Document:

Exhibit 10.27

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 26 2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (IF APPLICABLE) 0005 See Block 16C OS145103 6. ISSUED BY CODE ASPR-BARDA 7. ADMINISTERED BY (IF OTHER THAN ITEM 6) CODE ASPR-BARDA01 ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 ASPR-BARDA 330 Independence Ave, SW Rm G644 Washington DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code (x) 9A. AMENDMENT OF SOLICITATION NO. CEMPRA PHARMACEUTICALS, INC. 1425009 CEMPRA PHARMACEUTICALS, INC. BUILDING 4 QUADRANGLE 6340 QUADRANGLE DRIVE, SUITE 100 CHAPEL HILL NC 27517 9B. DATED (SEE ITEM 11) x 10a. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201300009C CODE 1425009 FACILITY CODE 10B. DATED (SEE ITEM 13) 05/24/2013 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIATIONS 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 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of the 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) ..2015.1992015.25106 Net Increase: $15,999,772.37 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 SUPPLIEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: D. OTHER (Specify type of modification and authority) X Bilateral: Mutual Agreement of the Parties and FAR Clause 52.217-9. E. IMPORTANT: Contractor is not. X is required to sign this document and return 0 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: 20-3905814 DUNS Number: 623713034 A. The purpose of this modification is for the Government to bilaterally modify the Statement of Work requirements for Option 1 CLIN 0002 ONLY and then exercise Option 1 under CLIN 0002 of the contract in accordance with the terms and conditions of both Option 1 under CLIN 0002 and the contract.  The Government and the Contractor hereby modify this contract for the purposes of both adding and exercising the total amount of Option 1 under CLIN 0002 in the amount of: Total Estimated cost: $14,953,058.29 Total Fixed Fee: $1,046,714.08 Continued . . . Except as provided herein, all terms and conditions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER ( Type or print) ETHAN J. MUELLER 15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED (Signature of person authorized to sign) (Signature of Contracting Officer) NSN 7540-01-152-8070 Previous edition unusable STANDARD FORM 30 (REV. 10-83) Prescribed by GSA FAR (48 CFR) 53.243

 

 

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201300009C/0005 PAGE 2 OF 26 NAME OF OFFEROR OR CONTRACTOR CEMPRA PHARMACEUTICALS, INC. 1425009 ITEM NO. (A) SUPPLIES/SERVICES (B) QUANTITY (C) UNIT (D) UNITE PRICE (E) AMOUNT (F) Total Estimated Cost Plus Fixed Fee: $15,999,772.37 The total period of performance of Option 1 CLIN 0002 under the contract is from 14 November 2014 through 30 November 2016. 1. This modification hereby results in an increase in the total amount of the contract From $18,280,922.25 By $15,999,772.37 To $34,280,694.62 as well as the following: Total Estimated Cost of the Contract: From $17,122,296.17 By $14,953,058.29 To $32,075,354.46. Total Fixed Fee of the Contract: From $1,158,626.08 By $1,046,714.08 To $2,205,340.16. Total Estimated cost plus fixed fee of the contract: from $18,280,922.25 by $15,999,772.37 to $34,280,694.62. 2. In Block 14 of the SF 26, the following CAN Number is added: Appropriation Year: 2015, Object Class: 25106, can# 1992015 $15,999,772.37. 3. In Block 15G of the SF 26, the amount of $18,280,922.25 is hereby changed to $34,280694.62. 4. The Government and the Contractor bilaterally modify Attachment 1, Statement of Work dated 22 April 2013, under PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J – LIST OF ATTACHMENTS is hereby deleted and replaced with the attached Statement of Work dated 16 October 2014 (23 pages attached herein). The efforts within Option Period 1 under CLIN 0002 that involve clinical human trials/studies and not-clinical animal studies cannot be performed until the receipt and approval of all required protocols by BARDA inclusive of all IRB, OHRP approvals and any required approved OLAW Assurances and IIA approvals from OLAW for any non clinical animal studies. 5. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged.  This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract.  In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged. 6. This bilateral modification does not add any additional travel expenses to any CLINs under Contract Number HHSO100201300009C. Continued . . . NSN 7540-01-152-8067 OPTIONAL FORM 336 (486) Sponsored by GSA FAR (48 CFR) 53.110

 

 

CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201300009C/0005 PAGE 3 OF 26 NAME OF OFFEROR OR CONTRACTOR CEMPRA PHARMACEUTICALS, INC. 1425009 ITEM NO. (A) SUPPLIES/SERVICES (B) QUANTITY (C) UNIT (D) UNIT PRICE (E) AMOUNT (F) 7. Under Article I.1, Section I Contract Clauses of the contract, the asterisk associated with HHSAR 352.231-70 salary rate limitation (Aug 2012) is deleted and replaced with the following: * The provisions set forth by this clause will only apply if and when any funds are obligated from HHS funding appropriated in the  2012, 2013, 2014 and 2015 Government Fiscal Years. B. This is a bilateral modification. All other terms and conditions remain unchanged. Delivery: 11/30/2016 Delivery Location Code: HHS HHS 200 Independence Avenue, SW Washington DC 20201 us Appr. Yr.: 2015 CAN: 1992015 Object Class: 25106 FOB: Destination Period of Performance: 05/24/2013 to 11/30/2016 Change item 2 to read as follows (amount shown is the obligated amount): 2 PK studies, safety studies, efficacy studies in animal models, clinical studies, regulatory and select chemical synthesis activities. 15,999,772.37 NSN 7540-01-152-8067 OPTIONAL FORM 336 (486) Sponsored by GSA FAR (48 CFR) 53.110

 

 

 

 

	
3.
	
STATEMENT OF WORK

	
3.1
	
Preamble

Independently and not as an agent 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 Broad Agency Announcement (BAA) BARDA CBRN BAA-12-100-SOL-00011.

The Government reserves the right to modify the milestones, progress, schedule, budget, or product to add or delete products, process, or schedule 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. In any event, the Government reserves the right to change product, process, schedule, or event to add or delete part or all of these elements as the need arises.

3.2Overall Objectives and Scope

The overall objective of this contract is to advance the development of solithromycin (SOLI) as an intravenous (IV) and orally-delivered antibiotic for use in the pediatric population for the treatment of community-acquired bacterial pneumonia (CABP) and for protection against biothreat organisms, including Bacillus anthracis and Francisella tularensis. The scope of work is organized in 5 severable phases (Clinical Line Item Number [CLIN] 1 through 5):

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1. CLIN 1

The Contractor will carry out the following tasks and subtasks and in accordance with the agreed upon Integrated Master Schedule, which further details the conduct of the specific tasks and subtasks.

	
1.1
	
Program Management (WBS 1.1)

The Contractor outsources a majority of the work to established practitioners in each discipline, with the Contractor team providing experienced program management, coordination, and oversight. All selected purchased commercial service providers for the BARDA project have proven their ability to deliver quality work cost-effectively and on schedule. The Contractor shall provide for the following program management activities as outlined below:

	
1.1.1
	
The Contractor will provide 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.

	
1.1.2
	
The Principal Investigator is responsible for overall leadership for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors.

	
1.1.3
	
The Project Manager will oversee the monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and program management.

	
1.1.4
	
The Principal Investigator and the Project Manager will act as the BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer.

	
1.1.5
	
The Contractor has adequate administrative staff and legal consultants 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.

	
1.1.6
	
The Contractor’s Project Management Team along with support from the Finance department has responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors and service providers.

	
1.1.7
	
Contract Review Meetings

	
1.1.7.1
	
The Contractor’s team will participate in regular face-to-face meetings on a quarterly basis 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 Contractor and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up

 

 

 

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 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.

	
1.1.7.2
	
The Contractor will participate in teleconferences every 2 weeks between the Contractor and BARDA to review technical progress. The Contractor will include subcontractors and service providers as necessary. If additional teleconferences or face-to-face meetings are requested by BARDA, the Contractor will be available.

	
1.1.8
	
Integrated Master Schedule (IMS)

	
1.1.8.1
	
Within 30 calendar days of the effective date of the contract, the Contractor will submit a first draft of an updated IMS in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for review and comment. The Integrated Master Schedule will be incorporated into the contract, and will be used to monitor performance of the contract. The Contractor will include the key milestones and Go/No Go decision gates. The IMS for the period of performance will be reviewed and accepted by BARDA at the PMBR.

	
1.1.9
	
Integrated Master Plan (IMP)

	
1.1.10
	
Work Breakdown Structure: The Contractor will utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor will expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting. The CWBS will be discernible and consistent. At BARDA’s request, the Contractor will furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task.

	
1.1.11
	
GO/ NO-GO Decision Gates/Contract Milestones: The IMP will outline key milestones with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions.

	
1.1.12
	
Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor will use principles of Earned Value Management System (EVMS) in the management of this contract. The Contractor will follow the Seven Principles:

	

	
I. The Contractor will plan all work scope for the program to completion.

	

	
II. The Contractor will 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. The Contractor will integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured.

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IV. The Contractor will use actual cost incurred and recorded in accomplishing the work performed.

	

	
V. The Contractor will objectively assess accomplishments at the work performance level.

	

	
VI. The Contractor will 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. The Contractor will use earned value information in the company’s management processes.

	
1.1.13
	
We understand that elements of EVMS will be applied to all applicable projects as part of the IMP. In addition, the Contractor will submit a written summary of the management procedures that will be used to establish, maintain and comply with EVMS requirements.

	
1.1.13.1
	
Decision Gate Reporting: On completion of a stage of the product development, as defined in the agreed upon IMS and IMP, the Contractor will prepare and submit to the Project Officer and the Contracting Officer a Decision Gate Report that contains (i) sufficient detail, documentation and analysis to support successful completion of the stage according to the predetermined qualitative and quantitative criteria that were established for Go/No Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to the next stage of product development.

	
1.1.14
	
Risk Management Plan: The Contractor will develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan will reference relevant WBS elements where appropriate. Updates to this plan will be included every 3 months (quarterly) in the monthly Project Status Report.

	
1.1.15
	
Performance Measurement Baseline Review (PMBR): The Contractor will submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA will mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines will be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as follows:

	

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

	

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

	

	

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

	

	
IV. Provide confidence in the validity of the Contractor’s reporting

	

	
V. Identify risks associated with the PMB

	

	
VI. Present any revised PMBs for mutual agreement

	

	
VII. Present an IMS: The Contractor will deliver an initial program IMS that rolls up all time-phased WBS elements down to the activity level. This IMS will include the dependencies that exist between tasks. This 1MS will be agreed to and finalized at the PMBR.

	

	
VIII. Present the Risk Management Plan

	
1.1.16
	
Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor will submit a Deviation Report. This report will be used to request a change in the agreed-upon IMS and timelines, if necessary. This report will include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.

	
1.1.17
	
Monthly and Annual Reports: The Contractor will deliver Project Status Reports on a monthly basis. The reports will address the items below cross referenced to the WBS, SOW, IMS, and EVMS:

	

	
I. Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory;

	

	
II. Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps;

	

	
III. Updated IMS;

	

	
IV. Updated EVMS;

	

	
V. Updated Risk Management Plan (Every 3 months);

	

	
VI. Three month rolling forecast of planned activities;

	

	
VII. Progress of regulatory submissions;

	

	
VIII. Estimated and actual expenses;

	
1.1.18
	
Data Management: The Contractor will develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all contract data;

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1.1.18.1
	
Provide for the statistical design and analysis of data resulting from the research;

	
1.1.18.2
	
Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request.

	
1.2
	
Non-Clinical Development (WBS 1.2) 

	
1.2.1
	
PK/PD (WBS 1.2.1 - reserved) 

	
1.2.2
	
Safety (WBS 1.2.2)

	
1.2.2.1
	
Segment 3 toxicology (WBS 1.2.2.1): A Segment 3 toxicology study will be conducted to evaluate effects of SOLI on gestation, parturition, and lactation.

	
1.2.2.2
	
Juvenile toxicology (WBS 1.2.2.2): This study is designed to characterize postnatal developmental toxicities that would not be detected in routine perinatal/postnatal toxicity study designs. NOTE: Segment II toxicology generally provides sufficient data to proceed with pediatric studies for antibiotics in the macrolide class. Therefore, although the Contractor has budgeted for juvenile toxicology in the Cost Proposal, the Contractor does not propose to do this study unless specifically requested by the FDA.

	
1.3
	
Non-Clinical Biodefense (WBS 1.3)

	
1.3.1
	
Agent Characterization (WBS 1.3.1 - reserved)

	
1.3.2
	
Model Development (WBS 1.3.2)

	
1.3.2.1
	
Determination of Protein Binding in Monkey Plasma (WBS 1.3.2.1): When modeling IV doses in monkeys that equate to the human therapeutic oral dose (for CABP), the degree of protein binding of SOLI in monkey plasma must be taken into consideration.

	
1.3.2.2
	
Reverse PK/PD Modeling for Non-Human Primate (NHP) Dose (WBS 1.3.2.1): IV dosing of monkeys is necessary to overcome the first pass metabolism that SOLI undergoes after oral administration in monkeys, which is unlike that seen in human oral studies. The pharmacokinetic (PK) data from a previously completed 28-day IV toxicology/toxicokinetic study in non-infected cynomolgus monkeys administered various SOLI dosing regimens will be used to develop a structural population PK model describing the disposition of SOLI. Using this population PK model, SOLI dosing regimens will be identified which provide concentration-time profiles similar to those for dosing regimens being developed for treatment of patients with community-acquired bacterial pneumonia (CABP).

	
1.3.2.3
	
Pilot NHP efficacy study in cynomolgus macaques for treatment of inhalational anthrax (WBS 1.3.2.2): In this non-GLP study, an established monkey model will be used to determine the effective dose & duration of SOLI necessary for treatment of inhalational anthrax.

	

	

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	1.3.2.4	
Pilot NHP efficacy study in cynomolgus macaques for treatment of pneumonic tularemia (WBS 1.3.2.3): In this non-GLP study, an established monkey model will be used to determine the effective dose & duration of SOLI necessary for treatment of inhalational tularemia.

	
1.3.2.5
	
PK/PD Confirmation Modeling and Determination of Dose for Pivotal Efficacy Studies (WBS 1.3.2.1): Using the data from the pilot treatment efficacy studies in NHPs, population PK and PK/PD analyses will be conducted. The population PK model based on data from non-infected cynomolgus monkeys will be refined as necessary to describe the data from cynomolgus monkeys infected with biothreat agents including B. anthracis or F. tularensis. This refined population PK model will be used to predict exposures for the humanized SOLI dosing regimens studied. PK-PD analyses for efficacy will then be conducted and PK-PD relationships based on these analyses will be used to guide selection of SOLI dosing regimens for further evaluation in pivotal studies.

	
1.3.3
	
Efficacy and Safety (WBS 1.3.3)

	
1.3.3.1
	
Pivotal NHP efficacy study in cynomolgus macaques for treatment of inhalational anthax (WBS 1.3.3.1): A protocol/synopsis will be drafted for a pivotal anthrax efficacy study in NHPs. Study design will be based on Animal Rule guidance and treatment efficacy data from the pilot anthrax study in NHPs.

	
1.3.3.2
	
Pivotal NHP efficacy study in cynomolgus macaques for treatment of pneumonic tularemia (WBS 1.3.3.2): A protocol/synopsis will be drafted for a pivotal tularemia efficacy study in NHPs. Study design will be based on Animal Rule guidance and treatment efficacy data from the pilot tularemia study in NHPs.

	
1.4
	
Clinical Studies (WBS 1.4) 

	
1.4.1
	
Phase 1 (WBS 1.4.1)

	
1.4.1.1
	
Pediatric Dose Determination (WBS 1.4.1.1 and WBS 1.4.1.2): Compartmental PK/PD modeling and simulation of doses that takes into account body weight, height and the volume of distribution differences in pediatrics will be conducted. In addition, pediatric dose-determination studies will be performed to determine dose adjustments from the adult dose that are related to differences in CYP-based metabolism and drug elimination pathways in young children. Population variability in the pediatric age groups as well as the potential for drug-drug interactions will be taken into consideration.

	
1.4.1.2
	
Phase la Adolescents PK and Safety Study (WBS 1.4.1.1): The doses determined by the modeling experiments will be tested to determine safety and PK of SOLI in adolescents. Since Phase 1 studies in pediatrics are performed as an add-on to standard therapy in patients, a multiple day dosing strategy is proposed as it can be beneficial to current therapy, while a single dose will have limited added benefit. The Phase la safety and PK study will be performed with oral capsules in an open-label study in adolescents (12-17 years) receiving concomitant antibiotic treatment. Each 

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cohort will contain 8-16 subjects. SOLI bioanalytical method development and validation in small volumes of human plasma and using dried blood spots (DBS) will be performed to support analysis of SOLI plasma levels in pediatric populations. Validation of DBS analysis will be performed if feasible and only if sufficient volume is available in blood draws.

	
1.4.1.3
	
Phase 1 Suspension Bioavailability Study (WBS 1.4.1.3): The relative bioavailability of the SOLI suspension formulation (relative to capsules) will be determined in healthy adult volunteers in an open-label, randomized, cross-over study.

	
1.4.1.4
	
Phase lb Pediatric PK and Safety Study site startup activities, including protocol development, site selection and startup activities, and shipment of drug and PK kits (WBS 1.4.1.2): The Phase lb safety and PK study will be designed for administration of oral capsules, suspension, and IV solution in children <12 years, and administration of IV solution-only in adolescents (12-17 years) receiving concomitant antibiotic treatment.

	
1.4.2
	
Phase 2/3 (WBS 1.4.2 - reserved)

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1.5Regulatory (WBS 1.5) 

	
1.5.1
	
IND (WBS 1.5.1)

	
1.5.1.1
	
Pediatric Study Plan: The Contractor will submit a pediatric plan to the FDA within 60 days after the EOP2 meeting for the adult CABP and gonorrhea (GC) indications. The Contractor will submit an Agreed Initial PSP within 90 days of a meeting with FDA or receipt of written comments from FDA on the PSP.

	
1.5.1.2
	
Meeting with FDA regarding Pediatric Development: When the Contractor submits the Pediatric Study Plan to FDA, a request will be made to hold a meeting with FDA to discuss the proposed pediatric studies.

	
1.5.1.3
	
The Contractor will submit the Phase la protocol (Adolescent PK study) to FDA for review and comment.

	
1.5.1.4
	
The Contractor will submit a new IND for SOLI Powder for Oral Suspension (POS) including full CMC information on the suspension formulation, an updated Investigator Brochure and the final protocol for the Phase 1 suspension bioavailability study. The new IND will cross-reference data in the oral capsule and IV INDs. The Contractor will provide BARDA with all data submitted with the new IND.

	
1.5.2
	
NDA Activities (WBS 1.5.2)

	
1.5.2.1
	
The Contractor will submit a CMC Amendment for newly manufactured capsules (to be used in the Phase la/lb Pediatric PK and Safety Studies).

	
1.5.2.2
	
The Contractor will submit a CMC Amendment for the new IV formulation containing tri-amino acid buffer (to be used in the Nonclinical Biodefense animal studies and Phase lb Pediatric PK and Safety Studies).

	
1.5.2.3
	
After completion of each study, the Contractor will update relevant IND modules/summaries and submit all data and reports to the IND.

	
1.5.2.4
	
After completion of the NHP pilot studies and data analysis, the Contractor will submit a meeting request to FDA to discuss study design for pivotal NHP treatment efficacy studies and the path forward for the Animal Rule indication. A briefing document containing study designs and issues for discussion will be submitted to the FDA at least 30 days before the meeting.

	
1.5.2.5
	
The Contractor will submit the pivotal NHP treatment efficacy protocols along with dose justification to the FDA.

	
1.5.2.6
	
The Contractor will submit the Phase la Adolescent PK Study protocol to the SOLI capsule IND prior to enrollment of the first patient.

	
1.5.2.7
	
The Contractor will submit a Phase lb Pediatric Study protocol including PK/PD modeling of IV and capsules to FDA for review. Prior to enrollment of the first patient, the Contractor will submit the Phase lb protocol to the IND. If necessary, after determination of the relative bioavailability of the suspension formulation, 

	

	

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and prior to enrollment of suspension cohorts, the Contractor will submit a Phase lb Study protocol amendment.

1.6CMC (WBS 1.6)

	
1.6.1
	
Chemistry (Formulation Studies) (WBS 1.6.1)

	
1.6.1.1
	
Obtain API: Drug substance will be sourced from the Contractor’s current API supplier.

	
1.6.1.2
	
Preformulation Studies: Preformulation studies will include pH solubility profiling, pH stability profiling, taste threshold evaluation and stress testing of SOLI. Part of the formulation development will be a study to assess excipients compatibility with SOLI. Commonly used pharmaceutical excipients suitable for a POS dosage formulation of SOLI, such as diluents, sugars, sugar alcohols, hydroxypropyl cellulose, viscosity improvers (xanthan gum, etc.) and preservatives (potassium sorbate, etc.) will be evaluated for compatibility with SOLI. Mixtures of SOLI and the excipients will be prepared and exposed to several stress conditions and placed on short term stability. Samples will be pulled after storage and stability will be assessed. To support the taste masking efforts the solubility of SOLI in the preferred suspending vehicles including water will be evaluated. SOLI In this study the water can be buffered to a pH in the range of 6 - 8, because SOLI solubility is low in this pH range.

	
1.6.1.3
	
Formulation development and stability studies: The target POS will be formulated to consist of approximately 10-20% SOLI as powder and to deliver approximately 30-70 mg/mL of SOLI as suspension upon reconstitution. Considerations for development of the POS formulation are: taste of suspension, suspendability, uniformity of dosage form (POS blend uniformity / sample from reconstituted suspension), powder flow, particle size, bulk density and moisture content. During trial formulations, the main considerations are: taste of suspension, suspendability, uniformity of dosage form and moisture content. Stability studies on prototype POS formulations in bottle packaging will be conducted. Stability studies on prototype reconstituted suspension will also be conducted. The need for an antioxidant in the formulation will be evaluated as part of the development.

	
1.6.1.4
	
Taste-masking formulation development: For initial approach, organoleptic method will be tried, which includes non-reducing sugars, sugar alcohols, other sweetener and other excipients to mask the bitter taste of the API. Initial taste masking development work may include a wet granulation technique using non-reducing sugars (e.g. powdered sucrose) and/or sugar alcohols as diluents and binders (e.g. hydroxypropyl cellulose). This approach will also establish a suspendability upon reconstitution, content uniformity, and flowability of the powder. If it is difficult to improve taste by organoleptic method, a POS formulation would be developed by physical taste masking method or combination of organoleptic method and physical method. Taste-masking sensory panels will evaluate the taste of the reconstituted suspension from the POS, and provide 

	

	

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feedback to the formulation team. Studies will also include the selection of the appropriate container size for the POS and evaluation of the ability of the dose measurement device (syringe or dose cup to deliver the required dose). Compatibility of the container closure with the POS and compatibility of the dosing device (syringe or Dosing cup) with the reconstituted POS will also be evaluated.

	
1.6.2
	
Pre-Clinical Manufacturing (WBS 1.6.2)

	
1.6.2.1
	
POS Feasibility Lots: The formulation and process variables that are critical to meet the target product profile will be reconfirmed and used to guide the manufacture of clinical trial material (CTM) for Phase 1. A stability study will be conducted on the drug product from the feasibility lot.

	
1.6.3
	
Pilot Scale Manufacturing (WBS 1.6.3)

	
1.6.3.1
	
Contractor will manufacture, package, label and release Capsule and IV drug product for shipment to Phase 1 clinical sites. Executed batch records will be sent to BARDA.

	
1.6.3.2
	
Contractor will manufacture, package, label and release applicable IV drug product supplies for the NHP pilot studies.

	
1.6.3.3
	
Phase 1 clinical trial material (CTM) lots of POS: Current plans are to manufacture CTM for Phase I studies. Excipients complying with the standard of USP/NF/EP and excipients that have already been used in commercially available drug products in US/EU will be used. A stability study will be performed at Toyama Chemical according to the ICH guidelines. Clinical (primary) packaging is planned. The POS for clinical studies will be packaged in wide-mouthed HDPE bottles with each bottle containing a 5 day course of therapy for Phase lb. The higher strength formulation will be packaged and shipped first to support the Bioavailability study. The bottles will be labeled based on English text provided by Cempra. Supplies should be shipped in time to start clinical trials in the US. A full Certificate of Analysis for the CTM batch will be provided.

	
1.6.4
	
Commercial (WBS 1.6.4 - reserved)

	
1.6.5
	
Controls/Analytical Validation (WBS 1.6.5)

	
1.6.5.1
	
Analytical methods will be set with the same conditions and concentration of sample/standard solution as those of the current SOLI 200 mg capsule drug product. Appropriate diluents will be selected to extract SOLI from the powder for oral suspension drug product. For method validation, Specificity, Linearity, Detection Limit, Quantitation Limit, Accuracy and Repeatability will be performed before the pediatric pharmacokinetic (PK) studies (early clinical stage) and Intermediate Precision and Robustness will be performed before completion of registration batches. The analytical methods required include:

Page 11 of 23

 

	
·
	
Appearance and Identification by HPLC

	
·
	
Product Assay and Related Substances Assay

	
·
	
Dissolution

	
·
	
Moisture Content

	
·
	
Microbial Limit Testing (MLT)

	
·
	
Preservative Assay (as appropriate)

	
·
	
Anti-oxidant Assay (as appropriate)

Page 12 of 23

 

2. CLIN 2

	
2.1
	
Program Management (WBS 2.1)

The Contractor outsources a majority of the work to established practitioners in each discipline, with the Contractor team providing experienced program management, coordination, and oversight. All selected purchased commercial service providers for the BARDA project have proven their ability to deliver quality work cost-effectively and on schedule. The Contractor shall provide for the following program management activities as outlined below: 

	
2.1.1
	
The Contractor will provide overall management, integration and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities. 

	
2.1.2
	
The Principal Investigator is responsible for overall leadership for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors. 

	
2.1.3
	
The Project Manager will oversee the monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities: costs incurred; and program management. 

	
2.1.4
	
The Principal Investigator and the Project Manager will act as the BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer. 

	
2.1.5
	
The Contractor has adequate administrative staff and legal consultants to provide development of compliant subcontracts, consulting, and other legal agreements, and ensure timely acquisition of all proprietary rights, including IP rights, and reporting all inventions made in the performance of the project. 

	
2.1.6
	
The Contractor’s Project Management Team along with support from the Finance department has responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors and service providers. 

	
2.1.7
	
Contract Review Meetings

	
2.1.7.1
	
The Contractor’s team will participate in regular face-to-face meetings on a quarterly basis 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 Contractor 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 

	

	

Page 13 of 23

 

		
ethical aspects of the program:, and meeting with technical consultants to discuss technical data provided by the Contractor. 

	
2.1.7.2
	
The Contractor will participate in teleconferences every 2 weeks between the Contractor and BARDA to review technical progress. The Contractor will include subcontractors and service providers as necessary. If additional teleconferences or face-to-face meetings are requested by BARDA, the Contractor will be available. 

	
2.1.8
	
Integrated Master Schedule (IMS)

	
2.1.8.1
	
Within 30 calendar days of the effective date of the contract, the Contractor will submit a first draft of an updated IMS to the Project Officer and the Contracting Officer for review and comment. The Integrated Master Schedule will be used to monitor performance of the contract. The Contractor will include key milestones and Go/No Go decision gates. The IMS for the period of performance will be reviewed and accepted by BARDA at the PMBR. 

	
2.1.8.2
	
Changes to the IMS: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor will submit a Baseline Change Request. This report will be used to request a change in the agreed-upon IMS and timelines, if necessary. 

	
2.1.9
	
Work Breakdown Structure: The Contractor will utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor will expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA. 

	
2.1.10
	
GO/ NO-GO Decision Gates/Contract Milestones: The Go/No Go Milestones will outline key objectives with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). The milestones should include, but not be limited to, objectives in manufacturing, non-clinical and clinical studies, and regulatory submissions. 

	
2.1.11
	
Earned Value Management System: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor will use principles of Earned Value Management System (EVMS) in the management of this contract. The Contractor will follow the Seven Principles: 

	

	
VIII. The Contractor will plan all work scope for the program to completion. 

	

	
IX. The Contractor will 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. 

	

	
X. The Contractor will integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. 

	

	
XI. The Contractor will use actual cost incurred and recorded in accomplishing the work performed. 

Page 14 of 23

 

	

	
XII. The Contractor will objectively assess accomplishments at the work performance level. 

	

	
XIII. The Contractor will analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed. 

	

	
XIV. The Contractor will use earned value information in the company’s management processes as it relates to the BARDA contract. 

	
2.1.12
	
Risk Management Plan: The Contractor will develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan will reference relevant WBS elements where appropriate. Updates to this plan will be made as deemed necessary. 

	
2.1.13
	
Performance Measurement Baseline Review (PMBR): The Contractor will submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA will mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines will be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as follows: 

	

	
IX. 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 

	

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

	

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

	

	
XII. Provide confidence in the validity of the Contractor’s reporting

	

	
XIII. Identify risks associated with the PMB 

	

	
XIV. Present any revised PMBs for mutual agreement

	

	
XV. Present an IMS: The Contractor will deliver an initial program IMS that rolls up all time-phased WBS elements down to the activity level. This IMS will include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. 

	

	
XVI. Present the Risk Management Plan

	
2.1.14
	
Monthly and Annual Reports: The Contractor will deliver Project Status Reports on a monthly basis. The reports will address the items below cross referenced to the WBS, SOW, IMS, and EVMS: 

	

	
IX. Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory 

	

	
X. Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps 

Page 15 of 23

 

	

	
XI. Updated 1MS 

	

	
XII. Updated EVMS 

	

	
XIII. Two month rolling forecast of planned activities

	

	
XIV. Progress of regulatory submissions 

	

	
XV. Estimated and actual expenses 

2.2Non-Clinical Development (WBS 2.2 — reserved)

2.3Non-Clinical Biodefense (WBS 2.3 — reserved)

2.4Clinical (WBS 2.4)

	
2.4.1
	
Phase 1 (WBS 2.4.1)

	
2.4.1.1
	
Phase lb Pediatric PK Study (WBS 2.4.1.1): The Contractor will conduct a multiple dose PK and safety study in pediatrics. This open-label study will be performed with oral capsules, suspension, or IV solution in children less than 12 years, and with IV solution-only in adolescents (12-17 years).  Each cohort can contain up to 16 subjects. PK and safety data may be published in a peer-reviewed scientific journal.  Changes to the clinical design may occur based on the Cempra’s assessment with input from BARDA. 

	
2.4.1.2
	
PK/PD-modeling for pediatric therapeutic dose justification for Phase 2/3 trial (WBS 2.4.1.2): Using PK data from Phase la/b studies, the population PK will be modeled. Pediatric therapeutic doses will be selected based upon the target attainment PK/PD modeling based on plasma and pulmonary levels in adult subjects.

	
2.4.2
	
Phase 2/3 (WBS 2.4.2)

	
2.4.2.1
	
Phase 2/3 pediatric CABP study Startup activities (WBS 2.4.2.1): The Phase 2/3 safety study will be designed for administration of oral capsules, suspension, and IV solution in pediatric CABP patients receiving concomitant antibiotic treatment. The Phase 2/3 study startup activities will include but are not limited to: development of a protocol and SAP, site feasibility/selection and activation activities, development of an Informed Consent Form, Clinical Monitoring Plan, Regulatory Binder, Safety Reporting Plan, Data Management Plan and other study documentation (to include any foreign regulatory submission documents), establishing a DSMC and charter, and shipment of CTM and PK kits. Changes to the clinical design may occur based on Cempra’s assessment with input from BARDA. 

Page 16 of 23

 

2.5Regulatory (WBS 2.5)

	
2.5.1
	
IND (WBS 2.5.1 — reserved)

	
2.5.2
	
NDA (WBS 2.5.2)

	
2.5.2.1
	
The Contractor will submit IND Amendments for CTM batches (WBS 2.5.2.1)

	
2.5.2.2
	
The contractor will submit IMPDs for Pediatric studies (multiple countries)

	
2.5.2.3
	
The contractor will submit taste optimization/ DOE work to FDA for POS formulation

	
2.5.2.4
	
The Contractor will submit the Pediatric Phase 2/3 protocol and Clinical Study Regulatory Documents to FDA (WBS 2.5.2.2)

	
2.5.2.5
	
The Contractor will submit an NDA for IV and oral capsules in adults for CABP and GC indications, including adolescent GC patients. PDUFA fees for these NDAs will be covered by the Contractor (WBS 2.5.2.3).

	
2.5.2.6
	
The Contractor will submit the Phase lb CSR to the FDA (WBS 2.5.2.4).

	
2.5.2.7
	
The Contractor will submit other BARDA related Regulatory/Ethics Committee amendments and summaries as deemed necessary by Cempra’s Regulatory team. 

2.6CMC (WBS 2.6)

	
2.6.1
	
Chemistry (Formulation Studies) (WBS 2.6.1)

	
2.6.1.1
	
Obtain API: Drug substance will be sourced from the Contractor’s current API supplier.

Page 17 of 23

 

	
2.6.1.2
	
Formulation studies will be conducted at a CMO. These include but are not limited to:

	
2.6.1.2.1
	
Excipient compatibility: Several studies will be performed to evaluate the effect of different excipients on the formulation. The excipients include but are not limited to: sucralose, magna-sweet, sodium chloride, flavor, colorant and citric acid. 

	
2.6.1.2.2
	
Formulation optimization: Several studies to optimize the formulation composition identified from taste evaluation work will be conducted at Catalent. A Design of Experiments (DoE), or similar approach, will be used. Studies will include, but are not limited to: 

	
·
	
Determination of buffer capacity

	
·
	
Determine the amount of anti-forming agent required

	
·
	
The amount of shaking to re-suspend the powder

	
·
	
The level of preservative in the formulation 

	
·
	
The addition of a colorant to improve aesthetic appeal 

	
·
	
The amount of water required for reconstitution to a target concentration 

	
·
	
A method for reconstitution

	
2.6.2
	
Pre-Clinical Manufacturing (WBS 2.6.2)

	
2.6.2.1
	
POS Process Optimization: After the formulation optimization DoE work is completed, manufacturing process development and optimization to support the manufacture of clinical supplies for the Phase 2/3 studies will be conducted. The key requirements of the process include, but are not limited to, these items listed below:

	
·
	
The process should consistently yield a homogeneous blend

	
·
	
The POS blend should flow sufficiently well for machine processing

	
·
	
The process should be scalable

	
·
	
The process should be efficient with just enough steps to yield a consistent product

The formulation and process variables that are critical to meet the target product profile will be determined and used to guide the manufacture of clinical trial material (CTM) for Phase 1. A stability study will be conducted on the POS manufactured at target parameters.

Page 18 of 23

 

	
2.6.2.2
	
Process confirmation: At least one process confirmation batch will be manufactured at the 20-50 kg scale. The batch(es) will be packaged and set on stability. The results from the process confirmation batch(es) will guide manufacture of a clinical batch for the phase 2/3 studies.

	
2.6.3
	
Pilot Scale Manufacturing (WBS 2.6.3)

	
2.6.3.1
	
Capsules and IV vials will be acquired and packaged for the pediatric Phase 2/3 study (WBS 2.6.3.2).

	
2.6.3.2
	
Phase 2/3 POS CTM (WBS 2.6.3.4): Manufacturing, packaging, quality studies, and stability study will be conducted at a CMO. Phase 2/3 CTM will be manufactured at an appropriate scale and, if possible, will suffice as 1 of the 3 registration batches needed for NDA submission. (Registration batch manufacturing, packaging and testing originally planned for CLIN 2 will now be conducted in a future CLIN). SOLI will be compared to the Standard of Care (SOC) treatment. If necessary, Cempra will have to procure SOC comparator products as well. 

	
2.6.4
	
Commercial (WBS 2.6.4 - reserved)

	
2.6.5
	
Controls/Analytical Validation (WBS 2.6.5).

	
2.6.5.1
	
POS Phase 1 CTM Stability Study (WBS 2.6.5.1)

	
2.6.5.2
	
Analytical methods to support formulation and process optimization will be adapted from those used in the manufacture of phase 1 clinical supplies. These methods will be further developed and validated to support the phase 2/3 study. The analytical methods required include, but are not limited to:

 

	
·
	
Appearance and Identification by HPLC

	
·
	
Product Assay and Related Substances Assay

	
·
	
Dissolution

	
·
	
Moisture Content

	
·
	
Microbial Limit Testing (MLT)

	
·
	
Preservative Assay (as appropriate)

	
·
	
Microbial Effectiveness Test (AET) methods

Page 19 of 23

 

3. CLIN 3

3.1Program Management (WBS 3.1)

	
3.1.1
	
Program management scope is consistent with that outlined in CLIN 2. 

	
3.2
	
Non-Clinical Development (WBS 3.2 - reserved)

	
3.3
	
Non-Clinical Biodefense (WBS 3.3)

	
3.3.1
	
Agent Characterization (WBS 3.3.1 — reserved)

	
3.3.2
	
Model Development (WBS 3.3.2 — reserved)

	
3.3.3
	
Efficacy and Safety (WBS 3.3.3)

	
3.3.3.1
	
Pivotal NHP Efficacy Study in cynomolgus macaques for treatment of inhalational anthrax (WBS 3.3.3.1): The therapeutic dose selected based on the pilot NHP study and PK/PD modeling will be tested in the pivotal GLP study to determine the efficacy of SOLI in the therapeutic model of inhalational anthrax in cynomolgus monkeys.

	
3.3.3.2
	
Pivotal NHP Efficacy Study in cynomolgus macaques for treatment of inhalational tularemia (WBS 3.3.3.2): The dose selected based on the pilot NHP study and PK/PD modeling will be tested in a pivotal GLP study to determine the efficacy of SOLI in the therapeutic model of inhalational tularemia in cynomolgus monkeys.

	
3.3.3.3
	
PK/PD Modeling and Translation to Human Dose for Treatment of Inhalational Anthrax and Tularemia (WBS 3.3.3.3): The plasma concentration-time data from the infected cynomolgus monkeys will be evaluated using a similar structural population PK model as that previously developed for the non-infected animals, and individual SOLI exposure measures (AUC) will be generated for each animal. These individual exposure measures will then be utilized in subsequent PK/PD analyses for both animal survival and SOLI microbiologic response. The relationship between the AUC:MIC ratio and the efficacy endpoints, animal survival, and the microbiological response to therapy measured at the end-of-therapy, will be examined. If trends for PK/PD relationships for efficacy are observed, initial graphical analyses of efficacy endpoints will be followed by univariable and multivariable logistic or other nonlinear regression modeling techniques. In addition, a survival analysis (i.e., time-to-event analysis) may be conducted if appropriate. These pharmacokinetic parameters will be used to calculate the therapeutic doses for inhalational anthrax and inhalational tularemia in human adults. Upon completion of pediatric PK studies, the therapeutic doses for children for biodefense indications will be extrapolated from the pediatric PK/PD results.

Page 20 of 23

 

3.4Clinical (WBS 3.4)

	
3.4.1
	
Phase 1 (WBS 3.4.1)

	
3.4.1.1
	
Phase 1 Multiple dose PK and Safety study in Human (Adult) Volunteers (WBS 3.4.1.1): The multidose study is planned for 21 days, but could be shortened if efficacy is demonstrated with a shorter duration of SOLI treatment in the NHP studies.

	
3.4.2
	
Phase 2/3 (WBS 3.4.2 - reserved)

3.5Regulatory (WBS 3.5)

	
3.5.1
	
IND (WBS 3.5.1 — reserved) 

	
3.5.2
	
NDA (WBS 3.5.2)

	
3.5.2.1
	
After completion of the NHP pilot studies, the Contractor will submit a meeting request to FDA to discuss submission of the supplemental NDA for the Animal Rule indications (WBS 3.5.2.1).

	
3.5.2.2
	
The Contractor will submit supplemental NDAs for use of SOLI capsule and IV formulations for the biodefense indications under the Animal Rule (WBS 3.5.2.2).

3.6CMC (WBS 3.6)

	
3.6.1
	
Chemistry (Formulation Studies) (WBS 3.6.1 - reserved)

	
3.6.1.1
	
Obtain API: Drug substance will be sourced from the Cempra’s current API supplier. Registration grade API is required for POS registration batches.

	
3.6.2
	
Pre-Clinical Manufacturing (WBS 3.6.2 - reserved)

	
3.6.3
	
Pilot Scale Manufacturing (WBS 3.6.3)

	
3.6.3.1
	
POS registration batches will be manufactured.

	
3.6.3.2
	
IV drug product supplies will be packaged for NHP pivotal studies (WBS 3.6.3.1) 

	
3.6.4
	
Commercial (WBS 3.6.4 - reserved)

	
3.6.5
	
Controls/Analytical Validation (WBS 3.6.5)

	
3.6.5.1
	
POS Phase 2/3 CTM Stability Study (WBS 3.6.5.1)

Page 21 of 23

 

4. CLIN 4 (GOVERNMENT/CONTRACTOR COST-SHARE) 

4.1Program Management (WBS 4.1)

	
4.1.1
	
Program management scope is consistent with that in CLIN 3. 

4.2Non-Clinical Development (WBS 4.2 - reserved)

4.3Non-Clinical Biodefense (WBS 4.3 - reserved)

4.4Clinical Studies (WBS 4.4)

	
4.4.1
	
Phase 1 (WBS 4.4.1 - reserved)

	
4.4.2
	
Phase 2/3 (WBS 4.4.2)

	
4.4.2.1
	
Phase 2/3 Pediatric CABP Trial (WBS 4.4.2.1): Since CABP infection in children is similar to that documented in adults, results of microbiological efficacy in adults could be extrapolated to children with similar antimicrobial exposure. Therefore, a Phase 2/3 study is proposed following completion of the Phase 1 studies. These studies will be conducted after successful completion of adult CABP trials and submission of the NDA for adult CABP. Sparse PK sampling will be conducted and used in Pop PK modeling. These outline of this study has been approved in the PSP and the PIP.

4.5Regulatory (WBS 4.5 - reserved)

4.6CMC (WBS 4.6 - reserved)

Page 22 of 23

 

5. CLIN 5

5.1Program Management (WBS 5.1)

	
5.1.1
	
Program management scope is consistent with that in CLIN 4. 

5.2Non-Clinical Development (WBS 5.2 - reserved)

5.3Non-Clinical Biodefense (WBS 5.3 - reserved)

5.4Clinical (WBS 5.4 - reserved)

5.5Regulatory (WBS 5.5)

	
5.5.1
	
IND (WBS 5.5.1 - reserved)

	
5.5.2
	
NDA (WBS 5.5.2)

	
5.5.2.1
	
At the completion of the Phase 2/3 pediatric CABP trial, the Contractor will submit an NDA for oral suspension for CABP in adults and pediatric populations to the FDA, including a biodefense indication under the Animal Rule (WBS 5.5.2.1).

	
5.5.2.2
	
The Contractor will submit supplemental NDAs for use of SOLI capsule and IV formulations for the CABP and biodefense indications in pediatric patients (WBS 5.5.2.2).

5.6CMC (WBS 5.6 - reserved)

6. OTHER ITEMS

6.1Facilities, Equipment, and Other Resources

The Contractor confirms the subcontractor and all purchased commercial service providers provide equipment, facilities and other resources under Federal and HHS regulations.

Page 23 of 23Exhibit 10.29

 

EMPLOYMENT AGREEMENT

 

This EMPLOYMENT AGREEMENT
(“Agreement”) is entered into to be effective as of the 15th day of June, 2012 (the “Effective Date”),
by and between Tronox LLC, a Delaware limited liability company (together with its successors and assigns, the “Company”),
and Willem Hendrik Van Niekerk, an individual (the “Executive”).

 

WHEREAS, the Company
and the Executive desire to enter into this Agreement to set out the terms and conditions for the continued employment relationship
of the Executive with the Company.

 

NOW, THEREFORE, in
consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration, the receipt
and sufficiency of which hereby are acknowledged, the parties hereto agree as follows:

 

1.                 
Employment Agreement. Effective on the Effective Date, on the terms and conditions set forth in this Agreement,
the Company agrees to employ the Executive and the Executive agrees to continue to be employed by the Company for the Employment
Period set forth in Section 2 and in the positions and with the duties set forth in Section 3. Terms used
herein with initial capitalization not otherwise defined are defined in Section 25.

 

2.                 
Term. The term of employment under this Agreement shall commence on the Effective Date and continue until
the third (3rd) anniversary of the Effective Date (the “Term”). Commencing on June 15, 2015 and each anniversary
thereof, the Term shall automatically be extended by twelve (12) months unless either party has provided written notice to the
other at least ninety (90) days before the end of the Term of its or his desire to not so extend the Term. The period of time between
the Effective Date and the termination of the Executive’s employment hereunder shall be referred to as the “Employment
Period.” Notwithstanding the foregoing, the Executive’s employment hereunder may be earlier terminated in accordance
with Section 9 hereof, subject to Section 10 hereof.

 

3.                 
Position and Duties. During the Employment Period, the Executive shall serve as the Senior Vice President,
Strategic Planning & Business Development of the Company’s ultimate parent company and shall report directly to
the Chief Executive Officer, Tronox Ltd (the Company’s ultimate parent company). The Executive shall have the duties, responsibilities
and authorities customarily associated with the position of Senior Vice President, Strategic Planning & Business Development
in a company the size and nature of the Company. The Executive shall devote the Executive’s reasonable best efforts and full
business time to the performance of the Executive’s duties hereunder and the advancement of the business and affairs of the
Company and shall be subject to, and shall comply in all material respects with, the policies of the Company and the Company Affiliates
applicable to the Executive; provided that the Executive shall be entitled (i) to serve on the corporate, civic or
charitable boards or committees on which the Executive is serving as of the Effective Date and has notified the Board of in writing,
(ii) to serve as a member of the board of directors of a reasonable number of other companies, subject to the advance approval
of the Board of Directors of the Company (the “Board”), (iii) to serve on civic, charitable, educational, religious,
public interest or public service boards, and (iv) to manage the Executive’s personal and family investments, in each case,
to the extent such activities do not materially interfere with the performance of the Executive’s duties and responsibilities
hereunder.

 

    	 

    	 

    

4.                 
Place of Performance. During the Employment Period, the Executive shall be based at the Company’s principal
executive offices in Stamford, Connecticut; provided that the Executive understands and agrees that the Executive may be
required to travel from time to time for business purposes.

 

5.                 
Compensation and Benefits; Equity Awards.

 

(a)               
Base Salary. During the Employment Period, the Company shall pay to the Executive a base salary (the “Base
Salary”) at the rate of no less than $470,000 per calendar year, less applicable deductions.

 

(b)              
U.S. Payroll Requirements. The Base Salary shall be paid in substantially equal installments. In order to
be paid through the U.S. payroll, Executive must apply for and receive an approved notice from the USCIS (form I-797) and have
the U.S. Consulate stamp Executive’s visa into Executive’s passport. Once the Company is satisfied that Executive has
completed all necessary steps to be paid in the U.S., Executive shall be paid in accordance with the Company’s regular payroll
procedures.

 

(c)               
Annual Bonus. During the Employment Period, the Executive shall be paid an annual cash performance bonus (an
“Annual Bonus”) under the Company’s annual bonus plan (as in effect from time to time for senior executives)
in respect of each fiscal year that ends during the Employment Period, to the extent earned based on performance against performance
criteria. The performance criteria for any particular fiscal year shall be determined by the Compensation Committee of the Board
(the “Committee”), in good faith, after consultation with the Company’s Chief Executive Officer, no later
than sixty (60) days after the commencement of the relevant bonus period. The Executive’s target annual bonus opportunity
shall be no less than 70% of the Executive’s Base Salary as of the beginning of the applicable performance period
(the “Target Bonus”) if target levels of performance for that year are achieved, up to a maximum of 140% of
the Executive’s Base Salary. The Executive’s Annual Bonus for a bonus period shall be determined by the Committee after
the end of the applicable bonus period and shall be paid to the Executive in the calendar year following the year to which such
Annual Bonus relates when annual bonuses for that year are paid to other senior executives of the Company generally.

 

(d)              
Equity Awards. On June 15, 2012, and on commencing at the beginning of the next fiscal year and each year
thereafter during the Employment Period, the Executive shall be granted an annual equity award under the Tronox Limited Management
Equity Incentive Plan (or successor plan) with a grant date fair value equal to one hundred fifty percent (150%) of the Executive’s
Base Salary on the first day of the applicable fiscal year (the “Annual Equity Award”). The terms and conditions
applicable to any Annual Equity Award shall be determined by the Committee in accordance with the Company’s applicable long-term
incentive plan.

 

(e)               
Vacation; Benefits. During the Employment Period, the Executive shall be entitled to six (6) weeks of paid
vacation per calendar year (as prorated for partial years) in accordance with the Company’s policy on accrual and use applicable
to employees as in effect from time to time.

 

    	2

    	 

    

(f)               
 During the Employment Period, the Executive shall be eligible to participate in such medical, dental and life insurance,
retirement and other plans as the Company may have or establish from time to time on terms and conditions applicable to other senior
executives of the Company generally.  The foregoing, however, shall not be construed to require the Company to establish
any such plans or to prevent the modification or termination of such plans once established.

 

6.                 
Expenses.

 

(a)               
Business Expenses. The Company shall reimburse the Executive promptly for all expenses reasonably incurred
by the Executive in the performance of his duties in accordance with policies which may be adopted from time to time by the Company
following presentation by the Executive of an itemized account, including reasonable substantiation, of such expenses.

 

(b)              
The Executive shall be entitled to relocation services and relocation expense reimbursement as set forth under the
terms of that certain Relocation Services Letter among the MI Group and the Executive, dated June 4, 2012, attached hereto as Exhibit
A and incorporated herein.

 

7.                 
Confidentiality, Non-Disclosure and Non-Competition Agreement. The Company and the Executive acknowledge and
agree that during the Executive’s employment with the Company, the Executive will have access to and may assist in developing
Confidential Information and will occupy a position of trust and confidence with respect to the affairs and business of the Company
and the Company Affiliates. The Executive agrees that the following obligations are necessary to preserve the confidential and
proprietary nature of Confidential Information and to protect the Company and the Company Affiliates against harmful solicitation
of employees and customers, harmful competition and other actions by the Executive that would result in serious adverse consequences
for the Company and the Company Affiliates:

 

(a)               
Non-Disclosure. During and after the Executive’s employment with the Company, the Executive will not
knowingly use, disclose, copy or transfer any Confidential Information other than as authorized in writing by the Company or within
the scope of the Executive’s duties with the Company as determined reasonably and in good faith by the Executive. Anything
herein to the contrary notwithstanding, the provisions of this Section 7(a) shall not apply (i) when disclosure
is required by law or by any court, arbitrator, mediator or administrative or legislative body (including any committee thereof)
with actual or apparent jurisdiction to order the Executive to disclose or make accessible any information, provided that
prior to any such disclosure the Executive shall provide the Company with reasonable notice of the requirements to disclose and
an opportunity to object to such disclosure and the Executive shall cooperate with the Company in filing such objection; (ii) as
to information that becomes generally known to the public or within the relevant trade or industry other than due to the Executive’s
violation of this Section 7(a) or (iii) as to disclosure which are reasonably necessary to be made in connection with
a good faith judicial proceeding to enforce or defend the Executive’s rights under this Agreement or any other agreement
between the Executive and the Company.

 

    	3

    	 

    

(b)              
Materials. The Executive will use Confidential Information only for normal and customary use in the Company’s
business, as determined reasonably and in good faith by the Company. The Executive will return to the Company all Confidential
Information and copies thereof and all other property of the Company or any Company Affiliate in his possession or under his control
at any time upon the reasonable request of the Company and in any event promptly after termination of the Executive’s employment.
The Executive agrees to identify and return to the Company any copies of any Confidential Information after the Executive ceases
to be employed by the Company. Anything to the contrary notwithstanding, nothing in this Section 7 shall prevent the
Executive from retaining a home computer (provided all Confidential Information has been removed), papers and other materials of
a personal nature, including diaries, calendars and Rolodexes, information relating to his compensation or relating to reimbursement
of expenses, information that may be needed for tax purposes, and copies of plans, programs and agreements relating to his employment.

 

(c)               
No Solicitation or Hiring of Employees. During the Non-Compete Period, the Executive shall not, except in
the furtherance of the Executive’s duties hereunder, solicit, entice, persuade or induce any individual who is employed by
the Company or the Company Affiliates (or who was so employed within six (6) months prior to the Executive’s action) to terminate
or refrain from continuing such employment or to become employed by or enter into contractual relations with any other individual
or entity other than the Company or the Company Affiliates, and the Executive shall not hire, directly or indirectly, for himself
or any other person, as an employee, consultant or otherwise, any such person. Anything to the contrary notwithstanding, the Company
agrees that (i) the Executive’s responding to an unsolicited request from any former employee of the Company for advice
on employment matters; and (ii) the Executive’s responding to an unsolicited request for an employment reference regarding
any former employee of the Company from such former employee, or from a third party, by providing a reference setting forth his
personal views about such former employee, shall not be deemed a violation of this Section 7(c); in each case, to the
extent the Executive does not encourage the former employee to become employed by a company or business that employs the Executive
or with which the Executive is otherwise associated (including, but not limited to, association as a sole proprietor, owner, employer,
partner, principal, investor, joint venturer, shareholder, associate, employee, member, consultant, contractor, director or otherwise).

 

(d)              
Non-Competition.

 

(i)                
During the Non-Compete Period, the Executive shall not, directly or indirectly, (A) solicit, service, or assist
any other individual, person, firm or other entity in soliciting or servicing for a Competitive Enterprise any Customer for the
purpose of providing and/or selling any products that are provided and/or sold by the Company or its subsidiaries, or performing
any services that are performed by the Company or its subsidiaries, (B) interfere with or damage (or attempt to interfere with
or damage) any relationship and/or agreement between the Company or its subsidiaries and any Customer or (C) associate (including,
but not limited to, association as a sole proprietor, owner, employer, partner, principal, investor, joint venturer, shareholder,
associate, employee, member, consultant, contractor, director or otherwise) with any Competitive Enterprise; provided, however,
that Executive may own, as a passive investor, securities of any such entity that has outstanding publicly traded securities so
long as his direct holdings in any such entity shall not in the aggregate constitute more than one percent (1%) of the voting power
of such entity. The Executive acknowledges that this covenant has a unique, very substantial and immeasurable value to the Company,
that the Executive has sufficient assets and skills to provide a livelihood for the Executive while such covenant remains in force
and that, as a result of the foregoing, in the event that the Executive breaches such covenant, monetary damages would be an insufficient
remedy for the Company and equitable enforcement of the covenant would be proper.

 

    	4

    	 

    

(ii)              
If the restrictions contained in Section 7(d)(i) shall be determined by any court of competent jurisdiction
to be unenforceable by reason of their extending for too great a period of time or over too great a geographical area or by reason
of their being too extensive in any other respect, Section 7(d)(i) shall be modified to be effective for the maximum
period of time for which it may be enforceable and over the maximum geographical area as to which it may be enforceable and to
the maximum extent in all other respects as to which it may be enforceable.

 

(e)               
Conflicting Obligations and Rights. The Executive agrees to inform the Company of any apparent conflicts between
the Executive’s work for the Company and any obligations the Executive may have to preserve the confidentiality of another’s
proprietary information or related materials before using the same on the Company’s behalf. The Company shall receive such
disclosures in confidence and consistent with the objectives of avoiding any conflict of obligations and rights or the appearance
of any conflict of interest.

 

(f)               
Enforcement. The Executive acknowledges that in the event of any breach of this Section 7, the
business interests of the Company and the Company Affiliates will be irreparably injured, the full extent of the damages to the
Company and the Company Affiliates will be impossible to ascertain, monetary damages will not be an adequate remedy for the Company
and the Company Affiliates, and the Company will be entitled to enforce this Agreement by a temporary, preliminary and/or permanent
injunction or other equitable relief, without the necessity of posting bond or security, which the Executive expressly waives.
The Executive understands that the Company may waive some of the requirements expressed in this Agreement, but that such a waiver
to be effective must be made in writing and should not in any way be deemed a waiver of the Company’s right to enforce any
other requirements or provisions of this Agreement. The Executive agrees that each of the Executive’s obligations specified
in this Agreement is a separate and independent covenant and that the unenforceability of any of them shall not preclude the enforcement
of any other covenants in this Agreement.

 

8.                 
Mutual Non-Disparagement. During the Employment Period and for the two year period following the Date of Termination,
other than in the good faith performance of the Executive’s duties to the Company, its ultimate parent and their affiliates
while the Executive is employed by the Company, the Executive agrees not to make public statements or communications that disparage
the Company, its business, services, products or its affiliates or its or their current, former or future directors or executive
officers (in their capacity as such), or with respect to any current or former director or executive officer of the Company or
its affiliates (in their capacity as such). During the Employment Period and for the two year period following Date of Termination,
the Company agrees that it shall not, and that it shall instruct its directors, executive officers and employees to not, make public
statements or communications that disparage the Executive, other than in the good faith performance of their duties to the Company.
The foregoing shall not be violated by truthful statements in response to legal process, required governmental testimony or filings,
or administrative or arbitral proceedings (including, without limitation, depositions in connection with such proceedings) or in
connection with any arbitral or judicial proceeding to enforce or defend the Executive’s or the Company’s rights under
this Agreement or any other agreement between the parties hereto.

 

    	5

    	 

    

9.                 
Termination of Employment.

 

(a)               
Permitted Terminations. The Executive’s employment hereunder may be terminated during the Employment
Period under the following circumstances:

 

(i)                
Death. The Executive’s employment hereunder shall terminate upon the Executive’s death.

 

(ii)              
By the Company. The Company may terminate the Executive’s employment:

 

(A)            
Disability. For Disability;

 

(B)             
Cause. For Cause or without Cause; or

 

(iii)            
Notice of Non-Renewal of the Term. If the Company or the Executive provides a notice of non-renewal of the
Term in accordance with Section 2, the Executive’s employment shall terminate upon expiration of the Term.

 

(iv)            
By the Executive. The Executive may terminate his employment for any reason or for no reason by giving thirty
(30) days advance Notice of Termination to the Company (or ninety (90) days in the event of a termination for Good Reason as provided
in Section 10(d) hereof).

 

(b)              
Termination. Any termination of the Executive’s employment by the Company or the Executive (other than
because of the Executive’s death or a notice of non-renewal of the Term) shall be communicated by written Notice of Termination
to the other party hereto in accordance with Section 12 hereof. For purposes of this Agreement, a “Notice of Termination”
shall mean a notice which shall indicate the specific termination provision in this Agreement relied upon, if any, and shall set
forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of the Executive’s employment
under the provision so indicated. Termination of the Executive’s employment shall take effect on the Date of Termination.

 

(c)               
Effect of Termination. Upon any termination of the Executive’s employment with the Company, and its
subsidiaries, the Executive shall resign from, and shall be considered to have simultaneously resigned from, all positions with
the Company and all of its subsidiaries.

 

    	6

    	 

    

10.             
Compensation Upon Termination.

 

(a)               
Death. If the Executive’s employment is terminated during the Employment Period as a result of the Executive’s
death pursuant to Section 9(a)(i), the Employment Period shall terminate without further notice or any action required by
the Company or the Executive’s legal representatives. Upon the Executive’s death, the Company shall pay or provide
to the Executive’s representative or estate (i) all Accrued Benefits, if any, to which the Executive is entitled, (ii) a
pro-rata portion of the Executive’s Annual Bonus for the fiscal year in which the Executive’s termination occurs based
on actual results for such year (determined by multiplying the amount of such bonus which would be due for the full fiscal year
by a fraction, the numerator of which is the number of days during the fiscal year of termination that the Executive is employed
by the Company and the denominator of which is 365) payable at the same time bonuses for such year are paid to other senior executives
of the Company (the “Pro-Rata Bonus”), and (iii) subject to (A) the Executive’s (or in the event of the
Executive’s death, his dependent’s) timely election of continuation coverage under the Consolidated Omnibus Budget
Reconciliation Act of 1985, as amended (“COBRA”), (B) the Executive’s (or in the event of the Executive’s
death, his dependent’s) continued copayment of premiums at the same level and cost to the Executive as if the Executive were
an employee of the Company (excluding, for purposes of calculating cost, an employee’s ability to pay premiums with pre-tax
dollars), and (C) the Executive’s (or in the event of the Executive’s death, his dependent’s) continued compliance
with the obligations in Sections 7 and 8 hereof, continued participation in the Company’s group health plan (to
the extent permitted under applicable law and the terms of such plan) which covers the Executive (and the Executive’s eligible
dependents) for a period of twelve (12) months at the Company’s expense, provided that the Executive is eligible and
remains eligible for COBRA coverage; and provided, further, that in the event that the Executive obtains other employment
that offers group health benefits, such continuation of coverage by the Company shall immediately cease (the benefits and conditions
specified in this Section 10(a)(iii), “COBRA Coverage”). Except as set forth herein, the Company shall
have no further obligation to the Executive (or the Executive’s legal representatives or estate) under this Agreement.

 

(b)              
Disability. If the Company terminates the Executive’s employment during the Employment Period because
of the Executive’s Disability pursuant to Section 9(a)(ii)(A), the Company shall pay to the Executive (i) all
Accrued Benefits, if any, to which the Executive is entitled, (ii) the Pro-Rata Bonus, and (iii) twelve (12) months of COBRA Coverage.
Except as set forth herein, the Company shall have no further obligations to the Executive (or the Executive’s legal representatives)
under this Agreement.

 

(c)               
Termination by the Company for Cause, by the Executive without Good Reason, or upon Expiration of the Term.
If, during the Employment Period, the Company terminates the Executive’s employment for Cause pursuant to Section 9(a)(ii)(B),
the Executive terminates his employment without Good Reason, or upon termination of the Executive’s employment at the expiration
of the Term pursuant to a notice of non-renewal by either party in accordance with Section 2 hereof, the Company shall
pay to the Executive all Accrued Benefits (other than, in the event the Company terminates the Executive’s employment for
Cause or the Executive terminates his employment without Good Reason, the amount specified in Section 25(a)(iii)), if any,
to which the Executive is entitled. Except as set forth herein, the Company shall have no further obligations to the Executive
under this Agreement.

 

    	7

    	 

    

(d)              
Certain Terminations Prior to or After a Change in Control. If, prior to the occurrence of a Change in Control
or after the 12-month protection period has expired in Section 10(e), the Company terminates the Executive’s
employment during the Employment Period other than for Cause, death or Disability or if the Executive terminates his employment
hereunder with Good Reason, the Company shall pay or provide the Executive (or the Executive’s estate, if the Executive
dies after such termination but before receiving such amount) (i) all Accrued Benefits, if any, to which the Executive is
entitled; (ii) the Pro-Rata Bonus; (iii) a lump sum payment of an amount equal to the product of (x) one (1.0) and (y) the
sum of the Executive’s (I) Base Salary, and (II) Target Bonus, payable in a lump sum on the first payroll date following
the execution (and non-revocation) of the general release of claims described in Section 10(f), subject to Section 10(g),
and (iv) twelve (12) months of COBRA Coverage.

 

(e)               
Certain Terminations Following a Change in Control. If, upon or within twelve (12) months following the date
of consummation of any Change in Control, the Company terminates the Executive’s employment other than for Cause, death or
Disability or if the Executive terminates his employment hereunder with Good Reason, the Company shall pay or provide the Executive
(or the Executive’s estate, if the Executive dies after such termination but before receiving such amount) (i) all Accrued
Benefits, if any, to which the Executive is entitled; (ii) the Pro-Rata Bonus; (iii) a lump sum payment of an amount
equal to the product of (x) two (2.0) and (y) the sum of the Executive’s (I) Base Salary, and (II) Target Bonus,
payable in a lump sum on the first payroll date following the execution (and non-revocation) of the general release of claims
described in Section 10(f), subject to Section 10(g); and (iv) eighteen (18) months of COBRA Coverage. For the
avoidance of doubt, Change in Control shall include the consummation of the transactions contemplated by the Amended and Restated
Transaction Agreement by and among Tronox Incorporated, Tronox Limited, Concordia Acquisition Corporation, Concordia Merger Corporation,
Exxaro Resources Limited, Exxaro Holdings Sands (Proprietary) Limited and Exxaro International BV, dated as of April 20, 2012,
as amended from time to time (the “Exxaro Transaction”). In addition, Change in Control shall also mean any
transaction or event or combination of transactions or events, that results in Exxaro, or any of its affiliated entities, owning
or controlling more than fifty percent (50%) of the stock of the combined company formed pursuant to the Exxaro Transaction.

 

(f)               
Release. As a condition of receiving any and all amounts payable and benefits or additional rights provided
pursuant to this Agreement beyond the Accrued Benefits, the Executive must execute and deliver to the Company and not revoke a
general release of claims in favor of the Company in substantially the form attached on Exhibit B hereto. Such release must
be executed and delivered (and no longer subject to revocation, if applicable) within sixty (60) days following the Executive’s
Date of Termination. The Company shall deliver to the Executive the appropriate form of release of claims for the Executive to
execute within five (5) business days following the Date of Termination.

 

(g)              
Liquidated Damages. The parties acknowledge and agree that the damages that will result to the Executive for
termination by the Company of the Executive’s employment without Cause or by the Executive for Good Reason shall be extremely
difficult or impossible to establish or prove, and agree that the amounts payable to the Executive under Section 10(d)
shall constitute liquidated damages for any such termination. The Executive agrees that, except for such other payments and benefits
to which the Executive may be entitled as expressly provided by the terms of this Agreement or any other applicable benefit plan
or compensation arrangement (including equity-related awards), such liquidated damages shall be in lieu of all other claims that
the Executive may make by reason of any such termination of his employment.

 

    	8

    	 

    

(h)              
Certain Payment Delays. Notwithstanding anything to the contrary set forth herein, to the extent that the
payment of any amount described in Section 10 constitutes “nonqualified deferred compensation” for purposes
of Code Section 409A (as defined in Section 24 hereof), any such payment scheduled to occur during the first sixty
(60) days following the termination of employment shall not be paid until the first regularly scheduled pay period following the
sixtieth (60th) day following such termination and shall include payment of any amount that was otherwise scheduled to be paid
prior thereto.

 

(i)                
No Offset. In the event of termination of his employment, the Executive shall be under no obligation to seek
other employment and there shall be no offset against amounts due to him on account of any remuneration or benefits provided by
any subsequent employment he may obtain. The Company’s obligation to make any payment pursuant to, and otherwise to perform
its obligations under, this Agreement shall not be affected by any offset, counterclaim or other right that the Company or the
Company Affiliates may have against the Executive for any reason.

 

(j)                
280G Payments. In the event the Company determines in good faith that any payments, entitlements or benefits
(whether made or provided pursuant to this Agreement or otherwise) provided to the Executive constitute “parachute payments”
within the meaning of Section 280G of the Internal Revenue Code of 1986, as amended (the “Code”), and may be
subject to an excise tax imposed pursuant to Section 4999 of the Code, then, if the Executive would be placed in a better after-tax
position, the Executive’s “parachute payments” will be reduced to an amount determined by the Company in good
faith to be the maximum amount that may be provided to the Executive without resulting in any portion of such “parachute
payment” being subject to such excise tax. The payment reduction contemplated by the preceding sentence shall be implemented
as follows: first, by reducing any payments to be made to the Executive under Section 10(d)(ii) and (iii) or Section
10(e)(ii) and (iii), as applicable; second, by reducing any other cash payments to be made to the Executive but only
if the value of such cash payments is not greater than the parachute value of such payments; third, by cancelling
the acceleration of vesting of any outstanding equity-based compensation awards that are subject to performance vesting, the performance
goals for which were met as of the Executive’s date of termination or if later the date of the occurrence of the change in
control; fourth, by cancelling the acceleration of vesting of any restricted stock or restricted stock unit awards;
fifth, by eliminating the Company’s payment of the cost of any post-termination continuation of medical and
dental benefits for the Executive and his eligible dependents and sixth, by cancelling the acceleration of vesting
of any stock options or stock appreciation rights. In the case of the reductions to be made pursuant to each of the above-mentioned
clauses, the payment and/or benefit amounts to be reduced and the acceleration of vesting to be cancelled shall be reduced or cancelled
in the inverse order of their originally scheduled dates of payment or vesting, as applicable, and shall be so reduced (x) only
to the extent that the payment and/or benefit otherwise to be paid or the vesting of the award that otherwise would be accelerated,
would be treated as a “parachute payment” within the meaning of Section 280G(b)(2)(A) of the Code, and (y) only to
the extent necessary to achieved the required reduction hereunder.

 

    	9

    	 

    

11.             
Indemnification. During the Employment Period and thereafter, the Company agrees to indemnify and hold the
Executive and the Executive’s heirs and representatives harmless, to the maximum extent permitted by law, against any and
all damages, costs, liabilities, losses and expenses (including reasonable attorneys’ fees) as a result of any claim or proceeding
(whether civil, criminal, administrative or investigative), or any threatened claim or proceeding (whether civil, criminal, administrative
or investigative), against the Executive that arises out of or relates to the Executive’s service as an officer, director
or employee, as the case may be, of the Company, or the Executive’s service in any such capacity or similar capacity with
a Company Affiliate or other entity at the request of the Company, both prior to and after the Effective Date, and to promptly
advance to the Executive or the Executive’s heirs or representatives such expenses upon written request with appropriate
documentation of such expense upon receipt of an undertaking by the Executive or on the Executive’s behalf to repay such
amount if it shall ultimately be determined that the Executive is not entitled to be indemnified by the Company. During the Employment
Period and thereafter, the Company also shall provide the Executive with coverage under its current directors’ and officers’
liability policy to the same extent that it provides such coverage to its other executive officers. If the Executive has any knowledge
of any actual or threatened action, suit or proceeding, whether civil, criminal, administrative or investigative, as to which the
Executive may request indemnity under this provision, the Executive will give the Company prompt written notice thereof; provided
that the failure to give such notice shall not affect the Executive’s right to indemnification. The Company shall be entitled
to assume the defense of any such proceeding and the Executive will use reasonable efforts to cooperate with such defense. To the
extent that the Executive in good faith determines that there is an actual or potential conflict of interest between the Company
and the Executive in connection with the defense of a proceeding, the Executive shall so notify the Company and shall be entitled
to separate representation at the Company’s expense by counsel selected by the Executive (provided that the Company may reasonably
object to the selection of counsel within ten (10) business days after notification thereof) which counsel shall cooperate,
and coordinate the defense, with the Company’s counsel and minimize the expense of such separate representation to the extent
consistent with the Executive’s separate defense. This Section 11 shall continue in effect after the termination of
the Executive’s employment or the termination of this Agreement.

 

12.             
Notices. All notices, demands, requests, or other communications which may be or are required to be given
or made by any party to any other party pursuant to this Agreement shall be in writing and shall be hand delivered, mailed by first-class
registered or certified mail, return receipt requested, postage prepaid, delivered by overnight air courier, or transmitted by
facsimile transmission addressed as follows:

 

(i)             If
to the Company:

 

Tronox LLC

One Stamford Plaza 

263 Tresser Blvd., Suite 1100 

Stamford, CT 06901

 

Attention: General Counsel

 

(ii)           If to the Executive:

 

Address last shown on the Company’s
records.

 

Each party may designate by notice in writing
a new address to which any notice, demand, request or communication may thereafter be so given, served or sent. Each notice, demand,
request, or communication that shall be given or made in the manner described above shall be deemed sufficiently given or made
for all purposes at such time as it is delivered to the addressee (with the return receipt, the delivery receipt, confirmation
of facsimile transmission or the affidavit of messenger being deemed conclusive but not exclusive evidence of such delivery) or
at such time as delivery is refused by the addressee upon presentation.

 

    	10

    	 

    

13.             
Severability. The invalidity or unenforceability of any one or more provisions of this Agreement, including,
without limitation, Section 7, shall not affect the validity or enforceability of the other provisions of this Agreement,
which shall remain in full force and effect.

 

14.             
Survival. It is the express intention and agreement of the parties hereto that the provisions of Sections
7, 8, 10, 11, 12, 13, 15, 16, 17, 19, 20, 21, 23,
24 and 25 hereof and this Section 14 shall survive the termination of employment of the Executive. In addition,
all obligations of the Company to make payments hereunder shall survive any termination of this Agreement on the terms and conditions
set forth herein.

 

15.             
Assignment. The rights and obligations of the parties to this Agreement shall not be assignable or delegable,
except that (i) in the event of the Executive’s death, the personal representative or legatees or distributees of the
Executive’s estate, as the case may be, shall have the right to receive any amount owing and unpaid to the Executive hereunder
and (ii) the rights and obligations of the Company hereunder shall be assignable and delegable in connection with any subsequent
merger, consolidation, sale of all or substantially all of the assets or equity interests of the Company or similar transaction
involving the Company or a successor corporation. Unless provided by applicable law, the Company shall require any successor to
the Company to expressly assume and agree to perform this Agreement in the same manner and to the same extent that the Company
would be required to perform it if no such succession had taken place. As used in this Agreement, “Company”
shall mean the Company and any successor to its business and/or assets, which assumes and agrees to perform the duties and obligations
of the Company under this Agreement by operation of law or otherwise, including, without limitation, any assumption or assignment
agreed upon in connection with the Exxaro Transaction.

 

16.             
Binding Effect. Subject to any provisions hereof restricting assignment, this Agreement shall be binding upon
the parties hereto and shall inure to the benefit of the parties and their respective heirs, devisees, executors, administrators,
legal representatives, successors and assigns.

 

    	11

    	 

    

17.             
Amendment; Waiver. This Agreement shall not be amended, altered or modified except by an instrument in writing
duly executed by the party against whom enforcement is sought. Neither the waiver by either of the parties hereto of a breach of
or a default under any of the provisions of this Agreement, nor the failure of either of the parties, on one or more occasions,
to enforce any of the provisions of this Agreement or to exercise any right or privilege hereunder, shall thereafter be construed
as a waiver of any subsequent breach or default of a similar nature, or as a waiver of any such provisions, rights or privileges
hereunder.

 

18.             
Headings. Section and subsection headings contained in this Agreement are inserted for convenience of reference
only, shall not be deemed to be a part of this Agreement for any purpose, and shall not in any way define or affect the meaning,
construction or scope of any of the provisions hereof.

 

19.             
Governing Law. This Agreement, the rights and obligations of the parties hereto, and any claims or disputes
relating thereto, shall be governed by and construed in accordance with the laws of the State of New York (but not including any
choice of law rule thereof that would cause the laws of another jurisdiction to apply).

 

20.             
Waiver of Jury Trial. Each of the parties agrees that any dispute between the parties shall be resolved only
in the courts of the State of New York or the United States District Court for the Southern District of New York and the appellate
courts having jurisdiction of appeals in such courts. In that context, and without limiting the generality of the foregoing, each
of the parties hereto irrevocably and unconditionally (a) submits in any proceeding relating to this Agreement or the Executive's
employment by the Company or any Company Affiliate, or for the recognition and enforcement of any judgment in respect thereof (a
“Proceeding”), to the exclusive jurisdiction of the courts of the State of New York, the court of the United
States of America for the Southern District of New York, and appellate courts having jurisdiction of appeals from any of the foregoing,
and agrees that all claims in respect of any such Proceeding shall be heard and determined in such New York State court or, to
the extent permitted by law, in such federal court, (b) consents that any such Proceeding may and shall be brought in such courts
and waives any objection that the Executive or the Company may now or thereafter have to the venue or jurisdiction of any such
Proceeding in any such court or that such Proceeding was brought in an inconvenient court and agrees not to plead or claim the
same, (c) waives all right to trial by jury in any Proceeding (whether based on contract, tort or otherwise) arising out of or
relating to this Agreement or the Executive's employment by the Company or any Company Affiliate, or the Executive's or the Company’s
performance under, or the enforcement of, this Agreement, (d) agrees that service of process in any such Proceeding may be
effected by mailing a copy of such process by registered or certified mail (or any substantially similar form of mail), postage
prepaid, to such party at the Executive's or the Company’s address as provided in Section 12 hereof, and (e) agrees
that nothing in this Agreement shall affect the right to effect service of process in any other manner permitted by the laws of
the State of New York.

 

21.             
Entire Agreement. This Agreement and its Exhibits constitute the entire agreement between the parties respecting
the subject matter hereof, there being no representations, warranties or commitments except as set forth herein and supersedes
and replaces all other agreements related to the subject matter hereof.

 

    	12

    	 

    

22.             
Counterparts. This Agreement may be executed in two counterparts, each of which shall be an original and all
of which shall be deemed to constitute one and the same instrument.

 

23.             
Withholding. The Company may withhold from any benefit payment under this Agreement all federal, state, city
or other taxes as shall be required pursuant to any law or governmental regulation or ruling.

 

24.             
Section 409A.

 

(a)               
The intent of the parties is that payments and benefits under this Agreement comply with Code Section 409A and the
regulations and guidance promulgated thereunder (collectively “Code Section 409A”) and, accordingly, to the
maximum extent permitted, this Agreement shall be interpreted to be in compliance therewith. If the Executive notifies the Company
(with specificity as to the reason therefor) that the Executive believes that any provision of this Agreement (or of any award
of compensation, including equity compensation or benefits) would cause the Executive to incur any additional tax or interest under
Code Section 409A and the Company concurs with such belief or the Company (without any obligation whatsoever to do so) independently
makes such determination, the Company shall, after consulting with the Executive, reform such provision to attempt to comply with
Code Section 409A through good faith modifications to the minimum extent reasonably appropriate to conform with Code Section 409A.
To the extent that any provision hereof is modified in order to comply with Code Section 409A, such modification shall be made
in good faith and shall, to the maximum extent reasonably possible, maintain the original intent and economic benefit to the Executive
and the Company of the applicable provision without violating the provisions of Code Section 409A.

 

(b)              
A termination of employment shall not be deemed to have occurred for purposes of any provision of this Agreement
providing for the payment of any amounts or benefits upon or following a termination of employment unless such termination is also
a “separation from service” within the meaning of Code Section 409A and, for purposes of any such provision of this
Agreement, references to a “termination,” “termination of employment”, “Date of Termination”
or like terms shall mean “separation from service.” If the Executive is deemed on the date of termination to be a “specified
employee” within the meaning of that term under Code Section 409A(a)(2)(B), then with regard to any payment or the provision
of any benefit that is considered deferred compensation under Code Section 409A payable on account of a “separation from
service,” such payment or benefit shall be made or provided at the date which is the earlier of (i) the expiration of
the six (6)-month period measured from the date of such “separation from service” of the Executive, and (ii) the date
of the Executive’s death, to the extent required under Code Section 409A. Upon the expiration of the foregoing delay period,
all payments and benefits delayed pursuant to this Section 24(b) (whether they would have otherwise been payable in a single
sum or in installments in the absence of such delay) shall be paid or reimbursed to the Executive in a lump sum, and any remaining
payments and benefits due under this Agreement shall be paid or provided in accordance with the normal payment dates specified
for them herein.

 

    	13

    	 

    

(c)               
To the extent that reimbursements or other in-kind benefits under this Agreement constitute “nonqualified deferred
compensation” for purposes of Code Section 409A, (i) all expenses or other reimbursements hereunder shall be made on or prior
to the last day of the taxable year following the taxable year in which such expenses were incurred by the Executive, (ii) any
right to reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (iii) no such
reimbursement, expenses eligible for reimbursement, or in-kind benefits provided in any taxable year shall in any way affect the
expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year.

 

(d)              
For purposes of Code Section 409A, the Executive’s right to receive any installment payments pursuant to this
Agreement shall be treated as a right to receive a series of separate and distinct payments. Whenever a payment under this Agreement
specifies a payment period with reference to a number of days, the actual date of payment within the specified period shall be
within the sole discretion of the Company.

 

(e)               
Notwithstanding any other provision of this Agreement to the contrary, in no event shall any payment under this Agreement
that constitutes “nonqualified deferred compensation” for purposes of Code Section 409A be subject to offset by any
other amount unless otherwise permitted by Code Section 409A.

 

25.             
Definitions.

 

(a)               
“Accrued Benefits” means (i) any unpaid Base Salary through the Date of Termination; (ii) any
earned but unpaid Annual Bonus, (iii) any unpaid Annual Bonus for performance periods which have ended prior to the Date of
Termination; (iv) any accrued and unpaid vacation and/or sick days; (v) any amounts or benefits owing to the Executive
or to the Executive’s beneficiaries under the then applicable benefit plans of the Company (excluding any severance plan,
program, agreement or arrangement) and any accrued and vested equity-incentive awards which shall be treated in accordance with,
and subject to, the terms and conditions of the applicable grant agreement(s) and equity plan(s) under which such awards were granted;
and (vi) any amounts owing to the Executive for reimbursement of expenses properly incurred by the Executive prior to the
Date of Termination and which are reimbursable in accordance with Section 6 or Section 10. Amounts payable
under (A) clauses (i), (ii) and (iv) shall be paid promptly after the Date of Termination, (B) clauses (iii) and (v) shall be paid
in accordance with the terms and conditions of the applicable plan, program or arrangement, and (C) clause (vi) shall be paid in
accordance with the terms of the applicable expense policy.

 

(b)              
 “Cause” means (i) the Executive’s conviction of, or plea of nolo contendere to, a
felony (other than for a traffic violation); (ii) the Executive’s continued failure to substantially perform the Executive’s
material duties hereunder (other than due to a mental or physical impairment) after receipt of written notice from the Company
that specifically identifies the manner in which the Executive has substantially failed to perform the Executive’s
material duties and specifies the manner in which the Executive may substantially perform his material duties in the future; (iii) an
act of fraud or gross or willful material misconduct by the Executive; or (iv) the Executive’s material breach of Sections
7(c) and 7(d). Anything herein to the contrary notwithstanding, the Executive shall not be terminated for “Cause”
hereunder unless (A) written notice stating the basis for the termination is provided to the Executive and (B) as to
clauses (ii) or (iv) of this paragraph, he is given fifteen (15) days to cure the neglect or conduct that is the
basis of such claim, to the extent curable.

 

    	14

    	 

    

(c)               
“Change in Control” shall have the meaning set forth in the Company’s 2010 Management Equity
Incentive Plan as well as the meaning set forth in Section 10(e).

 

(d)              
“Company Affiliate” means any entity controlled by, in control of, or under common control with,
the Company.

 

(e)               
“Competitive Enterprise” means (i) a business enterprise that engages in, or owns or controls
a significant interest in any entity that engages in competition with the Company or its subsidiaries with respect to the mining,
processing and sales of mineral sands and titanium bearing ores and/or TiO2 pigment (the “Company’s Business”)
(a) in the United States of America, (b) any other country where the Company or its subsidiaries operates facilities or sells products,
in each case related to the Company’s Business, but only if the Executive had operational, financial reporting, marketing
or other responsibility or oversight for the facility or business in the respective country. Notwithstanding the foregoing, in
the event a business enterprise has one or more lines of business that do not involve the Company’s Business, the Executive
shall be permitted to associate with such business enterprise if, and only if, the Executive does not participate in, or have supervisory
authority with respect to, any line of business involving the Company’s Business.

 

(f)               
“Confidential Information” means all non-public information concerning trade secrets, know-how,
software, developments, inventions, processes, technology, designs, financial data, strategic business plans or any proprietary
or confidential information, documents or materials in any form or media, including any of the foregoing relating to research,
operations, finances, current and proposed products and services, vendors, customers, advertising and marketing, and other non-public,
proprietary, and confidential information of the Company or the Company Affiliates. Notwithstanding anything to the contrary contained
herein, the general skills, knowledge and experience gained during the Executive’s employment with the Company, information
publicly available or generally known within the industry or trade in which the Company competes and information or knowledge possessed
by the Executive prior to his employment by the Company, shall not be considered Confidential Information.

 

(g)              
“Customer” means any person, firm, corporation or other entity whatsoever to whom the Company
or its subsidiaries provided services or sold any products to within a twelve (12)-month period on, before or after the Executive’s
Date of Termination.

 

(h)              
“Date of Termination” means (i) if the Executive’s employment is terminated by the
Executive’s death, the date of the Executive’s death; (ii) if the Executive’s employment is terminated because
of the Executive’s Disability pursuant to Section 9(a)(ii)(A), thirty (30) days after Notice of Termination,
provided that the Executive shall not have returned to the performance of the Executive’s duties on a full-time basis
during such thirty (30)-day period; (iii) if the Executive’s employment is terminated during the Employment Period by
the Company pursuant to Section 9(a)(ii)(B) or by the Executive pursuant to Section 9(a)(iv), the date
specified in the Notice of Termination; or (v) if the Executive’s employment is terminated upon the expiration of the Employment
Period pursuant to Section 2, the last day of the Employment Period.

 

    	15

    	 

    

(i)                
“Disability” means the inability of the Executive to perform the Executive’s material duties
hereunder due to a physical or mental injury, infirmity or incapacity, which is expected to exceed one hundred eighty (180) days
(including weekends and holidays) in any three hundred sixty-five (365)-day period, as determined by the Executive’s treating
physician in his or her reasonable discretion.

 

(j)                
“Good Reason” means (i) any material diminution in the Executive’s titles, duties or authorities
or any removal of the Executive as Chief Financial Officer of the Company’s ultimate parent company; (ii) a reduction
in the Executive’s Base Salary or target bonus opportunity as a percentage of Base Salary; (iii) a material adverse change
in the Executive’s reporting responsibilities to the Chief Executive Officer of the Company’s ultimate parent company;
(iv) the assignment of duties substantially inconsistent with the Executive’s status as an executive officer of the Company’s
ultimate parent company; (v) a relocation of the Executive’s primary place of employment to a location more than fifty
(50) miles from the location set forth in Section 4 (or such other place that the Executive has otherwise consented to in
writing); (vi) any other material breach of this Agreement; or (vii) the failure of the Company to obtain the assumption
in writing of its obligations under the Agreement by any successor to all or substantially all of the assets of the Company after
a merger, consolidation, sale or similar transaction in which such Agreement is not assumed by operation of law. In order to invoke
a termination for Good Reason, (A) the Executive must provide written notice within ninety (90) days of the occurrence
of any event of “Good Reason,” (B) the Company must fail to cure such event within thirty (30) days of the
giving of such notice and (C) the Executive must terminate employment within thirty (30) days following the expiration of
the Company’s cure period.

 

(k)              
 “Non-Compete Period” means the period commencing on the Effective Date and ending twelve (12)
months after the Executive’s Date of Termination.

 

[Remainder of Page Intentionally Left
Blank]

 

    	16

    	 

    

IN WITNESS WHEREOF,
the undersigned have duly executed and delivered this Agreement as of June 15, 2012, or have caused this Agreement to be duly executed
and delivered on their behalf.

 

	 	TRONOX LLC
	 	 	 	 
	 	By:	/s/ Michael J. Foster
	 	 	Name:	Michael J. Foster
	 	 	Title:	Vice President, General Counsel and Secretary
	 	 	 	 
	 	 	 	 
	 	EXECUTIVE
	 	 	 	 
	 	/s/ Willem H. Van Niekerk
	 	Willem H. Van Niekerk
	 	 	 	 
	 	 	 	 
	 	 	 	 
	 	 	 	 

 

 

 

 

 

 

 

 

 

 

Employment Agreement Signature Page

 

    	 

    	 

    

 

EXHIBIT A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    	A-1

    	 

    

 

EXHIBIT B

 

GENERAL RELEASE

 

I, Willem H Van Niekerk, in consideration
of and subject to the performance by Tronox Ltd (together with its parent companies and subsidiaries, the “Company”),
of its obligations under Section 10 of the Employment Agreement, dated as of June __, 2012 (the “Agreement”),
do hereby release and forever discharge as of the date hereof the Company and its respective affiliates and subsidiaries and all
present, former and future directors, officers, agents, representatives, employees, successors and assigns of the Company and/or
its respective affiliates and subsidiaries and direct or indirect owners (collectively, the “Released Parties”)
to the extent provided herein (this “General Release”). The Released Parties are intended third-party beneficiaries
of this General Release, and this General Release may be enforced by each of them in accordance with the terms hereof in respect
of the rights granted to such Released Parties hereunder. Terms used herein but not otherwise defined shall have the meanings given
to them in the Agreement.

 

1.                 
I understand that, other than the Accrued Benefits, the payments or benefits paid or granted to me under Section
10 of the Agreement represent, in part, consideration for signing this General Release and are not salary, wages or benefits to
which I was already entitled. I understand and agree that I will not receive the payments and benefits specified in Section 10
of the Agreement, other than the Accrued Benefits, unless I execute this General Release and do not revoke this General Release
within the time period permitted hereafter or breach this General Release. Such payments and benefits will not be considered compensation
for purposes of any employee benefit plan, program, policy or arrangement maintained or hereafter established by the Company or
its affiliates.

 

2.                 
Except as provided in paragraph 4 below and except for the provisions of the Agreement which expressly survive the
termination of my employment with the Company, I knowingly and voluntarily (for myself, my heirs, executors, administrators and
assigns) release and forever discharge the Company and the other Released Parties from any and all claims, suits, controversies,
actions, causes of action, cross-claims, counter-claims, demands, debts, compensatory damages, liquidated damages, punitive
or exemplary damages, other damages, claims for costs and attorneys’ fees, or liabilities of any nature whatsoever in law
and in equity, both past and present (through the date that this General Release becomes effective and enforceable) and whether
known or unknown, suspected, or claimed against the Company and/or any of the Released Parties which I, my spouse, or any of my
heirs, executors, administrators or assigns, ever had, now have, or hereafter may have, by reason of any matter, cause, or thing
whatsoever, from the beginning of my initial dealings with the Company to the date of this General Release, and particularly, but
without limitation of the foregoing general terms, any claims arising from or relating in any way to my employment relationship
with Company, the terms and conditions of that employment relationship, and the termination of that employment relationship (including,
but not limited to, any allegation, claim or violation, arising under: Title VII of the Civil Rights Act of 1964, as amended; the
Civil Rights Act of 1991; the Age Discrimination in Employment Act of 1967, as amended (including the Older Workers Benefit Protection
Act); the Equal Pay Act of 1963, as amended; the Americans with Disabilities Act of 1990; the Family and Medical Leave Act of 1993;
the Worker Adjustment Retraining and Notification Act; the Employee Retirement Income Security Act of 1974; any applicable Executive
Order Programs; the Fair Labor Standards Act; or their state or local counterparts; or under any other federal, state or local
civil or human rights law, or under any other local, state, or federal law, regulation or ordinance; or under any public policy,
contract or tort, or under common law; or arising under any policies, practices or procedures of the Company; or any claim for
wrongful discharge, breach of contract, infliction of emotional distress, defamation; or any claim for costs, fees, or other expenses,
including attorneys’ fees incurred in these matters) (all of the foregoing collectively referred to herein as the “Claims”).
I understand and intend that this General Release constitutes a general release of all claims and that no reference herein to a
specific form of claim, statute or type of relief is intended to limit the scope of this General Release.

 

    	B-1

    	 

    

3.                 
I represent that I have made no assignment or transfer of any right, claim, demand, cause of action, or other matter
covered by paragraph 2 above.

 

4.                 
I agree that this General Release does not waive or release any rights or claims that I may have under the Age Discrimination
in Employment Act of 1967 which arise after the date I execute this General Release. I acknowledge and agree that my separation
from employment with the Company in compliance with the terms of the Agreement shall not serve as the basis for any claim or action
(including, without limitation, any claim under the Age Discrimination in Employment Act of 1967).

 

5.                 
I agree that I hereby waive all rights to sue or obtain equitable, remedial or punitive relief from any or all Released
Parties of any kind whatsoever, including, without limitation, reinstatement, back pay, front pay, and any form of injunctive relief.
Notwithstanding the foregoing, I acknowledge that I am not waiving and am not being required to waive any right that cannot be
waived under law, including the right to file an administrative charge or participate in an administrative investigation or proceeding;
provided, however, that I disclaim and waive any right to share or participate in any monetary award resulting from the prosecution
of such charge or investigation or proceeding.

 

6.                 
In signing this General Release, I acknowledge and intend that it shall be effective as a bar to each and every one
of the Claims hereinabove mentioned or implied. I expressly consent that this General Release shall be given full force and effect
according to each and all of its express terms and provisions, including those relating to unknown and unsuspected Claims (notwithstanding
any state or local statute that expressly limits the effectiveness of a general release of unknown, unsuspected and unanticipated
Claims), if any, as well as those relating to any other Claims hereinabove mentioned or implied. I acknowledge and agree that this
waiver is an essential and material term of this General Release and that without such waiver the Company would not have agreed
to the terms of the Agreement. I further agree that in the event that I should bring a Claim seeking damages against the Company,
or in the event that I should seek to recover against the Company in any Claim brought by a governmental agency on my behalf, this
General Release shall serve as a complete defense to such Claims to the maximum extent permitted by law. I further agree that I
am not aware of any pending claim, or of any facts that could give rise to a claim, of the type described in paragraph 2 as of
the execution of this General Release.

 

    	B-2

    	 

    

7.                 
I agree that neither this General Release, nor the furnishing of the consideration for this General Release, shall
be deemed or construed at any time to be an admission by the Company, any Released Party or myself of any improper or unlawful
conduct.

 

8.                 
I agree that I will forfeit all amounts payable by the Company pursuant to the Agreement if I challenge the validity
of this General Release. I also agree that if I violate this General Release by suing the Company or the other Released Parties,
I will pay all costs and expenses of defending against the suit incurred by the Released Parties, including reasonable attorneys’
fees, and return all payments received by me pursuant to the Agreement on or after the termination of my employment.

 

9.                 
I agree that this General Release and the Agreement are confidential and agree not to disclose any information regarding
the terms of this General Release or the Agreement, except to my immediate family and any tax, legal or other counsel that I have
consulted regarding the meaning or effect hereof or as required by law, and I will instruct each of the foregoing not to disclose
the same to anyone.

 

10.             
Any non-disclosure provision in this General Release does not prohibit or restrict me (or my attorney) from responding
to any inquiry about this General Release or its underlying facts and circumstances by the Securities and Exchange Commission (SEC),
the Financial Industry Regulatory Authority (FINRA), or any other self-regulatory organization or governmental entity.

 

11.             
I hereby acknowledge that Sections 7, 8, 10, 11, 12, 13, 14, 15,
16, 17, 19, 20, 21, 23, and 24 of the Agreement shall survive my execution of
this General Release.

 

12.             
I represent that I am not aware of any Claim by me, and I acknowledge that I may hereafter discover Claims or facts
in addition to or different than those which I now know or believe to exist with respect to the subject matter of the release set
forth in paragraph 2 above and which, if known or suspected at the time of entering into this General Release, may have materially
affected this General Release and my decision to enter into it.

 

13.             
Notwithstanding anything in this General Release to the contrary, this General Release shall not relinquish, diminish,
or in any way affect any rights or claims arising out of any breach by the Company or by any Released Party of the Agreement after
the date hereof.

 

14.             
Whenever possible, each provision of this General Release shall be interpreted in such manner as to be effective
and valid under applicable law, but if any provision of this General Release is held to be invalid, illegal or unenforceable in
any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability shall not affect
any other provision or any other jurisdiction, but this General Release shall be reformed, construed and enforced in such jurisdiction
as if such invalid, illegal or unenforceable provision had never been contained herein. This General Release constitutes the complete
and entire agreement and understanding among the parties, and supersedes any and all prior or contemporaneous agreements, commitments,
understandings or arrangements, whether written or oral, between or among any of the parties, in each case concerning the subject
matter hereof.

 

    	B-3

    	 

    

BY SIGNING THIS GENERAL RELEASE, I REPRESENT
AND AGREE THAT:

 

		(i)	I HAVE READ IT CAREFULLY;

 

		(ii)	I UNDERSTAND ALL OF ITS TERMS AND KNOW THAT I AM GIVING UP IMPORTANT RIGHTS, INCLUDING BUT NOT
LIMITED TO, RIGHTS UNDER THE AGE DISCRIMINATION IN EMPLOYMENT ACT OF 1967, AS AMENDED, TITLE VII OF THE CIVIL RIGHTS ACT OF 1964,
AS AMENDED, THE EQUAL PAY ACT OF 1963, THE AMERICANS WITH DISABILITIES ACT OF 1990, AND THE EMPLOYEE RETIREMENT INCOME SECURITY
ACT OF 1974, AS AMENDED;

 

		(iii)	I VOLUNTARILY CONSENT TO EVERYTHING IN IT;

 

		(iv)	I HAVE BEEN ADVISED TO CONSULT WITH AN ATTORNEY BEFORE EXECUTING IT AND I HAVE DONE SO OR, AFTER
CAREFUL READING AND CONSIDERATION, I HAVE CHOSEN NOT TO DO SO OF MY OWN VOLITION;

 

		(v)	I HAVE HAD AT LEAST [21][45] DAYS FROM THE DATE OF MY RECEIPT OF THIS RELEASE
TO CONSIDER IT AND THE CHANGES MADE SINCE MY RECEIPT OF THIS RELEASE ARE NOT MATERIAL OR WERE MADE AT MY REQUEST AND WILL NOT RESTART
THE REQUIRED [21][45]-DAY PERIOD;

 

		(vi)	I UNDERSTAND THAT I HAVE SEVEN (7) DAYS AFTER THE EXECUTION OF THIS RELEASE TO REVOKE IT AND THAT
THIS RELEASE SHALL NOT BECOME EFFECTIVE OR ENFORCEABLE UNTIL THE REVOCATION PERIOD HAS EXPIRED;

 

		(vii)	I HAVE SIGNED THIS GENERAL RELEASE KNOWINGLY AND VOLUNTARILY AND WITH THE ADVICE OF ANY COUNSEL
RETAINED TO ADVISE ME WITH RESPECT TO IT; AND

 

		(viii)	I AGREE THAT THE PROVISIONS OF THIS GENERAL RELEASE MAY NOT BE AMENDED, WAIVED, CHANGED OR MODIFIED
EXCEPT BY AN INSTRUMENT IN WRITING SIGNED BY AN AUTHORIZED REPRESENTATIVE OF THE COMPANY AND BY ME.

 

	SIGNED:	 	 	DATE:	 

 

 

    	B-4

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