Document:

EX-10.7H

 Exhibit 10.7H 
  

 
 AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 CONTRACT ID CODE PAGE OF PAGE 1 31 2 AMENDMENT/MODIFICATION NO. 0009 3 EFFECTIVE
DATE See Block 16C 4 REQUISITION/PURCHASE REQ NO O5018975 5 PROJECT NO (If applicable) 6 ISSUED BY CODE ASPR-BARDA 7 ADMINISTERED BY (If other than Item 6) CODE ASPR-BARDA ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201
ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 8 NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X) 9A AMENDMENT OF SOLICITATION NO ACHAOGEN, INC. 1361331 ACHAOGEN, INC. 7000 SHORELINE 7000 SHORELINE
CT STE 371 SOUTH SAN FRANCISCO CA 940801957 9B DATED (SEE ITEM 11) X 10A MODIFICATION OF CONTRACT/ORDER NO HHSO100201000046C CODE 1361331 FACILITY CODE 10B DATED (SEE ITEM 13) 09/01/2010 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The
above numbered solicitation Is amended as set forth In Item 14. The hour and date specified for receipt of Offers is extended is not extended Offers must acknowledge receipt of this amendment prior to the hour and date specified In the solicitation
or as amended, by one of the following methods: (a) By completing Items 8 end 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which
Includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue
of this amendment you desire to change an offer already submitted. such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment. and Is received prior to the opening hour and
date specified 12 ACCOUNTING AND APPROPRIATION DATA (If required) Net Increase: $60,410.398.00 2013.1992002.25106 13 THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE A
THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A. B THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in
paying office, appropriation date. etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR 43 103(b) C THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF X D OTHER (Specify type of modification and authority Bilateral: Mutual
Agreement of the Parties and FAR Clause 52.217-7 E IMPORTANT: Contractor is not is required to sign this document and return 1 copies to the Issuing office 14 DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings. Including
solicitation/contract subject matter where feasible) Tax ID Number: 68-0533693 DUNS Number: 167293153 A. The purpose of this modification is to exercise Option 2 under CLIN 0003 of the contract in the amount of: Total Estimated Cost: [***] Total
Fixed Fee: [***] Total Estimated Cost Plus Fixed Fee: $60,410,398.00 The total period of performance of Option 2 CLIN 0003 under the contract is from 1 May 2013 through 15 November 2017. Continued ... Except as provided herein, all terms and
conditions of the document referenced In Item 9A or 10A, as heretofore changed, remains unchanged and In full force and effect 15A NAME AND TITLE OF SIGNER (Type or print) Kenneth Hillan, Chief Executive Officer 16A NAME AND TITLE OF CONTRACTING
OFFICER (Type or print) ETHAN J. MUELLER 15B CONTRACTOR/OFFICER (Signature of person authorized to sign) 15C DATE SIGNED 4/19/2013 16B UNITED STATES OF AMERICA (Signature of Contracting Officer) 16C DATE SIGNED NSN 7540-01-152-8070 Previous edition
unusable STANDARD FORM 30 (REV. 10-83) Prescribed by GSA FAR (48 CFR) 53.243 

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

					
	CONTINUATION SHEET	 	REFERENCE NO DOCUMENT BEING CONTINUED	  	PAGE OF
		 	HHSO100201000046C/0009	  	2    |    31
	
	 NAME OF OFFEROR OR CONTRACTOR

ACHAOGEN, INC. 1361331

  

													
	 ITEM NO.
(A)
	  	 SUPPLIES/SERVICES
(B)
	  	 QUANTITY
(C)
	  	 UNIT
(D)
	  	 UNIT PRICE
(E)
	  	 AMOUNT
(F)

		  	 1. This modification hereby results in an increase in the total amount of the contract from $43,397,995.00 by $60,410,398.00 to
$103,808,293.00 as well as the following:
  
 Total Estimated Cost of the Contract: From
[***]
  
 The Total Fixed Fee of the Contract will [***].

 
 Total Estimated Cost Plus Fixed Fee of the Contract: From $43,397,995.00 By $60,410,398.00
To $103,808,393.00
  
 2. In Block 14 of the SF 26, the following CAN Number is added:

 
 CAN # - 1992002: FY 13 $60,410,398.00

 
  
 3. This bilateral
modification and Option 2/CLIN 0003 exercise will result in the addition of a Phase 3 Clinical Study to replace a Phase 2 Clinical Study that is no longer needed in Option 2/CLIN 0003. In addition, several Non-Clinical animal study protocols will be
finalized under and regulatory documentation requirements will also be added to Option 2/CLIN 0003. This bilateral modification will also add some additional Non-Clinical studies and regulatory documentation requirements to Option 3/CLIN 0004. This
will result in no change to the total amount and no change to the period of performance to Option 3/CLIN 0004. All SOW changes to Option 2/CLIN 0003 and Option 3/CLIN 0004 are based on FDA guidance and have been determined to be within the general
scope of the contract. As a result, Under Part III—LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J LIST - OF ATTACHMENTS, Attachment 1, Statement of Work, dated 14 September 2012 is hereby
deleted and replaced with the attached Statement of Work dated 21 March 2013.
  
 4. The
incorporation of the attached Statement of Work (SOW) changes in the paragraph above also result in the incorporation of the attached changes into the contract into both the 1. Other Contract Deliverables and the Contract Milestones and Go/No Go
Decision Gates for Base and Option CLINs under Article F.2. Reporting Requirements and Deliverables.
  
  

5. Under Article B.4. PROVISIONS APPLICABLE TO DIRECT COSTS, b. Travel Costs, 1. Domestic Travel, a. is deleted and replaced with tie following:

 
 a. Total expenditures for domestic travel (transportation, lodging, subsistence, and
incidental expenses) incurred in direct performance of this contract shall not exceed [***] during the base period [***] and [***] during Option Period 1 [***] and [***] during Option Period 2 [***] (without the prior written approval of the
Contracting Officer via a Contracting Officer Authorization CO; Letter).
  
 6. This
modification does not change the total amount of the base period/CLIN 0001 and does not change the total amount of Option 1/C IN 0002. The period of performance for both the base period/CLIN 0001 and Option/CLIN 0002 also remain

 
 Continued ...
	  		  		  		  	
				
	NSN 7540-01-152-8067	  		  		  	 OPTIONAL FORM 336 (4-86)

Sponsored by GSA
 FAR (489 CFR) 53
110

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

					
	CONTINUATION SHEET        	 	Reference no document being continued	 	PAGE OF
		 	HHSO100201000046C/0009	 	3    |    31
		
	 NAME OF OFFEROR OR CONTRACTOR

ACHAOGEN, INC. 1361331
	 	

  

											
	 ITEM NO.
(A)
	  	 SUPPLIES/SERVICES
(B)
	  	 QUANTITY
(C)
	  	 UNIT
(D)
	  	 UNIT PRICE
(E)
	  	 AMOUNT
(F)

		  	 unchanged. This modification does not authorize any efforts or performance under Option 3/CLIN 0004.

 
 7. In Section I - Contract Clauses, under Article I.1, the following FAR Clause is hereby
added: FAR Clause 52.247-63 Preference for U.S. Flag Air Carriers (June 2003).
  
 8.
Under Part III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J - LIST OF ATTACHMENTS, Attachment 9, Non Clinical and Clinical Terms of Award, dated 29 July 2010, the section in Attachment 9 relating to Clinical Terms of Award is
hereby deleted and replaced with the attached Clinical Terms of Award document.
  
 9. The
first and second sentences in Article G.7. INDIRECT COST RATES of Contract Number HHS0100201000046C are hereby deleted and replaced with the following:
  

The following indirect rates will be utilized for billing purposes during the base period/CLIN 0001 ONLY. For 2010, [***]. For 2011, [***]. For both 2010 and
2011, [***]. The 2010 and 2011 [***]. The following indirect rates will be utilized for billing purposes during Option 1/CLIN 0002 and Option 2/CLIN 0003 ONLY. [***].
  

B. All other terms and conditions of the contract remain unchanged.
  

Delivery: 11/15/2017
  

Delivery Location Code: HHS HHS
  

200 Independence Avenue, SW Washington DC 20201 US
  

Appr. Yr.: 2013 CAN: 1992002 Object Class: 25106
 FOB:
Destination
 Period of Performance: 09/19/2010 to 11/15/2017
  

Change Item 3 to read as follows(amount shown is the obligated amount):
  
	  		  		  		  	
	3	  	 Option Period 2: Stage 2 Non-clinical studies, Phase 3 Clinical Study.

Obligated Amount: $60,410,398.00
	  		  		  		  	60,410,398.00
				
	NSN 7540-01-152-8067	  		  		  	 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (489 CFR) 53 110

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

 BAA BARDA-09-34 

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

Nuclear Medical Countermeasures 

ACHN-490: A NOVEL, BROAD SPRECTRUM “NEOGLYCOSIDE” 

ANTIBIOTIC FOR THE TREATMENT OF RESISTANT THREAT AGENTS 

Contractual Statement of Work 
 1.
Preamble 
 Independently and not as an agency of the Government, the Contractor shall be required to furnish all the necessary services, qualified
personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to the Broad Agency Announcement (BAA) BARDA 09- 34. 

Government reserves the right to modify the milestones, progress, schedule, budget, or product to add or delete products, process, or schedules as need may
arise. Because of the nature of this (R&D) contract and complexities inherent in this and prior programs, at designated milestones the Government will evaluate whether work should be redirected, removed, or whether schedule or budget adjustments
should be made. The Government reserves the right to change product, process, schedule, or events to add or delete part or all of these elements as the need arises. 

1.1 Overall Objectives and Scope 
 The overall
objective of this contract is to advance the development of ACHN-490 [also called Plazomicin since 2011] as a broad-spectrum therapeutic in an injectable formulation for the treatment of bacterial threat agent infection, including Y. pestis and
F. tularenisis or others, as directed by BARDA. The scope of work for this contract includes preclinical, clinical and manufacturing development activities that fall into the following areas: [***]; and all associated regulatory, quality
assurance, management, and administrative activities. 
 2. INTEGRATED PRODUCT DEVELOPMENT PLAN 

The contractor shall carry out the following tasks and subtasks, by stage, and in accordance with an agreed upon Integrated Product Development Plan (IPDP)
which shall further detail the conduct of the specific tasks and subtasks. 
 2.1. [***] 

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

 [***] 

  

	[***]	2 pages in this document have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

 [***]. 
  

	2.5	Project Management. The Contractor shall provide for the following as outlined below and in the contract deliverables list (reference): 

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

 2.5.1 The overall management, integration and coordination of all contract activities, including
a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities; 

2.5.2 A Principal Investigator (PI) responsible for project management, communication, tracking, monitoring and reporting on status and
progress, and recommending modification to the project requirements and timelines, including projects undertaken by subcontractors; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this
contract 
 2.5.3 Project Manager(s) with responsibility for monitoring and tracking day-to-day progress and timelines, coordinating
communication and project activities; costs incurred; and program management; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract 

2.5.4 A BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer. 

2.5.5 Administrative and legal staff to provide development of compliant subcontracts, consulting, and other legal agreements, and ensure
timely acquisition of all proprietary rights, including IP rights, and reporting all inventions made in the performance of the project; and 

2.5.6 Administrative staff with responsibility for financial management and reporting on all activities conducted by the Contractor and any
subcontractors. 
 2.5.7 Integrated Master Plan: The Contractor provided an Integrated Master Project Plan (including tabular and Gantt
forms) to BARDA that clearly indicates the critical path. The Integrated Master Project Plan shall be incorporated into the contract, and will be used to monitor performance of the contract. 

2.5.8 Critical Path Milestones: The Integrated Master Project Plan outlines key, critical path milestones, with “go/no go” decision
criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions. 

2.5.9 Work Breakdown Structure: The Contractor shall delineate the Contract Work Breakdown Structure (CWBS) to Level 5 as part of their
Integrated Master Project Plan. The CWBS shall follow a BARDA supplied structure to Level 3. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with
the task. 
 2.5.10 Risk Management Plan: The Contractor shall develop a risk management plan highlighting potential problems and/or issues
that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant WBS elements where appropriate. 

2.5.11 Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of
Earned Value Management System (EVMS) in the management of this contract. The Seven Principles are: 
  

	 	I.	Plan all work scope for the program to completion. 

  

	 	II.	Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives. 

 

	 	III.	Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline. 

 

	 	IV.	Use actual cost incurred and recorded in accomplishing the work performed. 

  

	 	V.	Objectively assess accomplishments at the work performance level. 

  

	 	VI.	Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed. 

	 	VII.	Use earned value information in the company’s management processes. 

 Elements of EVMS
shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements to
include the following topics: 
 2.5.12 Integrated Baseline Review: The Contractor shall submit a plan for an Integrated Baseline Review
(IBR) to occur within 90 days of contract award. At the IBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring
and reporting progress throughout the life of the contract. The IBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and
logically planned, and have adequate resources assigned. The goals of the IBR are as follows: 
  

	 	i.	Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks 

 

	 	ii.	Confirm the integrity of the Performance Measurement Baseline (PMB) 

  

	 	iii.	Foster the use of EVM as a means of communication 

  

	 	iv.	Provide confidence in the validity of Contractor reporting 

  

	 	v.	Identify risks associated with the PMB 

  

	 	vi.	Present any revised PMBs for approval 

 2.5.13 Integrated Master Schedule: The Contractor shall
deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at
the IBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/). 
 2.5.14 Monthly Performance
Metrics Report: The Contractor shall deliver an Earned Value Contract Performance Report on a Monthly basis. Contractor will provide a monthly Contract Performance Report (CPR) at an agreed upon reporting level using the BARDA provided WBS and a
Variance Analysis Report. Contractor will report EVM data on all CLINs. EV Variance thresholds will be +/- 10%. In conjunction with the CPR, the Contractor shall provide a quarterly update to the IMS with up to date performance data and should
include actual start/finish and projected start/finish dates. 
 2.6 Regulatory Compliance. The Contractor shall manage the ACHN-490 IND and shall be
responsible for: 
 2.6.1 Preparing materials for and requesting, scheduling and participating in all meetings with the FDA and other
global regulatory agencies, including meetings to review IND, EUA and/or all other data packages; 
 2.6.2 Providing the dates and times of
any meeting with the FDA and other global regulatory agencies to BARDA and make arrangements for appropriate BARDA staff to attend FDA meetings; 

2.6.3 Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft
minutes of any informal meeting with the FDA and other global regulatory agencies; and (iii) five business days to review and comment upon any documents to be submitted to the FDA; and 

2.6.4 Submitting all documentation to the FDA and other global regulatory agencies in a timely manner, consistent with timelines set out in the
contract and by the FDA and other global regulatory agencies. 
 2.7 Quality Assurance. The Contractor shall: 

2.7.1 Provide any relevant SOPs upon request from Project Officer/Contracting Officer; 

2.7.2 Ensure strict adherence to FDA regulations and guidance, including requirements for the conduct of animal studies and assays under GLP,
the manufacturing of the therapeutic candidate under cGMP, and the 

 
conduct of clinical trials under GCP standards (as defined by 21 CFR §312 and ICH Guidelines document E6). The Contractor shall maintain quality assurance documentation of support adherence
in these areas; and 
 2.7.3 Arrange for independent audits, as needed or as requested by the Project Officer. Audits may be requested to
assure that Contractor and/or subcontractor facilities and all planned procedures meet FDA regulations and guidance required for GLP, cGMP and GCP standards. In addition, the Contractor shall provide interim and final audit reports to the Project
Office and the Contracting Officer within thirty (30) calendar days of the completion of the audit. The Contractor agrees that BARDA may conduct independent audits of the Contractor and its subcontractors as needed to evaluate compliance with
the FDA regulations and guidance, including those required to meet GLP, cGMP or GCP standards. 
 2.8 Facilities, Equipment and Other Resources. The
Contractor shall provide equipment, facilities and other resources required for the implementation of the IPDP, such as the equipment and facilities, training and resources to comply with all Federal and HHS regulations in: 

2.8.1 The humane care and use of vertebrate animals; 

2.8.2 The handling, storage and shipping of potentially dangerous biological and chemical agents, including Select agents under biosafety
levels required for working with the biological agents under study; 
 2.8.3 The production, characterization, and release testing of active
pharmaceutical ingredient and final drug product under cGMP; 
 2.8.4 The design and conduct of NDA-enabling non-clinical studies under GLP;
and 
 2.8.5 The design and conduct of clinical trials in humans under GCP. 

2.9 Security. The contractor shall provide for: 

2.9.1 The establishment of a comprehensive security program that provides a security plan for the overall protection of personnel, information,
data, and facilities; 
 2.9.2 Security administration, as an element of the security program that addresses threat and risk assessments and
related policies and procedures for personnel security, physical security, information security, information technology; and 
 2.9.3
Security management, as an element of the security program that describes each element of security: physical, operations, personnel, information, information technology, transportation; and related training, auditing, and reporting requirements.

 2.10 Data Management. The Contractor shall: 

2.10.1 Be responsible for the development and implementation of data management and quality control systems/procedures, including transmission,
storage, confidentiality, and retrieval of all contract data; 
 2.10.2 Provide for the statistical design and analysis of data resulting
from the research; 
 2.10.3 Provide raw data or specific analyses of data generated with contract funding to the Project Officer upon
request. 
 2.11 Requirements for Implementing the Integrated Product Development Plan. 

2.11.1 Within 14 calendar days of the effective date of the contract, the Contractor shall submit an updated Integrated Product Development
Plan (IPDP) to the Project Officer and the Contracting Officer for approval prior to the initiation of any activities related to the implementation of these plans. 

 2.10.2 Stage Gate Reporting. On completion of a stage of the product development, as defined in
the approved IPDP, the Contractor shall prepare and submit to the Project Officer and the Contracting Officer a Stage Gate Report that contains (i) sufficient detail, documentation and analysis to support successful completion of the stage
according to the predetermined qualitative and quantitative criteria that were established for Go/No Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to
the next stage of product development. 
 2.10.3 Deviations to Integrated Product Development Plan. During the course of contract
performance, in response to a need to change the IPDP, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IPDP and timelines. This report shall include: (i) discussion of the
justification/rationale for the proposed change; (ii) options for addressing the needed changes from the approved timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes
a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget. 
 3. Other Items 

3.1 Contract Review Meetings. The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the
Contracting and Project Officers. Such meetings may include, but are not limited to, meeting of the Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing
development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and
meeting with technical consultants to discuss technical data provided by the Contractor. 
 The Contractor shall participate in bi-weekly
teleconferences between the Contractor and subcontractors and BARDA to review technical progress. Teleconferences or additional face-to-face meetings shall be more frequent at the request of BARDA. 

3.2 Publications. The Contractor shall submit to the Project Officer for review any manuscript or scientific meeting abstract containing data generated
under this contract no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days before abstract submission for public presentation or publication. The Contractor shall acknowledge contract support in all such
publications. 
 3.3 Press Releases. Press releases shall be considered to include the public release of information to any medium, excluding
peer-reviewed scientific publications. The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The contractor shall ensure that the Project Officer 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. 

 F.2. REPORTING REQUIREMENTS AND DELIVERABLES 

1. Other Contract Deliverables 
  

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

	1.	 	Project Meeting	 	Bi-Weekly or as amended by CO and PO	 	The Contractor shall participate in bi-weekly teleconferences with BARDA to discuss the performance of the contract. The Contractor prepares a proposed agenda and shall record, maintain and provide draft-meeting minutes to the
Project Officer (PO) for approval. The PO will approve the draft version and distribute the final version to the Contract Officer (CO) and Contractor.	 	 •   Contractor provides agenda 48hrs in advance of meeting to the PO

 
 •   PO approves (with CO
concurrence) and distributes agenda
  

•   Contractor provides meeting minutes within three business days of the meeting

 
 •   PO reviews, comments and
approves minutes
  
	 	1 Electronic Copy to PO and CO
	2.	 	Monthly, Quarterly and Annual Project Status Report/ Meeting	 	Monthly reports are due on the 15th of each month, except on months when Quarterly/ Annual Technical Progress Reports are due	 	 The Monthly/Quarterly Project/Annual Status Report shall address the items listed below and cross-referenced to the Work Breakdown Structure
(WBS), Scope of Work (SOW), Integrated Master Schedule (IMS), Integrated Baseline Review (IBR) report, Earned Value Management (EVM) Cost Performance Reports (CPR), and approval strategy.

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

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

•   Contractor provides
  

Monthly Status Report deliverables on the 15th of each month via
email/CD/e-room upload
  

•   PO and CO will review Monthly Reports with the Contractor and provide feedback

 
 Quarterly Meeting:

 
 •   Contractor provides
Quarterly Status Report five business days prior to meeting. This report is an expanded version of the Monthly Status Report
  

•   Contractor shall identify itinerary for the quarterly site visits

 
 •   Contractor provides
agenda to the PO 48hr in advance of meeting
  

•   PO approves (with CO concurrence) and distributes agenda

 
 •   Contractor provides
meeting minutes within three business days of the
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 	 differences between the two, and the corrective steps.
  

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

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

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

 
 6.      Estimated
and Actual Expenses: This report shall also have attached either: a) a tabular (excel file) Control Account Plan report generated from MPM; or b) an unofficial CPR Form I. This section of the report shall also contain estimates for the
subcontractors’ expenses from the previous month if the subcontractor did not submit a bill in the previous month. Estimates shall be listed for each subcontractor. If the subcontractor(s) was not working or did not incur any costs in the
previous month, then a statement to this effect should be included in this report for those respective subcontractors. This section should also include a summary of any cost savings identified by the contractor as part of the 5% cost savings
initiative.
  

7.      Contractor shall identify the itinerary for the quarterly site visits
(quarterly)
	 	    meeting
  

•   PO reviews, comments and approves minutes Annual Meeting:

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

•   Contractor shall ensure that the board of directors is available to meet with BARDA. BARDA
reserves the right to meet with the Contractor’s board of directors once a year to discuss the contract
  

•   PO approves (with CO concurrence) and distributes agenda

 
 •   PO approves (with CO
concurrence) all meeting material
  

•   Contractor provides meeting minutes within three business days

 
 •   PO reviews, comments and
approves minutes
  

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

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 		 	 Report
  

•   BARDA and Contractor shall participate in an in-process review

 
	 	
	3.	 	Integrated Baseline Review (IBR)	 	Within 90 days of contract award	 	 The IBR Report shall address each of the items listed below and be cross-referenced to the WBS, SOW, IMS and approval strategy.

 
 1.      Contractor
provides baseline proposal and PowerPoint brief
  

2.      A description of the work scope through control account Work Authorization
Documents (WADs)
  

3.      Template for Work Packages

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

5.      Baseline revision documentation and program logs (s) risk register.
	 	 •   Contractor provides baseline proposal, .ppt briefing, 10 business days prior
to meeting
  
 •   Contractor
provides agenda to the PO 48hr in advance of meeting
  

•   PO approves (with CO concurrence) and distributes agenda

 
 •   PO approves (with CO
concurrence) all meeting material
  

•   Contractor provides minutes within 48hr of the meeting

 
 •   PO reviews and approves
minutes
  
 •   BARDA will
review documentation and provide written comments and questions to Contractor
  

•   Contractor shall address BARDA’s comments and resubmit IBR for BARDA approval within 10
business days
	 	1 Electronic Copy to PO and CO
						
	4.	 	Integrated Master Plan	 	30 days following contract award and updated quarterly	 	 Integrated Master Plan (aka Integrated Product Development Plan) including WBS, critical path milestones and Earned Value Management Plan

 
 Contractor has the option to combine details from the IMP with the WBS Dictionary (#6) in
a single document, updated quarterly. Details include: milestones matched to planned EVM measurements; completion criteria; success criteria; assignments of responsible lead personnel for milestones, or for oversight of subcontractor effort required
to meet milestones; and dependencies that cross reference to the Risk Management Plan
	 	  

•   Contractor shall provide all the Integrated Master Plan deliverables 30

days following contract award, and thereafter on the 15th of each month. Deliverable should be included in the Quarterly or Annual Project
Status Reports,
  
 •   BARDA
shall provide Contractor with a written list of concerns in response to Contractor’s submitted Integrated Master Plan, and the
	 	

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 		 	 Contractor must address in writing all concerns raised by BARDA within twenty business days of Contractor’s receipt of this list of concerns.
	 	
						
	5.	 	 Risk
 Management

Plan
	 	90 days following contract award and updated quarterly (additional submissions as requested by CO or PO)	 	The Contractor will provide a Risk Management Plan that outlines the impacts of each risk in relation to the cost, schedule and performance objectives. The Risk Management Plan will include risk mitigation strategies. Each risk
mitigation strategy will capture how the corrective action will reduce impacts on cost, schedule and performance.	 	 •   Contractor shall provide a Risk Management Plan 90 days following contract
award and update on the 15th of each Quarter in their Quarterly or Annual Project Status Reports
  

•   BARDA shall provide Contractor with a written list of concerns in response to
Contractor’s submitted Risk Management Plan, and the Contractor must address in writing all concerns raised by BARDA within twenty business days of Contractor’s receipt of this list of concerns.
	 	1 Electronic Copy to PO and CO
						
	6.	 	Program Integrated Master Schedule and WBS Dictiona ry	 	The 15th of each quarter (additional submissions as requested by CO or PO)	 	The Contractor will provide Program Integrated Master Schedule (IMS) and WBS Dictionary with quarterly status updates to reflect changes in schedule, performance, and critical path	 	 •   Contractor shall provide an Integrated Master Schedule on the 15th of each
quarter in their quarterly or annual Project Status Reports
  

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

 
 •   BARDA shall provide
Contractor with a written list of concerns in response to Contractor’s submitted IMS, and the Contractor must address in writing all concerns raised by BARDA within twenty business
	 	1 Electronic Copy (PDF and Microsoft Project Schedule (.mmp) format to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 		 	 days of Contractor’s receipt of this list of concerns.
	 	
						
	7.	 	EVM / Contract Performance Report	 	The 30th day of each month covering the prior month (additional submissions as requested by CO or PO)	 	Contractor will provide a quarterly Contract Performance Report (CPR) at an agreed upon reporting level using the BARDA provided WBS (format 1) and a Variance Analysis Report (fonnat 5). Contractor will report EVM data on all Cost
Plus CLINs	 	 •   Contractor shall provide a CPR/format I and Variance Analysis Report/ format
5 on the 30th day of each month covering the prior month
  

•   Contractor shall provide a

 
 PDF of deliverables. BARDA may request, on a
quarterly or ad hoc basis that the Contractor provide raw data.
  

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

 
 •   The Contractor must
address in writing all concerns raised by BARDA staff to the satisfaction of BARDA
	 	1 Electronic Copy to PO and CO
						
	8.	 	Incident Report	 	Within 24 or 48 hrs of activity or incident	 	 The Contractor shall communicate and document all critical programmatic concerns, risks or potential risks with BARDA within 48 hours . The
Contractor shall communicate via email or telephone.
  
 The Contractor shall report to
the government any activity or incident that is in violation of established security standards or indicates the loss or theft of government products within 24 hrs of activity or incident. The Contractor shall communicate via email, oral or written
communication.
	 	 •   Email, Letter to CO Telephone (w/ written follow-up)

 
 •   Written communication
with BARDA PO and CO within 48 hrs of Contractor identifying a project risk or potential risk and 24 hrs for Security activities or

incident
  

•   Additional updates within 48 hrs of additional developments, additional information and/or
understanding
  

•   Contractor shall submit within 5 business days a Corrective Action Plan (if necessary) to
address any potential security issues
	 	1 Electronic Copy PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

						
		 		 		 		 	 •   If corrective action is required, the Contractor must address concerns
raised by BARDA
  

•   Contractor shall address BARDA’s concerns in writing within 5 business days
	 	
						
	9.	 	Deviation Request	 	TBD	 	Process for changing study protocols and/or the Integrated Master Plan (a.k.a Integrated Product Development Plan)	 	 •   Contractor shall submit a Deviation Request as soon as the Contractor has
sufficient data to support the need for a change from the approved study protocols and/or Integrated Master Plan
  

•   The BARDA CO will review and provide a written response to the Deviation Request.

 
 •   Contractor shall address
BARDA’s comments and resubmit the deviation request that addresses BA RDA’s comments within 5 business days
  

•   Contractor shall not proceed with the deviation until BARDA gives its approval
	 	1 Electonic Copy to PO and CO
						
	10.	 	Draft and Final Technical Progress Report	 	Draft 20 business days before and Final 10 business days after completion of the POP	 	 A draft of Final Technical Progress Report containing a summation of the work performed and the results obtained for the entire contract
period of performance. The draft report shall be duly marked as ‘Draft’.
  
 The
Final Technical Progress Report incorporating the feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire contract period of performance. This final report shall detail, document and
summarize the results of the entire contract. This report shall be in sufficient detail to fully describe the progress achieved under all milestones. The final report shall be duly marked as ‘Final’.
	 	 •   Contractor shall provide a draft report 20 business days and final 10
business days before completion of the
 contract period
  

•   PO provides edits and additional feedback, which Contractor will incorporate into the Final
Technical Progress Report
  

•   The Contractor shall submit one (1) copy of a comprehensive final report to the CO and two (2)
copies (one
	 	I Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 		 	 electronically on a CD) to the PO
	 	
						
	11.	 	Product Transition Strategy	 	90 days prior to end of the (base/ option) POP	 	 Contractor shall provide a Product Transition Strategy to support transition of the product(s) prior to end of the base and/or option(s) POP.
The Product Transition Strategy should provide a strategic plan for further development and/or stockpiling of the product
  

The transition strategy shall provide options and/or a specific approach for the transition of MCM product for further development, procurement, approval
and/or stockpile
	 	 •   Contractor shall provide a Product Transition Strategy to support transition of the product(s) 90 days prior to
end of the (base/option) POP as an addendum to that Quarter’s Quarterly Project Status Report.
	 	1 Electronic Copy to PO and CO
						
	12.	 	Decision Gate Presentation	 	Event Driven Review following completion of a pre- defined stage of product development and prior to initiation of a new stage	 	Contractor shall provide a presentation following a prescribed template provided by BARDA prior to the Decision Gate Review	 	 •   Contractor shall provide an update to technical progress made towards
completion of the Decision Gate and provide the presentation, 10 business days prior to the Decision Gate Review
  

•   Contractor shall submit written justification of progress towards satisfying Decision Gate
criteria
  
 •   After
reviewing, the BARDA PO and CO will provide a written response
	 	1 Electronic Copy to PO and CO
						
	13.	 	Standard Operating Procedures	 	As requested by PO and CO	 	Contractor shall provide Standard Operating Procedures (SOPs) to BARDA for review, as they are completed and updated	 	 •   Contractor shall submit the Standard Operating Procedures (SOPs) in the form requested by the PO and CO within
15 calendar days of request
	 	1 Electronic Copy to PO and CO
						
	14.	 	Approval Strategy	 	Within 90 days of contract award and updated as part of the quarterly report	 	Contractor shall provide overview of the approval strategy to include all clinical and non-clinical studies	 	 •   Contractor will submit proposed

clinical and non-clinical strategy to support approval
  

•   If corrective action is required, the Contractor must address concerns raised by
BARDA
	 	1 Electronic Copy to PO and CO
						
	15.	 	Study Protocols	 	At least 10 business days prior to FDA Submission	 	Contractor shall provide Pre-Clinical/Non-Clinical/ Clinical Trial Protocols to BARDA for evaluation,	 	 •   Contractor will submit proposed protocols to BARDA at least 10
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

						
		 		 		 	 prior to FDA submission
  

(The CO and PO reserves the right to request within the period of performance a non- proprietary Study Protocol for distribution within the United States
Government(USG))
	 	 business days prior to FDA submission. If corrective action is required, the Contractor must address in writing all
safety, regulatory, ethical, and conflict of interest concerns raised by BARDA to the satisfaction of BARDA before study execution
  

•   After receiving the corrected documentation, that satisfies BARDA the CO will provide a
written Contract Officer Authorization (COA) Letter to the Contractor. This COA provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by BARDA

 
 •   Contractor shall not
proceed with any study protocol until BARDA gives its approval
  

•   Final FDA submissions shall be submitted to BARDA concurrently or no later than one calendar
day after its submission to CDER
	 	
						
	16.	 	Study Reports	 	Within 30 (draft) or 60 (final) calendar days after completion of analysis and 15 business days prior to submission to FDA	 	 Contractor shall provide Draft and Final Pre-Clinical/Non-Clinical/Clinical Study Reports to BARDA for review and edits within 30 (draft) or
60 (final) calendar days after completion of analysis of Pre-Clinical/Non-Clinical/ Clinical data and 15 business days prior to submission to FDA
  

Alternatively, clinical draft study reports may be submitted 40 business days, and final reports submitted within 75 business days after database lock,
provided submission to BARDA
	 	 •   Contractor shall provide Draft and Final Pre- Clinical/Non-Clinical/
Clinical Study Reports to
 BARDA within 30 (draft) or 60 (final) calendar days after completion of each report. Clinical study reports
may be provided via the Alternative Schedule.
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 	 is still at least 15 days prior to FDA submission (“Alternative Schedule”)

 
 (The CO and PO reserves the right to request within the period of performance a
non-proprietary Study Report for distribution within the USG)
	 	 •   Contractor will submit proposed
Pre-Clinical/Non-Clinical/ Clinical Study Report to BARDA at least 15 business days prior to FDA Submission
  

•   If corrective action is required, The Contractor must address in writing all concerns raised
by BARDA to the satisfaction of BARDA before FDA Submission
  

•   Contractor shall not proceed with any study report until BARDA gives its approval

 
 •   Final FDA submissions
shall be provided to BARDA concurrently or no later than 1 calendar day of its submission to CDER
	 	1 Electronic Copy to PO and CO
						
	17.	 	Manufacturing Campaign Reports	 	Within 30 calendar days after receipt of batch records and 15 business days prior to submission to FDA	 	 Contractor shall provide Manufacturing Campaign Reports to BARDA for review and edits prior to submission to FDA

 
 (The CO and PO reserve the right to request within the period of performance a
non-proprietary Manufacturing Campaign Reports for distribution within the USG)
	 	 •   Contractor will submit proposed Analysis Reports and Manufacturing Campaign
Reports to BARDA at least 15 business days prior to FDA Submission.
  

•   If corrective action is required, the Contractor must address in writing all concerns raised
by BARDA to the satisfaction
 of BARDA before FDA Submission
  

•   Contractor shall not proceed with any FDA submission until BARDA gives its approval

 
 •   Final FDA submissions
shall be submitted to BARDA concurrently or no later than one (1)
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

						
		 		 		 		 	 calendar day after its submission to CDER
	 	
						
	18.	 	FDA Meeting Notification	 	No later than 10 business days prior to the scheduled meeting	 	The contractor shall forward the dates and times of any meeting with the FDA to BARDA and arrange for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people (PO, CO, and up to
two (2) Subject Matter Experts (SME(s)).	 	 •   Contractor must notify BARDA of an upcoming meeting with the FDA within 24 hours of scheduling the meeting with
the FDA and no later than 10 business days prior to the scheduled meeting
	 	1 Electronic Copy to PO and CO
						
	19.	 	FDA Correspondence and Meeting Minutes	 	Within three (3) calendar days of receiving correspondence from the FDA	 	 The contractor shall forward initial Contractor and CDER-issued draft minutes and final minutes of any

meeting with the FDA to BARDA. All documents shall be duly marked as either ‘Draft’ or ‘Final’.
	 	 •   Contractor provides FDA correspondence and meeting minutes within three (3) calendar days of the meeting or
correspondence
	 	1 Electronic Copy to PO and CO
						
	20.	 	FDA Submissions	 	At least 15 business days prior to submission to FDA	 	 The Contractor shall provide BARDA the opportunity to review and comment upon all draft regulatory documents before submission to the FDA.
Contractors shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either ‘Draft’ or ‘Final’.
  

The Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before FDA submission.
	 	 •   Contractor will submit proposed FDA Meeting Briefing Packets to BARDA at
least 15 business days prior to FDA submission
  

•   If corrective action is required, the Contractor must address in writing all concerns raised
by BARDA staff to the satisfaction of BARDA before FDA submission
  

•   Final FDA submissions shall be submitted to BARDA concurrently or no later than one (I)
calendar day of its submission to CDER
	 	1 Electronic Copy to PO and CO
						
	21.	 	FDA Audits	 	Within 10 business days of a scheduled audit or within 24 hours of an ad hoc site visits/audits if the FDA did not provide advanced notification	 	The Contractor shall notify the PO and CO within 24 hours of FDA’s arrival to conduct site visits/audits by any regulatory agency. In the event of an FDA inspection which occurs as a result of this contract and for this
product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the BARDA with an exact copy (non-redacted of the FDA Form 483, and the Establishment Inspection	 	 •   The Contractor

shall notify the PO and CO within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency

 
 •   Contractor provides QA
Audit Reports within 15 calendar days of the audit
  

•   The Contractor shall also provide copies
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

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

•   The Contractor shall notify the PO and CO within 5 business days of report completion
	 	1 Electronic Copy to PO and CO
						
	23.	 	BARDA Audit	 	Ad Hoc	 	The contractor shall accommodate for periodic or ad hoc site visits by BARDA. If BARDA, the Contractor or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential
solutions and provide a report to BARDA.	 	 •   If BARDA, the Contractor or other parties identifies any issues during an
audit, the Contractor shall capture the issues, identify potential solutions and provide a report to BARDA within 10 business days.
  

•   The PO and CO will review the deliverable and provide a response to the Contractor.

 
 •   Once corrective action,
approved by the CO, is
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 		 	 completed, the Contractor will provide a final report to BARDA
	 	
						
	24.	 	Technical Documents	 	Within 10 business days upon request by CO/P0	 	 Contractor shall provide PO and CO upon request with deliverables from the following contract funded activities: Process Development Reports,
Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, SOPs, Master Production Records, Certificate of Analysis
  

(The CO and PO reserves the right to request within the period of performance a non-proprietary Technical Documents for distribution within the USG)
	 	 •   Contractor provides deliverables within 15 calendar days of the completion
of activities
  
 •   If
additional time is required, Contractor shall request additional time from BARDA on a per deliverable basis
  

•   If corrective action is required, the Contractor must address in writing concerns raised by
BARDA
  
 •   Contractor will
submit proposed FDA Technical Documents to BARDA at least 15 business days prior to FDA submission
  

•   If corrective action is required the Contractor must address in writing all concerns raised by
BARDA to the satisfaction of BARDA before FDA Submission
	 	 For Final Documents:
  

1 Electronic Copy to PO and CO

						
	24.1	 	Clinical Study Interim Status Update	 	Every two weeks, if any changes since the previous update	 	Contractor shall provide PO with a status update of clinical studies that are actively enrolling patients by study site of: cumulative enrollment; new enrollments; activation or inactivation of study sites	 	 •   Updates, to the extent they are available, will be presented during
bi-weekly teleconferences
  

•   If no changes have occurred

since the prior update only a simple statement that there is no new data is required
	 	1 e-copy to PO contained in bi-weekly meeting materials
						
	24.2	 	Clinical Study Status Update	 	Every month, if any changes since previous update	 	Contractor shall provide PO with a status update of clinical studies that are actively enrolling patients to include by study site: cumulative enrollment; new enrollments; screen failures; patients dropped from study; AE and SAES;
activation or inactivation of study sites; investigator appointments or changes; and status of IRB/IEC review/approval/renewal. Contractor	 	 •   Update will be submitted by e-mail
or other electronic format to be provided by BARDA by the end of the 5th business day of each new month
  

•   Updates, to the extent they are
	 	1 Electronic copy to PO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 	will provide proposed format for BARDA PO review and approval	 	 available, will be presented during bi-weekly teleconferences

 
 •   If no changes have
occurred since the prior update only a simple statement that there is no new data is required
	 	
						
	25.	 	Animal Model or Other Technology Transfer Package	 	Within 10 business days of request by CO/P0	 	Contractor shall provide Animal Model or Other Technology Transfer Package relevant data	 	 •   Contractor shall provide Animal Model or other Technology Transfer Package within 10 business days of request
by CO/PO
	 	1 Electronic Copy to PO and CO
						
	26.	 	Raw Data or Data Analysis	 	Within 20 business days after receipt of request by CO/PO	 	Contractor shall provide Raw Data or Data Analysis for review by BARDA, if requested	 	 •   Contractor shall provide Raw Data or Data Analysis within 20 business days of request by CO/PO
	 	1 Electronic Copy to PO and CO
						
	27.	 	Samples of Therapeutics	 	Within 20 business days of request by CO/PO	 	Contractor shall provide samples of non-GMP candidate therapeutics and GMP material manufactured with contract funding to include raw material, Bulk Drug Substance (BDS), Final Drug Product (FDP) and/or labeled and packaged
treatment courses. The request will state the type of material and the amount but it is not to exceed the equivalent of 250 treatment courses or its individual manufacturing equivalent. The Contractor will be advised by the CO how samples are to be
packaged and where samples are to be shipped. It is acceptable to label material “Not for Clinical Use”. BARDA reserves the right to request samples throughout the period of performance.	 	 •   Contractor must submit samples of therapeutics within 20 business days of
request by CO/PO.
  
 •   The
Contractor will be advised by the CO how samples are to be packaged and where samples are to be shipped.
	 	CO will provide details upon request
						
	28.	 	Publications	 	20 business days for manuscripts and 10 business days for abstracts	 	Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to BARDA for review prior to submission	 	 •   Contractor must submit all manuscript or scientific meeting abstract to PO
and CO within 20 business days for manuscripts and 10 business days for abstracts
  

•   The CO will respond with written comments within 10 business days for manuscripts and 5
business days for
	 	1 Electronic Copy to PO and CO

											
	 #  
	 	 Type of

Deliverable
	 	 Frequency/

time periods
	 	 Description of Deliverable
	 	 Reporting

Procedures
	 	 Quantity/

Form

		 		 		 		 	 abstracts.
  

•   If corrective action is required, the Contractor must address in writing all concerns raised
by BARDA to the satisfaction of BARDA before Submission.
  

•   Any Final submissions shall be submitted to BARDA concurrently or no later than one (1)
calendar day of its submission
	 	
						
	29.	 	Press Releases	 	5 business days prior to release	 	The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases	 	 •   The Contractor shall ensure that the CO has received and approved an
advanced copy of any press release to this contract not less than 5 business days prior to the issuance of the press release
  

•   If corrective action is required, the Contractor agrees to accurately and factually represent
the work conducted under this contract in all press releases
  

•   Any final submissions shall be submitted to BARDA concurrently or no later than one (1)
calendar day of its submission.
	 	1 Electronic Copy to PO and CO
						
	30.	 	Contract financing Report	 	No later than the 30th business day after the end of the reporting period	 	The Financial Report shall be submitted by the Contractor in accordance with the instructions set forth in section G.4 of this contract.	 	 •   The Contractor shall provide the

contract financing report

no later than the 30th business day after the end of the reporting period in accordance with the instructions set forth in section G.4 of
this contract.
	 	

 Contract Milestones and GO/NO GO Decision Gates for Base and Option CLINs 

[***] 

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

 Clinical Terms of Award 

These Clinical Terms of Award detail an agreement between the Biomedical Advanced Research and Development Authority (BARDA) and the Awardee; they apply to
all grants and contracts that involve clinical research. 
 Draft protocols for each clinical study will be submitted to BARDA for evaluation and comment.
BARDA comments will be incorporated into the draft proposal prior to submission to the FDA for comment, if required. 
 BARDA owns all protocols, data
generated from the execution of these protocols, and final reports, funded by BARDA under this contract, as defined in Rights in Data Clause in FAR 52.227-14. BARDA reserves the right to request that the Awardee provide any contract deliverable in a
non-proprietary form, to ensure BARDA has the ability to review and distribute the deliverables, as BARDA deems necessary. 
 A. Safety and Monitoring
Issues 
 Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval 

Before award and then with the annual progress report, the Awardee must submit to BARDA a copy of the current IRB or IEC approved informed consent document,
documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site. 
 When a non-US
Institution becomes engaged in research to which the FWA applies, and the institution does not provide a FWA number, written project officer’s approval must be obtained before the site can be allowed to enroll any subjects under an alternative
human research subjects protection assurance including, but not limited to the following: 
  

	 	•	 	The Common Rule; 

  

	 	•	 	The U.S. Food and Drug Administration regulations at 21 CFR parts 50 and 56; 

  

	 	•	 	The current International Conference on Harmonization E-6 Guidelines for Good Clinical Practice; 

  

	 	•	 	The current Council for International Organizations of Medical Sciences International Ethical Guidelines for Biomedical Research Involving Human Subjects; 

 

	 	•	 	The current Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans; 

  

	 	•	 	The current Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects; or 

  

	 	•	 	Other standard(s) for the protection of human subjects recognized by U.S. federal departments and agencies which have adopted the U.S. Federal Policy for the Protection of Human Subjects. 

If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve
the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number, if applicable. 

The grantee institution must ensure that the application as well as all protocols are reviewed by their IRB or IEC. 

To help ensure the safety of participants enrolled in BARDA funded studies, the Awardee must provide BARDA copies of documents related to all major changes in
the status of ongoing protocols, including the following: 
  

	 	•	 	All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid. 

  

	 	•	 	All changes in template informed consent documents, identified by version number, date, or both and dates it is valid. 

  

	 	•	 	Termination or temporary suspension of patient accrual. 

	 	•	 	Termination or temporary suspension of the protocol. 

  

	 	•	 	Any change in IRB or IEC approval status (e.g. withdrawal or suspension). 

  

	 	•	 	Any other significant problems or issues that could affect the safety of participants in the studies. 

Awardees must notify BARDA through the Project Officer (PO) or Contracting Officer (CO) of any of the above changes within three working days by email or fax,
followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC. 

If a clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Awardee
must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules. Data and Safety Monitoring Requirements 

BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed
products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must be reviewed by an independent data and safety monitoring board (DSMB) or
data monitoring committee (DMC); other trials may require DSMB/DMC oversight as well. The Awardee shall inform BARDA of any co-monitoring and sponsor company oversight clinical or CRO site visits and/or audits of CRO facilities funded under this
effort. BARDA reserves the right to accompany the awardee on site visits and/or audits of CROs as BARDA deems necessary. The Awardee shall provide BARDA with an updated register of at (Awardee and CRO conducted) site visits that have been conducted
on a monthly basis. 
 A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than
those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater
than the risk of doing so as part of a routine physical examination (45 CFR 46.1021). 
 Final decisions regarding the type of monitoring to be used must be
made jointly by BARDA and the Awardee before enrollment starts. Discussions with the responsible BARDA Project Officer regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment
begins and may include discussions about the appointment of one of the following. 
  

	 	•	 	Independent Safety Monitor— a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other
safety issues. 

  

	 	•	 	Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) — a small group of independent investigators and biostatisticians who review data from a particular study. 

 

	 	•	 	Data and Safety Monitoring Board/Data Monitoring Committee — an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification,
and termination. The Awardee may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB/DMC; other trials may require DSMB oversight as well. Please refer to: NIAID
Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. 

 When a monitor or
monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and
approved by BARDA before enrollment starts. BARDA is entitled to have an observer (silent, non-voting) participant in the open DMC meetings/portions of meetings. 

 Additionally, the Awardee must submit written summaries of all open session reviews conducted by the monitoring
group to the BARDA within 30 days of reviews or meetings. Closed session summaries must be submitted within 30 days of their becoming available to the Awardee 

B. BARDA Protocol Review Process Before Patient Enrollment Begins 

BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials.
Therefore, before patient accrual or participant enrollment, the Awardee must provide the following (as applicable) for review and approval by BARDA. 
  

	 	1.	IRB or IEC approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria. 

 

	 	2.	Documentation of IRB or IEC approval, including OHRP FWA number or applicable documentation of compliance, and IRB or IEC name. 

  

	 	3.	Template informed consent document, identified by version number, date, or both and date it is valid. BARDA may have access to any site-specific informed consent documents and translations of these as requested.

  

	 	4.	Plans for the management of side effects. 

  

	 	5.	Procedures for assessing and reporting adverse events. 

  

	 	6.	Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory. 

  

	 	7.	Documentation that the Awardee and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects. 

BARDA staff comments will be forwarded to the Awardee within three weeks (15 business days) of receipt of the above information. The Awardee must address in
writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by the BARDA Project Officer (PO) to the satisfaction of BARDA before patient accrual or participant enrollment can begin. After receiving the corrected
documentation, that satisfies BARDA staff the BARDA Contracting Officer will provide a written Contract Officer Authorization (COA) Letter to the Awardee. This COA provides authorization to the awardee to execute the specific clinical study funded
in part or in whole by BARDA. 
 C. Investigational New Drug or Investigational Device Exemption Requirements 

Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions
(including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational
device exemption (IDE). 
 Exceptions must be granted in writing by FDA. If the proposed clinical trial will be performed under an IND or IDE, the Awardee
must provide BARDA with the name and institution of the IND or IDE sponsor, the date the IND or IDE was filed with FDA, the FDA IND or IDE number, any written comments from FDA, and the written responses to those comments. 

The Awardee must wait 30 days from FDA receipt of an initial IND or IDE application before initiating a clinical trial. 

The Awardee must notify BARDA if the FDA places the study on clinical hold and provide BARDA any written comments from FDA, written responses to the comments,
and documentation in writing that the hold has been lifted. 

 The Awardee must not use grant or contract funds during a clinical hold. 

Required Time-Sensitive Notification 
 Under an IND or
IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Awardee must submit copies to the responsible BARDA Project Officer or the Contracting Officer’s technical representative
(COTR) as follows: 
  

	 	•	 	Expedited safety report of unexpected or life-threatening experience or death — A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must
be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the BARDA program officer or the contracting officer’s technical
representative within 24 hours of FDA notification. 

  

	 	•	 	Expedited safety reports of serious and unexpected adverse experiences — A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests
in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 days after the IND sponsor’s receipt of the information, must be submitted to the BARDA
Project Officer or the Contracting Officer’s Technical Representative within 24 hours of FDA notification. 

  

	 	•	 	IDE reports of unanticipated adverse device effect — A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the BARDA Project Officer or the Contracting
Officer’s Technical Representative within 24 hours of FDA notification. 

  

	 	•	 	Expedited safety reports — should be sent to the BARDA Project Officer or the Contracting Officer’s Technical Representative concurrently with the report to FDA. 

 

	 	•	 	Other adverse events documented during the course of the trial should be included in the annual IND or IDE report and reported to the BARDA annually. 

In case of problems or issues, the BARDA Project Officer or the Contracting Officer’s Technical Representative will contact the Awardee within 10 working
days by email or fax, followed within 30 calendar days by an official letter to the principal investigator, with a copy to the institution’s office of sponsored programs, listing issues and appropriate actions to be discussed. 

 

	 	•	 	Safety reporting for research not performed under an IND or IDE 

 Final decisions regarding ongoing
safety reporting requirements for research not performed under an IND or IDE must be made jointly by the BARDA Project Officer or the Contracting Officer’s Technical Representative and the Awardee.EX-10.7I

 Exhibit 10.7I 
  

 
 AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 2 2. AMENDMENT/MODIFICATION NO. 0010 3. EFFECTIVE
DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. N/A. 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE ASPR-BARDA 7. ADMINISTERED BY (If other than Item 6) CODE ASPR-BARDA ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201
ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NO. ACHAOGEN, INC. 1361331 ACHAOGEN, INC. 7000 SHORELINE 7000
SHORELINE CT STE 371 SOUTH SAN FRANCISCO CA 940801957 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201000046C CODE 1361331 FACILITY CODE 10B. DATED (SEE ITEM 13) 09/01/2010 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF
SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended is not extended Offers must acknowledge receipt of this amendment prior to the hour and date specified in
the solicitation or as amended, by one of the following methods: (a) By completing Items 8 end 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter
or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR
OFFER. If by virtue of this amendment you desire to change an offer already submitted such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment. and Is received prior to
the opening hour and date specified 12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A. 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE A. THIS CHANGE ORDER
IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office,
appropriation date. etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X D. OTHER (Specify type of modification and authority Bilateral: Mutual Agreement
of the Parties. E. IMPORTANT: Contractor is not is required to sign this document and return 1 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings. Including solicitation/contract subject matter
where feasible.) Tax ID Number: 68-0533693 DUNS Number: 167293153 A. The purpose of this modification is to incorporate the following changes into Contract Number HHSO100201000046C. 1. The first and second sentences in Article G.7. INDIRECT COST
RATES of Contract Number HHSO100201000046C are hereby deleted and replaced with the following: The following indirect rates will be utilized for billing purposes during the entire base period/CLIN 0001 ONLY. For the entire base period/CLIN 0001,
[***] Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME
AND TITLE OF CONTRACTING OFFICER (Type or print) ETHAN J. MUELLER 15B. CONTRACTOR/OFFICER (Signature of person authorized to sign) 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA (Signature of Contracting Officer) 16C. DATE SIGNED NSN
7540-01-152-8070 Previous edition unusable STANDARD FORM 30 (REV. 10-83) Prescribed by GSA FAR (48 CFR) 53 243 

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

					
	CONTINUATION SHEET	  	 Reference no document being continued

HHSO100201000046C/0010
	  	 PAGE OF

2    |    2

		
	 NAME OF OFFEROR OR CONTRACTOR

ACHAOGEN, INC. 1361331
	  	

  

											
	 ITEM NO.
     (A)
	  	 SUPPLIES/SERVICES
(B)
	  	 QUANTITY
(C)
	  	 UNIT
(D)
	  	 UNIT
PRICE
(E)
	  	 AMOUNT
(F)

		  	 [***]. These final base period/CLIN 0001 indirect rates are the final indirect rates for the entire base period/CLIN 0001 ONLY and the
contractor agrees [***] for the base period/CLIN 0001 ONLY and the contractor also agrees to [***] and the contractor will not [***]. The following indirect rates will be utilized for billing purposes during Option 1/CLIN 0002 and Option 2/CLIN 0003
ONLY. [***].
  
 2. In addition, this no cost bilateral modification also amends the
indirect rate agreement dated 25 February 2013 for the purposes of adding the following ONLY to the agreement:
  

The following final indirect rates will be utilized for billing purposes during the entire base period/CLIN 0001 ONLY. For the entire base period/CLIN 0001,
[***]. These final base period/CLIN 0001 indirect rates are the final indirect rates for the entire base period/CLIN 0001 ONLY and the contractor agrees [***] and the contractor also agrees [***] and the contractor will not [***].

 
 B. This is a no cost modification. The total amount of Contract Number HHSO100201000046C
as well as all other terms and conditions of Contract Number HHSO100201000046C remain unchanged.
  

Period of Performance: 09/19/2010 to 11/15/2017
	  		  		  		  	
		
	NSN 7540.01-152-8067	  	 OPTIONAL FORM 338 (4-86)

Sponsored by GSA
 FAR (48 CFR) 53 110

  

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

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