-Exclusive License Grant

 

In the event that conduct of
the Research, or the development, making, having made, use, offer for sale, sale, export or import by Merck, or Merck’s Related
Parties, of Compound(s) or Product(s), infringes a claim of issued letters patent which Chimerix (or 

 

    	-13-

    	 

    

 

any of its Affiliates) owns
or otherwise has the right to license and which patents are not included in the Chimerix Patent Rights licensed in Section 2.1,
Chimerix (and its Affiliates) hereby grants to Merck, to the extent Chimerix is legally able to do so, a non-exclusive, sublicensable,
royalty-free license in the Territory under such issued letters patent for Merck and Merck’s Related Parties to conduct such
Research, and to develop, make, have made, use, sell, offer for sale, export and/or import Compound(s) and Product(s), in the Territory.
Nothing in this Section 2.2 shall obligate Chimerix in any way to obtain or procure, for Merck’s benefit, licenses or rights
under any Third Party intellectual property. For purposes of this Section 2.2, “Affiliates” shall exclude a Third Party
that becomes an Affiliate of Chimerix after the Effective Date as a result of a Change of Control of Chimerix in which Chimerix
is acquired by such Third Party; provided that in all cases, all letters patent owned or controlled by Chimerix or its Affiliates
and licensed to Merck pursuant to this Section 2.2 prior to the time that such Change of Control occurs shall continue to be included
in the licenses granted to Merck pursuant to this Section 2.2 following such Change of Control.

 

		2.3	No Implied Licenses

 

Except as specifically set forth
in this Agreement, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise,
in any Know-How, or Confidential Information disclosed to it under this Agreement or under any Patent Rights owned or controlled
by the other Party or its Affiliates.

 

		2.4	No Grant of Inconsistent Rights by Chimerix

 

Chimerix (and its Affiliates)
shall not assign, transfer, convey or otherwise grant to any Third Party, or otherwise encumber (including through lien, charge,
security interest, mortgage, encumbrance or otherwise), (i) any rights to any Chimerix Know-How (or any rights to any intellectual
property that would otherwise be included in the Chimerix Know-How) or any Chimerix Patent Rights, in any manner that is inconsistent
with or would interfere with the grant of the rights or licenses to Merck hereunder, or (ii) any rights to any Compounds or
Products (but excluding an Other Active in a given Combination Product as an individual separate component). Without limiting the
foregoing, during the Term, Chimerix (and its Affiliates) shall not use (and shall not grant to any Third Party the right to use)
any Compounds or Products for any purpose (including the research, development, manufacturing or commercialization thereof), except
(x) Chimerix may utilize CMX157 (and any other Compounds synthesized or generated by Chimerix) for its internal research purposes
in the course of the development or manufacture of any of Chimerix’s other proprietary compounds or products (other than
Compounds or Products) (the “Chimerix Internal Research”) and (y) as otherwise set forth in Section 3.3.5.

 

    	-14-

    	 

    

 

		2.5	Covenant Not to Sue

 

Chimerix hereby covenants that
during the Term, it (and its Affiliates) shall not sue nor otherwise attempt to enforce against Merck (or any of its Affiliates
or Related Parties) any letters patent or other intellectual property rights owned or otherwise controlled by Chimerix (or (x)
any of its Affiliates as of the Effective Date or (y) any other Person which becomes an Affiliate of Chimerix after the Effective
Date and over which Chimerix has control (as defined in Section 1.2)), as and to the extent such letters patent or other intellectual
property rights (i) cover or claim the Compounds or Products (or the development, manufacture, commercialization, use or sale
thereof, or the conduct of Research) and (ii) exist prior to or as of the date of expiration of the Initial Development Period.

 

		2.6	Joint Steering Committee

 

		2.6.1	Composition of the Joint Steering Committee. The Parties hereby establish a joint steering
committee (the “Committee”) to facilitate the collaboration hereunder during the Initial Development Period.
The Committee shall be comprised of three (3) representatives of Merck and three (3) representatives of Chimerix. Each Party shall
provide the other with a list of its initial members of the Committee no later than thirty (30) days after the Effective Date,
and each Party may change its representatives on the Committee from time to time, in its sole discretion, effective upon notice
to the other Party of such change. These representatives shall have appropriate technical credentials, experience and knowledge,
and familiarity with respect to development of pharmaceutical compounds. Additional representatives or consultants may from time
to time, by mutual consent of the Parties, be invited to attend Committee meetings, subject to such representative’s or consultant’s
written agreement to comply with the requirements of Section 4.1. The Committee shall be chaired by a representative of Merck,
who shall prepare written draft minutes of all Committee meetings within thirty (30) days following such meetings, and shall circulate
such minutes to the Committee members. Merck shall issue final minutes within thirty (30) days following receipt of Chimerix’s
written comments, if any. Decisions of the Committee shall be made unanimously by the representatives, with each Party having a
single vote. In the event that the Committee cannot or does not, after good faith efforts for a period of thirty (30) days, reach
agreement on an issue, the issue will be communicated to the appropriate Vice-President of Merck Research Laboratories and the
Chief Executive Officer of Chimerix (together, the “Executives”), who shall endeavor to facilitate a resolution
of such issue. If the Executives have not resolved such issue within ten (10) business days following the communication of the
issue to them, then the resolution and/or course of conduct shall be determined by Merck, in its sole discretion (and such matter
shall not be subject to dispute resolution pursuant to Section 10.6). Each Party shall bear its own expenses related to the attendance
of such meetings by its representatives.

 

    	-15-

    	 

    

 

		2.6.2	Meetings and Responsibilities. The Committee shall meet in accordance with a schedule established
by mutual written agreement of the Parties, but no less frequently than once per Calendar Quarter, with the location for such meetings
alternating between Chimerix and Merck facilities (or such other location as may be determined by the Committee). Alternatively,
the Committee may meet by means of teleconference, videoconference or other similar communications equipment. The Committee shall
be responsible for:

 

		(i)	Facilitating the development of the Compound during the Initial Development Period;

 

		(ii)	Reviewing and discussing the Development Plan including amendments and updates thereto;

 

		(iii)	Monitoring and reviewing the status of the development activities under the Development Plan;

 

		(iv)	To oversee and coordinate the transfer of technology and Inventory pursuant to Sections 3.1 and
3.2; and

 

		(v)	Resolution of any disputes within the purview of the Committee and that are referred from the Alliance
Managers, subject to the final decision-making rights under Section 2.6.1.

 

		2.6.3	Disbandment of Committee. At the end of the Initial Development Period, the Committee shall
be disbanded and shall have no further rights or obligations hereunder.

 

		2.7	Alliance Managers. Each Party shall appoint an employee who shall oversee interactions
between the Parties for all matters related to this Agreement (each, an “Alliance Manager”). During the Initial
Development Period, the Alliance Managers shall have the right to attend all Committee meetings as non-voting participants and
may bring to the attention of the Committee any matters or issues either of them reasonably believes should be discussed, and shall
have such other responsibilities as the Parties may mutually agree. Each Party may replace its Alliance Manager at any time or
may designate different Alliance Managers by notice in writing to the other Party. The role of the Alliance Manager shall terminate
at the end of the Initial Development Period.  

 

		2.8	Compliance with Law

 

Merck and Chimerix each shall
conduct its activities hereunder in compliance with all Applicable Laws.

 

    	-16-

    	 

    

 

Article
3

DEVELOPMENT, MANUFACTURING
AND COMMERCIALIZATION

 

		3.1	Technology Transfer; Transition of Activities. As soon as reasonably practicable
following the Effective Date (but in all cases within thirty (30) days after Chimerix’s receipt of the upfront payment pursuant
to Section 5.1), Chimerix shall (i) disclose to Merck in English (and deliver in an electronic format, or in written format to
the extent that electronic format is not available) all Chimerix Know-How as and to the extent embodied by the Compound or Product,
(ii) transfer to Merck all materials (other than Inventory) related to a Compound or Product in Chimerix’s (or any of its
Affiliate’s) possession or Control, and (iii) transfer and assign to Merck all Regulatory Documentation in Chimerix’s
(or any of its Affiliate’s) possession or Control (including the transfer to Merck of a database that contains all relevant
information regarding adverse events that have been observed during any clinical trials or studies with respect to a Compound or
Product prior to the Effective Date), including the transfer and assignment of IND #103,150 to Merck. Thereafter during the Term,
Chimerix shall cooperate with Merck and promptly disclose to Merck in English (and deliver in an electronic format, or in written
format to the extent that electronic format is not available) any other intellectual property relating to a Compound or Product
(or the development, making, use or sale thereof, or the Research) as may be developed or identified by Chimerix (or its Affiliates),
to the extent that Merck has a license thereto under this Agreement. Chimerix shall assist Merck to ensure an orderly transition
and uninterrupted development of the Compound, including providing technical assistance to Merck (or its designee) in connection
therewith from time to time during the Term as requested by Merck; provided, however, that with respect to any such technical assistance
under this Section 3.1 as well as with respect to any Manufacturing Consultation provided under Section 3.2.2, in each case, that
is requested by Merck after the ninety (90) day anniversary of the Effective Date (such period from the Effective Date through
the ninety (90) day anniversary of the Effective Date, the “Transfer Period”), Merck shall reimburse Chimerix
(within thirty (30) days after a receipt of an itemized invoice from Chimerix) for those reasonable costs and expenses for such
technical assistance under this Section 3.1 or Manufacturing Consultation under Section 3.2.2 (including on a pro-rata basis the
FTE rate of [...***...] per FTE per
annum for Chimerix’s personnel engaged in such technical assistance), as applicable, but solely to the extent that such costs
and expenses have been agreed to by Merck in writing prior to the commencement of such activities (and for clarity, Chimerix shall
be solely responsible for, and shall not be entitled to reimbursement for, any other costs or expenses in connection therewith).
For clarity, no such amounts shall be payable by Merck with respect to any such activities during the Transfer Period.  

 

 

		3.2	Inventory Transfer and Manufacturing Technology Transfer.

  

		3.2.1	Inventory Transfer.
As soon as reasonably practicable following the Effective Date (but in all cases within thirty (30) days after Chimerix’s
receipt of the upfront payment pursuant to Section 5.1), Chimerix shall transfer and deliver to

 

 

***Confidential
Treatment Requested

 

    	-17-

    	 

    

 

			Merck (at a location
to be specified by Merck to Chimerix), at no additional cost, all inventory of Compound and Product (including inventory of cGMP
and non-cGMP bulk Compound as well as bulk Product) held by or on behalf of Chimerix or any of its Affiliates (including any such
inventory held at any contract manufacturer) (the “Inventory”). The quantity of such Inventory shall be at
a minimum, the quantities as set forth on Schedule 3.2, which schedule shall be broken down by cGMP and non-cGMP bulk Compound
as well as by cGMP and non-cGMP bulk Product.

 

		3.2.2	Manufacturing Technology Transfer. Without limiting the provisions of Section 3.1, as soon
as reasonably practicable following the Effective Date (but in all cases within thirty (30) days after Chimerix’s receipt
of the upfront payment pursuant to Section 5.1), Chimerix shall transfer or cause to be transferred (including from its Third Party
contract manufacturers) to Merck, or a Third Party manufacturer designated by Merck, copies in English (in writing and in an electronic
format, or in written format to the extent that electronic format is not available) of all data, information and other Know-How
Controlled by Chimerix (or any of its Affiliates or its Third Party contract manufacturers) that is related to the manufacture
of the Compounds and/or Products, in order to enable Merck (or its designee) to manufacture the Compounds and Products, including
to replicate the process employed by or on behalf of Chimerix to manufacture Compounds and Products. In addition, at the request
of Merck from time to time during the eighteen (18) month period following the Effective Date, Chimerix shall make its (and its
Affiliates’) employees and consultants (including personnel of its Third Party contract manufacturers) available to Merck
to provide consultation and technical assistance in order to ensure an orderly transition of the manufacturing technology and operations
to Merck (or its designee) and to assist Merck (or its designee) in the start-up of its manufacture of Compound and Product (such
consultation, the “Manufacturing Consultation”). For clarity, the Manufacturing Consultation shall be at no
cost or expense to Merck during the Transfer Period; provided, however, that Merck shall at all times (including during the Transfer
Period) reimburse Chimerix (within thirty (30) days after a receipt of an itemized invoice from Chimerix) for those reasonable
out-of-pocket costs payable by Chimerix to its Third Party contract manufacturer for the use of such Third Party contract manufacturer’s
personnel in providing such Manufacturing Consultation to Merck to the extent applicable (but solely to the extent that Merck has
agreed to the amount of such costs in writing prior to such Manufacturing Consultation, and for clarity, Chimerix shall be solely
responsible for any costs incurred in excess of such agreed upon amount but shall not be obligated to incur such excess costs for
Merck’s benefit).

 

		3.3	Development, Manufacture and Commercialization

 

		3.3.1	General; Efforts. Merck (and its Affiliates), either itself or together with Third Party(ies),
shall have the sole right to (and shall control all aspects of) conduct

 

    	-18-

    	 

    

 

			Research, and to develop
(including pre-clinical and clinical development), manufacture, register and commercialize (including marketing, promoting, selling,
distributing and determining pricing for) Compounds and Products, and for clarity, Chimerix (and its Affiliates) shall have no
right to do so, except as may be expressly provided in Section 3.3.5 and Section 2.4 (with respect to the Chimerix Internal Research).
Merck shall use Commercially Reasonable Efforts to develop, seek Marketing Authorization (as necessary) for, and commercialize,
at least one Product for use in the Field in (i) the United States, and (ii) at least three (3) of the Major Markets in the EU.
For clarity, the Parties agree that Merck’s primary focus with respect to the development of Product hereunder initially
will be to use Commercially Reasonable Efforts to develop a Product for the HIV Indication, and following the First Commercial
Sale of a Product for the HIV Indication, Merck shall also use Commercially Reasonable Efforts to develop a Product for one or
more other Indications, which may include the HBV Indication; provided, however, that any failure to use Commercially Reasonable
Efforts to develop a Product for any such other Indications shall not give rise to a right of termination of this Agreement (in
whole or in part) by Chimerix under Section 8.3.1(a). All other development, seeking Marketing Authorizations, and commercialization
efforts with respect to the Compounds and Products shall be at the discretion of Merck.

 

		3.3.2	Development Plan. Attached hereto as Schedule 3.3.2 is the initial Development Plan
for the development of the Product for the HIV Indication. From time to time during the Initial Development Period (but no less
than once per Calendar Year), Merck shall update the Development Plan and provide such updated Development Plan, along with development
reports (pursuant to Section 3.4.2) summarizing the status of Merck’s development efforts as against such Development Plan,
to the Committee for its review and discussion (provided that for clarity, following the end of the Initial Development Period,
Merck shall no longer be obligated to update the Development Plan or provide any updates thereto to the Committee). Subject to
Section 3.3.3, all decisions with respect to the creation, amendment, modification and implementation of the Development Plan shall
be made by Merck. Notwithstanding the foregoing, the Development Plan shall be for informational purposes only.

 

		3.3.3	Amendment of Success Criteria. In the event that the Development Plan is amended by Merck
in any material way, then, at the request of either Party, the Parties shall discuss if the success criteria set forth in Schedule
1.53 should be amended as a result of the amendments to the Development Plan; provided, however, that such success criteria
shall not be amended unless and until the Parties agree in writing to an amendment of the success criteria set forth in Schedule
1.53 in accordance with Section 10.7.

 

		3.3.4	Regulatory Matters. In the event that Merck determines that any regulatory filings for any
Compounds or Products are required for any activities hereunder,

 

    	-19-

    	 

    

 

			including INDs, NDAs and other Marketing Authorizations (as applicable),
then as between the Parties, Merck shall have the sole right, in its discretion, to file for and seek to obtain such regulatory
filings (in its (or its Affiliate’s or its Related Party’s) name) and as between the Parties, Merck (or its Affiliate
or its Related Party) shall be the owner of all such regulatory filings. As between the Parties, Merck shall have the sole right
to communicate and otherwise interact with Regulatory Authorities with respect to the Compounds and/or Products. For clarity, Chimerix
(and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Compounds or Products or
otherwise communicate or interact with any Regulatory Authorities with respect to the Compounds or Products.

 

		3.3.5	Chimerix Manufacturing Opportunity. In the event that Merck determines to engage a Third
Party contract manufacturer to manufacture commercial quantities of the active pharmaceutical ingredient for a Product (but solely
with respect to active pharmaceutical ingredient containing the Compound, and, for clarity, this Section 3.3.5 shall not apply
to any Other Actives, if any, in such Product) for commercialization purposes (but excluding, for clarity, Product for development
or other non-commercial purposes), then Merck shall notify Chimerix thereof, and Chimerix shall have the right (but not the obligation)
to bid on the manufacture of such quantities of active pharmaceutical ingredient in accordance with bid procedures made available
by Merck to other potential Third Party manufacturers. Notwithstanding the foregoing, Merck shall have the right (in its sole discretion)
to accept or reject Chimerix’s bid and to accept or reject any other Third Party bid. In making such determination, Merck
may consider various factors, including (i) experience, capability, and capacity with respect to the active pharmaceutical ingredient
and relevant manufacturing technology, (ii) pricing, and (iii) Merck’s global regulatory, compliance and commercial policies
and expectations. If Merck accepts Chimerix’s bid to manufacture such active pharmaceutical ingredient, Chimerix’s
manufacture of such active pharmaceutical ingredient shall be conditioned upon Chimerix and Merck entering into a mutually satisfactory
manufacturing and supply agreement. For clarity, neither Merck nor any of its Affiliates is obligated to provide Chimerix with
any preference over any other Third Party contract manufacturer in making any determinations with respect to the selection of a
contract manufacturer.

 

		3.4	Records and Reports

 

		3.4.1	Records. Merck shall maintain accurate records relating to its development work with respect
to the Product hereunder.

 

		3.4.2	Reports. Within thirty (30) days following the end of each Calendar Year during the Initial
Development Period, Merck shall provide to Chimerix (through the Committee) a written progress report which shall summarize (a)
the development status of the Products and (b) the development efforts undertaken by Merck

 

    	-20-

    	 

    

 

			hereunder with respect
to the Products (including a comparison against the Development Plan) during such Calendar Year. Thereafter, following the Initiation
of the first Phase II Clinical Trial for the Product through the end of the Term, Merck shall provide to Chimerix a written progress
report, every six (6) months during a Calendar Year (which reports shall be due within thirty (30) days following June 30th and
December 31st), which shall (i) summarize the development status of the Products (if any), (ii) list any NDAs submitted by Merck
with respect to the Products, and any Marketing Authorizations (other than pricing approvals) obtained, and (iii) summarize the
general commercialization activities undertaken by Merck hereunder with respect to the Product, in each case, since the last such
report. After the Initial Development Period, Merck shall promptly respond in writing to Chimerix’s reasonable requests
or inquiries relating to the written progress reports provided hereunder pursuant to this Section 3.4.2 (but no more than once
per Calendar Year) to answer questions that Chimerix may have (provided, however, that all such requests, inquiries and questions
from Chimerix must be in writing).

 

		3.5	Excused Performance

 

In addition to the provisions
of Article 6 hereof, the obligations of Merck with respect to any Product under Section 3.3 are expressly conditioned upon the
continuing absence of any adverse condition or event relating to the safety or efficacy of the Product, and any obligation of Merck
to develop, manufacture, seek to obtain regulatory approval for, or commercialize any such Product may be delayed or suspended
so long as in Merck’s opinion any such condition or event exists.

 

Article
4

CONFIDENTIALITY AND PUBLICATION

 

		4.1	Nondisclosure Obligation

 

All Confidential Information
disclosed by one Party to the other Party hereunder shall be maintained in confidence by the receiving Party and shall not be disclosed
to any Third Party or used for any purpose except as set forth herein without the prior written consent of the disclosing Party,
except to the extent that such Confidential Information:

 

		(a)	is known by the receiving Party at the time of its receipt, and not through a prior disclosure
by the disclosing Party, as documented by the receiving Party’s business records;

 

		(b)	is in the public domain by use and/or publication before its receipt from the disclosing Party,
or thereafter enters the public domain through no fault of the receiving Party;

 

    	-21-

    	 

    

 

		(c)	is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is
not under an obligation of confidentiality to the disclosing Party;

 

		(d)	is developed by the receiving Party independently of Confidential Information received from the
disclosing Party, as documented by the receiving Party’s business records;

 

		(e)	with respect to Merck (and/or its Affiliates and/or Related Parties), is disclosed to governmental
or other regulatory agencies in order to gain or maintain approval to conduct clinical trials or to market Product, or with respect
to either Party (and/or its Affiliates and/or Related Parties), is disclosed to governmental or other regulatory agencies as may
be reasonably necessary in order to obtain patents (subject to the applicable provisions of Article 7);

 

		(f)	is deemed necessary or reasonably useful by Merck to be disclosed to Related Parties, agents, consultants,
and/or other Third Parties for any and all purposes Merck and its Affiliates deem necessary or advisable in the ordinary course
of business in accordance with this Agreement (including the exercise of licenses granted to Merck hereunder) on the condition
that such Third Parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than
those confidentiality and nonuse provisions contained in this Agreement; provided, however, that the term of confidentiality for
such Third Parties shall be no less than ten (10) years;

 

		(g)	is deemed necessary by counsel to the receiving Party to be disclosed to such Party’s attorneys,
independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial
advisors to provide advice to the receiving Party, on the condition that such attorneys, independent accountants and financial
advisors agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality
and nonuse provisions contained in this Agreement; provided, however, that the term of confidentiality for such attorneys, independent
accountants and financial advisors shall be no less than ten (10) years; or

 

		(h)	is deemed necessary to be disclosed to any bona fide potential or actual investor, investment banker,
acquirer, merger partner or other potential or actual financial partner in connection with a financing, merger, or acquisition,
in which case, each Party shall have the further right to disclose the material financial terms of this Agreement provided that
in connection with such disclosure each disclosee shall be under a

 

    	-22-

    	 

    

 

			confidentiality obligation no less protective than those set
forth in this Agreement.

 

Any combination of features or
disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available
to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation
are published or available to the general public or in the rightful possession of the receiving Party.

 

If a Party is required by judicial
or administrative process to disclose Confidential Information that is subject to the non-disclosure provisions of this Section
4.1 or Section 4.2, as applicable, such Party shall promptly inform the other Party of the disclosure that is being sought in order
to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed
by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Section
4.1 or Section 4.2, as applicable, and the Party disclosing Confidential Information pursuant to Applicable Law or court order
shall take all steps reasonably necessary, including without limitation, obtaining an order of confidentiality, to ensure the continued
confidential treatment of such Confidential Information. The Parties shall reasonably agree in advance with each other on the terms
of this Agreement to be redacted in any Securities and Exchange Commission filings.

 

		4.2	Chimerix Know-How. Without limiting the provisions of Section 4.1, Chimerix agrees
to keep all Chimerix Know-How relating solely to Compound or Product confidential, subject to Section 4.1(b). For clarity, Chimerix’s
obligation under this Section 4.2 shall not apply to the Lipid-Antiviral-Conjugate Technology.

 

		4.3	Publication

 

Chimerix shall not, and shall
cause its Affiliates and its and such Affiliates’ employees, consultants, contractors and agents not to, publish or present
any Confidential Information of Merck or any other information with respect to any Compound or Product without Merck’s prior
written consent (in its sole discretion). The foregoing sentence shall in no way prohibit or limit Chimerix’s and its Affiliates’
(and its and their respective employees’, contractors’ and agents’) right to publish or present any information
with respect to the Lipid-Antiviral-Conjugate Technology so long as such information is not specific to Compound or Product. For
clarity, notwithstanding the provisions of Section 4.1, Merck and its Affiliates (and its and their respective employees, consultants,
contractors and agents) shall have the right to publish the results of its or their Research, or the development with respect
to the Compounds and Products, including the right to publish the results or summaries of results of any clinical trials conducted
hereunder with respect to a Product on Merck’s clinical trial register; provided, however, in the event any such publication
describes Confidential Information of Chimerix related to the Lipid-Antiviral-Conjugate Technology, Merck shall provide Chimerix
the prior opportunity to review, as described hereafter. With respect to any

 

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publication describing Confidential Information of
Chimerix related to the Lipid-Antiviral-Conjugate Technology, Merck shall deliver to Chimerix a copy of the applicable sections
of the proposed written publication, or a detailed outline or draft presentation of an oral disclosure, at least thirty (30) days
prior to submission for publication or presentation. Chimerix shall have the right to request a reasonable delay in publication
or presentation of those portions of the publication containing Confidential Information of Chimerix regarding the Lipid-Antiviral-Conjugate
Technology in order to protect patentable information on the Lipid-Antiviral-Conjugate Technology. If Chimerix requests such delay
in publication for purposes of protecting such patentable information related to the Lipid-Antiviral-Conjugate Technology, Merck
shall delay submission or presentation of those portions of the publication containing Confidential Information of Chimerix regarding
the Lipid-Antiviral-Conjugate Technology for a period of sixty (60) days to enable filing of patent applications protecting the
Lipid-Antiviral-Conjugate Technology. Upon expiration of such sixty (60) days, Merck and its Affiliates (and its and their respective
employees, consultants, contractors and agents) shall be free to proceed with the publication or presentation of such portions
of the publication.

 

		4.4	Publicity/Use of Names

 

No disclosure of the existence,
or the terms, of this Agreement may be made by either Party, and neither Party shall use the name, trademark, trade name or logo
of the other Party, its Affiliates or their respective employees in any publicity, promotion, news release or disclosure relating
to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required
by Applicable Law; provided that in the event disclosure is required by Applicable Law, the disclosing Party shall use good-faith
efforts to give the non-disclosing Party an opportunity, with reasonable advance notice, to review and comment on any proposed
disclosure. Notwithstanding the foregoing, Chimerix shall have the right to issue a press release on execution of this Agreement
in the form set forth in Schedule 4.4. Disclosure of Confidential Information either for which consent has previously been
obtained (including the contents of the press release set forth in Section 4.4) or which has previously been disclosed publicly
will not require additional, advance approval.

 

		4.5	Remedies

 

Each Party shall be entitled
to seek, in addition to any other right or remedy it may have, at law or in equity, a temporary injunction, without the posting
of any bond or other security, enjoining or restraining the other Party from any violation or threatened violation of this Article
4.

 

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Article
5

PAYMENTS; ROYALTIES
AND REPORTS

 

		5.1	Upfront Payment

 

In consideration for the rights
and licenses granted to Merck hereunder, upon the terms and conditions contained herein, Merck shall pay to Chimerix, within
thirty (30) days following the Effective Date, a non-refundable, non-creditable upfront payment in the amount of Seventeen Million
Five Hundred Thousand Dollars ($17,500,000).

 

		5.2	Milestone Payments

 

		5.2.1	Milestones. In consideration for the rights and licenses granted to Merck hereunder, upon
the terms and conditions contained herein, Merck shall pay to Chimerix the following non-refundable, non-creditable amounts, for
the first Compound (or Product, as applicable) for which Merck achieves the following milestone event during the Term:

 

	Event	 	 	Payment Amount
 for the First
 Indication (if any)	 	 	 	Payment Amount
 for the Second
 Indication (if any)	 
	Demonstration of Proof of Concept for Compound	 	$	 [...***...	]	 	$	[...***...	]
	Initiation of the first Phase II Clinical Trial for Product	 	$	 [...***...	]	 	$	[...***...	]
	Initiation of the first Phase III Clinical Trial for Product	 	$	[...***...	]	 	$	[...***...	]
	Filing of the first NDA with the FDA in the United States for Product	 	$	[...***...	]	 	$	[...***...	]
	Filing of first NDA with the EMA (through the centralized filing procedure) for Product	 	$	[...***...	]	 	$	[...***...	]
	Approval by the FDA of Marketing Authorization in the United States for a Product (the “US Approval Milestone”)	 	$	[...***...	]	 	$	[...***...	]
	Approval by the relevant Regulatory Authorities of Marketing Authorization in the first three (3) Major Markets in the EU for a Product (the “EU Approval Milestone”) (The EU Approval Milestone collectively with the US	 	$	[...***...	]	 	$	[...***...	]
		 	 	 	 	 	 	 	 

  

***Confidential Treatment Requested

 

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	Approval Milestone are referred to as the “Approval Milestones”)	 	 	 	 	 	 	 	 

 

 

For clarity, each of the foregoing
milestones in this Section 5.2.1 shall be payable only one (1) time upon the initial achievement of the applicable milestone event
(regardless of how many Products or Compounds achieve the relevant milestone) and no amounts shall be due hereunder for subsequent
or repeated achievement of such milestones. For further clarity, the foregoing milestones will be payable only with respect to
the first and second Indications (if any), as applicable, achieving such milestones (with the first Indication milestone payments
being set forth in the column entitled “Payment Amount for the First Indication” and the second Indication milestone
payments being set forth in the column entitled “Payment Amount for the Second Indication”, if any) and no additional
milestones shall be payable for any subsequent additional Indications. For any given event listed above, the first and second Indications
may be achieved by the same Product or Compound, or achieved by different Products or Compounds, but in all cases, the second Indication
shall mean a different and distinct disease. The maximum amount payable by Merck under this Section 5.2.1 is one hundred fifty
one million dollars ($151,000,000) assuming each of the seven (7) milestones were achieved for each of two Indications.

 

Notwithstanding the foregoing,
in the event that the approval of Marketing Authorizations (which would otherwise trigger an Approval Milestone) is subject to
the satisfaction of additional requirements before Merck becomes legally permitted to market and sell the Product in the applicable
market (including all applicable pricing and governmental reimbursement approvals), then the Approval Milestone shall not become
payable until such requirements are satisfied.

 

In the event that Merck is required
to pay the “Initiation of the first Phase II Clinical Trial for a Product” milestone for the first Indication, and
Merck has previously determined that the Compound has not met the success criteria to establish Proof of Concept and thus not previously
paid the “Demonstration of Proof of Concept for Compound” milestone for such first Indication, then Merck shall pay
to Chimerix the “Demonstration of Proof of Concept for Compound” milestone simultaneously with the payment of such
“Initiation of the first Phase II Clinical Trial for a Product” milestone for such first Indication. For clarity, in
all cases, the “Demonstration of Proof of Concept for Compound” milestone shall be payable only one time.

 

		5.2.2	Reporting and Payment. Merck shall notify Chimerix in writing within thirty (30) days following
the achievement of each milestone as set forth in Section 5.2.1, as applicable, and shall make the appropriate milestone payment
along with such notification to Chimerix.

 

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		5.3	Royalties

 

		5.3.1	Royalties Payable By Merck. Subject to the terms and conditions of this Agreement, Merck
shall pay Chimerix royalties, calculated on a Product-by-Product basis, as set forth in this Section 5.3.

 

		5.3.2	Patent Royalties. Subject to the provisions of Section 5.3.3, on a Product-by-Product basis,
Merck shall pay Chimerix royalties in an amount equal to the following percentage of aggregate Net Sales of a given Product sold
by Merck or its Related Parties in countries in the Territory for use in the Field, provided that the sale of such Product by Merck
or its Related Parties would infringe a Valid Patent Claim in the country of sale:

 

		(a)	[...***...]
of such Net Sales of a given Product in the Territory in a given Calendar Year up to and including Net Sales of [...***...];

 

		(b)	[...***...] of such Net Sales of a given Product in the Territory in a given Calendar Year for
the portion of such Net Sales exceeding [...***...] up to and including [...***...]; and

 

		(c)	[...***...] of such Net Sales of a given Product in the Territory in a given Calendar Year for
the portion of such Net Sales exceeding [...***...].

 

For clarity, all Net Sales of the
applicable Product for which a royalty is payable in a given country in a given Calendar Year under this Section 5.3.2 and under
5.3.3 shall be included in aggregate Net Sales for purposes of determining the foregoing royalty tiers for such Calendar Year;
provided that in all cases, (i) if no royalty is payable on a given unit of Product, then the Net Sales of such unit of Product
shall not be included for determining the foregoing royalty tiers and (ii) Net Sales of a given Product will not be combined with
Net Sales of any other Product for purposes of determining the foregoing royalty tiers.

 

		5.3.3	Know-How Royalty. Notwithstanding the provisions of Section 5.3.2 above, on a Product-by-Product
basis, in countries in the Territory where the sale of such Product by Merck or its Related Parties would not infringe a Valid
Patent Claim, Merck shall pay royalties on Net Sales of such Product sold by Merck or its Related Parties for use in the Field
in such countries at royalty rates that shall be set at [...***...] of the applicable royalty rate determined according to Section
5.3.2, mutatis mutandis.

 

		5.3.4	Royalty Calculation
and Royalty Period. Royalties on a given Product at the rates set forth above shall, on a Product-by-Product basis, commence
with the First

 

 

 

***Confidential
Treatment Requested

 

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			Commercial Sale
of the Product and shall continue on a country-by-country basis until the expiration of the later of: (i) the last-to-expire Valid
Patent Claim that would be infringed by the sale of such Product in such country; or (ii) the period of [...***...] following
the First Commercial Sale of such Product in such country (the “Royalty Period”). Notwithstanding anything
to the contrary contained herein, all royalties are subject to the following conditions:

 

		(i)	that only one royalty shall be due with respect to the same unit of Product;

 

		(ii)	that no royalties shall be due upon the sale or other transfer among Merck or its Related Parties,
but in such cases the royalty shall be due and calculated upon Merck’s or its Related Party’s Net Sales to the first
independent Third Party;

 

		(iii)	no royalties shall accrue on the sale or other disposition of Product by Merck or its Related Parties
for use in a Clinical Trial;

 

		(iv)	no royalties shall accrue on the disposition of Product by Merck or its Related Parties as samples
(promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies for a non commercial purpose);

 

		(v)	the determination of whether a royalty will be paid at the rate set forth under Section 5.3.2 or
5.3.3 shall be determined on a Product-by-Product and country-by-country basis, provided that for clarity, with respect to a given
Product, the Net Sales of such Product in countries falling within the royalty scheme set forth in Section 5.3.2 and the Net Sales
of such Product in countries falling within the royalty scheme set forth in Section 5.3.3 shall be aggregated for purposes of determining
the applicable royalty tiers under Section 5.3.2 or 5.3.3, as applicable. Notwithstanding the foregoing, in order to calculate
the actual amount of the royalty payments under Section 5.3.2 (Patent Royalty) or 5.3.3 (Know-How Royalty), as applicable, with
respect to a given Product, the Net Sales subject to royalties under Section 5.3.2 and the Net Sales subject to royalties under
Section 5.3.3 shall be allocated proportionately across each of the relevant royalties tiers.

 

		5.3.5	Royalties for Bulk Compound. In those cases in which Merck sells bulk Compound
rather than Product in packaged form to an independent Third Party, the royalty obligations of this Section 5.3 shall be applicable
to the bulk Compound only (but solely to the extent that a royalty would otherwise be payable on the Product incorporating such
Compound).

 

***Confidential
Treatment Requested

 

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		5.3.6	Compulsory Licenses. If a compulsory license is granted to a Third Party with respect to
Product in any country in the Territory with a royalty rate lower than the royalty rate provided by Section 5.3.2 or 5.3.3, as
applicable, then the royalty rate to be paid by Merck on Net Sales in that country under Section 5.3.2 or 5.3.3, as applicable,
shall be reduced to the rate paid by the compulsory licensee.

 

		5.3.7	Merck Third Party Licenses. In the event that Merck or any of its Related Parties determines
that it is commercially reasonable to obtain one or more licenses under any Patent Rights or know-how from Third Parties in order
to make, have made, use, offer to sell, sell, export or import Compound(s) or Product(s) (but excluding any such licenses that
are solely and specifically related to an Other Active in a given Combination Product as an individual separate component) (hereinafter
“Additional Third Party Licenses”), then [...***...]
of the consideration (including upfront payments, licenses fees, milestone payments and royalties) actually paid under such Additional
Third Party Licenses by Merck or its Related Parties in connection with the manufacture, use, sale, export or import, as applicable,
of such Compound or Product in a country for a given Calendar Quarter shall be creditable against the royalty payments due Chimerix
by Merck with respect to the sale of such Compound or Product in such country; provided, however, that in no event shall the royalties
owed by Merck to Chimerix for such Calendar Quarter in such country be reduced by more than [...***...] pursuant to this Section
5.3.7 (provided, however, that if Merck is not able to fully recover the amounts paid by Merck or its Related Parties under Additional
Third Party Licenses as a result of the foregoing restriction, then Merck shall be entitled to carry forward such right of off-set
to future Calendar Quarters with respect to such excess amount, subject to such [...***...] cap for any such future Calendar Quarters).

 

		5.3.8	Generic Products. In the event that one or more Generic Product(s) is/are sold in a given
country, and such Generic Product(s) attain, in the aggregate among all such Generic Products, on a Calendar Quarter basis a market
share (which market share shall be calculated as the quotient of [...***...] divided by [...***...] plus [...***...] as measured
by [...***...], then the royalty rate to be paid by Merck on Net Sales in that country for the applicable Product under Section
5.3.2 or 5.3.3, as applicable, shall thereafter during the Royalty Term be reduced by [...***...] in such country.

 

***Confidential
Treatment Requested

 

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		5.4	Reports; Payment of Royalty

 

During the Term following the
First Commercial Sale of a Product, Merck shall furnish to Chimerix a quarterly written report for each Calendar Quarter showing,
on a country-by-country and Product-by-Product basis, the calculation of Net Sales (including the calculation of royalties from
Combination Products, if any, as determined in accordance with the applicable formula set forth under the definition of Net Sales),
showing the aggregate deductions from gross sales (as such term is defined by Merck in its standard practices) under the definition
of Net Sales, of all Products subject to royalty payments sold by Merck and its Related Parties in the Territory for use in the
Field during the reporting period and the royalties payable under this Agreement. Reports shall be due on the sixtieth (60th) day
following the close of each Calendar Quarter. Royalties shown to have accrued by each royalty report shall be due and payable on
the date such royalty report is due. Merck shall keep complete and accurate records in sufficient detail to enable the royalties
payable hereunder to be determined.

 

		5.5	Audits

 

		(a)	Upon the written request of Chimerix and not more than once in each Calendar Year, Merck shall
permit an independent certified public accounting firm of nationally recognized standing selected by Chimerix and reasonably acceptable
to Merck, at Chimerix’s expense, to have access during normal business hours to such of the books and records of account
of Merck as may be reasonably necessary to verify the accuracy and completeness of the royalty reports and payments hereunder for
any Calendar Year ending not more than [...***...]
prior to the date of such request. The accounting firm shall disclose to Chimerix only whether the royalty reports are correct
or incorrect, and the amount of and description of any discrepancy. No other information shall be provided to Chimerix.

 

		(b)	If such accounting firm correctly identifies a discrepancy made during such period, the appropriate
Party shall pay the other Party the amount of the discrepancy within thirty (30) days of the date Chimerix delivers to Merck such
accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by
such accounting firm shall be paid by Chimerix; provided, however, that if such audit uncovers an underpayment of royalties by
Merck that exceeds the greater of [...***...] or [...***...] of the total royalties owed for the period in question, the fees of
such accounting firm shall be paid by Merck.

 

		(c)	Merck shall include in each sublicense granted by it pursuant to this Agreement a provision requiring
the sublicensee to make reports to Merck

 

***Confidential
Treatment Requested

 

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			and to keep and maintain records of sales made pursuant to such sublicense to the same
extent required of Merck under this Agreement.

 

		(d)	Upon the expiration of [...***...]
following the end of any Calendar Year, the calculation of royalties payable with respect to such Calendar Year shall be binding
and conclusive upon Chimerix, and Merck and its Related Parties shall be released from any liability or accountability with respect
to royalties for such Calendar Year.

 

		(e)	Chimerix shall treat all financial information subject to review under this Section 5.5 or under
any sublicense agreement in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting
firm to enter into an acceptable confidentiality agreement with Merck and/or its Related Parties obligating it to retain all such
information in confidence pursuant to such confidentiality agreement.

 

		5.6	Payment; Exchange Rate

 

All payments to be made by Merck
to Chimerix under this Agreement shall be made in United States dollars and may be paid by check made to the order of Chimerix
or bank wire transfer in immediately available funds to such bank account in the United States as may be designated in writing
by Chimerix from time to time. In the case of sales outside the United States, the rate of exchange to be used in computing the
monthly amount of currency equivalent in United States dollars due Chimerix shall be made at the monthly rate of exchange utilized
by Merck in its worldwide accounting system (or such other globally accepted standard as Merck may choose from time-to-time) prevailing
on the third to the last business day of the month preceding the month in which such sales are recorded by Merck.

 

		5.7	Income Tax Withholding

 

Chimerix shall be liable for
all income and/or other taxes (including interest) (“Taxes”) imposed upon any payments made by Merck to Chimerix
under this Article 5 or otherwise under this Agreement (“License Payments”). If applicable laws, rules or regulations
require withholding of Taxes, Merck shall make such withholding payments and shall subtract the amount thereof from the License
Payments. Merck shall submit appropriate proof of payment of the withheld Taxes to Chimerix and shall provide Chimerix with the
official receipts within a reasonable period of time. Upon request by Chimerix, Merck shall provide Chimerix reasonable information
in its possession in order to assist Chimerix in obtaining the benefit of any present or future treaty against double taxation
which may apply to the License Payments.

 

If Merck is required to make
a payment to Chimerix subject to a deduction or withholding of Tax, and if such deduction or withholding of Tax obligation arises
solely as a result of the assignment of this Agreement by Merck or as a result of any failure on

 

***Confidential
Treatment Requested

 

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the part of Merck to comply with
Applicable Laws relating to the withholding of Tax, in each case, after the Effective Date, that has the effect of increasing the
deduction or withholding of Tax on such payment above the amounts of deduction or withholding of Tax that would otherwise be deducted
or withheld prior to such assignment of this Agreement or prior to such failure by Merck to comply with such Applicable Laws, as
applicable (a “Merck Withholding Tax Action”), then the payment by Merck (in respect of which such deduction
or withholding of Tax is required to be made) shall be increased by the amount of such additional deduction or withholding Tax
(the “Additional Tax”), but solely to the extent that (i) such Additional Tax arises solely as a direct result
of such Merck Withholding Tax Action and (ii) such Additional Tax cannot be recovered by Chimerix. The Additional Tax, along with
any other Tax deducted and withheld from the payment made by Merck, shall be timely remitted to the proper Governmental Authority
for the account of Chimerix in accordance with Applicable Laws.

 

		5.8	Chimerix Third Party Licenses. Notwithstanding the provisions of Section 5.3.7, Chimerix
shall be solely responsible for satisfying all costs and payments of any kind (including all upfront fees, annual payments, milestone
payments and royalty payments) arising under the Chimerix Third Party License Agreements, which payments arise as a result of any
activities hereunder.

 

Article
6

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

 

		6.1	Mutual Representations and Warranties

 

Each Party represents and warrants
to the other Party the following as of the Effective Date of this Agreement:

 

		(a)	Corporate Power. Such Party is duly organized and validly existing under the laws of the
state of its organization and has full corporate power and authority to enter into this Agreement and to perform its obligations
hereunder.

 

		(b)	Due Authorization and Execution. The execution and delivery of this Agreement and the consummation
of the transactions contemplated hereby have been duly authorized by the necessary corporate actions of such Party. This Agreement
has been duly executed by such Party. This Agreement and any other documents contemplated hereby constitute valid and legally binding
obligations of such Party enforceable against it in accordance with their respective terms, except to the extent that enforcement
of the rights and remedies created thereby is subject to bankruptcy, insolvency, reorganization, moratorium and other similar laws
of general application affecting the rights and remedies of creditors.

 

    	-32-

    	 

    

 

		(c)	Non-Contravention. The execution, delivery and performance by such Party of this Agreement
and any other agreements and instruments contemplated hereunder will not (i) in any material respect violate any statute, regulation,
judgment, order, decree or other restriction of any governmental authority to which such Party is subject, (ii) violate any provision
of the corporate charter, by-laws or other organizational documents of such Party, or (iii) constitute a material violation or
breach by such Party of any provision of any material contract, agreement or instrument to which such Party is a party or to which
such Party may be subject although not a party (including, with respect to Chimerix, the Chimerix Third Party License Agreements).

 

		6.2	Representations and Warranties

 

Chimerix represents and warrants
to Merck that as of the Effective Date of this Agreement:

 

		(a)	Schedule 1.11 sets forth a true, correct and complete list of Chimerix Patent Rights existing
as of the Effective Date and such schedule contains all application numbers and filing dates, registration numbers and dates, jurisdictions
and owners. The Chimerix Patent Rights and the Chimerix Know-How constitute all intellectual property owned or otherwise controlled
(through license or otherwise) by Chimerix (or any of its Affiliates) that are necessary or useful to conduct the Research and/or
to develop, manufacture, sell or use the Compounds and/or Products;

 

		(b)	all issued patents within the Chimerix Patent Rights are in full force and effect, and, to the
best of Chimerix’s knowledge, the Chimerix Patent Rights exist and are not invalid or unenforceable, in whole or in part;

 

		(c)	it has the full right, power and authority (including the full right, power and authority under
the Chimerix Third Party License Agreements) to enter into this Agreement, to perform the activities hereunder and to grant the
licenses and sublicenses granted herein (including the licenses and sublicenses granted under Article 2 hereof);

 

		(d)	it (and its Affiliates) has not previously (i) assigned, transferred, conveyed or otherwise encumbered
its right, title and/or interest in Chimerix Patent Rights or Chimerix Know-How, or (ii) otherwise granted any rights to any Third
Parties that would conflict with the rights granted to Merck hereunder, and, to the best of Chimerix’s knowledge, there is
no unauthorized use, infringement or misappropriation of any Chimerix Patent Rights or Chimerix Know-How;

 

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		(e)	it is the sole and exclusive owner or, to the best of Chimerix’s knowledge, the sole and
exclusive licensee (pursuant to the Chimerix Third Party License Agreements, as applicable) of the Chimerix Patent Rights (and,
to the best of Chimerix’s knowledge, the Chimerix Know-How), all of which are free and clear of any liens, charges and encumbrances,
and, to the best of Chimerix’s knowledge, no other Person has any claim of ownership whatsoever with respect to the Chimerix
Patent Rights and/or the Chimerix Know-How;

 

		(f)	to the best of Chimerix’s knowledge, the exercise of the license granted to Merck under the
Chimerix Patent Rights and Chimerix Know-How pursuant to Section 2.1, as well as the Research, and the development, manufacture,
use, sale, export and import of Compounds and Products (provided that no such representation or warranty is made with respect to
an Other Active in a given Combination Product as an individual separate component or in combination with the Compound), as contemplated
as of the Effective Date, does not and will not infringe or misappropriate any intellectual property rights owned or possessed
by any Third Party;

 

		(g)	there are no claims, judgments or settlements against or owed by Chimerix (or any of its Affiliates)
with respect to the Chimerix Patent Rights, Chimerix Know-How and/or the Compounds, and, to the best of Chimerix’s knowledge,
no pending or threatened claims or litigation, relating to the Chimerix Patent Rights and/or Chimerix Know-How and/or the Compounds;

 

		(h)	the Chimerix Third Party License Agreements are the only agreements (including any licenses), written
or, to the best of the Company’s knowledge, oral, granting any licenses or other rights to Chimerix (or any of its Affiliates)
relating to the Compounds, Products, Chimerix Patent Rights and/or Chimerix Know-How;

 

		(i)	with respect to each Chimerix Third Party License Agreement, (i) it is in full force and effect;
(ii) neither Chimerix nor any of its Affiliates is in breach thereof; (iii) neither Chimerix nor any of its Affiliates has received
any notice of breach or notice of threatened breach thereof; (iv) neither Chimerix nor any of its Affiliates has received any notice
of any intent to reduce the scope of the field or the licenses thereunder or render any license thereunder non-exclusive, and,
to the best of its knowledge, no event, act or omission has occurred which could give rise to the right of the counterparty to
such Chimerix Third Party License Agreement to reduce the scope of the field or the licenses thereunder or render any of the licenses
thereunder non-exclusive; and (v) Chimerix has made available to Merck all material written correspondence under Chimerix’s
reasonable control relating to such Chimerix Third Party License Agreement;

 

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		(j)	Chimerix has disclosed to Merck all material information regarding the Chimerix Patent Rights and
Chimerix Know-How, including any licenses and material agreements related to the Chimerix Patent Rights and/or Chimerix Know-How;

 

		(k)	Chimerix has obtained all necessary consents, approvals and authorizations of all governmental
authorities and other Persons required to be obtained by it as of the Effective Date, as applicable, in connection with the execution,
delivery and performance of this Agreement;

 

		(l)	neither Chimerix nor any of its Affiliates has obtained, or filed for, any INDs (other than IND
#103,150), NDAs or Marketing Authorizations for any Compounds or Products, and, to the best of Chimerix’s knowledge, no other
Person has obtained, or filed for, any INDs, NDAs or Marketing Authorizations for any Compounds or Products;

 

		(m)	Chimerix has disclosed to Merck all material information and data, including all correspondences
to/from any Regulatory Authority, in each case related to any Compounds or Products (but excluding such information or data solely
and specifically related to an Other Active in a given Combination Product as an individual separate component), regardless of
whether such data and information would have a positive, negative or neutral impact on the potential commercial, scientific or
strategic value or attractiveness of the Compounds or Products, and including in all cases, all safety or efficacy information
and data related to the Compounds or Products (but excluding such information or data solely and specifically related to an Other
Active in a given Combination Product as an individual separate component);

 

		(n)	Chimerix (and its Affiliates) has not employed or otherwise used in any capacity, and will not
employ or otherwise use in any capacity, the services of any Person debarred under United States law, including to Section 21 USC
335a, or any foreign equivalent thereof with respect to the Compounds;

 

		(o)	all research and development (including non-clinical studies and Clinical Studies) related to the
Compounds and/or Products (but excluding any research and development solely and specifically related to an Other Active in a given
Combination Product as an individual separate component, if applicable) prior to the Effective Date, including the research and
development set forth on Schedule 6.2(o), has been conducted by or on behalf of Chimerix (and/or any of its Affiliates),
and, to the best of Chimerix’s knowledge, any other Person, in accordance and compliance with all Applicable Laws and all
GLPs, GCPs and GMPs;

 

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		(p)	except as set forth in Schedule 6.2(p), there are no ongoing research or development activities
(including any Clinical Trials) being conducted by or on behalf of Chimerix or any of its Affiliates with respect to the Compounds
or Products;

 

		(q)	the compounds set forth on Schedule 1.18 as well as the compound known as “CMX157”
are the only compounds owned by Chimerix (or any of its Affiliates) or to which Chimerix (or any of its Affiliates) has rights
(by license or otherwise) that are known to be Tenofovir Diphosphate Converting Compounds; and

 

		(r)	the Inventory to be provided to Merck hereunder was (and at all times up until delivery of such
Inventory hereunder shall remain) manufactured, packaged, labeled, tested, stored and handled in accordance with all Applicable
Laws, cGMPs, specifications (including release specifications as provided by Chimerix to Merck in writing prior to the Effective
Date) and all applicable regulatory approvals, except as otherwise set forth on Schedule 3.2. Such Inventory is not adulterated
or misbranded within the meaning of the Act and is not an article that could not, under the provisions of the Act, be introduced
into interstate commerce. All such Inventory is free and clear of all encumbrances (including through lien, charge, security interest,
mortgage, encumbrance or otherwise). The Inventory set forth on Schedule 3.2 constitutes all of the inventory of Compound
and Product held by or on behalf of Chimerix or any of its Affiliates (including any such inventory held at any contract manufacturer).

 

		6.3	Chimerix Further Representations, Warranties and Covenants

 

		6.3.1	Chimerix Third Party License Agreements. Chimerix represents and warrants to Merck that
it has provided to Merck in writing prior to the Effective Date a true, correct and complete copy of each of the Chimerix Third
Party License Agreements, and each such copy includes any and all amendments, restatements, side letters, and other modifications
thereto, as each such Chimerix Third Party License Agreement is in effect as of the Effective Date. Chimerix further covenants
and agrees that during the Term of this Agreement, (a) it will satisfy all of its obligations (including all payment obligations)
under, and take all steps necessary to maintain in full force and effect, each of the Chimerix Third Party License Agreements,
including taking all reasonable steps to ensure that all licenses granted thereunder remain in full force and effect (on an exclusive
basis) and that the scope of such licenses (including with respect to all licensed Patent Rights and other intellectual property
and all fields) are not reduced or limited in any way; (b) it will not assign (except an assignment to a party to which this Agreement
has been assigned as permitted under Section 10.2), amend, restate, amend and restate, terminate in whole or in part, or otherwise
modify any of the

 

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			Chimerix Third Party License
Agreements in any manner that would have an adverse effect on the Chimerix Patent Rights licensed to Merck hereunder or any other
rights of Merck hereunder without the prior written consent of Merck; (c) it will provide Merck with prompt notice of any claim
of a breach under any of the Chimerix Third Party License Agreements or notice of termination of any of the Chimerix Third Party
License Agreements, made by either Chimerix or the counterparty to such Chimerix Third Party License Agreement (or any party acting
on behalf of such counterparty); and (d) it will promptly send to Merck copies of all other material correspondence to or from
the counterparty to any such Chimerix Third Party License Agreement related to such Chimerix Third Party License Agreement and
related to the rights licensed Merck hereunder. For the purposes of clarity, Chimerix (and not Merck) shall be responsible for
all of the financial and other obligations of Chimerix (and/or any of its Affiliates) under any of the Chimerix Third Party License
Agreements, including any and all financial obligations thereunder with respect to Net Sales of Merck and its Related Parties.

 

		6.4	Disclaimer

 

EACH PARTY HEREBY DISCLAIMS ANY
AND ALL REPRESENTATIONS AND WARRANTIES IN CONNECTION WITH THE TRANSACTIONS CONTEMPLATED HEREIN NOT EXPRESSLY MADE IN THIS AGREEMENT
TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAWS, INCLUDING WITH RESPECT TO THE COMPOUNDS, PRODUCTS, OR ANY TECHNOLOGY OR
OTHER INTELLECTUAL PROPERTY LICENSED OR GRANTED UNDER THIS AGREEMENT, INCLUDING ANY WARRANTY OF NON-INFRINGEMENT, QUALITY, PERFORMANCE,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. FOR THE AVOIDANCE OF DOUBT, NOTHING CONTAINED IN THIS SECTION 6.4 SHALL
OPERATE TO LIMIT OR INVALIDATE ANY EXPRESS WARRANTY CONTAINED HEREIN OR ANY IMPLIED WARRANTY OF GOOD FAITH AND/OR FAIR DEALING.

 

Article
7

IP OWNERSHIP; PATENT PROVISIONS 

 

		7.1	Ownership of Collaboration Inventions; Know-How 

 

		7.1.1	Ownership. Inventorship of Collaboration Inventions shall be determined in accordance with
United States patent laws (regardless of where the applicable activities occurred). Notwithstanding the foregoing, all right, title
and interest in or to any and all Collaboration Inventions shall be determined in accordance with the following terms and conditions:

 

		(a)	Chimerix Collaboration Inventions shall be owned solely by Chimerix;

 

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		(b)	Merck Collaboration Inventions shall be owned solely by Merck; and

 

		(c)	Joint Collaboration Inventions shall be owned jointly by Chimerix and Merck.

 

		7.1.2	Chimerix Rights in Lipid-Antiviral-Conjugate Technology. Subject to the rights and licenses
granted to Merck hereunder with respect to the Lipid-Antiviral-Conjugate Technology solely as related to the Compound or Product,
nothing in the provisions of this Agreement shall be construed as limiting Chimerix’s right to practice, transfer, license,
assign (or otherwise exploit its rights with respect to) the Lipid-Antiviral-Conjugate Technology for the development and commercialization
of compounds or products other than Compounds or Products (e.g., CMX001).

 

		7.2	Filing, Prosecution and Maintenance of Patents for Collaboration Inventions

 

		7.2.1	Joint Collaboration Inventions. With respect to Joint Collaboration Inventions, Merck shall
have the first right to file patent applications for Joint Collaboration Inventions (in the name of both Merck and Chimerix)
and thereafter prosecute and maintain Patent Rights for such Joint Collaboration Inventions. In connection therewith, Chimerix
shall execute such documents and perform such ministerial acts as may be reasonably necessary for Merck to continue such prosecution
or maintenance of Patent Rights claiming such Joint Collaboration Invention. Any and all of the expenses and costs incurred by
Merck with respect to the filing of patent applications for, and the prosecution and maintenance of Patent Rights for, Joint Collaboration
Inventions, shall be shared equally by the Parties. With respect to Patent Rights for a given Joint Collaboration Invention, Merck
(i) may elect not to file, (ii) may elect not to file in a particular country (including electing not to validate in a particular
country) and/or (iii) may elect not to maintain in a particular country; and in any such case, Merck shall provide Chimerix with
at least thirty (30) days prior notice and Chimerix shall have the right, at its sole expense, to assume responsibility for such
Patent Rights for such Joint Collaboration Invention (in the name of both Merck and Chimerix), including thereafter prosecuting,
maintaining, and validating Patent Rights for such Joint Collaboration Invention to the extent Merck has elected not to do so (and
Merck shall have no further obligations in connection therewith).

 

		7.2.2	Chimerix Collaboration Inventions. With respect to Chimerix Collaboration Inventions, Chimerix
shall have the first right, at its sole expense, to file patent applications for Chimerix Collaboration Inventions and thereafter
prosecute and maintain Patent Rights for such Chimerix Collaboration Inventions. With respect to Patent Rights for a given Chimerix
Collaboration Invention, Chimerix (i) may elect not to file, (ii) may elect not to file in a particular country (including electing
not to validate in a particular country) and/or (iii) may elect not to maintain in a particular country; and in any such case,
Chimerix shall provide Merck with at

 

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			least thirty (30) days
prior notice and Merck shall have the right (in its discretion and at its sole expense) to assume responsibility for such Patent
Rights for such Chimerix Collaboration Invention, including thereafter prosecuting, maintaining, and validating Patent Rights
for such Chimerix Collaboration Invention to the extent Chimerix has elected not to do so. In such event, Chimerix shall execute
such documents and perform such ministerial acts, at Merck’s expense, as requested by Merck as may be reasonably necessary
to, in a timely manner, allow Merck to make such filings and/or continue such prosecution, maintenance and validation. In such
case, all of the expenses and costs incurred by Merck to fund such filing and/or continued prosecution and maintenance and validation
of such Patent Rights shall be fully creditable against royalties due under Section 5.3 of this Agreement.

 

		7.2.3	Right of Review and Consultation. In each of the foregoing cases with respect to Joint Collaboration
Inventions and/or Chimerix Collaboration Inventions, as applicable, the filing Party shall give the non-filing Party an opportunity
to review the text of the application before filing, shall consult with the non-filing Party with respect thereto, and shall supply
the non-filing Party with a copy of the application as filed, together with notice of its filing date and serial number. Chimerix
shall keep Merck advised of the status of the actual and prospective patent filings and, upon Merck’s request, shall provide
advance copies of any papers related to the filing, prosecution and maintenance of such patent filings. Chimerix shall promptly
give notice to Merck of the grant, lapse, revocation, surrender, invalidation or abandonment of any Chimerix Patent Rights or Joint
Patent Rights for which Chimerix is responsible for the filing, prosecution and maintenance.

 

		7.2.4	Merck Collaboration Inventions. Notwithstanding the foregoing provisions of this Section
7.2, Merck shall have the sole right, in its discretion, to file, prosecute and maintain Patent Rights claiming or covering Merck
Collaboration Inventions (the “Merck Patent Rights”), and Chimerix shall have no rights in connection therewith.

 

		7.3	Filing, Prosecution and Maintenance of Other Chimerix Patents; Option of Merck to Prosecute
and Maintain Other Chimerix Patents

 

		7.3.1	Chimerix Patent Rights Licensed from UC. The rights of the Parties set forth in Section
7.3.2 shall be subject the rights of UC under the UC License with respect to Chimerix Patent Rights Controlled by Chimerix through
the UC License (the “Chimerix/UC Patent Rights”). Subject to the terms of the UC License, Chimerix agrees to
keep Merck advised of the status of the actual and prospective patent filings within such Chimerix/UC Patent Rights and shall provide
copies of all relevant documentation relating to the prosecution thereof, upon Chimerix’s receipt of the same from UC.

 

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		7.3.2	Chimerix Patent Rights (other than Chimerix Patent Rights for Chimerix Collaboration Inventions).
With respect to Chimerix Patent Rights other than Chimerix Patent Rights for Chimerix Collaboration Inventions (which shall be
handled pursuant to Section 7.2.2), Chimerix agrees to, and shall, file, prosecute and maintain in the Territory, upon consultation
with Merck, all such other Chimerix Patent Rights. Chimerix shall keep Merck advised of the status of the actual and prospective
patent filings with respect to such other Chimerix Patent Rights and shall provide advance copies of any papers related to the
filing, prosecution and maintenance of such patent filings prior to the submission thereof. Merck shall have the right to review
and comment on such filings and papers prior to the submission thereof, and Chimerix shall give due consideration to Merck’s
comments. Chimerix shall promptly give notice to Merck of the grant, lapse, revocation, surrender, invalidation or abandonment
of any Chimerix Patent Rights for which Chimerix is responsible for the filing, prosecution and maintenance. In the event Chimerix
desires not to file, or to cease prosecution and/or maintenance of, any such other Chimerix Patent Rights, on a country-by-country
basis in the Territory (at Chimerix’s discretion), Chimerix will give at least thirty (30) days prior notice to Merck, and
Merck shall have the right (at Merck’s discretion), to file and/or take over the prosecution and maintenance thereof. If
Merck elects to file and/or to continue such prosecution or maintenance, as applicable, Chimerix shall execute such documents and
perform such ministerial acts at Merck’s expense as may be reasonably necessary to perform such filing, prosecution or maintenance.
In such case, all of the expenses and costs incurred by Merck to fund such filing and/or continued prosecution and maintenance
of such Chimerix Patent Rights shall be fully creditable against royalties due under Section 5.3 of this Agreement.

  

		7.4	Interference, Opposition, Invalidation, Reexamination and Reissue

 

		7.4.1	Interpretation. The Parties hereby acknowledge and agree that any Patent Rights with respect
to Joint Collaboration Inventions filed by Merck in accordance with the foregoing Section 7.2.1 shall be considered “Merck
Patent Rights” for purposes of this Section 7.4 and any Patent Rights with respect to Joint Collaboration Inventions filed
by Chimerix in accordance with the foregoing Section 7.2.1 shall be considered “Chimerix Patent Rights” for purposes
of the remaining provisions of this Section 7.4.

 

		7.4.2	First Right with Respect
to Chimerix Patent Rights. Chimerix shall, within ten (10) days of learning of such event, inform Merck of any request for,
or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination relating to Chimerix Patent
Rights. With respect to any request for, or filing or declaration of, any interference, opposition, invalidation, reissue or reexamination
relating to the Chimerix Patent Rights, Chimerix shall have the first right (in its discretion) to initiate, prosecute and/or
respond, to such action or proceeding; provided that Chimerix shall consult with Merck with respect to any such action

 

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			or proceeding and
shall consider Merck’s positions in good faith. In the event that Chimerix elects to initiate, prosecute and/or respond
to any interference, opposition, invalidation, reexamination, or reissue proceeding relating to any Chimerix Patent Rights, the
expenses thereof shall be borne solely by Chimerix. Subject to the rights of UC under the UC License with respect to the Chimerix/UC
Patent Rights, Chimerix shall not settle any interference, opposition, invalidation, reissue or reexamination action or proceeding
relating to any Chimerix Patent Rights (or otherwise initiate any interference, opposition, invalidation, reissue or reexamination
action or proceeding relating to any Chimerix Patent Rights) without the prior written consent of Merck, which consent shall not
be unreasonably withheld, and Merck shall have the right to review and approve any submission to be made in connection with such
proceeding, such approval not to be unreasonably withheld. 

 

		7.4.3	Right to Be Informed. Chimerix shall keep Merck informed of developments in any such action
or proceeding involving the Chimerix Patent Rights, including the status of any settlement negotiations and the terms of any offer
related thereto.

 

		7.4.4	Back-Up Rights of Merck. Chimerix shall promptly inform Merck in the event that Chimerix
elects not to initiate, prosecute and/or respond to any interference, opposition, invalidation, reissue or reexamination relating
to Chimerix Patent Rights, and in such case, subject to the rights of UC under the UC License with respect to the Chimerix/UC Patent
Rights, Merck shall have the right to do so (in Merck’s discretion), at its cost and expense. In such case, Merck and Chimerix
shall consult and cooperate fully to determine a course of action with respect to such action or proceeding. At the request of
Merck, Chimerix will provide Merck with reasonable assistance that Merck may reasonably request (including that Chimerix will join
such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate, prosecute
and/or respond to any interference, opposition, invalidation, reissue or reexamination relating to Chimerix Patent Rights in the
event that Merck is unable to do so in its own name). All of the expenses and costs incurred by Merck shall be fully creditable
against royalties due under Section 5.3 of this Agreement.

 

		7.4.5	Merck Patent Rights. Notwithstanding the foregoing provisions of this Section 7.4, Merck
shall have the sole right, in its discretion, to handle any interference, opposition, invalidation, reissue, or reexamination proceeding
relating to Merck Patent Rights, and Chimerix shall have no rights in connection therewith; provided, however, that at the request
and sole expense of Merck, Chimerix will provide Merck with reasonable assistance that Merck may reasonably request.

 

		7.5	Enforcement and Defense.

 

		7.5.1	Interpretation. The Parties hereby acknowledge and agree that any Patent Rights with respect
to Joint Collaboration Inventions filed by Merck in accordance with

 

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			the foregoing Section
7.2.1 shall be considered “Merck Patent Rights” for purposes of this Section 7.5 and any Patent Rights with respect
to Joint Collaboration Inventions filed by Chimerix in accordance with the foregoing Section 7.2.1 shall be considered “Chimerix
Patent Rights” for purposes of the remaining provisions of this Section 7.5.

 

		7.5.2	First Right to Enforce Relevant Chimerix Patent Claims. Chimerix shall give Merck, and Merck
shall give Chimerix, notice of any infringement of any Chimerix Patent Rights, but only where such infringement relates to claims
within the Chimerix Patent Rights which claim or cover the Compounds or Products or their use or manufacture (the “Relevant
Chimerix Patent Claims”), that may come to Chimerix’s or Merck’s attention. Subject to the rights of UC under
the UC License with respect to the Chimerix/UC Patent Rights, Merck shall have the first right (in its discretion) to initiate
and prosecute any legal action for infringement of Relevant Chimerix Patent Claims against one or more Third Parties based on the
manufacture, use, sale, offer for sale, import or export of one or more products which have as an active agent, a Tenofovir Diphosphate
Converting Compound (including any Compound) (a “Product Infringement Action”), and in the name of Merck and/or
Chimerix (as determined by Merck), or to control the defense of any declaratory judgment action relating to such Relevant Chimerix
Patent Claim involved therein. For any such action, in the event that Merck is unable to initiate or prosecute such action solely
in its own name, Chimerix will join such action voluntarily and will execute and cause its Affiliates to execute all documents
necessary for Merck to initiate litigation to prosecute and maintain such action. In connection with any such action, Chimerix
will provide reasonable assistance that Merck may reasonably request at Merck’s sole expense. In the event that Merck elects
to initiate and prosecute an action as provided in this Section 7.5.2, any and all costs incurred by Merck in connection therewith,
including the costs of any legal action commenced or the defense of any declaratory judgment, shall be borne solely by Merck; provided
that [...***...] of all Merck’s
reasonable out-of-pocket legal costs shall be fully creditable against royalties due based upon the Net Sales of Products in any
applicable country under Section 5.3 of this Agreement.

 

		7.5.3	Back Up Right to Enforce Relevant Chimerix Patent Claims. Merck shall promptly inform Chimerix
if it elects not to exercise such first right under Section 7.5.2 above, and Chimerix shall thereafter have the right to initiate
and prosecute such Product Infringement Action or control the defense of such declaratory judgment action. In such case, Merck
and Chimerix shall consult and cooperate fully to determine a course of action, including but not limited to the commencement of
legal action by Chimerix, to terminate any infringement of the Relevant Chimerix Patent Claims in such Product Infringement Action.
To the extent legally permissible, Merck shall have the right to join and participate in such action at its own expense. Each Party
shall have the right to be represented by counsel of its own choice. Any and all costs in connection therewith,

 

***Confidential
Treatment Requested

 

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			including without limitation
the costs of any legal action commenced or the defense of any declaratory judgment, shall be borne solely by Chimerix.

 

		7.5.4	Cooperation and Consultation. In connection with the foregoing, each Party shall keep the
other informed of developments in any action or proceeding, including the status of any settlement negotiations and the terms of
any offer related thereto. Neither Merck nor Chimerix shall settle any such action or proceeding set forth in the foregoing clauses
7.5.2 or 7.5.3 with respect to the Relevant Chimerix Patent Claims in a Product Infringement Action, as applicable, without the
prior written consent of the other Party, such consent not to be unreasonably withheld.

 

		7.5.5	Recovery. Any recovery obtained by either or both Merck and Chimerix in connection with
or as a result of any action contemplated by the foregoing provisions of this Section 7.5 with respect to Relevant Chimerix Patent
Claims in a Product Infringement Action, whether by settlement or otherwise, shall be shared in order as follows:

 

		(i)	on a pro rata and dollar for dollar basis, the recovery shall first be used to: (a) recoup all
of Merck’s costs and expenses incurred in connection with the action, and (b) recoup all of Chimerix’s costs and expenses,
including any payments to UC required by the UC License, incurred in connection with the action.

 

		(ii)	then, to the extent possible, in the case where Merck is prosecuting such action, reimbursement
dollar for dollar of any amounts of royalties withheld by Merck pursuant to Section 7.5.2; and

 

		(iii)	the amount of any recovery remaining shall then be shared equally between the Parties, subject
to any payments to UC required by the UC License.

 

		7.5.6	Enforcement of Chimerix Patent Rights Against an Agent that is not a Tenofovir Diphosphate Converting
Compound. Chimerix shall have the sole right to enforce Chimerix Patent Rights against a compound that is not a Tenofovir Diphosphate
Converting Compound (including any Compound), based on the manufacture, use, sale, offer for sale, import or export of such compound,
provided, however, that (i) Chimerix shall keep Merck informed of any such contemplated action, or developments in any action or
proceeding, including the status of any settlement negotiations and (ii) Chimerix shall not settle or compromise any such action
(or enter into any consent order for the settlement or compromise thereof) without the prior written consent of Merck, which consent
shall not be unreasonably withheld, conditioned or delayed, if such settlement or compromise: (i) involves an admission of invalidity
or limitation of the scope with respect to a Compound or enforceability of any Relevant Chimerix Patent Claim; and (ii) would impose
any financial obligations on Merck or its Affiliates,

 

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			or otherwise adversely
impact Merck's rights, with respect to the Compound and/or the Product.

 

		7.5.7	Patent Certification. Chimerix shall inform Merck of any certification regarding any Chimerix
Patent Rights it has received pursuant to either 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor
provisions, or any similar provisions in a country in the Territory, and Chimerix shall provide Merck with a copy of such certification
within five (5) days of receipt. Chimerix’s and Merck’s rights with respect to the initiation and prosecution of any
legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as defined in
Sections 7.5.1 through 7.5.6 hereof; provided, however, that Merck may exercise its first right to initiate and prosecute any action
(in accordance with Section 7.5.2) and shall inform Chimerix of such decision within ten (10) days of Chimerix’s receipt
of the certification, after which time Chimerix shall have the right to initiate and prosecute such action; and provided, further,
that if such certification pertains to any of the Chimerix/UC Patent Rights, then the foregoing five (5)-day and ten (10)-day notification
periods shall be reduced to two (2) days and five (5) days, respectively, in order to permit Chimerix to comply with its notification
obligations under the UC License. Regardless of which Party has the right to initiate and prosecute such action, both Parties shall,
as soon as practicable after receiving notice of such certification, convene and consult with each other regarding the appropriate
course of conduct for such action. The non-initiating Party shall have the right to be kept fully informed and participate in decisions
regarding the appropriate course of conduct for such action, and the right to join and participate in such action.

 

		7.5.8	Merck Patent Rights. Notwithstanding the foregoing provisions of this Section 7.5, Merck
shall have the sole right, in its discretion, to handle any action with respect to any infringement of Merck Patent Rights, and
Chimerix shall have no rights in connection therewith. For any action with respect to any infringement of Merck Patent Rights,
in the event that Merck is unable to initiate or prosecute such action solely in its own name, Chimerix will join such action voluntarily
and will execute and cause its Affiliates to execute all documents necessary for Merck to initiate litigation to prosecute and
maintain such action. In connection with any action, at the request and sole expense of Merck, Chimerix will provide Merck with
reasonable assistance that Merck may reasonably request. As between the Parties, any recovery obtained in connection with or as
a result of any action contemplated by this Section 7.5.8, whether by settlement or otherwise, shall be shall be retained solely
by Merck. Merck shall also have the sole right, in its discretion, to handle any certification matter regarding any Merck Patent
Rights pursuant to either 21 U.S.C. §§355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions, or any similar
provisions in a country in the Territory, and Chimerix shall have no rights in connection therewith.

 

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		7.6	Patent Term Extensions

 

Subject to the rights of UC with
respect to the Chimerix/UC Patent Rights, as between the Parties, Merck shall have the exclusive right, but not the obligation,
to seek, in Chimerix’s name if so required, patent term extensions or supplemental patent protection in any country in the
Territory in relation to all Chimerix Patent Rights. Merck and Chimerix shall reasonably cooperate in connection with such activities.
In the event that elections with respect to obtaining such patent term restoration are to be made, subject to the rights of UC
with respect to the Chimerix/UC Patent Rights, Merck shall have the right to make the election and Chimerix agrees to abide by
such election; provided that Merck shall consider any comments of Chimerix with respect thereto in good faith.

 

		7.7	Third Party Infringement Suits

 

Without limiting Merck’s
rights under Sections 5.3.7, 5.8 and 9.2, in the event that a Third Party sues, or otherwise brings a claim against, Merck (or
any of its Related Parties) alleging that the making, having made, using, selling, offering for sale, exporting or importing Compound(s)
or Product(s) infringes or will infringe any Patent Rights or other intellectual property rights of such Third Party, then Merck
may elect to defend such suit. Merck shall have the right to apply [...***...]
of the expenses incurred by Merck (or its Related Party) in connection with defending such suits against the royalties due Chimerix
hereunder; but only to the extent such suits are not solely related to the manufacture, use, sale or offer for sale or import of
any Other Actives and provided that in no event shall such royalties be reduced by more than [...***...] of the amount otherwise
owed in any given Calendar Quarter (provided, however, that if Merck is not able to fully recover the amounts as a result of the
foregoing restriction, then Merck shall be entitled to carry forward such right of off-set to future Calendar Quarters with respect
to such excess amount, subject to such [...***...] cap for any such future Calendar Quarters).

 

		7.8	UC License

 

To the extent the rights of Merck
under this Article 7 are subject to the terms of the UC License with respect to the Chimerix/UC Patent Rights, Chimerix agrees
to use its reasonable efforts to facilitate interactions between UC and Merck so as to allow for Merck to exercise its rights as
set forth in this Article 7, and Chimerix agrees to reasonably consult and cooperate with Merck and UC in connection therewith.

 

 

Article
8

TERM AND TERMINATION

 

		8.1	Term and Expiration

 

This Agreement shall be effective
as of the Effective Date and unless terminated earlier pursuant to Sections 8.2 or 8.3 below, this Agreement shall continue in
full force and

 

 

***Confidential Treatment
Requested

 

    	-45-

    	 

    

 

effect on a Product-by-Product and country-by-country basis until expiration of all Merck royalty obligations
hereunder with respect to such Product in such country. The period from the Effective Date until the date of expiration or earlier
termination of this Agreement in its entirety, or as the case may be, until the date of the expiration or earlier termination of
this Agreement in part with respect to a given Product on a country-by-country basis, shall be referred to herein as the “Term”.
Upon expiration of the Term, Merck’s licenses pursuant to Section 2.1 and Section 2.2 shall become a fully paid-up, perpetual,
irrevocable licenses.

 

		8.2	Termination by Merck

 

Merck shall have the right to
terminate this Agreement at any time in its sole discretion either in its entirety or on a Region-by-Region basis. Any termination
under this Section 8.2 shall be accomplished by Merck giving ninety (90) days’ advance written notice to Chimerix (provided,
however that Merck shall have the right to terminate this Agreement with respect to a given Product immediately upon written notice
to Chimerix in the event that Merck has a safety concern with respect to such Product, which safety concern either (i) has been
demonstrated or evidenced by the FDA or applicable Regulatory Authority or (ii) has otherwise been reasonably determined by Merck
and Merck has provided evidence of such safety concern to Chimerix (each, a “Safety Termination”)). The effects
of termination as set forth in Sections 8.4(b) and (c) shall apply upon Merck’s termination under this Section 8.2; provided,
however, that in the event that this Agreement is terminated only with respect to a given Region pursuant to this Section 8.2,
then such effects of termination shall only apply with respect to such terminated Region.

 

		8.3	Termination for Cause

 

		8.3.1	Cause for Termination. This Agreement may be terminated at any time during the Term of this
Agreement:

 

		(a)	upon written notice by either Party if the other Party is in breach of its material obligations
hereunder, and has not cured such breach within ninety (90) days after notice requesting cure of the breach (except for any breach
based upon failure to pay any amount when due hereunder, which shall have a cure period of thirty (30) days); provided, however,
that in the event of a good faith dispute with respect to the existence of a material breach, the ninety (90) (or thirty (30),
as applicable) day cure period shall be tolled until such time as the dispute is resolved pursuant to Section 10.6 hereof; provided
further, however, that notwithstanding the foregoing, it is agreed that termination pursuant to this Section 8.3.1(a) shall be
on a Product-by-Product and Region-by-Region basis to which the material breach relates, as applicable, and that the non-breaching
Party cannot terminate this Agreement under this Section 8.3.1(a) with respect to non-affected Products and/or non-affected Regions,
as applicable (and the effects of termination as set forth in Section 8.4 shall only apply with

 

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			respect to such terminated Product
and/or Region, as applicable). Notwithstanding the foregoing, any failure to use Commercially Reasonable Efforts to develop a Product
for Indications other than the HIV Indication as required under Section 3.3.1 shall not be deemed to be a breach of Merck’s
material obligations under this Agreement which is subject to termination of this Agreement (in whole or in part) under this Section
8.3.1(a), and any breach of such obligation shall be subject only to those financial remedies available at law (if any); or

 

		(b)	by either Party upon the filing or institution of bankruptcy, reorganization, liquidation or receivership
proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided,
however, that in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if the Party
consents to the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the filing thereof.

 

		8.4	Effect of Early Termination 

 

		(a)	If Merck terminates this Agreement under Section 8.3.1(a), then (i) Merck’s licenses pursuant
to Sections 2.1 and 2.2 shall survive and shall become perpetual, irrevocable licenses; provided, however, that Merck shall continue
to be obligated to pay the milestone and royalty amounts under Sections 5.2 and 5.3 for the terminated Product and/or Region, as
applicable, that would otherwise have been payable under the terms of this Agreement during its Term; provided further, however,
that such amounts shall be reduced to [...***...]
of the amount that would otherwise have been payable under the terms of this Agreement during its Term and (ii) except with respect
to the reduced royalties and milestones as provided in the foregoing clause (i), no further payments of any kind shall be owed
to Chimerix on account of the Products or Regions for which this Agreement was terminated, other than any share of any potential
recovery in the case of infringement litigation as and to the extent provided under Article 7, or any amounts owed Chimerix pursuant
to the indemnification provisions of Article 9. In addition, Chimerix shall, within thirty (30) days after the effective date of
such termination, return or cause to be returned to Merck all Confidential Information relating to the terminated Product and/or
Region, as applicable, delivered or provided by Merck and all copies thereof. For clarity, the effects of termination under this
Section 8.4(a) shall only apply with respect to the terminated Product and/or Region, as applicable, to which Chimerix’s
uncured material breach relates.

 

		(b)	If Chimerix terminates this Agreement under Section 8.3.1(a) or Merck terminates this Agreement
under Section 8.2, except as provided for

 

 

 

***Confidential Treatment
Requested

 

    	-47-

    	 

    

 

			below, each Party shall, within thirty (30) days after the effective date of such termination,
return or cause to be returned to the other Party all Confidential Information relating to the terminated Product and/or Region,
as applicable, of the other Party provided by such other Party and all copies thereof (provided, however, that receiving Party
may keep one copy of Confidential Information received from the other Party in its confidential files for record purposes).

 

In addition, if Chimerix terminates
this Agreement under Section 8.3.1(a) or Merck terminates this Agreement under Section 8.2, Merck’s licenses pursuant to
Sections 2.1 and 2.2 as they relate to the terminated Product and/or Region, as applicable, shall terminate as of such termination
date, and Merck shall (except in the case of a Safety Termination, in which case the following provisions of Section 8.4(b)(i)
through (v) shall not apply), promptly after such termination:

 

(i)          transfer and assign to
Chimerix (or to an Affiliate designated by Chimerix) ownership of all Marketing Authorizations (in each case, to the extent transferable)
obtained hereunder, in each case, that relate solely and exclusively to the terminated Product in the terminated Region,
as applicable (but excluding any Marketing Authorizations that relate to Combination Products (including fixed-dose combination
products)) owned by, and in the possession of, Merck or its Affiliates, and, if such Marketing Authorizations have not been obtained
by Merck or its Affiliates as of the date of termination, Merck shall inform Chimerix of the status of any such regulatory filings
in progress and provide to Chimerix any such regulatory filings in progress prepared by Merck or its Affiliates, provided that
such applications are provided on an “as is” basis;

 

(ii)          deliver to Chimerix
copies of the material clinical data and material adverse event reports (including all such material adverse event reports contained
in Merck’s or its Affiliates’ regulatory and/or safety databases) generated hereunder and owned by Merck or its Affiliates,
which is in Merck’s or its Affiliates’ possession (and in the same form in which Merck or its Affiliates maintains
such data or reports, as applicable), in each case, relating solely and exclusively to the terminated Product in the terminated
Region, as applicable (but excluding any of the foregoing that relate to Combination Products (including fixed-dose combination
products)); but in all cases, solely to the extent that such material data and reports are necessary for Chimerix to develop and
commercialize the specific form of the terminated Product that is in clinical development or is being commercialized by Merck or
its Affiliates as of the effective date of such termination;

 

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(iii)          deliver to Chimerix,
in the same form in which Merck maintains such items, copies of the material regulatory correspondence generated hereunder and
owned by Merck or its Affiliates, which is in Merck’s or its Affiliates’ possession relating solely and exclusively
to the pre-clinical and clinical development of the terminated Product in the terminated Region, as applicable (but excluding
any correspondence that relates to Combination Products (including fixed-dose combination products); but in all cases, solely to
the extent that such material regulatory correspondence is necessary for Chimerix to develop and commercialize for the specific
form of the terminated Product that is in clinical development or is being commercialized by Merck or its Affiliates as of the
effective date of such termination;

 

The following clauses (iv) and
(v) shall only apply with respect to terminations which are effective after the Initiation of a Phase II Clinical Trial by Merck
with respect to the applicable Product hereunder for which this Agreement is being terminated:

 

(iv) subject to Section 8.4(c),
deliver to Chimerix all remaining Inventory (if any, and to the extent applicable), and inventory of cGMP and non-cGMP bulk terminated
Product, in each case, generated hereunder and relating solely and exclusively to the terminated Product in the terminated
Region, as applicable, in each case owned by Merck (or its Affiliate) and which is in Merck’s (or its Affiliates) possession
or control, but excluding, in all cases, any of the foregoing that relate to Combination Products (including fixed-dose combination
products)). In connection therewith, Chimerix shall pay to Merck, within thirty (30) days after invoice therefor, an amount equal
to Merck’s (or its Affiliate’s, as applicable) fully burdened costs of goods sold for such inventory (including Inventory)
plus a mark-up of [...***...]; and

 

(v) upon written request
of Chimerix (which written request must be made by Chimerix to Merck within thirty (30) days after such termination), grant (and
hereby grants) to Chimerix a non-exclusive license in the terminated Region, as applicable, with the right to sublicense (through
multiple tiers of sublicenses), under all of Merck’s (and its Affiliates’) right, title and interest in and to those
Merck Collaboration Inventions which are Controlled by Merck or its Affiliates as of the effective date of such termination and
which are actually incorporated into the terminated Product as of the date of such termination, solely for Chimerix to develop,
manufacture, use and sell the terminated Product in the Field in the terminated Regions, as applicable; provided, however, that
the foregoing license is only for the specific form of the terminated Product that is in clinical development or is being commercialized
by Merck or its Affiliates as of the effective date of such termination.

 

***Confidential Treatment Requested

 

    	-49-

    	 

    

 

Notwithstanding the foregoing,
the foregoing license grant shall exclude any Merck Collaboration Inventions and/or any other intellectual property related to
any Combination Product (including fixed-dose combination products). In partial consideration of the foregoing license grant, Chimerix
shall be required to pay to Merck royalties on Products in accordance with Section 5.3, mutatis mutandis, at the following
rates:

 

(i) where such termination occurred
following Initiation of the first Phase II Clinical Trial, but prior to Initiation of the first Phase III Clinical Trial, a royalty
on Chimerix’s (and any of its Affiliate’s and sublicensee’s) Net Sales, at the rate equal to [...***...]
of the amount that would otherwise have been payable under Section 5.3 by Merck (i.e., [...***...] of Net Sales);

 

(ii) where such termination occurred
following Initiation of the first Phase III Clinical Trial, but prior to receipt of approval of the first NDA for the applicable
Product anywhere in the Territory by the applicable Regulatory Authority, a royalty on Chimerix’s (and any of its Affiliate’s
and sublicensee’s) Net Sales at the rate equal to [...***...] of the amount that would otherwise have been payable under
Section 5.3 by Merck (i.e., [...***...] of Net Sales); and

 

(iii) where such termination occurred
following receipt of approval of the first NDA for the applicable Product anywhere in the Territory by the applicable Regulatory
Authority, a royalty on Chimerix’s (and any of its Affiliate’s and sublicensee’s) Net Sales at the rate equal
to [...***...] of the amount that would otherwise have been payable under Section 5.3 by Merck (i.e., [...***...] of Net
Sales).

 

For purposes of clarity, in
determining the royalty payments due by Chimerix, such royalty payments shall be calculated in accordance with Section 5.3, mutatis
mutandis, provided that, (i) references to Net Sales shall refer to Net Sales of the applicable terminated Product by Chimerix
and its Affiliates and their respective sublicensees in the Field and in the terminated countries (or Regions, as applicable),
(ii) references to First Commercial Sale shall refer to the First Commercial Sale of the applicable Product in the applicable
terminated country by Chimerix (or its Affiliate or sublicensee), (iii) references to Related Parties shall refer to Chimerix,
its Affiliates and their respective sublicensees, and (iv) references to Valid Patent Claim shall refer to Valid Patent Claims
under (x) the Chimerix Patent Rights or (y) any Patent Rights licensed to Chimerix hereunder (if any), in each case, as applicable.
In connection with the calculation and

 

 

***Confidential Treatment Requested

 

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payment of the foregoing royalties,
Chimerix shall comply with, and shall be entitled to the rights under, the provisions of Sections 5.3 (including reductions allowed
under Sections 5.3.6, 5.3.7 and 5.3.8), 5.4, 5.5, 5.6 and 5.7, mutatis mutandis, and for clarity, Merck shall have the
rights of the party receiving such payments as set forth in such Sections (including the right to audit as set forth in Section
5.5), mutatis mutandis. In addition to payment of the foregoing royalties, in the event that Merck (or any of its Affiliates)
is required to pay a Third Party(ies) any license fees or other payments as a result of the licenses granted to Chimerix under
this Section 8.4(b)(v), then Chimerix shall reimburse Merck for such amounts within thirty (30) days after issuance by Merck of
an invoice therefor. In connection with any such payments, Chimerix shall provide to Merck such reasonably necessary information
(including Net Sales information) related to the applicable terminated Products as Merck may reasonably request in order to determine
the amounts of such payments owed to such Third Party and to report the relevant information to such Third Party.

 

Notwithstanding the foregoing
provisions of Sections 8.4(b)(i) through (v), any good faith, inadvertent failure by Merck to provide data, information, correspondence
or other item to Chimerix shall not be a breach of Merck’s obligations under this Section 8.4(b). For clarity, the foregoing
items (i) through (v) shall only apply as they relate to the terminated Product and/or Region, as applicable. All of the foregoing
items provided by Merck (or its Related Parties, as applicable) pursuant to this Section 8.4(b) shall be provided on a one-time
basis and on an “as-is” basis, and shall only be provided as they exist as of the effective date of termination. Chimerix
shall provide reasonable assistance to Merck in connection with the transfer and delivery of the foregoing items.

 

		(c)	Notwithstanding the foregoing, upon termination of this Agreement by Merck pursuant to Section
8.2, or by Chimerix pursuant to Section 8.3.1(a), the licenses set forth in Sections 2.1 and 2.2 shall become non-exclusive and
survive for a period of twelve (12) months solely in order for Merck and its Affiliates, Related Parties, sublicensees and distributors,
at their discretion, during such twelve (12) month period immediately following the effective date of termination, to finish any
Product related manufacturing work-in-progress and to sell such Products and any other Products or Compound remaining in inventory,
in accordance with the terms of this Agreement (including amounts payable by Merck to Chimerix pursuant to Section 5.3), in each
case, utilizing such licenses. For clarity, the foregoing shall only apply as they relate to the terminated Product and/or Region,
as applicable.

 

		(d)	If this Agreement is terminated
by Merck pursuant to Section 8.3.1(b), then the provisions of Section 8.4(a) shall apply, and in addition, if such

 

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			termination is due to the rejection of this Agreement by or on behalf of Chimerix
under Section 365 of the United States Bankruptcy Code (the “Code”), all licenses and rights to licenses granted
under or pursuant to this Agreement by Chimerix to Merck are, and shall otherwise be deemed to be, for purposes of Section 365(n)
of the Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. The Parties
agree that Merck, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and
elections under the Code, and that upon commencement of a bankruptcy proceeding by or against Chimerix under the Code, Merck shall
be entitled to a complete duplicate of, or complete access to (as Merck deems appropriate), any such intellectual property and
all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly delivered
to Merck (i) upon any such commencement of a bankruptcy proceeding upon written request therefor by Merck, unless Chimerix elects
to continue to perform all of its obligations under this Agreement or (ii) if not delivered under (i) above, upon the rejection
of this Agreement by or on behalf of Chimerix upon written request therefore by Merck.

 

The foregoing provisions of Section
8.4(d) are without prejudice to any rights Merck may have arising under the Code or other Applicable Law.

 

		8.5	Effect of Expiration or Termination; Survival

 

		(a)	Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing
prior to such expiration or termination. Each Party shall pay all amounts then due and owing as of the expiration or termination
date. Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other
accrued or accruing under this Agreement prior to expiration or termination. In case of partial termination of this Agreement where
termination is only with respect to one or more of the countries, Regions and/or Products in the Territory, then the consequences
of termination described under this Article 8 shall only apply to the countries, Regions and/or Products terminated.

 

		(b)	The provisions of Article 4 shall survive the expiration or termination of this Agreement and shall
continue in effect for ten (10) years; provided, however, that if Merck terminates this entire Agreement under Section 8.2,
or Chimerix terminates this entire Agreement under Section 8.3.1(a) or Section 8.3.1(b), Sections 4.2 and 4.3 shall
terminate. In addition, the provisions of Articles 1 (as necessary for the interpretation of other surviving provisions) and 10,
and Sections 5.4, 5.5, 5.6, 5.7, 5.8,

 

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			 6.4, 7.1, 8.1, 8.4, 9.1 through 9.4, and this Section 8.5, shall survive any expiration or
termination of this Agreement.

 

Article
9

INDEMNIFICATION; LIMITATION ON LIABILITY

 

		9.1	Indemnification by Merck

 

Merck hereby agrees to indemnify,
hold harmless and defend Chimerix, its Affiliates and their respective officers, directors, agents, employees, successors and assigns
(collectively, the “Chimerix Indemnified Parties”) against any and all losses, costs, expenses, fees or damages
arising out of or relating to claims, allegations, suits, actions or proceedings asserted by any Third Party, whether governmental
or private, arising out of or relating to (i) the breach of any of Merck’s covenants, representations or warranties under
this Agreement, (ii) the research, development, manufacture, use, sale or other disposition of any Compound or Product by Merck,
or (iii) the negligence or willful misconduct by Merck, its Affiliates or their respective officers, directors, agents or employees,
in performing any obligations under this Agreement; provided, however, that Merck shall not be required to indemnify, hold harmless
or defend any Chimerix Indemnified Party against any claim to the extent that Chimerix has an obligation to indemnify the Merck
Indemnified Parties under Sections 9.2(i) or (iii).

 

		9.2	Indemnification by Chimerix

 

Chimerix agrees to indemnify,
hold harmless and defend Merck, its Affiliates and their respective officers, directors, agents, employees, successors and assigns
(collectively, the “Merck Indemnified Parties”) against any and all losses, costs, expenses, fees or damages
arising out of or relating to claims, allegations, suits, actions or proceedings asserted by any Third Party, whether governmental
or private, arising out of or relating to (i) the breach of any of Chimerix’s covenants, representations or warranties under
this Agreement, (ii) the research, development, manufacture, use, sale or other disposition of any Compound or Product by Chimerix,
or (iii) the negligence or willful misconduct by Chimerix, its Affiliates or their respective officers, directors, agents or employees,
in performing any obligations under this Agreement; provided, however, that Chimerix shall not be required to indemnify, hold harmless
or defend any Merck Indemnified Party against any claim to the extent that Merck has an obligation to indemnify the Chimerix Indemnified
Parties under Sections 9.1(i) or (iii).

 

		9.3	Procedure

 

If either Party is seeking indemnification
under Section 9.1 or 9.2 (the “Indemnified Party”), it shall inform the other Party (the “Indemnifying
Party”) of the claim giving rise to the obligation to indemnify pursuant to such Section as soon as reasonably practicable
after receiving notice of the claim (provided, however, any delay or failure to provide such notice shall not constitute a waiver
or release of, or otherwise limit, the

 

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Indemnified Party’s rights
to indemnification under, as applicable, Section 9.1 or 9.2, except to the extent that such delay or failure materially prejudices
the Indemnifying Party’s ability to defend against the relevant claims). The Indemnifying Party shall have the right to
assume the defense of any such claim for which it is obligated to indemnify the Indemnified Party. The Indemnified Party shall
cooperate with the Indemnifying Party and the Indemnifying Party’s insurer as the Indemnifying Party may reasonably request,
and at the Indemnifying Party’s cost and expense. The Indemnified Party shall have the right to participate, at its own
expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnifying Party. The
Indemnifying Party shall not settle any claim without the prior written consent of the Indemnified Party, not to be unreasonably
withheld or delayed. The Indemnified Party shall not settle or compromise any such claim without the prior written consent of
the Indemnifying Party, which it may provide in its sole discretion. If the Parties cannot agree as to the application of Section
9.1 or 9.2 to any claim, pending resolution of the dispute pursuant to Section 10.6, the Parties may conduct separate defenses
of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 9.1
or 9.2 upon resolution of the underlying claim.

 

		9.4	Limitation of Liability

 

NEITHER PARTY SHALL BE LIABLE
TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES (INCLUDING LOST PROFITS) ARISING FROM OR
RELATING TO THIS AGREEMENT (INCLUDING BREACH OF THIS AGREEMENT) OR THE EXERCISE OF ITS RIGHTS HEREUNDER, REGARDLESS OF ANY NOTICE
OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.4 IS INTENDED TO AND SHALL NOT LIMIT
OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 9.1 OR 9.2.

 

		9.5	Insurance

 

Each Party shall procure and
maintain insurance, including product liability insurance (or self-insure), adequate to cover its obligations hereunder and which
is consistent with normal business practices of prudent companies similarly situated. It is understood that such insurance shall
not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this
Article 9 or otherwise. Each Party shall provide the other Party with written evidence of such insurance upon request. Each Party
shall provide the other Party with written notice at least thirty (30) days prior to the cancellation, non renewal or material
change in such insurance or self insurance which materially adversely affects the rights of the other Party hereunder.

 

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Article
10

MISCELLANEOUS

 

		10.1	Force Majeure

 

Neither Party shall be held liable
to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation
under this Agreement to the extent that such failure or delay is caused by or results from causes beyond the reasonable control
of the affected Party, potentially including, embargoes, war, acts of war (whether war be declared or not), acts of terrorism,
insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts,
omissions or delays in acting by any governmental authority or the other Party. The affected Party shall notify the other Party
of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary
to cure such force majeure circumstances.

 

		10.2	Assignment/Change of Control

 

Except as provided in this Section
10.2, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred,
by either Party without the consent of the other Party. Notwithstanding the foregoing, Merck may, without Chimerix’s consent,
assign this Agreement and its rights and obligations hereunder in whole or in part to (i) a Merck Affiliate (provided that Merck
shall remain fully liable under this Agreement) or (ii) in connection with a Change of Control of Merck. Chimerix may, without
Merck’s consent, assign this Agreement and its rights and obligations to (a) a Chimerix Affiliate (provided that Chimerix
shall remain fully liable under this Agreement) or (b) in connection with a Change of Control of Chimerix; provided, however,
that Chimerix must notify Merck upon completion of any such Change of Control, and Merck shall have the right (but not the obligation),
at any time during the six (6) months after receipt of such notice, to elect any one or more of the following options: (X) require
Chimerix, including its acquiring party, to adopt reasonable procedures to be agreed upon in writing with Merck to prevent the
disclosure of all Confidential Information of Merck and its Affiliates and other information with respect to the development and
commercialization of Compounds or Products (the “Sensitive Information”) beyond Chimerix personnel having access
to and knowledge of Sensitive Information prior to the Chimerix Change of Control, and to control the dissemination of Sensitive
Information disclosed after the Chimerix Change of Control, which procedures shall include reasonable restrictions on the scope
of any Sensitive Information to be provided by Merck; (Y) terminate Chimerix’s involvement on the Committee; and/or (Z) limit
Merck’s obligation to provide any reports hereunder to providing just royalty reports pursuant to Article 5 with respect
to Merck’s total worldwide royalty obligations. Any permitted assignee shall assume all obligations of its assignor under
this Agreement. Any attempted assignment not in accordance with this Section 10.2 shall be void.

 

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		10.3	Severability

 

If any one or more of the provisions
contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability
of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated
provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts
to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as
practical, implement the purposes of this Agreement.

 

		10.4	Notices

 

All notices which are required
or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by
personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent
by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

 

	If to Chimerix, to:	 	Chimerix, Inc.
	 	 	2505 Meridian Parkway
	 	 	Suite 340
	 	 	Durham, NC 27713
	 	 	Attn: Corporate Counsel
	 	 	Facsimile No.: (919) 806-1146
	 	 	 
	and:	 	Cooley LLP
	 	 	4401 Eastgate Mall
	 	 	San Diego, California 92121-1909
	 	 	Attn: Jason Kent
	 	 	Facsimile No.: (858) 550-6420
	 	 	 
	If to Merck, to:	 	Merck Sharp & Dohme Corp.
	 	 	One Merck Drive
	 	 	P.O. Box 100, WS 3A-65
	 	 	Whitehouse Station, NJ 08889-0100
	 	 	Attn:  Office of Secretary
	 	 	Facsimile No.: (908) 735-1246
	 	 	 
	and:	 	Merck Sharp & Dohme Corp.
	 	 	One Merck Drive
	 	 	P.O. Box 100, WS 2A-50
	 	 	Whitehouse Station, NJ 08889-0100
	 	 	Attn:  Chief Licensing Officer
	 	 	Facsimile No.: (908) 735-1201

 

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or to such other address(es)
as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice
shall be deemed to have been given: (a) when delivered, if personally delivered or sent by facsimile on a business day (or if delivered
or sent on a non-business day, then on the next business day); (b) on the business day after dispatch, if sent by nationally-recognized
overnight courier; or (c) on the fifth (5th) business day following the date of mailing, if sent by mail.

 

		10.5	Applicable Law

 

This Agreement shall be governed
by and construed in accordance with the laws of the State of New York and the patent laws of the United States, without reference
to any rules of conflict of laws or renvoi.

 

		10.6	Dispute Resolution

 

		10.6.1	The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy
or claim arising from or related to this Agreement or the breach thereof. If the Parties do not fully settle, and a Party wishes
to pursue the matter, each such dispute, controversy or claim that is not an “Excluded Claim” shall be finally resolved
by binding arbitration in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes
of the American Arbitration Association (“AAA”), and judgment on the arbitration award may be entered in any
court having jurisdiction thereof.

 

		10.6.2	The arbitration shall be conducted by a panel of three persons experienced in the pharmaceutical
business: within thirty (30) days after initiation of arbitration, each Party shall select one person to act as arbitrator; and
the two Party-selected arbitrators shall select a third arbitrator within thirty (30) days of their appointment. If the arbitrators
selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the AAA.
The Parties shall not be obligated to select arbitrators from the AAA panel of arbitrators. The place of arbitration shall be New
York, New York, and all proceedings and communications shall be in English.

 

		10.6.3	Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award
is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek
from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party
pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured
by a Party’s compensatory damages. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal
share of the arbitrators’ fees and any administrative fees of arbitration.

 

    	-57-

    	 

    

 

		10.6.4	Except to the extent necessary to confirm an award or as may be required by Applicable Law, neither
a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of
both Parties. In no event shall arbitration be initiated after the date when commencement of a legal or equitable proceeding based
on the dispute, controversy or claim would be barred by the applicable New York statute of limitations.

 

		10.6.5	The Parties agree that, in the event of a good faith dispute over the nature or quality of performance
under this Agreement, neither Party may terminate this Agreement until final resolution of the dispute through arbitration or other
judicial determination. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute
shall be refunded if an arbitrator or court determines that such payments are not due.

 

		10.6.6	As used in this Section, the term “Excluded Claim” shall mean a dispute, controversy
or claim that concerns (a) the validity or infringement of a patent, trademark or copyright; or (b) any antitrust, anti-monopoly
or competition law or regulation, whether or not statutory.

 

		10.7	Entire Agreement; Amendments

 

This Agreement together with
the Schedules hereto contains the entire understanding of the Parties with respect to the subject matter hereof, including the
licenses granted hereunder. Any other express or implied agreements and understandings, negotiations, writings and commitments,
either oral or written, with regard to the subject matter hereof, including the licenses granted hereunder, are superseded by the
terms of this Agreement. The Schedules to this Agreement are incorporated herein by reference and shall be deemed a part of this
Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized
representatives of both Parties hereto.

 

		10.8	Headings and Interpretation

 

The captions to the several Articles
and Sections and subsections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and
reading the several Articles and Sections hereof. Any reference in this Agreement to an Article, Section, subsection, paragraph,
clause, or Schedule or Exhibit shall be deemed to be a reference to an Article, Section, subsection, paragraph, clause, or Schedule
or Exhibit, of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement otherwise
requires, (a) words of any gender include each other gender, (b) words such as “herein”, “hereof”, and
“hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear,
(c) words using the singular shall include the plural, and vice versa, (d) whenever any provision of this Agreement uses the term
“including” (or “includes” or words of similar import), such

 

    	-58-

    	 

    

 

        term shall not be limiting and such term
shall be deemed to mean “including without limitation” (or “includes without limitation”), (e) the word
“or” shall not be construed as exclusive, and (f) references to any Articles or Sections include Sections and subsections
that are part of the reference Article or section (e.g., a section numbered “Section 2.2.1” would be part of “Section
2.2.”, and references to “Article 2” or “Section 2.2.” would refer to material contained in the
subsection described as “Section 2.2.2”). 

 

		10.9	Business Day Requirements

 

In the event that any notice
or other action or omission is required to be taken by a Party under this Agreement on a day that is not a business day then such
notice or other action or omission shall be deemed to be required to be taken on the next occurring business day.

 

		10.10	Independent Contractors

 

It is expressly agreed that Chimerix
and Merck shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint
venture or agency. Neither Chimerix nor Merck shall have the authority to make any statements, representations or commitments of
any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

 

		10.11	Waiver

 

The waiver by either Party hereto
of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed
a waiver of any other right hereunder or of any other breach by or failure of such other Party, whether of a similar nature or
otherwise.

 

		10.12	Cumulative Remedies

 

No remedy referred to in this
Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement
or otherwise available under law.

 

		10.13	Waiver of Rule of Construction

 

Each Party has had the opportunity
to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction
that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

 

		10.14	Counterparts

 

This Agreement may be executed
in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the
same

 

    	-59-

    	 

    

 

 instrument. For purposes hereof, a scanned copy of this Agreement, including the signature pages hereto, will be deemed to
be an original. 

 

		10.15	Further Actions

 

Each Party will execute, acknowledge
and deliver such further instruments, and to do all such other ministerial, administrative or similar acts, as may be necessary
or appropriate in order to carry out the purposes and intent of this Agreement.

 

		10.16	No Third Party Rights

 

The provisions of this Agreement
are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by
reason of these provisions or be entitled to enforce any of these provisions against any Party.

 

		10.17	Expenses

 

Except as otherwise specifically
provided in this Agreement, each Party (and its Affiliates) shall bear its own costs and expenses in connection with entering into
this Agreement and the consummation of the transactions and performance of its obligations contemplated hereby.

 

		10.18	Extension to Affiliates

 

Merck shall have the right to
extend the rights, licenses, immunities and obligations granted in this Agreement to one or more of its Affiliates (so long as
it remains an Affiliate). All applicable terms and provisions of this Agreement shall apply to any such Affiliate to which this
Agreement has been extended to the same extent as such terms and provisions apply to Merck. Merck shall remain fully liable for
any acts or omissions of such Affiliates.

 

[Remainder of this page is left intentionally
blank]

 

    	-60-

    	 

    

 

IN WITNESS WHEREOF,
the Parties have executed this Collaboration and Exclusive License Agreement as of the date first set forth above.

 

	MERCK SHARP & DOHME CORP.	 
	 	 	 
	By:	    /s/ Kenneth C. Frazier	 
	Name: Kenneth C. Frazier	 
	Title: Chief Executive Officer and President	 
	 	 	 
	CHIMERIX, INC.	 
	 	 	 
	By:	   /s/ Kenneth I. Moch	 
	Name: Kenneth I. Moch	 
	Title: President and Chief Executive Officer	 

 

SIGNATURE PAGE TO COLLABORATION AND EXCLUSIVE LICENSE AGREEMENT

 

    	 

    	 

    

 

Schedule 1.11

 

Chimerix Patent Rights

 

[See Attached]

 

    	 

    	 

    

 

	Country	 	Status	 	Application No.	 	Effective

Filing Date	 	Patent No.	 	Issue Date	 	Owner
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]

 

***Confidential Treatment Requested

 

    	- 2 -

    	 

    

 

	Country	 	Status	 	Application No.	 	Effective

Filing Date	 	Patent No.	 	Issue Date	 	Owner
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]

 

***Confidential Treatment Requested

 

    	- 3 -

    	 

    

 

	Country	 	Status	 	Application No.	 	Effective

Filing Date	 	Patent No.	 	Issue Date	 	Owner
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	 	 	 	 	[...***...]

   

***Confidential Treatment Requested

 

    	- 4 -

    	 

    

 

Schedule 1.18

 

Other Chimerix Tenofovir Diphosphate Converting
Compounds

 

	HDP-(R)-PMPA (CMX157)	 
	[...***...]	 
	[...***...]	 
	[...***...]	 

 

***Confidential Treatment Requested

 

    	- 5 -

    	 

    

 

Schedule 1.53

 

Proof of Concept – Success Criteria

 

[See Attached]

 

    	- 6 -

    	 

    

 

Demonstration of Proof of Concept for Compound

 

Overview:

 

Proof of Concept for CMX157 shall be based on the outcome of
a two part clinical study establishing an effective, safe, commercially acceptable dose of CMX157 suitable for [...***...],
as well as on [...***...] and will be supported by establishing a suitable formulation.

 

Overall Success Criteria:

 

CMX157 must achieve all three goals: Clinical, Toxicology, and
Formulation to have met Success Criteria for Proof of Concept.

		·	Clinical goal: [...***...] with suitable [...***...] to proceed to [...***...]. Doses identified in the [...***...] will be
compared to criteria established by [...***...] of [...***...] directed at [...***...]

		·	Toxicology goal: CMX157 must be shown to have an acceptable [...***...] in[...***...][...***...] to support [...***...].

		·	Formulation goal: CMX157 can be administered as [...***...] in [...***...] or [...***...] with an image size no larger
than that of [...***...].

 

Study:

 

Part 1: evaluation of the potential for [...***...]. 

		·	Primary outcome parameter: [...***...]

		·	Subjects: [...***...], [...***...] ]individuals [...***...]; [...***...] subjects per group

		·	Dose: highest dose that is found to be safe in [...***...]

		·	Treatment duration: [...***...]

		·	Design: [...***...], [...***...], [...***...], [...***...] study:

		o	[...***...]: [...***...]

		o	[...***...]: [...***...]

		o	[...***...]: [...***...]

		·	Timeline: [...***...]

 

Outcomes:

		·	Scenario 1:

		o	Endpoint 1: [...***...] as defined in the [...***...] at [...***...] equal to or greater [...***...] at [...***...] and a posterior
probability of at least [...***...] to rule out a difference no larger than [...***...] change from baseline between
groups [...***...].

 

***Confidential Treatment Requested

 

    	- 7 -

    	 

    

 

		§	Endpoint met: [...***...]should
be conducted to establish [...***...] dose for [...***...].

		·	Next Step: Go to [...***...]

		o	Endpoint not met: [...***...].

 

		·	Scenario 2:

		o	Endpoint 2: [...***...] as defined in the [...***...] at [...***...] equal to or greater than [...***...] and a posterior probability
of at least [...***...] to rule out a difference no larger than [...***...] change from baseline between groups [...***...]
AND a posterior probability of at least [...***...] to rule out a difference of no larger than [...***...] change from baseline
between groups at [...***...].

			

		§	Endpoint 2 is met: provides evidence for [...***...] for [...***...] post dosing and supports use of [...***...] to
                                                                                                             achieve [...***...].

		·	Next Step: compare [...***...] and [...***...] for [...***...] or [...***...]:

		o	Endpoint: [...***...] as defined in the [...***...] and [...***...] [...***...] after last [...***...] equal to or greater
than [...***...] and a posterior probability of at least [...***...] to rule out a difference no larger than [...***...]
change from baseline between groups [...***...]

		§	Endpoint met: [...***...] supports [...***...]

		·	Next Step: Go to [...***...]

		§	Endpoint not met: [...***...].

 

		·	If neither Scenario 1 nor Scenario 2 endpoints are met: [...***...]. Merck option remains to continue development to further
[...***...] and [...***...]

 

Part 2: [...***...]

[...***...], [...***...] and [...***...] guided by [...***...]

 

***Confidential Treatment Requested

 

    	- 8 -

    	 

    

 

Schedule 3.2

 

Inventory

 

	Inventory Description	Quantity

 

cGMP CMX157:

 

	CMX157 cGMP
	Lot	 	Form	 	Manufacturer	 	# Containers	 	Amount
	CMX157-CTM-002	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	CMX157-021	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]kg

 

non-cGMP CMX157 API:

 

	CMX157
	Lot	 	Form	 	Manufacturer	 	# Containers	 	Grams
	004	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	008	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	011	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	013	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	018	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	022	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	024	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	025	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	026	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]

 

***Confidential Treatment Requested

 

    	- 9 -

    	 

    

 

Schedule 3.3.2

 

Initial Development Plan for the development
of the Product for the HIV Indication

 

[See Attached]

 

    	- 10 -

    	 

    

 

Plan is for informational purposes only
and the activities and dates are subject to change by Merck (itself or through the JSC)

 

	
        Agreed-to in principle

        [...***...]
        
	 	 	 	 	 	 
	 	 	 	 	 	 	 
	CLINICAL	 	 	 	 	 	 
	Phase I	 	FPFV	 	LPLV	 	Sample Size
	[...***...] 	 	[...***...]	 	[...***...]	 	[...***...]
	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 	 	 	 	 	 	 
	[...***...] studies (parallel to Phase 2/3)	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 
	[...***...] 	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 

 

	Phase Ib – Description	 	FPFV	 	LPLV	 	Sample Size
	 	 	 	 	 	 	[...***...]
	[...***...]	 	 	 	 	 	[...***...]
	 	 	[...***...]	 	[...***...]	 	 
	 	 	[...***...]	 	[...***...]	 	 
	 	 	 	 	 	 	 
	Phase 2 – Description 	 	 	 	 	 	 
	[...***...] 	 	[...***...]	 	[...***...]	 	[...***...]

 

	Phase III – Description	 	FPFV	 	LPLV	 	Estimate size
	Phase III programs and/or sample size may change due

to additional assessment and health authority input	 	 	 	 	 	 
	 	 	 	 	 	 	 
	[...***...]	 	TBD	 	TBD	 	[...***...]

 

	Additional Clinical Studies (Phase II and III)	 	FPFV	 	LPLV	 	Estimate size
	TBD	 	 	 	 	 	 

 

	 	 	 	 	 	 	 
	TOXICOLOGY / PHARMACOLOGY/Preclinical	 	Start	 	Finish	 	 
	 [...***...]	 	 	 	 	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 

 

***Confidential Treatment Requested

 

    	- 11 -

    	 

    

 

	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]:	 	 	 	 	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 
	[...***...]	 	TBD	 	TBD	 	 

 

	PHARMDEV 	 	Start	 	Finish	 	 
	Timing subject to change 	 	 	 	 	 	 
	[...***...]	 	[...***...]	 	[...***...]	 	 
	[...***...]	 	[...***...]	 	[...***...]	 	 
	[...***...]	 	[...***...]	 	[...***...]	 	 
	[...***...]	 	[...***...]	 	[...***...]	 	 
	[...***...]	 	[...***...]	 	[...***...]	 	 
	 	 	 	 	 	 	 
	RESEARCH	 	Start	 	Finish	 	 
	 	 	 	 	 	 	 
	[...***...]	 	 	 	 	 	 
	[...***...]	 	TBD	 	TBD	 	 

 

***Confidential Treatment Requested

 

    	- 12 -

    	 

    

 

Schedule 4.4

Form of Press Release

 

[See Attached]

 

    	- 13 -

    	 

    

 

 

 

CHIMERIX SIGNS WORLDWIDE LICENSE AGREEMENT
WITH MERCK FOR CMX157, A NOVEL CANDIDATE FOR THE TREATMENT OF HIV 

 

RESEARCH TRIANGLE PARK, NC –
July 24, 2012 – Chimerix, Inc. today announced the execution of a license agreement granting Merck, known as MSD outside
the United States and Canada, exclusive worldwide rights to CMX157, Chimerix’s novel lipid acyclic nucleoside phosphonate
currently being evaluated to treat HIV infection.

 

Under the terms of the agreement, Merck
receives an exclusive worldwide license and will be responsible for development and commercialization of CMX157, an investigational
oral nucleoside reverse transcriptase inhibitor (NRTI). Chimerix will receive a $17.5 million upfront payment and will be eligible
to receive up to $151 million in milestones, as well as royalties on future sales.

 

“This agreement is a significant
milestone in Chimerix’s mission of developing best-in-class therapies for major unmet medical needs based on our lipid technology
platform,” said Kenneth I. Moch, President and CEO of Chimerix. “Merck is the ideal collaborator to develop this drug
and help us to maximize the potential of CMX157, given its commitment to its HIV franchise. The value created through the licensure
of CMX157 will help us continue to advance our lead compound, CMX001, through its critical Phase 3 trial, for which we currently
plan to begin enrolling patients early next year." 

 

"Merck is committed to bringing forward
new treatment options for patients with HIV/AIDs," said Daria Hazuda, Vice President and Worldwide Discovery Head for Infectious
Diseases, Merck Research Laboratories. "We look forward to working closely with Chimerix to advance development of this NRTI
candidate."

 

About CMX157

CMX157 is a novel lipid acyclic nucleoside
phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate. CMX157 is more
than 200-fold more potent in vitro versus tenofovir against all major HIV subtypes resistant to current therapies, which may allow
activity against tenofovir-resistant viruses (e.g., K65R), and against HBV. CMX157's novel structure results in decreased circulating
levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. CMX157 has completed
a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile.

 

About Chimerix

 

    	- 14 -

    	 

    

 

Chimerix is developing novel oral antiviral
therapeutics with the potential to improve quality of life for patients in multiple settings, including transplant, oncology, acute
care and global health. The company’s proprietary lipid technology has given rise to two clinical stage compounds, CMX001
and CMX157, which have demonstrated the potential for enhanced activity, bioavailability and safety compared to currently approved
drugs.

 

Chimerix’s
lead compound, CMX001, is a broad spectrum lipid acyclic nucleoside phosphonate that inhibits double-stranded DNA (dsDNA) viruses
including cytomegalovirus (CMV), adenovirus, BK virus, herpes simplex virus and variola (smallpox). CMX001 has completed Phase
2 clinical development for the prophylaxis of CMV and is in Phase 2 development for the preemption and treatment of adenovirus
infection in hematopoietic stem cell transplant (HSCT) recipients. To date, more than 750 patients have been dosed with CMX001
in controlled clinical trials and open-label treatment protocols. Antiviral activity from completed and ongoing studies, coupled
with the lack of myelotoxicity and nephrotoxicity that are associated with currently available therapies, indicate that CMX001
has the potential to improve outcomes for stem cell and solid organ transplant recipients. Chimerix has completed an End of Phase
2 meeting with the FDA for CMX001 and is preparing to initiate Phase 3 clinical development of CMX001 for the prophylaxis of CMV
in HSCT recipients.

 

Led by an experienced antiviral drug development
team, Chimerix is also leveraging its lipid technology and novel chemical library to pursue new treatments for other areas of high
unmet medical need. For additional information on Chimerix, please visit http://www.chimerix.com. 

 

# # #

 

Chimerix Media Contacts:

 

Rebecca Heath, 919.972.7124

 

Elizabeth Kelly, 919.972.7109

 

    	- 15 -

    	 

    

 

Schedule 6.2(o)

 

Compound Research and Development

 

CMX157 001 Phase I Clinical Trial

 

    	- 16 -

    	 

    

 

Schedule 6.2(p)

 

List of Active Material Transfer Agreements

 

		1.	Public Health Service Material Transfer Agreement between Chimerix, Inc. and [...***...]
dated February 7, 2012.

 

***Confidential Treatment Requested

 

    	- 17 -Exhibit 10.16 

 

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested 

Under 17 C.F.R. Sections 200.80(b)(4)

and 230.406

 

OMB Approval 0990-0115

 

	 	1.THIS
    CONTRACT IS A RATED ORDER    	RATING	PAGE
    OF PAGES
	AWARD/CONTRACT	UNDER
    DPAS (15 CFR 350)                   ►	N/A.	 1 	     61
	2.
    CONTRACT (Proc. Inst. Ident.) NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQUEST/PROJECT NO.
	HHSO100201100013C	See
    Block 20C.	OS57601
	5. ISSUED BY	CODE	 	6. ADMINISTERED BY (If other than Item 6)	CODE	 
	Office
                                                                                                                          of Acquisitions
                                                                                                                          Management,
                                                                                                                          Contracts,
                                                                                                                          and
                                                                                                                          Grants
                                                                                                                          (AMCG)

        330 Independence
        Ave., S.W. Room G640

        Washington,
        D.C. 20201

         
	See
                                                                                       Block 5.

         

         

	7. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, state and ZIP Code)	8.
    DELIVERY 
	 

        Chimerix, Incorporated
	See
    Schedule.
	2505 Meridian Parkway, Suite 340	9/
    DISCOUNT FOR PROMPT PAYMENT
	Durham, NC 27713	N/A.
	 	 
	CAGE: 4WYN4	10.
    SUBMIT INVOICES	ITEM
	CODE
    DUNS No. [...***...]	FACILITY
    CODE	ADDRESS
    SHOWN IN:	See Section G.
	11.
    SHIP TO/MARK FOR                      CODE	N/A	12.
                                                 PAYMENT WILL BE MADE BY
	CODE
	N/A
	 

        See Block 5.
	 	 

        See Block 5.

	13.
                                                                                     AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:
                                                                                     N/A

        £ 10
        U.S.C. 2304(c)( )£ 41 U.S.C. 253(c)( )
	14.
                                                  ACCOUNTING AND APPROPRIATION DATA

        Appropriation
        Year: 2011; Object Class: 25329; CAN# 1992002 $24,819,527.00

         

	15A.
    ITEM NO.	15B.
    SUPPLIES/SERVICES	15C.
    UNIT PRICE 	15D.
    AMOUNT	15E.
    UNIT PRICE	15F.
    AMOUNT
	 

        See Section B.

         

         
	 	 	 

         
	 

         

         

	15G.
TOTAL AMOUNT OF CONTRACT    ►	$24,819,527.00
	16.
    TABLE OF CONTENTS
	(ü)
	SEC.
	DESCRIPTION	PAGE(S)
	(ü)
	SEC.
	DESCRIPTION
	PAGE(S)
	PART
                                                                                                                          I -
                                                                                                                          THE
                                                                                                                          SCHEDULE
	PART
    II - CONTRACT CLAUSES
	x	A
	SOLICITATION/CONTRACT
    FORM	1	x	I
	CONTRACT
                                                                                      CLAUSES
	54
	x	B
	SUPPLIES
    OR SERVICES AND PRICE/COST	3
	PART
    III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
	x	C
	DESCRIPTION
    / SPECS / WORK STATEMENT	9
	x	J
	LIST
                                                                                                                          OF ATTACHMENTS
	60
	x	D
	PACKAGING
    AND MARKING	16
	 	PART
    IV - REPRESENTATIONS AND INSTRUCTIONS
	x	E
	INSPECTION
    AND ACCEPTANCE	16
	x	K
	REPRESENTATIONS,
                                                                                                                                    CERTIFICATIONS
                                                                                                                                    AND
                                                                                                                                    OTHER
                                                                                                                                    STATEMENTS
                                                                                                                                    OF
                                                                                                                                    OFFERORS
	61
     
	x	F
	DELIVERIES
    OR PERFORMANCE	17

	x	G
	CONTRACT
    ADMINISTRATION DATA	39
	 ̈	L
	INSTRS.,
                                                                                      CONDS., AND NOTICES TO OFFERORS
	 
	x	H
	SPECIAL
    CONTRACT REQUIREMENTS	44
	 ̈	M
	EVALUATION
                                                                                      FACTORS FOR AWARD
	 
	CONTRACTING
    OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
	17.
    x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this
    document and return      1      copies to issuing office.) Contractor agrees to furnish and deliver all items or perform
    all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein.
    The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a)
    this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications,
    as are attached or incorporated by reference herein. (Attachments are listed herein.)	18.
    £  AWARD (Contractor is not required to sign this document.)
    Your offer on Solicitation Number  _________________________________, including the additions or changes made
    by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any
    continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s
    solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.
	19A.
    NAME AND TITLE OF SIGNER (Type or print)	20A. NAME OF CONTRACTING OFFICER
	GEORGE
    R. PAINTER, PH.D., CSO AND CHAIRMAN	__ETHAN
                                                  J. MUELLER AMCG, ASPR, OS, DHHS

         

	19B.
    NAME OF CONTRACTOR	19C.
    DATE SIGNED	20B.
                                                                                                                       UNITED
                                                                                                                       STATES
                                                                                                                       OF AMERICA
	20C.
    DATE SIGNED
	_________/s/
                                                                                                                                                 George
                                                                                                                                                 R.
                                                                                                                                                 Painter__________

        (Signature
        of person authorized to sign)
	 

        2/15/11
	BY
                                                                                                                                                 _____/s/
                                                                                                                                                 Ethan
                                                                                                                                                 J.
                                                                                                                                                 Mueller
                                                                                                                                                 ___________

        (Signature
        of Contracting Officer)
	2/16/11
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

	NSN 7540-01-152-8069 	26-107	STANDARD FORM 26 (REV.
    4-85)
	PREVIOUS EDITION UNUSABLE 	Computer Generated	Prescribed by GSAFAR (48 CFR) 53.214(a)

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

CONTRACT TABLE OF CONTENTS

 

	PART I –
    THE SCHEDULE	3
	SECTION
    B - SUPPLIES OR SERVICES AND PRICES/COSTS	3
	SECTION
    C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT	9
	SECTION
    D - PACKAGING, MARKING AND SHIPPING	16
	SECTION
    E - INSPECTION AND ACCEPTANCE	16
	SECTION
    F - DELIVERIES OR PERFORMANCE	17
	SECTION
    G - CONTRACT ADMINISTRATION DATA	39
	SECTION
    H - SPECIAL CONTRACT REQUIREMENTS	44
	PART II – CONTRACT
    CLAUSES	54
	SECTION
    I - CONTRACT CLAUSES	54
	PART III - LIST OF DOCUMENTS,
    EXHIBITS AND OTHER ATTACHMENTS	60
	SECTION
    J - LIST OF ATTACHMENTS	60
	PART IV – REPRESENTATIONS
    AND INSTRUCTIONS	61
	SECTION
    K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS	61

 

    	2

    	 

    

 

PART I – THE SCHEDULE

 

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

This contract is for the development of CMX001 for
the Treatment of Smallpox. The Research and Development (R&D) effort for the antiviral will progress in specific stages that
cover the base performance segment and each of the four (4) option segments specified in this contract. Work performed during
the base segment and during each of the option segments is considered to constitute a non-severable discrete work segment that
is necessary for the R&D effort related to the antiviral. The Contractor must complete specific tasks required in each discrete
work segment before the Government will exercise any of the follow-on option segments. Exercise of the follow-on options is solely
at the discretion of the Government. The contractor’s success in completing the required tasks under each work segment must
be demonstrated through the Deliverables and Milestones specified under Article F.2. Those deliverables will support the GO/NO
GO Decision Gates specified therein. The GO/NO GO Decision Gates will constitute the basis for the Government’s decision,
at its sole discretion, to exercise any follow-on option segment.

 

Work under this contract will proceed for a maximum
of 5 years. The base and option segments under Contract Line Items (CLINs) 0001 through 0005 are event driven work segments rather
than time driven CLINs. The periods of performance listed under each of the CLINs under Article B.2 and B.3 below are estimated
time periods. Those individual time periods may be extended to complete the tasks required under each work segment. However, if
exercised, the completion of the final tasks required under CLIN 0005 and option segment 4 must be completed no later than 5 years
after initial award of this contract.

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

 

		a.	The total estimated cost of the base performance
                                                                   segment is [...***...].

		b.	The total fixed fee for the base performance segment
                                                                   is $[...***...]. The fixed fee shall
                                                                   be paid as a percentage of costs incurred on any given month,
                                                                   subject to Allowable Cost and Payment and Fixed Fee Clauses.

		c.	The total amount of the base performance segment,
                                                                   CLIN 0001, represented by the sum of the total estimated
                                                                   cost plus fixed fee is $24,819,527.00.

		d.	It is estimated that the amount currently allotted will
                                                                   cover performance of the contract through 15 February
                                                                   2012.

 

	CLIN	 	 	 	Estimated
 Period of
 Performance	 	 	Supplies/Services	 	 	Total
 Estimated
 Cost	 	Fixed Fee	 	Total Estimated
 Cost Plus
 Fixed Fee	 
	0001	 	 	 	[...***...]	 	 	Research and development of CMX001 for the Treatment of Smallpox to include [...***...].		$	[...***...]	 	$	[...***...]	 	$	24,819,527.00	 

 

***Confidential Treatment Requested

 

    	3

    	 

    

 

	 	 	 	 	 	 	 	Reports and Other Data Deliverables.	 	 	 	 	 	 	 	 	 	 

 

ARTICLE B. 3. OPTION PRICES

 

		a.	Unless the government exercises its option pursuant to
                                                                   the option clause contained in ARTICLE I.3, the contract consists
                                                                   only of the Base Work segment specified in the Statement of
                                                                   Work as defined in SECTONS C and F, for the price set forth
                                                                   in ARTICLE B.2 of the contract.

		b.	Pursuant to FAR Clause 52.217-9 (Option to Extend the Term
                                                                   of the Contract), the Government may, by unilateral contract
                                                                   modification, require the Contractor to perform the Option
                                                                   Work Segments specified in the Statement of Work as defined
                                                                   in SECTIONS C and F of this contract. If the Government exercises
                                                                   the/these option(s), written notice must be given to the Contractor
                                                                   within 30 days after the Government has completed its analysis
                                                                   of the deliverables associated with the applicable GO/NO GO
                                                                   Decision gate; and the Government must give the Contractor
                                                                   a preliminary written notice of its intent to exercise the
                                                                   option at least 30 days before the contract expires. Specific
                                                                   information regarding the time frame for this notice is set
                                                                   forth in the OPTION CLAUSE Article in SECTION G of this contract.
                                                                   The estimated cost of the contract will be increased as set
                                                                   forth below:

 

OPTIONS

Option 1 (CLIN 0002)

Option 2 (CLIN 0003)

Option 3 (CLIN 0004)

Option 4 (CLIN 0005)

 

	CLIN	 	 	Estimated
 Period of
 Performance	 	 	Supplies/Services	 	 	Total
 Estimated
 Cost	 	Fixed Fee	 	Total
 Estimated
 Cost Plus
 Fixed Fee	 
	0002	 	 	 	[...***...]	 	 	 	[...***...]

[...***...]
	 	 	[...***...]	 	[...***...]	 	[...***...]	 
	0003	 	 	 	[...***...]	 	 	 	[...***...][...***...][...***...]	 	 	[...***...]	 	[...***...]	 	[...***...]	 
	0004	 	 	 	[...***...]	 	 	 	[...***...][...***...][...***...]	 	 	[...***...]	 	[...***...]	 	[...***...]	 

 

***Confidential Treatment Requested  

 

    	4

    	 

    
 

	0005	 	 	 	[...***...]	 	 	 	[...***...][...***...]	 	 	[...***...]	 	[...***...]	 	[...***...]	 

 

ARTICLE B. 4. PROVISIONS APPLICABLE TO DIRECT COSTS

 

		a.	Items Unallowable
                                                                               Unless Otherwise Provided

 

Notwithstanding the clauses, ALLOWABLE COST AND
PAYMENT and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the cost of the
following items or activities shall be unallowable as direct costs: 1) Acquisition, by purchase or lease, of any interest in real
property; 2) Special rearrangement or alteration of facilities; 3) Purchase or lease of any item of general purpose office
furniture or office equipment regardless of dollar value; and 4) Accountable Government Property.

 

		b.	Travel Costs

		1.	Travel

 

a.    Total expenditures for
travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during
the base segment or any option segment(s) shall not exceed $[...***...] without the prior written approval of the
Contracting Officer. The Contractor shall notify the Contracting Officer in writing when travel has exceeded $[...***...]
within the base segment.

 

b.    Subject to the annual dollar
limitation specified under B.4.b.1.a. above, the Contactor shall invoice and be reimbursed for all travel costs in accordance
with Federal Acquisition Regulations (FAR) 31.2 – Contracts with Commercial Organizations, Subsection 31.205-46, Travel
Costs.

 

ARTICLE B.5. ADVANCE UNDERSTANDINGS

 

		a.	Man-in-Plant

 

With 7 days advance notice to the Contractor in writing
from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility, who shall be subject
to the Contractor’s polices and procedures regarding security and facility access at all times while in the Contractor’s
facility.

 

		b.	Security Plan 

 

No Security Plan is required for this effort due to
an approved security waiver dated 12 November 2010.

 

***Confidential Treatment Requested

 

    	5

    	 

    

 

		c.	Subcontracts and Consultants

 

Award of any FFP subcontract or FFP consulting agreement
in excess of $100,000 or any cost reimbursement subcontract or consulting agreement shall not proceed without the prior written
consent of the Contracting Officer via a Contracting Officer Authorization (COA) Letter upon review of the supporting documentation
required by FAR Clause 52.244-2, Subcontracts. The Contracting Officer shall complete review of such documentation within eight
(8) business days and provide either an approval or request changes or additional information from the Contractor. Upon receipt
of the changes and additional information from the Contractor, the Contracting Officer will have eight (8) business days to review
the submitted information and respond. After receiving written consent of the subcontract by the Contracting Officer, a copy of
the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer.

 

		d.	Site Visits
                                                                                  and Inspections

 

At the discretion of the U.S. Government and independent
of activities conducted by the Contractor, within ten (10) business days notice to the Contractor via written notification from
the Contracting Officer, the U.S. Government reserves the right to conduct site visits and inspections on an as needed basis,
including collection of samples limited to 250 treatment courses of Final Drug Product and samples of key intermediates held at
the Contractor’s or Subcontractor’s site, provided that the Government’s collection of such samples shall not
frustrate the Contractor’s ability to perform under the contract, and provided further that such samples shall be used for
internal Government purposes only and not provided to any third party without the express written permission of Contractor.

 

		e.	Invoices
                                                                                  - Cost and Personnel Reporting, and Variances
                                                                                  from the Negotiated Budget

The Contractor agrees to provide a detailed breakdown
on invoices of the following cost categories:

		a.	Direct Labor - List individuals by name, title/position, hourly/annual
                                                             rate, level of effort, and amount claimed.

		b.	Fringe Benefits - Cite rate and amount

		c.	Overhead - Cite rate and amount

		d.	Materials & Supplies - Include detailed breakdown when total
                                                             amount is over $1,000.

		e.	Travel - Identify travelers, dates, destination, purpose of trip,
                                                             and amount. Cite COA, if appropriate. List separately domestic travel,
                                                             general scientific meeting travel, and foreign travel.

		f.	Consultant Fees - Identify individuals and amounts.

		g.	Subcontracts - Attach Subcontractor invoice(s).

		h.	Equipment - Cite authorization and amount.

		i.	Other Direct Costs - Include detailed breakdown when total amount
                                                             is over $1,000.

		j.	G&A - Cite rate and amount.

		k.	Total Cost

		l.	Fixed Fee

		m.	Total CPFF

 

Monthly Invoices must include the cumulative total
expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

 

    	6

    	 

    

 

		f.	Confidential
                                                                                  Treatment of Sensitive Information

 

The Contractor shall guarantee strict confidentiality of any
information/data of a sensitive nature that is provided to the Contractor by the Government during the performance of the contract.
The Government has determined that the information/data that the Contractor will be provided during the performance of the contract
is of a sensitive nature.

 

Disclosure of information/data that is sensitive in nature,
in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting
Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor
shall obtain a written determination from the Contracting Officer. (See also HHSAR clause 352.224-70).

 

Notwithstanding the foregoing,
such information/data shall not be deemed of a sensitive nature with respect to the Contractor for purposes of this contract if
such information/data: (a) was already known to the Contractor; (b) was generally available or known, or was otherwise part of
the public domain, at the time of its disclosure to the Contractor; (c) became generally available or known, or otherwise became
part of the public domain, after its disclosure to, or, with respect to the information/data by, the Contractor through no fault
of the Contractor; (d) was disclosed to the Contractor, other than under an obligation of confidentiality or non-use, by a third
party who had no obligation to the Government that controls such information/data not to disclose such information/data to others;
or (e) was independently discovered or developed by the Contractor, as evidenced by its written records, without the use of information/data
belonging to the Government. 

 

Contractor may disclose information/data
of a sensitive nature provided by the Government to the extent that such disclosure is: (a) made in response to a valid order
of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial or local governmental
or regulatory body of competent jurisdiction; provided, however, that the Contractor shall first have given notice
to the Government and give the Government a reasonable opportunity to quash such order and to obtain a protective order requiring
that the information/data of a sensitive nature that is the subject of such order be held in confidence by such court or agency
or, if disclosed, be used only for the purposes for which the order was issued; and provided further that if a disclosure
order is not quashed or a protective order is not obtained, the information/data disclosed in response to such court or governmental
order shall be limited to that information which is legally required to be disclosed in response to such court or governmental
order; (b) otherwise required by law, in the opinion of legal counsel to the Contractor as expressed in an opinion letter in form
and substance reasonably satisfactory to the Government, which shall be provided to the Government at least two (2) business days
prior to the Contractor’s disclosure of the information/data; or (c) made by the Contractor to the Regulatory Authorities
as required in connection with any filing, application or request for Regulatory Approval; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such information/data.

 

		g.	RESERVED.

  

    	7

    	 

    

 

		h.	Sharing of
                                                                                  contract deliverables within United States Government
                                                                                  (USG)

 

In an effort to build a robust
medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible
for Medical Countermeasure Development.  In accordance with recommendations from the Public Health Emergency Medical Countermeasure
Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory
Committee (PAC) Charter, Technology Transfer Agreements (TTA) between BARDA and the Defense Threat Reduction Agency and the National
Institute of Allergies and Infectious Diseases (NIAID), BARDA may share technical deliverables set forth in Article F.2 with colleagues
within the Integrated Portfolio.  This advance understanding does not authorize BARDA to share financial information outside
HHS. The Contractor is advised to review the terms of FAR Clause 52.227-14, Alternative II, regarding the Government’s rights
to deliverables submitted during performance as well as the Government’s rights to data contained within those deliverables.

 

		i.	Earned
                                                                                                                           Value
                                                                                                                           Management
                                                                                                                           System
                                                                                                                           (EVMS)
                                                                                                                           Implementation
                                                                                                                           Requirements

 

The Contractor and BARDA agree that the EVMS implementation
requirements that are contained in this contract are limited to the implementation requirements outlined by the 7 Principles of
Earned Value Management Tier 2 System Implementation Intent Guide contained in Attachment 9 of the contract. The total amount
of this contract reflects the use of the 7 Principles of EVMS Implementation. Any EVMS implementation requirements that are beyond
the intent of the 7 Principles of EVMS Implementation and/or exceed the negotiated cost to implement of $[...***...] shall not
proceed until the Contracting Officer sends a written request for a proposal to the Contractor and a bilateral modification is
issued to the contract for the purposes of incorporating the additional costs for the performance of these requirements into the
contract.

 

		j.	Recognition
                                                                                  of Dual Use Nature of CMX001

 

The Contractor and BARDA recognize and
acknowledge that CMX001 is being developed for several commercial indications (outside of the smallpox indication funded by BARDA
under this contract) using funds from financing sources independent of BARDA. As such, the development and commercialization of
CMX001 for such commercial indications shall not be impeded or in any way restricted by BARDA in the implementation of, or in
connection with, this contract. This includes an express acknowledgment by BARDA that the Contractor has no obligation to submit
for prior review or approval any information (including, but not limited to, clinical trial protocols, publications, and/or regulatory
submissions) regarding those activities funded 100% independently for commercial development efforts for CMX001. This excludes
activities directly funded in part/or in whole by BARDA. The Contractor agrees to work in good faith to provide BARDA with any
information related to the commercial development of CMX001 that the Contractor deems relevant, in its sole discretion, to the
development of the product for the smallpox indication.

 

		k.	Recognition
                                                                                  of Chimerix Control Over CMX001 Development
                                                                                  Program

 

In accordance with Articles C.2 and F.2 below, BARDA shall
have the opportunity to review and comment on certain Contractor documents, including study protocols, study reports, minutes
of meetings with the FDA, and other regulatory filings to FDA.  Wherever such review and comment is specifically required
by the terms of this contract, the Contractor shall provide BARDA with a minimum of eight (8) business days in which to review
and provide comments back to the Contractor provided, however, that at BARDA’s request, the Contractor shall provide
BARDA with such additional time for review and comment as Contractor deems practicable under the circumstances.  As the drug
sponsor, Contractor shall have sole discretion over the development of CMX001 and regarding how to respond to BARDA’s comments.
BARDA shall not require

 

***Confidential Treatment Requested

 

    	8

    	 

    

 

 Contractor to change a submission to FDA or other submission
that may impact the development of CMX001.  Except for study protocols, Contractor may make its submission to the FDA and/or
otherwise proceed with performance upon the expiration of the specified review period (if the Contractor has not received BARDA’s
comments), or upon issuance of the response to BARDA’s comments that is required by the terms of the contract.  For
study protocols, Contractor may make the submission and/or otherwise proceed with performance upon the expiration of the specified
review period (if the Contractor has not received BARDA’s comments), or upon issuance of the COA Letter. BARDA shall issue
COA Letters for study protocols within eight (8) business days of receipt of Contractor’s response to BARDA’s comments.

 

BARDA and the Contractor agree that wherever a contractual
deadline for review, comment and/or submission to BARDA is established within this contract, such deadline(s) may be impacted
by events currently unknown or unknowable that may trigger a need for the Contractor to respond to FDA without the ability to
provide the agreed upon advance notice to BARDA.  Contractor’s response to such events, should they occur, shall not
be deemed by BARDA to be a breach of this contract.

 

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

ARTICLE C.1. STATEMENT OF WORK

 

Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the
Government as needed to perform the Statement of Work dated 10 February 2011 as set forth in SECTION J-List of Attachments, attached
hereto and made a part of the contract.

 

ARTICLE C.2. REPORTING REQUIREMENTS

 

Technical Reports

 

In addition to those reports required by the other terms of
this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with
the DELIVERIES Article in SECTION F of this contract and in SECTION J-List of Attachments, attached hereto and made a part of
the contract. Such reports relate solely to the development activity funded under this contract.

 

A. Monthly Progress Report

 

This report shall include a description of the activities
during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists
of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist
of each calendar month.

 

The Contractor shall submit a Monthly Progress Report
on or before the 20th calendar day following the last day of each reporting period and shall include the following:

 

A cover page that includes the contract number and
title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail
address; and the date of submission; The progress report shall include a Table of Contents and Executive summary in accordance
with the DELIVERIES Article in SECTION F of this contract.

SECTION I-An introduction covering the purpose and
scope of the contract effort;

SECTION II-PROGRESS

SECTION II Part A: OVERALL PROGRESS-A description
of overall progress;

 

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SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE
UPDATE-A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress
on administration and management issues (e.g. evaluating, and managing subcontractor performance, and personnel changes);

SECTION II Part C: TECHNICAL PROGRESS-For each activity
related to Gantt chart, document the results of work completed and cost incurred during the period covered in relation to proposed
progress, effort and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The description
shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions
resulting from analysis and scientific evaluation of data accumulated to date under the contract. The report shall include a description
of problems encountered and proposed corrective action; differences between planned and actual progress, why the differences have
occurred and what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of
data accumulated to date under the project;

SECTION II Part D; PROPOSED WORK-A summary of work
proposed related to Gantt chart for the next reporting period and preprints/reprints of papers and abstracts.

 

SECTION III Part A: Earned Value Management Reporting:
Contractor will provide a monthly Contract Performance Report (CPR) at an agreed upon reporting level (WBS level 3) using the
BARDA provided WBS and a Variance Analysis Report. EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated
Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR 52.215-2, Audit and Records-Negotiation,
BARDA may request, on a quarterly or ad hoc basis that the Contractor provide raw data. BARDA may request additional data at a
reporting level or at lower levels, as BARDA deems necessary so long as such requests do not impose requirements beyond what has
been specifically agreed to and funded by BARDA regarding EVMS implementation as provided in the Advance Understanding “Earned
Value Management System (EVMS) Implementation.”

 

A Monthly Progress Report will not be required in
the same month that the Quarterly or Annual Technical Progress Report is submitted.

 

B. Quarterly Progress Report

 

This report shall include a description of the activities
during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists
of the first full quarter of performance plus any fractional part of the initial quarter. Thereafter, the reporting period shall
consist of each calendar quarter.

 

The Contractor shall submit a Quarterly Progress
Report on or before the 20th calendar day following the last day of each reporting period and shall include the following:

A cover page that includes the contract number and
title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail
address; and the date of submission;

SECTION I-An introduction covering the purpose and
scope of the contract effort. The progress report shall include a Table of Contents and Executive summary in accordance with the
DELIVERIES Article in SECTION F of this contract.

SECTION II-PROGRESS

SECTION II Part A: OVERALL PROGRESS-A description
of overall progress;

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE
UPDATE-A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress
on administration and management issues (e.g. evaluating, managing subcontractor performance and personnel changes);

 

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SECTION II Part C: TECHNICAL PROGRESS-For each activity
related to Gantt chart, document the results of work completed and cost incurred during the period covered in relation to proposed
progress, effort and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The description
shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions
resulting from analysis and scientific evaluation of data accumulated to date under the contract. The report shall include a description
of problems encountered and proposed corrective action; differences between planned and actual progress, why the differences have
occurred and what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of
data accumulated to date under the project;

SECTION II Part D; PROPOSED WORK- A summary of work
proposed for the next reporting period; and preprints/reprints of papers, abstracts and a current/updated Gantt chart. A Quarterly
Progress Report will not be required in the same month that the Annual Progress Report is submitted.

SECTION III Part A: Earned Value Management Reporting:
Contractor will provide a quarterly Contract Performance Report (CPR) at an agreed upon reporting level (WBS level 3) using the
BARDA provided WBS and a Variance Analysis Report. EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated
Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR 52.215-2, Audit and Records-Negotiation,
BARDA may request, on a quarterly or ad hoc basis that the Contractor provide raw data. BARDA may request additional data at a
reporting level or at lower levels, as BARDA deems necessary so long as such requests do not impose requirements beyond what has
been specifically agreed to and funded by BARDA regarding EVMS implementation as provided in the Advance Understanding “Earned
Value Management System (EVMS) Implementation.”

 

C. Annual Progress Report

 

This report shall include a summation of the results
of the entire contract work for the period covered. An Annual Technical Progress Report will not be required for the period when
the Final Technical Progress Report is due. Monthly and Quarterly Progress Reports shall not be submitted in the same month when
an Annual Progress Report is due.

 

The first Annual Progress Report shall be due on
or before the 20th calendar day following the last day of the reporting period. Each Annual Progress Report shall include:

A Cover page that includes the contract number and
title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and email address;
and the date of submission; The progress report shall include a Table of Contents in accordance with the DELIVERIES Article in
SECTION F of this contract.

SECTION I: EXECUTIVE SUMMARY - A brief overview
of the work completed, and the major accomplishments achieved during the reporting period;

SECTION II: PROGRESS

SECTION II Part A: OVERALL PROGRESS-A description
of overall progress;

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE
UPDATE-A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress
on administration and management issues (e.g. evaluating, and managing subcontractor performance; regulatory compliance audits,
and personnel changes);

SECTION II Part C: TECHNICAL PROGRESS - A detailed
description of the work performed structured to follow the activities and decision gates outlined at the Integrated Baseline Review
and as described in the Integrated Master Plan. The Report should include a description of any problems (technical or financial)
that occurred or were identified during the reporting period, and how these problems were resolved;

SECTION II Part D; PROPOSED WORK-A summary of work
proposed for the next year period to include an updated Gantt Chart.

 

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SECTION III Part A: Earned Value Management Reporting:
Contractor will provide a quarterly Contract Performance Report (CPR) at an agreed upon (WBS level 3) reporting level using the
BARDA provided WBS and a Variance Analysis Report. EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated
Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR 52.215-2, Audit and Records-Negotiation,
BARDA may request, on a quarterly or ad hoc basis that the Contractor provide raw data. BARDA may request additional data at a
reporting level or at lower levels, as BARDA deems necessary so long as such requests do not impose requirements beyond what has
been specifically agreed to and funded by BARDA regarding EVMS implementation as provided in the Advance Understanding “Earned
Value Management System (EVMS) Implementation.”

 

Contractor also should include the following in
the Annual Progress Report:

 

		1.	Copies of manuscripts (published and unpublished), abstracts,
                                                                and any protocols or methods developed specifically under the
                                                                contract during the reporting period; and

 

		2.	A summary of any Subject Inventions per the requirements under
                                                                FAR Clause 52.227-11

 

		D.	Draft Final Technical Progress Report and Final Technical
Progress Report

 

These reports are to include a summation of the
work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to
describe comprehensively the results achieved. The Draft Final Report and Final Report shall be submitted in accordance with the
DELIVERIES Article in SECTION F of the contract. An Annual Technical Progress Report will not be required for the period when
the Final Technical Progress Report is due. The Draft Final Technical Progress Report shall be submitted 75 calendar days before
the agreed completion date of the contract and the Final Technical Progress Report shall be submitted on or before the completion
date of the contract. The report shall conform to the following format:

 

		1.	Cover page to include the contract number, contract title, performance
                                                            period covered, Contractor's name and address, telephone number, fax
                                                            number, email address and submission date; The progress report shall
                                                            include a Table of Contents in accordance with the DELIVERIES Article
                                                            in SECTION F of this contract.

 

		2.	SECTION I: EXECUTIVE SUMMARY-Summarize the purpose and scope
                                                                of the contract effort including a summary of the major accomplishments
                                                                relative to the specific activities set forth in the Statement
                                                                of Work.

 

		3.	SECTION II: RESULTS-A detailed description of the work performed
                                                            related to the Gantt chart, the results obtained, and the impact of
                                                            the results on the scientific and/or public health community, including
                                                            a listing of all manuscripts (published and in preparation) and abstracts
                                                            presented during the entire period of performance, and a summary of
                                                            all inventions.

 

Draft Technical Progress Report: The Contractor
is required to submit the Draft Final Technical Progress Report to the Contracting Officer’s Technical Representative and
Contracting Officer. This draft report is due 75 calendar days before the completion date of the contract. The Contracting Officer’s
Technical Representative and Contracting Officer will review the Draft Final Technical Progress Report and provide the Contractor
with comments within 8 business days after receipt.

 

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Final Technical Progress Report: The Contractor
will deliver the final version of the Final Technical Progress Report on or before the completion date of the contract. The final
version shall include or address the Contracting Officer’s Technical Representative comments and Contracting Officer comments
on the draft report. Final Technical Progress Report shall be submitted on or before the completion date of the contract.

 

		E.	Summary of Salient Results

The Contractor shall submit, with the Final Technical Progress Report, a summary (not to exceed 200 words) of salient results
achieved during the performance of the contract.

 

		F.	Other Technical Progress Reports

 

		1.	Draft Report for Clinical and
                                                                Non-Clinical Studies and Final Report for Clinical and Non-Clinical
                                                                Studies 

		·	The non-clinical
                                                                                                              and clinical trial
                                                                                                              reports shall follow
                                                                                                              the format of International
                                                                                                              Conference on Harmonization
                                                                                                              document ICH E3
                                                                                                              “Guidelines
                                                                                                              on Structure and
                                                                                                              Content of Clinical
                                                                                                              Study Reports”
                                                                                                              (http://www.pharmacontract.ch/support/su_ich_liste.htm).

		·	Draft
                                                                                                              Final Report for
                                                                                                              Clinical and Non-Clinical
                                                                                                              Studies funded by
                                                                                                              this contract will
                                                                                                              be submitted to
                                                                                                              the Contracting
                                                                                                              Officer’s
                                                                                                              Technical Representative
                                                                                                              and Contracting
                                                                                                              Officer (CO) for
                                                                                                              review and comment
                                                                                                              within 45 calendar
                                                                                                              days (draft) or
                                                                                                              75 calendar days
                                                                                                              (final) after completion
                                                                                                              of analysis of Pre-Clinical/Non
                                                                                                              Clinical/Clinical
                                                                                                              data and 8 business
                                                                                                              days prior to submission
                                                                                                              to FDA. Subcontractor
                                                                                                              prepared reports
                                                                                                              shall be submitted
                                                                                                              to the Contracting
                                                                                                              Officer’s
                                                                                                              Technical Representative
                                                                                                              and Contracting
                                                                                                              Officer (CO) for
                                                                                                              review and comment
                                                                                                              no later than 5
                                                                                                              business days after
                                                                                                              receipt by the prime
                                                                                                              contractor.

		·	The Contracting
                                                                                                              Officer shall provide
                                                                                                              written comments
                                                                                                              within 8 business
                                                                                                              days after the submission
                                                                                                              of the Draft Final
                                                                                                              Report for Clinical
                                                                                                              and Non-Clinical
                                                                                                              Studies.

		·	The
                                                                                                              comprehensive Final
                                                                                                              Report for Clinical
                                                                                                              and Non-Clinical
                                                                                                              Studies will be
                                                                                                              submitted to the
                                                                                                              Contracting Officer
                                                                                                              and the Contracting
                                                                                                              Officer’s
                                                                                                              Technical Representative
                                                                                                              within 30 calendar
                                                                                                              days after receiving
                                                                                                              comments on the
                                                                                                              Draft Final Report
                                                                                                              for Clinical and
                                                                                                              Non-Clinical Studies
                                                                                                              from the Contracting
                                                                                                              Officer.
                                                                                                              The final version
                                                                                                              shall include or
                                                                                                              address the Contracting
                                                                                                              Officer’s
                                                                                                              Technical Representative
                                                                                                              comments and Contracting
                                                                                                              Officer comments
                                                                                                              on the draft report.

		·	See section
                                                                                                              ARTICLE F.2. REPORTING
                                                                                                              REQUIREMENTS AND
                                                                                                              DELIVERABLES for
                                                                                                              additional clarification
                                                                                                              and deliverable
                                                                                                              requirements.

 

		G.	Audit Reports

 

Within three (3) business days of receipt of an FDA
Form 483 related to conformance to FDA regulations and guidance, including adherence to GLP, GMP, or GCP guidelines, as it relates
to performance under this contract where the results will adversely impact contract performance, the Contractor shall provide
the Contracting Officer’s Technical Representative and the Contracting Officer with copies of the form. Within fifteen (15)
business days of receipt of the form Contractor shall provide a plan for addressing areas of nonconformance to FDA regulations
and guidance for GLP, GMP or GCP guidelines as identified in the final audit report. See section ARTICLE F.2. REPORTING REQUIREMENTS
AND DELIVERABLES for additional clarification and deliverable requirements.

 

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		H.	Clinical and Non-Clinical
                                                                       Protocols

 

BARDA has a responsibility to obtain documentation
concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical
trials and non-clinical studies. Therefore the Contractor shall develop a protocol for each clinical trial and non-clinical study
funded under this contract and submit all such protocols and protocol amendments to the BARDA Contracting Officer’s Technical
Representative (COTR) for review by the Contracting Officer. Subject to Article B.5.k. above, the Contractor’s consideration
of the BARDA COTR comments shall be addressed in writing or by corrective action in the protocol prior to the issuance of a Contracting
Officer Authorization (COA) Letter authorizing the execution of the specific clinical trial or non-clinical study(ies).

 

Important information regarding performing human
subject research is available at http://www3.niaid.nih.gov/healthscience/clinicalstudies/. For additional information contractor
shall review the Attachment 11: Non-Clinical and Clinical Terms of Award set forth in SECTION J-List of Attachments and ARTICLE
F.2. REPORTING REQUIREMENTS AND DELIVERABLES.

 

Any updates to technical reports are to be addressed
in the Monthly, Quarterly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Technical Representative
or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

 

		I.	Other Reports/Deliverables

 

The Contractor shall provide
all deliverables as outlined in the table under ARTICLE F.2. REPORTING REQUIREMENTS AND DELIVERABLES section of this document.

 

ARTICLE C.3. SUBJECT INVENTION REPORTING REQUIREMENT

 

All reports and documentation required by FAR Clause
52.227-11, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support
certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 2207, MSC 7987, Bethesda, Maryland 20892-7987 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report,
and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see
FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract. See also FAR clause
52.227-11 (Patent Rights-Ownership by the Contractor).

 

Reports and documentation submitted to the Contracting
Officer shall be sent to the following address:

 

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Contracting Officer

Ethan J. Mueller

Office of Acquisitions Management, Contracts, and
Grants (AMCG)

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

Ethan.Mueller@hhs.gov

 

If no invention is disclosed or no activity has
occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the
Contracting Officer at the address listed above.

 

To assist contractors in complying with invention
reporting requirements of the clause, "Interagency Edison," an electronic invention reporting system has been developed.
Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system
is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information
relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the
Extramural Inventions and Technology Resources Branch, OPERA, NIH.

 

ARTICLE C.4. PROJECT MEETING CONFERENCE CALLS
ONCE EVERY TWO WEEKS

			A conference call between the Contracting Officer’s Technical
                                                         Representative and the Contractor’s Program Manager shall occur
                                                         once every two weeks. During this call, the Program Manager will discuss
                                                         the activities during the reporting period, any problems that have arisen
                                                         and the activities planned for the ensuing reporting period. The first
                                                         reporting period consists of the first full month of performance plus
                                                         any fractional part of the initial month. Thereafter, the reporting period
                                                         shall consist of each calendar month. The Contractor’s Program
                                                         Manager may choose to include other key personnel on the conference call
                                                         to give detailed updates on specific projects or this may be requested
                                                         by the Contracting Officer’s Technical Representative.

 

ARTICLE C.5.  PROJECT MEETINGS  

The Contractor shall participate in Project Meetings
to coordinate the performance of the contract, as requested by the Contracting Officer’s Technical Representative. 
These meetings may include face-to-face meetings with BARDA/AMCG in Washington, D.C. and at work sites of the Contractor and its
subcontractors.  Such meetings may include, but are not limited to, meetings of the Contractor (and subcontractors invited
by the Contractor) to discuss study designs, site visits to the Contractor’s and subcontractor’s facilities, and meetings
with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program.  The Contractor
must provide data, reports, and presentations to groups of outside experts (subject to appropriate protections for Contractor
confidential or proprietary data) and USG personnel as required by the Contracting Officer’s Technical Representative in
order to facilitate review of contract activities. Subject to other provisions specified in this contract (See for example Article
F.2), the Contractor shall provide notice to

 

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the COTR no later than 10 business days where practicable, prior to both formal and
informal meetings and communications with the Food and Drug Administration (FDA) related to the efforts funded by this contract
including anticipated telephone communications. In the event that the COTR or other authorized BARDA representative is unable
to participate in a meeting or telephone conference the Contractor shall provide the COTR with a written summary of all subjects
discussed no later than three (3) business days following the meeting or conference.

 

 

 

SECTION D – PACKAGING, MARKING AND SHIPPING

 

All deliverables required under this contract shall be packaged,
marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract
number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable
and acceptable condition.

 

Report Deliverables

 

Unless otherwise specified by the Contracting Officer, delivery
of reports to be furnished to the Government under this contract (including invoices), shall be delivered to BARDA electronically
along with a concurrent email notification to the Contracting Officer, Contract Specialist, and COTR summarizing the electronic
delivery.

 

In addition, a physical hard copy, will be sent unless otherwise
specified by the Contracting Officer. Delivery of reports to be furnished to the Government under this contract (including invoices),
shall be addressed as follows:

 

Tyler Merkeley, M.S., MBA

Contracting Officer’s Technical Representative (COTR)

330 Independence Avenue, S.W.

Washington, D.C. 20201

202-260-0315 (Office)

Tyler.Merkeley@hhs.gov

 

Ethan J. Mueller, Contracting Officer (CO)

DHHS/OS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

Ethan.Mueller@hhs.gov

 

SECTION E – INSPECTION AND ACCEPTANCE

 

		1.	The Contracting Officer (CO) or the duly authorized representative
                                                                  will perform inspection and acceptance of materials and services
                                                                  to be provided under this contract.

 

		2.	For the purpose of this SECTON, the designated Contracting
                                                                  Officer’s Technical Representative (COTR) is the authorized
                                                                  representative of the Contracting Officer. The COTR will assist
                                                                  in resolving technical issues that arise during performance.
                                                                  The COTR however is not authorized to change any contract terms
                                                                  or authorize any changes in the Statement of Work or modify
                                                                  or extend the period of performance, or authorize reimbursement
                                                                  of any costs incurred during performance.

 

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		3.	Inspection and acceptance will be performed at:

 

Biomedical Advanced Research and Development Authority/Office
of Acquisition Management, Contracts, and Grants (AMCG)

Office of the Assistant Secretary for Preparedness
and Response

U.S. Department of Health and Human Services

330 Independence Avenue, S.W., Room G644

Washington, D.C. 20201

 

		4.	The contract incorporates the following clause by reference
                                                                  with the same force and effect as if it were given in full text.
                                                                  Upon request, the Contracting Officer will make its full text
                                                                  available.

 

FAR Clause 52.246-9, Inspection of Research and Development
(Short Form) (April 1984)

 

SECTION F – DELIVERIES OR PERFORMANCE

 

Deliveries and performance under these Contract
Line Item Numbers (CLINs) and Option CLINs shall be as follows:

 

ARTICLE F.1. ESTIMATED PERIOD OF PERFORMANCE

 

a. Under CLIN 0001, the estimated period of performance
for the base work segment of this contract shall be from 2/16/2011-2/15/2012. As discussed under Article B.1, this estimated period
of performance may be subject to adjustment. The period of performance for each of the Option work segments under CLINS 0002 through
0005 may also be subject to adjustment in order to complete the tasks required under each work segment.

 

	CLIN	 	Estimated Period of Performance	 	 	Supplies/Services	 
	0002	 	[...***...]	 	 	[...***...]

[...***...]

	 
	0003	 	[...***...]	 	 	[...***...]

[...***...]

	 
	0004	 	[...***...]	 	 	[...***...]

[...***...]

	 
	 	 	 	 	 	 	 	 	 

***Confidential Treatment Requested

 

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	0005	 	[...***...]	 	 	[...***...]

[...***...]

	 
	 	 	 	 	 	 	 	 	 

ARTICLE F.2. DELIVERABLES

 

Successful performance of the final contract shall be deemed
to occur upon performance of the work set forth in the Statement of Work dated 10 February 2011 set forth in SECTION J-List of
Attachments of this contract and upon delivery and acceptance, as required by the Statement of Work, by the Contracting Officer,
or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

 

The items specified below as described in the REPORTING REQUIREMENTS
Article in SECTION C of this contract and the Statement of Work dated 10 February 2011 set forth in SECTION J-List of Attachments
will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEE’S
PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING,
MARKING AND SHIPPING, of this contract. All reports identified below relate solely to the development activity funded under this
contract:    

 

1. Other Contract Deliverables

 

	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	1.	Project
    Meeting	Every two weeks

        or as amended by CO and COTR
	The Contractor shall participate in teleconferences
        every two weeks

        with BARDA to discuss the performance of the contract.
        The Contractor prepares a proposed agenda and shall record, maintain and provide draft-meeting minutes to the COTR for
        approval. The COTR will approve the draft version and distribute the final version to the Contract Officer (CO) and Contractor.
	·Contractor
        provides agenda 48hrs in advance of meeting to the COTR. COTR approves (with CO concurrence) and distributes agenda.

        ·Contractor
        provides meeting minutes within 2 business days of the meeting

        ·COTR
        reviews, comments and approves minutes
	1
    Electronic Copy to COTR and CO
	2.	Monthly,
    Quarterly and Annual Project Status Report/ Meeting	Monthly
    reports are due on the 20th of each month, except on months when Quarterly/Annual Technical Progress Reports are due	The
Monthly/Quarterly Project/Annual Status Report shall address the items listed below and cross-referenced to the Work Breakdown
Structure (WBS), Scope of Work (SOW), Integrated Master Schedule (IMS), Integrated Baseline
Review (IBR) report, Earned Value Management (EVM) Contract Performance Reports (CPR), and approval strategy.

1.An Executive Summary in MS PowerPoint (.ppt)
        format,
	Monthly Reports:

        ·Contractor
        provides Monthly Status Report deliverables on the 20th of each month. 

        ·COTR
and CO will review Monthly Reports with the Contractor and provide feedback

         

        Quarterly Meeting:

        ·
Contractor provides Quarterly Status Report
	1
    Electronic Copy 

to COTR and CO

 

***Confidential Treatment Requested

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	 	 	due	highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory.
        The Executive Summary should be limited to 2-3 pages and highlight critical issues for that reporting period. The Monthly,
        Quarterly, and Annual Technical Progress Report shall address each of the items below and be cross-referenced to the Critical
        Path, Integrated Master Schedule (IMS), EVM, WBS and the Risk Mitigation Matrix.

         

        2.Progress in meeting contract milestones - broken
        out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions. The
        reports shall detail the planned progress and actual progress during the period covered, explaining occurrences of any
        differences between the two, and the corrective steps.

        3.Provide EVM CPR (monthly) and Updated Risk Management
        Plan/Register (quarterly)

        4.The reports shall also include a three-month
        rolling forecast of key planned activities, referencing the WBS/IMS.

        5.A tracking log of progress on regulatory submissions
with the FDA submission number, description of submission, date of submission, status of submission, and next steps shall be updated
upon submission for all activities supported in part or whole with BARDA funding. 

6.	Estimated and Actual Expenses: This report shall also contain a narrative statement or in table form as to whether there is any significant discrepancy (greater than 10%) at this time between the % of work completed and the cumulative costs incurred to date. Monthly and Actual Expenses should be broken down to the appropriate WBS reporting level. This section of the report shall also contain estimates for the 
	five
business days prior to meeting. This report is an expanded version of the Monthly Status Report

        ·Contractor
        shall identify itinerary for the quarterly site visits 

        ·Contractor
        provides agenda to the COTR 48hrs in advance of meeting 

        ·COTR
        approves (with CO concurrence) and distributes agenda

        ·Contractor
        provides meeting minutes within 2 business days of the meeting

        ·COTR
        reviews, comments and approves minutes

         

        Annual Meeting:

        ·Contractor
provides Annual Project Status Report deliverables five business days prior to meeting. A draft report including .ppt slides should
be provided 5 business days prior to the meeting. The annual report should also include information from the annual meeting due
15 business days after the meeting.

        ·BARDA reserves the right to meet with the Contractor’s board of directors once a year to discuss
the contract at a time and place agreed upon by the parties. 

        · COTR approves (with CO concurrence) and distributes agenda

        · COTR approves (with CO concurrence) all meeting material

        · Contractor
provides 

         
	

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	 	 	 	subcontractors' expenses from the previous month if the subcontractor did not submit a bill in the previous month. Estimates
        shall be listed for each subcontractor. If the subcontractor(s) was not working or did not incur any costs in the previous
        month, then a statement to this effect should be included in this report for those respective subcontractors. This section
        should also include a summary of any cost savings identified by the Contractor. .

        7.Contractor shall identify the itinerary for the
        quarterly site visits (quarterly)
	 meeting
minutes within 2 business days of meeting

        ·COTR
        reviews, comments and approves minutes

        ·Contractor
        provides a FINAL annual report within 15 business days after the conclusion of the annual meeting. COTR (with CO concurrence)
        reviews, comments and approves FINAL Annual Report

        ·BARDA
        and Contractor shall participate in an in-process review
	 
	3.	Performance
    Measurement Baseline Review (PMBR)	Within
    90 days of contract award	
The PMBR Report shall
        address each of the items listed below and be cross-referenced to the WBS, SOW, IMS, Risk Management Plan and product
        approval strategy. 

        1.Contractor provides
        baseline proposal and PowerPoint brief

        2.Responsibility
        Assignment Matrix

        3.A description
        of the work scope through control account Work Authorization Documents (WADs) and/or WBS Dictionary down to the control
        account level

        4.Template for
        Work Packages

        5.Integrated Master
        Schedule (IMS) with the inclusion of agreed major milestones and control account plans (CAP) for all control accounts

        6.Baseline revision
        documentation and program logs (s) risk management plan.
	·Contractor
        provides baseline proposal, .ppt briefing, 10 business days prior to meeting

        ·Contractor
        provides agenda to the COTR 48hr in advance of meeting 

        ·COTR
        approves (with CO concurrence) and distributes agenda

        ·COTR
        approves (with CO concurrence) all meeting material

        ·Contractor
        provides minutes within 2 business days of the meeting

        ·COTR
        reviews and approves minutes 

        ·BARDA
        will review documentation and provide written comments and questions to Contractor

        ·Contractor
shall address its consideration of BARDA’s comments and resubmit PMBR Report within 10 business days
	1 Electronic Copy to COTR and CO

        

         

	4.	Risk
    	90 days 	The Contractor will provide
    a Risk	·Contractor shall provide 	1

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
		Management Plan	following contract award
        and updated quarterly

         
	Management Plan that outlines the impacts of each risk in relation to the cost, schedule and performance objectives.
    The Risk Management Plan will include risk mitigation strategies. Each risk mitigation strategy will capture how the corrective
    action will reduce impacts on cost, schedule and performance.	   a Risk Management Plan 90 days following contract award and update on
        the 20th of each Quarter in their Quarterly or Annual Project Status Reports 

        ·BARDA
        shall provide Contractor with a written list of concerns in response to Contractor’s submitted Risk Management Plan,
        and the Contractor must address in writing its consideration of all concerns raised by BARDA within 20 business days of
        Contractor’s receipt of this list of concerns.
	Electronic
Copy to COTR and CO
	5.	Integrated
    Master Schedule	The 20th of each month

         
	The
    Contractor will provide Integrated Master Schedule (IMS) with monthly status updates to reflect changes in schedule, performance,
    and critical path. Contractor will include BARDA Portfolio Management Milestones in their IMS and provide monthly updates
    within their IMS.	·The
        first draft IMS is due 30 days after contract award. The contractor and BARDA will establish an agreed upon IMS at the
        PMBR. 

        ·Thereafter
        the Contractor shall provide an Integrated Master Schedule on the 20th of each
        month in their Project Status Reports

        ·Integrated
        Master Schedule shall be in both PDF and Microsoft Project Form

        ·BARDA
        shall provide Contractor with a written list of concerns in response to Contractor’s submitted IMS, and the Contractor
        must address in writing its consideration of all concerns raised by BARDA within 10 business days of Contractor’s
        receipt of this list of concerns.
	1
    Electronic Copy (PDF and Microsoft Project Schedule (.mmp) format to COTR and CO
	6.	EVM / Contract Performance
    Report	The 20th day of the month after
        	Contractor will provide a monthly Contract Performance Report (CPR) Format 1 at WBS level 3 using the

	·Contractor
        shall provide a CPR and Variance Analysis Report on the
	Electronic
    Copy to COTR

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
			each calendar month

         
	BARDA provided WBS and a Variance Analysis Report (Format 5).

         

        A supplemental monthly Control Account Plan (CAP) report
        shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted
        cost of work performed (BCWP)) and actual costs of work performed (ACWP) as captured in Contractor’s EVM systems.
        The contractor shall provide a rationale in the package of its use of % complete as EVMS methodology or identity if any
        other EVMS methodology is being used.
	20th day of the month after the end of each Month.
        ·Contractor
        shall discuss any anticipated cost savings or risks in its Variance Analysis Report. 

        ·Contractor
        shall provide a PDF of deliverables or in a format as directed by COTR.

        ·BARDA
        may request additional data at a reporting level or at lower levels, as BARDA deems
        necessary

        ·The
        Contractor must address in writing its consideration of all concerns raised by BARDA staff 
	 and CO
	7.	Incident Report	Within 24 or 48 hrs
    of activity or incident	The Contractor shall communicate to BARDA and document
        all critical programmatic concerns or risks within 48 hours. The Contractor shall communicate via email or telephone.

         

        In addition, the Contractor shall report to the government
        any activity or incident that is in violation of established security standards or indicates the loss or theft of government
        products within 24 hrs of loss or theft. The Contractor shall communicate via email, oral or written communication.
	·Email,
        Letter to CO Telephone (w/ written follow-up)

        ·Written
        communication with BARDA COTR and CO within 48 hrs of Contractor identifying a critical programmatic risk. Additional
        updates within 48 hrs of additional developments, additional information and/or understanding

        ·Contractor
        shall submit within 5 business days a Corrective Action Plan (if deemed necessary by Contractor)

        ·If
        corrective action is recommended, the Contractor must address in writing, within 5 business days, its consideration of
        concerns raised by BARDA

         
	1
    Electronic Copy COTR and CO 

 

    	22

    	 

    

 

	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	8.	Deviation Request	TBD	Process
    for changing the IMS activities as baselined at the PMBR.	·Contractor
        shall submit a Deviation Request as soon as the Contractor has sufficient data to support the need for a significant change
        from the baselined IMS, mutually agreed upon at the PMBR (in excess of one (1) month) and/or PBMR costs (in excess of
        10%)

        ·The
        BARDA CO will review and provide a written response to the Deviation Request which may include rebaseline of the IMS and/or
        PBMR.

        ·Contractor
        shall address its consideration of BARDA’s comments within 10 business days. 
	1 Electronic Copy to COTR and CO

        

         

	9.	Draft and Final Technical
    Progress Report	Draft 75 calendar
    days before and Final shall be submitted on or before the completion date of the POP	A draft of Final Technical
        Progress Report containing a summation of the work performed and the results obtained
        for the entire contract period of performance. The draft report shall be duly marked as 'Draft'.

         

        The Final Technical
        Progress Report addressing Contractor’s consideration of the feedback received from
        BARDA and containing a summation of the work performed and the results obtained for the entire contract period of performance.
        This final report shall detail, document and summarize the results of the entire contract. This report shall be in sufficient
        detail to fully describe the progress achieved under all milestones. The final report shall be duly marked as 'Final'.
        
	·Contractor
        shall provide a draft Technical Progress Report 75 calendar days before the end of the POP and the Final Technical Progress
        Report shall be submitted on or before the completion date of the POP 

        ·COTR
        provides suggested edits and additional feedback, which Contractor will consider for incorporation into the Final Technical
        Progress Report 

        ·The
        Contractor shall submit one (1) copy of a comprehensive final report to the CO and one (1) copy (electronically on a CD)
        to the COTR
	1 Electronic Copy to COTR and CO

        

         

	10.	Product Transition
    Strategy	90 days prior to end
    of the	Contractor shall provide
        a 2-3 page summary document containing a Product Transition Strategy to 	·Contractor
shall provide a Product Transition Strategy to support
	1 Electronic
Copy to 

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
		
    	 (base/option) POP	support
transition of the product(s) prior to end of the base and/or option(s) POP. The Product Transition Strategy should provide a strategic
plan for further development and/or stockpiling of the product.

         

        The transition strategy shall provide options and/or
        a specific approach for the transition of MCM product for further development, procurement, approval by FDA and/or stockpile.
	transition
of the product(s) 90 days prior to end of the (base/option) POP as an addendum to that Quarter’s Quarterly Project Status
Report.
	COTR and CO

        

         

	11.	GO/NO GO Decision
    Gate Presentation	Event Driven Review
    following completion of a pre-defined stage of product development and prior to initiation of a new stage	Contractor
    shall provide a presentation following a prescribed template provided by BARDA prior to the Decision Gate Review	·Contractor
        shall provide an update to technical progress made towards completion of the GO/NO GO Decision
        Gate and provide the presentation, 10 business days prior to the Decision Gate Review

        ·Contractor
        shall submit written justification of progress towards satisfying GO/NO GO Decision
        Gate criteria

        ·After
        reviewing, the BARDA COTR and CO will provide a written response. 
	1 Electronic Copy to COTR and CO

        

         

         

	12.	Standard Operating
    Procedures	As requested by COTR
    and CO	Contractor
    shall provide Standard Operating Procedures (SOPs) relevant to the activities under this contract to BARDA for review,
    as they are completed and updated	·Contractor
    shall submit the Standard Operating Procedures (SOPs) in the form requested by the COTR
    and CO within 15 business days of request	1
    Electronic Copy to COTR and CO
	13.	Approval Strategy	Within 90 days of
    contract award and updated as part of the quarterly report (if strategy changes)	Contractor
    shall provide a 2-3 page summary of the approval strategy for all indications supported by this contract to include
    all clinical and non-clinical studies	·Contractor
        will submit proposed clinical and non-clinical strategy to support approval

        ·If
        corrective action is recommended by the BARDA COTR, the Contractor shall address in writing its consideration of concerns
        raised by BARDA 
	1
    Electronic Copy to COTR and CO
	14.	Study Protocol	At least 8 business
    	Contractor shall provide Pre-Clinical/Non-Clinical/ Clinical Trial

	· Contractor
        will submit proposed protocols to
	
1 Electronic 

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
			days for BARDA to review protocols prior to FDA submission and 30 days for study protocols that are not submitted to FDA	Protocols for studies funded under this contract to BARDA for review,
        prior to FDA submission
         

        (The CO and COTR reserves the right to request within
        the period of performance a non-proprietary Study Protocol for distribution within the United States Government(USG))
	·BARDA at least 8 business days prior to FDA submission or at least 30 days prior to
        study execution for study protocols that are not being submitted to the FDA 

        ·If
        corrective action is recommended , the Contractor must address in writing its consideration of all safety, regulatory,
        ethical, and conflict of interest concerns raised by BARDA 

        ·After
        receiving the required documentation the CO will provide a written Contract Officer Authorization (COA) Letter to the
        Contractor. This COA Letter provides authorization to the Contractor to execute the specific clinical or non-clinical
        study funded in part or in whole by BARDA

        ·If
        study protocols require submission to the FDA prior to execution, then FDA shall have final authority over Study Protocols
        and all amendments thereto.

        ·Final
        FDA submissions shall be submitted to BARDA concurrently or no later than 1 business day after its submission to CDER

         
	Copy to COTR and CO

        

         

	15.	Study Reports	Within 45 (draft)
    or 75 (final) calendar days after completion of analysis and 8 	Contractor shall provide
        Draft and Final Pre-Clinical/Non-Clinical Study Reports for studies funded under this contract to BARDA for review
        and edits within 45 (draft) or 75 (final) calendar days after completion of analysis of Pre-Clinical/Non-Clinical/ Clinical
        data and 15 business days	·Contractor shall provide Draft and Final Pre-Clinical/Non-Clinical Study Reports to BARDA within 45 (draft) or 75 (final) calendar days after completion of analyses
	
Electronic Copy to COTR and CO 

 

    	25

    	 

    

 

	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
			business days prior to submission to FDA	prior
to submission to FDA

         

        (The CO and COTR reserves the right to request within
        the period of performance a non-proprietary Study Report for distribution within the USG)

         

        Contractor shall submit an interim study report to
        BARDA for any severable discrete work segments. If funding for a severable study is scheduled in two separate periods
        of performance than an interim study report is due on or before the completion date of the POP
	

        ·Contractor
        will submit proposed Pre-Clinical/Non-Clinical Study Report to BARDA for review
        and comment at least 8 business days prior to FDA Submission

        ·If
        corrective action is recommended , the Contractor must address in writing its consideration of all concerns raised by
        BARDA before FDA Submission

        ·Final
        FDA submissions shall be provided to BARDA concurrently or no later than 1 business day of its submission to CDER
	

 
        

	16.	Manufacturing Campaign
    Reports	Within 30 calendar
    days after receipt of batch records and 8 business days prior to submission to FDA	Contractor shall provide
        any Manufacturing Campaign Reports required by FDA to BARDA for review and comment prior to submission to FDA

         

        (The CO and COTR reserve the right to request within
        the period of performance a non-proprietary Manufacturing Campaign Reports for distribution within the USG)
	·Contractor
        will submit proposed Manufacturing Campaign Reports to BARDA at least 8 business
        days prior to FDA Submission.

        ·If
        corrective action is recommended , the Contractor must address in writing its consideration of all concerns raised by
        BARDA before FDA Submission

        ·Final
        FDA submissions shall be submitted to BARDA concurrently or no later than one (1) business day after its submission to
        CDER
	1
    Electronic Copy to COTR and CO
	17.	FDA Meeting Notification	Within 24 hours of
    scheduling meeting	The
    contractor shall forward the dates and times of any meeting with the FDA relating to work funded under this contract to BARDA
    and to the extent practicable arrange for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up
    to a maximum of four people (PO, CO, and up to two (2) Subject Matter Experts (SME(s)).	·Contractor
    must notify BARDA of an upcoming meeting with the FDA relating to work funded under this contract within
    24 hours of scheduling the meeting, if practicable. To the extent practicable, Contractor will give	1
    Electronic Copy to COTR and CO

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	 	 	 	 	BARDA 10 business days
    notice prior to the scheduled meeting.	 
	18.	FDA Correspondence
    and Meeting Minutes	Within three (3) business
    days of receiving correspondence from the FDA	The
    contractor shall forward initial Contractor and CDER-issued draft minutes and final minutes of any meeting with the FDA relating
    to work funded under this contract to BARDA. All documents shall be duly marked as either 'Draft' or 'Final'.	·Contractor
    provides FDA correspondence and meeting minutes within three (3) business days of the
    meeting or correspondence
	1
Electronic Copy to COTR and CO

	19.	FDA Submissions	At least 15 business
    days where practicable, but no less than 8 business days prior to submission to FDA	The Contractor shall provide BARDA the opportunity
        to review and comment upon all draft regulatory filings and other material submissions and correspondence relating to
        work funded under this contract before submission to the FDA. Contractors shall provide BARDA with an electronic copy
        of the final FDA submission. All documents shall be duly marked as either 'Draft' or 'Final'.

         

         
	·Contractor
        will submit proposed FDA Meeting Briefing Packets to BARDA at least 15 business days where practicable, but no
        less than 8 business days prior to FDA submission
        

        ·If
        corrective action is recommended , the Contractor must address in writing its consideration of all concerns raised by
        BARDA staff before FDA submission

        ·Final
        FDA submissions shall be submitted to BARDA concurrently or no later than one (1) business day of its submission to CDER
	1
    Electronic Copy to COTR and CO 
	20.	FDA Audits	Within 10 business
    days of a scheduled audit or within 24 hours of an ad hoc site visits/audits if the FDA did not provide advanced notification	The
Contractor shall notify the COTR and CO within 24 hours of FDA's arrival to conduct site visits/audits by any regulatory agency.
In the event of an FDA inspection which occurs as a result of this contract and for this product, or for any other FDA inspection
that has the reasonable potential to impact the performance of this contract, the Contractor shall provide BARDA with an exact
copy (non-redacted of the FDA Form 483, Establishment Inspection Report (EIR). The contractor shall provide the COTR and CO copies
of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit
report within 10 business days, status updates	·The
        Contractor shall notify the COTR and CO within 10 business days of a scheduled audit or within 24 hours of an ad hoc site
        visits/audits if the FDA did not provide advanced notification. Contractor must provide QA Audit Reports within 15 business
        days of the audit.

        ·The
        Contractor shall also provide copies of any FDA audit report received from subcontractors that occur as a result of this
        contract or for this product within three (3)

         
	1 Electronic Copy to COTR and CO

        

         

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	 	 	 	during the plan’s execution, and a copy of all final responses
    to the FDA. The Contractor shall also provide redacted copies of any FDA audit report received from subcontractors that occur
    as a result of this contract or for this product within three (3) business days of receiving correspondence from the FDA and/or
    third party. The Contractor shall make arrangements for a BARDA representative(s) to be present during the final debrief by
    the regulatory inspector.	business days of receiving such a report from the FDA and/or third party	 
	21.	QA Audit Reports	5 business days of
    report completion	The
    Contractor shall inform the COTR and CO in advance of upcoming audits/site visits of subcontractors
    funded under this contract as part of the regularly scheduled communications, including goals and agenda. BARDA reserves
    the right to observe the audit. Upon completion of the audit/site visit the Contractor shall provide a report capturing the
    findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, details
    addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report,
    must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans
    for corrective action execution.	·The
        Contractor shall inform the COTR and CO 10 days in advance of upcoming audits/site visits of subcontractors 

        ·The
        Contractor shall notify the COTR and CO within 5 business days of report completion
	1 Electronic Copy to COTR and CO

        

         

	22.	BARDA Audit	Ad Hoc	The
    contractor shall accommodate periodic or ad hoc site visits by BARDA. If BARDA or the
    Contractor identifies any material issues during an audit, the Contractor shall capture the issues, identify potential solutions,
    and provide a report to BARDA. 	·If
        BARDA or the Contractor identifies any material issues during an audit, the Contractor shall capture the issues, identify
        potential solutions, and provide a report to BARDA within 10 business days.

        ·The
        COTR and CO will review the deliverable and provide a response to the Contractor.

        ·If
        corrective action is recommended and

         
	1
    Electronic Copy to COTR and CO

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
	 	 	 	 	undertaken, then Contractor will provide a final report to BARDA upon completion.	 
	23.	Technical Documents	Within 10 business
    days upon request by CO/COTR and 8 business days prior to submission to FDA	Contractor shall provide COTR and CO upon request with
        deliverables from the following contract funded activities: Process Development Reports, Assay Qualification Plan/Report,
        Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, SOPs, Master Production Records, Certificate
        of Analysis

         

        (The CO and COTR reserves the right to request within
        the period of performance a non-proprietary Technical Documents for distribution within the USG)
	·Contractor
        shall provide Technical documents within 10 business days upon request by CO/COTR 

        ·If
        additional time is required, Contractor shall request additional time from BARDA on a per deliverable basis

        ·If
        corrective action is recommended , the Contractor must address in writing its consideration of concerns raised by BARDA

        ·Contractor
        will submit proposed FDA Technical Documents to BARDA at least 5 business days
        prior to FDA submission 

        ·If
        corrective action is recommended, the Contractor must address in writing its consideration of all concerns raised by BARDA
        before FDA Submission
	For Final Documents:

         

        1 Electronic Copy to COTR and CO

        

         

         

	24.	Animal Model or Other
    Technology Transfer Package	Within 10 business
    days of request by CO/COTR	Contractor
    shall provide Animal Model or Other Technology Transfer Package relevant data	·Contractor
    shall provide Animal Model or other Technology Transfer Package within 10 business days of request by CO/COTR	1 Electronic Copy to COTR and CO

        

         

	25.	EVMS Raw Data	Within 20 business
    days after receipt of request by CO/COTR	 

        Contractor shall provide EVMS Raw Data for review by
        BARDA, if requested, in accordance with FAR 52.215-2, Audit and Records-Negotiation

         

         
	·Contractor
    shall provide Raw Data within 20 business days of request by CO/COTR	1 Electronic Copy to COTR and CO

        

         

	26.	Samples of Therapeutics	Within 20 business
    	Contractor
    shall provide samples of non-GMP candidate therapeutics 	·Contractor must submit samples of therapeutics 
	CO
    will provide 

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
			days of request by CO/COTR	and
GMP material manufactured with contract funding to include raw material, Bulk Drug Substance (BDS), Final Drug Product (FDP) and/or
labeled and packaged treatment courses. The request will state the type of material and the amount but it is not to exceed the
equivalent of 250 treatment courses or its individual manufacturing equivalent. The Contractor will be advised by the CO how samples
are to be packaged and where samples are to be shipped. It is acceptable to label material "Not for Clinical Use".
BARDA reserves the right to request samples throughout the period of performance.	within 20 business days of request by CO/COTR.
        ·The
        Contractor will be advised by the CO how samples are to be packaged and where samples are to be shipped. 
	details upon request
	27.	Publications	20 business days for
    manuscripts and 10 business days for abstracts	Any
    manuscript or scientific meeting abstract containing data generated under this contract must be submitted to BARDA for review
    prior to submission 	·Contractor
        must submit all manuscript or scientific meeting abstract to COTR and CO within 20 business days for manuscripts
        and 10 business days for abstracts

        ·Any
        Final submissions shall be submitted to BARDA concurrently or no later than one (1) business day of its submission
	1 Electronic Copy to COTR and CO

        

         

	28.	Press Releases	4 business days prior
    to release	The
    Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases	·The
        Contractor shall ensure that the CO has received and approved an advanced copy of any press release to this contract not
        less than 4 business days prior to the issuance of the press release

        ·Any
        final submissions shall be submitted to BARDA concurrently or no later than one (1) business day of its submission.
	1 Electronic Copy to COTR and CO

        

         

	29.	Contract financing
    Report	No later than the
    30th business day after the end of the 	The
    Financial Report shall be submitted by the Contractor in accordance with the instructions set forth in section G.4 of this
    contract. 	The
    Contractor shall provide the contract financing report no later than the 30th business day after the end of the reporting
    period in 	 

 

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	#	Type of

    Deliverable	Frequency/

    time periods 	Description of Deliverable	Reporting Procedures	Quantity/

    Form
			reporting period		accordance with the instructions set forth in section G.4 of this contract. 	 

 

2. WBS Milestones/Deliverables
and Technical Deliverables 

 

	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	1.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	2.	[...***...]	
        [...***...]

        [...***...]
	
        [...***...]

        [...***...]
	
        [...***...]

        [...***...]

        [...***...]
	
        [...***...]

        [...***...]

         
	
        [...***...]

        [...***...]

	3.	[...***...]	[...***...]	[...***...]	
        [...***...][...***...][...***...]

        [...***...][...***...]
	[...***...][...***...]	
        [...***...]

        [...***...]

 

****Confidential Treatment Requested

 

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	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	4.	[...***...]	[...***...]	[...***...]	[...***...][...***...]	[...***...][...***...]	
        [...***...]

        [...***...]

	5.	[...***...]	[...***...]	[...***...]	
        [...***...]

        [...***...]

        [...***...]
	
        [...***...]

        [...***...]
	
        [...***...]

        [...***...]

        [...***...]

	6.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	7.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	8.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	 

 

****Confidential Treatment Requested

 

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	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	 	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	9.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...][...***...]	[...***...]
	10.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	11.	[...***...]	[...***...]	[...***...]	[...***...]	
        [...***...]

        [...***...]

        [...***...]

        [...***...]
	
        [...***...]

        [...***...]

        [...***...]

 

****Confidential Treatment Requested

 

    	33

    	 

    

 

	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	 	[...***...]	[...***...]	 	 	 	 
	12.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	13.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	14.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	15.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]

 

****Confidential Treatment Requested

 

    	34

    	 

    

 

	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	 	[...***...]	[...***...]	[...***...]	 	 	[...***...]
	16.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...] 
	17.	[...***...]	[...***...]	[...***...]	[...***...] 	[...***...]	[...***...] 
	18.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	19.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]

 

****Confidential Treatment Requested

 

    	35

    	 

    

 

	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	 	 	[...***...]	[...***...]	[...***...]	 	[...***...]
	20.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	21.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	
        [...***...]

        [...***...]

        [...***...]

	22.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	23.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	24.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]

 

****Confidential Treatment Requested

 

    	36

    	 

    

 

	Contract Milestones and GO/NO GO Decision Gates
	Milestone	Milestone	GO/NO GO Decision Gates	 	 	 
	#	Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	25.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]
	26.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]	[...***...]

 

Unless otherwise specified by the Contracting Officer, reports
to be furnished to the Government under this contract (including invoices), shall be delivered electronically along with a concurrent
email notification to the Contracting Officer, Contract Specialist, and COTR summarizing the electronic delivery.

 

In addition, unless otherwise specified by the Contracting
Officer, a physical hard copy of reports to be furnished to the Government under this contract (including invoices), shall be
sent and addressed as follows:

 

Contracting Officer’s and Contracting Specialist’s
address:

 

Ethan J. Mueller, Contracting Officer (CO)

DHHS/OS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

Ethan.Mueller@hhs.gov

 

 

****Confidential Treatment Requested

    	37

    	 

    

 

Contracting Officer’s Technical Representative’s
address:

 

Tyler Merkeley, M.S., MBA

Contracting Officer’s Technical Representative (COTR)

330 Independence Avenue, S.W.

Washington, D.C. 20201

202-260-0315 (Office)

Tyler.Merkeley@hhs.gov

 

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2
(FEBRUARY 1998)

 

The contract incorporates the following clause(s) by reference,
with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text
available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

 

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

 

52.242-15, Stop Work Order (August 1989) with Alternate I (April
1984).

 

    	38

    	 

    

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1. CONTRACTING OFFICER

 

The following Contracting Officer (CO)
will represent the Government for the purpose of this contract:

 

Ethan J. Mueller, Contracting Officer

DHHS/OS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 2020

E-mail: Ethan.Mueller@hhs.gov

 

		1)	The Contracting Officer is the only individual who can legally
                                                           commit the Government to the expenditure of public funds. No person
                                                           other than the Contracting Officer can make any changes to the terms,
                                                           conditions, general provisions, or other stipulations of this contract.

		2)	The Contracting Officer is the only person with the authority to
                                                           act as agent of the Government under this contract. Only the Contracting
                                                           Officer has authority to (1) direct or negotiate any changes in the
                                                           statement of work; (2) modify or extend the period of performance;
                                                           (3) change the delivery schedule; (4) authorize reimburse to the Contractor
                                                           of any costs incurred during the performance of this contract; (5)
                                                           otherwise change any terms and conditions of this contract.

		3)	No information other than that which may be contained in an authorized
                                                           modification to this contract, duly issued by the Contracting Officer,
                                                           which may be received from any person employed by the US Government,
                                                           other otherwise, shall be considered grounds for deviation from any
                                                           stipulation of this contract.

		4)	The Government may unilaterally change its COTR designation.

 

ARTICLE G.2. CONTRACTING OFFICER'S TECHNICAL REPRESENTATIVE
(COTR)

 

The following Contracting Officer's Technical Representative
(COTR) will represent the Government for the purpose of this contract:

 

Tyler Merkeley, M.S., MBA

Contracting Officer’s Technical Representative (COTR)

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

202-260-0315 (Office)

Tyler.Merkeley@hhs.gov

 

Mailing Address:

330 Independence Avenue, SW

Washington, D.C. 20201

202-260-0315 (Office)

e-mail: Tyler.Merkeley@hhs.gov

 

    	39

    	 

    

 

Alternate PO/COTR:

Dr. Joseph Larsen

Alternate Contracting Officer’s Technical Representative
(COTR)

BARDA/ASPR/HHS

330 Independence Avenue, SW

Washington, D.C. 20201

202-260-0050(Office)

e-mail: Joseph.Larsen@hhs.gov

 

The COTR is responsible for: (1) monitoring the Contractor's
technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes
in requirements; (2) assisting the contracting Officer in interpreting the statement of work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by
this contract; and (5) assisting in the resolution of technical problems encountered during performance.

 

ARTICLE G.3. KEY PERSONNEL

 

Pursuant to the Key Personnel clause incorporated in Section
I of this contract, the following individuals are considered to be essential to the work being performed hereunder:

 

	#	NAME	ORGANIZATION	TITLE
	1	[...***...]	Chimerix	[...***...]
	2	[...***...]	Chimerix	[...***...]
	3	[...***...]	Chimerix	[...***...]
	4	[...***...]	Chimerix	[...***...]
	5	[...***...]	Chimerix	[...***...]
	6	[...***...]	Chimerix	[...***...]
	7	[...***...]	Chimerix	[...***...]
	8	 	 	 
	9	 	 	 
	10	 	 	 
	11	 	 	 
	12	 	 	 
	13	 	 	 
	14	 	 	 
	15	 	 	 
	16	 	 	 

 

The key personnel specified in this contract
are considered to be essential to work performance. At least 30 business days prior to diverting any of the specified individuals
to other programs or contracts, including, where practicable, an instance when an individual must be replaced as a result of leaving
the employ of the Contractor, the Contractor shall notify the Contracting Officer and shall submit comprehensive justification
for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government
of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without
the written consent of the Contracting Officer.

 

***Confidential Treatment Requested

 

    	40

    	 

    

 

ARTICLE G.4. CONTRACT FINANCIAL REPORT

 

a. Financial reports on the attached Financial Report
of Individual Project/Contract (see Attachments 2 and 3) shall be submitted by the Contractor in accordance with the instructions
for completing this form, which accompany the form, in an original and two copies, not later than the 30th business day after
the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which
shall be reported within the total contract are discussed in paragraph e., below. Subsequent changes and/or additions in the line
entries shall be made in writing.

 

b. Unless otherwise stated in that part of the instructions
for completing this form, entitled " PREPARATION INSTRUCTIONS ," (see Attachment 4) all columns A through J, shall be
completed for each report submitted.

 

c. The first financial report shall cover the period
consisting of the first full three calendar months following the date of the contract, in addition to any fractional
part of the initial month. Thereafter, reports will be on a quarterly basis.

 

d. The Contracting Officer may require the Contractor
to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record
retention requirements in FAR Part 4.7.

 

e. The listing of expenditure categories to be reported
is incorporated within the Attachment entitled, "Financial Report of Individual Project/Contract," located in SECTION
J and made a part of this contract.

 

f. The Government may unilaterally revise the “Financial
Report of Individual Project/Contract” to reflect the allotment of additional funds.

 

ARTICLE G.5. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL
REPORTING

 

		1)	The Contractor shall submit an electronic copy of contract monthly
                                                           invoices/financial reports to the address shown below:

 

DHHS/OS/ASPR/AMCG

Attn: Ethan J. Mueller, Contracting Officer

330 Independence Ave., S.W.

Room G640

Washington, D.C. 20201

 

		2)	Contractor invoices/financial reports shall conform to
the form, format, and content requirements of the instructions for Invoice/Financing requests and Contract Financial Reporting
made a part of the contract in Section J (See also Attachment 2) .

 

		3)	Monthly invoices must include the cumulative total expenses to
                                                           date, adjusted (as applicable) to show any amounts suspended by the
                                                           Government.

 

		4)	The Contractor agrees to immediately
                                                           notify the Contracting Officer in writing if there is an anticipated
                                                           overrun (any amount) or unexpended balance (greater than 10 percent)
                                                           of the estimated costs for the base segment or any option segment(s)
                                                           (See estimated costs under Articles B.2. and B.3., CLINs 0001 through
                                                           0005 to the contract) and the reasons for the variance. Also refer
                                                           to the requirements of the Limitation of Cost FAR 52.232-20 clause
                                                           in the contract.

 

    	41

    	 

    

 

		5)	All invoice submissions shall be in
                                                           accordance with FAR Clause 52.232-25 (c) in Section I of this contract.

 

ARTICLE G.6. REIMBURSEMENT OF COST

 

		1)	The Government shall reimburse the Contractor the cost determined
                                                           by the Contracting Officer to be allowable (hereinafter referred to
                                                           as allowable cost) in accordance with the clause entitled Allowable
                                                           Cost and Payment in Section I, Contract Clauses, and FAR Subpart 31.2.
                                                           Examples of allowable costs include, but are not limited to, the following:

 

		a)	All direct materials and supplies
                                                                that are used in the performing of the work provided for under
                                                                the contract, including those purchased for subcontracts and purchase
                                                                orders.

 

		b)	All direct labor, including supervisory,
                                                                that is properly chargeable directly to the contract, plus fringe
                                                                benefits.

 

		c)	All other items of cost budgeted
                                                                for and accepted in the negotiation of this basic contract or
                                                                modifications thereto.

 

		d)	Travel costs including per diem
                                                                or actual subsistence for personnel while in an actual travel
                                                                status in direct performance of the work and services required
                                                                under this contract subject to the following:

 

		(i)	Air travel shall be by the most direct
                                                             route using “air coach” or “air tourist”
                                                             (less than first class) unless it is clearly unreasonable or impractical
                                                             (e.g., not available for reasons other than avoidable delay in making
                                                             reservations, would require circuitous routing or entail additional
                                                             expense offsetting the savings on fare, or would not make necessary
                                                             connections).

 

		(ii)	Rail travel shall be by the most
                                                              direct route, first class with lower berth or nearest equivalent.

 

		(iii)	Costs incurred for lodging, meals,
                                                               and incidental expenses shall be considered reasonable and allowable
                                                               to the extent that they do not exceed on a daily basis the per
                                                               diem rates set forth in the Federal Travel Regulation (FTR).

 

		(iv)	Travel via privately owned automobile
                                                              shall be reimbursed at not more than the current General Services
                                                              Administration (GSA) FTR established mileage rate.

 

ARTICLE G.7. INDIRECT COST RATES

 

The following rates will be utilized for billing purposes during
the base period. Fringe benefits at [...***...]% and G&A at [...***...]%. The billing rates for each option period will be
based on the incurred cost submission for the previous calendar year, subject to Government audit adjustments. Final rate proposals must
be sent to the Contracting Officer, within 6 months subsequent to the fiscal year end. (See also FAR Clause 52.216-7 incorporated
herein)

 

****Confidential Treatment Requested

 

    	42

    	 

    

 

 

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

1. Contractor Performance Evaluations

 

Interim and final evaluations of Contractor performance
will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the
time of completion of work. In addition to the final evaluation, an interim evaluation shall be submitted June 29, 2012.

 

Interim and final evaluations will be provided to
the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review
the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties,
the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.

 

Copies of the evaluations, Contractor responses,
and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

 

2. Electronic Access to Contractor Performance
Evaluations

 

Contractors that have Internet capability may access
evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following
address:

 

http://oamp.od.nih.gov/OD/CPS/cps.asp

 

The registration process requires the Contractor
to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review
and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying
the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required
30-day time frame.

 

ARTICLE G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY
1999)

 

The Contractor shall identify all correspondence, reports,
and other data pertinent to this contract by imprinting the contract number from Page 1 of the contract.

 

    	43

    	 

    

 

ARTICLE G.10. GOVERNMENT PROPERTY

 

1. In addition to the requirements of the clause, GOVERNMENT
PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's
Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed
at:

 

http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf
.. Among other issues, this publication provides a summary of the Contractor's responsibilities regarding purchasing
authorizations and inventory and reporting requirements under the contract.

 

2.
Notwithstanding the provisions outlined in the HHS Publication, "Contractor's Guide for Control of Government
Property," which is incorporated in this contract in paragraph 1. above, the Contractor shall use the form entitled, "Report
of Government Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by
the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

 

3. Title will vest in the Government for equipment purchased
as a direct cost.

 

SECTION H - SPECIAL CONTRACT REQUIREMENTS

 

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS,
HHSAR 352.270-4 (January 2006)

 

			(a) The Contractor agrees that the rights and welfare of human subjects
                                                         involved in research under this contract shall be protected in accordance
                                                         with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance
                                                         on file with the Office for Human Research Protections (OHRP), Department
                                                         of Health and Human Services. The Contractor further agrees to provide
                                                         certification at least annually that the Institutional Review Board has
                                                         reviewed and approved the procedures, which involve human subjects in
                                                         accordance with 45 CFR Part 46 and the Assurance of Compliance.

 

(b) The Contractor shall bear full responsibility
for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work
is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to
control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to
constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution,
or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this
contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional
judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the
Contractor or its employees.

 

    	44

    	 

    

 

(c) If at any time during the performance of this
contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the
requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole
or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer
may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective
action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer
may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's name may be removed from
the list of those contractors

with approved Human Subject Assurances.

 

ARTICLE H.2. HUMAN MATERIALS (ASSURANCE
OF OHRP COMPLIANCE)

 

The acquisition and supply of all human specimen
material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable
Federal, State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation of human material.

 

The Contractor shall provide written documentation
that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating
sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research
Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction
applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured
by the Contractor.

 

Provision by the Contractor to the Contracting Officer
of a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption",
Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials
were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self
designated form provided that it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310).

 

ARTICLE H.3. RESEARCH INVOLVING HUMAN FETAL
TISSUE

 

All research involving human fetal tissue shall
be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance
for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/guide/notice-files/not93-235.html
 and any subsequent revisions to this NIH Guide to Grants and Contracts ("Guide") Notice.

 

The Contractor shall make available, for audit by
the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access
to those records, if maintained by an entity other than the Contractor.

 

ARTICLE H.4. NEEDLE EXCHANGE

 

The Contractor shall not use contract funds to
carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

 

ARTICLE H.5.

 

RESERVED.

 

    	45

    	 

    

  

ARTICLE H.6. CARE OF LIVE VERTEBRATE ANIMALS,
HHSAR 352.270-5 (October 2009)

 

(a) Before undertaking performance of any contract
involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of
Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish
evidence of the registration to the Contracting Officer.

 

(b) The Contractor shall acquire vertebrate animals
used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from
a source that is exempt from licensing under those sections.

 

(c) The Contractor agrees that the care, use and
intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS)
Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for
the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the
United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between
standards, the more stringent standard shall govern.

 

(d) If at any time during performance
of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National
Institutes of

 

Health (NIH), that the Contractor is not in compliance
with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately
suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice
of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action
within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in
consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list
of those contractors with approved Assurances.

 

Note: The Contractor may request registration of
its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service
(APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office,
as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road,
Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/animal_welfare).

 

ARTICLE H.7. ANIMAL WELFARE

 

All research involving live, vertebrate animals
shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy
may be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm

  

ARTICLE H.8. PROTECTION OF PERSONNEL WHO WORK
WITH NONHUMAN PRIMATES

 

All Contractor personnel who work with nonhuman
primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy

 

    	46

    	 

    

 

Manual 3044-2, entitled, "Protection of
NIH Personnel Who Work with Nonhuman Primates," located at the following URL:

http://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/

 

ARTICLE H.9. PUBLICATION AND PUBLICITY

 

No information related to data obtained under this
contract shall be released or publicized without the prior written consent of the Contracting Officer Technical Representative.

 

In addition to the requirements set forth in HHSAR
Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge
the support of the Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in
any media by including an acknowledgment substantially as follows:

"This project has been funded in whole or in part
with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness
and Response, Office of the Secretary, Department of Health and Human Services, under Contract No.                          
"

 

ARTICLE H.10. REPORTING MATTERS INVOLVING
FRAUD, WASTE AND ABUSE

 

Anyone who becomes aware of the existence or apparent
existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General's
Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone
calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

 

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

 

ARTICLE H.11. PROHIBITION ON CONTRACTOR
INVOLVEMENT WITH TERRORIST

 

ACTIVITIES

 

The Contractor acknowledges that U.S. Executive
Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources
and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure
compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

 

ARTICLE H.12. CONFLICT OF INTEREST

 

The Contractor represents and warrants that, to
the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational
conflict of interest, as defined in FAR Subpart 9.5, or that the Contractor has disclosed all such relevant information. 
Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge
and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential
conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within
five (5) working days.  The Contractor agrees that if an actual or potential organizational conflict of interest is identified
during performance, the

 

    	47

    	 

    

  

Contractor shall promptly make a full disclosure in writing to the Contracting
Officer. This disclosure shall include a description of actions, which the Contractor has taken or proposes to take, after consultation
with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall
continue performance until notified by the Contracting Officer of any contrary action to be taken.  Remedies include termination
of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an
organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award
or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the
Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting,
or pursue such other remedies as may be permitted by law or this contract.

 

ARTICLE H.13. EXERCISE OF OPTIONS

 

Unless the Government exercises its option pursuant
to the Option Clause set forth in Section I, Article I.3, the contract will consist only of CLIN 0001 of the Statement
of Work, Deliverables and Requirements as defined in Sections C, F and J of the contract. Pursuant to FAR Clause 52.217-9 (Option
to Extend the Term of the Contract) set forth in Section I of this contract, under Article I.3., the Government may, by unilateral
contract modification, require the Contractor to perform any of the additional CLINs listed in Section B, Article B.3., and
as also defined in Sections C, F and J of this contract. If the Government exercises an option, written notice must be given to
the Contractor within 30 days after the Government has completed its analysis of the deliverables associated with the applicable
GO/NO GO Decision gate; and the Government must give the Contractor a preliminary written notice of its intent to exercise
the option at least 30 days before the contract expires. The amount of the contract may then be increased as set forth in Section
B, Article B.3 provided that funds are available.

 

ARTICLE H.14. PROHIBITION ON THE USE OF APPROPRIATED
FUNDS FOR LOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (Jan 2006)

 

The Contractor is hereby notified of the restrictions
on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

 

Section 1352 of Title 10, United Stated Code (Public
Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract,
grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person
for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee
of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding
of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative
agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions
against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

 

In addition, as set forth in HHSAR 352.203-70 “Anti-Lobbying”
(January 2006), the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation
contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or
propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television,
or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature
except in presentation to the Congress, or any State or Local legislative body itself.

 

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The current Department of Health and Human Services
Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses
of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation
or appropriations pending before the Congress, or any State or Local legislature.

 

ARTICLE H.15. PRIVACY ACT APPLICABILITY (Apr 2000)

 

		1)	Notification is hereby given that the Contractor and its employees
                                                           are subject to criminal penalties for violation of the Privacy Act
                                                           to the same extent as employees of the Government. The Contractor shall
                                                           assure that each of its employees knows the prescribed rules of conduct
                                                           and that each is aware that he or she can be subjected to criminal
                                                           penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy
                                                           Act Regulations, may be obtained at http://www.gpoaccess.gov/cfr/index.html

 

		2)	The Project Officer is hereby designated as the official who is
                                                           responsible for monitoring contractor compliance with the Privacy Act.

 

		3)	The Contractor shall follow the Privacy Act guidance as contained
                                                           in the Privacy Act System of Records number 09-25-0200. This document
                                                           may be obtained at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm

 

ARTICLE H.16. LABORATORY LICENSE REQUIREMENTS (May 1998)

 

The Contractor shall comply with all applicable
requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement
shall also be included in any subcontract for services under the contract.

 

ARTICLE H.17. DISSEMINATION OF INFORMATION (May 1998)

 

No
information related to data obtained under this contract shall be released or publicized without the prior written consent of
the Contracting Officer.

 

ARTICLE H.18. IDENTIFICATION AND DISPOSITION OF DATA

 

The Contractor will be required to provide certain data generated
under this contract to the Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data determined
by DHHS generated under this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration
(FDA) relevant to this contract for the time specified by the FDA.

 

ARTICLE H.19. INFORMATION ON COMPLIANCE WITH ANIMAL CARE
REQUIREMENTS

 

Registration with the U. S. Dept. of Agriculture (USDA) is
required to use regulated species of animals for biomedical purposes. USDA is responsible for the enforcement of the Animal Welfare
Act (7 U.S.C. 2131 et. seq.), http://www.nal.usda.gov/awic/legislat/awa.htm.

 

The Public Health Service (PHS) Policy is administered by the
Office of Laboratory Animal Welfare (OLAW) http://grants2.nih.gov/grants/olaw/olaw.htm. An essential requirement of the
PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every institution using live vertebrate animals
must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. Public Health Service.

 

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The PHS Policy requires that Assured institutions base their
programs of animal care and use on the Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/legislat/usdaleg1.htm
issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations
in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.

 

The Association for Assessment and Accreditation of Laboratory
Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs
of animal care for institutions at their request. Those that meet the high standards are given the accredited status. As of the
2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC Accreditation is not
required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as their primary evaluation tool.
They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. It is published
by the Federated of Animal Science Societies http://www.fass.org.

 

ARTICLE H.20. REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION
OF VERTEBRATE ANIMAL SUBJECTS

 

The PHS Policy on Humane Care and Use of Laboratory Animals
requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office
for Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the humane care and use of live
vertebrate animals involved in research activities supported by the PHS. The PHS Policy stipulates that an applicant organization,
whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS-supported research activities.
Also, the PHS policy defines “animal” as “any live, vertebrate animal used, or intended for use, in research,
research training, experimentation, biological testing or for related purposes”. This Policy implements and supplements
the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and
requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing
an institutional animal care and use program. This Policy does not affect applicable State or local laws or regulations that impose
more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with
the Animal Welfare Act as amended (7 USC 2131 et. seq.) and other Federal statutes and regulations relating to animals. These
documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301)
496-7163. See http://grants.nih.gov/grants/olaw/olaw.htm.

 

No PHS supported work for research involving vertebrate animals
will be conducted by an organization, unless that organization is operating in accordance with an approved Animal Welfare Assurance
and provides verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed
activity in accordance with the PHS policy. Applications may be referred by the PHS back to the institution for further review
in the case of apparent or potential violations of the PHS Policy. No award to an individual will be made unless that individual
is affiliated with an assured organization that accepts responsibility for compliance with the PHS Policy. Foreign applicant organizations
applying for PHS awards for activities involving vertebrate animals are required to comply with PHS Policy or provide evidence
that acceptable standards for the humane care and use of animals will be met. Foreign applicant organizations are not required
to submit IACUC approval, but should provide information that is satisfactory to the Government to provide assurances for the
humane care of such animals.

 

 

ARTICLE H.21. APPROVAL OF REQUIRED ASSURANCE BY OLAW

 

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Under governing regulations, federal funds which are administered
by the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (BARDA) shall
not be expended by the Contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved
in research activities by the Contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and
9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office of Laboratory Animal
Welfare (OLAW). Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with
the following restriction: Only activities which do not directly involve live vertebrate animals (i.e. are clearly severable and
independent from those activities that do involve live vertebrate animals) may be conducted by the Contractor or individual performance
sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional
information regarding OLAW may be obtained via the Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm.

 

ARTICLE H.22. REGISTRATION WITH THE SELECT AGENT PROGRAM
FOR WORK INVOLVING THE POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

 

Work involving select biological agents or toxins shall not
be conducted under this contract until the Contractor and any affected subcontractor(s) are granted a certificate of registration
or are authorized to work with the applicable select agents.

 

For prime or subcontract awards to domestic institutions who
possess, use, and/or transfer Select Agents under this contract, the institution must complete registration with the Centers for
Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection
Services (APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work involving Select Agents, in accordance
with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR 73, if the final registration
certificate is denied.

 

For prime or subcontract awards to foreign institutions who
possess, use, and/or transfer Select Agents under this contract, the institution must provide information satisfactory to the
Government that a process equivalent to that described in 42 CFR 73 (http://www.cdc.gov/od/sap/docs/42cfr73.pdf ) for U.S.
institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these
funds for any work directly involving the Select Agents. The Contractor must provide information addressing the following key
elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73.
The Government will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part
73. When requested by the contracting officer, the Contractor shall provide key information delineating any laws, regulations,
policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select
Agents. This includes summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the
purpose of security risk assessments, the Contractor must provide the names of all individuals at the foreign institution who
will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to
Select Agents under the contract.

 

Listings of HHS select agents and toxins, biologic agents and
toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent
Program Web site at http://www.cdc.gov/od/sap/.

 

    	51

    	 

    

 

ARTICLE H.23. EPA ENERGY STAR REQUIREMENTS

 

In compliance with Executive Order 12845 (requiring Agencies
to purchase energy efficient computer equipment) all microcomputers, including personal computers, monitors, and printers that
are purchased using Government funds in performance of a contract shall be equipped with or meet the energy efficient low-power
standby feature as defined by the EPA Energy Star program unless the equipment always meets EPA Energy Star efficiency levels.
The microcomputer, as configured with all components, must be Energy Star compliant.

 

This low-power feature must already be activated when the computer
equipment is delivered to the agency and be of equivalent functionality of similar power managed models. If the equipment will
be used on a local area network, the vendor must provide equipment that is fully compatible with the network environment. In addition,
the equipment will run commercial off-the-shelf software both before and after recovery from its energy conservation mode.

 

ARTICLE H.24. MANUFACTURING STANDARDS

 

The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts
210-211) and regulations pertaining to small molecules will be the standard to be applied for manufacturing, processing, packaging,
storage and delivery of this product.

 

If at any time during the life of the contract, the Contractor
fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured
drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity
or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from
the time such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period, the
Contractor fails to take such an action to the satisfaction of the USG Project Officer, or fails to provide a remediation plan
that is acceptable to the COTR, then the contract may be terminated.

 

ARTICLE H.25. EXPORT CONTROL NOTIFICATION

 

Offerors are responsible for ensuring compliance with all export
control laws and regulations that maybe applicable to the export of and foreign access to their proposed technologies. Offerors
may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22
CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).

 

ARTICLE H.26. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING
INTERESTS OF INVESTIGATORS

 

The Contractor shall comply with the requirements
of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure
that investigators (defined as the principal investigator and any other person who is responsible for the design, conduct, or
reporting of research funded under BARDA contracts) will not be biased by any conflicting financial interest.  For the purposes
of this part relating to financial interests, "Investigator" includes the Investigator's spouse and dependent children. 
45 CFR Part 94 is available at the following Web site:

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=9f130b6d2d48bb73803ca91ce943be3a;rgn=div5;view=text;node=45%3A1.0.1.1.53;idno=45;cc=ecfr

 

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As required by 45 CFR Part 94, the Contractor shall, at a minimum:

 

a. Maintain a written, enforceable policy on conflict of interest
that complies with 45 CFR Part 94 and inform each

investigator of the policy, the investigator's reporting responsibilities,
and the applicable regulations. The Contractor must take reasonable steps to ensure that investigators working as collaborators
or subcontractors comply with the regulations.

 

b. Designate an official(s) to solicit and review financial
disclosure statements from each investigator participating in BARDA-funded research. Based on established guidelines consistent
with the regulations, the designated official(s) must determine whether a conflict of interest exists, and if so, determine what
actions should be taken to manage, reduce, or eliminate such conflict. A conflict of interest exists when the designated official(s)
reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct,
or reporting of the BARDA-funded research. The Contractor may require the management of other conflicting financial interests
in addition to those described in this paragraph, as it deems appropriate. Examples of conditions or restrictions that might be
imposed to manage actual or potential conflicts of interests are included in 45 CFR Part 94, under Management of Conflicting Interests.

 

c. Require all financial disclosures to be updated during the
period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

 

d. Maintain records, identifiable to each award, of all financial
disclosures and all actions taken by the Contractor with respect to each conflicting interest 3 years after final payment or,
where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

 

e. Establish adequate enforcement mechanisms and provide for
sanctions where appropriate.

 

If a conflict of interest is identified, the Contractor
shall report to the Contracting Officer the existence of the conflicting interest found. This report shall be made and the conflicting
interest managed, reduced, or eliminated, at least on a temporary basis, within sixty (60) days of that identification.

 

If the failure of an investigator to comply with
the conflict of interest policy has biased the design, conduct, or reporting of the BARDA-funded research, the Contractor must
promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will take appropriate
action or refer the matter to the Contractor for further action which may include directions to the Contractor on how to maintain
appropriate objectivity in the funded research.

 

The Contracting Officer may at any time inquire into
the Contractor's procedures and actions regarding conflicts of interests in BARDA-funded research including a review of all records
pertinent to compliance with 45 CFR Part 94. The Contracting Officer may require submission of the records or review them on site.
On the basis of this review, the Contracting Officer may decide that a particular conflict of interest will bias the objectivity
of the BARDA-funded research to such an extent that further corrective action is needed or that the Contractor has not managed,
reduced, or eliminated the conflict of interest. The issuance of a Stop Work Order by the Contracting Officer may be necessary
until the matter is resolved.

 

If the Contracting Officer determines that BARDA-funded
clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been
designed, conducted, or reported by an investigator with a conflict of interest that was not disclosed or managed, the Contractor
must require disclosure of the conflict of interest in each public presentation of the results of the research.

 

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ARTICLE H.27. REVIEW OF PRESS RELEASES

 

The contractor agrees to accurately and factually represent
the work conducted under the contract in all press releases. Misrepresenting contract results or releasing information that is
injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public
release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the COTR
has received an advance copy of any press release related to the contract not less than four (4) working days prior to the issuance
of the press release.

 

PART II - CONTRACT CLAUSES

 

SECTION I - CONTRACT CLAUSES

 

ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE
(FEBRUARY 1998)

 

This contract incorporates the following clauses by reference,
with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full
text available. Also, the full text of a clause may be accessed electronically at these addresses: http://www.arnet.gov

 

General Clauses for Cost-Reimbursement Research and Development
Contract

 

		(1)	FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

	FAR

        CLAUSE NO.
	 	DATE	 	TITLE
	 	 	 	 	 
	52.202-1	 	Jul 2004	 	Definitions
	 	 	 	 	 
	52.203-3	 	Apr 1984	 	Gratuities (Over $100,000)
	 	 	 	 	 
	52.203-5	 	Apr 1984	 	Covenant Against Contingent Fees (Over $100,000)
	 	 	 	 	 
	52.203-6	 	Sep 2006	 	Restrictions on Subcontractor Sales to the Government (Over $100,000)
	 	 	 	 	 
	52.203-7	 	Oct 2010	 	Anti-Kickback Procedures (Over $100,000)
	 	 	 	 	 
	52.203-8	 	Jan 1997	 	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)
	 	 	 	 	 
	52.203-10	 	Jan 1997	 	Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
	 	 	 	 	 
	52.203-12	 	Oct 2010	 	Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
	 	 	 	 	 
	52.203-13	 	Apr 2010	 	Contractor Code of Business Ethics and Conduct
	 	 	 	 	 
	52.203-14	 	Dec 2007	 	Display of Hotline Poster
	 	 	 	 	 
	52.204-4	 	Aug 2000	 	Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
	 	 	 	 	 
	52.204-7	 	Apr 2008	 	Central Contractor Registration
	 	 	 	 	 
	52.209-6	 	Sep 2006	 	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for
    Debarment (Over $25,000)

 

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	52.215-2	 	Oct 2010	 	Audit and Records - Negotiation (Over $100,000)
	 	 	 	 	 
	52.215-8	 	Oct 1997	 	Order of Precedence - Uniform Contract Format
	 	 	 	 	 
	52.215-10	 	Oct 2010	 	Price Reduction for Defective Certified Cost or Pricing Data
	 	 	 	 	 
	52.215-12	 	Oct 2010	 	Subcontractor Certified Cost or Pricing Data (Over $500,000)
	 	 	 	 	 
	52.215-14	 	Oct 2010	 	Integrity of Unit Prices (Over $100,000)
	 	 	 	 	 
	52.215-15	 	Oct 2010	 	Pension Adjustments and Asset Reversions
	 	 	 	 	 
	52.215-18	 	Jul 2005	 	Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
	 	 	 	 	 
	52.215-19	 	Oct 1997	 	Notification of Ownership Changes
	 	 	 	 	 
	52.215-21	 	Oct 2010	 	Requirements for Certified Cost or Pricing Data or Information Other Than Certified Cost or Pricing Data – Modifications
	 	 	 	 	 
	52.216-7	 	Dec 2002	 	Allowable Cost and Payment (Note: the following language is included in this clause – "(3) The designated payment
    office will make interim payments for contract financing on the 30th day after the designated billing office receives
    a proper payment request...”
	 	 	 	 	 
	52.216-8	 	Mar 1997	 	Fixed Fee
	 	 	 	 	 
	52.219-8	 	Dec 2010	 	Utilization of Small Business Concerns (Over $100,000)
	 	 	 	 	 
	52.219-9	 	Oct 2010	 	Small Business Subcontracting Plan (Over $500,000)
	 	 	 	 	 
	52.219-16	 	Jan 1999	 	Liquidated Damages - Subcontracting Plan (Over $500,000)
	 	 	 	 	 
	52.222-3	 	Jun 2003	 	Convict Labor
	 	 	 	 	 
	52.222-19	 	Jul 2010	 	Child Labor – Cooperation with Authorities and Remedies
	 	 	 	 	 
	52.222-21	 	Feb 1999	 	Prohibition of Segregated Facilities
	 	 	 	 	 
	52.222-26	 	Mar 2007	 	Equal Opportunity
	 	 	 	 	 
	52.222-35	 	Sep 2010	 	Equal Opportunity for Veterans
	 	 	 	 	 
	52.222-36	 	Oct 2010	 	Affirmative Action for Workers with Disabilities
	 	 	 	 	 
	52.222-37	 	Sep 2010	 	Employment Reports on Veterans
	 	 	 	 	 
	52.222-50	 	Feb 2009	 	Combating Trafficking in Persons
	 	 	 	 	 
	52.222-54	 	Jan 2009	 	Employment Eligibility Verification
	 	 	 	 	 
	52.223-6	 	May 2001	 	Drug-Free Workplace
	 	 	 	 	 
	52.223-14	 	Aug 2003	 	Toxic Chemical Release Reporting (Over $100,000)
	 	 	 	 	 
	52.224-1	 	April 1984	 	Privacy Act Notification
	 	 	 	 	 
	52.224-2	 	April 1984	 	Privacy Act
	 	 	 	 	 
	52.225-1	 	Feb 2009	 	Buy American Act – Supplies

 

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	52.225-13	 	Jun 2008	 	Restrictions on Certain Foreign Purchases
	 	 	 	 	 
	52.227-1	 	Dec 2007	 	Authorization and Consent, Alternate I (Apr 1984)
	 	 	 	 	 
	52.227-2	 	Dec 2007	 	Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)
	 	 	 	 	 
	52.227-11	 	Dec 2007	 	Patent Rights - Ownership by the Contractor
	 	 	 	 	 
	52.227-14	 	Dec 2007	 	Rights in Data – General, Alternate II (Dec 2007)
	 	 	 	 	 
	52.229-8	 	Mar 1990	 	Taxes—Foreign Cost-Reimbursement Contracts
	 	 	 	 	 
	52.230-4	 	Jun 2010	 	Disclosure and Consistency of Cost Accounting Practices—Foreign Concerns
	 	 	 	 	 
	52.232-9	 	Apr 1984	 	Limitation on Withholding of Payments
	 	 	 	 	 
	52.232-17	 	Oct 2010	 	Interest (Over $100,000)
	 	 	 	 	 
	52.232-20	 	Apr 1984	 	Limitation of Cost
	 	 	 	 	 
	52.232-23	 	Jan 1986	 	Assignment of Claims
	 	 	 	 	 
	52.232-25	 	Oct 2008	 	Prompt Payment
	 	 	 	 	 
	52.232-33	 	Oct 2003	 	Payment by Electronic Funds Transfer—Central Contractor Registration
	 	 	 	 	 
	52.233-1	 	Jul 2002	 	Disputes
	 	 	 	 	 
	52.233-3	 	Aug 1996	 	Protest After Award, Alternate I (June 1985)
	 	 	 	 	 
	52.233-4	 	Oct 2004	 	Applicable Law for Breach of Contract Claim
	 	 	 	 	 
	52.242-1	 	Apr 1984	 	Notice of Intent to Disallow Costs
	 	 	 	 	 
	52.242-3	 	May 2001	 	Penalties for Unallowable Costs (Over $500,000)
	 	 	 	 	 
	52.242-4	 	Jan 1997	 	Certification of Final Indirect Costs
	 	 	 	 	 
	52.242-13	 	Jul 1995	 	Bankruptcy (Over $100,000)
	 	 	 	 	 
	52.242-15	 	Aug 1989	 	Stop Work Order. Alt I (Aug 1984)
	 	 	 	 	 
	52.243-2	 	Aug 1987	 	Changes - Cost Reimbursement, Alternate V (Apr 1984)
	 	 	 	 	 
	52.244-2	 	Oct 2010	 	Subcontracts
	 	 	 	 	 
	52.244-5	 	Dec 1996	 	Competition in Subcontracting (Over $100,000)
	 	 	 	 	 
	52.244-6	 	Oct 2010	 	Subcontracts for Commercial Items
	 	 	 	 	 
	52.245-1	 	Aug 2010	 	Government Property
	 	 	 	 	 
	52.245-9	 	Aug 2010	 	Use and Charges
	 	 	 	 	 
	52.246-23	 	Feb 1997	 	Limitation of Liability (Over $100,000)
	 	 	 	 	 
	52.249-6	 	May 2004	 	Termination (Cost-Reimbursement)
	 	 	 	 	 
	52-249-14	 	Apr 1984	 	Excusable Delays
	 	 	 	 	 
	52.253-1	 	Jan 1991	 	Computer Generated Forms

 

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		(2)	DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
                                                            (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

	HHSAR

CLAUSE NO.	 	DATE	 	TITLE
	 	 	 	 	 
	352.202-1	 	Jan 2006	 	Definitions - with Alternate paragraph (h) (Jan 2001)
	 	 	 	 	 
	352.203-70	 	Jan 2006	 	Anti-Lobbying
	 	 	 	 	 
	352.216-70	 	Jan 2006	 	Additional Cost Principles
	 	 	 	 	 
	352.227-70	 	Jan 2006	 	Publications and Publicity
	 	 	 	 	 
	352.228-7	 	Dec 1991	 	Insurance - Liability to Third Persons
	 	 	 	 	 
	352.231-71	 	Jan. 2001	 	Pricing of adjustments.
	 	 	 	 	 
	352.233-71	 	Jan 2006	 	Litigation and Claims
	 	 	 	 	 
	352.234-3	 	Oct 2008	 	Full Earned Value Management System
	 	 	 	 	 
	352.242-70	 	Jan 2006	 	Key Personnel
	 	 	 	 	 
	352.242-73	 	Jan 2006	 	Withholding of Contract Payments
	 	 	 	 	 
	352.242-74	 	Apr 1984	 	Final Decisions on Audit Findings

 

ARTICLE I.2. ADDITIONAL CONTRACT CLAUSES

 

This contract incorporates the following clauses
by reference, with the same force and effect, as if they were given in full text.  Upon request, the Contracting Officer
will make their full text available.

 

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1)
CLAUSES

 

		1.	FAR
                                                                                                                                       Clause
                                                                                                                                       52.215-17,
                                                                                                                                       Waiver
                                                                                                                                       of
                                                                                                                                       Facilities
                                                                                                                                       Capital
                                                                                                                                       Cost
                                                                                                                                       of
                                                                                                                                       Money
                                                                                                                                       (October
                                                                                                                                       1997).

 

		2.	FAR
                                                                                                                                       Clause
                                                                                                                                       52.219-25,
                                                                                                                                       Small
                                                                                                                                       Disadvantaged
                                                                                                                                       Business
                                                                                                                                       Participation
                                                                                                                                       Program—Disadvantaged
                                                                                                                                       Status
                                                                                                                                       and
                                                                                                                                       Reporting
                                                                                                                                       (April
                                                                                                                                       2008).

 

		3.	FAR
                                                                                                                                       Clause
                                                                                                                                       52.227-16,
                                                                                                                                       Additional
                                                                                                                                       Data
                                                                                                                                       Requirements
                                                                                                                                       (June
                                                                                                                                       1987).

 

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CHAPTER 3) CLAUSES:

 

1. HHSAR Clause 352.223-70, Safety and Health (January
2006).

2. HHSAR Clause 352.224-70, Privacy Act (January
2006).

3. HHSAR Clause 352.201-70, Paperwork Reduction
Act (January 2006).

 

    	57

    	 

    

 

ARTICLE I.3. ADDITIONAL FAR CONTRACT CLAUSES
INCLUDED IN FULL TEXT

 

This contract incorporates the following clauses
in full text.

 

FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER
1)CLAUSES:

 

a.FAR Clause 52.217-9, Option to Extend the
Term of the Contract (Mar 2000)

 

(a)   The Government may extend the term of this contract by
written notice to the Contractor within 30 days after the Government has completed its analysis of the deliverables associated
with the applicable GO/NO GO Decision gate; provided that the Government gives the Contractor a preliminary written notice
of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to
an extension.

 

(b)   If the Government exercises this option, the extended contract
shall be considered to include this option clause.

 

(c)   The total duration of this contract, including the exercise
of any options under this clause, shall not exceed 5 years.

 

b.   FAR Clause 52.219-28, Post-Award Small Business
Program Representation (April 2009).

 

(a) Definitions . As used in this clause—

 

Long-term contract means
a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five
years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the
clause at 52.217-8, Option to Extend Services, or other appropriate authority.

Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant
in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria
in 13 CFR part 121 and the size standard in paragraph (c) of this clause.  Such a concern is "not dominant in its field
of operation" when it does not exercise a controlling or major influence on a national basis in a kind of business activity
in which a number of business concerns are primarily engaged.  In determining whether dominance exists, consideration shall
be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status
or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature
of business activity.

 

(b) If the Contractor represented that it was a small
business concern prior to award of this contract, the Contractor shall represent its size status according to paragraph (e) of
this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following:

 

(1) Within 30 days after execution of a novation agreement
or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion
of this clause in the contract.

 

(2) Within 30 days after a merger or acquisition that
does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition
occurred prior to inclusion of this clause in the contract.

 

    	58

    	 

    

 

(3) For long-term contracts—

 

(i) Within 60 to 120 days prior to the end of the fifth
year of the contract; and

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

 

(c) The Contractor shall represent its size status
in accordance with the size standard in effect at the time of this representation that corresponds to the North American Industry
Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code
can be found at http://www.sba.gov/contractingopportunities/officials/size/index.html .

 

(d) The small business size standard for a Contractor
providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500
employees.

(e) Except as provided in paragraph (g) of this clause,
the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations
in the Online Representations and Certifications Application and its data in the Central Contractor Registration, as necessary,
to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting office in writing within
the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of
the validation or update.

 

(f) If the Contractor represented that it was other
than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required
by paragraphs (e) or (g) of this clause.

 

(g) If the Contractor does not have representations
and certifications in ORCA, or does not have a representation in ORCA for the NAICS code applicable to this contract, the Contractor
is required to complete the following representation and submit it to the contracting office, along with the contract number and
the date on which the representation was completed:

 

[...***...].

 

[Contractor to sign and date and insert authorized
signer's name and title].

 

***Confidential Treatment Requested

 

    	59

    	 

    

 

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

SECTION J - LIST OF ATTACHMENTS

 

The following documents are attached and incorporated
in this contract:

 

1. Statement of Work

 

Statement of Work, dated 10 February 2011.

 

2. Invoice/Financing Request Instructions and
Contract Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts,

 

Invoice/Financing Request Instructions and Contract
Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts, 5 pages.

 

3. Financial Report of Individual Project/Contract,
1 page

 

4. Instructions for Completing Financial Report
of Individual Project/Contract, 3 pages

 

5. Inclusion Enrollment Report

 

Inclusion Enrollment Report, 5/01 (Modified OAMP:
10/01), 1 page.

 

6. Research Patient Care Costs

 

Research Patient Care Costs, 1 page.

 

7. Report of Government Owned, Contractor Held
Property

 

Report of Government Owned, Contractor Held Property,
dated 12/2/09, 1 page. Located at: http://rcb.cancer.gov/rcb-internet/forms/Govt-Owned-Prop.pdf (Not Attached)

 

8. Earned Value Management (EVM) Requirements

 

9. 7 Principles of Earned Value Management Tier
2 System Implementation Intent Guide

 

10. Communication Management Plan

 

11. Non-Clinical and Clinical Terms of Award

 

    	60

    	 

    

 

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER
STATEMENTS OF OFFERORS

 

The following documents are incorporated by reference in this
contract:

 

	1)	Annual Representations and Certifications completed at the Online Representations Applications (ORCA) website.
	 	 
	2)	Representations & Certifications dated 3 December 2010.
	 	 
	3)	Human Subjects Assurance Identification Number: 00010398.
	 	 
	4)	Animal Welfare Assurance Numbers:

  

	 	Battelle	A3034-01
	 	USAMRIID	A3473-01

 

    	61

    	 

    

 

Attachment 1 - Statement of Work.
dated 10 February 2011

 

    	 

    	 

    
  

BARDA
Broad Agency Announcement (BAA)

(CBRN-BAA-10-100-SOL-00012)

Advanced Research and Development of Chemical, Biological, Radiological, and

Nuclear Medical Countermeasures

DEVELOPMENT OF CMX-001 FOR THE TREATMENT OF SMALLPOX

Topical Area of Interest No. 3, Antimicrobial Drugs

Contractual Statement of Work

 

		1.	PREAMBLE

 

Independently and not as an agency of
the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to
the BARDA Broad Agency Announcement (BAA) CBRN-BAA-10-100-SOL-00012.

 

In accordance with FAR 52.243-2, Changes-Cost
Reimbursement (Alt. V), the Government reserves the right to modify the milestones, progress, schedule, budget, or deliverables
to add or delete deliverables , process, or schedules if the need arises. Because of the nature of this research and development
(R&D) contract and the complexities inherent in this and prior programs, at designated milestones the Government will evaluate
whether work should be redirected, removed, or whether schedule or budget adjustments should be made.

 

		1.0	Overall Objectives and Scope

 

The overall objective of this contract
is to advance the development of CMX-00l as a broad-spectrum therapeutic antiviral for the treatment of smallpox infections and
dsDNA viruses. The scope of work for this contract includes preclinical, clinical and manufacturing development activities that
fall into the following areas: non-clinical efficacy studies; clinical activities; manufacturing activities; and all associated
regulatory, quality assurance, management, and administrative activities. The Research and Development (R&D) effort for the
antiviral will progress in specific stages that cover the base performance segment and four (4) option segments as specified in
this contract. The Contractor must complete specific tasks required in each of the five discrete work segments. The scope of work
has been broken into the following five phases which are discrete work segments:

 

		I.	       [...***...]

		II.	       [...***...]

		III.	       [...***...]

		IV.	       [...***...]

		V.	       [...***...]

 

***Confidential Treatment Requested

 

    	1

    	 

    

 

		2.	PHASE
                                                                                                                 I: [...***...]

 

Research and development of
CMX-001 for the treatment of smallpox and dsDNA viruses to include the following activities: [...***...]. The contractor shall
carry out the following tasks and subtasks and in accordance with an agreed upon Integrated Master Schedule and Integrated Master
Plan (defined in 2.1.8 and 2.1.9 below) which shall further detail the conduct of the specific tasks and subtasks.

 

2.1Program Management

 

The Contractor shall provide for the following
as outlined below and in the contract deliverables list (Article F.2):

 

		2.1.1	The overall management, integration and coordination of
                                                                  all contract activities, including a technical and administrative
                                                                  infrastructure to ensure the efficient planning, initiation,
                                                                  implementation, and direction of all contract activities;

		2.1.2	A Principal Investigator (PI) responsible for project management,
                                                                  communication, tracking, monitoring and reporting on status
                                                                  and progress, and modification to the project requirements and
                                                                  timelines, including projects undertaken by subcontractors;
                                                                  The contract deliverables list (reference), identifies all contract
                                                                  deliverables and reporting requirements for this contract.

		2.1.3	Project Manager(s) with responsibility for monitoring and
                                                                  tracking day-to-day progress and timelines, coordinating communication
                                                                  and project activities; costs incurred; and program management;
                                                                  The contract deliverables list (reference), identifies all contract
                                                                  deliverables and reporting requirements for this contract.

		2.1.4	A BARDA Liaison with responsibility for effective communication
                                                                  with the Project Officer and Contracting Officer.

		2.1.5	Administrative and legal staff to provide development of
                                                                  compliant subcontracts, consulting, and other legal agreements,
                                                                  and ensure timely acquisition of all proprietary rights, including
                                                                  IP rights, and reporting all inventions made in the performance
                                                                  of the project.

		2.1.6	Administrative staff with responsibility for financial management
                                                                  and reporting on all activities conducted by the Contractor
                                                                  and any subcontractors.

  

***Confidential Treatment Requested

 

    	2

    	 

    

 

		2.1.7	Contract Review Meetings.

		2.1.7.1	The Contractor shall participate in regular meetings to
                                                                   coordinate and oversee the contract effort as directed by the
                                                                   Contracting and Project Officers. Such meetings may include,
                                                                   but are not limited to, meeting of the Contractors and subcontractors
                                                                   to discuss clinical manufacturing progress, product development,
                                                                   product assay development, scale up manufacturing development,
                                                                   clinical sample assays development, preclinical/clinical study
                                                                   designs and regulatory issues; meetings with individual contractors
                                                                   and other HHS officials to discuss the technical, regulatory,
                                                                   and ethical aspects of the program; and meeting with technical
                                                                   consultants to discuss technical data provided by the Contractor.

		2.1.7.2	The Contractor shall participate in teleconferences every
                                                                   two weeks between the Contractor and subcontractors and BARDA
                                                                   to review technical progress. Teleconferences or additional
                                                                   face-to-face meetings shall be more frequent at the request
                                                                   of BARDA.

		2.1.8	Integrated Master Schedule

		2.1.8.1	Within 30 calendar days of the effective date of the contract,
                                                                   the Contractor shall submit a first draft of an updated Integrated
                                                                   Master Schedule in a format agreed upon by BARDA to the Project
                                                                   Officer and the Contracting Officer for review and comment.
                                                                   The Integrated Master Schedule shall be incorporated into the
                                                                   contract, and will be used to monitor performance of the contract.
                                                                   Contractor shall include the key milestones and Go/No Go decision
                                                                   gates. The IMS for the period of performance will be mutually
                                                                   agreed upon at the PMBR

		2.1.9	Integrated Master Plan

		2.1.9.1	Work Breakdown Structure: The Contractor shall utilize
                                                                   a WBS template agreed upon by BARDA for reporting on the contact.
                                                                   The Contractor shall expand and delineate the Contract Work
                                                                   Breakdown Structure (CWBS) to a level agreed upon by BARDA
                                                                   as part of their Integrated Master Plan for contract reporting.
                                                                   The CWBS shall be discernable and consistent, BARDA may require
                                                                   Contractor to furnish WBS data at the work package level or
                                                                   at a lower level if there is significant complexity and risk
                                                                   associated with the task.

		2.1.9.2	GO/ NO-GO Decision Gates: The Integrated Master Plan outlines
                                                                   key milestones with “Go/No Go” decision criteria
                                                                   (entrance and exit criteria for each phase of the project).
                                                                   The project plan should include, but not be limited to milestones
                                                                   in manufacturing, non-clinical and clinical studies, and regulatory
                                                                   submissions.

		2.1.9.3	Earned Value Management System Plan: Subject to the requirements
                                                                   under 1-11-ISAR Clause 352.234-4, the Contractor shall use
                                                                   principles of Earned Value Management System (EVMS) in the
                                                                   management of this contract. The Seven Principles are:

		          I.	Plan all work scope for the program to completion.

 

    	3

    	 

    

 

		        II.	Break down the program work scope into finite pieces
that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.

		       III.	Integrate program work scope, schedule, and cost objectives
into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline.

		       IV.	Use actual cost incurred and recorded in accomplishing
the work performed.

		        V.	Objectively assess accomplishments at the work performance
level.

		       VI.	Analyze significant variances from the plan, forecast
impacts, and prepare an estimate at completion based on performance to date and work to be performed.

		      VII.	Use earned value information in the company’s management
processes.

 

Elements of EVMS shall be applied to all Cost Plus
Fixed Fee CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management
procedures that it will establish, maintain and use to comply with EVMS requirements.

 

		2.1.10	Decision Gate Reporting: On completion of a stage of the
                                                                   product development, as defined in the agreed upon Integrated
                                                                   Master Schedule and Integrated Master Plan, the Contractor
                                                                   shall prepare and submit to the Project Officer and the Contracting
                                                                   Officer a Decision Gate Report that contains (i) sufficient
                                                                   detail, documentation and analysis to support successful completion
                                                                   of the stage according to the predetermined qualitative and
                                                                   quantitative criteria that were established for Go/No Go decision
                                                                   making; and (ii) a

                                                                   description of the next stage of product development to be
                                                                   initiated and a request for approval to proceed to the next
                                                                   stage of product development.

 

		2.1.11	Risk Management Plan: The Contractor shall develop a risk
                                                                   management plan within 90 days of contract award highlighting
                                                                   potential problems and/or issues that may arise during the
                                                                   life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan
                                                                   should reference relevant RIBS elements where appropriate.
                                                                   Updates to this plan shall be included every three months (quarterly) in the monthly
                                                                   Project Status Report.

  

    	4

    	 

    
 

		2.1.12	Performance Measurement Baseline Review (PMBR): The Contractor
                                                                   shall submit a plan for a PMBR to occur within 90 days of contract
                                                                   award. At the PMBR, the Contractor and BARDA shall mutually
                                                                   agree upon the budget, schedule and technical plan baselines
                                                                   (Performance Measurement Baseline). These baselines shall be
                                                                   the basis for monitoring and reporting progress throughout
                                                                   the life of the contract. The PMBR is conducted to achieve
                                                                   confidence that the baselines accurately capture the entire
                                                                   technical scope of work, are consistent with contract schedule
                                                                   requirements, are reasonably and logically planned, and have
                                                                   adequate resources assigned. The goals of the PMBR are as FOLLOWS:

 

		          I.	Jointly assess areas such as the Contractor’s planning
for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent
risks

		        II.	Confirm the integrity of the Performance Measurement
Baseline (PMB)

		       III.	Foster the use of INM as a means of communication

		       IV.	Provide confidence in the validity of Contractor reporting

		        V.	Identify risks associated with the PMB

		       VI.	Present any revised PMBs for mutual agreement

		      VII.	Present an Integrated Master Schedule: The Contractor
shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the
activity level. This 1MS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at
the PMBR. DI-MGMT-8 1 650 may be referenced as guidance in creation of the IMS (see

http://www.acq.osdanil/pm/).

		     VIII.	Present the Risk Management Plan

 

		2.1.13	Deviation Request: During the course of contract performance,
                                                                   in response to a need to change IMS activities as baselined
                                                                   at the PMBR, the Contractor shall submit a Deviation Report.
                                                                   This report shall request a change in the agreed-upon IMS and
                                                                   timelines. This report shall include: (i) discussion of the
                                                                   justification/rationale for the proposed change; (ii) options
                                                                   for addressing the needed changes from the agreed upon timelines,
                                                                   including a cost-benefit analysis of each option; and (iii)
                                                                   recommendations for the preferred option that includes a full
                                                                   analysis and discussion of the effect of the change on the
                                                                   entire product development program, timelines, and budget.

		2.1.14	Monthly and Annual Reports: The Contractor shall deliver
                                                                   Project Status Reports on a monthly basis. The reports shall
                                                                   address the items below cross referenced to the WBS, SOW, IMS,
                                                                   and EVM:

 

		          I.	Executive summary highlighting the progress, issues,
and relevant activities in manufacturing, non-clinical, clinical, and regulatory;

		         II.	Progress in meeting contract milestones, detailing the
planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps;

		        III.	Updated IMS;

		        IV.	Updated EVM;

 

    	5

    	 

    

		        V.	Updated Risk Management Plan (Every 3 months);

		       VI.	Three month rolling forecast of planned activities;

		      VII.	Progress of regulatory submissions;

		     VIII.	Estimated and actual expenses;

 

		2.1.15	Data Management: The Contractor shall develop and implement
                                                                   data management and quality control systems/procedures, including
                                                                   transmission, storage, confidentiality, and retrieval of all
                                                                   contract data;

		2.1.15.1	Provide for the statistical design and analysis of data
                                                                    resulting from the research;

		2.1.15.2	Provide raw data or specific analyses of data generated
                                                                    with contract funding to the Project Officer, upon request.

 

		2.2	Non-Clinical Toxicology

		2.2.1	N/A (no scope)

 

		2.3	Non-Clinical

	 	2.3.1	Develop and validate [...***...] to lower ...***...].
	 	 	 
	 	2.3.2	[...***...]: Conduct [...***...] studies including [...***...] studies, [...***...], and [...***...] studies in [...***...].
	 	 	 
	 	2.3.3	[...***...]

	 	2.3.3.1	Conduct [...***...] study in [...***...].
	 	 	 
	 	2.3.3.2	Conduct [...***...] studies including [...***...] studies, [...***...] studies including [...***...] for CMX-001 and [...***...] in [...***...].

	 	2.3.4	Use of [...***...] as a CMX-001 Surrogate in [...***...] Studies.

	 	2.3.4.1	Dose [...***...] with [...***...] to identify the concentration of the [...***...] in [...***...] associated with [...***...] of [...***...].

	 	2.3.5	Scaling of [...***...] to [...***...] by conducting studies with [...***...] to determine [...***...] in [...***...].
	 	 	 
	 	2.3.6	[...***...] determination of CMX00l, [...***...] and [...***...] in the [...***...].
	 	 	 
	 	2.3.7	Conduct [...***...] experiments to demonstrate [...***...] following effective [...***...] prior to [...***...].
	 	 	 
	 	2.3.8	Conduct studies to optimize [...***...] in [...***...].

 

		2.4	Clinical

		2.4.1	Measurement of [...***...] levels in [...***...] and correlate
                                                                  the [...***...] to studies conducted in [...***...].

		2.4.2	Conduct expanded access protocol ([...***...]).

 

***Confidential Treatment Requested

 

    	6

    	 

    

 

		2.5	Regulatory

		2.5.1	Engaging the FDA on a path to support the treatment of smallpox
                                                                  indication with CMX-001.

		2.5.2	Preparing materials for and requesting, scheduling and participating
                                                                  in all meetings with the FDA, including meetings to review EUA
                                                                  and/or all other data packages;

		2.5.3	Providing BARDA with (i) the initial draft minutes
                                                                  and final draft minutes of any formal meeting with the FDA;
                                                                  (ii) final minutes of any informal meeting with the FDA;

 

		2.6	CMC

		2.6.1	Chemical development and manufacture of one [...***...],
                                                                  to prepare for [...***...].

 

		3.	PHASE
                                                                                                                 II: [...***...]

 

Research and development of
CMX-001 for the treatment of smallpox to include the following activities: [...***...]. The contractor shall carry out the following
tasks and subtasks and in accordance with the agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8
and 2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

 

		3.1	Program Management (consistent with section 2.1)

		3.1.1	Program management scope in BASE year is consistent with
                                                                  program management scope in each option year.

 

		3.2	Non-toxicology

		3.2.1	N/A (no scope)

 

***Confidential Treatment Requested

 

    	7

    	 

    

 

		3.3	Non-Clinical

		3.3.1	Quantify [...***...] levels in [...***...] in [...***...].

		3.3.2	Determine [...***...] for CMX-001, [...***...], and [...***...]
                                                                  in [...***...].

		3.3.3	Scaling of [...***...] to [...***...] studies to determine
                                                                  scaling between [...***...] and [...***...] using [...***...]
                                                                  as well as comparisons of levels of [...***...] in the [...***...].

		3.3.4	[...***...] in the [...***...]. This study will determine
                                                                  the [...***...] in [...***...] and the concentration of [...***...]
                                                                  in [...***...] when [...***...] are treated with [...***...]
                                                                  at the effective dose and regimen.

		3.3.5	[...***...]- (Final Report from Sections 2.3.2.). The initial
                                                                  study ([...***...]) will compare different regimens of [...***...]
                                                                  administered after the [...***...]. The studies will include
                                                                  [...***...] and [...***...], as well as [...***...] including
                                                                  [...***...].

 

		3.4	Clinical

		3.4.1	Conduct [...***...] study in [...***...] will be conducted
                                                                  as part of the scope of work to determine whether CMX001 has
                                                                  a [...***...], as detected by [...***...].

		3.4.2	Analyze data and provide a Final Report for [...***...]
                                                                  evaluation of CMX001 in [...***...].

 

		3.5	Regulatory

		3.5.1	Engaging the FDA on a path to support the treatment of smallpox
                                                                  indication with CMX-001

		3.5.2	Preparing materials for and requesting, scheduling and participating
                                                                  in all meetings with the FDA, including meetings to review EUA
                                                                  and/or all other data packages;

		3.5.3	Providing BARDA with (i) the initial draft minutes and final
                                                                  draft minutes of any formal meeting with the FDA; (ii) final
                                                                  draft minutes of any informal meeting with the FDA;

 

***Confidential Treatment Requested

 

    	8

    	 

    

 

		3.6	CMC

		3.6.1	Validation of the [...***...] process: Validation of the
                                                                  process to demonstrate the [...***...] of a [...***...] of [...***...]
                                                                  will be performed.

		3.6.2	Validation of the [...***...] process to produce [...***...]:
                                                                  Validation of the process to demonstrate the [...***...] of
                                                                  a [...***...] of [...***...] will be performed.

 

		4.	PHASE
                                                                                                                 III: [...***...]

  

Research and development of CMX-001
for the treatment of smallpox and dsDNA viruses to include the following activities: [...***...].

The contractor shall carry
out the following tasks and subtasks and in accordance with agreed upon Integrated Master Schedule and Integrated Master Plan
(defined in 2.1.8 and 2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

 

		4.1	Program Management (Consistent with section 2.1)

		4.1.1	Program management scope in BASE year is consistent with
                                                                  program management scope in each option year.

 

		4.2	Non-toxicology

		4.2.1	N/A (no scope)

 

		4.3	Non-Clinical

		4.3.1	[...***...] studies: [...***...] will be conducted with
                                                                  the [...***...] of CMX001 identified in the [...***...] studies.
                                                                  [...***...] will be [...***...] to receive [...***...] beginning
                                                                  at the [...***...]. These studies will include [...***...] and
                                                                  [...***...] as well as [...***...] including [...***...] in
                                                                  [...***...]. The primary endpoint will be [...***...]

		4.3.2	[...***...] studies: This study will determine the [...***...]
                                                                  at the [...***...]. [...***...] and [...***...] at the [...***...].
                                                                  The primary endpoint will be [...***...]

		4.3.3	Initiate [...***...]: Conduct [...***...] studies for [...***...].
                                                                  This study will determine the [...***...] at doses selected
                                                                  based on [...***...]. [...***...] and [...***...].

 

***Confidential Treatment Requested

 

    	9

    	 

    

 

		4.4	Clinical

		4.4.1	Phases I [...***...] study, If acceptable to FDA, the [...***...]
                                                                  database will be supplemented by a study in [...***...]. The
                                                                  size of this study will be determined to ensure an adequate
                                                                  [...***...] database is available at the time of [...***...]

		4.4.2	[...***...] study. This study will [...***...] doses of
                                                                  CMX001 to [...***...] to determine if the [...***...] of CMX001
                                                                  are comparable to those observed for [...***...], and to determine
                                                                  if any dose adjustment is necessary in [...***...].

 

		4.5	Regulatory

		4.5.1	Generating all necessary data and preparing documentation
                                                                  for [...***...] submissions to regulatory agencies;

		4.5.2	Preparing materials for and requesting, scheduling and participating
                                                                  in all meetings with the FDA, including meetings to review [...***...],
                                                                  EUA and/or all other data packages;

		4.5.3	Providing BARDA with (i) the initial draft minutes
                                                                  and final draft minutes of any formal meeting with the FDA;
                                                                  (ii) final draft minutes of any informal meeting with the
                                                                  FDA;

		4.5.4	Filing of an [...***...]

 

		4.6	CMC

		4.6.1	Manufacture of [...***...] in sufficient quantities for
                                                                  use in non-clinical and late phase clinical studies. Develop
                                                                  [...***...].

 

		5.	PHASE
                                                                                                                 IV: [...***...]

 

Research and development of
CMX-001 for the treatment of smallpox to include the following activities: [...***...]. [...***...] studies and phase I [...***...]
study. The contractor shall carry out the following tasks and subtasks and in accordance with agreed upon Integrated Master Schedule
and Integrated Master Plan (defined in 2.1.8 and 2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

 

		5.1	Program Management (Consistent with section 2.1)

		5.1.1	Program management scope in BASE year is consistent with
                                                                  program management scope in each option year.

 

		5.2	Non-toxicology

		5.2.1	N/A (no scope)

 

***Confidential Treatment Requested

 

    	10

    	 

    

 

		5.3	Non-Clinical

		5.3.1	[...***...] studies. [...***...] will be randomized to receive
                                                                  [...***...] beginning at the [...***...]. These studies will
                                                                  include [...***...] and [...***...] as well as [...***...] including
                                                                  [...***...]. The primary endpoint will be [...***...]

		5.3.2	[...***...] Studies. This study will determine the [...***...]
                                                                  at the [...***...]. [...***...] and [...***...] at the [...***...].
                                                                  The primary endpoint will be [...***...]. If FDA requires a
                                                                  [...***...] in the [...***...] studies, the [...***...] study
                                                                  may not be needed.

		5.3.3	Conduct [...***...] Studies. This study will determine the
                                                                  [...***...] at the [...***...]. [...***...] and [...***...]
                                                                  at the [...***...].

 

		5.4	Clinical

		5.4.1	Phase 3 development including [...***...] study, [...***...]
                                                                  study, phases II [...***...] study. A [...***...] study will
                                                                  be conducted to compare the [...***...] of CMX001 in [...***...]
                                                                  to [...***...]. A [...***...] study will be conducted to compare
                                                                  the [...***...] of CMX001 when [...***...]. A [...***...] study
                                                                  will be conducted to [...***...] to support an NDA.

 

		5.5	Regulatory

		5.5.1	Generating all necessary data and preparing documentation
                                                                  for NDA submissions to regulatory agencies;

		5.5.2	Preparing materials for and requesting, scheduling and participating
                                                                  in all meetings with the FDA, including meetings to review IND,
                                                                  EUA and/or all other data packages;

		5.5.3	Providing BARDA with (i) the initial draft minutes
                                                                  and final draft minutes of any formal meeting with the FDA;
                                                                  (ii) final draft minutes of any informal meeting with the
                                                                  FDA;

 

		5.6	CMC

		5.6.1	[...***...]. [...***...] of the process to demonstrate the
                                                                  [...***...] of a [...***...] will be performed.

 

		6.	PHASE V: [...***...]

 

 

***Confidential Treatment Requested

 

    	11

    	 

    

  

Research and development of CMX-001
for the treatment of smallpox to include the following activities: [...***...]. The contractor shall carry out the following tasks
and subtasks and in accordance with an agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and
2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

 

		6.1	Program Management (Consistent with section 2.1)

		6.1.1	Program management scope in BASE year is consistent with
                                                                  program management scope in each option year.

 

		6.2	Non-toxicology

		6.2.1	N/A (no scope)

 

		6.3	Non-Clinical

		6.3.1	[...***...] Studies. This study replicates [...***...] if
                                                                  a [...***...] is necessary to achieve a [...***...] result.

 

		6.4	Clinical

		6.4.1	Compile [...***...]. A database of [...***...] data collected
                                                                  from all CMX001 clinical studies, irrespective of [...***...],
                                                                  will be populated and analyzed in order to support an [...***...]
                                                                  for smallpox.

 

		6.5	Regulatory

		6.5.1	Generating all necessary data and preparing documentation
                                                                  for NDA submissions to regulatory agencies;

		6.5.2	Submitting NDA documentation to the FDA in a timely manner,
                                                                  consistent with timelines set out in the contract and by the
                                                                  FDA.

		6.5.3	Preparing materials for and requesting, scheduling and participating
                                                                  in all meetings with the FDA, including meetings to review IND,
                                                                  EUA and/or all other data packages;

		6.5.4	Providing BARDA with (i) the initial draft minutes
                                                                  and final draft minutes of any formal meeting with the FDA;
                                                                  (ii) final draft minutes of any informal meeting with the
                                                                  FDA;

 

		6.6	CMC

		6.6.1	[...***...]. [...***...] of the process to demonstrate the
                                                                  [...***...] of a [...***...] will be performed.

 

		7.	Other
                                                                                                                 Items

 

		7.1	Facilities, Equipment and Other Resources. (Contract:
Section J)

The Contractor shall provide equipment; facilities
and other resources required for implementation of the SOW dated January 11, 2011 to comply with all Federal 

 

***Confidential Treatment Requested

 

    	12

    	 

    

 

and HHS regulations in:  

 

		7.1.1	The
[...***...] and use of [...***...];

		7.1.2	The
acquisition, handling, storage and shipment of [...***...], including
[...***...] required for working with the [...***...];

		7.1.3	The
[...***...] of [...***...]
under cGMP;

		7.1.3.1	The
design and conduct of [...***...]; and

		7.1.4	Design
and conduct of [...***...] under GCP.

 

***Confidential Treatment Requested

 

    	13

    	 

    

 

ATTACHMENT 2

 

INVOICE/FINANCING REQUEST AND CONTRACT
FINANCIAL REPORTING

INSTRUCTIONS FOR BARDA COST-REIMBURSEMENT TYPE CONTRACTS

 

Format: Payment requests shall be submitted on the Contractor’s
self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard
Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated
form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter
with the payment request.

 

Number of Copies: Payment requests shall be submitted
in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

Frequency: Payment requests shall not be submitted more
frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract.
Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting
Officer.

 

Cost Incurrence Period: Costs incurred must be within
the contract performance period or covered by precontract cost provisions.

 

Billing of Costs Incurred: If billed costs include (1)
costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed
after the contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs.

 

Contractor’s Fiscal Year: Payment requests shall
be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.

 

Currency: All BARDA contracts are expressed in United
States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment
by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations
may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract
may not exceed the United States dollars

authorized.

 

Costs Requiring Prior Approval: Costs requiring the
Contracting Officer’s approval, which are not set forth in an Advance Understanding in the contract, shall be identified
and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set
forth in an Advance Understanding as a separate line item on the payment request.

 

Invoice/Financing Request Identification: Each payment
request shall be identified as either:

 

		(a)	Interim Invoice/Contract Financing Request: These are interim
                                                           payment requests submitted during the contract performance period.

 

		(b)	Completion Invoice: The completion invoice shall be submitted
                                                           promptly upon completion of the work, but no later than one year from
                                                           the contract completion date, or within 120 days after settlement of
                                                           the final indirect cost rates covering the year in which the contract
                                                           is physically complete (whichever date is later). The Contractor shall
                                                           submit the completion invoice when all costs have been assigned to
                                                           the contract and it completes all performance provisions.

 

		(c)	Final Invoice: A final invoice may be required after the
                                                           amounts owed have been settled between the Government and the Contractor
                                                           (e.g., resolution of all suspensions and audit exceptions).

 

Preparation and Itemization of the Invoice/Financing Request:
The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries
on the Sample Invoice/Financing Request.

  

    	 

    	 

    

 

		(a)	Designated Billing Office Name and Address: Enter the designated
                                                           billing office name and address, as identified in the Invoice Submission
                                                           Instructions in Section G of the Contract Schedule.

 

		(b)	Contractor’s Name, Address, Point of Contact, VIN, and
                                                           DUNS or DUNS+4 Number: Show the Contractor’s name and address
                                                           exactly as they appear in the contract, along with the name, title,
                                                           phone number, and e-mail address of the person to notify in the event
                                                           of an improper invoice or, In the case of payment by method other than
                                                           Electronic Funds Transfer, to whom payment is to be sent. Provide the
                                                           Contractor’s Vendor Identification Number (VIN), and Data Universal
                                                           Numbering System (DUNS) number or DUNS+4. The DUNS number must identify
                                                           the Contractor’s name and address exactly as stated on the face
                                                           page of the contract. When an approved assignment has been made by
                                                           the Contractor, or a different payee has been designated, provide the
                                                           same information for the payee as is required for the Contractor (i.e.,
                                                           name, address, point of contact, VIN, and DUNS).

 

		(c)	Invoice/Financing Request Number: Insert the appropriate
                                                           serial number of the payment request.

 

		(d)	Date Invoice/Financing Request Prepared: Insert the date
                                                           the payment request is prepared.

 

		(e)	Contract Number and Order Number (if applicable): Insert
                                                           the contract number and order number (if applicable).

 

		(f)	Effective Date: Insert the effective date of the contract
                                                           or if billing under an order, the effective date of the order.

 

		(g)	Total Estimated Cost of Contract/Order: Insert the total
                                                           estimated cost of the contract, exclusive of fixed-fee. If billing
                                                           under an order, insert the total estimated cost of the order, exclusive
                                                           of fixed-fee. For incrementally funded contracts/orders, enter the
                                                           amount currently obligated and available for payment.

 

		(h)	Total Fixed-Fee: insert the total fixed-fee (where applicable).
                                                           For incrementally funded contracts/orders, enter the amount currently
                                                           obligated and available for payment.

 

		(i)	Two-Way/Three-Way Match: Identify whether payment is to
                                                           be made using a two-way or three-way match. To determine required payment
                                                           method, refer to the Invoice Submission Instructions in Section G of
                                                           the Contract Schedule.

 

		(j)	Office of Acquisitions: Insert the name of the Office of
                                                           Acquisitions, as identified in the Invoice Submission Instructions
                                                           in Section G of the Contract Schedule.

 

		(k)	Central Point of Distribution: Insert the Central Point
                                                           of Distribution, as identified in the Invoice Submission Instructions
                                                           in Section G of the Contract Schedule.

 

		(I)	Billing Period: Insert the beginning and ending dates (month,
                                                           day, and year) of the period in which costs were incurred and for which
                                                           reimbursement is claimed.

 

		(m)	Amount Billed - Current Period: Insert the amount claimed
                                                           for the current billing period by major cost element, including any
                                                           adjustments and fixed-fee. If the Contract Schedule contains separately
                                                           priced line items, identify the contract line item(s) on the payment
                                                           request and include a separate breakdown (by major cost element) for
                                                           each line item.

 

		(n)	Amount Billed - Cumulative: Insert the cumulative amounts
                                                           claimed by major cost element, including any adjustments and fixed-fee.
                                                           If the Contract Schedule contains separately priced line items, identify
                                                           the contract line item(s) on the payment request and include a separate
                                                           breakdown (by major cost element) for each line item.

 

		(o)	Direct Costs: Insert the major cost elements. For each element,
                                                           consider the application of the paragraph entitled “Costs Requiring
                                                           Prior Approval” on page 1 of these instructions.

 

    	 

    	 

    

 

		(1)	Direct Labor: Include salaries and wages paid
(or accrued) for direct performance of the contract.

 

For Level of Effort contracts only, the Contractor
shall provide the following information on a separate sheet of paper attached to the payment request:

 

- hours or percentage of effort and cost by labor category
(as specified in the Level of Effort Article in Section F of the contract) for the current billing period, and

 

- hours or percentage of effort and cost by labor category
from contract inception through the current billing period.  (NOTE: The Contracting Officer may require the Contractor
to provide additional breakdown for direct labor, such as position title, employee name, and salary or hourly rate.)

 

		(2)	Fringe Benefits: List any fringe benefits applicable
                                                                to direct labor and billed as a direct cost. Do not include in
                                                                this category fringe benefits that are included in indirect costs.

 

		(3)	Accountable Personal Property: Include permanent research
                                                                equipment and general purpose equipment having a unit acquisition
                                                                cost of $1,000 or more, with a life expectancy of more than two
                                                                years, and sensitive property regardless of cost (see the HHS
                                                                Contractor’s Guide for Control of Government Property).
                                                                Show permanent research equipment separate from general purpose
                                                                equipment.

 

On a separate sheet of paper attached to the payment
request, list each item for which reimbursement is requested. An asterisk (*) shall precede the item if the equipment is below
the $1,000 approval level. Include reference to the following (as applicable):

 

- item number for the specific piece of equipment listed
in the Property Schedule, and - COA number, if the equipment is not covered by the Property Schedule.

 

The Contracting Officer may require the Contractor
to provide further itemization of property having specific limitations set forth in the contract.

 

		(4)	Materials and Supplies: Include equipment with unit
                                                                costs of less than $1,000 or an expected service life of two years
                                                                or less, and consumable material and supplies regardless of amount.

 

		(5)	Premium Pay: List remuneration in excess of the basic
                                                                hourly rate.

 

		(6)	Consultant Fee: List fees paid to consultants. Identify
                                                                consultant by name or category as set forth in the contract or
                                                                COA, as well as the effort (i.e,, number of hours, days, etc.)
                                                                and rate billed.

 

		(7)	Travel: Include domestic and foreign travel. Foreign
                                                                travel is travel outside of Canada, the United States and its
                                                                territories and possessions. However, for an organization located
                                                                outside Canada, the United States and its territories and possessions,
                                                                foreign travel means travel outside that country. Foreign travel
                                                                must be billed separately from domestic travel.

 

		(8)	Subcontract Costs: List subcontractor(s) by name and
                                                                amount billed.

 

		(9)	Other: List all other direct costs in total unless
                                                                exceeding $1,000 in amount. If over $1,000, list cost elements
                                                                and dollar amounts separately. If the contract contains restrictions
                                                                on any cost element, that cost element must be listed separately.

 

		(p)	Cost of Money (COM): Cite the COM factor and base in effect
                                                           during the time the cost was incurred and for which reimbursement is
                                                           claimed.

 

		(q)	Indirect Costs: Identify the indirect cost base (IDC), indirect
                                                           cost rate, and amount billed for each indirect cost category.

 

		(r)	Fixed-Fee: Cite the formula or method of computation for
                                                           fixed-fee, if applicable. The fixed-fee must be claimed as provided
                                                           for by the contract.

 

		(s)	Total Amounts Claimed: Insert the total amounts claimed
                                                           for the current and cumulative periods.

 

    	 

    	 

    

 

		(t)	Adjustments: Include amounts conceded by the Contractor,
                                                           outstanding suspensions, and/or disapprovals subject to appeal.

 

		(u)	Grand Totals

 

		(v)	Certification of Salary Rate Limitation: If required by
                                                           the contract (see Invoice Submission Instructions in Section G of the
                                                           Contract Schedule), the Contractor shall include the following certification
                                                           at the bottom of the payment request:

                                                           

“I hereby certify that the
salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.”

 

The Contracting Officer may require the Contractor to submit
detailed support for costs claimed on one or more interim payment requests.

 

FINANCIAL REPORTING INSTRUCTIONS:

 

These instructions are keyed to the Columns on the sample invoice/financing
request.

 

Column A - Expenditure Category: Enter the expenditure
categories required by the contract.

 

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated:
Enter the percentage of effort or number of hours agreed to for each employee or labor category listed in Column A.

 

Column C - Cumulative Percentage of Effort/Hrs. - Actual:
Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.

 

Column D - Amount Billed - Current: Enter amounts billed
during the current period.

 

Column E - Amount Billed - Cumulative: Enter the cumulative
amounts to date.

 

Column F - Cost at Completion: Enter data only when
the Contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates are
essential.

 

Column G - Contract Amount: Enter the costs agreed to
for all expenditure categories listed in Column A.

 

Column H - Variance (Over or Under): Show the difference
between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made in Column F.
This column need not be filled in when Column F is blank. When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance should be submitted. In the case of an overrun (net
negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

 

Modifications: Any modification In the amount negotiated
for an item since the preceding report should be listed in the appropriate cost category.

 

Expenditures Not Negotiated: An expenditure for an item
for which no amount was negotiated (e.g., at the discretion of the Contractor in performance of its contract) should be listed
in the appropriate cost category and all columns filled in, except for G.  Column H will of course show a 100 percent
variance and will be explained along with those identified under H above.

 

    	 

    	 

    

 

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

	
        (a)       Designated Billing Office
        Name and Address:

         

        DHHS/OS/ASPR/BARDA

        Attn: Contracting Officer

        330 Independence Ave., S.W.

        Room G644

        Washington, D.C. 20201

         

        (b)       Contractor’s Name,
        Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:

         

        ABC CORPORATION

        100 Main Street

        Anywhere, USA Zip Code

         

        Name, Title, Phone Number, and E-mail Address of
        person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer,
        to whom payment is to be sent.

         

        VIN:

        DUNS or DUNS+4:

         
	
        (c)     Invoice/Financing Request No.:

         

        (d)     Date Invoice Prepared:

         

        (e)     Contract No, and Order No. (if applicable): __________

         

        (f)      Effective Date:

         

        (g)     Total Estimated Cost of Contract/Order:

         

        (h)     Total Fixed-Fee (if applicable):

         

        (i)       ̈Two-Way
Match: 

              ̈Three-way
Match:

         

        (j)      Office of Acquisitions:

         

        (k)     Central Point of Distribution:

	(i)  This invoice/financing request represents reimbursable costs for the period from _________ to 
	
        Expenditure Category*

        A
	Cumulative Percentage of

Effort/Hrs.	Amount Billed	Cost at Completion

F	Contract

Amount

G	Variance

H
	Negotiated

B	Actual

C	(m)

Current

D	(n)

Cumulative

E
	  (o)Direct Costs	 	 	 	 	 	 	 
	   (1)   Direct Labor	 	 	 	 	 	 	 
	   (2)   Fringe Benefits	 	 	 	 	 	 	 
	   (3)   Accountable Property	 	 	 	 	 	 	 
	   (4)   Materials & Supplies	 	 	 	 	 	 	 
	   (5)   Premium Pay	 	 	 	 	 	 	 
	   (6)   Consultant Fees	 	 	 	 	 	 	 
	   (7)   Travel	 	 	 	 	 	 	 
	   (8)   Subcontracts	 	 	 	 	 	 	 
	   (9)   Other	 	 	 	 	 	 	 
	  Total Direct Costs	 	 	 	 	 	 	 
	  (p)  Cost of Money	 	 	 	 	 	 	 
	  (q)  Indirect Costs	 	 	 	 	 	 	 
	  (r)  Fixed Fee	 	 	 	 	 	 	 
	  (s)  Total Amount Claimed	 	 	 	 	 	 	 
	  (t)  Adjustments	 	 	 	 	 	 	 
	  (u) Grand Totals	 	 	 	 	 	 	 
	
        I certify that all payments are for appropriate purposes and
        in accordance with the contract.

        ___________________________                            _____________________

(Name of Official)                                                     
(Title)

        ‘ Attach details as specified in the contract

 

    	 

    	 

    
 

ATTACHMENT 3

 

	FINANCIAL
        REPORT OF INDIVIDUAL

        PROJECT/CONTRACT

         

        Note:
        Complete this Form in Accordance with

        Accompanying Instructions.
	Project Task:

         

         
	Contract
    No.	Date
    of Report:	0990-0134

        0990-0131

	Reporting
    Period:	Contractor
    Name and Address:
	Expenditure
    Category	

                                                                                Percentage
                                                                                of
 Effort/Hours

                                                                                 
	Cumulative

    Incurred Cost

    at End of Prior

    Period	Incurred

    Cost-

    Current

    Period	Cumulative

    Cost to Date

    (D + E)	Estimated

    Cost to

    Complete	Estimated
    Cost at

    Completion

    (F + G)	Negotiated

    Contract

    Amount	Variance
    (Over

    or Under) (I -

    H)
	Negotiated	Actual
	A	B	C	D	E	F	G	H	I	J
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 

 

    	 

    	 

    
 

 

ATTACHMENT 4

INSTRUCTIONS FOR COMPLETING

“FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT”

 

GENERAL INFORMATION

 

Purpose. This Quarterly Financial Report is designed
to: (1) provide a management tool for use by be BARDA in monitoring the application of financial and personnel resources to the
BARDA contracts; (2) provide contractors with financial and personnel management data which is usable in their management processes;
(3) promptly indicate potential areas of contract underruns or overruns by making possible comparisons of actual performance and
projections with prior estimates on individual elements of cost and personnel; and (4) obtain contractor’s analyses of cause
and effect of significant variations between actual and prior estimates of financial and personnel performance.

 

REPORTING REQUIREMENTS

 

Scope. The specific cost and personnel elements to be
reported shall be established by mutual agreement prior to award. The Government may require the contractor to provide detailed
documentation to support any element(s) on one or more financial reports.

 

Number of Copies and Mailing Address. An original and
two (2) copies of the report(s) shall be sent to the contracting officer at the address shown on the face page of the contract,
no later than 30 working days after the end of the period reported. However, the contract may provide for one of the copies to
be sent directly to the Contracting Officer’s Technical Representative.

 

REPORTING STATISTICS

 

A modification which extends the period of performance of an
existing contract will not require reporting on a separate quarterly report, except where it is determined by the contracting officer
that separate reporting is necessary. Furthermore, when incrementally funded contracts are involved, each separate allotment is
not considered a separate contract entity (only a funding action). Therefore, the statistics under incrementally funded contracts
should be reported cumulatively from the inception of the contract through completion.

 

Definitions and Instructions for Completing the Quarterly
Report. For the purpose of establishing expenditure categories in Column A, the following definitions and instructions will
be utilized. Each contract will specify the categories to be reported.

 

		(1)	Key Personnel. Include key personnel regardless of annual salary rates. All such individuals should be listed by names
and job titles on a separate line including those whose salary is not directly charged to the contract but whose effort is directly
associated with the contract. The listing must be kept up to date.

 

		(2)	Personnel—Other. List as one amount unless otherwise required by the contract.

 

		(3)	Fringe Benefits. Include allowances and services provided by the contractor to employees as compensation in addition
to regular salaries and wages. If a fringe benefit rate(s) has been established, identify the base, rate, and amount billed for
each category. If a rate has not been established, the various fringe benefit costs may be required to be shown separately. Fringe
benefits which are included In the Indirect cost rate should not be shown here.

 

		(4)	Accountable Personal Property. Include nonexpendable personal property with an acquisition cost of $1,000 or more and
with an expected useful life of two or more years, and sensitive items regardless of cost. Form HHS 565, “Report of Accountable
Property,” must accompany the contractor’s public voucher (SF 1034/SF 1035) or this report if not previously submitted.
See “Contractor’s Guide for Control of Government Property.”

 

		(5)	Supplies. Include the cost of supplies and material and equipment charged directly to the contract, but excludes the
cost of nonexpendable equipment as defined in (4) above.

 

		(6)	Inpatient Care. Include costs associated with a subject while occupying a bed in a patient care setting. It normally
includes both routine and ancillary costs.

 

    	 

    	 

    

 

		(7)	Outpatient Care. Include costs associated with a subject while not occupying a bed. It normally includes ancillary costs
only.

 

		(8)	Travel. Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses. Travel
for staff and consultants shall be shown separately. Identify foreign and domestic travel separately. If required by the contract,
the following information shall be submitted: (i) Name of traveler and purpose of trip; (ii) Place of departure, destination and
return, including time and dates; and (iii) Total cost of trip.

 

		(9)	Consultant Fee. Include fees paid to consultant(s). Identify each consultant with effort expended, billing rate, and
amount billed.

 

		(10)	Premium Pay. Include the amount of salaries and wages over and above the basic rate of pay.

 

		(11)	Subcontracts. List each subcontract by name and amount billed.

 

		(12)	Other Costs. Include any expenditure categories for which the Government does not require individual line item reporting.
It may include some of the above categories.

 

		(13)	Overhead/Indirect Costs. Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.

 

		(14)	General and Administrative Expense. Cite the rate and the base. In the case of nonprofit organizations, this item will
usually be included in the indirect cost.

 

		(15)	Fee. Cite the fee earned, if any.

 

		(16)	Total Costs to the Government.

 

PREPARATION INSTRUCTIONS

 

These instructions are keyed to the Columns on the Quarterly
Report.

 

Column A—Expenditure Category. Enter the expenditure
categories required by the contract.

 

Column B—Percentage of Effort/Hours Negotiated.
Enter the percentage of effort or number of hours agreed to during contract negotiations for each labor category listed in Column
A.

 

Column C—Percentage of Effort/Hours-Actual. Enter
the cumulative percentage of effort or number of hours worked by each employee or group of employees listed in Column A.

 

Column D—Cumulative Incurred Cost at End of Prior Period.
Enter the cumulative incurred costs up to the end of the prior reporting period. This column will be blank at the time of the submission
of the initial report.

 

Column E—Incurred Cost-Current Period. Enter the
costs which were incurred during the current period. Column F—Cumulative Incurred Cost to Date. Enter the combined total
of Columns D and E.

 

Column G—Estimated Cost to Complete. Make entries
only when the contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates
are essential.

 

Column H—Estimated Costs at Completion. Complete
only if an entry is made in Column G.

 

Column I—Negotiated Contract Amount. Enter in this
column the costs agreed to during contract negotiations for all expenditure categories listed in Column A.

    	 

    	 

    

 

Column J—Variance (Over or Under). Complete only
if an entry is made in Column H. When entries have been made in Column H, this column should show the difference between the estimated
costs at completion (Column H) and negotiated costs (Column I). When a line item varies by plus or minus 10 percent, i.e., the
percentage arrived at by dividing Column J by Column I, an explanation of the variance should be submitted. In the case of an overrun
(net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

 

Modifications. List any modification in the amount negotiated
for an Item since the preceding report in the appropriate cost category.

 

Expenditures Not Negotiated. List any expenditure for
an item for which no amount was negotiated (e.g., at the discretion of the contractor in performance of its contract) in the appropriate
cost category and complete all columns except for 1. Column J will of course show a 100 percent variance and will be explained
along with those identified under J above.

 

    	 

    	 

    

 

Attachment 5

INCLUSION ENROLLMENT REPORT

 

This report format should NOT be used for
data collection from study participants

	Study Title:
	Total Enrollment:	Protocol Number:
	Contract Number:	 
	PART
    A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race
	Ethnic Category	Sex/Gender
	Females	Males	Unknown or Not Reported	Total
	Hispanic or Latino	 	 	 	 
	Not Hispanic or Latino	 	 	 	 
	Unknown (Individuals not reporting ethnicity)	 	 	 	 
	Ethnic Category: Total of All Subjects*	 	 	 	 
	Racial Categories
	American Indian/Alaska Native	 	 	 	 
	Asian	 	 	 	 
	Native Hawaiian or Other Pacific Islander	 	 	 	 
	Black or African American	 	 	 	 
	White	 	 	 	 
	More than one race	 	 	 	 
	Unknown or not reported	 	 	 	 
	Racial Categories: Total of All Subjects*	 	 	 	 
	 
	PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)
	Racial
Categories	Females	Males	Unknown or Not Reported	Total
	American Indian/Alaska Native	 	 	 	 
	Asian	 	 	 	 
	Native Hawaiian or Other Pacific Islander	 	 	 	 
	Black or African American	 	 	 	 
	White	 	 	 	 
	More than one race	 	 	 	 
	Unknown or not reported	 	 	 	 
	Racial Categories: Total of Hispanics or Latinos**	 	 	 	 
	*These totals must agree

**These totals must agree	 	 	 	 
	 	 	 	 	 	 

 

    	 

    	 

    

 

ATTACHMENT 6

Research Patient Care Costs

 

(a) Research patient care costs are the costs of routine and
ancillary services provided to patients participating in research programs described in this contract.

 

(b) Research patient care costs shall be computed in a manner
consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based
on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine research patient care costs.
Research patient care rates or amounts shall be established by the Secretary of HHS or his/her duly authorized representative.

 

(c) Prior to submitting an invoice for research patient care
costs under this contract, the contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to
pay all or a portion of the charges incurred under this contract for research patient care.

 

(d) The contractor must maintain adequate procedures to identify
those research patients participating in this contract who are eligible for third party reimbursement.

 

(e) Only those charges not recoverable from third party payors
or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract

 

    	 

    	 

    

 

Attachment 8 - Earned Value Management
(EVM) Requirements

 

The Contractor shall propose and provide a Performance Measurement
System that meets the Seven Principles of Earned Value Management. The Seven Principles are:

 

		1.	Plan all work scope for the program to completion of the contract.

 

		2.	Break down the program work scope into finite pieces that can be assigned to

a responsible person or organization for control of technical, schedule, and cost objectives.

 

		3.	Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments
may be measured. Control changes to the baseline,

 

		4.	Use actual cost incurred and recorded in accomplishing the work performed.

 

		5.	Objectively assess accomplishments at the work performance level.

 

		6.	Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to
date and work to be performed.

 

		7.	Use Performance Based information in the company’s management processes.

 

The Contractor shall develop a Work Breakdown Structure (WBS)
to an appropriate level and a WBS dictionary which lists and defines the WBS elements that also is inclusive of the applicable
EVM requirements.

 

Contractors required to provide Earned Value Management to their
project can obtain additional instruction from the 7 Principles of EVM Intent Guide.

 

The EVM requirements for this contract will be as follows:

 

Tier 2 — Contracts greater than $25m in total
value (includes base and options) and with a proposed product that has a Technology Readiness Level (TRL) of 6 or greater.

 

    	 

    	 

    

 

GLOSSARY OF TERMS

 

	Actual Cost of Work Performed (ACWP)	 	The costs actually applied and recorded in accomplishing the work performed within a specified period.
	 	 	 
	Baseline	 	(See Performance Measurement Baseline).
	 	 	 
	Budget at Completion (BAC)	 	The sum of all budgets (BCWS) allocated to the contract. Synonymous with the term Performance Measurement Baseline.
	 	 	 
	Budgeted Cost for Work Performed (BCWP)	 	The sum of the budgets for completed Work Packages and completed portions of open Work Packages, plus the appropriate portion of the budgets for level of effort and apportioned effort (Also see Earned Value).

 

    	 

    	 

    

 

	Control Account	 	A management control point at which actual costs can be accumulated and compared to budgeted cost for work performed. A control account is a natural control point for cost/schedule planning and control since it represents the work assigned to one responsible organizational element on one contract work breakdown structure (CWBS) element.
	 	 	 
	Control Account Manager	 	A member of a functional organization responsible for (CAM) task performance detailed in a Control Account and for managing the resources authorized to accomplish the tasks.
	 	 	 
	Control Account Plan

(CAP) Report	 	A CAP report is a timephased report which reflects all the work and effort to be performed in a control account. The CAP report will reflect the hours and dollars by element of cost (labor, subcontract, ODC, etc).

 

    	 

    	 

    

 

	Contract Performance Report (CPR)	 	The monthly report submitted to the customer showing the current, cumulative and at completion status, the performance measurement baseline, manpower 

loading, and a narrative explanation of significant program variances.
	 	 	 
	Contract Target Cost	 	The dollar value (excluding fee or profit) negotiated in the original contract plus the cumulative cost (excluding fee or profit) applicable to all definitizcd changes to the contract. It consists of the estimated

cost negotiated for a cost plus fixed fee contract and the definitized target cost for an incentive contract. The contract target cost does not include the value of authorized/un-negotiated work, and is thus equal to the contract budget base only when all authorized work has been negotiated/definitized.
	 	 	 
	Earned Value	 	See Budgeted Cost for Work Performed (BCWP)
	 	 	 
	Earned Value Management System (EVMS)	 	A project management system utilized for measuring project progress in an objective manner. Combines measurements of scope, schedule, and cost in a single integrated system.

 

    	 

    	 

    

 

	Estimate at Completion 

(EAC)	 	A value (expressed in dollars and/or hours) developed to represent a realistic appraisal of the final cost of tasks when accomplished. It’s the sum of direct & indirect costs to date plus the estimate of costs for all authorized Work remaining. The EAC = ACWP + the Estimate-to-Complete.
	 	 	 
	Estimate to Completion 

(ETC)	 	A value (expressed in dollar and/or hours) developed to represent a realistic appraisal of the cost of the work still required to be accomplished in completing a task.
	 	 	 
	Integrated Master Schedule (IMS)	 	The IMS expands the IMP to the work planning level. It defines the tasks, their durations, milestones, milestone dates which relate to the IMP completion criteria, and interdependencies required to complete the program. The IMP and IMS are used to track and execute the program.
	 	 	 
	Negotiated Contract Target Cost	 	The estimated cost negotiated in a Cost Plus Award 

Fee (CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed Price Incentive Fee (BPIF) contract.

 

    	 

    	 

    

 

	Performance Measurement Baseline (PMB)	 	The time-phased budget plan against which contract performance is measured. It is formed by the budgets assigned to scheduled Control Accounts and the allocation of overhead costs. For future effort, not planned to the Control Account level, the performance measurement baseline also includes budgets assigned to higher level WBS elements, and undistributed budgets. It equals the total assigned budget less management reserve.
	 	 	 
	Risk Register	 	Is a tool commonly used in project planning and organizational risk assessments. It is °lien referred to as a Risk Log. It is used for identifying, analyzing and managing risks.
	 	 	 
	Variance Analysis Report (VAR)	 	The internal report completed by the Control Account Manager and submitted, through the Intermediate Manager, to the program manager for those Control Accounts which have variances in excess of established thresholds.

 

    	 

    	 

    

 

	Work Authorization Document (WAD)	 	A form used to formally authorize and budget work to the Control Account Manager. This document must include, as a minimum, the Control Account number, Statement of Work, scheduled start and finish dates, budget, and the identity of the CAM. It must be approved by Intermediate Manager, and be agreed to by the Control Account Manager.

 

    	 

    	 

    

 

 

Attachment 9 - Department of Health
& Human Services

HHS

Office of the Assistant Secretary for Preparedness and Readiness

ASPR

Biomedical Advanced Research and Development Authority

BARDA

 

7 Principles of Earned Value

Management

Tier 2

System implementation 

Intent Guide

 

01 November 2010

 

 

    	 

    	 

    

 

TABLE OF
CONTENTS

 

	OVERVIEW	1
	 	 
	EVM IMPLEMENTATION TIERS	3
	 	 
	SEVEN PRINCIPLES OF EVM	4
	 	 
	Principle I Plan all Work Scope	4
	 	 
	Principle 2: Break Work into Finite Pieces and Define Person/Organization Responsible for Work	4
	 	 
	Principle 3a: Integrate Scope, Schedule and Budget into a Performance Measurement Baseline	5
	 	 
	Principle 3b: Control Changes to the Baseline 	5
	 	 
	Principle 4: Use Actual Costs Incurred and Recorded in Accomplishing the Work Performed	6
	 	 
	Principle 5: Objectively Assess Accomplishments at the Work Performance Level	7
	 	 
	Principle 6a: Analyze Significant Variances From the Plan	8
	 	 
	Principle 6b: Prepare an Estimate at Completion Based on Performance to Date and Work to be Performed	9
	 	 
	Principle 7: Use EVMS Information in the Company’s Management Processes	9
	 	 
	APPENDIX: GLOSSARY OF TERMS	I0

 

    	 

    	 

    

 

		

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

OVERVIEW

 

Earned Value Management (EVM) is a program management
tool, technique, and discipline that facilitates systematic planning for and monitoring of, high value, complex projects. It
integrates a project’s scope of work with the related budget and schedule to permit detailed assessment of overall
performance during the life of the project.

 

Several government-wide guidance documents govern the
definition and use of EVM systems. Guidelines outlining the qualities and characteristics of an EVM system are set forth in
the American National Standards Institute/Electronic Industries Alliance (ANSI/EIA) Standard-748 (most current version).
More detailed and specific guidance and direction is contained in OMB Circular A-11, Preparation, Submission and Execution
fo the Budget, specifically in Part 7 of that Circular A-11, Planning, Budgeting, Acquisition, and Management of
Capital Assets, and its supplement, the Capital Programming Guide. Based on this collective OMB guidance, EVMS is
intended to be used on those pads of acquisitions that will involve developmental effort. This would include not only
those acquisitions designated by the agency as major systems but also those acquisitions that include significant
developmental, modification, or upgrade during the operational or steady-state phase of a program.

 

The FAR rule on EVMS became effective on July 5, 2006.
Its purpose is to implement EVMS policy in accordance with OMB Circular A-11. Because the new FAR coverage applies throughout
the executive branch and to agencies with disparate definitions of and processes and procedures for major systems
acquisitions, the FAR Council decided against a “one-size-fits all” approach and left several significant
aspects attic detailed implementation up to the discretion of each covered agency.

 

The FAR and Health and Human Services
Acquisition Regulations (HHSAR) language for EVMS will be utilized for all construction or Information Technology (IT)
projects. Since most of the acquisitions at the Biomedical Advanced Research and Development Agency (BARDA) are unique in
that most acquisitions are not Information Technology projects or construction projects, BARDA is developing EVM language
that incorporates the 7 Principles of Earned Value Management. These principles allow flexibility to an EVM system
structure but still meet the spirit of the ANSI/EIA Standard-748. It also incorporates discipline in implementation and
operations and also provides the same reporting data outlined by OMB.

 

The Seven Principles of Earned Value Management are as follows:

 

		1.	Plan all work scope to completion

 

		2.	Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control
of technical, schedule and cost objectives

 

		3.	Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments
can be measured. Control changes to the baseline.

 

		4.	Use actual costs incurred and recorded in accomplishing the work performed.

 

    	1

    	 

    

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

 

		5.	Objectively assess accomplishments at the work performance level.

 

		6.	Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to
date and work to be performed.

 

		7.	Use earned value information in the company’s management processes.

 

    	2

    	 

    

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

 

 

 

EVM IMPLEMENTATION TIERS

 

BARDA will be implementing a tiered approach to EVM based on
the type of acquisition, size of the acquisition and the technical readiness level. There are three tiers and they are as follows:

 

TIER I

 

For all construction contracts and IT contracts the ANSI/EIA-748
Standard for Earned Value Management Systems will apply and all relevant FAR/HHSAR clauses pertaining to EVMS will be incorporated
in the contract. The National Defense Industrial Association (NDIA) Program Management Systems Committee (PMSC) ANSI/EIA-748 Standard
for Earned Value Management Systems Intent Guide should be used as guidance.

 

TIER 2

 

For countermeasure research and development contracts that
have a total acquisition costs greater than or equal to $25 million and have a Technical Readiness Level (TRL) of less than 7
will apply EVM principles for tracking cost, schedule and technical performance that comply with the 7 Principles of EVM
Implementation.

 

TIER 3

 

For countermeasure research and development contracts that are
greater than or equal to $10 million but less than $25 million and/or have a TRL of less than 7 will apply EVM principles for tracking
cost, schedule and technical performance that comply with the 7 Principles of EVM Implementation.

 

This Guide is an explanation of the intent of what is expected
for a Tier 2 or 3 system implementation of the 7 Principles of EVM.

 

    	3

    	 

    

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

SEVEN PRINCIPLES OF EVM

 

Principle 1: Plan all Work Scope

 

in a performance measurement system implementation the
Statement of Work (SOW) should reflect all work that is to be performed. In a 7 Principles implementation a Work Breakdown
Structure (WBS) shall be developed to include all elements of the SOW. The level of the WBS may not be as detailed as in a
Tier I implementation. It would be developed at a higher level, such as level three or four. It is beneficial and required to
develop a WBS dictionary that explains what work is going to be performed in each WBS. This will ensure that the
contractor has identified all work scope and left no major work undefined. It is recommended that the work packages
descriptions are clear and detailed so that there is an understanding of the work that is to be performed in the work
packages. For the 7 Principles implementation programs it would be acceptable for the WBS Dictionary be expanded to include
information that would normally be kept on a Work Authorization Document, such as charge numbers associated with the work,
period of performance, the manager who is responsible for the work, and budget associated with the WBS. The additional
“WAD info” would only be added to the lowest level (i.e. level 3 or 4) of the WBS. The roll up level WBS would
only include scope. By doing this documentation is limited to one document instead of two.

 

By developing a WBS and a WBS Dictionary/Work Authorization
Document the work scope has been defined but the documentation is greatly reduced and the costs associated with developing and
updating the documentation is reduced. The intent of the combination document is not to reduce the level of information provided
to the government but to reduce the amount of documents that need to be produced.

 

Principle 2: Break Work into Finite Pieces and Define Person/Organization
Responsible for Work

 

In a 7 Principles Tier 2 implementation it is recommended
that the work be broken into finite pieces in the schedule tool. It is recommended to plan the work by the lowest level WBS.
The lowest level WBS (level 3 or 4) should be the control account and the activities would act as the work packages. For Tier
2 programs that are of larger value (greater than $25M) the expectation is that the control account will be at least at level
4 and potentially level 5. Most of the normal functions accomplished when scheduling will be required on a 7 Principles Tier
2 implementation. These normal functions include, network scheduling, horizontal and vertical traceability, forecasting
schedule start and completion dates, and running critical path analysis. As part of vertical traceability it is expected
that all contract milestones will be listed on the schedule.

 

The schedule should include but is not limited to include the
following fields:

 

WBS number

Control Account number

Work package number

Task name

Duration

Baseline Start and Finish Dates

 

    	4

    	 

    

 

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

 

 

 

Actual Start and Finish Dates

Forecast Start and Finish Dates

Predecessor/Successors

Activity Percent Complete

 

All the work scheduled at the lowest level WBS should be
identified by a single responsible manager. This manager, known as a Control Account Manager should be identified in the
schedule tool and/or in a cost tool. In a 7 Principles implementation, only individuals at the lowest level WBS need be
identified and there is no requirement for the costs to roll up by organization, although if it is not cost intensive or tool
restricted then developing the OBS is recommended. In many cases, BARDA will provide the top three levels of the WBS for the
contractor to use.

 

Principle 3a: Integrate Scope, Schedule and Budget into a
Performance Measurement Baseline

 

This principle integrates the work scope, the schedule and the
budget into a performance measurement baseline. Since we discussed work scope and schedule the focus of this principle is the incorporation
of the budget in a time-phased manner. The budget must be integrated with the scope of work and the schedule into a Performance
Measurement Baseline (PMB). An accepted way of incorporating the budget and integrating with the scope and schedule is to resource
load the Microsoft Project (or other scheduling tool) schedule. This is done by loading the individual people and their loaded rate
into the tool. This budget data will be input at the work package level with a rate that includes the indirect costs. The budget will have to have the capability to be rolled up to the control
account level and will need to be reported in a way that provides the responsible manager (Control Account Manager) with information
needed to manage the program. Resource loading of the schedule is not the only way to incorporate the budget. As long as the budget in the budget/EV tool is linked to the schedule activities and it is flexible to change when schedule baseline
dates change, then loading the budget in the Budget/EV tool is an acceptable way to integrate the cost and schedule baselines.

 

It is recommended that management reserve and undistributed
budget be utilized in the budgeting process. Undistributed budget is budget that has not yet been distributed to a control account
and it requires additional time to plan the work and distribute the budget to a control account. It is a temporary holding account
and budget should only stay in Undistributed Budget for one or two months. If the work scope is easily identified to all the control
accounts then the use of Undistributed Budget may not be necessary.

 

Management Reserve is budget that is set aside, normally by
the Program Manager, to be used to budget future but currently unknown tasks. It is associated with risk issues and is to be used
to mitigate risk. It is not part of the Performance Measurement Baseline and it should not be used for out of scope work and to cover overruns.

 

Principle 3b: Control Changes to the Baseline

 

A properly
controlled PMB is crucial to effective program management. The timely and accurate incorporation of contractual changes ensures
that the information generated from the execution of

 

    	5

    	 

    

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

 

 the baseline plan provides an accurate picture of progress and facilitates
correct management actions and decisions. The accurate and timely incorporation of authorized and negotiated changes into the
PMB ensures that valid performance measurement information is generated for the new scope being executed. Near term new scope
effort should be planned and have budget in control accounts. Far term new scope effort that cannot be reasonably planned in the
near term can either be put in planning packages in the control account or left in Undistributed Budget if the control account
has not been identified. The timely and accurate incorporation of authorized and negotiated changes into the PMB ensures that
valid performance measurement information is generated for the new scope being executed. Budget revisions are made when work is
added to the contract and are traceable from authorized contract target costs to the control account budgets or from management
reserve. Management reserve may be used for future work when additional in-scope work has been identified.

 

Retroactive changes to the baseline may mask variance trends
and prevent the use of performance data to project estimates of cost and schedule at completion. Controlling retroactive adjustments,
which should only be made in the current period, if possible, is imperative because they could arbitrarily eliminate existing cost
and schedule variances.

 

The use of program budget logs should be used to track and log
all budget changes. The ability to track budget values for both the internal and external changes will help in the maintenance
of the performance measurement baseline from program start to completion. Contractor is expected to utilize baseline change documentation
facilitating the change. It should provide the rationale/justification, approval process, work scope additions or deletions, dollars,
changes to schedules, estimate at completion, etc. It should also include contractual change documents for external changes, such
as a contract modification, letter to proceed, not to exceed letter, change order, etc., that transmit and authorize the change
or addition to work, budget, and schedule. Other documents that should change if a change of scope has been authorized is: Statement
of Work, WBS (changes if applicable); WBS Dictionary (additions or deletions to scope); work authorization documents authorizing
new scope, schedule and budget; schedules.

 

Principle 4: Use Actual Costs Incurred and Recorded in Accomplishing
the Work Performed

 

Some of the new acquisitions at BARDA will be required to be
compliant with the Cost Accounting Standards. For 7 Principles implementation contractors must utilize a work order/job order/task
code charge number structure that uniquely identifies costs at the control account level. This will allow for accumulation and
summarization of costs to higher levels of the work breakdown structure. Actual costs are accumulated in the formal accounting
system in a manner consistent with the way the related work is planned and budgeted. Actual costs reported in the performance reports
agrees with the costs recorded in the accounting system or can be explained as timing differences. The contractor will have to
be able to incorporate and reconcile to the accounting system actual costs on their Contract Performance Reports (CPR) to the customer.

 

Depending on the amount of material and subcontractors on the
program, it is beneficial for management purposes, to include accruals, or estimated actuals, for these costs. Since material and
subcontractor invoices are not paid and recorded in the accounting system for up to several months after the work has been planned,
performance data will be skewed. Accruing or

 

    	6

    	 

    

 

7 Principles of EVM Tier 2 System Implementation
Intent Guide

 

 

 

 estimating actual costs based on receipt (for material) and expended hours for subcontractors
will alleviate this issue. The use of accrual/estimated actuals should be reviewed on a case by case basis depending on the size
of program, the amount of material or subcontractor budget and costs. If the material and subcontract effort is minimal then the
time and effort needed to manage the accruals would outweigh the benefit of having the costs accrued since the performance data
would only be minimally affected.

 

If the subcontractor has a fixed price contract the prime contractor,
then the prime contractor must report actual costs in line with the work that is accomplished. The way this is accomplished is
to record the actual costs equal to the work that was performed on the CPR.

 

Principle 5: Objectively Assess Accomplishments at the Work
Performance Level

 

In order to meet this Principle, the scheduling of the scope
of work in work packages or activities need to incorporate measurable units or milestones in order to objectively assess accomplishments
or obtain what we call “earned value”. These units or milestones are given a value based on labor resources needed
to accomplish the work (which becomes the Budgeted Cost of Work Scheduled or BCWS). When they arc accomplished (known as Budgeted
Cost of Work Performed or BCWP) they receive the value associated with the budget which measures progress.

 

Schedule status to measure progress needs to be on at least
on a monthly basis although it is preferred on a bi-weekly basis. As part of the status process progress dates, such as actual
start/complete and forecast start/complete need to be updated.

 

Since Microsoft Project seems to be the schedule tool of choice
by most contractors, there are four types of earned value methodologies utilized by Microsoft Project of which two assess progress
by the completion of milestones and they are the 50/50 and 0/100 methodologies. In both cases, progress is reported for completion
milestones and in the 50/50 methodology fifty percent of the value of the work package/activity is credited for stalling the work.
The other two earned value methodologies are assessed percent complete (also know as Supervisor’s Estimate) and level of
effort (LOE). All four methodologies are legitimate earn value measurement techniques but the assessed percent complete based or
supervisor’s estimates are highly discouraged. The reason is that it is highly subjective and is not based on any quantifiable
criteria. BARDA will not accept these earned value methodologies unless approved as an exception on a case by ease basis. If percent
complete on work packages is used with objective measurable activities, the contractor must show distinct relationship between
the budget planned at the work package level and the value earned at the activity level. If this is done properly then the measurement
will be objective and the schedule variance will be clearly understood and easy to explain. If this is not done properly then schedule
activities are not aligned with the budget in the performance measurement baseline and schedule variances will not be easy to understand.
If the latter is the case, BARDA will not accept that as an acceptable earned value methodology.

 

There are built in weaknesses with the 0/100 and 50/50 methodologies
also. If the responsible manager is being asked to plan their work in monthly increments in order to utilize the 0/100 methodology
then they may be asked to break the work up in pieces that don’t make logical sense or represent the natural ending of the
work. Also the 50/50 methodology, which is usually used for a two month work package, will provide skewed monthly data if the
resources in the work

 

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7 Principles of EVM Tier 2 System Implementation
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 package are not loaded equally for each month. It will give
an artificial positive or negative schedule variance the first month and vice versa the next month.

 

Additional earned value methodologies, such as the weighted
milestone methodology and percent complete with milestone gates may be utilized. The weighted milestone method allows value to
be earned based on the resource value in each month, which eliminates artificial schedule variances.

 

For all discrete measurable work packages or control accounts,
there must be an activity in each month to measure. Gaps, in which there is nothing to measure in a month or months is not acceptable.

 

For subcontractors that have a fixed price contract with the
prime contractor, the expectation is that there will be no cost variance. The ACWP reported on the CPR will equal the BCWP earned,
regardless of the payment schedule with subcontractor.

 

Principle 6a: Analyze Significant Variances From the Plan

 

The purpose of this principle is to ensure that the earned value
data is analyzed by the contractor and reported to the customer. The 7 Principles programs should be able to calculate the cost
variance (BCWP minus Actual Cost of Work Performed (ACWP) and the schedule variance (BCWP minus BCWS) at least on a cumulative
basis. It is recommended that variances be calculated on a current month basis also. The EVM system should also provide both monthly
and cumulative Cost Performance Index (BCWP divided by ACWP) and Schedule Performance

Index (BCWP divided by the BCWS). This data should be provided at the control account level and at the roll up levels and it needs
to be in a format for Control Account Managers and program management to be able to utilize in managing the work.

 

It is also recommended that the To-Complete Performance Index
(TCPI) be included in the Control Account Manager performance report. The TCPI is a valuable index that calculates the cost performance
the control account needs to perform at in order to complete the work within the current reported EAC. When the TCPI is compared
against the cumulative CPI it gives a good indication whether or not the current EAC is reasonable. For example, if a cumulative
CPI is .85 and the TCPI calculates to equal 1.15 that is the performance factor that work would need to perform at in order to
meet the current EAC. If the cumulative CPI is .85 then it can be determined that the current EAC might not be reasonable. It allows
management and Project Controls the opportunity to question the Control Account Manager as to the validity of the current EAC.
As a rule in thumb if the deviation between the CPI and the TCPI is greater than .2 then the CAM should reassess the control account
EAC.

 

These reports, which should be provided monthly, should also
include the current Budget at Completion (BAC) and the current Estimate at Completion (BAC). In addition, it would be a plus if
the CAM could see a report with their time-phased spread of hours and dollars for their budget plan (BCWS), work accomplished (BCWP)
and actual costs (ACWP).

 

For all variances that exceed the contractual variance threshold
will include a description of what caused the variance, impact to the control account and the program, and a corrective action.

 

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7 Principles of EVM Tier 2 System Implementation
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Principle 6b: Prepare an Estimate at Completion Based on
Performance to Date and Work to be Performed

 

Providing an updated EAC is a prime concern of the customer
and the contractor. Therefore a robust EAC process should be in place whether the program is ANSI compliant or not.

 

Based on the performance to date the Estimates at Completion
can be updated on a monthly basis by the Control Account Manager in the scheduling tool during the status process or in the cost/EVM
tool at the end of the month’s process prior to submittal of the EVM report. The EAC is an element of the performance
measurement system that needs to accurately reflect the contractor’s best estimate of what it will cost to complete the project.

 

Program management should be able to validate control account
manager’s EACs by looking at performance indices, such as the To-Complete Performance Index, as well as independent statistical
EACs.

 

Principle 7: Use EVMS Information in the Company’s
Management Processes

 

One of the key areas that concerns government Program Management
Offices (PMO) is the level of importance that contractor’s place on EVM as a management tool. During a site visit, such as
conducting an Integrated Baseline Review, the PMO gauges what the interest, knowledge, and most importantly, the usage of the performance
measurement data in managing the program. They want to know that the managers on the program, including the program manager, have received
some earned value training. The level of involvement and use of the EVM data to manage their schedule, cost and technical issues
is ascertained by questions. The PMO can also tell by how robust the EACs are and if the variance narratives are being written
with impacts to the program and corrective actions being monitored by the contractor. It is important that the contractor’s
management team, including the Program Manager, utilize the data from the performance measurement system as a management tool.
They should be knowledgeable and understand the data. They should know what is causing the variances and ensure that the variance
narratives are written properly and answer what the issues, impacts and corrective actions are. They should be able to demonstrate
that they use the information to assist them in the management decision process. They should hold their Control Account Managers
accountable to use the data and write clear proper variance analysis report (VAR). If the Control Account Manager does not write
a proper VAR then Project Controls needs to help instruct them how to do it. It is recommended that prior to the Earned Value report
be sent to the government that the Program Manager has a meeting with the Control Account Managers and Project Control and review
the data and ensure that the variance analysis is complete and that the Program Manager agrees with it. This review is also used
to ensure that the EACs arc acceptable to the Program Manager, who is ultimately responsible for the program EAC. This is an efficient
and quick way to make any adjustments to the earned value report since all the key personnel are in one room. If the data appears
to be unreliable then the PM needs to hold Project Controls accountable to ensure that they are using discipline in changing baselines,
assessing process properly, and capturing actual costs to ensure that the data that is reported is accurate.

 

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APPENDIX: GLOSSARY OF TERMS

 

	Actual Cost of Work 

Performed (ACWP)	The costs actually applied and recorded in accomplishing the work performed within a specified period.
	 	 
	Actual Direct Cost	Those costs identified specifically with a contract, based upon the contractor’s cost identification and accumulation system as accepted by the cognizant DCAA representatives. (See Direct Costs).
	 	 
	Advance Agreement (AA)	An agreement between the contractor and the Contract Administration Office concerning the application of an approved earned value management system to contracts within the affected facility.
	 	 
	Authorized Work	That effort which has been authorized and is on contract, or that for which authorized contract costs have not been agreed to but for which written authorization has been received.
	 	 
	Baseline	(See Performance Measurement Baseline).
	 	 
	Budget at Completion (BAC)	The sum of all budgets (BCWS) allocated to the contract. Synonymous with the term Performance Measurement Baseline.
	 	 
	Budgeted Cost for Work Performed (BCWP)	The sum of the budgets for completed Work Packages and completed portions of open Work Packages, plus the appropriate portion of the budgets for level of effort and apportioned effort (Also see Earned Value).
	 	 
	Budgeted Cost for Work Scheduled (BCWP)	The sum of the budgets for completed Work Packages, planning packages, etc., scheduled to be accomplished (including in-process Work Packages), plus the amount of level of effort and apportioned effort scheduled to be accomplished within a given time period.

 

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	Change Order (CO)	A formal authorization by the Procuring Contracting Officer for a change of scope to an existing contract 
	 	 
	Contract Modification	A written and binding authorization to proceed created after change proposal negotiations.
	 	 
	Contract Budget Base (CBB)	The negotiated contract cost plus the estimated cost of authorized unpriced work, where:
	 	 
	 	(1) Negotiated Contract Cost is that cost on which contractual agreement has been reached. For an incentive contract, it is the definitized contract target cost plus/minus the value of changes which have been priced and incorporated into the contract through contract change order or supplemental agreement. For fixed-fee contracts, it is the negotiated estimated cost. Changes to the estimated cost will consist only of the formal contract modifications or change orders or change in the contract statement of work, not for cost growth, and
	 	(2) Estimated cost of authorized, unpriced work is the estimated cost (excluding fee or profit) for that work for which written authorization has been received, but for which definitized contract prices have not been incorporated into the contract through supplemental agreement.
	 	 
	Control Account	A management control point at which actual costs can be accumulated and compared to budgeted cost for work performed. A control account is a natural control point for cost/schedule planning and control since it represents the work assigned to one responsible organizational element on one contract work breakdown structure (CWBS) element.
	 	 
	Control Account Manager (CAM)	A member of a functional organization responsible for task performance detailed in a Control Account and for managing the resources authorized to accomplish the tasks.

 

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	Control Account Plan (CAP) Report	A CAP report is a timephased report which reflects all the work and effort to be performed in a control account. The CAP report will reflect the hours and dollars by element of cost (labor, subcontract, ODC, etc).
	 	 
	Contract Performance Report (CPR)	The monthly report submitted to the customer showing the current, cumulative and at completion status, the performance measurement baseline, manpower loading, and a narrative explanation of significant program variances.
	 	 
	Contract Target Cost	The dollar value (excluding fee or profit) negotiated in the original contract plus the cumulative cost (excluding fee or profit) applicable to all definitized changes to the contract. It consists of the estimated cost negotiated for a cost plus fixed fee contract and the definitized target cost for an incentive contract. The contract target cost does not include the value of authorized/un-negotiated work, and is thus equal to the contract budget base only when all authorized work has been negotiated/definitized.
	 	 
	Cost Performance Index (CPI)	An efficiency rating reflecting a project’s budget performance - either over or under. Measured as a ratio of the budgeted value of work accomplished versus the actual costs expended for a given project time period. The formula for CPI is BCWP/ACWP.
	 	 
	Discrete Effort	Program effort that has a measurable output, product or service.
	 	 
	Direct Costs	Those costs (labor, material, etc.) that can be reasonably and consistently related directly to service performed on a unit of work, and are charged directly to the contract, without distribution to an overhead unit.

 

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	Earned Value	See Budgeted Cost for Work Performed (BCWP)
	 	 
	Earned Value Management System (EVMS)	A project management system utilized for measuring project progress in an objective manner. Combines measurements of scope, schedule, and cost in a single integrated system.
	 	 
	Estimate at Completion (EAC)	A value (expressed in dollars and/or hours) developed to represent a realistic appraisal of the final cost of tasks when accomplished. It’s the sum of direct & indirect costs to date plus the estimate of costs for all authorized Work remaining. The EAC ACWP ± the Estimate-to-Complete.
	 	 
	Estimate to Completion (ETC)	A value (expressed in dollar and/or hours) developed to represent a realistic appraisal of the cost of the work still required to be accomplished in completing a task.
	 	 
	Indirect Costs	Represents those costs, because they are incurred for common or joint objectives, are not readily subject to treatment as direct costs. (See overhead).
	 	 
	Integrated Baseline Review (IBR)	An Integrated Baseline Review (IBR) is a formal review led by the Government Program Manager and Technical Support Staff. An IBR is conducted jointly with the Government and their Contractor counterparts.
	 	 
	 	The purpose of an IBR is to: verify the technical content of the Performance Measurement Baseline (PMB); assess the accuracy of the related resources (budgets) and schedules; identify potential risks.
	 	 
	Integrated Master Plan (IMP)	The overall program plan including the work definition, technical approach, performance criteria, and completion criteria.

 

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	Integrated Master Schedule (IMS)	The IMS expands the IMP to the work planning level. It defines the tasks, their durations, milestones, milestone dates which relate to the IMP completion criteria, and interdependencies required to complete the program. The IMP and 1MS are used to track and execute the program.
	 	 
	Integrated Product Team (IPT)	A grouping of project personnel along project objective lines rather than along organizational lines. Integrated Product Teams are work teams that represent a transition from a functional organization structure to a multi-functional project objective arrangement.
	 	 
	Internal Replanning	Replanning actions performed by the program for remaining effort within the recognized total allocated budget.
	 	 
	Level of Effort (LOE)	Work that does not result in a final product, e. g., liaison, coordination, follow-up, or other support activities, and which cannot be effectively associated with a definable end product process result. It is measured only in terms of resources actually consumed within a given time period.
	 	 
	Management Reserve (MR)	An amount of the total Contract Budget Base (CBB) withheld for management control purposes rather than designated for the accomplishment of a specific task or set of tasks. It is not a part of the Performance Measurement Baseline.
	 	 
	Negotiated Contract Target Cost	The estimated cost negotiated in a Cost Plus Award Fee (CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed Price Incentive Fee (FPIF) contract.
	 	 
	Original Budget	The budget established at, or near, the time the contract was signed, based on the negotiated contract cost.

 

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	Overhead	Indirect labor and material, supplies and services costs and other charges, which cannot be consistently identified with individual programs.
	 	 
	Other Direct Costs	A group of accounting elements which can be isolated to specific tasks, other than labor and material. Included in ODC are such items as travel, computer time, and services
	 	 
	Performance Measurement Baseline (PMB)	The time-phased budget plan against which contract performance is measured. It is formed by the budgets assigned to scheduled Control Accounts and the allocation of overhead costs. For future effort, not planned to the Control Account level, the performance measurement baseline also includes budgets assigned to higher level WBS elements, and undistributed budgets. It equals the total assigned budget less management reserve.
	 	 
	Performing Organization	A defined unit within the program organization structure, which applies the resources to performs the authorized scope of work.
	 	 
	Planning Package	A logical aggregation of far term work within a Control Account that can be identified and budgeted but not yet defined into Work Packages.
	 	 
	Reprogramming	Replanning of the effort remaining in the contract, resulting in a new budget allocation which exceeds the contract budget base. The resulting baseline is called an Over Target Baseline (OTB).
	 	 
	Responsible Organization	A defined unit within program’s organization structure that is assigned responsibility for accomplishing specific tasks.

 

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	Risk Register	Is a tool commonly used in project planning and organizational risk assessments. It is often referred to as a Risk Log. It is used for identifying, analyzing and managing risks.
	 	 
	Schedule Performance Index (SPI)	An efficiency rating reflecting how quickly or slowly project work is progressing. Measured as a ratio of work accomplished versus work planned for a given period of time. The formula for SP1 is BCWP/BCWS.
	 	 
	Significant Variances	Those differences between planned and actual cost and schedule performance which require further review, analysis, or action. Appropriate thresholds are established as to the magnitude of variances which will require variance analysis.
	 	 
	Statistical Estimate at Completion	Is a single point estimate that can be quickly prepared and used to test the reasonableness of the current cost estimates and budget and to indicate when a comprehensive EAC should be prepared
	 	 
	To Complete Performance Index (TCPI)	An efficiency rating that provides a projection of the anticipated performance required to achieve the EAC. TCPI indicates the future required cost efficiency needed to achieve a target EAC (Estimate At Complete). Any significant difference between TCPI and the CPI needed to meet the EAC should be accounted for by management in their forecast of the final cost.
	 	 
	Total Allocated Budget (TAB)	The sum of all budgets allocated to the contract. Total allocated budget consists of the performance measurement baseline and all management reserve. The total allocated budget will reconcile directly to the Contract Budget Base (CBB). Any differences will be documented as to quantity and cause.

 

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	Undistributed Budget (UB)	Budget applicable to contract effort which has not yet been identified to WBS elements at or below the lowest level of reporting to the Government.
	 	 
	Variance Analysis Report (VAR)	The internal report completed by the Control Account Manager and submitted, through the Intermediate Manager, to the program manager for those Control Accounts which have variances in excess of established thresholds.

 

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	Variances	(See Significant Variances).
	 	 
	Work Authorization Document (WAD)	A form used to formally authorize and budget work to the Control Account Manager. This document must include, as a minimum, the Control Account number, Statement of Work, scheduled start and finish dates, budget, and the identity of the CAM. It must be approved by Intermediate Manager, and be agreed to by the Control Account Manager.
	 	 
	Work Breakdown Structure (WBS)	A product-oriented, family-tree composed of hardware, software, services, data and facilities which results from system engineering efforts. A work breakdown structure displays and defines the product(s) to be developed and/ or produced and relates the elements of work to be accomplished to each other and to the end product.
	 	 
	 	(1) Program WBS. The work breakdown structure that covers the acquisition of a specific defense material item and is related to contractual effort. A program work breakdown structure includes all applicable elements consisting of at least the first three levels of the work breakdown structure and extended by the program manager and /or contractor(s). A program work breakdown structure has uniform element terminology, definition, and placement in the family tree structure.
	 	 
	 	(2) Contract WBS (CWBS) The complete WBS for a contract, developed and used by a contractor within the guidelines of MIL-Handbook 881 (latest revision) or NASA WBS Handbook (insert reference) or other customer guidelines and according to the contract work statement. It includes the approved work breakdown structure for reporting purposes and its discretionary extension to the lower levels by the contractor, in accordance with MIL-Handbook 881 and the contract work statement. It includes all the elements for the products (hardware, software, data, or services) which are the responsibility of the contractor.

 

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	Work Packages	Detailed short-span jobs, or material items, identified by the contractor for accomplishing work required to complete the contract. A Work Package has the following characteristics.
	 	 
	 	1.       It represents units of work at levels where work is performed.
	 	 
	 	2.        It is clearly distinguishable from all other work packages.
	 	 
	 	3.        It is assignable to a single organizational element.
	 	 
	 	4.        It has scheduled start and finish dates and, as applicable, interim milestones, all of which are representative of physical accomplishment.
	 	 
	 	5.        It has a budget or assigned value expressed in terms of dollars, man-hours or other measurable units.
	 	 
	 	6.        Its duration is limited to a relatively short span of time or it is subdivided by discrete value milestones to facilitate the objective measurement of work performed.
	 	 
	 	7.        It is integrated with detailed engineering, manufacturing, or other schedules.
	 	 
	Work Package Budgets	Resources which are formally assigned by the CAM to accomplish a Work Package, expressed in dollars and/or hours.

 

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Attachment 10

 

Communication Management Plan

Biomedical Advanced Research and Development
Authority

(BARDA)

Broad Spectrum Antimicrobial Program

Chimerix Contract

Number HHSO100201100013C

330 Independence Ave. SW

Washington, DC 20201

 

    	 

    	 

    

 

BSA Communications Management Plan

 

Introduction:

 

The purpose of the Broad Spectrum Antimicrobial (BSA) communications
management plan is to define the communication requirements for the project and outline how BARDA and the Contractor will distribute
information. The communications management plan defines the following:

		o	Communication requirements based on roles,

		o	What information will be communicated,

		o	How the information will be communicated,

		o	When will information be distributed,

		o	Who does the communication,

		o	Who receives the communication,

 

This BSA communications management plan sets the communications
framework for this project. It will serve as a guide for communications throughout the period of performance and will be updated,
as communication needs change. This plan identifies and defines the roles of persons involved in the project. The BSA communications
management plan provides an in-depth guide on how the program plans to conduct meetings between stakeholders to ensure a successful
outcome. A project team directory is below to provide contact information for all stakeholders directly involved in the project.

 

Communications Management Approach

 

The BARDA Project Officer (PO) and Contracting Officer (CO)
and Contractor’s Program Manager will take a proactive role in ensuring effective communication between all parties on this
contract. The goal of all parties is to maintain a transparent communicative relationship that fosters the sharing of information
to relevant Stakeholders in a timely and efficient manor to facilitate the successful outcome of the programs mutual objectives,
the development of CMX-001 as a novel broad spectrum antibiotic for the therapeutic treatment of individuals exposed to biodefense
threat agents. This communication plan documents the communication requirements for all parties that will support the implementation
of this contract. The Communications Matrix will provide a guide for the communication process, including:

		o	What type of information Stakeholders will communicate,

		o	Who is responsible for communicating relevant information,

		o	When should stakeholders communicate program relevant information,

 

Roles

 

Project Sponsor: BSA Branch Chief

 

The project sponsor is responsible for overseeing the BSA contracts
and the champion of the project and has authorized the project by signing the project charter. This person is responsible for the
funding of the project and is ultimately responsible for its success. Since the Project Sponsor is at the executive level, communications
should be presented in summary format unless the Project Sponsor requests more detailed communications. Communication from the
Contractor to the Project Sponsor should flow through the BARDA

 

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BSA Communications Management Plan

 

 

Contracting Officer or Project Officer through the appropriate
chain of command to the Project Sponsor, unless otherwise indicated by the Project Sponsor.

 

Contract Officer

 

The BARDA Contract Officer (CO) oversees the project at the
program level and is responsible for all contract related issues. The CO is the United State Government’s representative
that has the legal authority to bind BARDA to a contract with the Contractor. The CO will communicate directly with the Contractor
and shall be included on all communications between the Contractor and BARDA staff. At any time, if the Contractor shall have contractual
or programmatic concerns regarding the contract, scope of work, or any other issues, the Contractor should immediately address
all concerns directly to the CO.

 

Project Officer

 

The BARDA Project Officer (PO) [and/or Contracting Officer’s
Technical Representative (COTR)] oversees the project at the program level and is responsible for the technical implementation
of the BSA contract. The PO is responsible for managing the cost, schedule, and performance parameters for the contract. The PO
will be in regular communication with Contractor’s POC to ensure the contract is maintaining cost, schedule, and performance
objectives.

 

The PO manages day-to-day resources, provides project guidance,
monitors, and reports on the projects metrics as defined in the Project Management Plan. The PO is responsible for the execution
of the project and is the primary communicator for the project.

 

The PO is responsible for briefing the Project Sponsor and subsequent
leadership levels. The PO is the individual responsible for communicating program progress, program risk, and contract relevant
issues raised by the Product Coordination Team charter, stakeholders, and/or Contractor.

 

Program Manager

 

The BARDA Program Manager (PM) a contractor for BARDA will support
the Project Officer. The PM may communicate with the contractor on program management related issues on behalf of the BARDA PO.
The intent of the communication is to provide information and is not to be taken as a directive.

 

Key Stakeholders and the Product Coordination Team

 

The BARDA Branch Chief responsible for overseeing the BSA contract
signed a Product Coordination Team (PCT) Charter, identifying internal and external BARDA program members and stakeholders supporting
this contract. The BARDA BSA PCT will meet regularly to review the project. The PO will chair the PCT. Based on their technical
or program management expertise, each stakeholder and PCT member will play a key role. All BARDA and USG Team members will work
to communicate all activities through the PO.

 

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BSA Communications Management Plan

 

Members of the PCT may at times work directly with other stakeholders
and/or the Contractor with consent of the CO and PO. In such situations, the CO, PO, and Contractor POC shall be included on all
communications. It is important to note that the intent of this communication is to provide information and is not to be taken
as a directive by the Contractor. If the recipient(s) believe(s) the information provided herein may be construed as a directive,
the recipient(s) should disregard that portion of the communication and contact the BARDA BSA Contracting Officer.

 

Contractor Liaison

 

The Contractor has identified a BARDA Liaison (BL) as a primary
POC and alternative POC (in the advent that the primary POC is unavailable) to communicate directly with the BARDA CO and PO. The
Contractor BL will work closely with the CO and BARDA PO to manage the implementation of this contract. This communication shall
be transparent and informative for all entities. Communication from the Contractor to BARDA should flow through the Contractor
BL to the CO and PO to ensure proper coordination within BARDA and the Contractor’s organization.

 

The Contractor’s BL is responsible for the implementation
of the scope of work agreed to under the contract. The Contractor’s BLprovide reports on the project’s metrics
as defined in the Project Management Plan. As the person responsible for the implementation of the project, the Contractor’s
BL is the primary communicator for the Contractor and responsible for distributing information according to the Communications
Management Plan.

 

Food and Drug Administration

 

The Food and Drug Administrations’, Center for Drug Evaluation
and Research (CDER) is the regulatory authority overseeing the development of the BSA Medical Countermeasure. CDER plays a critical
role in the success of this contract between BARDA and the Contractor. In an effort to provide open communication, the communications
management plan encourages the sharing of communications between the FDA, BARDA, and the Contractor. The communication management
plan does not prevent either BARDA or the Contractor from engaging CDER.

 

Project Team Directory

 

	Role	Name	Email	Phone
	Project Sponsor	[...***...]	[...***...]	[...***...]
	Contracting Officer	[...***...]	[...***...]	[...***...]
	Project Officer/PCT Chair	[...***...]	[...***...]	[...***...]
	Program Manager (Contractor)	[...***...]	[...***...]	[...***...]
	Contractor POC/BARDA Liaison	[...***...]	[...***...]	[...***...]
	Alternative Contractor	 	 	 

 

***Confidential Treatment Requested

 

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BSA Communications Management Plan

 

Communication Deliverables and Procedures

 

The Contract Deliverables List (reference) outlines the communication
requirements and expectations for various types of meetings and program deliverables.

 

Guidelines for Meetings

 

Meeting Agenda

 

The Contractor will send the meeting agenda to the PO in advance
of the meeting as outlined in the Contract Deliverables List. The agenda will include ongoing action items, requested participants
and provide a brief agenda for the meeting. The BARDA PO will review and finalize the meeting agenda and distribute accordingly.

 

Meeting Minutes

 

The Contractor will draft meeting minutes and forward to the
PO within a specific amount of time as outlined in Contract Deliverables List. The meeting minutes will provide a synopsis of the
meeting, list of participants, highlight decisions made, reference supportive material and include the status of all open and closed
action items and a parking lot list. The BARDA PO will review and finalize meeting minutes.

 

Action Items

 

The meeting agenda and minutes will record action items. Action
items will include the action item, owner of the action item, and the anticipated date of completion. Meetings will start with
a review of the status of all action items from previous meetings and end with a review of all new action items resulting from
the meeting. The review of the new action items will include identifying the owner for each action item and setting a date for
completing the action item.

 

Meeting Chair - BARDA Project Officer

 

The meeting chair is responsible for distributing the meeting
agenda, facilitating the meeting and distributing the meeting minutes. As the meeting chair, the BARDA Project Officer will ensure
that the meeting starts and ends on time and that all presenters adhere to their allocated time frames. The Contractor will be
responsible for developing the initial agenda, drafting the minutes, capturing action items, and following up on meeting outcomes.

 

Note Taker: Contractor

 

The Contractor is the note taker responsible for documenting
the status of all meeting items, maintaining a parking lot item list and taking notes of anything else of importance during the
meeting. The note taker will give a copy of their minutes to the BARDA CO for final approval of meeting minutes.

 

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BSA Communications Management Plan

 

Parking Lot

 

The parking lot is a tool used by the facilitator to record
and defer items which are not on the meeting agenda but that, merit further discussion later or through another forum.

A parking lot record should identify an owner for the item,
as this person will he responsible for ensuring follow-up. The Contractor will include a parking lot list in the meeting minutes.

 

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Attachment 11

Non-Clinical Terms of Award

 

These Non-Clinical Terms of Award detail an agreement between
the Biomedical Advanced Research and Development Authority (BARDA) and the Awardee (i.e., the Contractor); they apply to all grants
and contracts that involve non-clinical research.

 

Draft protocols for each nonclinical study funded by BARDA will
be submitted to BARDA for review and comment. Contractor will address in writing its consideration of BARDA comments prior to submission
of protocols to the FDA for comment.

 

BARDA shall have rights to all protocols, data resulting from
execution of these protocols, and final reports, funded by BARDA under this contract, as defined in Rights in Data Clause
in FAR 52.227-14, Alternative II. BARDA reserves the right to request that the Awardee provide any contract deliverable in a non-proprietary
form, to ensure BARDA has the ability to review and distribute the deliverables, as BARDA deems necessary.

 

A.Safety and Monitoring Issues

 

PHS Policy on Humane Care and Use of Laboratory Animals

 

Before award and then with the annual progress report, the Awardee
must submit to BARDA a copy of the current Institutional Animal Care and Use Committees (IACUC) documentation of continuing review
and approval and the Office of Laboratory Animal Welfare (OLAW- National Institutes of Health) Federal Wide Assurance (FWA) number
for the institution or site.

 

If other institutions are involved in the research (e.g., a
multicenter trial or study), each institution’s IACUC must review and approve the protocol. They must also provide BARDA
initial documentation and documentation of continuing review and approval and FWA number.

 

The Awardee must ensure that the application as well as all
protocols are reviewed by the performing institution’s IACUC.

 

To help ensure the safety of animals used in BARDA funded studies,
the Awardee must provide BARDA copies of documents related to all major changes in the status of ongoing protocols for studies
funded by BARDA, including the following:

 

		o	All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.

		o	All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if
applicable)

		o	Termination or temporary suspension of the study(ies) for regulatory issues

		o	Termination or temporary suspension of the protocol.

		o	Any change that is made in the specific IACUC approval for the indicated study(ies).

		o	Any other problems or issues that could affect the scientific integrity of the study(ies), i.e. fraud, misrepresentation, misappropriation
of funds, etc.

 

Awardees must notify BARDA by email or fax of any of the above
changes within five business days from the time awardee becomes aware of such changes, followed by a letter signed by the institutional
business official, detailing notification of the change of status to the local IACUC and a copy of any responses from the IACUC.

 

    	 

    	 

    

 

If a non-clinical protocol has been reviewed by an institutional
biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Awardee must provide information about the initial
and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

 

Non-Clinical Data and Safety Monitoring Requirements

 

BARDA strongly recommends continued safety monitoring for all
non-clinical studies of investigational drugs, devices, or biologics. FDA expects non-clinical studies to include safety in addition
to efficacy. Awardee should consider evaluation of clinical relevant safety markers in the pivotal and non-pivotal, non-clinical
studies.

 

BARDA will provide input to the Awardee decisions regarding
the type and extent of safety data accrual to be employed before the start of efficacy or safety studies.

 

The Awardee shall inform BARDA of any upcoming site visits and/or
audits of CRO facilities funded under this effort. BARDA reserves the right to accompany the awardee on site visits and/or audits
of CROs as BARDA deems necessary.

 

B.BARDA Review Process Before Non-Clinical Study Execution
Begins

 

BARDA is under the same policy-driven assurances as NIH in that
it has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety and
welfare of animals used in BARDA funded non-clinical trials. Therefore, before study execution, the Awardee must provide the following
(as applicable) for review by BARDA:

 

		o	IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study
design, euthanasia criteria, proposed interventions, and exclusion criteria.

 

		o	Documentation of IACUC approval, including OLAW FWA number, IACUC registration number, and IACUC name.

 

		o	Awardee should reduce the number of animals required for a study using power of statistics

 

		o	Plans for the management of side effects, rules for interventions and euthanasia criteria

 

		o	Procedures for assessing and collecting safety data

 

		o	If a study is contracted through CRO(s), work orders and service agreements the Awardee shall assure that an integrated safety
documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and
laboratory services (including histopathology).

 

		o	Documentation that the Awardee or CRO and all staff responsible for the conduct of the research have received required training
in the protection and handling of animals

 

		o	Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval
by the Contracting Officer in accordance with the contract. The Awardee must have the ability to return/re-sell animals, at purchase
price, to distributor or a third party, in the event that the Contracting Officer Authorization is not granted.

 

		o	Provide justification for whether studies require good laboratory practice (GLP) conditions

 

		o	Provide justification for whether studies will be classified as non-pivotal or pivotal studies

 

Non-Clinical Studies not being submitted to the FDA prior
to execution:

 

Awardee will submit proposed protocols to BARDA at least 30
days prior to study execution for study protocols that are not being submitted to the FDA. BARDA staff comments will be forwarded
to the Awardee within 8 business days of receipt of the above information provided. The Awardee must address in writing its consideration
of all study design, safety, regulatory, ethical, and conflict of interest concerns raised by BARDA . After receiving the documentation,
the BARDA Contracting Officer will provide a written Contract Officer Authorization (COA) Letter to

 

    	 

    	 

    

 

the Awardee. This COA provides
authorization to the Awardee to execute the specific nonclinical study funded in part or in whole by BARDA.

 

Non-Clinical Studies that will be submitted to the FDA prior
to execution:

 

BARDA staff continents will be forwarded to the Awardee within
8 business days of receipt of the above information. The Awardee must address in writing its consideration of all study design,
safety, regulatory, ethical, and conflict of interest concerns raised by BARDA, However the FDA shall have final authority over
such protocols and protocol amendments. After receiving the documentation, the BARDA Contracting Officer will provide a Contracting
Officer Authorization (COA) Letter authorizing the execution of the study.

 

Final decisions regarding ongoing safety reporting requirements
for research not performed under an Investigational New Drug Application (IND) or investigational device exemption (IDE) must be
made by the Awardee in consultation with BARDA.

 

References

		o	Public Health Service Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/InvestigatorsNeed2Know.pdf)

		o	USDA Animal Welfare Act 

(http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=3&tax_subject=182&top

ic_id=1118&Ievel3_d=6735&level4_id=0&level5_id=0&placement_default=0)

 

    	 

    	 

    

 

Clinical Terms of Award

 

These Clinical Terms of Award detail an agreement between the
Biomedical Advanced Research and Development Authority (BARDA) and the Awardee; they apply to all grants and contracts that involve
clinical research.

 

Draft protocols for each clinical study funded by BARDA will
be submitted to BARDA for review and comment. Contractor will address in writing its consideration of BARDA comments prior to submission
of protocols to the FDA for comment.

 

BARDA shall have rights to all protocols, data generated from
the execution of those protocols, and final reports, funded by BARDA under this contract, as defined in Rights in Data Clause in
FAR 52.227-14, Alternative II. BARDA reserves the right to request that the Awardee provide any contract deliverable in a non-proprietary
form, to ensure BARDA has the ability to review and distribute the deliverables, as BARDA deems necessary.

 

A.Safety and Monitoring Issues

 

Institutional Review Board (IRB) or independent Ethics Committee
(IEC) Approval

 

Before award and then with the annual progress report, the Awardee
must submit to BARDA a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and
approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

 

If other institutions are involved in the research (e.g., a
multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also
provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent
document and FWA number.

 

The Awardee must ensure that the application as well as all
protocols are reviewed by their IRB or IEC.

 

To help ensure the safety of participants enrolled in BARDA
funded studies, the Awardee must provide BARDA copies of documents related to all major changes in the status of ongoing protocols
for studies funded by BARDA, including the following:

 

		o	All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.

 

		o	All changes in informed consent documents, identified by version number, date, or both and dates it is valid.

 

		o	Termination or temporary suspension of patient accrual.

 

		o	Termination or temporary suspension of the protocol.

 

		o	Any change in IRB approval.

 

		o	Any other problems or issues that could affect the participants in the studies.

 

Awardees must notify BARDA through the Contracting Officer’s
Technical Representative (COTR) or Contracting Officer (CO) of any of the above changes within five working days by email or fax,
followed by a letter signed by the institutional business official, detailing notification of the change of status to the local
IRB and a copy of any responses from the IRB or IEC.

 

If a clinical protocol has been reviewed by an institutional
biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Awardee must provide information about the initial
and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

 

    	 

    	 

    

 
 

 

Data and Safety Monitoring Requirements

 

BARDA strongly recommends independent safety monitoring for
clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of
any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms, Phase III clinical
trials must be reviewed by an independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well.
The Awardee shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort. BARDA reserves
the right to accompany the awardee on site visits and/or audits of CROs as BARDA deems necessary.

 

A risk is minimal where the probability and magnitude of harm
or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood
from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination
(45 CFR 46.102l).

 

Final decisions regarding the type of monitoring to be used
must be made by the Awardee before enrollment starts in consultation with BARDA. Discussions with the responsible BARDA COTR regarding
appropriate safety monitoring must occur before patient enrollment begins and may include discussions about the appointment of
one of the following.

 

		o	Independent Safety Monitor - a physician or other appropriate expert who is independent of the study and available in
real time to review and recommend appropriate action regarding adverse events and other safety issues.

 

		o	Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) - a small group of independent investigators
and biostatisticians who review data from a particular study.

 

		o	Data and Safety Monitoring Board - an independent committee charged with reviewing safety and trial progress and providing
advice with respect to study continuation, modification, and termination. All phase III clinical trials must be reviewed by a DSMB;
other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board
(DSMB) For Oversight of Clinical Trials Policy.

 

When a monitor or monitoring board is organized, a description
of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster
and curriculum vitae from all members must be submitted to BARDA before enrollment starts.

 

Additionally, the Awardee must submit written summaries of all
reviews conducted by the monitoring group to the BARDA within 30 days of reviews or meetings.

 

		B.	BARDA Protocol Review Process Before Patient Enrollment
Begins

 

BARDA has a responsibility to obtain documentation concerning
mechanisms and procedures that are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore,
before patient accrual or participant enrollment, the Awardee must provide the following (as applicable) for review by BARDA.

 

		o	IRB or IEC approved clinical research protocol identified by version number, date, or both, including details of study design,
proposed interventions, patient eligibility, and exclusion criteria.

 

		o	Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name.

 

		o	IRB or IEC approved informed consent document, identified by version number, date, or both and date it is valid.

 

		o	Plans for the management of side effects.

 

		o	Procedures for assessing and reporting adverse events.

 

    	 

    	 

    

 

		o	Plans for data and safely monitoring (see A above) and monitoring of the clinical study site, pharmacy, and laboratory.

 

		o	Documentation that the Awardee and all study staff responsible for the design or conduct of the research have received Good
Clinical Practice (GCP) training in the protection of human subjects.

 

BARDA staff comments will be forwarded to the Awardee within
8 business days of receipt of the above information. The Awardee must address in writing its consideration of BARDA COTR comments.
However the FDA shall have final authority over such protocols and protocol amendments. After receiving the documentation, the
BARDA Contracting Officer will provide a Contracting Officer Authorization (COA) Letter authorizing the execution of the study.
This COA provides authorization to the awardee to execute the specific clinical study funded in part or in whole by BARDA.

 

		C.	Investigational New Drug or Investigational Device
Exemption Requirements

 

Consistent with federal regulations, clinical research projects
involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices
for a purpose other than that for which they were licensed) in humans under a research protocol must he performed under a Food
and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

 

Exceptions must be granted in writing by FDA. If the proposed
clinical trial will be performed under an IND or IDE, the Awardee must provide BARDA with the name and institution of the IND or
IDE sponsor, the date the IND or IDE was filed with FDA, the FDA IND or IDE number, any written comments from FDA, and the written
responses to those comments.

 

Unless FDA notifies Awardee otherwise, the Awardee must wait
30 calendar days from FDA receipt of an initial IND or IDE application before initiating a clinical trial.

 

The Awardee must notify BARDA if the FDA places a study on clinical
hold and provide BARDA any written comments from FDA, written responses to the comments, and documentation in writing that the
hold has been lifted.

 

The Awardee must not use grant or contract funds during a clinical
hold to fund clinical studies that are on hold.

 

Required Time-Sensitive Notification

 

Under an IND or IDE, the sponsor must provide FDA safely reports
of serious adverse events. Under these Clinical Terms of Award, the Awardee must submit copies to the responsible BARDA Project
Officer or the Contracting Officer’s technical representative (COTR) as follows:

 

		o	Expedited safety report of unexpected or life-threatening experience or death — A copy of any report of unexpected
or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax
as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to
the BARDA program officer or the contracting officer’s technical representative within 24 hours of FDA notification.

 

		o	Expedited safety reports of serious and unexpected adverse experiences — A copy of any report of unexpected and
serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant
risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 days after the IND sponsor’s
receipt of the information, must be submitted to the BARDA Project Officer or the Contracting Officer’s Technical Representative
within 24 hours of FDA notification.

 

		o	IDE reports of unanticipated adverse device effect — A copy of any reports of unanticipated adverse device effect
submitted to FDA must be submitted to the BARDA Project Officer or the Contracting Officer’s Technical Representative within
24 hours of FDA notification.

 

    	 

    	 

    

 

		o	Expedited safety reports — should be sent to the BARDA Project Officer or the Contracting Officer’s Technical
Representative concurrently with the report to FDA.

 

		o	Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported
to the BARDA annually.

 

In case of problems or issues, the BARDA Project Officer or
the Contracting Officer’s Technical Representative will contact the Awardee within 10 working days by email or fax.

 

		o	Safety reporting for research not performed under an IND or IDE

 

Final decisions regarding ongoing safety reporting requirements
for research not performed under an IND or IDE must be made by the Awardee in consultation with the BARDA Contracting Officer’s
Technical Representative.

 

    	 

    	 

    

  

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	1

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0001	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, SW, Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
    MERIDIAN P	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
	x	B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 	 

	E.
    IMPORTANT:         Contractor       x
    is not.          o is
    required to sign this document and return                  
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of
        this modification is to delete [...***...] to Article G.3. KEY PERSONNEL under contract number HHSO100201100013C.

        B.    This is a unilateral
        no cost modification. The total amount and all other terms and conditions of contract number HHSO100201100013C remain
        unchanged.

         

        Period of Performance:
        02/16/2011 to 02/15/2016

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME AND TITLE OF CONTRACTING OFFICER
    (Type or print)
	 	 
	 	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		 8/16/11
	 	 	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

 

 

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0002	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, SW, Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
    MERIDIAN P	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
	x	B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 	 

	E.
    IMPORTANT:         Contractor       x
    is not.          o is
    required to sign this document and return                  
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The
purpose of this modification is to correct an administrative error in Modification 0001 under Contract Number HHSO100201100013C.
In Modification 0001 under Contract Number HHSO100201100013C under paragraph B, the incorrect Period of Performance was stated
as “Period of Performance: 2/16/2011 to 2/15/2016.” The statement “Period of Performance: 2/16/2011 to 2/15/2016.”
Under Modification 0001 under Contract Number HHSO100201100013C is hereby deleted. The correct Period of Performance for Contract
Number HHSO100201100013C under this Modification is 2/16/2011 to 2/15/2012.

         

        B.    This is a no cost modification. The total amount and all other terms and conditions of

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME AND TITLE OF CONTRACTING OFFICER
    (Type or print)
	 	 
	 	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		11/10/11

	 	 	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE         OF
	 	HHSO100201100013C/0002	2	2

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	Contract number HHSO100201100013C remain unchanged.	 	 	 	 
	 	 	 	 	 	 
	 	Period of Performance: 02/16/2011 to 02/15/2012	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 53.110

 

    	 

    	 

    

 

 

 

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0003	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, SW, Rm G640

        Washington,
        DC 20201

         

	8. NAME
                                                                   AND ADDRESS OF CONTRACTOR (No., street, county, State and
                                                                   ZIP Code)

	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
    MERIDIAN P	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
		B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 S	Bilateral:
    Mutual Agreement of the Parties.
	 	 

	E.
IMPORTANT:         Contractor       £
is not.          S is required to sign this document and return         1         
copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The
        purpose of this modification is to incorporate the following changes into contract number HHSO100201100013C:

         

        1.    The
        period of performance for the base performance segment CLIN 0001 of contract number HHSO100201100013C is hereby changed
        from 16 February 2011 through 15 February 2012 to 16 February 2011 through 15 April 2012, at no additional cost to the
        Government.

         

        2.    The
        period of performance for the Option 1 performance segment CLIN 0002 of contract number HHSO100201100013C is hereby changed
        from 16 February 2012 through 15 February 2013

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME AND TITLE OF CONTRACTING OFFICER
    (Type or print)
	 	 
	KENNETH
                                                                                                                        I. MOCH,
                                                                                                                        CHIEF
                                                                                                                        EXECUTIVE
                                                                                                                        OFFICER

	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		11/30/11

	/s/
                                                                                                  Kenneth I. Moch

	11/30/11

	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE       OF
	 	HHSO100201100013C/0003	2	2

 

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

 

	
        ITEM NO.

        (A)
	
        SUPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	to 16 April 2012 through 15 April 2013, at no additional cost to the Government. If exercised by a unilateral contract modification, the option exercise date for the Option 1 performance segment CLIN 0002 will be 16 April 2012.	 	 	 	 
	 	 	 	 	 	 
	 	B.      This is a no cost modification. The total amount and all other terms and conditions of contract number HHSO100201100013C remain unchanged.	 	 	 	 
	 	 	 	 	 	 
	 	Period of Performance: 02/16/2011 to 04/15/2012	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 53.110

 

 

    	 

    	 

    

  

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROJECT NO. (if applicable)
	0004	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        DC 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W., Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No., street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
    MERIDIAN P	 	 
	2505 MERIDIAN PKWY, STE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
	x	B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 	 

	E.
    IMPORTANT:         Contractor       x
    is not.          o is
    required to sign this document and return                  
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this modification is to change the Contracting Officer’s Technical Representative
(COTR) under Contract number HHSO100201100013C:

         

        1.    All references throughout Contract Number HHSO100201100013C concerning the COTR, Tyler Merkeley and all
related information such as agency, address, telephone and email, etc. is hereby deleted and replaced with:

         

        

Claiborne O. Hughes

Contracting Officer’s Technical
Representative (COTR)

Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME AND TITLE OF CONTRACTING OFFICER
    (Type or print)
	 	 
	 	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		2/10/12

	 	 	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

  

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE         OF
	 	HHSO100201100013C/0004	2	2

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	
        Biomedical Advanced Research and Development Authority
        (BARDA)

        Office of the Assistant Secretary for Preparedness
        and Response (ASPR)

        Department of Health and Human Services (HHS)

        375 E Street, SW

        Patriot Plaza 2

        Washington, D.C. 20024

        Telephone: 202-260-1790

        E-Mail: Claiborne.Hughes@hhs.gov

         

        2. The Alternate COTR will remain Dr. Joseph Larsen.

         

        B. This is a no cost modification. The total amount
        and al1 other terms and conditions of Contract Number HHSO100201100013C remain unchanged.

         

        Period of Performance: 02/16/2011 to 04/15/2012
	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 53.110

 

 

    	 

    	 

    

  

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0005	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, SW, Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt
of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
		B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 S	Bilateral:
    Mutual Agreement of the Parties.
	 	 

	E.
IMPORTANT:         Contractor       £
is not.          S is required to sign this document and return          1        
copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.   The purpose of this modification is to incorporate the following changes into contract number HHSO100201100013C:

         

        1.    The period of performance for the base performance segment CLIN 0001 of contract number HHSO100201100013C
is hereby changed from 16 February 2011 through 15 April 2012 to 16 February 2011 through 15 June 2012, at no additional cost to
the Government.

         

        

2.    The period of performance
for the Option 1 performance segment CLIN 0002 of contract number HHSO100201100013C is hereby changed from 16 April 2012 through
15 April 2013 to 16

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF CONTRACTING
    OFFICER
	 	 
	KENNETH
                                                                                                                                            I.
                                                                                                                                            MOCH,
                                                                                                                                            PRESIDENT
                                                                                                                                            AND
                                                                                                                                            CEO

	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		 
	/s/
Kenneth I. Moch 

	2/24/12

	
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    
 

 

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE    OF      PAGES
	 	HHSO100201100013C/005	2	     2  

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	
         June 2012 through 15 June 2013, at no additional
        cost to the Government. If exercised by a unilateral contract modification, the option exercise date for the Option 1 performance
        segment CLIN 0002 will be 16 June 2012.

         

        B. This is a no cost modification. The total amount
        and al1 other terms and conditions of contract number HHSO100201100013C remain unchanged.

         

        Period of Performance: 02/16/2011 to 06/15/2012
	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)	 
	 	Sponsored by GSA	 
	 	FAR (48 CFR) 63.110	 
	 	 	
	 	 	 	 	 

  

    	 

    	 

    
  

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0006	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W. Rm G640

        Washington,
        D.C. 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment. and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
		B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 S	Bilateral:
    Mutual Agreement of the Parties.
	 	 

	E.
IMPORTANT:         Contractor      £ 
is not.          S is required to sign this document and return           1       
copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this modification is to delete [...***...] to Article G.3. KEY PERSONNEL under Contract
Number HHSO100201100013C.

         

        1.    The period of performance for the base performance segment CLIN 0001 of contract number HHSO100201100013C
is hereby changed from 16 February 2011 through 15 June 2012 to 16 February 2011 through 31 October 2012, at no additional cost
to the Government.

         

        2.    The
        period of performance for the Option 1 performance segment CLIN 0002 of contract number HHSO100201100013C is hereby changed
        from 16 June 2012 through 15 June 2013 to 1

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF CONTRACTING OFFICER

	 	 
	 KENNETH
    I. MOCH, PRESIDENT AND CEO	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		
	/s/
                                                                                                                                      Kenneth
                                                                                                                                      I.
                                                                                                                                      Moch

	 5/4/12	
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 	

    
 

	CONTINUATION
SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE      OF     PAGES
	 	HHSO100201100013C/006	2	2

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	
        November 2012 through 31 October 2013, at no additional
        cost to the Government. If exercised by a unilateral contract modification, the option exercise date for the Option 1 performance
        segment CLIN 0002 will be 16 June 2012.

         

        B. This is a no cost modification. The total amount
        and al1 other terms and conditions of contract number HHSO100201100013C remain unchanged.

         

        Period of Performance: 02/16/2011 to 10/31/2012
	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

 

    	 

    	 

    
  

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	1

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ. NO.	5.
    PROECT NO. (if applicable)
	0007	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W. Rm G640

        Washington,
        D.C. 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
	x	B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 	 

	E.
    IMPORTANT:         Contractor       x
    is not.          o is
    required to sign this document and return                  
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of
        this modification is to delete [...***...] to Article G.3. KEY PERSONNEL under contract number HHSO100201100013C.

         

        B.    This is a unilateral
        no cost modification. The total amount and all other terms and conditions of contract number HHSO100201100013C remain
        unchanged.

         

        Period of Performance:
        02/16/2011 to 10/31/2012

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF CONTRACTING OFFICER
	 	 
	 	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		

	 	 	/s/
        Ethan J. Mueller
	5/21/12 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	17

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ. NO.	5.
    PROECT NO. (if applicable)
	0008	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W. Rm G640

        Washington,
        D.C. 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)             Net
                                     Increase:                   $4,638,693.00

        See Schedule

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
		B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 S	D.OTHER
    (Specify type of modification and authority)
	 	Bilateral: Mutual Agreement of the Parties.

	E.
    IMPORTANT:         Contractor        ̈
    is not.          x is
    required to sign this document and return          1        
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this modification is to add the following efforts into the base segment of Contract Number
HHSO100201100013C and to replace the Principal Investigator:

         

        

1.    Conduct
the [...***...] in the [...***...].

 

2.    Complete
the [...***...].

 

3.    Complete
the [...***...] of the [...***...],

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF CONTRACTING OFFICER
	 	 
	 TIMOTHY W. TROST, CHIEF FINANCIAL OFFICER	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		

	 /s/ Timothy W. Trost	7/9/12

	
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

  

***Confidential Treatment Requested

 

    	 

    	 

    
 

	CONTINUATION SHEET	
        REFERENCE NO. OF DOCUMENT BEING
        CONTINUED

        HHSO100201100013C/008
	PAGEOFPAGES
	2	17

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	
         

        4.
        Support ongoing [...***...].

         

        5. Technical Management/Regulatory/Quality Support.

         

        As a result, Attachment 1, Statement of Work dated
        10 February 2012, under PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J - LIST OF ATTACHMENTS is hereby
        deleted and replaced with the attached Statement of Work dated 19 June 2012.

         

        1. Under Article F.2. DELIVERABLES, the attached changes
        are hereby incorporated into 2. WBS Milestones/Deliverables and Technical Deliverables.

         

        2. The addition of these efforts to the base segment
        of Contract Number HHSO0100201100013C results in Contract Line Item Number (CLIN) 0001 being changed as follows:

         

        Total Estimated Cost: From[...***...] By [...***...
        ]To [...***...]

         

        Total Fixed Fee: From [...***...] By [...***...] To
        [...***...]

         

        Total Estimated Cost Plus Fixed Fee: From $24,819,527.00
        By $4,638,693.00 To $29,458,220.00

         

        3. This modification hereby results in an increase
        in the total amount of the contract from $24,819,527.00 by $4,638,693.00 to $29,458,220.00.

         

        4. Block 15G of the SF 26, the amount of $24,819,527.00
        shall be changed to $29,458,220.00. Also in Block 14 of the SF 26, the following CAN Number is added as follows:

         

        Appropriation Year: 2012; Object Class: 25329; CAN
        1992002 $4,638,693.00

         

        5. The period of performance for the base segment
        CLIN 0001 of Contract Number HHSO100201100013C is hereby changed from 16 February 2011 through 31 October 2012 to 16 February 2011
        through 31 March 2013.

         

        6. The period of performance for the Option 1 performance
        segment CLIN 0002 of Contract Number HHSO100201100013C of 1 November 2012 through 31 October 2013 will remain unchanged. This bilateral
        modification does not authorize the performance of any Option segments under the contract.

         

        7. Delete [...***...] to Article G.3. KEY PERSONNEL
        under contract Number HHSO100201100013C.

         

        B. All other terms and conditions of the contract
        remain unchanged.

        Delivery: 03/31/2013

        Delivery Location Code: OS-BARDA-SWITZER

        OS-BARDA-SWITZER

        330 Independence Ave, SW, Rm G644

        Continued ...
	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

 

***Confidential Treatment Requested

    	 

    	 

    

 

	CONTINUATION
SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE       OF       PAGES
	 	HHSO100201100013C/008	3	17

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

		
        Washington DC 20201 US

         

        FOB: Destination

        Period of Performance: 02/16/2011 to 03/31/2013

         

        Change Item 1 to read as follows(amount shown is the
        obligated amount):

         

        

        
	 	 	 	
	1	Research and development of CMXOOl for the Treatment of Smallpox to include [...***...].

                                                                                 

                                                                                

Reports and Other Data Deliverables.

 

Obligated Amount: $4,638,693.00

 

Amount: $24,819,527.00

Accounting Info:

2011.1992002.25329 Appr. Yr. : 2011 CAN: 1992002 Object
Class: 25329

Funded: $0.00

 

Amount: $4,638,693.00

Accounting Info:

2012.1992002.25329 Appr. Yr. : 2012 CAN: 1992002 Object
Class: 25329

Funded: $4,638,693.00

                                                                                 
	 	 	 	4,638,693.00
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

 

***Confidential Treatment Requested

    	 

    	 

    

 

BARDA
Broad Agency Announcement (BAA)

(CBRN-BAA-10-100-SOL-00012)

Advanced Research and Development of Chemical,
Biological, Radiological, and

Nuclear Medical Countermeasures

DEVELOPMENT
OF CMX-001 FOR THE TREATMENT OF SMALLPOX 

Topical Area of Interest No. 3, Antimicrobial
Drugs

 

Contractual Statement of Work

 

1. PREAMBLE

 

Independently
and not as an agency of the Government, the Contractor shall be required to furnish all the
necessary services, qualified personnel, material, equipment, and facilities, not otherwise
provided by the Government, as needed to perform the Statement of Work submitted in response
to the BARDA Broad Agency Announcement (BAA) CBRN-BAA-1 0-1 00-SOL-00012.

 

In accordance
with FAR 52.243-2, Changes-Cost Reimbursement (Alt. V), the Government reserves the right
to modify the milestones, progress, schedule, budget, or deliverables to add or delete deliverables,
process, or schedules if the need arises. Because of the nature of this research and development
(R&D) contract and the complexities inherent in this and prior programs, at designated
milestones the Government will evaluate whether work should be redirected, removed, or whether
schedule or budget adjustments should be made.

 

1.0 Overall Objectives and Scope

 

The overall
objective of this contract is to advance the development of CMX-001 as a broad-spectrum therapeutic
antiviral for the treatment of smallpox infections and dsDNA viruses. The scope of work for
this contract includes preclinical, clinical and manufacturing development activities that
fall into the following areas: non-clinical efficacy studies; clinical activities; manufacturing
activities; and all associated regulatory, quality assurance, management, and administrative
activities. The Research and Development (R&D) effort for the antiviral will progress
in specific stages that cover the base performance segment and four (4) option segments as
specified in this contract. The Contractor must complete specific tasks required in each of
the five discrete work segments. The scope of work has been broken into the following five
phases which are discrete work segments:

 

	 	I.	 	[...***...]
	 	II.	 	[...***...]
	 	III.	 	[...***...]
	 	IV.	 	[...***...]
	 	V.	 	[...***...]

 

***Confidential Treatment Requested

    	1

    	 

    

 

		2	PHASE 1: [...***...]

 

Research
and development of CMX-001 for the treatment of smallpox and dsDNA viruses to include the
following activities: [...***...]. The contractor shall carry out the following tasks and subtasks and in
accordance with an agreed upon Integrated Master Schedule and Integrated Master Plan (defined
in 2.1.8 and 2.1.9 below) which shall further detail the conduct of the specific tasks and
subtasks.

 

		2.1	Program Management

 

The
Contractor shall provide for the following as outlined below and in the contract deliverables
list (Article F.2):

 

		2.1.1	The overall management, integration and coordination of all contract activities,
including a technical and administrative infrastructure to ensure the efficient planning,
initiation, implementation, and direction of all contract activities;

 

		2.1.2	A Principal Investigator (PI) responsible for project management, communication,
tracking, monitoring and reporting on status and progress, and modification to the project
requirements and timelines, including projects undertaken
by subcontractors; The contract deliverables list (reference), identifies all contract deliverables
and reporting requirements for this contract.

 

		2.1.3	Project Manager(s) with responsibility for monitoring and tracking day-to-day progress
and timelines, coordinating communication and project activities; costs incurred; and program
management; The contract deliverables list (reference), identifies all contract deliverables
and reporting requirements for this contract.

 

		2.1.4	A BARDA Liaison with responsibility for effective communication with the Project
Officer and Contracting Officer.

 

		2.1.5	Administrative and legal staff to provide development of compliant subcontracts,
consulting, and other legal agreements, and ensure timely acquisition of all proprietary rights,
including IP rights, and reporting all inventions made
in the performance of the project.

 

		2.1.6	Administrative staff with responsibility for financial management and reporting
on all activities conducted by the Contractor and any subcontractors.

 

***Confidential Treatment
Requested

    	2

    	 

    
 

 

		2.1.7	Contract Review Meetings.

		2.1.7.1	The Contractor shall participate in regular meetings to coordinate and oversee
the contract effort as directed by the Contracting and Project Officers. Such meetings may
include, but are not limited to, meeting of the Contractors and subcontractors to discuss
clinical manufacturing progress, product development, product assay development, scale up
manufacturing development, clinical sample assays development, preclinical/clinical
study designs and regulatory issues; meetings with individual contractors and other HHS officials
to discuss the technical, regulatory, and ethical aspects of the program; and meeting with
technical consultants to discuss technical data provided by the Contractor.

		2.1.7.2	The Contractor shall participate in teleconferences every two weeks between
the Contractor and subcontractors and BARDA to review technical progress. Teleconferences
or additional face-to-face meetings shall be more frequent at the request of BARDA.

		2.1.8	Integrated Master Schedule

		2.1.8.1	Within 30 calendar days of the effective date of the contract, the Contractor
shall submit a first draft of an updated Integrated Master Schedule in a format agreed upon
by BARDA to the Project Officer and the Contracting Officer for review and comment. The Integrated
Master Schedule shall be incorporated into the contract, and will be used to monitor
performance of the contract. Contractor shall include the key milestones and Go/No Go decision
gates. The IMS for the period of performance will be mutually agreed upon at the PMBR

		2.1.9	Integrated Master Plan

		2.1.9.1	Work Breakdown Structure: The Contractor shall utilize a WBS template
agreed upon by BARDA for reporting on the contact. The Contractor shall expand and delineate
the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their
Integrated Master Plan for contract reporting. The CWBS shall be discernable
and consistent. BARDA may require Contractor to furnish WBS data at the work package level
or at a lower level if there is significant complexity and risk associated with the task.

		2.1.9.2	GO/NO-GO Decision Gates: The Integrated Master Plan outlines key milestones with "Go/No Go" decision criteria (entrance
and exit criteria for each phase of the project). The project plan should include, but not

be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions.

		2.1.9.3	Earned Value Management System Plan: Subject to the requirements under
HHSAR Clause 352.234-4, the Contractor shall use principles of Earned Value Management System
(EVMS) in the management of this contract. The Seven Principles are:

		I.	Plan all work scope for the program to completion.

 

    	3

    	 

    

 

		II.	Break down the program
work scope into finite pieces that can be assigned to a responsible person or organization
for control of technical, schedule, and cost objectives.

		III.	Integrate program work
scope, schedule, and cost

objectives into a performance measurement baseline plan against
which accomplishments may be measured. Control Changes to the baseline.

		IV.	Use actual cost incurred
and recorded in accomplishing the work performed.

		V.	Objectively assess accomplishments
at the work

performance level.

		VI.	Analyze significant variances
from the plan, forecast impacts, and prepare an estimate at completion based on performance
to date and work to be performed.

		VII.	Use earned value information
in the company's management processes.

 

Elements of EVMS shall
be applied to all Cost Plus Fixed Fee CLINs as part of
the Integrated Master Project Plan, the Contractor shall submit a written summary of the management
procedures that it will establish, maintain and use to comply with EVMS requirements.

 

		2.1.10	Decision Gate Reporting: On completion of a stage of the product development,
as defined in the agreed upon Integrated Master Schedule and Integrated Master Plan, the Contractor
shall prepare and submit to the Project Officer and the Contracting Officer a Decision Gate
Report that contains (i) sufficient detail, documentation and analysis to support successful
completion of the stage according to the predetermined qualitative and quantitative
criteria that were established for Go/No Go decision making; and (ii) a description
of the next stage of product development to be initiated and a request for approval to proceed
to the next stage of product development.

 

		2.1.11	Risk Management Plan: The Contractor shall develop a risk management plan within
90 days of contract award highlighting potential problems and/or issues that may arise during
the life of the contract, their impact on cost, schedule and performance, and appropriate
remediation plans. This plan should reference relevant WBS elements where appropriate. Updates
to this plan shall be included every three months (quarterly) in the monthly Project Status
Report.

 

    	4

    	 

    
 

		2.1.12	Performance Measurement Baseline Review (PMBR): The Contractor shall submit
a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and
BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance
Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress
throughout the life of the contract. The PMBR is conducted to achieve confidence
that the baselines accurately capture the entire technical scope of work, are consistent with
contract schedule requirements, are reasonably and logically planned, and have adequate resources
assigned. The goals of the PMBR are as FOLLOWS:

 

		I.	Jointly assess areas such
as the Contractor's planning for complete coverage of the SOW, logical scheduling of the
work activities, adequate resources, and identification of inherent risks

		II.	Confirm the integrity of
the Performance Measurement Baseline (PMB)

		III.	Foster the use of EVM as
a means of communication

		IV.	Provide confidence in the
validity of Contractor reporting

		V.	Identify risks associated
with the PMB

		VI.	Present any revised PMBs
for mutual agreement

		VII.	Present an Integrated Master
Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule
(IMS) that rolls up all time-phased WBS elements down to the activity level. This
IMS shall include the dependencies that exist between tasks.
This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced
as guidance in creation of the IMS (see http://www.acq.osd.mil/pml).

		VIII.	Present the Risk Management
Plan

 

		2.1.13	Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at
the PMBR, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IMS and timelines.
This report shall include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the
needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for
the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development
program, timelines, and budget.
	 	 	 

		2.1.14	Monthly and Annual Reports: The Contractor shall deliver Project Status Reports on a monthly basis. The reports shall address
the items below cross referenced to the WBS, SOW, IMS, and EVM:

		I.	Executive summary highlighting the progress, issues,
and relevant activities in manufacturing, non-clinical, clinical, and regulatory;

		II.	Progress in meeting contract milestones, detailing the
planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps;

 

			

    	5

    	 

    

 

 

		III.	Updated IMS;

		IV.	Updated EVM;

		V.	Updated Risk Management Plan (Every 3 months);

		VI.	Three month rolling forecast of planned activities;

		VII.	Progress of regulatory submissions;

		VIII.	Estimated and actual expenses;

 

		2.1.15	Data Management: The Contractor shall develop and implement data management and quality control systems/procedures, including
transmission, storage, confidentiality, and retrieval of all contract data;

		2.1.15.1	Provide for the statistical design and analysis of data resulting from the research;

		2.1.15.2	Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request.

 

		2.2	Non-Clinical Toxicology

		2.2.1	N/A (no scope)

 

		2.3	Non-Clinical

		2.3.1	Develop and validate [...***...] to lower [...***...].

		2.3.2	[...***...]: Conduct [...***...] studies including [...***...] studies, [...***...], and [...***...]
studies in [...***...].

		2.3.3	[...***...]

		2.3.3.1	Conduct [...***...] study in [...***...].

		2.3.3.2	Conduct [...***...] studies including [...***...] studies, [...***...] studies including [...***...]
for CMX-001 and [...***...] in [...***...].

		2.3.4	Use of [...***...] as a CMX-001 Surrogate in [...***...] Studies.

		2.3.4.1	Dose [...***...] with [...***...] to identify the concentration of the [...***...] in [...***...]
associated with [...***...] of [...***...].

		2.3.5	Scaling of [...***...] to [...***...] by conducting studies with [...***...] to determine [...***...]
in [...***...].

		2.3.6	[...***...] determination of CMX00l, [...***...] and [...***...] in the [...***...].

		2.3.7	Conduct [...***...] experiments to demonstrate
[...***...] following effective [...***...] prior to [...***...].

		2.3.8	Conduct studies to optimize [...***...] in [...***...].

		2.3.9	Conduct CMX-001 [...***...] study in [...***...] at a dose of CMX001 equivalent or less than [...***...]
with treatment beginning at the [...***...]

 

***Confidential Treatment Requested

    	6

    	 

    

 

		2.4	Clinical

		2.4.1	Measurement of [...***...] levels in [...***...] and correlate the [...***...] to studies conducted in
[...***...].

		2.4.2	Conduct expanded access protocol ([...***...]).

		2.4.3	Analyze data and provide a Final Report for [...***...] evaluation of CMX001 in patients ([...***...])

 

		2.5	Regulatory

		2.5.1	Engaging the FDA on a path to support the treatment of smallpox indication with CMX-001

		2.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review
EUA and/or all other data packages;

		2.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final minutes
of any informal meeting with the FDA;

		2.5.4	Obtain FDA concurrence on the feasibility of the proposed [...***...] with CMX001/[...***...]/[...***...]
in the [...***...] ([...***...]), including FDA feedback on [...***...] and review of data for the first [...***...]
enrolled in the [...***...] sub-study

		2.5.5	Develop and submit a revised [...***...] for CMX001 for Treatment of Smallpox, including [...***...] for FDA
review and comment, and revise the [...***...] as requested by FDA

 

		2.6	CMC

		2.6.1	Validation of the [...***...] process: Validation of the process to demonstrate the [...***...] of a [...***...]
of acceptable quality will be performed.

		2.6.2	Validation of the [...***...] process to produce [...***...]: Validation of the process to demonstrate the [...***...]
of a [...***...] of acceptable quality will be performed.

 

		3.	PHASE II: [...***...]

 

Research and development of
CMX-001 for the treatment of smallpox to include the following activities: [...***...]. The contractor shall carry out the
following tasks and subtasks and in accordance with the agreed upon Integrated Master Schedule and Integrated Master Plan (defined
in 2.1.8 and 2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

 

***Confidential Treatment
Requested

    	7

    	 

    

 

		3.1	Program Management (consistent with section 2.1)

		3.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

 

		3.2	Non-toxicology

		3.2.1	N/A (no scope)

 

		3.3	Non-Clinical

		3.3.1	Quantify [...***...] levels in [...***...] in [...***...].

		3.3.2	Determine [...***...] for CMX-001, [...***...], and [...***...] in [...***...].

		3.3.3	Scaling of [...***...] to [...***...] studies to determine scaling between [...***...] and [...***...]
using [...***...] as well as comparisons of levels of [...***...] in the [...***...].

		3.3.4	[...***...] in the [...***...]. This study will determine the [...***...] in [...***...] and the
concentration of [...***...] in [...***...] when [...***...] are treated with [...***...] at the effective
dose and regimen

		3.3.5	[...***...]- (Final Report from Sections 2.3.2.). The initial study ([...***...]) will compare different regimens
of [...***...] administered after the [...***...]. The studies will include [...***...] and [...***...],
as well as [...***...] including [...***...].

 

		3.4	Clinical

		3.4.1	Conduct [...***...] study in [...***...] will be conducted as part of the scope of work to determine whether
CMX00l has a [...***...], as detected by [...***...].

 

		3.5	Regulatory

		3.5.1	Engaging the FDA on a path to support the treatment of smallpox indication with CMX-001

 

		3.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review
EUA and/or all other data packages;

 

***Confidential Treatment
Requested

    	8

    	 

    

 

		3.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft
minutes of any informal meeting with the FDA;

 

		3.6	CMC

		3.6.1	N/A (NO SCOPE)

 

		4.	PHASE III: [...***...]

 

Research and development of CMX-001 for the treatment
of smallpox and dsDNA viruses to include the following activities: [...***...]. 

The contractor shall carry out the following tasks
and subtasks and in accordance with agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and 2.1.9)
which shall further detail the conduct of the specific tasks and sub tasks.

 

		4.1	Program Management (Consistent with section 2.1)

		4.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

 

		4.2	Non-toxicology

		4.2.1	N/ A (no scope)

 

		4.3	Non-Clinical

		4.3.1	[...***...] studies: [...***...] will be conducted with the [...***...] of CMX001 identified in the [...***...]
studies. [...***...] will be [...***...] to receive [...***...] beginning at the [...***...]. These
studies will include [...***...] and [...***...] as well as [...***...] including [...***...] in [...***...].
The primary endpoint will be [...***...]

		4.3.2	[...***...] studies: This study will determine the [...***...] at the [...***...]. [...***...]
and [...***...] at the [...***...]. The primary endpoint will be [...***...]

		4.3.3	Initiate [...***...]: Conduct [...***...] studies for [...***...]. This study will determine the [...***...]
at doses selected based on [...***...]. [...***...] and [...***...].

 

***Confidential Treatment
Requested

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		4.4	Clinical

		4.4.1	Phases I [...***...] study, If acceptable to FDA, the [...***...] database will be supplemented by a study in
[...***...]. The size of this study will be determined to ensure an adequate [...***...] database is available at
the time of [...***...]

		4.4.2	[...***...] study. This study will [...***...] doses of CMX001 to [...***...] to determine if the [...***...]
of CMX001 are comparable to those observed for [...***...], and to determine if any dose adjustment is necessary in [...***...].

 

		4.5	Regulatory

		4.5.1	Generating all necessary data and preparing documentation for [...***...] submissions to regulatory agencies;

		4.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review
[...***...], EUA and/or all other data packages;

		4.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft
minutes of any informal meeting with the FDA;

		4.5.4	Filing of [...***...]

 

		4.6	CMC

		4.6.1	Manufacture of [...***...] in sufficient quantities for use in non-clinical and late phase clinical studies. Develop
[...***...].

 

		5.	PHASE IV: [...***...]

 

Research and development of
CMX-001 for the treatment of smallpox to include the following activities: [...***...]. [...***...] studies and phase
I [...***...] study. The contractor shall carry out the following tasks and subtasks and in accordance with agreed upon
Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and 2.1.9) which shall further detail the conduct of the
specific tasks and subtasks.

 

		5.1	Program Management (Consistent with section 2.1)

		5.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

 

		5.2	Non-toxicology

		5.2.1	N/A (no scope)

 

***Confidential Treatment Requested

    	10

    	 

    

 

		5.3	Non-Clinical

		5.3.1	[...***...] studies. [...***...] will be randomized to receive [...***...] beginning at the [...***...].
These studies will include [...***...] and [...***...] as well as [...***...] including [...***...].
The primary endpoint will be [...***...]

		5.3.2	[...***...] Studies. This study will determine the [...***...] at the [...***...]. [...***...]
and [...***...] at the [...***...]. The primary endpoint will be [...***...]. If FDA requires a [...***...]
in the [...***...] studies, the [...***...] study may not be needed.

		5.3.3	Conduct [...***...] Studies. This study will determine the [...***...] at the [...***...]. [...***...]
and [...***...] at the [...***...].

 

		5.4	Clinical

		5.4.1	Phase 3 development including [...***...] study, [...***...] study, phases II [...***...] study. A [...***...]
study will be conducted to compare the [...***...] of CMX001 in [...***...] to [...***...]. A [...***...]
study will be conducted to compare the [...***...] of CMX001 when [...***...]. A [...***...] study will be
conducted to [...***...] to support an NDA.

 

		5.5	Regulatory

		5.5.1	Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;

		5.5.2	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review
IND, EUA and/or all other data packages;

		5.5.3	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft
minutes of any informal meeting with the FDA;

 

		5.6	CMC

		5.6.1	[...***...]. [...***...] of the process to demonstrate the [...***...] of a [...***...] will be
performed.

 

6. PHASE V: [...***...]

 

***Confidential Treatment Requested

    	11

    	 

    

 

Research and development of CMX-001 for the treatment
of smallpox to include the following activities: [...***...]. The contractor shall carry out the following tasks and subtasks
and in accordance with an agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and 2.1.9) which
shall further detail the conduct of the specific tasks and subtasks.

 

		6.1	Program Management (Consistent with section 2.1)

		6.1.1	Program management scope in BASE year is consistent with program management scope in each option year.

 

		6.2	Non-toxicology

		6.2.1	N/A (no scope)

 

		6.3	Non-Clinical

		6.3.1	[...***...] Studies. This study replicates [...***...] if a [...***...] is necessary to achieve a [...***...]
result.

 

		6.4	Clinical

		6.4.1	Compile [...***...]. A database of [...***...] data collected from all CMX001 clinical studies, irrespective
of [...***...], will be populated and analyzed in order to support an [...***...] for smallpox.

 

		6.5	Regulatory

		6.5.1	Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;

		6.5.2	Submitting NDA documentation to the FDA in a timely manner, consistent with timelines set out in the contract and by the FDA.

		6.5.3	Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review
IND, EUA and/or all other data packages;

		6.5.4	Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft
minutes of any informal meeting with the FDA;

 

		6.6	CMC

		6.6.1	[...***...]. [...***...] of the process to demonstrate the [...***...] of a [...***...] will be
performed.

 

		7.	Other Items

 

	7.1	Facilities, Equipment and Other Resources. (Contract:
Section J)
	 	The Contractor shall provide equipment;
facilities and other resources required for implementation of the SOW dated January 11, 2011 to comply with all Federal

 

***Confidential Treatment
Requested

    	12

    	 

    

 

 and HHS regulations in:

 

		7.1.1	The [...***...] and use of [...***...];

		7.1.2	The acquisition, handling, storage and shipment of [...***...], including [...***...] required for working with
the [...***...];

		7.1.3	The [...***...] of [...***...] under cGMP;

		7.1.3.1	The design and conduct of [...***...]; and

		7.1.3.2	The conduct of [...***...] studies to determine [...***...] of [...***...]

		7.1.4	Design and conduct of [...***...] under GCP.

  

 

***Confidential Treatment Requested

 

    	13

    	 

    

 

	NEW BASE CONSIDERATION ACTIVITY TO BE ADDED TO ARTICLE F.2 DELIVERABLES
	Current 

Milestone #	Milestone Definition	Go Criteria	No-Go Criteria	Deliverable	WBS/SOW #	Date
	NEW 

MILESTONE	[...***...]	[...***...]	[...***...]	[...***...]	[...***...][...***...]	[...***...]
	OPTION 1 WORK SEGMENT ACTIVITIES MOVED TO BASE SEGMENT
	6.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...][...***...]	[...***...]
	15.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...][...***...]	[...***...]
	25.	[...***...]	[...***...]	[...***...]	[...***...]	[...***...][...***...]	[...***...]

 

 

***Confidential Treatment Requested

 

    	 

    	 

    

  

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	1

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0009	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W. Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
	x	B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 	Bilateral:
                                                                                                 Mutual Agreement of the Parties.

	 	 

	E.
    IMPORTANT:         Contractor       x
    is not.          o is
    required to sign this document and return                  
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this no cost unilateral administrative modification is to make the following administrative
correction under Contract Number HHSO100201100013C:

         

        1.    Under Article F.2. DELIVERABLES,
        under the NEW MILESTONE, under the column titled WBS/SOW#, the reference to WBS Number 1.3 is hereby deleted and replaced
        by WBS Number 1.8.

         

        B.    This
        is a no cost unilateral modification. All other terms and conditions of the contract remain unchanged.

 

        Period of Performance:
        02/16/2011 to 03/31/2013

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF
                                                             CONTRACTING OFFICER

	 	 
	 	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		7/25/12

	 	 	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

  

***Confidential Treatment Requested

 

    	 

    	 

    

   

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ. NO.	5.
    PROECT NO. (if applicable)
	0010	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W. Rm G640

        Washington,
        D.C. 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
	x	B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 	Bilateral: Mutual Agreement of the Parties.

	 	 

	E.
    IMPORTANT:         Contractor        ̈
    is not.          x is
    required to sign this document and return           1       
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this modification is to incorporate the following changes into contract number HHSO100201100013C:

         

        1.    The
        period of performance for the Option 1 performance segment CLIN 0002 of contract number HHSO100201100013C is hereby changed
        from 1 November 2012 through 31 October 2013 to 1 April 2013 through 31 March 2014, at no additional cost to the Government.
        If exercised by a contract modification,· the option exercise date for the Option 1 performance segment CLIN 0002
        will be 1 April 2013.

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF
                                                             CONTRACTING OFFICER

	 	 
	KENNETH
                                                                                    I. MOCH, PRESIDENT AND CEO

	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		10/17/12

	 /s/ Kenneth I. Moch	 	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

 

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE      OF     PAGES
	 	HHSO100201100013C/005	2	2

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	
        B. This is a no cost modification . The total amount
        and all other terms and conditions of contract number HHSO100201100013C remain unchanged.

        Period of Performance: 02/16/2011 to 03/31/2013

         
	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

 

 

    	 

    	 

    

 

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	3

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0011	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, SW, Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)                          Net
Increase:                          $1,497,322.00

        See Schedule

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
		B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 S	Bilateral: Mutual Agreement of the Parties.
	 	 

	E.
IMPORTANT:         Contractor       £
is not.          S is required
to sign this document and return           1       
copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this modification is to add funding in the amount of $1,497,322.00 for the purpose of funding
a cost growth due to increases in indirect rates into the base segment ONLY of Contract Number HHSO100201100013C.

         

        1.     The
        addition of this cost growth to the base segment of Contract Number HHSO100201100013C results in Contract Line Item Number
        (CLIN) 0001 being changed as follows:

         

        

Total Estimated Cost: From $27,531,047.00
By $1,497,322.00 To $29,028,369.00

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF
                                                             CONTRACTING OFFICER

	 	 
	 KENNETH I. MOCH, PRESIDENT AND CEO	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		11/8/12

	/s/
                                                                                                  Kenneth I. Moch

	 11/7/12	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

  

***Confidential Treatment Requested

 

    	 

    	 

    
 

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE      OF      PAGES
	 	HHSO100201100013C/005	2	3

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	
         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

        
	
        No change to the Total Fixed Fee Amount of $1,927,173.00

         

        Total Estimated Cost Plus fixed Fee: From $29,458,220.00
        By $1,497,322.00 To $30,955,542.00

         

        2. This modification hereby results in an increase
        in the total amount of the contract from $29,458,220.00 by $1,497,322.00 to $30,955,542.00.

         

        3. Block 15G of the SF 26, the amount of $29,458,220.00
        shall be changed to $30,955,542.00. Also in Block 14 of the SF 26, the following CAN Number is added as follows:

         

        Appropriation Year: 2013; Object Class: 25329; CAN
        1992002 $1,497,322.00

         

        4. The period of performance for the base segment
        CLIN 0001 of Contract Number HHSO100201100013C remains unchanged at 16 February 2011 through 31 March 2013. The Statement of Work
        also remains unchanged. This bilateral modification does not authorize the performance of any Option segments under the contract.

         

        5. The second sentence in Article G.7. INDIRECT COST
        RATES of the contract is replaced with the following:

         

        FY 11 (Retroactive Adjustment ONLY) - Fringe Benefits
        at [...***...]% and Indirect at [...***...]%.

         

        FY 12 and FY 13 (Retroactive Adjustment and Billing)
        - Fringe Benefits at [...***...]% and Indirect at [...***...]%.

         

        6. Under Article F.2., DELIVERABLES, under the NEW
        MILESTONE, under the column titled WBS/SOW#, the reference to WBS Number 1.8 is hereby deleted and replaced with 11.0 (Base Consideration
        Activities).

         

        B. All other terms and conditions of the contract
        remain unchanged.

        Delivery: 03/31/2013

        FOB: Destination

        Period of Performance: 02/16/2011 to 03/31/2013

         

        Change Item 1 to read as follows(amount shown
is the obligated amount):
	 	 	 	
         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

         

        

	1	Research and development of CMX001 for the Treatment of Smallpox to include [...***...].

                                                                            

                                                                           Reports
and Other Data Deliverables.

                                                                            

                                                                           Obligated
Amount: $1,497,322.00

                                                                            

                                                                           Delivery
Location Code: OS-BARDA-SWITZER

                                                                           OS-BARDA-SWITZER

 

	 	 	 	1,497,322.00
	 	Continued ... 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

 

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

 

	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED	PAGE     OF   PAGES
	 	HHSO100201100013C/005	3	3

	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	
        330 Independence Ave, SW, Rm G644

        Washington DC 20201 US

        Amount: $24,819, 527.00

        Accounting Info:

        2011.1992002.25329 Appr. Yr. : 2011 CAN: 1992002 Object
        Class: 25329

        Funded: $0.00

         

        Delivery Location Code: OS-BARDA-SWITZER

        OS-BARDA-SWITZER

        330 Independence Ave, SW, Rm G644

        Washington DC 20201 US

        Amount: $4,638,693.00

        Accounting Info:

        2012.1992002.25329 Appr. Yr. : 2012 CAN: 1992002 Object
        Class: 25329

        Funded: $0.00

         

        Delivery Location Code: HHS

        HHS

        200 Independence Avenue, SW

        Washington DC 20201 US

        Amount: $1,497,322.00

        Accounting Info:

        2013.1992002.25329 Appr. Yr. : 2013 CAN: 1992002 Object
        Class: 25329

        Funded: $1,497,322.00

         
	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

 

    	 

    	 

    
 

 

 

	AMENDMENT
    OF SOLICITATION/MODIFICATION OF CONTRACT	1.
    CONTRACT ID CODE	PAGE     OF    PAGES
	 	 	1	2

	2.
    AMENDMENT/MODIFICATION NO.	3. EFFECTIVE DATE	4.
    REQUISITION/PURCHASE REQ NO.	5.
    PROECT NO. (if applicable)
	0012	See
    Block 16C	N/A.	 

	6. ISSUED BY	CODE	ASPR-BARDA	7.
ADMINISTERED BY (If other than Item 6) 
	CODE	ASPR-BARDA02
	ASPR-BARDA

        200 Independence
        Ave., S.W.

        Room 640-G

        Washington,
        D.C. 20201

         
	ASPR-BARDA

        330 Independence
        Ave, S.W. Rm G640

        Washington,
        DC 20201

         

	8. NAME AND ADDRESS OF CONTRACTOR
    (No. street, county, State and ZIP Code)	x	9A. AMENDMENT
    OF SOLICITATION NO.
	 	 	 
	CHIMERIX, INC. 1377270	 	9B. DATED
    (SEE ITEM 11)
	CHIMERIX, INC.              2505
MERIDIAN	 	 
	2505 MERIDIAN PARKWAY, SUITE 340	x	10A MODIFICATION
    OF CONTRACT/ORDER NO.
	DURHAM, NC 277135246		HHSO100201100013C
	 	 	 
	 	 	10B. DATED (SEE ITEM 13)
	 	 	02/16/2011
	CODE
    	1377270	FACILITY
    CODE	 	 

	11.
    THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	oThe
                                                                          above numbered solicitatIon is amended as set forth
                                                                          in Item 14. The hour and date specified for receipt
                                                                          of Offers        o
                                                                          is extended.           o
                                                                          is not extended

        Offers must acknowledge
        receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following
        methods: (a) By completing Items 8 and 15, and returning _____________ copies of the amendment; (b) By acknowledging receipt
        of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference
        to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
        FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of
        this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided
        each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening
        hour and date specified.

	12.
                                     ACCOUNTING AND APPROPRIATION DATA (if required)

        N/A.

	13.
    THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	CHECK
    ONE	A.THIS
    CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
    NO. IN ITEM 10A.
	 	 
		B.THE
    ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation
    date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)
	 	C.THIS
    SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
	 	D.OTHER
    (Specify type of modification and authority)
	 S	Bilateral:
    Mutual Agreement of the Parties.
	 	 

	E.
    IMPORTANT:         Contractor       £
    is not.          S is
    required to sign this document and return          1        
    copies to the issuing office.
	14. DESCRIPTION OF AMENDMENT/MODIFICATION
    (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
	 
	Tax ID Number:            33-0903395

        DUNS Number:      [...***...]

        A.    The purpose of this modification is to incorporate the following changes into contract number HHSO100201100013C:

         

        1.     Under
        Attachment 1, Statement of Work dated 19 June 2012, under PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS,
        SECTION J - LIST OF ATTACHMENTS, under 2.5.4 the word "8 patients" is hereby deleted and replaced with the word
        "7 patients."

         

        2.     Under
        Article G. 3. KEY PERSONNEL under contract number HHSO100201100013C, [...***...] is hereby deleted and replaced by [...***...]

         

        Continued ...

	 
	Except
    as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains
    unchanged and in full force and effect.

	15A.
    NAME AND TITLE OF SIGNER (Type or print)	16A. NAME OF
                                                             CONTRACTING OFFICER

	 	 
	 KENNETH
    I. MOCH, PRESIDENT AND CEO	ETHAN J. MUELLER
	 	 
	15B.
    CONTRACTOR/OFFEROR	15C.
    DATE SIGNED	16B.
        UNITED STATES OF AMERICA
	16C. DATE SIGNED
	 	 		11/26/12

	 /s/ Kenneth I. Moch	 	/s/
        Ethan J. Mueller
	 
	(Signature
    of person authorized to sign)	 	(Signature
        of Contracting Officer)
	 

	NSN 7540-01-152-8070	STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	Prescribed by GSA
	 	FAR (48 CFR) 53.243

 

***Confidential Treatment Requested

 

    	 

    	 

    

 

 

 

	CONTINUATION SHEET	
        REFERENCE NO. OF DOCUMENT BEING
        CONTINUED

        HHSO100201100013C/005
	PAGEOFPAGES
	2	2
	
        NAME OF OFFEROR OR CONTACTOR

        CHIMERIX, INC. 1377270

	
        ITEM NO.

        (A)
	
        SUPPLIES/SERVICES

        (B)
	
        QUANTITY

        (C)
	
        UNIT

        (D)
	
        UNIT PRICE

        (E)
	
        AMOUNT

        (F)

	 	 	 	 	 	 
	 	
        and
        [...***...]
        is hereby deleted and replaced with [...***...].

         
	 	 	 	 
	 	 	 	 	 	 
	 	
        B. This is a no cost modification. The total amount and
        all other terms and conditions of contract number HHSO100201100013C remain unchanged.

         
	 	 	 	 
	 	 	 	 	 	 
	 	Period of Performance: 02/16/2011 to 03/31/2013	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 

 

	NSN 7540-01-152-8067	OPTIONAL FORM 336-(4-86)
	 	Sponsored by GSA
	 	FAR (48 CFR) 63.110

  

***Confidential Treatment Requested

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00214-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00214-of-00352.parquet"}]]