Document:

Agreement with the National Institute of Allergy and Infectious Diseases

 Exhibit 10.3 
 Enanta has requested that portions of this document be accorded confidential treatment pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended. 

 
 

 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 CONTRACT TABLE OF CONTENTS 

 

							
	 PART I - THE SCHEDULE
	  	 	1	  
		
	 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
	  	 	1	  
			
	 ARTICLE B.1.
	 	 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
	  	 	1	  
			
	 ARTICLE B.2.
	 	 ESTIMATED COST - OPTION
	  	 	1	  
			
	 ARTICLE B.3.
	 	 ADVANCE UNDERSTANDINGS
	  	 	1	  
			
	 ARTICLE B.4.
	 	 PROVISIONS APPLICABLE TO DIRECT COSTS
	  	 	2	  
		
	 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
	  	 	4	  
			
	 ARTICLE C.1.
	 	 STATEMENT OF WORK
	  	 	4	  
			
	 ARTICLE C.2.
	 	 REPORTING REQUIREMENTS
	  	 	4	  
			
	 ARTICLE C.3.
	 	 INVENTION REPORTING REQUIREMENT
	  	 	7	  
		
	 SECTION D - PACKAGING, MARKING AND SHIPPING
	  	 	9	  
		
	 SECTION E - INSPECTION AND ACCEPTANCE
	  	 	10	  
		
	 SECTION F - DELIVERIES OR PERFORMANCE
	  	 	11	  
			
	 ARTICLE F.1.
	 	 PERIOD OF PERFORMANCE
	  	 	11	  
			
	 ARTICLE F.2.
	 	 DELIVERIES
	  	 	11	  
			
	 ARTICLE F.3.
	 	 CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998
	  	 	13	  
		
	 SECTION G - CONTRACT ADMINISTRATION DATA
	  	 	15	  
			
	 ARTICLE G.1.
	 	 CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR
	  	 	15	  
			
	 ARTICLE G.2.
	 	 KEY PERSONNEL, HHSAR 352.242-70 (JANUARY 2006
	  	 	15	  
			
	 ARTICLE G.3.
	 	 INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
	  	 	16	  
			
	 ARTICLE G.4.
	 	 INDIRECT COST RATES
	  	 	17	  
			
	 ARTICLE G.5.
	 	 POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
	  	 	17	  
		
	 SECTION H - SPECIAL CONTRACT REQUIREMENTS
	  	 	19	  
			
	 ARTICLE H.1.
	 	 PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(B) (JANUARY 2006
	  	 	19	  
			
	 ARTICLE H.2.
	 	 HUMAN SUBJECTS
	  	 	19	  
			
	 ARTICLE H.3.
	 	 REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
	  	 	19	  
			
	 ARTICLE H.4.
	 	 DATA AND SAFETY MONITORING IN CLINICAL TRIALS
	  	 	20	  
			
	 ARTICLE H.5.
	 	 REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV
	  	 	20	  
			
	 ARTICLE H.6.
	 	 HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE
	  	 	21	  
			
	 ARTICLE H.7.
	 	 SALARY RATE LIMITATION, HHSAR 352.231-70 (JANUARY 2010
	  	 	21	  
			
	 ARTICLE H.8.
	 	 NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH
	  	 	22	  

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - i - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

							
			
	 ARTICLE H.9.
	 	 NEEDLE DISTRIBUTION
	  	 	22	  
			
	 ARTICLE H.10.
	 	 PRESS RELEASES
	  	 	22	  
			
	 ARTICLE H.11.
	 	 RESTRICTION ON ABORTIONS
	  	 	22	  
			
	 ARTICLE H.12.
	 	 CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
	  	 	22	  
			
	 ARTICLE H.13.
	 	 DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION
	  	 	23	  
			
	 ARTICLE H.14.
	 	 RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS
	  	 	23	  
			
	 ARTICLE H.15.
	 	 CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(B) (OCTOBER 2009
	  	 	23	  
			
	 ARTICLE H.16.
	 	 ANIMAL WELFARE
	  	 	23	  
			
	 ARTICLE H.17.
	 	 OPTION PROVISION
	  	 	24	  
			
	 ARTICLE H.18.
	 	 INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS
	  	 	24	  
			
	 ARTICLE H.19.
	 	 PUBLICATION AND PUBLICITY
	  	 	25	  
			
	 ARTICLE H.20.
	 	 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
	  	 	25	  
			
	 ARTICLE H.21.
	 	 SHARING RESEARCH DATA
	  	 	25	  
			
	 ARTICLE H.22.
	 	 POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
	  	 	26	  
			
	 ARTICLE H.23.
	 	 HIGHLY PATHOGENIC AGENTS
	  	 	27	  
			
	 ARTICLE H.24.
	 	 HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391
	  	 	27	  
		
	 PART II - CONTRACT CLAUSES
	  	 	28	  
		
	 SECTION I - CONTRACT CLAUSES
	  	 	28	  
			
	 ARTICLE I.1.
	 	 GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT
	  	 	28	  
			
	 ARTICLE I.2.
	 	 AUTHORIZED SUBSTITUTION OF CLAUSES
	  	 	32	  
			
	 ARTICLE I.3.
	 	 ADDITIONAL CONTRACT CLAUSES
	  	 	33	  
			
	 ARTICLE I.4.
	 	 ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
	  	 	34	  
		
	 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
	  	 	35	  
		
	 SECTION B - LIST OF ATTACHMENTS
	  	 	35	  
		
	 PART IV - REPRESENTATIONS AND INSTRUCTIONS
	  	 	36	  
		
	 SECTION K - REPRESENTATIONS AND CERTIFICATIONS
	  	 	36	  

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - ii - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 PART I - THE SCHEDULE 
 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS 
 ARTICLE B.1. BRIEF DESCRIPTION OF
SUPPLIES OR SERVICES 
 The overall objective for this contract with Enanta Pharmaceuticals will develop EDP-788, a prodrug of EDP- 322 with
enhanced bioavailability and water solubility, for oral and intravenous administration. Then move EDP-788 from preclinical to clinical development and toward licensure for use as a medical countermeasure for anthrax, plague and tularemia.

 ARTICLE B.2. ESTIMATED COST - OPTION 
  

	 	a.	The estimated cost of the Base Period of this contract is $14,315,157. 

  

	 	b.	Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT referenced in the General Clause Listing in Part II, ARTICLE I.1. of
this contract. 

  

	 	c.	If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government’s total estimated contract amount
represented by the sum of the estimated cost will be increased as follows: 

  

					
	 Estimated Cost
	 
	 Base Period
	  	$	14,315,157	  
	 Option 1
	  	$	1,922,683	  
	 Option 2
	  	$	7,296,268	  
	 Option 3
	  	$	3,143,236	  
	 Option 4
	  	$	10,183,163	  
	 Option 5
	  	$	827,085	  
	 Option 6
	  	$	5,057,348	  
		  	  
	  
	 
	 Total (Base and Options)
	  	$	42,744,940	  
		  	  
	  
	 

 ARTICLE B.3. ADVANCE UNDERSTANDINGS 
 Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer. 

 

	 	a.	Establishment of Indirect Cost Rate 

 Indirect costs are funded at a rate of 75% of Base Costs which includes: Direct Salaries and wages excluding vacation pay, Fringe Benefits, Subcontractors, Consultants, Travel, and Other Direct Costs;
however, the Contractor shall not bill or be reimbursed for indirect costs until such time as an indirect cost proposal has been submitted to the cognizant office responsible for negotiating the indirect cost rates, unless a temporary billing
rate(s) has been included herein. Unless otherwise specified below, the indirect cost rate proposal shall be submitted no later than three (3) months after the date of contract award. 

The Contractor may bill indirect costs at a temporary billing rate of 75% of Base Costs which includes: Direct Salaries and wages
excluding vacation pay, Fringe Benefits, Subcontractors, Consultants, Travel, and Other Direct Costs as authorized by the Contracting Officer; until such time as indirect costs have been established. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 1 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

	 	b.	Subcontract 

 A Cost and
Reimbursement type subcontract with the following subcontractors for the base award and option(s) specified in the Statement of Work not to exceed the following amounts provided in direct performance of this contract: 

 

																			
	 SUBCONTRACT #
	  	Base
Period	  	Option1	  	Option
2	  	Option
3	  	Option
4	  	Option
5	  	Option
6	  	TOTAL per
Subcontractor	 
	 [*****]
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
	 [*****]
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
	 [*****]
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
	 [*****]
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
	 [*****]
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
	 [*****]
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  
	 
	 TOTAL
	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	[*****]	  	 	[*****]	  
		  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  	  
	  
	 

  

	 	c.	Advance Copies of Press Releases 

 The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. In accordance with NIH Manual Chapter 1754, misrepresenting contract results or
releasing information that is injurious to the integrity of NIH may be construed as improper conduct. The complete text of NIH Manual Chapter 1754 can be found at: http://www1.od.nih.gov/oma/manualchapters/management/1754/ 

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 Contracting Officer’s Technical Representative (COTR) has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance
of the press release. 
 ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS 

 

	 	a.	Items Unallowable Unless Otherwise Provided 

 Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs 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. (General purpose equipment is defined as any
items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.); 

  

	 	4.	Travel to attend general scientific meetings; 

  

	 	5.	Foreign travel; 

  

	 	6.	Consultant costs; 

  

	 	7.	Subcontracts; 

  

	 	8.	Patient care costs; 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 2 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

	 	9.	Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more and “sensitive items” (defined as
items of personal property (supplies and equipment that are highly desirable and easily converted to person use), regardless of acquisition value. 

  

	 	b.	Travel Costs 

  

	 	1.	Domestic Travel 

 Total
expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract base period and all options shall not exceed the amount listed for its respective base and option period
listed below without the prior written approval of the Contracting Officer. 
  

					
	 Domestic Travel Costs
	 
	 Base Period
	  	$	26,000	  
	 Option 1
	  	$	12,000	  
	 Option 2
	  	$	10,000	  
	 Option 3
	  	$	12,000	  
	 Option 4
	  	$	14,000	  
	 Option 5
	  	$	0	  
	 Option 6
	  	$	10,000	  
		  	  
	  
	 
	 Total of Base and All Option(s)
	  	$	84,000	  
		  	  
	  
	 

  

	 	2.	The Contractor 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. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 3 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 

ARTICLE C.1. STATEMENT OF WORK 
  

	 	a.	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 September 13, 2011, set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract. 

ARTICLE C.2. REPORTING REQUIREMENTS 
 All
reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer. 
 All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including
specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under “Helpful Resources.” 
 All
paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b). 

 

	 	a.	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: 

[Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed
Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.] 
  

	 	1.	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. 
  

	 	2.	Annual Progress Report 

 This
report shall include a summation of the results of the entire contract work for the period covered. An annual report will not be required for the period when the Final Report is due. A Monthly Report shall not be submitted when an Annual Report is
due. 
  

	 	3.	Annual Technical Progress Report for Clinical Research Study Populations 

 PopulationsIn addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical
trials, see II.B of these guidelines. The Guidelines may be found at the following website: 

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 4 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 Include a description of the plans to conduct analyses, as appropriate, by sex/gender
and/or racial/ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis
reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the
Contractor shall include all final analyses of the data on sex/gender and race/ethnicity. 
  

	 	4.	Final Report 

 This report is 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 Final Report shall be submitted in
accordance with the DELIVERIES Article in SECTION F of this contract. A/An Annual report will not be required for the period when the Final Report is due. 
  

	 	5.	Summary of Salient Results 

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

	 	6.	Report on Select Agents or Toxins and/or Highly Pathogenic Agents 

 For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each Annual Progress
Report: 
  

	 	1.	Any changes in the use of the Select Agent or Toxin including initiation of “restricted experiments,” and/or a Highly Pathogenic Agent, that
have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official. 

 

	 	2.	If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

  

	 	a.	A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied; 

 

	 	b.	A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not
the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html) or listed on the U.S. National Select Agents Registry
restricted experiments website (http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html); 

  

	 	c.	The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at
which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location. 

 

	 	d.	For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For
work with Select Agents performed in a non-U.S. country prior NIAID approval is required. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 5 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 If the IBC or equivalent body or institutional biosafety official has determined, for
example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included
in each Annual Progress Report. 
 If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been
performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report. 
  

	 	b.	Other Reports/Deliverables 

  

	 	1.	Decision Gate Report 

 A
Decision Gate Report shall be submitted when the Contractor has completed a stage of product development and has reached a Go/No Go decision point, as defined in the approved Strategic Staged Product Development Plan. These reports shall be in
sufficient detail to explain comprehensively the results achieved. The description shall also include pertinent data and/or conclusions resulting from the analysis and scientific evaluation of data accumulated to date under the project. 

Decision Gate Reports shall include the following specific information: 

a) Cover page that lists the contract number and title, the period of performance being reported, the Contractor’s name and address,
telephone number, fax number, email address, and the date of submission. 
 b) An introduction covering the purpose and scope of
the contract effort, and the specific Decision Gate that has been reached. 
 c) Document and summarize the results of work
undertaken that supports the completion of the stage of product development, including an analysis of the data as it relates to the qualitative and quantitative criteria established for Go/No Go decision-making. 

d) Actual costs incurred in relation to costs estimated in the original approved budget. 

e) A description of the next stage of product development to be initiated and a request for COTR’s approval to proceed to the next
stage of product development. 
  

	 	2.	Decision Gate and Work Plan Change Request 

 The Contractor shall submit a written request any changes in the approved Strategic Staged Product Development Plan and Work Plan. This request shall include the following: 

a) A discussion of the justification/rationale for the request based on current data and a description of those data. 

b) Options for addressing the needed change/deviation from the approved timelines and/or decision gates, including a cost-benefit
analysis of each option. 
 c) A recommendation for the preferred option that includes a full analysis and discussion of the
effects of the change on the entire product development program, timelines, and budget. 
  

	 	3.	Draft and Final Clinical Trial Protocols 

 The NIAID has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in NIAID-funded clinical trials. Therefore, as described in the NIAID Clinical
Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), the Contractor shall develop a protocol for each clinical trial and submit draft protocols for review and all final protocols and protocol amendments for approval by the COTR.
The consultative review period for submission of draft protocols will be negotiated with the COTR. The review period of final protocols will be negotiated with the COTR and must occur prior to FDA submission and enrollment. An additional review and
approval period may be required for changes in the final protocol. Three (3) weeks should be planned for each review period. It is 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 6 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 
recommended that protocols be submitted using the approved DMID template and include a sample Informed Consent and Clinical Trials Monitoring Plan. The DMID templates and other important
information regarding performing human subject research are available at http://www3.niaid.nih.gov/research/resources/DMIDClinRsrch/. 
  

	 	4.	Strategic Staged Product Development Plan and Work Plan 

 The Contractor shall all correspondence from the FDA and shall prepare and submit minutes of all meetings with the FDA in accordance with Article F.2. Deliveries. At any time during the contract period
the COTR may request additional detail from the Contractor regarding the Strategic Staged Product Development Plan and the Work Plan. 
  

	 	5.	External Advisory Group Approval Request 

 The Contractor shall submit the following to the COTR and the Contracting Officer to request approval of External Advisory Group membership: 

a) A brief biosketch for each member being proposed. 
 b) A description of the roles and duties of each member. 
 c) The proposed
compensation for each member. 
 The Contractor shall plan to have the External Advisory Group consulting agreements in place
within six months of the effective date of the contract. 
  

	 	6.	Contract Meeting Reports 

 A
report of the Post-Award Contract Initiation Meeting, Annual Review Meetings and External Advisory Group meetings shall be prepared by the Contractor and submitted in accordance with F.2. Deliveries. These reports shall include the slide
presentations and all other meeting materials as well as summaries of all discussions. 
  

	 	7.	Institutional Biosafety Approval 

The Contractor shall provide documentation of materials submitted for Institutional Biosafety Committee Review and documentation of
approval of experiments at the request of the COTR. 
 ARTICLE C.3. INVENTION REPORTING REQUIREMENT 

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention
disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda,
Maryland 20892-7980 (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. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 7 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F
of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address: 

Contracting Officer 
 National Institutes of Health 
 National Institute of Allergy and Infectious
Diseases 
 Office of Acquisition 
 6700-B Rockledge Drive 
 MSC 7612, Room 3214 

Bethesda, Maryland 20892-7612 

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, the NIH has developed “Interagency Edison,” an electronic invention reporting system. 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. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 8 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 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. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 9 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 SECTION E - INSPECTION AND ACCEPTANCE 

 

	 	a.	The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided. 

 

	 	b.	For the purpose of this SECTION, the COTR is the authorized representative of the Contracting Officer. 

 

	 	c.	Inspection and acceptance will be performed at: 

 National Institutes of Health 
 National Institute of Allergy and Infectious
Diseases 
 Division of Microbiology and Infectious Diseases 

Office of Biodefense Research Affairs 
 Drug Development Section 
 6610 Rockledge Drive, Room 3610 

Bethesda, Maryland 20892 
 Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt. 

 

	 	d.	This 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). 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 10 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 SECTION F - DELIVERIES OR PERFORMANCE 
 ARTICLE F.1. PERIOD OF PERFORMANCE 
  

	 	a.	The period of performance of this contract shall be from September 30, 2011 through March 30, 2014. 

ARTICLE F.2. DELIVERIES 
 Satisfactory
performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in accordance with the stated delivery schedule: 
  

	 	a.	The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set
forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984): 

  

							
	 Item
	  	 Description
	  	 Quantity
	  	 Delivery Schedule

	1	  	Staged Specific Product Development Plan (SSPDP) and Workplan, and their revisions	  	2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO	  	Within 14 days after the contract award for the baseline SSPDP and Workplan, and during the course of the contract when revision is requested.
				
	2	  	Monthly Technical Progress Reports	  	2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO	  	Each report is due on/before the 15th of each month following each reporting period.
				
	3	  	Annual Technical Progress Reports	  	2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO	  	Each report is due on/before the 15th of the month following each anniversary date. Monthly Progress Reports will not be submitted the month the Annual Progress Report is
due.
				
	4	  	Final Invention Statement	  	1 copy to CO	  	On or before completion date of the contract.
				
	5	  	Draft and Final Technical Reports and Summary of Salient Results	  	1 hard copy to COTR, 1 original copy to CO, 1 electronic copy to COTR and CO	  	Draft Final Report is due 90 calendar days prior to the completion date of the contract. Final Report and Summary of Salient Results for the entire contract period to include key
achievements (organized by Milestone) is due on or before the contract end date.
				
	6	  	Technical Transfer Reports	  	1 hard copy to COTR, 1 electronic copy to COTR and CO	  	Each report will be provided as available.
				
	7	  	Meeting minutes and reports (kickoff and annual meetings and teleconferences with DMID)	  	Electronic copy to COTR and CO	  	Within 5 business days for teleconference and within 21 calendar days for kickoff or annual meeting
				
	8	  	Audit Reports	  	2 hard copies to COTR and 1 original to CO, 1 electronic copy to COTR and CO	  	Within 30 days after the completion of the audits.

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 11 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

							
	 Item
	  	 Description
	  	 Quantity
	  	 Delivery Schedule

	9	  	Clinical Protocols, amendments, and supporting documents (draft, revisions and final)	  	1 electronic copy to COTR and CO	  	Submit according to timelines or specified by DMID clinical operation guidelines.
				
	10	  	GO/NO GO Decision Gate Reports or Deviation/Change request	  	2 hard copy to COTR, 1 original copy to CO, 1 electronic copy to COTR and CO	  	30 calendar days prior to date planned for exercising an option.
				
	11	  	Draft and Final Regulatory Submission Documents to the FDA, including pre-IND, IND, and End of Phase I packages, as necessary.	  	electronic copy to COTR and CO	  	Submit as needed per current NIAID-DMID Regulatory and Clinical Operational guidelines.
				
	12	  	Copies of FDA correspondence and meeting summaries	  	1 hard copy to COTR, 1 electronic copy to COTR and CO	  	Within 5 business days upon receipt of these documents from the FDA.
				
	13	  	Draft and Final nonclinical study protocols (safety, toxicity, and efficacy)	  	1 electronic copy to COTR and CO	  	Prior to study initiation and as requested
				
	14	  	Draft and Final Nonclinical Study Reports (safety, toxicity, and efficacy)	  	1 electronic copy to COTR and CO	  	Prior to regulatory submission to the FDA and as requested or as available
				
	15	  	Draft and Final Clinical Study Reports	  	1 electronic copy to COTR and CO	  	Prior to regulatory submission to the FDA and as requested or as available
				
	16	  	Other clinical reports (for example, IND annual reports, NIH clinical population reports, SMC reports and clinical monitoring reports)	  	1 electronic copy to COTR	  	Submit according to timelines or specified by NIAID-DMID clinical operation guidelines.
				
	17	  	Sample of therapeutics (not for human use)	  	50 doses or equivalent amount delivered to COTR as directed by COTR	  	On or before the completion of the last exercised option.

  

	 	b.	The items below are deliverables specific to the base award and each option: 

 

							
	 Item
	  	 Stage
	  	 Reporting Deliverables
	  	 Days

	Base Award	  	Successful completion of oral IND enabling safety studies and manufacturing of non-GMP and cGMP API and oral drug product, formulation and stability studies, protocol development,
IND preparation and submission	  	Monthly and annual technical progress reports, Decision Gate Report, and study reports as needed.	  	On or before 30 months of the Contract Award.
				
	Option 1	  	Successful completion of IV preclinical non-GLP PKs and safety studies and completion of IV formulation development.	  	Monthly and annual technical progress reports, Decision Gate Report, and study reports as needed.	  	On or before 10 months from the date of the executed option.

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 12 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

							
	 Item
	  	 Stage
	  	 Reporting Deliverables
	  	 Days

	Option 2	  	Successful completion of oral clinical Phase 1a SAD, Phase 1b MAD and oral human BAL lung distribution studies	  	Monthly and annual technical progress reports, clinical study reports, other study and audit reports as needed, and FDA communications.	  	On or before 18 months from the date of the executed option.
				
	Option 3	  	Successful completion of IV GLP IND enabling safety studies, IV clinical protocol development and IV IND preparation and reviews	  	Monthly and annual technical progress reports, and study reports as needed.	  	On or before 15 months from the date of the executed option.
				
	Option 4	  	Successful completion NHP efficacy studies and demonstration of efficacy against one or more biodefense pathogens	  	Monthly and annual technical progress reports, FDA communication, and efficacy study reports	  	On or before 34 months from the date of the executed option.
				
	Option 5	  	Successful completion of IV drug product manufacturing, IV IND submission and drug product stability.	  	Monthly, annual technical progress reports, Decision Gate Report, and other study and audit reports, FDA communication and study reports.	  	On or before 27 months from the date of the executed option.
				
	Option 6	  	Successful completion of IV Phase 1a SAD and 1b MAD studies	  	Monthly and annual technical progress reports, FDA communications, and clinical study reports.	  	On or before 14 months from the date of the executed option.

  

	 	c.	The above items shall be addressed and delivered to: 

 Contracting Officer’s Technical Representative (COTR) 
 National Institutes of
Health 
 National Institute of Allergy and Infectious Diseases 

Division of Microbiology and Infectious Diseases 
 Office of Biodefense Research Affairs 
 Drug Development Section

6610 Rockledge Drive, Room 3610 
 Bethesda, Maryland 20892 
 and 

Contracting Officer (CO) 
 Microbiology and Infectious Diseases Research Contracts Branch A 
 Office of
Acquisitions, DEA, NIAID, NIH, DHHS 
 6700-B Rockledge Drive, Room 3214 

Bethesda, Maryland 20892-7612 
 (Express Mail: Bethesda, MD 20817) 
 ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR
52.252-2 (FEBRUARY 1998) 
 This 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 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 13 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE: 52.242-15, Stop Work Order (August
1989) with Alternate I (April 1984). 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 14 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 SECTION G - CONTRACT ADMINISTRATION DATA 
 ARTICLE G.1. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR) 
 The following
Contracting Officer’s Technical Representative (COTR) will represent the Government for the purpose of this contract: 
 Helen F. Schiltz
Ph.D. 
 Office of Biodefense Research Affairs 
 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) 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. 
 The alternate COTR is responsible for carrying
out the duties of the COTR only in the event that the COTR can no longer perform his/her duties as assigned or is officially covering for the COTR when they are on scheduled leave. 
 The alternate COTR for the purpose of this contract is: 
 Ping Chen Ph.D. 

Office of Biodefense Research Affairs 
 The
Contracting Officer is the only person with 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 reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this
contract. 
 The Government may unilaterally change its COTR designation. 
 ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (JANUARY 2006) 
 The key personnel specified in
this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, 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. The Government may modify the contract to
add or delete key personnel at the request of the Contractor or Government. 
 (End of Clause) 

The following individual(s) is/are considered to be essential to the work being performed hereunder: 

 

			
	 Name
	  	 Title

	 Ly Phan Ph.D.
	  	 Principal Investigator

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 15 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

  

	 	a.	Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract.
The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment. 

 

	 	1.	Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with
your payment request unless specified elsewhere in the contract or requested by the Contracting Officer. 

  

	 	a.	The original invoice shall be submitted to the following designated billing office: 

National Institutes of Health 
 Office of Financial Management 
 Commercial Accounts 

2115 East Jefferson Street, Room 4B-432, MSC 8500 
 Bethesda, MD 20892-8500 
  

	 	b.	One copy of the invoice shall be submitted to the following approving official: 

Contracting Officer 
 National Institutes of Health 
 National Institute of Allergy and Infectious
Diseases 
 Office of Acquisitions, DEA Room 3214 
 6700-B Rockledge Drive MSC 7612 
 Bethesda, Maryland 20892-7612 

E-Mail: NIAIDOAInvoices@niaid.nih.gov 
 The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address
listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor’s name, contract
number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a “proper invoice.”] 

 

	 	2.	In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment
requests: 

  

	 	a.	Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIAID. 

 

	 	b.	Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAIDOAInvoices. 

 

	 	c.	Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment
request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 16 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

	 	d.	DUNS or DUNS+4 Number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract and as registered in the Central
Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the
face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer. 

  

	 	e.	Invoice Matching Option. This contract requires a two-way match. 

  

	 	f.	Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or
orders held by an organization. 

  

	 	b.	Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452. 

 

	 	c.	The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION
LEGISLATION PROVISIONS Article in SECTION H of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period
utilizing the applicable Fiscal Year funds: 

 “I hereby certify that the salaries charged in this invoice
are in compliance with the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract.” 

ARTICLE G.4. INDIRECT COST RATES 
 In
accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible
for negotiating provisional and/or final indirect cost rates is identified as follows: 
 Director, Division of Financial
Advisory Services 
 Office of Acquisition Management and Policy 

National Institutes of Health 
 6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663 
 BETHESDA MD 20892-7663 

These rates are hereby incorporated without further action of the Contracting Officer. 
 ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE 
  

	 	a.	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, interim evaluation(s) will be prepared on the anniversary date of the contract. 

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. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 17 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

	 	b.	Electronic Access to Contractor Performance Evaluations 

 Contractors may access evaluations through a secure Web site for review and comment at the following address: 
 http://www.cpars.csd.disa.mil 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 18 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 SECTION H - SPECIAL CONTRACT REQUIREMENTS 

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

  

	 	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. 

 (End of clause) 
 ARTICLE H.2. HUMAN SUBJECTS 
 Research involving human subjects shall not be conducted under
this contract until the protocol developed in Phase I has been approved by NIAID, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer 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. The human subject
certification can be met by submission of the Contractor’s 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). 
 When research involving Human Subjects will take place at
collaborating sites or other performance sites, the Contractor shall obtain, and keep on file, 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 research. 
 ARTICLE H.3. REQUIRED EDUCATION IN THE
PROTECTION OF HUMAN RESEARCH PARTICIPANTS 
 NIH policy requires education on the protection of human subject participants for all
investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the
NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website: 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 19 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 The information below is a summary of the NIH Policy Announcement: 

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals
working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one
sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants
under the contract. 
 Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or
conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the
replacement. 
 ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS 
 The Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites: 

http://grants.nih.gov/grants/guide/notice-files/not98-084.html 
 http://grants.nih.gov/grants/guide/notice-files/not99-107.html 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html 
 The Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract. 

Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan. 

The Data and Safety Monitoring Board shall be established and approved prior to beginning the conduct of the clinical trial. 

ARTICLE H.5. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV 

The Food and Drug Administration Amendments Act of 2007 (FDAAA) at:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf, Title VIII, expands the National Institutes of Health’s (NIH’s) clinical trials registry and results database known as
ClinicalTrials.gov and imposes new requirements that apply to specified “applicable clinical trials,” including those supported in whole or in part by NIH funds. FDAAA requires: 

 

	 	•	 	 the registration of certain “applicable clinical trials” (see Definitions at:
http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and 

 

	 	•	 	 the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above)
for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of
FDCA. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 20 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 In addition, the Contractor shall notify the Contracting Officer’s Technical Representative (COTR),
with the trial registration number (NCT number), once the registration is accomplished. This notification may be included in the Technical Progress Report covering the period in which registration occurred, or as a stand alone notification.

 The Contractor is the Sponsor, therefore the “Responsible Party” for the purposes of compliance with FDAAA which includes
registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov (http://www.ClinicalTrials.gov). 

Additional information is available at: http://prsinfo.clinicaltrials.gov. 
 ARTICLE H.6. 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 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.7. SALARY RATE LIMITATION, HHSAR 352.231-70 (JANUARY 2010) 

 

	 	a.	Pursuant to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual at a rate in
excess of the Federal Executive Schedule Level I in effect on the date an expense is incurred. 

  

	 	b.	For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary” have the same meaning and
are collectively referred to as “direct salary” in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary
excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and
administrative [F&A] costs). 

 Note: The salary rate limitation does not restrict the salary that an
organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds. 
  

	 	c.	The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by
the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to
establish contract or order funding. 

  

	 	d.	See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and
prior periods. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 21 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 (End of clause) 
 See the following Web site for Executive Schedule rates of pay: http://www.opm.gov/oca/. 

(For current year rates, click on Salaries and Wages / Executive Schedule / Rates of Pay for the Executive Schedule. For prior year rates,
click on Salaries and Wages / select Another Year at the top of the page / Executive Schedule / Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.) 

ARTICLE H.8. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH 

NIH-funded investigators shall submit to the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) an electronic version of the author’s
final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final version accepted for journal publication, and includes
all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the
NIH/NLM/PMC: http://www.pubmedcentral.nih.gov. 
 Additional information is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. 
 ARTICLE H.9. NEEDLE DISTRIBUTION 

The Contractor shall not use contract funds to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any
location that has been determined by the local public health or local law enforcement authorities to be inappropriate for such distribution. 

ARTICLE H.10. PRESS RELEASES 
 The
Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the
total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that
will be financed by nongovernmental sources. 
 ARTICLE H.11. RESTRICTION ON ABORTIONS 

The Contractor shall not use contract funds for any abortion. 
 ARTICLE H.12. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH 
 The Contractor
shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater
than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human
subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. 

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 22 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 ARTICLE H.13. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION

 The Contractor shall not use contract funds to disseminate scientific information that is deliberately false or misleading. 

ARTICLE H.14. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS 
 The Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows: 

“(3) Definition of unauthorized alien. - As used in this section, the term ‘unauthorized alien’ means, with respect to the
employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.” 

ARTICLE H.15. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(B) (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). 

(End of Clause) 
 ARTICLE
H.16. 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 (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 23 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 In addition, the research involving live vertebrate animals shall be conducted in accordance with the
description set forth in the Vertebrate Animal Section (VAS) of the contractor’s technical proposal, as modified in the Final Proposal Revision (FPR), dated September 23, 2011, which is incorporated by reference. 

ARTICLE H.17. OPTION PROVISION 

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., the contract will consist only of the Base Period of
the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-6, Option for Increased Quantity set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the
Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 30 days prior to the expiration date of this
contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST PLUS FIXED FEE Article in SECTION B of this contract. 
 ARTICLE H.18. 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 NIH 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/textidx? c=ecfr;sid=cfc3d0caac2d06e14935ada5731b763d;rgn=div5;view=text;node=45%3A1.0.1.1.52;idno=45;cc=ecfr 

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 NIH-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 NIH-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. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 24 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 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 NIH-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 NIH-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 NIH-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 NIH-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. 

ARTICLE H.19. PUBLICATION AND PUBLICITY 
 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 National Institutes of Health 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 National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human
Services, under Contract No. HHSN272201100029C” 
 ARTICLE H.20. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

 Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH 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.21. SHARING RESEARCH DATA 
 [The data sharing plan submitted by the Contractor is acceptable/The Contractor’s data sharing plan, dated September 13, 2011 is hereby incorporated by reference.] The Contractor agrees to
adhere to its plan and shall request prior approval of the Contracting Officer for any changes in its plan. 
 The NIH endorses the sharing of
final research data to serve health. this contract is expected to generate research data that must be shared with the public and other researchers. NIH’s data sharing policy may be found at the following Web site: 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 25 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional
policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/). The rights and privacy of people who participate
in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the
identity of individual subjects. 
 ARTICLE H.22. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS 

The work being conducted under this contract may involve the possession, use, or transfer of a select agent or toxin. The contractor shall not conduct
work involving a Select Agent or Toxin under this contract until it and any associated subcontractor(s) comply with the following: 
 For prime or subcontract awards to domestic institutions that possess, use, and/or transfer a Select Agent or Toxin under this contract, the institution must comply with the provisions of 42
CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 (http://www.selectagents.gov/Regulations.html) as required, before using NIH funds for work involving a Select Agent or Toxin. No NIH funds can be used for research involving
a Select Agent or Toxin at a domestic institution without a valid registration certificate. 
 For prime
or subcontract awards to foreign institutions that possess, use, and/or transfer a Select Agent or Toxin, before using NIH funds for any work directly involving a Select Agent or Toxin, the foreign institution must
provide information satisfactory to the NIAID that safety, security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be administered on behalf of all Select Agent or
Toxin work supported by these funds. The process for making this determination includes a site visit to the foreign laboratory facility by an NIAID representative. During this visit, the foreign institution must provide the following information:
concise summaries of safety, security, and training plans; names of individuals at the foreign institution who will have access to the Select Agent or Toxin and procedures for ensuring that only approved and appropriate individuals, in
accordance with institution procedures, will have access to the Select Agents or Toxins under the contract; and copies of or links to any applicable laws, regulations, policies, and procedures applicable to that institution for the safe and
secure possession, use, and/ or transfer of select agents. Site visits to foreign laboratories are conducted every three years after the initial review. No NIH funds can be used for work involving a Select Agent or Toxin at a
foreign institution without written approval from the Contracting Officer. 
 Prior to conducting a restricted experiment with a Select
Agent or Toxin under this contract or any associated subcontract, the contractor must discuss the experiment with the Contracting Officer’s Technical Representative (COTR) and request and obtain written approval from the Contracting Officer.
Domestic institutions must submit to the Contracting Officer written approval from the CDC to perform the proposed restricted experiment. Foreign institutions require review by a NIAID representative. The prime contractor must contact
the COTR and the NIAID Office of International Extramural Activities (OIEA) at mailto:niaidforeignawards@niaid.nih.gov for guidance on the process used by NIAID to review proposed restricted experiments. The NIAID website provides an overview
of the review process at http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/saconproc.aspx. The Contracting Officer will notify the prime contractor when the process is complete. No NIH funds can be used for a restricted
experiment with a Select Agent or Toxin at either a domestic or foreign institution without written approval from the Contracting Officer. 
 Listings of HHS and USDA select agents and toxins, and overlap select agents or toxins as well as information about the registration process for domestic institutions, are available on the Select Agent
Program Web site at http://www.selectagents.gov/ and http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html. 

For foreign institutions, see the NIAID Select Agent Award information: 
 (http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/default.aspx). 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 26 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 ARTICLE H.23. HIGHLY PATHOGENIC AGENTS 

The work being conducted under this contract may involve a Highly Pathogenic Agent (HPA). The NIAID defines an HPA as a pathogen that, under any
circumstances, warrants a biocontainment safety level of BSL3 or higher according to either: 
  

	 	1.	The current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)(http:// www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm);

  

	 	2.	The Contractor’s Institutional Biosafety Committee (IBC) or equivalent body; or 

 

	 	3.	The Contractor’s appropriate designated institutional biosafety official. 

 If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an IBC or equivalent body, or institutional biosafety official, the highest recommended containment level must be
used. 
 ARTICLE H.24. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391) 

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting, convention, conference or training seminar
that is conducted in, or that otherwise uses the rooms, facilities, or services of a place of public accommodation that do not meet the requirements of the fire prevention and control guidelines as described in the Public Law. This restriction
applies to public accommodations both foreign and domestic. 
 Public accommodations that meet the requirements can be accessed at:
http://www.usfa.fema.gov/hotel/index.htm. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 27 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 PART II - CONTRACT CLAUSES 
 SECTION I - CONTRACT CLAUSES 
 ARTICLE I.1. GENERAL CLAUSES FOR A
COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT 
 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 as follows: FAR Clauses at:
https://www.acquisition.gov/far/. HHSAR Clauses at: http:// www.hhs.gov/policies/hhsar/subpart352.html. 
  

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

 

					
	 FAR CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	52.202-1	  	Jul 2004	  	Definitions (Over the Simplified Acquisition Threshold)
			
	52.203-3	  	Apr 1984	  	Gratuities (Over the Simplified Acquisition Threshold)
			
	52.203-5	  	Apr 1984	  	Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)
			
	52.203-6	  	Sep 2006	  	Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)
			
	52.203-7	  	Oct 2010	  	Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)
			
	52.203-8	  	Jan 1997	  	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
			
	52.203-10	  	Jan 1997	  	Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
			
	52.203-12	  	Oct 2010	  	Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)
			
	52.204-4	  	May 2011	  	Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (Over the Simplified Acquisition Threshold)
			
	52.204-7	  	Apr 2008	  	Central Contractor Registration
			
	52.204-10	  	Jul 2010	  	Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)
			
	52.209-6	  	Dec 2010	  	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
			
	52.215-2	  	Oct 2010	  	Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified
Acquisition Threshold funded exclusively with non-Recovery Act funds.]
			
	52.215-8	  	Oct 1997	  	Order of Precedence - Uniform Contract Format
			
	52.215-10	  	Aug 2011	  	Price Reduction for Defective Certified Cost or Pricing Data (Over $700,000)
			
	52.215-12	  	Oct 2010	  	Subcontractor Cost or Pricing Data (Over $700,000)
			
	52.215-14	  	Oct 2010	  	Integrity of Unit Prices (Over the Simplified Acquisition Threshold)

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 28 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

					
	 FAR CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	52.215-15	  	Oct 2010	  	Pension Adjustments and Asset Reversions (Over $700,000)
			
	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 and Data Other Than Certified Cost or Pricing Data - Modifications
			
	52.215-23	  	Oct 2009	  	Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)
			
	52.216-7	  	Jun 2011	  	Allowable Cost and Payment
			
	52.216-8	  	Jun 2011	  	Fixed Fee
			
	52.219-8	  	Jan 2011	  	Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold)
			
	52.219-9	  	Jan 2011	  	Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)
			
	52.219-16	  	Jan 1999	  	Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction)
			
	52.222-2	  	Jul 1990	  	Payment for Overtime Premium (Over the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the
contract.)
			
	52.222-3	  	Jun 2003	  	Convict Labor
			
	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 ($100,000 or more)
			
	52.222-36	  	Oct 2010	  	Affirmative Action for Workers with Disabilities
			
	52.222-37	  	Sep 2010	  	Employment Reports on Veterans ($100,000 or more)
			
	52.222-40	  	Dec 2010	  	Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)
			
	52.222-50	  	Feb 2009	  	Combating Trafficking in Persons
			
	52.222-54	  	Jan 2009	  	Employment Eligibility Verification (Over the Simplified Acquisition Threshold)
			
	52.223-6	  	May 2001	  	Drug-Free Workplace
			
	52.223-18	  	Aug 2011	  	Encouraging Contractor Policies to Ban Text Messaging While Driving
			
	52.225-1	  	Feb 2009	  	Buy American Act - Supplies
			
	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
			
	52.227-11	  	Dec 2007	  	Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv).
The frequency of reporting in (i) is annual.

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 29 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

					
	 FAR CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	52.227-14	  	Dec 2007	  	Rights in Data - General
			
	52.232-9	  	Apr 1984	  	Limitation on Withholding of Payments
			
	52.232-17	  	Oct 2010	  	Interest (Over the Simplified Acquisition Threshold)
			
	52.232-20	  	Apr 1984	  	Limitation of Cost
			
	52.232-23	  	Jan 1986	  	Assignment of Claims
			
	52.232-25	  	Oct 2008	  	Prompt Payment, Alternate I (Feb 2002)
			
	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 (Jun 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 $700,000)
			
	52.242-4	  	Jan 1997	  	Certification of Final Indirect Costs
			
	52.242-13	  	Jul 1995	  	Bankruptcy (Over the Simplified Acquisition Threshold)
			
	52.243-2	  	Aug 1987	  	Changes - Cost Reimbursement, Alternate V (Apr 1984)
			
	52.244-2	  	Oct 2010	  	Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007)
			
	52.244-5	  	Dec 1996	  	Competition in Subcontracting (Over the Simplified Acquisition Threshold)
			
	52.244-6	  	Dec 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 the Simplified Acquisition Threshold)
			
	52.249-6	  	May 2004	  	Termination (Cost-Reimbursement)
			
	52.249-14	  	Apr 1984	  	Excusable Delays
			
	52.253-1	  	Jan 1991	  	Computer Generated Forms

  

	 	b.	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 2006)
			
	352.203-70	  	Jan 2006	  	Anti-Lobbying (Over Simplified Acquisition Threshold)
			
	352.216-70	  	Jan 2006	  	Additional Cost Principles
			
	352.222-70	  	Jan 2010	  	Contractor Cooperation in Equal Employment Opportunity Investigations
			
	352.227-70	  	Jan 2006	  	Publications and Publicity

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 30 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

					
	 HHSAR CLAUSE NO.
	  	 DATE
	  	 TITLE

			
	352.228-7	  	Dec 1991	  	Insurance - Liability to Third Persons
			
	352.233-71	  	Jan 2006	  	Litigation and Claims
			
	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

 [End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 08/2011].

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 31 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES 

ARTICLE I.1. of this SECTION is hereby modified as follows: 
  

	 	a.	THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION. 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 32 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 ARTICLE I.3. 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 52.203-13, Contractor Code of Business Ethics and Conduct (April 2010). 

 

	 	2.	FAR Clause 52.203-14, Display of Hotline Poster(s) (December 2007). 

 “....(3) Any required posters may be obtained as follows: 
  

			
	 Poster(s)
	  	 Obtain From”

	HHS Contractor Code of Ethics and Business Conduct Poster	  	http://oig.hhs.gov/fraud/hotline/ OIG Hotline Poster.pdf

  

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

 

	 	4.	FAR Clause 52.217-6, Option for Increased Quantity (March 1989). 

 “....The Contracting Officer may exercise the option by written notice to the Contractor any point prior to 30 days of the completion date of the contract ....” 

 

	 	5.	FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (January 2011). 

“(c) Waiver of evaluation preference 
 [ ] Offeror elects to waive the evaluation preference.” 
  

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

  

	 	7.	FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001). 

  

	 	8.	FAR Clause 52.251-1, Government Supply Sources (August 2010). 

  

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

 

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

  

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

  

	 	3.	HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to Persons with Disabilities (January 2001). 

 

	 	c.	NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES: 

 The following clauses are attached and made a part of this contract: 
  

	 	1.	NIH(RC)-11, Research Patient Care Costs (4/1/84). 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 33 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 ARTICLE I.4. 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 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (January 2011) 

(a) The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a
semi-annual basis, throughout the life of the contract, by posting the required information in the Central Contractor Registration database at http://www.ccr.gov. 
 (b)(1) The Contractor will receive notification when the Government posts new information to the Contractor’s record. 
 (2) The Contractor will have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained,
i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them. 

(3) (i) Public requests for system information prior to April 15, 2011, will be handled under Freedom of Information Act
procedures, including, where appropriate, procedures promulgated under E.O. 12600. 
 (ii) As required by section 3010 of Public
Law 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. 
 (End of clause) 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 34 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS 

SECTION B - LIST OF ATTACHMENTS 
 The
following documents are attached and incorporated in this contract: 
 1. Statement of Work 

Statement of Work, dated September 13, 2011, 3 pages. 
 2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4 
 Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (8/08), 6 pages. 
 3. Inclusion Enrollment Report 
 Inclusion Enrollment Report, PHS 398/2590, (Rev. 6/09), 1
page. Located at: http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf 
 4. Inclusion Table 

Inclusion Table (Formerly Annual Technical Progress Report Format for Each Study), April, 1998, 1 page. Located at:
http://grants.nih.gov/grants/funding/women_min/InclusionOld_Form.pdf 
 5. Safety and Health 

Safety and Health, HHSAR Clause 352.223-70, (1/06), 1 page. 
 6. Research Patient Care Costs 
 Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.

 7. Disclosure of Lobbying Activities, SF-LLL 
 Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages. 
 8. Conference Expense Offset
Worksheets 
 Contractor Pre-Conference Expense Offset Worksheet, dated 3/2008, 1 page. Located
at:http://rcb.cancer.gov/rcb-internet/forms/Pre-Conf-worksheet.pdf 
 Post Conference Expense Offset Worksheet, dated 3/2008, 2 pages.
Located at: http://rcb.cancer.gov/rcb-internet/forms/Post-Conf-worksheet.pdf 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 35 - 

 Contract Number: HHSN272201100029C 

Reference Number: NIHAI2010097 
  

 PART IV - REPRESENTATIONS AND INSTRUCTIONS 

SECTION K - REPRESENTATIONS AND CERTIFICATIONS 
 The following documents are incorporated by reference in this contract: 
  

	 	1.	Annual Representations and Certifications completed and located at the Online Representations and Certifications Application (ORCA) website. [This includes the changes
identified in paragraph (b) of the FAR provision 52.204-8, Annual Representations and Certifications, contained in the Contractor’s proposal.] 

  

	 	2.	NIH Representations & Certifications, dated September 20, 2011 

 

	 	3.	Human Subjects Assurance Identification Number. Enanta Pharmaceuticals will conduct clinical trials in human subjects under their subcontract agreement with PPD in this
contract. PPD’s Human Subjects Assurance Identification Number is FWA00003916. 

  

	 	4.	Animal Welfare Assurance Number Animal Welfare Assurance Number. Enanta Pharmaceuticals will conduct work involving vertebrate animals under their subcontract agreement
with MPI in this contract. MPI’s Animal Welfare Assurance Numbers is A3181?01. 

 NOTE: Restriction- Funds
included in this award for research involving live vertebrate animals are restricted and may not be used for any other purpose without the written prior approval of the NIH awarding component. Under governing PHS Policy no funds may be drawn down
from the payment system and no obligations made against federal funds for research involving live vertebrate animals prior to approval by the Office of Laboratory Animal Welfare (OLAW) of an Animal Welfare Assurance in accordance with the PHS Policy
on Humane Care and Use of Laboratory Animals. This restriction applies to the applicant organization and all performance sites (e.g., collaborating institutions, sub-contractors, sub-grantees) lacking OLAW-approved Assurances, whether domestic,
foreign or inter-institutional. If the applicant organization does not have an Animal Welfare Assurance and the animal work will be conducted at an institution with an Assurance, the grantee must obtain an Inter-institutional Assurance from OLAW.
Animal Welfare Assurances must be submitted to OLAW not later than November 30, 2011. Failure to submit the Animal Welfare Assurance to OLAW within the required timeframe or to otherwise comply with the above requirements can result in
suspension and/or termination of this award, withholding of support, audit disallowances, and/or other appropriate action. 

END of the SCHEDULE 
 (CONTRACT) 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 36 - 

			
	Final Proposal (Revision #4) – 9/13/2011	 	ENANTA Pharmaceuticals, Inc

  

 CHANGES IN THE FINAL BUSINESS PROPOSAL (Revision #4, September 13, 2011)

 (RFP): BAA-NIAID-DMID-NIHAI2010097 
 “Development of Therapeutics for Biodefense” 
 The following items in the table
below summarizes the major changes to the Business Proposal Revision #3 dated September 1, 2011, with the corresponding page numbers in the current Final Proposal (Revision #4), as per the teleconference discussion on September 12th.

  

							
	 Changes
	  	 Major Changes
	  	 Comment
	  	 Page #

	1.	  	Revised Business Proposal Cover Sheet	  	 •       Reflect change to total amount requested (reduced $119,000) due to deletion of
the budget for the Safety Monitoring Committee reports in Options 2 and 5 as per NIAID’s request
	  	1
	2.	  	Revised Pricing Proposal Signature Page	  	 •       Reflect change to total amount requested (reduced $119,000)
	  	2
	3.	  	Revised Proposal Summary and Data Record Page	  	 •       Reflect change to estimated direct costs requested (reduced
$68,000)
	  	3
	4.	  	Revised Detailed budget for Enanta	  	Revised to reflect requested changes to Options 2 and 5; removed funds for Safety Monitoring Committee; reclassified Materials & Supplies, Consultants’ travel, External
Advisory Board fees and travel, Vendor Costs, and Subcontractor Costs as per NIAID’s request	  	6-25
	5.	  	Revised Budget Justification	  	Revised to reflect requested changes to Enanta’s Detailed Budget	  	67-70

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 37 - 

			
	Final Proposal (Revision #4) – 9/13/2011	 	ENANTA Pharmaceuticals, Inc

  

 BAA contract structure 
 Base period and 6 options for the 5-year award. 
 Contractor: Enanta Pharmaceuticals, Inc.

 Title: BAA NIAID-DMID-NIHAI2010097 “Development of Therapeutics for Biodefense” 

Total award amount: $42,744,940 

Award period: 9/30/2011 – 9/29/2016 

Non-severable tasks within the Base period 
 Duration (months): 30 months  
 Budget: $ 14,315,157 

The major focus of the R&D activities conducted in the base period is: 

 

	 	•	 	 Microbiology 

  

	 	•	 	 Non-GLP and GLP IND enabling safety studies 

  

	 	•	 	 Medicinal chemistry for back up candidate (if needed) 

 

	 	•	 	 Non-GMP and cGMP manufacturing of the active pharmaceutical ingredient (API), formulation, and manufacturing of oral drug product

  

	 	•	 	 Long term stability studies of API and drug product 

  

	 	•	 	 Clinical protocol development for oral studies, oral IND preparation, review and submission 

The molecule is expected to be safe and active against B. anthracis, F. tularensis, Y. pestis, MRSA and streptococci. 

Decision Gate Criteria: Successful completion of oral IND enabling safety studies and manufacturing of non-GMP and cGMP API and oral drug product,
formulation and stability studies, protocol development, IND preparation and submission. 
 Deliverables: Monthly and annual technical
progress reports, Decision Gate Report, other study reports as needed. 
 Non-severable tasks within Option Period 1 

Duration (months): 10 months  

Budget: $ 1,922,683 
 Activities during
the Option Period 1 will include: 
  

	 	•	 	 IV preclinical PKs and non-GLP IV safety studies 

  

	 	•	 	 IV clinical formulation development 

 Decision Gate Criteria: Successful completion of IV preclinical non-GLP PKs and safety studies and completion of IV formulation development. 

Deliverables: Monthly and annual technical progress reports, Decision Gate report, and other study reports as needed. 

Criteria for Exercising Option: Successful completion of oral IND enabling safety studies with adequate safety margin (in Base period).

 Non-severable tasks within Option Period 2 
 Duration (months): 18 months  
 Budget: $ 7,296,268 

Activities during the Option Period 2 will include: 
  

	 	•	 	 Oral clinical Phase 1a SAD and 1b MAD studies 

  

	 	•	 	 Oral human BAL lung distribution study 

 Decision Gate Criteria: Successful completion of oral clinical Phase 1a SAD, Phase 1b MAD and oral human BAL lung distribution studies. 
 Deliverables: Monthly and annual technical progress reports, clinical study reports, other study and audit reports as needed, and FDA communications. 

Criteria for Exercising Option: Successful completion of oral IND enabling safety studies with adequate safety margin (in Base period).

 Non-severable tasks within Option Period 3 
 Duration (months): 15 months  
 Budget: $ 3,143,236 

Activities during the Option Period 3 will include: 
  

	 	•	 	 IV GLP IND enabling safety studies 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 38 - 

			
	Final Proposal (Revision #4) – 9/13/2011	 	ENANTA Pharmaceuticals, Inc

  

	 	•	 	 IV clinical protocol development 

  

	 	•	 	 IV IND preparation and reviews 

 Milestone: Successful completion of IV GLP IND enabling safety studies, IV clinical protocol development and IV IND preparation and reviews. 

Deliverables: Monthly and annual technical progress reports, and other study reports as needed. 

Criteria for Exercising Option: Successful completion of IV range finding safety studies with adequate safety margin (in Option 1)

 Non-severable tasks within Option Period 4 
 Duration (months): 34 months 
 Budget: $ 10,183,163 

Activities during the Option Period 4 will include: 
  

	 	•	 	 Humanization of NHP PK 

  

	 	•	 	 Discussion with the FDA regarding NHP efficacy studies with select agents for biodefense indications 

 

	 	•	 	 NHP efficacy studies for biodefense pathogens 

 Decision Gate Criteria: Successful completion NHP efficacy studies and demonstration of efficacy against one or more biodefense pathogens. 
 Deliverables: Monthly and annual technical progress reports, FDA communication, and efficacy study reports. 
 Criteria for Exercising Option: 1) Demonstrate efficacy in small animal models (mice, rats or rabbits) for biodefense pathogens (in Base period). 2) Demonstrate adequate safety and tolerability in
oral Phase 1a/1b studies (in Option 2) 
 Non-severable tasks within Option Period 5 

Duration (months): 27 months 

Budget: $ 827,085 
 Activities during the
Option Period 5 will include: 
  

	 	•	 	 IV drug product manufacturing 

  

	 	•	 	 24 months drug product stability study 

  

	 	•	 	 Submission of IV IND application to the FDA 

 Decision Gate Criteria: Successful completion of IV drug product manufacturing, IV IND submission and drug product stability. 
 Deliverables: Monthly and annual technical progress reports, FDA communication, and study reports. 
 Criteria for Exercising Option: Successful completion of IV IND enabling safety studies with adequate safety margin (in Option 3) 
 Non-severable tasks within Option Period 6 
 Duration (months): 12 months 

Budget: $ 5,057,348 
 Activities during
the Option Period 6 will include: 
  

	 	•	 	 V clinical Phase 1a SAD and 1b MAD studies 

 Decision Gate Criteria: Successful completion of IV Phase 1a SAD and 1b MAD studies 

Deliverables: Monthly and annual technical progress reports, FDA communications, and clinical study reports (Note: Clinical study
report (CSR) for Phase 1b will not be available until 2 months after the end of the funding period [No Cost Extension will be required] due to the NIAID requested delay in starting the IV clinical studies, to be initiated in Year 5). 

Criteria for Exercising Option: Successful completion of IV IND enabling safety studies with adequate safety margin (in Option 3). 

  

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

 - 39 -<![CDATA[Third Amended & Restated Registration Rights Agreement ]]>

 Exhibit 10.4 
 THIRD AMENDED AND RESTATED 
 REGISTRATION RIGHTS AGREEMENT 

THIS THIRD AMENDED AND RESTATED REGISTRATION RIGHTS AGREEMENT (this “Agreement”) is entered into as of August 23,
2012 by and among (i)Enanta Pharmaceuticals, Inc., a Delaware corporation (the “Corporation”), (ii) the investors listed on Schedule 1 attached hereto (the “Series C Investors”), (iii) the investors listed
on Schedule 2 attached hereto (the “Series D Investors”), (iv) the holders of Common Stock Purchase Warrants listed on Schedule 3 attached hereto (the “Warrant Holders”), (v) the investors listed on
Schedule 4 attached hereto (the “Series E Investors”), (vi) the investors listed on Schedule 5 attached hereto (the “Series F Investors”), and (vii) the investors listed on Schedule 6 attached hereto (the
“Series G Investors,” and together with the Series C Investors, the Series D Investors, the Warrant Holders, the Series E Investors, and the Series F Investors, the “Investors”). 

WHEREAS, the Corporation issued shares of its Series C Convertible Preferred Stock, par value $.01 per share (the “Series C
Preferred Stock”), to the Series C Investors pursuant to that certain Series C Convertible Preferred Stock Purchase Agreement, dated December 17, 1998, among the Corporation and the Series C Investors and in connection therewith the
Corporation and certain Series C Investors entered into a Registration Rights Agreement, dated December 17, 1998, as amended by an Amendment to Registration Rights Agreement dated September 10, 1999 by and among the Corporation, Phoenix
Leasing Incorporation, and certain Series C Investors (the “Original Registration Rights Agreement”); 

WHEREAS, the Corporation issued shares of its Series D Convertible Preferred Stock, par value $.01 per share (the “Series D
Preferred Stock”), to the Series D Investors pursuant to that certain Series D Convertible Preferred Stock Purchase Agreement, dated as of April 28, 2000, among the Corporation and the Series D Investors and in connection therewith the
Corporation and certain Series D Investors entered into an Amended and Restated Registration Rights Agreement dated April 28, 2000, as amended by Amendments No. 1, 2 and 3 to the Amended and Restated Registration Rights Agreement dated as of
August 1, 2000, February 5, 2001 and May 7, 2001, respectively (the “Prior Registration Rights Agreement”), which amended and restated and further amended (to include the Warrant Holders as parties) the Original
Registration Rights Agreement; 
 WHEREAS, the Corporation issued shares of its Series E Convertible Preferred Stock, par value
$.01 per share (the “Series E Preferred Stock”), to the Series E Investors pursuant to that certain Series E Convertible Preferred Stock Purchase Agreement, dated as of June 6, 2002, among the Corporation and the Series E
Investors and in connection therewith the Corporation and certain Series E Investors entered into an Second Amended and Restated Registration Rights Agreement dated June 6, 2002, as amended by Amendment No. 1 to the Second Amended and
Restated Registration Rights Agreement dated as of January 23, 2003 (the “Second Amended and Restated Registration Rights Agreement”), which amended and restated and further amended (to include the Warrant Holders as parties)
the Prior Registration Rights Agreement; 
 WHEREAS, the Corporation issued shares of its Series F Convertible Preferred Stock,
par value $.01 per share (the “Series F Preferred Stock”), to Series F Investors pursuant to that certain Series F Convertible Preferred Stock Purchase Agreement, dated as of June 18, 2004,

 
among the Corporation and the Series F Investors and in connection therewith the Corporation and certain Series F Investors entered into an Amendment No. 2 to the Second Amended and Restated
Registration Rights Agreement dated as of June 18, 2004 (the “Amendment No. 2”); 
 WHEREAS, the
Corporation issued shares of its Series G-1 Convertible Preferred Stock, par value $.01 per share (the “Series G-1 Preferred Stock”) and Series G-2 Convertible Preferred Stock, par value $.01 per share (the “Series G-2
Preferred Stock,” and together with the Series C Preferred Stock, the Series D Preferred Stock, the Series E Preferred Stock and the Series F Preferred Stock, the “Preferred Stock”), to the Series G Investors pursuant to
that certain Series G Convertible Preferred Stock Purchase Agreement, dated as of December 20, 2006, among the Corporation and the Series G Investors and in connection therewith the Corporation and certain Series G Investors entered into an
Amendment No. 3 to the Second Amended and Restated Registration Rights Agreement dated as of June 18, 2004 (the “Amendment No. 3,” and together with Amendment No. 2 and the Second Amended and Restated
Registration Rights Agreement, the “Existing Agreement”); 
 WHEREAS, the Corporation, the Investors and the
Warrant Holders wish to amend and restate the Existing Agreement and replace it in its entirety with the rights and obligations set forth in this Agreement. 
 NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Corporation, Investors and the Warrant Holders party hereto hereby completely and irrevocably waive any and all application of the Second Amended and Restated Registration Rights Agreement and agree that the Second Amended and Restated Registration
Rights Agreement is hereby amended and restated to read in its entirety as set forth in this Agreement, and such parties hereby further agree, as follows: 
 1. Definitions. As used in this Agreement, the following terms shall have the following meanings: 
 (a) The term “1934 Act” shall mean the Securities Exchange Act of 1934, as amended. 
 (b) The term “Holder” means any holder of Registrable Securities. 

(c) The term “Investor Rights Agreement” means the Amended and Restated Investor Rights Agreement, of even date
herewith, by and among the Corporation and the Investors listed therein, as the same may be amended, restated, supplemented or otherwise modified from time to time. 
 (d) The terms “register,” “registered,” and “registration” refer to a registration effected by preparing and filing a registration statement in
compliance with the Securities Act and the declaration or ordering of effectiveness of such registration statement. 
 (e) The
term “Registrable Securities” means: 
 (1) the Common Stock issued or issuable upon conversion of the
Series C Preferred Stock; 

  
 2 

 (2) the Common Stock issued or issuable upon conversion of the Series D
Preferred Stock; 
 (3) the Common Stock issued or issuable upon conversion of the Series E Preferred Stock,
including all of the shares of Common Stock issuable, upon conversion of the warrants to purchase shares of Series E Preferred Stock issued by the Corporation to Silicon Valley Bank dated December 2002; 

(4) the Common Stock issued or issuable upon conversion of the Series F Preferred Stock; 

(5) the Common Stock issued or issuable upon conversion of the Series G Preferred Stock; 

(6) any Common Stock purchased by a Series C Investor (or its permitted transferees) pursuant to Section 2 of the
Investor Rights Agreement (or Common Stock issuable with respect to other securities purchased thereunder); 

(7) any Common Stock purchased by a Series D Investor (or its permitted transferees) pursuant to Section 5 of the
Stock Restriction Agreement or Section 2 of the Investor Rights Agreement (or Common Stock issuable with respect to other securities purchased thereunder); 

(8) any Common Stock purchased by a Series E Investor (or its permitted transferees) pursuant to Section 5 of the
Stock Restriction Agreement or Section 2 of the Investor Rights Agreement (or Common Stock issuable with respect to other securities purchased thereunder); 

(9) any Common Stock of the Corporation issued as a dividend or other distribution with respect to, or in exchange or in
replacement of, such Series C Preferred Stock, Common Stock or other securities described in clauses (1) and (6) above; 
 (11) any Common Stock of the Corporation issued as a dividend or other distribution with respect to, or in exchange or in replacement of, such Series D Preferred Stock, Common Stock or other securities
described in clauses (2) and (7) above; 
 (12) any Common Stock of the Corporation issued as a
dividend or other distribution with respect to, or in exchange or in replacement of, such Series E Preferred Stock, Common Stock or other securities described in clauses (3) and (8) above; 

  
 3 

 (13) any Common Stock of the Corporation issued as a dividend or other
distribution with respect to, or in exchange or in replacement of, such Series F Preferred Stock, Common Stock or other securities described in clause (4) above; 

(14) any Common Stock of the Corporation issued as a dividend or other distribution with respect to, or in exchange or in
replacement of, such Series G Preferred Stock, Common Stock or other securities described in clause (5) above; 

provided, however, that any shares of the Corporation shall cease to be Registrable Securities at such time as the
Corporation’s obligations with respect to such shares pursuant to Sections 2, 3 and 11 of this Agreement terminate pursuant to the provisions of Section 12 of this Agreement. 

(f) The term “SEC” means the Securities and Exchange Commission. 

(g) The term “Securities Act” means the Securities Act of 1933, as amended. 

(h) The term “Series C Registrable Securities” means the Registrable Securities described in clauses (1), (6) and
(11) of Section 1(e) above. 
 (i) The term “Series D Registrable Securities” means the Registrable
Securities described in clauses (2), (7) and (12) of Section 1(e) above. 
 (j) The term “Series E
Registrable Securities” means the Registrable Securities described in clauses (3), (8) and (13) of Section 1(e) above. 
 (k) The term “Series F Registrable Securities” means the Registrable Securities described in clauses (4) and (14) of Section 1(e) above. 

(l) The term “Series G Registrable Securities” means the Registrable Securities described in clauses (5) and
(15) of Section 1(e) above. 
 (m) The term “Stock Restriction Agreement” means the Third Amended and
Restated Stock Restriction Agreement, of even date herewith, by and among the Corporation, the Founders and the Investors listed therein, as the same may be amended, restated, supplemented or otherwise modified from time to time. 

In addition, for purposes of all calculations and notices under this Agreement, and all other provisions of this Agreement where the
context permits, a holder of Preferred Stock shall be deemed the Holder of the Registrable Securities issuable upon conversion thereof, and such Preferred Stock shall be deemed outstanding Registrable Securities hereunder. Notwithstanding the
foregoing, nothing in this Agreement shall require the Corporation actually to register any shares of Preferred Stock. 

  
 4 

 2. Request for Registration. If at any time after the date six months after the
closing of the Corporation’s first public offering of securities, the Corporation shall receive a written request (specifying that it is being made pursuant to this Section 2) from one or more Holders (other than Silicon Valley Bank or its
permitted transferee) that hold, in the aggregate, at least fifty percent (50%) of the then outstanding Registrable Securities, that the Corporation file a registration statement under the Securities Act, or a similar document pursuant to any
other statute then in effect corresponding to the Securities Act, covering the registration of at least twenty percent (20%) of the then outstanding Registrable Securities or Registrable Securities the expected price to the public of which
equals or exceeds $10,000,000, then the Corporation shall promptly notify all other Holders of such request and shall use its best efforts to cause all Registrable Securities that Holders have requested be registered to be registered under the
Securities Act. 
 Notwithstanding the foregoing: (a) the Corporation shall not be obligated to effect a registration
pursuant to this Section 2 during the period starting with the date sixty (60) days prior to the Corporation’s estimated date of filing of, and ending on a date six (6) months following such estimated date of filing of a
registration statement pertaining to an underwritten public offering of securities for the account of the Corporation that the Holders are entitled to join under Section 3, provided that the Corporation is actively employing in good faith its
best efforts to cause such registration statement to become effective and that the Corporation’s estimate of the date of filing such registration statement is made in good faith; (b) if the Corporation shall furnish to the Holders a
certificate signed by the President of the Corporation stating that in the good faith judgment of the Board of Directors it would be seriously detrimental to the Corporation or its shareholders for a registration statement to be filed at such time,
then the Corporation’s obligation to use its best efforts to file a registration statement shall be deferred for a period not to exceed three (3) months; provided, however, that the Corporation may not use such right described in
this clause (b) more than once in any twelve month period; and (c) the Corporation may postpone a registration pursuant to this election for such period of time as may be required to permit the use of regular audited year-end financial
statements with supplemental short period figures for a period not exceeding three (3) months unless the Holders agree to bear the costs of any special audit. 
 The Corporation shall not be obligated to effect more than three (3) registrations pursuant to this Section 2. 
 3. Corporation Registration. Subject to Section 8 of this Agreement, if at any time the Corporation proposes to register, other than on Forms S-4 or S-8 or applicable successor forms
regardless of their designations, any of its Common Stock under the Securities Act in connection with the public offering of such securities for its own account or for the accounts of shareholders, solely for cash on a form that would also permit
the registration of the Registrable Securities, the Corporation shall, each such time, promptly give each Holder written notice of such determination. Upon the written request of any Holder given within thirty (30) days after giving of any such
notice by the Corporation, the Corporation shall, subject to the limitations set forth in Section 8(a), use its best efforts to cause to be registered under the Securities Act all of the Registrable Securities that each such Holder has
requested be registered. 

  
 5 

 4. Obligations of the Corporation. Whenever required under Section 2, 3, or 11
to use its best efforts to effect the registration of any Registrable Securities, the Corporation shall, as expeditiously as reasonably possible: 
 (a) Prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its best efforts to cause such registration statement to become and remain effective until
the distribution thereof has been completed; provided, however, that in connection with any proposed registration intended to permit an offering of any securities from time to time (i.e., a so-called “shelf registration”),
the Corporation shall in no event be obligated to cause any such registration to remain effective for more than one hundred eighty (180) days. 
 (b) Prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with
the provisions of the Securities Act with respect to the disposition of all securities covered by such registration statement. 

(c) Furnish to the Holders and the underwriters such numbers of copies of a prospectus, including a preliminary prospectus, in conformity
with the requirements of the Securities Act, and such other documents as they may reasonably request in order to facilitate the disposition of such Registrable Securities owned by them. 

(d) Use its best efforts to register and qualify the securities covered by such registration statement under such other securities or
Blue Sky laws of such jurisdictions as shall be reasonably appropriate for the distribution of the securities covered by the registration statement, provided that the Corporation shall not be required in connection therewith or as a condition
thereto to qualify to do business or to file a general consent to service of process in any such states or jurisdictions where it is not qualified to do business, and further provided that (anything in this Agreement to the contrary notwithstanding
with respect to the bearing of expenses) if any jurisdiction in which the securities shall be qualified shall require that expenses incurred in connection with the qualification of the securities in that jurisdiction be borne by selling
shareholders, then such expenses shall be payable by selling shareholders pro rata, to the extent required by such jurisdiction. 
 (e) Provide a transfer agent for the Common Stock no later than the effective date of the first registration of any Registrable Securities. 

(f) Otherwise use its best efforts to comply with all applicable rules and regulations of the SEC. 

(g) Use its best efforts either (i) to cause all such Registrable Securities to be listed on a national securities exchange (if such
securities are not already so listed) and on each additional national securities exchange on which similar securities issued by the Corporation are then listed, if the listing of such securities is then permitted under the rules of such exchange
and, without limiting the generality of the foregoing, to arrange for at least two (2) market makers to register as such with respect to Registrable Securities with the Financial Industry Regulatory Authority. 

  
 6 

 (h) Enter into such customary agreements (including an underwriting agreement in customary
form) and take such other actions as the selling Holders of Registrable Securities shall reasonably request in order to expedite or facilitate the disposition of such Registrable Securities. 

(i) Make available for inspection by any selling Holder of Registrable Securities, by any underwriter participating in any disposition to
be effected pursuant to such registration statement and by any attorney, accountant or other agent retained by any such selling Holder or any such underwriter, all pertinent financial and other records and pertinent corporate documents and
properties of the Corporation, and cause all of the Corporation’s officers, directors and employees to supply all information reasonably requested by any such selling Holder, underwriter, attorney, accountant or agent in connection with such
registration statement. 
 (j) Use every reasonable effort to prevent the issuance of any stop order suspending the
effectiveness of such registration statement or of any order preventing or suspending the use of any preliminary prospectus and, if any such order is issued, to obtain the lifting thereof at the earliest reasonable time and advise each selling
Holder, promptly after it shall receive notice or obtain knowledge thereof, of the issuance of any stop order suspending the effectiveness of such registration statement or the initiation or threatening of any proceeding for such purpose.

 (k) Make such representations and warranties to the selling Holders of Registrable Securities and the underwriters as are
customarily made by issuers to selling stockholders and underwriters, as the case may be, in primary underwritten public offerings. 
 (l) Immediately notify each Holder and each underwriter under such registration statement, at any time when a prospectus relating thereto is required to be delivered under the Securities Act, of the
happening of any event of which the Corporation has knowledge as a result of which the prospectus contained in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required
to be stated therein or necessary to make the statements therein not misleading in light of the circumstances then existing. 

(m) If the offering is underwritten and at the request of any Holder, use its best efforts to furnish on the date that Registrable
Securities are delivered to the underwriters for sale pursuant to such registration: (i) an opinion dated such date of counsel representing the Corporation for the purposes of such registration, addressed to the underwriters and to such seller,
covering such matters with respect to the Registration Statement, the prospectus and each amendment or supplement thereto, proceedings under state and federal securities laws, other matters relating to the Company, the securities being registered
and the offer and sale of such securities as are customarily the subject of opinions of issuer’s counsel provided to the underwriters in underwritten public offerings, and (ii) a letter dated such date from the independent public
accountants retained by the Corporation, addressed to the underwriters and to such seller, stating that they are independent public accountants within the meaning of the Securities Act and that, in the opinion of such accountants, the financial
statements of the Corporation included in the registration statement or the prospectus, or any amendment or supplement thereof, comply as to form in all material respects with the applicable accounting

  
 7 

 
requirements of the Securities Act, and such letter shall additionally cover such other financial matters (including information as to the period ending no more than five business days prior to
the date of such letter) with respect to such registration as such underwriters reasonably may request. 
 (n) Permit any Holder
of Registrable Securities, which Holder, based on the written advice of counsel reasonably satisfactory to the Company and its counsel, might be deemed to be a controlling person of the Corporation, to participate in good faith in the preparation of
such registration or comparable statement and to require the insertion therein of material, furnished to the Corporation in writing, which in the reasonable judgment of such holder and its counsel should be included, subject to review by the
Corporation and its counsel after consultation with such Holder. 
 5. Furnish Information. It shall be a condition
precedent to the obligations of the Corporation to take any action pursuant to this Agreement with respect to the registration of any Holder’s Registrable Securities that such Holder shall furnish to the Corporation such information regarding
such Holder, the Registrable Securities held by such Holder, and the intended method of disposition of such securities, as the Corporation shall reasonably request and as shall be required in connection with the action to be taken by the
Corporation. 
 6. Expenses of Demand Registration. All expenses incurred in connection with registrations pursuant to
Section 2 (excluding underwriters’ discounts and commissions), including, without limitation, all registration and qualification fees, printers’ and accounting fees, fees and disbursements of counsel for the Corporation, and the
reasonable fees and disbursements of one special counsel for the selling Holders, shall be borne by the Corporation. 
 7.
Corporation Registration Expenses. All expenses (excluding underwriters’ discounts and commissions) incurred in connection with a registration pursuant to Section 3, including, without limitation, any additional registration and
qualification fees and any additional fees and disbursements of counsel to the Corporation that result from the inclusion of securities held by the selling Holders in such registration and the reasonable fees and disbursements of one special counsel
for the selling Holders, shall be borne by the Corporation. 
 8. Underwriting Requirements. 

(a) In connection with any offering under Section 3 involving an underwriting of shares being issued by the Corporation, the
Corporation shall not be required to include any Holder’s Registrable Securities in such underwriting unless such Holder accepts the terms of the underwriting as agreed upon between the Corporation and the underwriters selected by it, and then
only in such quantity as will not, in the reasonable opinion of the underwriters, jeopardize the success of the offering by the Corporation. If the total amount of securities that all Holders request to be included in an underwritten offering under
Section 3 exceeds the amount of securities that the underwriters reasonably believe compatible with the success of the offering, no securities of any shareholder except Registrable Securities of Holders shall be included in such offering unless
all Registrable Securities which the Holders have requested to be included are included, and the Corporation shall only be required to include in the offering so many of the Registrable Securities of the Holders as the underwriters reasonably
believe will not jeopardize 

  
 8 

 
the success of the offering (the Registrable Securities so included to be apportioned pro rata among the selling Holders according to the total amount of Registrable Securities owned by such
selling Holders, or in such other proportions as shall mutually be agreed to by such selling Holders) ; provided, however, in no event may less than 20% of the total number of shares of Common Stock to be included in such underwriting be made
available for Registrable Securities. 
 (b) With respect to any underwriting of shares to be registered under Section 2,
or any underwriting of shares to be registered under Section 11, the selling Holders shall have the right to designate the managing underwriter or underwriters, subject to the consent of the Corporation, which consent shall not be unreasonably
withheld or delayed. If, in connection with any underwriting of shares to be registered under Section 2, in the opinion of the managing underwriter the inclusion of all of the Registrable Securities requested to be registered under
Section 2 would adversely affect the marketing of such shares, shares to be sold by the Holders of Registrable Securities shall be excluded only after any shares to be sold by the Corporation and any other holder of the Corporation’s
securities (other than the Holders) have been excluded, in such manner that the shares to be sold shall be allocated among the selling holders pro rata based on their ownership of Registrable Securities. In connection with any underwritings of
shares to be registered under Section 3, the Corporation shall have the right to designate the managing underwriter or underwriters. 
 9. Delay of Registration. Without the written approval of at least 50% of the Registrable Securities then outstanding (voting on a Common Stock equivalent basis), no Holder shall have any right to
take any action to restrain, enjoin, or otherwise delay any registration as the result of any controversy that might arise with respect to the interpretation or implementation of this Agreement. 

10. Indemnification. In the event any Registrable Securities are included in a registration statement under this Agreement:

 (a) To the extent permitted by law, the Corporation will indemnify and hold harmless each Holder requesting or joining in a
registration, any underwriter (as defined in the Securities Act) for it, and each person, if any, who controls any such Holder or underwriter within the meaning of the Securities Act, and any of their respective officers, directors and agents,
against any losses, claims, damages or liabilities, joint or several, to which they may become subject under the Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are
based on any untrue or alleged untrue statement of any material fact contained in such registration statement, including, without limitation, any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto,
or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the statements therein not misleading or arise out of any violation by the Corporation of any
rule or regulation promulgated under the Securities Act applicable to the Corporation and relating to action or inaction required of the Corporation in connection with any such registration, and will reimburse each such Holder, underwriter,
controlling person, officer, director and agent for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability, or action; provided, however, that the
indemnity agreement contained in this Section 10(a) shall not apply to amounts paid in settlement of any such loss, 

  
 9 

 
claim, damage, liability or action if such settlement is effected without the consent of the Corporation (which consent shall not be unreasonably withheld or delayed) nor shall the Corporation be
liable in any such case for any such loss, claim, damage, liability or action to the extent that it arises out of or is based upon an untrue statement or alleged untrue statement or omission or alleged omission made in connection with such
registration statement, preliminary prospectus, final prospectus, or amendments or supplements thereto, in reliance upon and in conformity with written information furnished expressly for use in connection with such registration by any such Holder,
underwriter, controlling person officer, director or agent. 
 (b) To the extent permitted by law, each Holder requesting or
joining in a registration will indemnify and hold harmless the Corporation, each of its directors, each of its officers who has signed the registration statement, each person, if any, who controls the Corporation within the meaning of the Securities
Act, and any underwriter for the Corporation (within the meaning of the Securities Act) against any losses, claims, damages or liabilities to which the Corporation or any such director, officer, controlling person or underwriter may become subject,
under the Securities Act or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereto) arise out of or are based upon any untrue statement or alleged untrue statement of any material fact contained in such
registration statement, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto, or arise out of or are based upon the omission or alleged omission to state therein a material fact required
to be stated therein or necessary to make the statements therein not misleading, in each case to the extent, but only to the extent, that such untrue statement or alleged untrue statement or omission or alleged omission was made in such registration
statement, preliminary prospectus or final prospectus, or amendments or supplements thereto, in reliance upon and in conformity with written information furnished by such Holder expressly for use in connection with such registration, and will
reimburse the Corporation or any such director, officer, controlling person or underwriter for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action;
provided, however, that the indemnity agreement contained in this Section 10(b) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of such
Holder (which consent shall not be unreasonably withheld or delayed) and provided further that no Holder shall have any liability under this Section 10(b) in excess of the net proceeds actually received by such Holder in the relevant public
offering. 
 Promptly after receipt by an indemnified party under this Section 10 of notice of the commencement of any
action, such indemnified party will, if a claim in respect thereof is to be made against any indemnifying party under this Section 10, notify the indemnifying party in writing of the commencement thereof and the indemnifying party shall have
the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume the defense thereof with counsel mutually satisfactory to the parties; provided,
however, that, if the defendants in any such action include both the indemnified party and the indemnifying party and the indemnified party shall have reasonably concluded that there may be reasonable defenses available to it which are different
from or additional to those available to the indemnifying party or if the interests of the indemnified party reasonably may be deemed to conflict with the interests of the indemnifying party, the indemnified party shall have the right to select a
separate counsel and to assume such 

  
 10 

 
legal defenses and otherwise to participate in the defense of such action, with the expenses and fees of such separate counsel and other expenses related to such participation to be reimbursed by
the indemnifying party as incurred. The failure to notify an indemnifying party promptly of the commencement of any such action shall not relieve it from any liability which it may have to such indemnified party other than under this Section 10
and shall only relieve it from any liability which it may have to such indemnified party under this Section 10 if and to the extent the indemnifying party is prejudiced by such omission. 

11. Registrations on Form S-3. 
 (a) If, at any time, (i) the Corporation shall receive a written request (specifying that it is being made pursuant to this Section 11) from one or more Holders that the Corporation file a
registration statement on Form S-3 (or any successor form to Form S-3 regardless of its designation) for a public offering of Registrable Securities the reasonably anticipated aggregate price to the public of which would exceed Two Million Dollars
($2,000,000), and (ii) the Corporation is a registrant entitled to use Form S-3 to register such shares, then the Corporation, each such time, shall use its best efforts to cause such shares to be registered on Form S-3 (or any successor form
to Form S-3). 
 (b) Expenses. All expenses (excluding underwriters’ discounts and commissions) incurred in
connection with a registration requested pursuant to Section 11(a), including, without limitation, all registration, qualification, printing, and accounting fees, and fees and disbursements of one special counsel to the selling Holders and
counsel to the Corporation, shall be borne by the Corporation for a maximum of two (2) such registrations per year. 
 (c)
The Holders’ rights to registration under this Section 11 are in addition to, and not in lieu of, their rights to registration under Sections 2 and 3 of this Agreement. 

12. Limitation on Corporation Offerings. The Corporation shall not register securities for sale for its own account or, except as
permitted by Section 14, any securities other than Registrable Securities, in any registration requested pursuant to Section 2 or 11 unless permitted to do so by the written consent of the Holders of more than two-thirds (2/3) of the
Registrable Securities as to which registration has been requested. The Corporation may not cause any other registration of securities for its own account (other than a registration effected solely to implement an employee benefit plan or on Form
S-4 or applicable successor form regardless of its designation) which would become effective less than six (6) months after the effective date of any registration requested pursuant to Section 2 or 11 to be initiated after receiving such
request. 
 The Corporation’s obligations pursuant to Sections 2, 3 and 11 shall terminate with respect to any holder of
Registrable Securities if all shares of Registrable Securities held by such holder have been sold pursuant to a registration statement or Rule 144 of the Securities Act or, in the case of any holder of Registrable Securities holding less than 50,000
shares of Registrable Securities, may be sold under Rule 144 of the Securities Act. 
 13. Reports Under Securities Exchange
Act of 1934. With a view to making available to the Holders the benefits of Rule 144 promulgated under the Securities Act and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Corporation to
the public without registration, the Corporation agrees to use its best efforts to: 
 (a) make and keep public information
available, as those terms are understood and defined in Rule 144, at all times subsequent to ninety (90) days after the effective date of the first registration statement covering an underwritten public offering filed by the Corporation;

  
 11 

 (b) file with the SEC in a timely manner all reports and other documents required of the
Corporation under the Securities Act and the 1934 Act; and 
 (c) furnish to any Holder forthwith upon request a written
statement by the Corporation that it has complied with the reporting requirements of Rule 144 (at any time after ninety (90) days after the effective date of said first registration statement filed by the Corporation), and of the Securities Act
and the 1934 Act (at any time after it has become subject to such reporting requirements), a copy of the most recent annual or quarterly report of the Corporation, and such other reports and documents so filed by the Corporation as may be reasonably
requested in availing any such Holder to take advantage of any rule or regulation of the SEC permitting the selling of any such securities without registration. 
 14. Limitations in Connection with Future Grants of Registration Rights. Without the prior written consent of the Holders of two-thirds in voting power of then outstanding Series C Registrable
Securities, Series D Registrable Securities, Series E Registrable Securities, Series F Registrable Securities and Series G Registrable Securities, voting together as a single class on a Common Stock equivalent basis, the Corporation shall not grant
rights to cause the Corporation to register any of its securities to any person or entity. 
 15. Transfer of Registration
Rights. The registration rights of any Holder (and of any permitted transferee of any Holder or its permitted transferees) under this Agreement with respect to any Registrable Securities may be transferred to any Affiliate of such Holder or such
permitted transferee, or to any transferee who acquires (otherwise than in a registered public offering) at least 200,000 shares of Registrable Securities held or acquired as of the date hereof by such Holder; provided, however, that the
Corporation is given written notice by the Holder at the time of such transfer stating the name and address of the transferee and identifying the securities with respect to which the rights under this Agreement are being assigned. For such purpose,
an “Affiliate” of any Holder (or any such transferee) means any general or limited partner of any Holder (or transferee), if a partnership, or any person or entity that, directly or indirectly, through one or more intermediaries,
controls, or is controlled by, or is under common control with, such Holder or transferee. 
 16. Mergers, Etc. The
Corporation shall not, directly or indirectly, enter into any merger, consolidation or reorganization in which the Corporation shall not be the surviving corporation unless the proposed surviving corporation shall, prior to such merger,
consolidation or reorganization, agree in writing to assume the obligations of the Corporation under this Agreement (except that any such surviving corporation shall not be obligated to undertake a registration of the Holders’ Registrable
Securities at any time before the date six months after the closing of such surviving corporation’s first public offering of securities), and for that purpose references hereunder to “Registrable Securities” shall be deemed to
be references to the 

  
 12 

 
securities which the Holders would be entitled to receive in exchange for Registrable Securities under any such merger, consolidation or reorganization; provided, however, that the
provisions of this Agreement shall not apply in the event of any merger, consolidation or reorganization in which the Corporation is not the surviving corporation if the Holders of Registrable Securities are entitled to receive in exchange therefor
(i) cash, or (ii) securities of the acquiring corporation which may be immediately sold to the public without registration under the Securities Act. 
 17. Stand-Off Agreement. Each Holder, if requested by the Corporation and the managing underwriter of an offering by the Corporation of Common Stock or other securities of the Corporation pursuant
to a registration statement under the Securities Act, shall agree not to sell publicly or otherwise transfer or dispose of any Registrable Securities or other securities of the Corporation held by such Holder for a specified period of time (not to
exceed 180 days) following the effective date of such registration statement; provided, that: 
 (a) such agreement shall apply
only to the first registration statement covering Common Stock to be sold on the Corporation’s behalf to the public in an underwritten offering; and 
 (b) all persons who hold shares of Common Stock, or securities convertible into or exchangeable or exercisable for shares of Common Stock, which in aggregate represent one percent (1%) or more of the
shares of Common Stock then outstanding, and all officers and directors of the Corporation, enter into similar agreements, which similar agreements shall prohibit the managing underwriter from releasing any shares subject thereto prior to the
scheduled expiration date of such agreements without the written consent of at least the same percentages of Holders that would be required to amend this Agreement or waive any provision hereof as set forth in Section 19(b) hereof. 

The covenant contained in this Section 17 is in addition to any market stand-off covenant contained in any other agreement between
the Corporation and any Holder. 
 18. Notices. All notices, requests, consents and other communications hereunder
(“Notices”) to any party shall be contained in a written instrument addressed to such party at the address set forth below or such other address as may hereafter be designated in writing by the addressee to the addressor listing all
parties and shall be deemed given (a) when delivered in person or duly sent by fax showing confirmation of receipt, (b) three days after being sent by first class mail postage prepaid (other than in the case of Notices to or from any
non-U.S. resident) or (c) two days after being sent by DHL, Federal Express or other recognized express international courier service: 
  

	 	(i)	if to the Corporation, to its address for Notices set forth in the Investor Rights Agreement; 

 

	 	(ii)	if to the Investors (or their transferees), to their respective addresses for Notices as set forth in the Investor Rights Agreement; and 

 

	 	(iii)	if to the Warrant Holders, to their respective addresses for Notices as set forth on Schedule 3 attached hereto. 

  
 13 

 19. Miscellaneous. 

(a) This Agreement states the entire agreement of the parties concerning the subject matter hereof, and supersedes all prior agreements,
written or oral, between or among them concerning such subject matter. 
 (b) This Agreement may be amended, and compliance with
any provision of this Agreement may be omitted or waived, only by the written agreement of the Corporation and the Holders of at least two-thirds in voting power of the then outstanding Series C Registrable Securities, Series D Registrable
Securities, Series E Registrable Securities, Series F Registrable Securities and Series G Registrable Securities, voting together as a single class on a Common Stock equivalent basis. 

(c) This Agreement shall be governed by, and construed and enforced in accordance with, the substantive laws of the Commonwealth of
Massachusetts, without regard to its principles of conflicts of laws. 
 (d) This Agreement may be executed in any number of
counterparts, each such counterpart shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement. Any such counterpart may contain one or more signature pages. 

(e) Wherever in this Agreement there is a reference to a specific number of shares of Common Stock, Preferred Stock or Registrable
Securities of the Corporation, then, upon the occurrence of any subdivision, combination or stock dividend of such class or series of stock, the specific number of shares so referenced in this Agreement shall automatically be proportionally adjusted
to reflect the affect on the outstanding shares of such class or series of stock by such subdivision, combination or stock dividend. 
 (f) All shares held or acquired by affiliated entities or persons shall be aggregated together for the purpose of determining the availability of any rights under this Agreement. 

[Remainder of page intentionally left blank.] 

  
 14 

 IN WITNESS WHEREOF, the parties have executed this Third Amended and Restated Registration
Rights Agreement as a contract under seal as of the date first written above. 
  

			
	ENANTA PHARMACEUTICALS, INC.
		
	By:	 	 /s/ Jay R. Luly

	Name:	 	Jay R. Luly
	Title:	 	President and Chief Executive Officer

 [Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series C Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series C Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	TVM MEDICAL VENTURES GMBH & CO. KG
		
	By:	 	 /s/ Mark G. Cipriano

	Name:	 	Mark G. Cipriano
	Title:	 	Authorized Signatory
		
	By:	 	 /s/ Dr. Helmut Schühsler

	Name:	 	Dr. Helmut Schühsler
	Title:	 	Managing Limited Partner

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series C Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series C Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	PRIVATE EQUITY HOLDING (CAYMAN) LTD.
		
	By:	 	 /s/ Gwendolyn McLaughlin

	Name:	 	Gwendolyn McLaughlin
	Title:	 	Director
		
	By:	 	 /s/ Rich Gorter

	Name:	 	Rich Gorter
	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series C Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series C Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	AP PRIVATE EQUITY INVESTMENTS III B.V.
	
	Represented by: AlpInvest Partners B.V., its managing Director
		
	By:	 	 /s/ E.M.J. Thyssen

	Name:	 	E.M.J. Thyssen
	Title:	 	Managing Partner
		
	By:	 	 /s/ P.F.F. de van der Schueren

	Name:	 	P.F.F. de van der Schueren
	Title:	 	Chief Legal Officer

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	ADVENT HEALTH CARE AND LIFE SCIENCES II LIMITED PARTNERSHIP
		
	By:	 	Advent International Limited Partnership, General Partner
			
		 	By:	 	Advent International Corporation,
		 		 	General Partner
			
		 	By:	 	 /s/ Jason S. Fisherman

		 		 	Name:  Jason S. Fisherman
		 		 	Title:    Attorney-in-Fact

  
 [Signature
Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

									
	ADVENT HEALTH CARE AND LIFE SCIENCES II BETEILIGUNG GMBH & CO. KG
		
	By:	 	Advent Health Care and Life Sciences II Beteiligung GmbH, General Partner
			
		 	By:	 	Advent International Limited Partnership, General Partner
				
		 		 	By:	 	Advent International Corporation, General Partner
					
		 		 		 	By:	 	 /s/ Jason S. Fisherman

		 		 		 	Name:	 	Jason S. Fisherman
		 		 		 	Title:	 	Attorney-in-Fact

  
 [Signature
Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	ADVENT PARTNERS HLS II LIMITED PARTNERSHIP
		
	By:	 	 Advent International Corporation,
 General Partner

			
		 	By:	 	 /s/ Jason S. Fisherman

		 	Name:	 	Jason S. Fisherman
		 	Title:	 	Attorney-in-Fact

  
 [Signature
Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	ADVENT PARTNERS LIMITED PARTNERSHIP
		
	By:	 	 Advent International Corporation,
 General Partner

			
		 	By:	 	 /s/ Jason S. Fisherman

		 	Name:	 	Jason S. Fisherman
		 	Title:	 	Attorney-in-Fact

  
 [Signature
Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	TVM MEDICAL VENTURES GMBH & CO. KG
		
	By:	 	 /s/ Mark G. Cipriano

	Name:	 	Mark G. Cipriano
	Title:	 	Authorized Signatory
		
	By:	 	 /s/ Dr. Helmut Schühsler

	Name:	 	Dr. Helmut Schühsler
	Title:	 	Managing Limited Partner

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	PRIVATE EQUITY HOLDING (CAYMAN) LTD.
		
	By:	 	 /s/ Gwendolyn McLaughlin

	Name:	 	Gwendolyn McLaughlin
	Title:	 	Director
		
	By:	 	 /s/ Rich Gorter

	Name:	 	Rich Gorter
	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	TVM IV GMBH & CO. KG
		
	By:	 	 /s/ Mark G. Cipriano

	Name:	 	Mark G. Cipriano
	Title:	 	Authorized Signatory
		
	By:	 	 /s/ Dr. Helmut Schühsler

	Name:	 	Dr. Helmut Schühsler
	Title:	 	Managing Limited Partner

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	AP PRIVATE EQUITY INVESTMENTS III B.V.
	
	Represented by: AlpInvest Partners B.V., its managing Director
		
	By:	 	 /s/ E.M.J. Thyssen

	Name:	 	E.M.J. Thyssen
	Title:	 	Managing Partner
		
	By:	 	 /s/ P.F.F. de van der Schueren

	Name:	 	P.F.F. de van der Schueren
	Title:	 	Chief Legal Officer

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	OBP III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	OBP (BERMUDA) III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	OBP (ADJUNCT) III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series D Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series D Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	mRNA – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

									
	ADVENT HEALTH CARE AND LIFE SCIENCES II BETEILIGUNG GMBH & CO. KG
		
	By:	 	Advent Health Care and Life Sciences II
		 	Beteiligung GmbH, General Partner
			
		 	By:	 	Advent International Limited Partnership,
		 		 	General Partner
				
		 		 	By:	 	Advent International Corporation,
		 		 		 	General Partner
					
		 		 		 	By:	 	 /s/ Jason S. Fisherman

		 		 		 	Name:	 	Jason S. Fisherman
		 		 		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

							
	ADVENT HEALTH CARE AND LIFE SCIENCES II LIMITED PARTNERSHIP
		
	By:	 	Advent International Limited Partnership,
		 	General Partner
			
		 	By:	 	Advent International Corporation,
		 		 	General Partner
			
		 	By:	 	 /s/ Jason S. Fisherman

		 		 	Name:	 	Jason S. Fisherman
		 		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	ADVENT PARTNERS HLS II LIMITED PARTNERSHIP
		
	By:	 	Advent International Corporation,
		 	General Partner
			
		 	By:	 	 /s/ Jason S. Fisherman

		 	Name:	 	Jason S. Fisherman
		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	ADVENT PARTNERS LIMITED PARTNERSHIP
		
	By:	 	Advent International Corporation,
		 	General Partner
			
		 	By:	 	 /s/ Jason S. Fisherman

		 	Name:	 	Jason S. Fisherman
		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	TVM IV GMBH & CO. KG
		
	By:	 	 /s/ Mark G. Cipriano

	Name:	 	Mark G. Cipriano
	Title:	 	Authorized Signatory
		
	By:	 	 /s/ Dr. Helmut Schühsler

	Name:	 	Dr. Helmut Schühsler
	Title:	 	Managing Limited Partner

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	TVM V LIFE SCIENCE VENTURES GMBH & CO. KG
		
	By:	 	 /s/ Mark G. Cipriano

	Name:	 	Mark G. Cipriano
	Title:	 	Authorized Signatory
		
	By:	 	 /s/ Dr. Helmut Schühsler

	Name:	 	Dr. Helmut Schühsler
	Title:	 	Managing Limited Partner

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	BIOVENTURES INVESTORS LIMITED PARTNERSHIP II
		
	By:	 	BioVentures Investors II, LLC,
		 	its General Partner
			
		 	By:	 	 /s/ Marc E. Goldberg

		 	Name:	 	Marc E. Goldberg
		 	Title:	 	Managing Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

					
	WHEATLEY MEDTECH PARTNERS, L.P.
		
	By:	 	Wheatley MedTech Partners, LLC,
		 	its General Partner
			
		 	By:	 	 /s/ Barry Rubenstein

		 	Name:	 	Barry Rubenstein
		 	Title:	 	CEO

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	PRIVATE EQUITY HOLDING (CAYMAN) LTD.
		
	By:	 	 /s/ Gwendolyn McLaughlin

	Name:	 	Gwendolyn McLaughlin
	Title:	 	Director
		
	By:	 	 /s/ Rich Gorter

	Name:	 	Rich Gorter
	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	PRIVATE EQUITY CO-FINANCE
		
	By:	 	 /s/ Gwendolyn McLaughlin

	Name:	 	Gwendolyn McLaughlin
	Title:	 	Director
		
	By:	 	 /s/ Rich Gorter

	Name:	 	Rich Gorter
	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	AP PRIVATE EQUITY INVESTMENTS III B.V.
	
	Represented by: AlpInvest Partners B.V., its managing Director
		
	By:	 	 /s/ E.M.J. Thyssen

	Name:	 	E.M.J. Thyssen
	Title:	 	Managing Partner
		
	By:	 	 /s/ P.F.F. de van der Schueren

	Name:	 	P.F.F. de van der Schueren
	Title:	 	Chief Legal Officer

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	OBP III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	OBP (BERMUDA) III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	OBP (ADJUNCT) III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	mRNA – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

							
	OMEGA FUND IV, L.P.
		
	By:	 	Omega Fund IV GP, L.P., its General Partner
			
		 	By:	 	Omega Fund IV GP Manager, Ltd.,
		 		 	Its General Partner
				
		 		 	By:	 	 /s/ Richard J. Lim

		 		 	Name:	 	Richard J. Lim
		 		 	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series E Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series E Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals, Inc.
and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the Registration
Rights Agreement. 
  

			
	HBM HEALTHCARE INVESTMENTS (CAYMAN) LTD.
		
	By:	 	 /s/ John Arnold

	Name:	 	John Arnold
	Title:	 	Chairman and Managing Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

									
	ADVENT HEALTH CARE AND LIFE SCIENCES II BETEILIGUNG GMBH & CO. KG
		
	By:	 	Advent Health Care and Life Sciences II
		 	Beteiligung GmbH, General Partner
			
		 	By:	 	Advent International Limited Partnership,
		 		 	General Partner
				
		 		 	By:	 	Advent International Corporation,
		 		 		 	General Partner
					
		 		 		 	By:	 	 /s/ Jason S. Fisherman

		 		 		 	Name:	 	Jason S. Fisherman
		 		 		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

							
	ADVENT HEALTH CARE AND LIFE SCIENCES II LIMITED PARTNERSHIP
		
	By:	 	Advent International Limited Partnership,
		 	General Partner
			
		 	By:	 	Advent International Corporation,
		 		 	General Partner
				
		 		 	By:	 	 /s/ Jason S. Fisherman

		 		 	Name:	 	Jason S. Fisherman
		 		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

					
	ADVENT PARTNERS HLS II LIMITED PARTNERSHIP
		
	By:	 	Advent International Corporation,
		 	General Partner
			
		 	By:	 	 /s/ Jason S. Fisherman

		 	Name:	 	Jason S. Fisherman
		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

					
	ADVENT PARTNERS LIMITED PARTNERSHIP
		
	By:	 	Advent International Corporation,
		 	General Partner
			
		 	By:	 	 /s/ Jason S. Fisherman

		 	Name:	 	Jason S. Fisherman
		 	Title:	 	Attorney-in-Fact

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	AP PRIVATE EQUITY INVESTMENTS III B.V.
	
	Represented by: AlpInvest Partners B.V., its managing Director
		
	By:	 	 /s/ E.M.J. Thyssen

	Name:	 	E.M.J. Thyssen
	Title:	 	Managing Partner
		
	By:	 	 /s/ P.F.F. de van der Schueren

	Name:	 	P.F.F. de van der Schueren
	Title:	 	Chief Legal Officer

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

					
	BIOVENTURES INVESTORS LIMITED PARTNERSHIP II
		
	By:	 	BioVentures Investors II, LLC,
		 	its General Partner
			
		 	By:	 	 /s/ Marc E. Goldberg

		 	Name:	 	Marc E. Goldberg
		 	Title:	 	Managing Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	PRIVATE EQUITY HOLDING (CAYMAN) LTD.
		
	By:	 	 /s/ Gwendolyn McLaughlin

	Name:	 	Gwendolyn McLaughlin
	Title:	 	Director
		
	By:	 	 /s/ Rich Gorter

	Name:	 	Rich Gorter
	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	TVM V LIFE SCIENCE VENTURES GMBH & CO. KG
		
	By:	 	 /s/ Mark G. Cipriano

	Name:	 	Mark G. Cipriano
	Title:	 	Authorized Signatory
		
	By:	 	 /s/ Dr. Helmut Schühsler

	Name:	 	Dr. Helmut Schühsler
	Title:	 	Managing Limited Partner

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

					
	WHEATLEY MEDTECH PARTNERS, L.P.
		
	By:	 	Wheatley MedTech Partners, LLC,
		 	its General Partner
			
		 	By:	 	 /s/ Barry Rubenstein

		 	Name:	 	Barry Rubenstein
		 	Title:	 	CEO

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	OBP III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	OBP (BERMUDA) III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	OBP (ADJUNCT) III – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	mRNA – HOLDINGS LLC
		
	By:	 	 /s/ Scott Halsted

	Name:	 	Scott Halsted
	Title:	 	Managing Member

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement 
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

							
	OMEGA FUND IV, L.P.
		
	By:	 	Omega Fund IV GP, L.P., its General Partner
			
		 	By:	 	Omega Fund IV GP Manager, Ltd.,
		 		 	Its General Partner
				
		 		 	By:	 	 /s/ Richard J. Lim

		 		 	Name:	 	Richard J. Lim
		 		 	Title:	 	Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Enanta Pharmaceuticals, Inc. 

Third Amended and Restated Registration Rights Agreement  
 Series G-2 Investor Signature Page 
 By executing this page in the space
provided, the undersigned hereby agrees (i) that it is a “Series G-2 Investor” as defined in the Third Amended and Restated Registration Rights Agreement dated as of August 23, 2012, by and among Enanta Pharmaceuticals,
Inc. and the parties named therein (the “Registration Rights Agreement”), (ii) that it is a party to the Registration Rights Agreement for all purposes and (iii) that it is bound by all terms and conditions of the
Registration Rights Agreement. 
  

			
	HBM HEALTHCARE INVESTMENTS (CAYMAN) LTD.
		
	By:	 	 /s/ John Arnold

	Name:	 	John Arnold
	Title:	 	Chairman and Managing Director

  

[Signature Page to Third A&R Registration Rights Agreement] 

 Schedule 1 
 Series C Investors 
 TVM Medical Ventures GmbH & Co. KG 

KB Lux Venture Capital Fund-Biotechnology 

Ernst Günter Afting 
 John Fried

 HEH Investment Partners, LP 
 Karl
M. Kliem 
 Peter O. Kliem 
 W.J.
McCune Jr. 
 Private Equity Holding (Cayman) Ltd. 
 Dr. Jochen Mackenrodt 
 Erik Hornnaess 
 AP Private Equity Investments III B.V. 

 Schedule 2 
 Series D Investors 
 Advent Health Care and Life Sciences II Limited Partnership

 Advent Health Care and Life Sciences II Beteiligung GmbH & Co. KG 
 Advent Partners HLS II Limited Partnership 
 Advent Partners Limited Partnership 

Lancet Capital Health Ventures L.P. 
 TVM
Medical Ventures GmbH & Co. KG 
 TVM IV GmbH & Co. KG 
 Private Equity Holding (Cayman) Ltd. 
 KB Lux Venture Capital Fund – Biotechnology

 Tsvetelina Lazarova 
 Peter O.
Kliem 
 Philip Eaton 
 Erik Hornnaess

 AP Private Equity Investments III B.V. 
 OBP III – Holdings LLC 
 OBP (Bermuda) III – Holdings LLC 

OBP (Adjunct) III – Holdings LLC 
 mRNA
– Holdings LLC 

 Schedule 3 
 Warrant Holders 
 Silicon Valley Bank 

40 William Street 
 Wellesley, MA 02481

 Attn: Ms. Melissa Stepanis, Assistant Vice President 
 Fax: (781) 431-9906 

 Schedule 4 
 Series E Investors 
 Advent Health Care and Life Sciences II Limited Partnership

 Advent Health Care and Life Sciences II Beteiligung GmbH & Co. KG 
 Advent Partners HLS II Limited Partnership 
 Advent Partners Limited Partnership 

Lancet Capital Health Ventures, L.P. 
 Private
Equity Co-Finance 
 TVM IV GmbH & Co. KG 
 TVM V Life Science Ventures GmbH & Co. KG 
 BioVentures Investors Limited Partnership II

 Private Equity Holding (Cayman) Ltd. 
 Wheatley MedTech Partners, L.P. 
 Ernst Günter Afting 

Erik Hornnaess 
 Karl M. Kliem 

Peter O. Kliem 
 Dr. Jochen Mackenrodt

 HBM Healthcare Investments (Cayman) Ltd. 
 AP Private Equity Investments III B.V. 
 OBP III – Holdings LLC 

OBP (Bermuda) III – Holdings LLC 
 OBP
(Adjunct) III – Holdings LLC 
 mRNA – Holdings LLC 
 Omega Fund IV, L.P. 

 Schedule 5 
 Series F Investors 
 Shionogi & Co., Ltd. 

1-8, Doshomachi 3-chome 
 Chuo-ku, Osaka 541-0045
Japan 
 Fax: (81) 6-6202-0886 

Attn: Masaharu Mori, General Manager, License Dept. 

 Schedule 6 
 Series G-1 Investors 
 Abbott Laboratories 

Series G-2 Investors 

Advent Health Care and Life Sciences II Limited Partnership 
 Advent Health Care and Life Sciences II Beteiligung GmbH & Co. KG 
 Advent Partners HLS
II Limited Partnership 
 Advent Partners Limited Partnership 
 AP Private Equity Investments III B.V. 
 BioVentures Investors Limited Partnership II 

HBM Healthcare Investments (Cayman) Ltd. 

Private Equity Holding (Cayman) Ltd. 
 TVM V
Life Sciences Ventures GmbH & Co. KG 
 Wheatley MedTech Partners, L.P. 
 ReMY Capital Partners III, L.P. 
 Ernst Günter Afting, M.D., Ph.D. 

Karl M. Kliem 
 Peter O. Kliem 

Dr. Jochen Mackenrodt 
 OBP III –
Holdings LLC 
 OBP (Bermuda) III – Holdings LLC 
 OBP (Adjunct) III – Holdings LLC 
 mRNA – Holdings LLC 

Omega Fund IV, L.P.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00209-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00209-of-00352.parquet"}]]