Document:

Document

Exhibit 10.4
[***] = Certain confidential information contained in this document, 
marked by brackets, has been omitted because it is both 
(i) not material and (ii) would be competitively harmful if publicly disclosed.

																																	
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	1. CONTRACT ID CODE	PAGE OF PAGES
	1	23
	2. AMENDMENT/MODIFICATION NO

P00029
	3. EFFECTIVE DATE

See Block 16C
	4. REQUISITION/PURCHASE REQ NO

OS161878
	5. PROJECT NO (if applicable)

	6. ISSUED BY    CODE	ASPR-BARDA	7. ADMINISTERED BY (if other than line item 6)    CODE
	ASPR-BARDA02
	ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
		ASPR-BARDA
330 Independence Ave., SW, Rm G640
Washington DC 20201
	
	8. NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code)
	(x)	9A AMENDMENT OF SOLICITATION NO.
	CHIMERIX, INC.  1377270
CHIMERIX, INC.    2505 MERIDIAN P
2505 MERIDIAN PKWY STE 340
DURHAM NC 277135246
		
	9B DATED (SEE ITEM 11)

	X	10A MODIFICATION OF CONTRACT/ORDER NO
HHSO100201100013C

	10B DATED (SEE ITEM 13)
 02/16/2011

	CODE     1377270
	FACILITY CODE
	11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
	    The above numbered solicitation is amended as set forth in Item 14.  The hour and date specified of receipt of Offers     is extended.      is not extended
Offers must acknowledge receipt of this amendment prior to the hour end dale specified in the solicitation or as amended, by one or the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

	12. ACCOUNTING AND APPROPRIATION DATA (if required)
2015.1992015.25103                                                                                             Net Increase:                              $12,918,174.00

	13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
	CHECK ONE	A.    THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority)  THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A

	
		B.    THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

		C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF

	X	D.    OTHER (Specify type of modification and authority)
Bilateral:  Mutual Agreement of the Parties.

	E. IMPORTANT:            Contractor               is not.             is required to sign this document and return             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: 33-0903395
DUNS Number: 121785997
A. The purpose of this modification is to perform the following:
1. The Government and the Contractor to bilaterally modify the Statement of Work requirements for CLIN 0004 for the purpose of adding within scope Non-Clinical Pivotal Studies and within scope Process Validation efforts per recent FDA guidance and to delete Clinical Studies that are not needed at this time per recent FDA guidance. The Government and the Contractor bilaterally agree to the Contractor's performance of a revised CLIN 0004 under the contract. The Government and the Contractor hereby bilaterally modify this contract for the purposes of adding the total amount of CLIN 0004 to the contract as
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)
 Michael D. Rogers
	16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
ETHAN J. MUELLER

	15B. CONTRACTOR/OFFEROR
 /s/ Michael D. Rogers     
(Signature of person authorized to sign)
	15C. DATE SIGNED
9/11/2015
	16B. UNITED STATES OF AMERICA
  /s/ Ethan J. Mueller     
(Signature of person authorized to sign)
	16C. DATE SIGNED
9/11/2015

NSN 7540-152-8070    STANDARD FORM 30 (REV 10-83)
Previous edition unusable    Prescribed by GSA
    FAR (48 CFR) 53.243

																											
	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/P00029    
	PAGE      OF
	2	23
	NAME OF OFFEROR OR CONTRACTOR
CHIMERIX, INC. 1377270

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

		follows:
CLIN 0004:

Total Estimated Cost: $[***]
Total Fixed Fee: $[***]
Total Estimated Cost Plus Fixed Fee: $12,918,174.00

The total period of performance of CLIN 0004 under the contract is from 11 September 2015 through 31 October 2016.

2. This modification also results in an increase in the total amount of the contract from $53,213,599.00 by $12,918,174.00 to $66,131,773.00 as well as the following:

Total Estimated Cost of the Contract: From $[***] By $[***] To $[***].

Total Fixed Fee of the Contract: From $[***] By $[***] To $[***]

Total Estimated Cost Plus Fixed Fee of the Contract: From $53,213,599.00 By $12,918,174.00 To $66,131,773.00.

3. In Block 14 of the SF 26, the following CAN Number is added: Appropriation Year: 2015, Object Class: 25103, CAN# 1992015 $12,918,174.00

4. In Block 15G of the SF 26, the amount of $53,213,599.00 is hereby changed to $66,131,773.00.

5. The Government and the Contractor bilaterally modify Attachment 1, Statement of Work dated 20 August 2015, under PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J - LIST OF ATTACHMENTS for the purposes of incorporating within scope Non-Clinical Pivotal Studies and within scope Process Validation efforts per recent FDA guidance under CLIN 0004 and to delete Clinical Studies that are not needed at this time per recent FDA guidance under CLIN 0004. As such, Attachment 1, Statement of Work dated 20 August 2015, 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 11 September 2015 (14 Pages attached herein). The efforts within CLIN 0004 that involve [***] and [***] cannot be performed until the receipt and approval of all required Protocols by BARDA inclusive of all IRB, OHRP approvals and any required Ethics Approvals for any clinical trials/studies and any required approved OLAW Assurances and IIA approvals from OLAW for any non clinical animal studies.

6. The incorporation of the attached Statement of Work (SOW) changes in the paragraph above also results in the incorporation of the attached changes (6 Pages attached herein) into the contract into WBS Milestones/Deliverables and Technical Deliverables and Contract Milestones and Go/No Go Decision Gates dated 11
Continued ...

NSN 7540-152-8067    STANDARD FORM 336 (4-86)
    Sponsored by GSA
    FAR (48 CFR) 53.110

																											
	CONTINUATION SHEET	REFERENCE NO. OF DOCUMENT BEING CONTINUED
HHSO100201100013C/P00029    
	PAGE      OF
	3	23
	NAME OF OFFEROR OR CONTRACTOR
CHIMERIX, INC. 1377270

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

		September 2015 under Article F.2. Deliverables. 
7. Total expenses for all domestic and foreign travel (transportation, lodging, subsistence and incidental expenses) incurred in direct performance of this contract shall not exceed $[***] during the base segment/CLIN 0001, $[***] during Option Period 1/CLIN 0002, $[***] during Option Period 2/CLIN 0003 and $[***] for CLIN 0004.

8. The first and second sentences in Article G.7 INDIRECT COST RATES of the contract are replaced with the following:

The following rates will be utilized for billing purposes during both the base period/CLIN 0001, Option 1/CLIN 0002, Option 2/CLIN 0003 and CLIN 0004 ONLY.

FY 11 (Retroactive Adjustment base period/CLIN 0001 ONLY) - Fringe Benefits at [***]% and Indirect at [***]%.

FY 12 and 13 (Retroactive Adjustment and Billing, base period/CLIN 0001 ONLY and Billing, Option 1/CLIN 0002, Optioin 2/CLIN 0003 and CLIN 0004 ONLY) - Fringe Benefits at [***]% and Indirect at [***]%.

9. The total amount, scope and period of performance of all other CLIN(s) 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.  

B. This is a bilateral modification. All other terms and conditions of the contract remain unchanged.
Delivery: 10/31/2016
Delivery Location Code: HHS
HHS
200 Independence Avenue, SW
Washington DC 20201 US

Appr. Yr.: 2015 CAN: 1992015 Object Class: 25103
FOB: Destination
Period of Performance: 02/16/2011 to 10/31/2016

Change Item 4 to read as follows (amount shown is the obligated amount):

Pivotal Studies and Validation Studies.                                                                                                                 12,918,174.00

Reports and Other Data Deliverables.

BARDA Broad Agency Announcement (BAA)
(CBRN-BAA-10-100-SOL-00012)
Advanced Research and Development of Chemical, Biological, Radiological, and
Nuclear Medical Countermeasures
DEVELOPMENT OF CMX-001 FOR THE TREATMENT OF SMALLPOX
Topical Area of Interest No. 3, Antimicrobial Drugs

Contractual Statement of Work

1.PREAMBLE

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

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

1.0    Overall Objectives and Scope

The overall objective of this contract is to advance the development of CMX-001 as a broad-spectrum therapeutic antiviral for the treatment of smallpox infections and dsDNA viruses.  The scope of work for this contract includes preclinical, clinical and manufacturing development activities that fall into the following areas: non-clinical efficacy studies; clinical activities; manufacturing activities; and all associated regulatory, quality assurance, management, and administrative activities.  The Research and Development (R&D) effort for the antiviral will progress in specific stages that cover the base performance segment and four (4) option segments as specified in this contract.  The Contractor must complete specific tasks required in each of the five discrete work segments. The scope of work has been broken into the following five phases which are discrete work segments:
i.[***]
ii.[***]
iii.[***]
iv.[***]
v.[***]

2.PHASE I: [***]
Research and development of CMX-001 for the treatment of smallpox and dsDNA viruses to include the following activities: [***].The contractor shall carry out the 

following tasks and subtasks and in accordance with an agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and 2.1.9 below) which shall further detail the conduct of the specific tasks and subtasks.

2.1    Program Management

The Contractor shall provide for the following as outlined below and in the contract deliverables list (Article F.2):

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

2.1.2    A Principal Investigator (PI) responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.

2.1.3    Project Manager(s) with responsibility for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and program management; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.

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

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

2.1.6    Administrative staff with responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors.

2.1.7    Contract Review Meetings.
2.1.7.1          The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting and Project Officers. Such meetings may include, but are not limited to, meeting of the Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with technical consultants to discuss technical data provided by the Contractor.
2.1.7.2       The Contractor shall participate in teleconferences every two weeks between the Contractor and subcontractors and BARDA to review technical progress. Teleconferences or additional face-to-face meetings shall be more frequent at the request of BARDA.
2.1.8    Integrated Master Schedule
2.1.8.1          Within 30 calendar days of the effective date of the contract, the Contractor shall submit a first draft of an updated Integrated Master Schedule in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for review and comment. The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract. Contractor shall include the key milestones and Go/No Go decision gates. The IMS for the period of performance will be mutually agreed upon at the PMBR
2.1.9    Integrated Master Plan
2.1.9.1          Work Breakdown Structure: The Contractor shall utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor shall expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting. The CWBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task.
2.1.9.2       GO/NO-GO Decision Gates: The Integrated Master Plan outlines key milestones with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions.
2.1.9.3       Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract. The Seven Principles are:
I.Plan all work scope for the program to completion.

II.Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.
III.Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline.
IV.Use actual cost incurred and recorded in accomplishing the work performed.
V.Objectively assess accomplishments at the work performance level.
VI.Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.
VII.Use earned value information in the company’s management processes.

Elements of EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements.

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

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

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

I.Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks
II.Confirm the integrity of the Performance Measurement Baseline (PMB)
III.Foster the use of EVM as a means of communication
IV.Provide confidence in the validity of Contractor reporting
V.Identify risks associated with the PMB
VI.Present any revised PMBs for mutual agreement
VII.Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).
VIII.Present the Risk Management Plan

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

2.1.14  Monthly and Annual Reports: The Contractor shall deliver Project Status Reports on a monthly basis. The reports shall address the items below cross referenced to the WBS, SOW, IMS, and EVM:
I.Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory;
II.Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps;

III.Updated IMS;
IV.Updated EVM;
V.Updated Risk Management Plan (Every 3 months);
VI.Three month rolling forecast of planned activities;
VII.Progress of regulatory submissions;
VIII.Estimated and actual expenses;

2.1.15  Data Management:  The Contractor shall develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all contract data;
2.1.15.1     Provide for the statistical design and analysis of data resulting from the research;
2.1.15.2     Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request.

2.2    Non-Clinical Toxicology
2.2.1  N/A (no scope)

2.3    Non-Clinical
2.3.1  Develop and validate [***] to lower [***].
2.3.2  [***]: Conduct [***] studies including [***] studies, [***], and [***] studies in [***].
2.3.3  [***]
2.3.3.1       Conduct [***] study in [***].
2.3.3.2       Conduct [***] studies including [***] studies, [***] studies including [***] for CMX-001 and [***] in [***].
2.3.4  Use of [***] as a CMX-001 Surrogate in [***] Studies.
2.3.4.1   Dose [***] with [***] to identify the concentration of the [***] in [***] associated with [***] of [***].
2.3.5   Scaling of [***] to [***] by conducting studies with [***] to determine [***] in [***].
2.3.6   [***] determination of CMX001, [***] and [***] in the [***].
2.3.7  Conduct [***] experiments to demonstrate [***] following effective [***] prior to [***].
2.3.8   Conduct studies to optimize [***] in [***].
2.3.9  Conduct CMX001 [***] study in [***] at a dose of CMX001 equivalent or less than [***] with treatment beginning at the [***] 

2.4    Clinical
2.4.1  Measurement of [***] levels in [***] and correlate the [***] levels to studies conducted in [***].
2.4.2    Conduct expanded access protocol ([***]).
2.4.3    Analyze data and provide a Final Report for [***] evaluation of CMX001 in patients [***]
2.5    Regulatory
2.5.1   Engaging the FDA on a path to support the treatment of smallpox indication with CMX-001
2.5.2   Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA and/or all other data packages;
2.5.3   Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final minutes of any informal meeting with the FDA;
2.5.4   Obtain FDA concurrence on the feasibility of the proposed [***] with CMX001/[***]/[***] in the [***], including FDA feedback on [***] and review of data for the first [***] enrolled in the [***] sub-study
2.5.5   Develop and submit a revised [***] for CMX001 for Treatment of Smallpox, including [***] for FDA review and comment, and revise the [***] as requested by FDA

2.6    CMC
2.6.1   Validation of the [***] process: Validation of the process to demonstrate the [***] of a [***] of acceptable quality will be performed.
2.6.2  Validation of the [***] process to produce [***]: Validation of the process to demonstrate the [***] of a [***] of acceptable quality will be performed.

3.   PHASE II: [***]

Research and development of CMX001 for the treatment of smallpox to include the following activities: [***]. The contractor shall carry out the following tasks and subtasks and in accordance with the agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and 2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

3.1    Program Management (consistent with section 2.1)
3.1.1   Program management scope in BASE year is consistent with program management scope in each option year.

3.2    Non-Clinical toxicology
3.2.1   N/A (no scope)

3.3    Non-Clinical
3.3.1   Quantify [***] concentrations in [***] from [***].
3.3.2   Determine [***] for CMX001 in [***] in [***].
3.3.3  Scaling of [***] to [***] - Review with BARDA and FDA the [***] generated to support scaling between [***] and [***] using [***] as well as comparisons of [***] in the [***].
3.3.4   Determine [***] for CMX001 in [***] in [***]. 
3.3.5   Conduct [***].
3.3.6   Conduct [***] and [***]
3.3.7   Chimerix will provide [***] for the [***] and [***] conducted under [***]

3.4    Clinical
3.4.1   N/A (No scope)

3.5    Regulatory
3.5.1   Engaging the FDA on a path to support the treatment of smallpox indication with CMX001
3.5.2    Generating all necessary documentation for [***]. [***]
3.5.3   Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA (if needed) and/or all other data packages;
3.5.4   Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to the smallpox program; (ii) final draft minutes of any informal meeting with the FDA relating to the smallpox program.

3.6    CMC
3.6.1   N/A (No scope)

4.PHASE III: [***]

Research and development of CMX001 for the treatment of smallpox and dsDNA viruses to include the following activities: [***] Study, [***] Study, [***]. The contractor shall carry out the following tasks and subtasks and in accordance with agreed upon Integrated Master Schedule and Integrated Master Plan (defined in 2.1.8 and 2.1.9) which shall further detail the conduct of the specific tasks and subtasks.

4.1    Program Management (Consistent with section 2.1)
4.1.1   Program management scope in BASE year is consistent with program management scope in each option year.

4.2    Non-Clinical toxicology
4.2.1   N/A (no scope)

4.3    Non-Clinical 
4.3.1   [***] studies: A [***] study will be conducted with the [***] of CMX001 selected based on the results of the [***] and [***] studies. [***] will be [***] to receive [***] beginning at the [***] or the FDA agreed upon trigger for treatment. The first [***] study will be a [***] study of CMX001 in the [***] model. A study will be conducted with an [***] of CMX001 to determine the [***] after observation of the FDA agreed upon trigger for treatment. These studies will include [***] and [***]. The primary endpoint will be [***].
4.3.2    A [***] study of CMX001 in the [***]: The delayed treatment study will evaluate the [***] of CMX001 at [***]. The study will include [***] and [***] agreed upon with the FDA. The primary endpoint will be [***]. A [***] study to measure [***] in the selected [***] will be conducted to confirm the [***]. A [***] study will be conducted prior to [***] studies in the [***] to 1) determine [***] and [***] of [***] and 2) to confirm presence of [***] at fixed intervals [***].
4.3.3   Conduct additional studies in [***] to determine [***] and [***] for CMX001 at [***].
4.3.4    Conduct [***] of [***].
4.3.5    Conduct additional studies for [***] of [***] to be used in [***].

4.4    Clinical
4.4.1   Clinical [***] studies to evaluate [***] used in previous clinical studies and [***] used in previous clinical studies and [***]. This study will [***] to [***] to determine if [***] are comparable.

4.5    Regulatory
4.5.1  Generating all necessary data and preparing documentation for an [***] meeting submissions to regulatory agencies;
4.5.2   Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including the [***] Meeting, meetings to review [***], EUA (if needed) and/or all other data packages;
4.5.3   Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to this Contract; (ii) final draft minutes of any informal meeting with the FDA;
4.5.4    Preparing an [***] submission [***].

4.6    CMC
4.6.1   [***] in order to generate [***] for registration and clinical trial supplies.
4.6.2  [***]. Validation of the process to demonstrate the [***] of a [***] of acceptable quality will be performed.

5.PHASE IV: [***]

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

5.1    Program Management (Consistent with section 2.1)
5.1.1  Program management scope in BASE year is consistent with program management scope in each option year.

5.2    Non-Clinical toxicology
5.2.1  N/A (no scope)

5.3    Non-Clinical
5.3.1  [***] study. A [***] study will be conducted with dose and study design subject to FDA feedback received at the [***] Meeting. [***] will be randomized to receive [***] beginning at the [***]. These studies will include [***] and appropriate [***] assessments. The primary endpoint will be [***]. 

5.3.2    [***] study. A [***] study will be conducted with dose and study design subject to FDA feedback received at the [***] Meeting. The study design proposed may be a [***] study of CMX001 in the [***]. The [***] study will evaluate the [***] of CMX001 at various fixed intervals after [***]. The study will include [***] and appropriate [***] agreed upon with the FDA. The primary endpoint will be [***]. Additional [***] studies per FDA feedback may be conducted as lead-in studies.

5.4    Clinical
5.4.1    N/A (No scope)

5.5    Regulatory
5.5.1   Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;
5.5.2   Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, NDA and/or all other data packages relating to this Contract;
5.5.3   Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA relating to this Contract

5.6    CMC
5.6.1   [***]. [***] of the process to demonstrate the [***] of the final [***] process of [***] will be performed at new manufacturing site either at commercial scale or larger scale. May include a campaign of [***] and [***], the production of [***] to support the [***] of required necessary reference standards to support [***].

6.PHASE V: [***]

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

6.1    Program Management (Consistent with section 2.1)
6.1.1   Program management scope in BASE year is consistent with program management scope in each option year.

6.2    Non-Clinical toxicology
6.2.1   N/A (no scope)

6.3    Non-Clinical
6.3.1  [***] Studies.  This study replicates [***] if a larger sample size is necessary to achieve a [***] result.

6.4    Clinical
6.4.1   Compile [***].  A database of [***] data collected from all CMX001 clinical studies, irrespective of [***], will be populated and analyzed in order to support an NDA for smallpox.

6.5    Regulatory
6.5.1   Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies;
6.5.2  Submitting NDA documentation to the FDA in a timely manner, consistent with timelines set out in the contract and by the FDA.
6.5.3   Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, EUA and/or all other data packages;
6.5.4   Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA;

6.6    CMC
6.6.1   [***]. [***] of the process to demonstrate the [***] of a [***] will be performed.

7.Other Items

7.1    Facilities, Equipment and Other Resources. (Contract: Section J)
The Contractor shall provide equipment; facilities and other resources required for implementation of the SOW dated 27-OCT-14 to comply with all Federal and HHS regulations in:

7.1.1   The [***] and use of [***];
7.1.2   The acquisition, handling, storage and shipment of [***], including [***] required for working with the [***];
7.1.3    The [***] of [***] under cGMP;
7.1.3.1       The design and conduct of [***]; and
7.1.3.2       The conduct of [***] studies to determine [***] of [***]
7.1.5     Design and conduct of [***] under GCP.

																						
	REVISED MILESTONES ARTICLE F.2 DELIVERABLES

	Current Milestone #
	Milestone Definition
	Go Criteria
	No-Go Criteria
	Deliverable
	WBS/SOW #
	Segment

	1	[***]
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	2	[***]
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	3	[***]
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	8	[***]
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	9	No longer in development plan
				N/A	N/A
	10	No longer in development plan
				N/A	N/A
	11	[***]
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	12	No longer in development plan.
				N/A
	N/A

	13	No longer in development plan.
				N/A
	N/A

	14	[***]
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	15	[***]
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	16	[***]
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	17	No longer in development plan.
				N/A
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	18	[***]
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	19	[***]
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	20	[***]
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	23	[***]
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	BCA MILESTONE
	[***]
	[***]
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	NEW OPTION MILESTONES TO BE ADDED TO ARTICLE F.2 DELIVERABLES OF THE CONTRACT

	25	[***]
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	26	[***]
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	28	[***]
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	[***]Document

AMENDED WORKING COPY OF
COLUMBIA SPORTSWEAR COMPANY
401(k) EXCESS PLAN

As Amended by Amendments Nos. 1-10

Columbia Sportswear Company
An Oregon Corporation
14375 NW Science Park Drive
Portland, OR  97229-5418

        Columbia Sportswear Company (the Company) establishes this 401(k) Excess Plan (the Plan) for a select group of management or highly compensated employees.  The Plan is intended to permit eligible employees to defer amounts in excess of the amounts that may be deferred under the Columbia Sportswear Company 401(k) Profit Sharing Plan (the Qualified Plan) and receive matching contributions on certain of those deferrals, if the Company, in its discretion, makes such contributions.  The Plan is intended to be an unfunded, nonqualified Plan that complies with §409A of the Internal Revenue Code of 1986, as amended, (the Code) and related regulations and the related trust is intended to comply with the rules regarding grantor trusts.

    1.    Relevant Dates; Adoption by Affiliates

        1.1    This Plan shall be effective April 1, 2008.

        1.2    The Plan Year shall be the calendar year, except that the first Plan Year shall be a short year beginning on the effective date in 1.1 above and ending December 31, 2008.

        1.3    The Company adopts this Plan for eligible employees of the Company or any affiliate, other than an affiliate excluded from the Plan by the Company.

    1.3-1    “Affiliate” means a corporation, person or other entity that is a member, with an Employer, of a controlled group under §414(b) of the Code, a group of trades or businesses under common control under §414(c) of the Code, an affiliated service group under §414(m) of the Code or a group that is designated a controlled group pursuant to §414(o) of the Code.

    1.3-2    “Employer” means the Company and any non-excluded affiliate.

        1.4    Transfer of employment from one affiliate to another shall not cause a separation from service.

        1.5    If an employee is employed by two or more affiliates at the same time, the following shall apply:

Page 1 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

    1.5-1    The employee may elect contributions out of compensation from each Employer but may not elect contributions out of compensation from an excluded affiliate.

    1.5-2    The employee shall be eligible to receive matching contributions from each Employer based on elective contributions and compensation from each.

        1.6    The Company shall establish the effective date of adoption of this Plan by non-excluded affiliates and any special provisions that are to be applicable only to employees of a particular affiliate.  The Company may exclude an affiliate from this Plan at any time, regardless of whether the affiliate was previously a non-excluded affiliate.

    2.    Administration

        2.1    The Plan shall be administered by the Chief Human Resources Officer of the Company (the Administrator).  The Administrator shall interpret the Plan, decide any questions about the rights of participants and their beneficiaries and in general administer the Plan; provided however, that the Claims Committee shall have the authority to interpret Sections 6.1 and 9 of the Plan and decide any questions about the rights of participants and their beneficiaries under Sections 6.1 and 9 of the Plan.  Unless the Plan provides otherwise or the Administrator otherwise interprets the Plan, terms used in this Plan and also in the Qualified Plan shall have the same meaning. The ‘Claims Committee’ under this Plan shall consist of the Chief Human Resources Officer, one additional member of the 401(k) Committee and one member of the Compensation Committee of the Board of Directors.

2.2    The Administrator may delegate all or part of the administrative duties to one or more agents (the Agents).  The Administrator and the Claims Committee may retain advisors for assistance.  The Administrator and the Claims Committee may consult with and rely upon the advice of counsel, who may be counsel for an Employer.  Any decision by the Administrator, the Claims Committee or the Agents within the decisionmaker’s authority shall be final and bind all parties.  The Administrator and the Claims Committee shall have absolute discretion to administer and interpret the Plan with respect to the portion of the Plan over which each has authority and carry out their duties pursuant to this Plan.

        2.3    The Administrator shall be the plan administrator under federal laws and regulations applicable to plan administration and shall comply with such laws and regulations, except that the Claims Committee shall be the plan administrator under federal laws and regulations applicable to plan administration and shall comply with such laws and regulations for its responsibilities under Sections 6.1 and 9 of the Plan.  The Administrator shall be the agent for service of process at the Company’s address.  Any person having an interest under this Plan may consult the Administrator at any reasonable time.”

Page 2 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

        2.4    The Administrator may resign by giving ten days’ written notice, or such shorter notice accepted by the Company.  The Company shall fill any vacancy thus created as soon as practicable.

        2.5    The Administrator or the Agents shall make available at least two investment vehicles for the Participants’ Deferred Compensation Accounts.  The investment of each Participant’s Deferred Compensation Account will be governed by the election procedure in 4.6 below.  Amounts deferred, and gains or losses on such amounts, shall be credited to each Participant’s Deferred Compensation Account on dates determined by the Administrator or the Agents, but not less frequently than annually.  The Administrator or Agents may permit Participants to designate different allocations for all prior deferred amounts and future deferrals.

    3.    Eligibility

        3.1    The Administrator shall designate the employees who may participate in the Plan for a Plan Year from among those employees of the Employers who are eligible for designation.  In general, an employee shall not be eligible for a year unless the employee’s base compensation for the year is expected to be at least $225,000, as adjusted by the Administrator, determined as of the later of the preceding November 1 or the employee’s date of hire by the Employer.  Each employee the Administrator has designated for participation and each current or former employee with a Deferred Compensation Account shall be known as a Participant.

        3.2    Participation shall begin on the later of the effective date of the Administrator’s designation or the date the Administrator or the Agents give notice to the employee of his or her eligibility.

        3.3    Participation in the Plan will be on a Plan-Year-by-Plan-Year basis, and participation for any Plan Year will not, of itself, entitle a Participant to participate for any other Plan Year.  If a Participant ceases to be eligible to participate in the Plan but remains an employee of the Employer, the loss of eligibility shall not be treated as a separation from service and the Participant’s Deferred Compensation Account shall be paid as specified in the Participant’s Deferred Compensation Agreements, subject to Section 6.

    4.    Compensation Deferral

        4.1    Each employee designated for participation may elect to defer part of what would otherwise be Compensation for a Plan Year.

    4.1-2    The minimum deferral is $1,000.  The maximum deferral is 70% of Compensation.  Deferrals must be in multiples of $100 or a stated percentage of Compensation.

    4.1-3    “Compensation” for purposes of this Plan has the same meaning as the term “Earnings” in the Qualified Plan, except that (a) the limitation in Code §401(a)(17), currently set out in paragraph 1.1.33(c) of the Qualified Plan, on 
Page 3 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

Earnings counted shall not apply under this Plan; and (b) “Compensation” shall include any amounts deferred by an employee under this Plan pursuant to the employee’s election in a Deferred Compensation Agreement.  If the definition of Earnings in the Qualified Plan is modified, this Plan’s definition of Compensation shall be modified to correspond, except to the extent this Plan explicitly provides otherwise.

    4.1-4    A Participant may make a separate election for each of the elements comprising the Participant’s Compensation.  Deferrals from base salary shall be withheld in substantially equal amounts from the base salary otherwise payable for the Plan Year for which the deferral is made.  Deferrals from bonuses or incentive payments and supplemental compensation shall be withheld from the bonus or incentive payment and supplemental payments otherwise payable for the Plan Year for which the deferral is made.

    4.1-5    The election shall be made in a Deferred Compensation Agreement (Agreement) on a form acceptable to the Administrator or the Agents.  Each Plan Year deferral will be covered by a separate Agreement.

        4.2    Subject to 4.3 and the following rules, elections to defer shall be made by the date established by the Administrator or the Agents, which shall not be later than the December 31 prior to the beginning of the Plan Year in which the Compensation shall be earned.

    4.2-1    For bonuses or incentive payments described in 4.2-2, the election shall be made no later than six months before the end of the performance period.

    4.2-2    The rule contained in 4.2-1 shall apply only to payments contingent upon the satisfaction of preestablished organizational or individual performance criteria relating to a performance period of at least 12 consecutive months and only to a Participant who performed services for the Employer continuously from the later of the start of the incentive period or the date that Participant’s performance criteria are established through the date of the election.

    4.2-3    Subject to Section 6, any election shall be irrevocable with respect to that Plan Year.  If no election is timely made, all Compensation shall be paid on a regular basis during the Plan Year.

    4.2-4    For the first Plan Year, the election to defer shall be made by February 29, 2008, unless the Administrator or Agents set an earlier or later deadline, but not later than April 30, 2008.

        4.3    An employee who becomes a Participant during a Plan Year may make an election to defer within 30 days of the date the employee becomes eligible pursuant to 3.2 above.

Page 4 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

    4.3-1    The Agreement must be completed and returned to the Administrator on or before such date as the Administrator or the Agents specify, and in any event before the first day of the period to which the election applies.

    4.3-2    No election may be made with respect to bonuses or incentive payments for a year if the Participant becomes eligible after June 30 of the year.

        4.4    Each year, the Employer may, in its discretion, credit to each Participant’s Deferred Compensation Account a matching amount pursuant to the following rules.  

    4.4-1    A participant’s matching credit, if any, for a year under this Plan shall be equal to the lesser of (a) or (b) below, minus the participant’s share of the FICA tax due on the lesser of the amount determined in (a) or (b) below:

    (a)    The remainder of the following equation:

    (1)    100% of the Participant’s combined deferrals under this Plan (as defined in 4.4-5) and the Qualified Plan for the year, up to 4% of the Participant’s Compensation under 4.1-3 for the year; plus

    (2)    50% of the Participant’s combined deferrals under this Plan (as defined in 4.4-5) and the Qualified Plan for the year that exceed 4% but do not exceed 6% of the Participant’s Compensation under 4.1-3 for the year; minus

    (3)    The matching contribution the Participant would have been eligible to receive under the Qualified Plan for the year if the Participant had made the maximum permitted elective deferral to the Qualified Plan; or

    (b)    100% of the Participant’s deferrals for the year under this Plan (as defined in 4.4-5) alone. This includes, but is not limited to, the effect that a Participant who elects no deferrals to this Plan for a year will receive no matching credit for the year, regardless of the Participant’s deferrals under the Qualified Plan.

    4.4-2    The matching credit, if any, for a year shall be made only for Participants employed by an Employer on the last day of the Plan Year, unless the Participant’s employment ended during the Plan Year due to the Participant’s death or Total Disability or retirement at Normal Retirement Date under the Qualified Plan.  Any matching credit shall be fully vested when made.

    4.4-3    The matching credit shall be made in the time and form determined by the Administrator.  In general, the credit shall be made at or after the end of the 
Page 5 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

Plan Year, regardless of whether matching contributions to the Qualified Plan are made during the Plan Year.

    4.4-4    All of the percentages in 4.4-1(a)(1) and (2) shall be modified at the same time and to the same extent as those figures are modified in the Qualified Plan.

    4.4-5    For purposes of 4.4-1, “deferrals under this Plan” for a year shall be the sum of compensation and bonus deferred under this Plan that would otherwise have been paid in the year.  Thus, bonus deferral for a year for this purpose relates to the bonus earned during a prior year but that would, absent deferral under this Plan, have been payable during the year for which the matching credit is made.

        4.5    The Administrator shall maintain a Deferred Compensation Account (the Account) for each Participant to hold the Participant’s cumulative deferrals and any Employer matching credits, plus or minus any investment gains and losses, and minus any Plan expenses and any payments made to the Participant in accordance with the provisions of Sections 5 and 6 of the Plan.  Participants’ Accounts shall be held in a grantor trust established between the Company and a Trustee.

        4.6    Participants shall select an investment vehicle for their Accounts with the initial Agreement and may change such selection effective the first day of each calendar quarter, or at such other times as the Administrator or the Agents permit, on advance written notice to the Administrator pursuant to procedures adopted by the Administrator or Agents.  If no election is made, the Account shall remain in the same investment vehicle as the previous calendar quarter.

        4.7    The Company may elect to pay any administrative fees or expenses and may allocate the cost among the Employers.  Otherwise, the expenses and fees shall be deducted from Participants’ Accounts.  Expenses related to the individual Account of a Participant or Beneficiary may be charged directly to that Account.

    5.    Payment from Accounts

        5.1    Subject to Sections 6 and 7, a Participant’s Payment Date shall be one of the following, as selected by the Participant pursuant to 5.3 below:

    5.1-1    A date specified in the Agreement that is at least one year after the effective date of the Agreement but not later than the date the Participant would reach age 70.  For example, a December 2008 election deferring compensation to be earned in 2009 could provide for payment on January 1, 2010.

    5.1-2    The date that is six months after the date the Participant separates from service, for any reason, with the Company and Affiliates as defined in 1.3-1, regardless of whether the Participant serves as a director of the Company or an 
Page 6 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

Affiliate.  For example, if a Participant were to elect in December 2008 to defer compensation to be earned in 2009 until six months after separation from service and then separates from service on May 1, 2010, the Payment Date under this Plan with respect to that deferral would be November 1, 2010.

    5.1-3    The later of the date that is six months after the date the Participant separates from service with the Company and all Affiliates as defined in 1.3-1, regardless of whether the Participant continues to serve as a director of the Company or an Affiliate, or the date the Participant reaches an age up to 70 specified in the Agreement.  For example, if, in the situation described in 5.1-2, the Participant had elected to defer until the later of six months after separation from service or attainment of age 65, and reached age 65 on April 1, 2015, the Payment Date under this Plan would be April 1, 2015.

        5.2    A Participant’s vested Account shall be paid in one of the following ways as selected by the Participant subject to 5.3 below:

    5.2-1    In a lump sum within 30 days after the Payment Date under 5.1.

    5.2-2    In a lump sum within 30 days after the January 1 following the Payment Date selected pursuant to 5.1 above.

    5.2-3    In annual installments under 5.4 over a period of up to ten years, starting as soon as practicable after the January 1 following the Payment Date selected pursuant to 5.1 above.

        5.3    Subject to Section 6 and the following rules, the Participant shall specify in the Agreement the Payment Date pursuant to 5.1 and the payment form pursuant to 5.2 above.

    5.3-1    The selection shall be irrevocable for the portion of the Account covered by the Agreement.

    5.3-2    If different selections are made in Agreements applicable to different Plan Years (or in an Agreement for a single Plan Year), the Account shall be appropriately divided for distribution, subject to 5.3-4.

    5.3-3    If the vested balance of the Participant’s Account is less than $5,000, or to the extent any of the Account is not covered by a timely, complete election, payment of any such amount shall be made pursuant to 5.1-2 and 5.2-2.

    5.3-4    No Participant may have more than ten different time-and-form-of-payment elections in effect at any time.  For example, a five-year deferral with payment in a single sum is one payment election, a deferral to age 62 with payment in five-year installments is a second election and a deferral to age 65 with payment in five-year installments is a third election.  Similarly, a deferral in 
Page 7 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

the first year of participation for five years with payment in a single sum is a separate election from a five-year deferral in the second year of participation with payment in a single sum; if the second-year deferral were for only four years with payment in a single sum, it would not be a time and form of payment different from the first year’s election.

        5.4    If the Participant elects payment in installments under 5.2-3, the payment term must be specified in the Agreement.  The installment size shall be fixed on the Payment Date and on each later January 1 based on the distributable amount divided by the number of installments remaining.  If the annual payment computed under the preceding sentence is less than $5,000, the minimum annual payment shall be $5,000, with a corresponding reduction in the number of annual installments.  Installment payments shall be treated as a series of separate payments for purposes of 6.4 below.

        5.5    The Employer shall withhold from any payments any income taxes or other amounts as required by law.

        5.6    The Administrator or the Agents may in their discretion direct that payment be made in one or more of the following ways:

    5.6-1    To a spouse, parent or child of legal age.

    5.6-2    To one having actual custody of the person.

    5.6-3    To a legal guardian or conservator.

    5.6-4    To one furnishing maintenance, support or hospitalization.

    6.    Adjustment of Time and Form of Payment

        6.1    Participants may withdraw all or part of their Accounts because of Serious Financial Hardship, as determined by the Claims Committee.  A payment due because of a separation from service may not be made less than six months after the date of separation from service, even upon a showing of Serious Financial Hardship.

    6.1-1    “Serious Financial Hardship” means a Participant’s immediate and heavy financial need that cannot be met from other reasonably available resources and is caused by one or more of the following:

    (a)    Accident or illness involving the Participant, or the Participant’s spouse or dependent (as defined in §152 of the Code).

    (b)    Loss of the Participant’s property due to casualty.

Page 8 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

    (c)    The need to pay uninsured medical expenses, including prescription drugs.

    (d)    The need to pay the funeral expenses of a spouse or dependent (as defined in §152 of the Code).

    (e)    Any other similar extraordinary and unforeseeable circumstances arising from events beyond the Participant’s control, not including sending a child to college or purchasing a home.

    6.1-2    The withdrawal shall be limited to the amount reasonably necessary to meet the Serious Financial Hardship.  

    6.1-3    If a Participant is determined by the Claims Committee to have a  Serious Financial Hardship, the Claims Committee has the right to determine if the Serious Financial Hardship can be resolved by (a) cancellation of Participant’s deferral election for the Plan Year only, or (b) cancellation of Participant’s deferral election for the Plan Year and withdrawal of funds.  Cancellation of Participant’s deferral election for the Plan Year shall be canceled, effective with the pay period starting after the date the Claims Committee grants the hardship withdrawal application.

    6.1-4    The Administrator or the Agents shall establish procedures for implementing withdrawals, which shall include requirements for a written application signed by the Participant and a statement of the facts causing the Serious Financial Hardship, as well as any other items required by the Claims Committee, the Administrator or the Agents.

    6.1-5    The withdrawal date shall be fixed by the Administrator or the Agents, who may require a minimum advance notice and limit the amount, time and frequency of withdrawals.

        6.2    On application from a Participant, the Administrator, or the Agents, in their sole discretion, may defer the Payment Date or extend the term of payment for amounts not already payable, subject to the following rules:

    6.2-1    The application may request deferral or extension with respect to any or all of the time-and-form-of-payment elections in effect for the Participant.  Only two such applications may be granted for any Participant, regardless of whether the application previously granted applied to fewer than all of the Participant’s time-and-form-of-payment elections.  The application shall include the reason the deferral or extension is requested, the changed circumstances underlying the application and any other information or documents required by the Administrator or the Agents.  The Administrator or Agents may, in their 
Page 9 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

discretion, approve a deferred date for payment that would be later than would be permitted for an initial Payment Date pursuant to 5.1 above.

    6.2-2    Neither the Administrator nor the Agents shall grant an application to change a Payment Date selected pursuant to 5.1-1 or one or more of the dates on which installment payments are scheduled to be made pursuant to 5.2-3 unless the application is made at least 12 months before each date on which a payment is scheduled.  For example, a Participant who elected to defer a portion of salary until January 1, 2011, to be paid in a lump sum at that time, would have to apply before January 1, 2010 to be eligible to change that Payment Date and, pursuant to 6.2-4, the revised Payment Date could not be earlier than January 1, 2016.

    6.2-3    An application to change a Payment Date selected pursuant to 
5.1-2 or 5.1-3 or the date of an installment payment pursuant to 5.2-3 shall not apply to any amount that would be payable during the 12 months after the date the Administrator or the Agents receive the application.  For example, if a Participant who elected to defer a portion of salary for payment in five annual installments starting on January 1 following the date that is six months after the date of separation from service were to apply in May 2011 to defer the start of the five annual installments until the January following the fifth anniversary of separation from service and then separate from service in June 2011, the application would not apply to the payment due January 1, 2012 (because that is less than 12 months after the date of the application), but could defer one or more of the next four payments, as designated in the application, subject to the five-year rule in 6.2-4.

    6.2-4    An application shall not be granted to the extent it defers the Payment Date less than five years.  For example, in 6.2-3, the Participant would either have to defer each installment whose scheduled payment changes for at least five years from its originally scheduled payment date (so the second installment payment, originally scheduled for January 1, 2013, would have to be deferred at least until January 1, 2018 and the third installment payment, if deferred, could not be paid earlier than January 1, 2019, at least five years after its originally scheduled date of January 1, 2014).  Alternately, if the Participant wanted a lump sum, it would have to be paid at least five years from the last scheduled installment payment date (so at least to January 1, 2021, five years after the last installment payment, which would have been due January 1, 2016).

    7.    Effect of Death

        7.1    If the Participant dies, any portion of the Account for which the Payment Date had not been reached before death shall be paid to the Participant’s Beneficiary, determined pursuant to 7.3, beginning as soon as practicable after the Participant’s death, as follows:

    7.1-1    If the amount payable to a Beneficiary is less than $5,000, such amount shall be paid in a lump sum.
Page 10 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

    7.1-2    If 7.1-1 does not apply, payment shall be made in five substantially equal annual installments, unless a Beneficiary requests acceleration under Section 6.  The first installment shall be paid as soon as practicable after the Participant’s death and the second installment shall be paid in January of the year following the year of death; subsequent installments shall be paid as near as practicable to the anniversary of the second installment.  If the annual payment computed under the preceding sentence is less than $5,000, the minimum annual payment shall be $5,000, with a corresponding reduction in the number of annual installments.

        7.2    If the Participant dies, any portion of the Account for which the Payment Date had been reached before death shall continue to be paid under the payment schedule in effect at death, unless a Beneficiary requests withdrawal pursuant to 6.1.

        7.3    “Beneficiary” means the person or persons or other entity or entities that have been designated by the Participant to receive, after the Participant’s death, benefits under the Plan in accordance with the terms of the Plan.  

    7.3-1    The designation by the Participant must be on forms prescribed by the Administrator or the Agents and filed with the Administrator or Agents.  Beneficiary designations may be revoked or changed by filing a new Beneficiary designation with the Administrator or Agents.

    7.3-2    If more than one designated Beneficiary survives the Participant, payments shall be made equally to the surviving designated Beneficiaries, unless otherwise provided in the Beneficiary designation.  Participants may designate primary and secondary Beneficiaries and Beneficiaries by right of representation.

    7.3-3    If the Participant was married when the designation was made and is not married to the same spouse at death, the designation shall be void if the spouse was named as Beneficiary but the designation shall remain valid if a nonspouse Beneficiary was named.

    7.3-4    Should the Participant fail to designate a Beneficiary, or should the designated Beneficiary fail to survive the Participant, the Participant’s Account shall be paid to the Participant’s estate.

    7.3-5    Unless a proper beneficiary designation explicitly states otherwise, the designation shall apply to the Participant’s entire Account.

    8.    Nature of the Employers’ Obligations

        8.1    This Plan is intended to be and shall be construed as an unfunded plan.  The benefits provided under this Plan shall be a general, unsecured obligation of each Employer 
Page 11 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

with respect to the Participants employed by that Employer, regardless of the existence of the grantor trust.  Neither the Participant nor the Participant’s Beneficiaries or estate shall have any interest in any assets of an Employer by virtue of this Plan.  

        8.2    The Employers shall set aside assets in a grantor trust to offset their obligations to pay benefits pursuant to this Plan, but any funds set aside shall remain subject to the general creditors of the Employers, as provided in the trust agreement.

    9.    Claims Procedure

        9.1    Any person claiming a benefit or requesting an interpretation, a ruling or information under this Plan shall present the request in writing to the Claims Committee, who shall respond in writing as soon as practicable. 

        9.2    If the claim or request is denied, the written notice of denial shall state: 

    9.2-1    The reasons for denial, with specific reference to the Plan provisions on which the denial is based.

    9.2-2    A description of any additional material or information required and an explanation of why it is necessary.

    9.2-3    An explanation of this claim review procedure, including a statement of the right to sue, after exhausting this claims procedure. 

        9.3    Any person whose claim or request is denied or who has not received a response within 60 days may request review by notice in writing to the Administrator.  The original decision shall be reviewed by the Administrator, who may, but shall not be required to, grant the claimant a hearing.  On review, whether or not there is a hearing, the claimant may have representation, examine and obtain copies of relevant documents and submit issues and comments in writing. 

        9.4    The decision on review shall take into account all comments, documents and other information submitted by the claimant relating to the claim and shall normally be made within 60 days.  If an extension of time is required for a hearing or other special circumstances, the claimant shall be so notified of the special circumstances and the time limit shall be 120 days.  The decision shall be in writing and shall state the reasons and the relevant provisions and offer reasonable access to documents and other information relevant to the claim.  All decisions on review shall be final and bind all parties concerned.

    10.    Miscellaneous Provisions

        10.1    This Plan may be amended from time to time or terminated by a written document signed the Chief Executive Officer of the Company, but no such amendment or termination may accelerate the time of payment of benefits to Participants beyond what the Code 
Page 12 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

permits, except that if the Internal Revenue Service issues a final ruling that any amounts held under this Plan will be subject to current income tax, the Administrator may direct payment as soon as practicable to the affected Participants of the amounts to which the ruling applies.

        10.2    The Chief Executive Officer of the Company may terminate further deferrals under the Plan for any reason with respect to deferrals for months beginning after the date of termination of the Plan.  In the event of such cessation of deferrals, all other rights and obligations shall continue until all Deferred Compensation Accounts have been paid to all Participants under the terms of the Plan.

        10.3    This Plan shall inure to the benefit of and be binding on the Employers and their successors and assigns and any corporation into which an Employer is merged or consolidated, and the Participants and their successors, heirs and legal representatives.

        10.4    If a Participant terminates employment for any reason during a Plan Year for which Compensation is to be deferred, the actual deferral specified in the Participant’s Agreement for the Plan Year shall be adjusted to equal the actual amounts deferred pursuant to the Agreement before such termination.

        10.5    Subject to 5.6 above and the following rules, no interest provide pursuant to the Plan may be assigned, transferred, pledged, sold, conveyed, or otherwise alienated or encumbered in any way by any Participant or Beneficiary, and no such interest shall be subject to execution, attachment or similar process.  

    10.5-1    Any attempted sale, conveyance, assignment, pledge or encumbrance of any interest provided pursuant to the Plan, or the levy or any attachment or similar process, shall be null and void and without effect.

    10.5-2    Benefits may be paid in accordance with a qualified domestic relations order (QDRO) as defined in §414(p) of the Code pursuant to procedures established by the Administrator.  Benefits may be paid to an alternate payee pursuant to a QDRO before payment to the Participant would be permitted.

        10.6    Except as otherwise required or permitted by this Plan or applicable law, any notice or direction under this Plan shall be in writing and effective when actually delivered or, if mailed, when deposited postpaid as first-class mail.  Mail shall be directed to the address stated in this Plan or to such other address as a party specifies by notice to the other parties.

        10.7    Following termination of employment, a Participant shall not be an employee of an Employer for any purpose and the payments pursuant to Sections 5, 6 or 7 shall not constitute salary or wages.  A Participant shall receive such payments as retirement benefits, not as compensation for performance of any substantial services.

        10.8    The Plan shall be governed by, and interpreted and enforced in accordance with, the laws of the State of Oregon, except as preempted by federal law.
Page 13 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

Original Plan Executed as Follows:        COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      December 31, 2007        

Amendment No. 1 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      April 18, 2011            

Amendment No. 2 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      August 28, 2013        

Amendment No. 3 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      April 10, 2015            

Amendment No. 4 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      November 4, 2015        

Amendment No. 5 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      May 4, 2017            

Amendment No. 6 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

Page 14 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

                        Executed:      July 7, 2017            

Amendment No. 7 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      October 25, 2018        

Amendment No. 8 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      December 31, 2018        

Amendment No. 9 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      June 5, 2020            

Amendment No. 10 Executed as Follows:    COLUMBIA SPORTSWEAR COMPANY

                        By        s/T. Boyle            

                        Executed:      October 8, 2020        
Page 15 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

                        
Page 16 of 15 – Amended Working Copy of Columbia Sportswear Company 401(k) Excess Plan

TABLE OF CONTENTS

						
		Page

	    1.    Relevant Dates; Adoption by Affiliates

	1
	    2.    Administration

	2
	    3.    Eligibility

	3
	    4.    Compensation Deferral

	3
	    5.    Payment from Accounts

	6
	    6.    Adjustment of Time and Form of Payment

	8
	    7.    Effect of Death

	11
	    8.    Nature of the Employers’ Obligation

	12
	    9.    Claims Procedure

	12
	    10.    Miscellaneous Provisions

	13

1

INDEX OF TERMS

									
	Term	Section	Page

	Account	4.5	6
	Administrator	2.1	2
	Affiliate	1.3-1	1
	Agent for Service of Process	2.3	2
	Agents	2.2	2
	Agreement

	4.1-5	4
	Beneficiary
Claims Committee
	7.3
2.1
	11
2

	Code	Preamble	1
	Company	Preamble	1
	Compensation

	4.1-3	3
	Effective Date	1.1	1
	Employer

	1.3-2	1
	Matching Credit

	4.4	4
	Participant	3.1	3
	Payment Date	5.1	6
	Plan	Preamble	1
	Plan Administrator	2.3	2
	Plan Year

	1.2	1
	Qualified Domestic Relations Order	10.5-2	13
	Qualified Plan

	Preamble	1
	Serious Financial Hardship

	6.1-1	9
	Vesting

	4.4-2	5

2

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