Document:

Document

Exhibit 10.2

April 8, 2022
VIA ELECTRONIC MAIL 
Personal and Confidential
David Meline
[***]
[***]

Re:    Executive Retirement and Strategic Consulting Agreement
Dear David: 
Under the Offer of Employment dated June 2, 2020 between you and ModernaTX, Inc. (together with its parents, subsidiaries, and affiliates, the “Company” and, together with you, the “Parties”), this Executive Retirement and Strategic Consulting Agreement (the “Agreement”) sets forth the terms of your voluntary retirement from the Company on your planned retirement date of July 8, 2022 (the “Retirement Date”) or such earlier date if your employment is terminated due to your death or Disability or by the Company for Cause1 (whichever date is earlier, the “Last Day Worked”) and, in the event of your planned retirement on the Retirement Date, offers you the opportunity to provide consulting services for the Company through July 8, 2024.  Until the Last Day Worked, you will continue to receive your current base salary and benefits and continue to vest in any outstanding equity, but you will not be expected to perform duties other than transitional duties as requested by the Company’s Chief Executive Officer (“CEO”) and other members of the Executive Committee. 
Regardless of whether you enter into this Agreement, the following terms shall apply:  
•The Company shall pay you for all base salary plus payment for any unused vacation accrued through the Last Day Worked.  
•Your eligibility to participate in the Company’s medical plans will cease on the last day of the month inclusive of the Last Day Worked.  You may elect to continue your medical benefits under the federal COBRA law.  You will be notified by separate notice of your rights and obligations under COBRA.  
•Your eligibility to participate in the Company’s other employee benefit plans and programs will cease on the Last Day Worked.  You are not eligible to receive an annual bonus or other forms of incentive compensation with respect to your work for the Company during the fiscal year 2022 or thereafter.
•You shall have the right to retain any and all vested restricted stock units and to exercise any and all vested options that you hold to purchase the equity of the Company, and any such exercise shall be made under and shall be subject to, the terms of any and all applicable unit option and grant plans, equity incentive plans, and all other equity award plans and all agreements relating to any of the foregoing (collectively referred to as the “Equity Documents”), including without limitation the time limits on exercise.   
•You and the Company have agreed that your voluntary retirement does not constitute Good Reason as defined in and for purposes of the ESP. 

1     The terms “Cause” and “Disability” are defined by the Company’s Amended and Restated Executive Severance Plan in effect as of the Retirement Date (the “ESP”).  
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•On the Last Day Worked, or such alternative earlier date designated by the Company, you will be deemed to have resigned from all officer positions that you hold with the Company or any of its respective subsidiaries and affiliates.  You shall execute any documents in the form requested by the Company to confirm or effectuate any such resignations.  
•You are obligated, to the maximum extent permitted by applicable law, to comply with the obligations outlined in the Employee Confidentiality, Assignment, Noncompetition, and Nonsolicitation Agreement you executed in connection with the inception of your employment (the “Restrictive Covenants Agreement”), although the Company acknowledges that any non-competition and employee non-solicitation provisions contained in the Restrictive Covenants Agreement are not enforceable in the state in which you currently reside.    
The terms set forth above are not affected by whether or not you enter into this Agreement.  
With those understandings, you and the Company agree as follows:  
1.Conditions.  Subject to the terms of this Agreement, you will be entitled to continue to be employed at the Company through the Retirement Date and receive the Transition  Benefits (defined below) provided you satisfy each of the following (collectively, the “Conditions”):  (i)  you timely enter into this Agreement, do not timely revoke it, and at all times comply with its terms; (ii) your employment is not terminated by the Company for Cause, due to death or Disability, or as a result of your voluntary resignation before the Retirement Date; (iii) you work cooperatively and in good faith with the Company on all transition-related matters; and (iv) you comply with the Restrictive Covenants Agreement (as modified by this Agreement).  
2.Transition Benefits.  If you satisfy each of the Conditions, the Company will provide you with the following post-employment benefits (collectively, the “Transition Benefits”):
(a)Strategic Consulting.
1.You agree to provide, between the Retirement Date and July 8, 2024 (the “Strategic Consulting Period”), strategic consulting services concerning financial matters (the “Services”) as requested by the CEO, on a timetable mutually agreed between you and the CEO via telephone and/or written consultations.  You shall retain the sole control and discretion to determine the methods by which you perform the Services.  
2.As full consideration for the performance of the Services, you shall continue to vest through July 8, 2024 in (i) the unvested portions of the New Hire Equity Award, as that term is defined in the Offer of Employment dated June 2, 2020 between you and ModernaTX, Inc. (the “Offer Letter”) and (b) the unvested portions of the 2021 Annual Equity Grant issued on February 9, 2021 (which shall include the portions of the 2021 Annual Equity Grant issued as an option award and as an RSU award), both subject to the terms of the Equity Documents; the vesting for the portion of your 2021 Annual Equity Grant issued as a performance-based restricted stock unit award, or PSU, will end on the Last Day Worked, as contemplated by that award.    
3.You acknowledge and agree that you are not eligible for any cash compensation related to performing the Services and that the opportunity to continue vesting in the New Hire Equity Award and the 2021 Annual Equity Grant is adequate consideration to support this Agreement.  You may exercise any vested portions of either the New Hire Equity Award or the 2021 Annual Equity Grant under the terms of the Equity Documents and subject to the Insider Trading Policy of Moderna, Inc., a copy of which you acknowledge you have received, as 
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well as any applicable time limits on exercisability, which for the avoidance of doubt, will extend through the date that is three months after the end of the Strategic Consulting Period.    
4.You further acknowledge that the Company’s Code of Business Ethics and Conduct (available at www.modernatx.com) will be applicable throughout the Strategic Consulting Period.
3.General Release of Claims.  In consideration for, among other terms, remaining employed through the Retirement Date and receipt of the Transition  Benefits, to which you acknowledge that you would otherwise not be entitled, you voluntarily release and forever discharge the Company, its affiliated and related entities (including, without limitation, direct and indirect parent companies (including, without limitation, Moderna, Inc.), and direct and indirect subsidiaries and direct and indirect affiliates), its and their respective predecessors, successors and assigns, its and their respective employee benefit plans and fiduciaries of such plans, and the past, present and future officers, directors, stockholders, members, managers, employees, attorneys, accountants, agents and representatives of each of the foregoing in their official and personal capacities (collectively referred to as the “Releasees”) generally from all claims, demands, debts, damages and liabilities of every name and nature, known or unknown (“Claims”) that, as of the date when you sign this Agreement, you have, ever had, now claim to have or ever claimed to have had against any or all of the Releasees, to the maximum extent permitted by applicable law.  This release includes, without limitation, all Claims: relating to your employment by and termination of employment with the Company; of wrongful discharge; of breach of contract; of discrimination or retaliation under federal, state, or local law (including, without limitation, Claims of discrimination or retaliation under Title VII of the Civil Rights Act of 1964, the Civil Rights Act of 1866, the Rehabilitation Act of 1973, the Civil Rights Act of 1991, the Americans with Disabilities Act of 1991 (ADA), the Family and Medical Leave Act (FMLA), the Age Discrimination In Employment Act (ADEA), the Older Workers Benefit Protection Act (OWBPA), the Employee Retirement Income Security Act (ERISA), the Worker Adjustment and Retraining Notification Act (WARN), the California Labor Code, the California Fair Employment and Housing Act (FEHA), the Massachusetts Fair Employment Practices Act, Massachusetts General Laws ch. 151B,  and any other federal, state, or local statute or regulation regarding discrimination in employment or the termination of employment; any claims or allegations brought under the Equal Pay Act, the National Labor Relations Act (NLRA), or for non-payment of wages, bonuses, commissions, severance pay (under the ESP or otherwise), or other compensation, including but not limited to under the California Labor Code, the Massachusetts Civil Rights Act, the Massachusetts Equal Rights Act, the Massachusetts Parental Leave Act, the Massachusetts Labor and Industries Act, the Massachusetts right of privacy law, the Massachusetts Wage Act, the Massachusetts Earned Sick Time law, the Massachusetts Equal Pay Act, and the Massachusetts Minimum Fair Wage Law; and for libel, slander, breach of contract, breach of the implied covenant of good faith and fair dealing, unjust enrichment, quantum meruit, assault, battery, intentional infliction of emotional distress, tort or any other theory under the common law of any state); for stock, stock options, unit options, units, incentive units, restricted stock units or any other equity interests or rights to acquire equity interests in the Company or any other Releasee; and for damages or other remedies of any sort, including, without limitation, compensatory damages, punitive damages, injunctive relief and attorney’s fees.  
Notwithstanding the foregoing, this general release does not release any Claim: (a) that arises after the Revocation Period, including any rights that may arise under the Equity Documents; (b) for unemployment or workers’ compensation benefits; (c) for vested rights under ERISA-covered employee benefit plans as applicable on the date you sign this Agreement; (d) for coverage under any officer, director, or executive indemnification agreement (the “Indemnification Agreement”) and under applicable directors and officers liability insurance for acts or omissions while serving as an officer of the Company; (e) under this Agreement or (f) that by law cannot be waived.   You agree not to accept damages of any nature, other equitable or legal remedies for your benefit, or attorney’s fees or costs from any of the Releasees concerning any Claim released by this Agreement.  As a material 
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inducement to the Company to enter into the Agreement, you represent that you have not assigned any Claim to any third party and that you have not filed any complaints, charges, applications, lawsuits, or arbitrations against the Company or any of the Releasees. To the extent that you have knowledge concerning a potential violation of any federal, state, or local law, you represent that you have fully disclosed such information to the Company as of the Effective Date of this Agreement.
You covenant not to sue the Company and/or the Releasees for any of the Claims released above, agree not to participate in any class, collective, representative, or group action that may include any of the Claims released above, and will affirmatively opt out of any such class, collective, representative, or group action. You agree not to participate in, seek to recover in, or assist in any litigation or investigation by other persons or entities against the Company and/or the Releasees, except as required by law. 
Waiver of Unknown Claims. The Parties acknowledge the language of Section 1542 of the California Civil Code, which provides:
“A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY.” 
The Parties expressly waive the protection of Section 1542 and understand and agree that claims or facts in addition to or different from those which are now known or believed by them to exist may be discovered. The Parties intend to settle fully and release all claims they now have against one another and by you against the Company and the other Releasees, whether known or unknown, suspected, or unsuspected, except as to claims that cannot lawfully be released. 
4.Cooperation.    You agree that, to the maximum extent permitted by law, you have not and shall not in any way voluntarily assist, aid, or participate in the pursuit of any claims or actions brought by another against the Company or Releasees. If your assistance is requested or required in the pursuit of any claims brought against the Company or Releasees, you agree to provide written notice to the Company within two (2) business days of such request, unless requested by a governmental authority to the contrary.  Without additional compensation, you agree to cooperate with the Company and Releasees (including its and their counsel) in investigating, defending, prosecuting, litigating, filing, initiating, or asserting any actual or potential claims or other matters involving the Company and Releasees.  You agree to make yourself available during and outside of regular business hours for such cooperation; provided that the Company shall not utilize this Section to require you to make yourself available to an extent that would unreasonably interfere with any subsequent professional responsibilities that you may have.  You agree to appear without the necessity of a subpoena to testify truthfully in any legal proceedings in which the Company calls you as a witness.  In connection with fulfilling your obligations under this section, pre-approved, out-of-pocket reasonable expenses will be reimbursed by the Company, which shall not include any attorneys’ fees, except as provided by the Company’s by-laws and/or applicable insurance policies.
5.Return of Company Property.  You agree not to dispose of any property of the Company including, without limitation, information, or documents (including, without limitation, computerized data and any copies made of any computerized data or software) (all the foregoing are collectively referred to as the “Documents”) without the prior written authorization of the Company.  On or before the Last Day Worked, you shall return to the Company all property of the Company, including, without limitation, computer equipment, electronic devices, iPads, iPhones, mobile devices, software, access cards, credit cards, files, and any Documents containing information concerning the Company, and its actual or prospective business or business relationships.  After 
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returning all Documents and property of the Company, you shall delete and purge any duplicates of files or documents that may contain Company information from any non-Company computer or other devices that remain in your property.  If you discover that you continue to retain any such property, you shall return it to the Company or destroy it immediately.  
6.Non-disparagement.   
(a)Subject to Section 7 below, you agree not to make any false, disparaging, critical, or detrimental statements concerning the Company or any of the Releasees; its or their products or services provided or to be provided; its or their current or former officers, directors, stockholders, members, employees, managers, or agents; and its or their business affairs or financial condition.  You further agree not to take any actions or conduct yourself in any way that would reasonably be expected to affect adversely the reputation or goodwill of the Company or its affiliates; or its or their products or services provided or to be provided; or its or their current or former officers, directors, stockholders, members, employees, managers, or agents.  This non-disparagement obligation shall not in any way affect your obligation to testify truthfully in any legal proceeding.  
(b)The Company agrees that each of the members of the Company’s current Executive Committee will not make any false, disparaging, critical, or detrimental statements concerning your employment with the Company or take any actions that would reasonably be expected to affect adversely your professional reputation.  This non-disparagement obligation shall not in any way affect any Executive Committee member’s obligation to perform their fiduciary duties for the Company or testify truthfully in any legal or administrative proceeding.  
(c)You agree to limit any communications regarding your transition to statements that are consistent with the Company’s prior and contemporaneous announcement on or before the Last Day Worked.
7.Protected Disclosures.  Nothing contained in this Agreement (including, without limitation, the Restrictive Covenants Agreement) limits your ability to file a charge or complaint with any federal, state, or local governmental agency or commission (a “Government Agency”).  In addition, nothing contained in this Agreement limits your ability to communicate with any Government Agency or otherwise participate in any investigation or proceeding that may be conducted by any Government Agency, nor does anything contained in this Agreement apply to truthful testimony in litigation.  If you file any charge or complaint with any Government Agency and if the Government Agency pursues any claim on your behalf, or if any other third party pursues any claim on your behalf, you waive any right to monetary or other individualized relief (either individually or as part of any collective or class action); provided however that nothing in this Agreement limits any right you may have to receive a whistleblower award or bounty for information provided to the Securities and Exchange Commission.  Nothing in this Agreement (including, without limitation, the Restrictive Covenants Agreement) is intended to conflict with 18 U.S.C. § 1833(b), which provides that: “An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.”
8.Tax Treatment.  The Company shall undertake to make deductions, withholdings, and tax reports with respect to payments and benefits under this Agreement to the extent that it reasonably and in good faith determines that it is required to make such deductions, withholdings, and tax reports.  Nothing in this Agreement shall be construed to require the Company to make any payments to compensate you for any adverse tax effects incurred because of the Transition Benefits.
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9.Section 409A.
(a)The parties intend that this Agreement will be administered in accordance with Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”).  To the extent that any provision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that such payments comply with, or are exempt from, Section 409A of the Code.  The parties agree that this Agreement may be amended, as reasonably requested by either party, and as necessary to fully comply with, or be exempt from, Section 409A of the Code and all related rules and regulations.  
(b)Anything in this Agreement to the contrary notwithstanding, if at the time of your separation from service within the meaning of Section 409A of the Code you are a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that you become entitled to under this Agreement on account of your separation from service would be considered deferred compensation otherwise subject to the twenty percent (20%) additional tax imposed under Section 409A(a) of the Code, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (A) six months and one day after your separation from service, or (B) your death.  If any such delayed cash payment is otherwise payable on an installment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six-month period but for the application of this provision, and the balance of the installments shall be payable under their original schedule.  
(c)To the extent that any payment or benefit described in this Agreement constitutes “nonqualified deferred compensation” under Section 409A of the Code, and to the extent that such payment or benefit is payable upon your separation of employment, then such payments or benefits shall be payable only upon your “separation from service.”  The determination of whether and when a separation from service has occurred shall be made following the presumptions outlined in Treasury Regulation Section 1.409A-1(h).
(d)The Company makes no representation or warranty and shall have no liability to you or any other person if any provisions of this Agreement are determined to constitute deferred compensation subject to Section 409A of the Code but do not satisfy an exemption from, or the conditions of, such Section.
10.No Liability.  This Agreement shall not be construed as an admission of any liability by the Company or you of any act of wrongdoing.  The Parties specifically disclaim that the Company or any of the Releasees has engaged in any wrongdoing or has taken any action that would be the basis for any finding of liability.
11.Enforceability.  Except for the General Release of Claims above, if any portion or provision of this Agreement (including, without limitation, any portion or provision of the Restrictive Covenants Agreement) shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable shall not be affected, and each portion and provision shall be valid and enforceable to the fullest extent permitted by law.  If the General Release of Claims is found to be invalid or unenforceable in whole or in part, the Company will have the option in its sole discretion either to sever the invalid or unenforceable portion and enforce the rest of the Agreement or to cancel the entire Agreement.  In the event the Company exercises the option to cancel the entire Agreement, the Agreement shall be null and void and none of the Transition Benefits shall be owing, paid, or provided, and if such amounts or benefits have been paid or provided, you shall repay to the Company the total gross amount or value of any such benefits already paid or provided, and the total gross amount of the amounts otherwise being waived.
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12.Effect of Breach.  If you fail to comply with any of your obligations under this Agreement (including the obligations under the Restrictive Covenants Agreement), in addition to any other legal or equitable remedies it may have for such breach, including for damages and equitable relief, the Company shall have the right to (i) if you are still employed, end your employment for Cause, (ii) terminate its payments to you under the Agreement; and/or (iii) seek recovery of any payments made to you or for your benefit under this Agreement.  Any such consequences of a breach by you will not affect the release or your continuing obligations under this Agreement or under the Restrictive Covenants Agreement.
13.Waiver; Amendment.  No waiver of any provision of this Agreement shall be effective unless made in writing and signed by the waiving party.  The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.  This Agreement may not be modified or amended except in a writing signed by both you and an authorized Company executive.
14.Forum; Relief, Interpretation.
(a)The Parties agree that Massachusetts federal courts shall have the exclusive jurisdiction to consider any matters related to this Agreement, including without limitation any claim for violation of this Agreement.  With respect to any such court action, you (i) submit to the personal jurisdiction of such court, (ii) consent to service of process, and (iii) waive any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personal jurisdiction or venue.  This Agreement shall be construed under the laws of the Commonwealth of Massachusetts, without giving effect to any conflict of law provisions that would cause the application of the laws of other jurisdictions.  
(b)The Parties agree that this Agreement shall not be construed more strictly against one party than another because it may have been prepared in whole or in part by one of the Parties.  The Agreement’s headings are for reference purposes only and shall not affect its meaning or interpretation.  References to agreements and other documents shall be deemed to include all subsequent amendments and other modifications.  References to statutes shall include all associated regulations or amendments.
(c)You agree that it would be difficult to measure the harm caused to the Company that might result from any breach by you of your promises outlined in this Agreement and that money damages would be an inadequate remedy for any such breach.  Accordingly, you agree that if you breach, or propose to breach, any of your obligations under this Agreement, the Company shall be entitled, in addition to all other remedies, to an injunction or other appropriate equitable relief without showing or proving any actual damage to the Company and without the necessity of posting a bond.
15.Entire Agreement.  This Agreement constitutes the entire agreement between you and the Company and supersedes any previous agreements or understandings between you and the Company, including the June 2, 2020, Offer of Employment, provided however that the ESP, Indemnification Agreement, Restrictive Covenants Agreement, and Equity Documents remain in full force and effect.
16.Time for Consideration; Effective Date.  You acknowledge that you have been given the opportunity to consider this Agreement for at least 21 calendar days before signing it (the “Consideration Period”).  Any changes to this Agreement, material or otherwise, will not restart the running of the Consideration Period.  In signing this Agreement, you acknowledge that you have knowingly and voluntarily entered into this Agreement without any undue influence on the part of the Company or any of the Releasees.  You acknowledge that the General Release of Claims is knowing and voluntary, including without implication of limitation all claims under the Age 
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Discrimination in Employment Act, 29 U.S.C. § 621 et seq.  If you sign this Agreement before the end of the Consideration Period, you acknowledge that such decision was voluntary and that you had the opportunity to consider this Agreement for the entire Consideration Period.  You have seven (7) business days following your execution of this Agreement to revoke your assent by written notice to me (such period, the “Revocation Period”).  For a revocation to be effective, it must be received by me on or before the expiration of the Revocation Period.  This Agreement shall become effective only as of the first (1st) business day after the expiration of the Revocation Period (the “Effective Date”).  If you do not enter into this Agreement, your retirement will still be effective, but you will not be entitled to all the Transition Benefits.  You are advised to consult with an attorney before executing this Agreement.  
17.Counterparts.  This Agreement may be executed in two counterparts, each of which shall be considered an original and all of which shall constitute one agreement.  The signatures may be delivered by DocuSign or by scanned image (e.g., .pdf or .tiff file extension name) as an attachment to an electronic mail (e-mail), and such electronic signature shall be treated in all respects as having the same effect as an inked signature.  
To accept this Agreement, please return a signed, unmodified counterparty of this Agreement to me on or before the expiration of the Consideration Period.   By signing below, you acknowledge that you have been advised to discuss all aspects of this Agreement with your attorney, that you have carefully read and fully understand all the provisions of this Agreement, and that you are voluntarily entering into this Agreement.  
Thank you for your contributions to the Company and its mission of delivering on the promise of mRNA science to create a new generation of transformative medicines for patients.
ModernaTX, Inc., by:
/s/ Tracey Franklin    
 
Tracey Franklin
Chief Human Resources Officer

The foregoing is agreed to and accepted by:  

David Meline

/s/ David Meline            
Signature                                         

10 April 2022
Date
Page 8 of 8Document

Exhibit 10.4
Certain confidential portions of this exhibit have been omitted and replaced with “[***].” Such identified information has been excluded from this exhibit because it (i) is not material and (ii) is the type of information that the registrant treats as private or confidential.

																																																			
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
	1. CONTRACT ID CODE
	PAGE OF PAGES

	1
	       11

	2. AMENDMENT/MODIFICATION NO.
P00012
	3. EFFECTIVE DATE
See Block 16C
	4. REQUISITION/PURCHASE REQ. NO.

	5. PROJECT NO.(If applicable)
	6. ISSUED BY
ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201
	CODE	ASPR-BARDA	7. ADMINISTERED BY (If other than item 6)    
US DEPT OF HEALTH & HUMAN SERVICES
ASST SEC OF PREPAREDNESS & RESPONSE
ACQ MANAGEMENT, CONTRACTS, & GRANTS
O'NEILL HOUSE OFFICE BUILDING
Washington DC 20515
	CODE	ASPR-BARDA02
			
	8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)
MODERNATX, INC. 1492235
Attn: [***]
MODERNATX, INC. 
200 TECHNOLOGY SQ
CAMBRIDGE MA 02139-3578

	X	9A. AMENDMENT OF SOLICITATION NO.
		9B. DATED (SEE ITEM 11)
	X	10A. MOD. OF CONTRACT/ORDER NO.
75A50120C00034

	10B. DATED (SEE ITEM 13)
04/03/2020

	CODE    1492235
			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 for receipt of Offer     is extended,    ☐ is not extended.

Offer mist 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 ACKNOWLEDGMENT 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)
See Schedule

Net Increase:    $308,495,451.00

						
	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 data, 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)
FAR 43.103(a)

	E. IMPORTANT:    Contractor        ☐ is not,        ☒  is required to sign this document and return       1       copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)
Tax ID Number:    27-0226313 DUNS Number:    069723520
The purpose of this "no cost" bilateral modification is to:

The purpose of this modification is to
1)Provide funding in CLIN 0004 to support the additional scope of the Clinical Development Plan for the Adolescent Study P203 (WBS 1.4.2.3), Pediatric Study P204 (WBS 1.4.2.4) and Phase 3 Pivotal Study P301 (WBS 1.4.3.1) and
2)Update Section G.8 Negotiated Indirect Rates and Ceiling.

All other terms and conditions remain unchanged.
 Continued ...

Except as provided herein, all terms and conditions of the document referenced in Item 9 A 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)
[***]

	15B. CONTRACTOR/OFFEROR
[***]
(Signature of person authorized to sign)
	15C. DATE SIGNED
3/23/2022
	16B. UNITED STATES OF AMERICA
[***]
(Signature of Contracting Officer)
	16C. DATE SIGNED
2022.03.23

															
					STANDARD FORM 30 (REV. 11/2016)
Prescribed by GSA FAR (48 CFR) 53.243

												
	CONTINUATION SHEET
	REFERENCE NO. OF DOCUMENT BEING CONTINUED
75A50120C00034/P00012
	PAGE    OF

	2	11

NAME OF OFFEROR OR CONTRACTOR
MODERNATX, INC 1492235

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

		Period of Performance: 04/03/2020 to 08/31/2023
				
		Add Item 4 as follows:
				
	4	CLIN 0004 - Additional scope for the Adolescent
Study P203 (WBS 1.4.2.3), Pediatric Study P204
(WBS 1.4.2.4) and Phase 3 Pivotal Study P301 (WBS
1.4.3.1)
Requisition No: OS290293, OS290310
				308,495,451.00
		Accounting Info:
2022.199C035.25103 Appr. Yr.: 2022 CAN: 199C035 Obj
Funded:$137,493,755.00
	

ect Cla
	

ss:
	

25103
	
		Accounting Info:
2022.199C092.25103 Appr. Yr.: 2022 CAN: 199C092 Obj
Funded: $171,001,696.00
	

ect Cla
	

ss:
	

25103
	

															
	NSN 7540-01-152-8067
				OPTIONAL FORM 336 (4-86)
Sponsored by GSA 
FAR (48 CFR) 53.110

     

									
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	Contract #75A50120C00034		Modification P00012

The purpose of this modification is to:
1)Provide funding to support the additional scope of the Clinical Development Plan for the Adolescent Study P203 (WBS 1.4.2.3), Pediatric Study P204 (WBS 1.4.2.4) and Phase 3 Pivotal Study P301 (WBS 1.4.3.1) and
2)Update Section G.8 Negotiated Indirect Rates and Ceiling.
The chart below shows the budget increase to support the additional scope for the Adolescent Study P203 (WBS 1.4.2.3), Pediatric Study P204 (WBS 1.4.2.4) and Phase 3 Pivotal Study P301 (WBS 1.4.3.1) in the total amount of $[***]. BARDA will fund $308,495,451 and Moderna will contribute $[***].

																								
	Contract
Modification Scope
	Moderna
% Share
	BARDA
% Share
	

Total
		Total Budget Increase
	Moderna Amount
	BARDA
Amount (NTE)

	P203 Expansion
	[***]%
	[***]%
	100%
	$ [***]
	$    [***]
	$    -

	P204 Expansion
	[***]%
	[***]%
	100%
	$ [***]
	$    [***]
	$ 137,493,755

	P301 Boost
	[***]%
	[***]%
	100%
	$ [***]
	$    [***]
	$ 171,001,696

	Total				$ [***]
	$  [***]
	$ 308,495,451

–BARDA’s funding is a Not-To-Exceed (NTE) in the amount of $308,495,451 which is based on funding
•P203 – [***]%; P204 – [***]% and P301 – [***]%

–Moderna’s contributions are solely and specifically for the increase in scope captured in Modification 12. Moderna will contribute $[***] based on the following percents.
•P203 – [***]%; P204 – [***]% and P301 – [***]%

Below is the CLIN Structure as a result of this request (Modification 12). CLIN 0004 will fund BARDA’s portion of the additional scope for the Adolescent Study P203, Pediatric Study P204, and Phase 3 Pivotal Study P301.

CLIN    WBS    Description
0002    Clinical 1.4.2.3    P203 Adolescent Study age 12 years to < 18 years.
0002    Clinical 1.4.2.4    P204 Pediatrics children aged 6 months to < 12 years.
0002    Clinical 1.4.3.1    P301 Phase 3 Pivotal Study
**0004    Revised Scope Mod 12    Moderna/USG Contribution

** CLIN 0004 was set up to fund the additional/revised scope of the Adolescent Study P203, Pediatric Study P204, and Phase 3 Pivotal Study P301. This modification was negotiated such that BARDA’s funding will not exceed $308,495,451. Any costs incurred in excess of the agreed-upon Not-To-Exceed (NTE) amount of $308,495,451 would not be billable under this contract and will be borne by Moderna unless separately agreed by both parties.

Moderna will continue to invoice allowable cost against CLIN 0002 until the funding on CLIN 0002 is fully exhausted. At that time, Moderna will begin allocating costs to CLIN 0004, with BARDA contributions not to exceed $308,495,451.

CLIN 0004 will remain CPFF. Fee will not be applied to the additional scope. CLIN 0004 POP will commence upon the exhaustion of CLIN 0002 funding and end 8/31/2023.

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	Contract #75A50120C00034		Modification P00012

The chart below summaries the modifications on this contract. As a result of this modification, the contract value increased from $1,398,105,892 to $1,706,601,343.

															
	

DATE
	

MOD NO.
	

TYPE/PURPOSE OF MODIFICATION
	

CONTRACT VALUE CHANGE
	

CUMULATIVE CONTRACT VALUE

	4/16/2020
	Basic	Basic Award
	$430,298,520
	$430,298,520

	5/24/2020
	P00001	Exercise Option 1 CLIN 0003
	$53,000,000
	$483,298,520

	7/25/2020
	P00003	Increased SOW
	$471,596,459
	$954,894,979

	8/31/2020
	P00004	Add DPAS Priority Language
	$0
	$954,894,979

	9/14/2020
	P00005	Realign SOW in CLIN 0002 $48M
	$0
	$954,894,979

	2/16/2021
	P00006	Transfer vials to CDC
	$0
	$954,894,979

	3/12/2021
	P00007	P201, P203 & Program Management
	$62,705,357
	$1,017,600,336

	4/18/2021
	P00008	P301
	$236,364,615
	$1,253,964,951

	6/15/2021
	P00009	P204 & Press Release Update
	$144,140,941
	$1,398,105,892

	9/8/2021
	P00010	Rescind DPAS & update Section H.3 Key Personnel
	$0
	$1,398,105,892

	11/5/2021
	P00011	52.223-99 Ensuring Adequate COVID-19
& Update FY 21 Indirect Rates
	$0
	

$1,398,105,892

		P00012	P203, P204, P301 & Indirect Rates
	$308,495,451	$1,706,601,343

Section G.8 Negotiated Indirect Rates and Ceiling are revised as follows:

(a)Pending the establishment of final indirect cost rates, which shall be determined annually, based on audit of actual costs as provided in Subparts 31.201-6, 42.7 and 52.216-7(d) of the Federal Acquisition Regulation, the Contractor shall be reimbursed for allowable indirect costs at the approved agreed upon provisional billing rates. The Contractor's audited final indirect costs are allowable, to the extent that they do not lead the Contractor to exceed the established total contract cost or the Ceiling Rates established under this contract. If the Contractor’s final indirect cost rates are less than the established ceiling rates, the Contractor shall issue a credit for the difference between the ceiling rates and the lower final rates and update billings within 60 days after settlement of final indirect cost rates. The Contractor is also directed to the requirement to provide the USG with notice, when that actual costs are expected to exceed the costs estimates, as required by FAR 52.232-20

(b)The contractor is responsible for tracking all costs during performance, including indirect costs, and providing all required notices.
The Chart Below Shows the Indirect Ceiling Rates
									
	Indirect Cost Pool
	Provisional Billing Rate / Allocation Base
	2020 Rate Ceiling NTE

	Fringe
	[***]% of Total Labor Dollars
	[***]%

	Tech. Dev. 
Overhead
	[***]% of Tech Dev Direct Labor Dollars and
Allocated Fringe Dollars
	[***]%

	Research Overhead
	[***]% of Research Direct Labor Dollars and
Allocated Fringe Dollars
	

[***]%

	Development
 Overhead
	[***]% of Development Direct Labor Dollars and AllocatedFringe Dollars
	[***]%

	G&A
	[***]% of Total Cost Input
	[***]%

(c)The Government is not obligated to reimburse the Contractor for costs incurred in excess of the cost established in the contract.

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	Contract #75A50120C00034		Modification P00012

C. Statement of Work
Updated with Modification P000012
The contractor shall furnish all necessary services, qualified professional, technical, and administrative personnel, material, equipment and facilities as needed to perform the tasks set forth below that are not otherwise provided by the Government under the terms of this contract.

mRNA-1273 Vaccine Development (WBS 1.0)
The Contractor, Moderna, Inc. (“Moderna”) shall execute the preclinical, clinical, and chemistry, manufacturing and controls (CMC) activities required to license a vaccine against the SARS-CoV-2 virus (hereafter referred to as “mRNA-1273”). Building upon early clinical development already underway, this proposal will support the late stage development, including the demonstration of clinical efficacy and generation of a dataset supportive of licensure. Moderna will additionally evaluate the platform manufacturing capabilities relative to the needs for supply in response to a pandemic.

Program Management (WBS 1.1)
mRNA-1273 Program Management (WBS 1.1.1)
Moderna’s mRNA-1273 program team is composed of a multidisciplinary, highly matrixed, group of functional leads with experience in, and responsibility for, integrating plans and operationalizing strategies across Research, Toxicology, CMC, Regulatory Affairs, Clinical Development, and Quality. Collectively, the team has advanced ten programs to first-in-human studies within five years. The group will be led by a program lead (PL) who will oversee and coordinate the activities necessary to meet the program objective of licensure. The PL will be the point of accountability for the development and deployment of mRNA-1273. The Principal Investigator will set the strategic objectives for the program and ensure that Moderna is prepared to license a vaccine as early as the end of 2020. The Sub Principal Investigator will be responsible for ensure sufficient manufacturing capacity and production of mRNA-1273. A program management office (PMO) will be responsible for managing the cost and schedule constraints of the contract via an integrated master schedule and corresponding budget, identifying and managing program risk, and ensuring contract compliance. With the input from the mRNA-1273 project team, the PMO will be responsible for coordinating the drafting of and management to an integrated development plan. Upon execution of the contract, weekly meetings with BARDA will be held to monitor program performance and monthly and annual reports will be will delivered to BARDA for the record.

Nonclinical Toxicology (WBS 1.2)
Development and Reproductive Toxicology of mRNA-1273 (WBS 1.2.2.1)
To assess the risk of administering the vaccine to pregnant women, a complete GLP rat developmental and reproductive toxicology (DART) study is planned. Female Sprague Dawley rats will be dosed at the highest anticipated clinical dose level and include a control arm of phosphate-buffered saline (PBS). As is typical for DART evaluations for vaccines, the animals will be immunized three times prior to mating and two times during gestation. Each group will have two cohorts (one group will undergo Cesarean section with examination of the uteri and embryos; the other group will have natural delivery and will be terminated at weaning).

Nonclinical (WBS 1.3)
For the purposes of this proposal it is assumed that the VRC continues to support nonclinical activities to develop murine and non-human primate efficacy studies, and animal models to assess the potential of vaccine-enhanced disease. The scope of work below will execute additional robustness experiments in these developed models.

Assess Disease Enhancement (WBS 1.3.3.1)
The CoV spike protein expressed by the mRNA-1273 vaccine is stabilized in the prefusion conformation which should be optimal for inducing high quality antibody responses with low binding antibody to neutralizing antibody ratios. mRNA delivery and induction of CD8 T cells and Th1 CD4 T cells will avoid Th2-biased responses. The SARS-CoV-2 S protein expressed by the mRNA-1273 vaccine is stabilized in the pre-fusion conformation which should be optimal for inducing high functional antibody responses with low binding antibody to neutralizing antibody ratios, as it has been seen in RSV DS-Cav1 clinical trials and 2P-stabilized CoV S animal studies. In addition, mRNA vaccines induce Th1 skewed response as has been evident in several pre-clinical and clinical vaccine programs at Moderna, including pandemic flu and CMV (PMID 28457665, 29456015). By expressing pre-fusion SARS-CoV-2 S delivered with mRNA we should induce CD8 T cells and Th1-biased CD4 T cell responses as shown in both human, NHP, and murine studies, thus avoiding a Th2-biased response.

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	Contract #75A50120C00034		Modification P00012

We plan to perform studies in mouse and NHPs to assess the theoretical risk of vaccine induced disease enhancement triggered by CoV infection following vaccination with imRNA-1273. [***].

[***].

Ralph Baric is also developing a human ACE-2 transgenic mouse model, resulting in viremia and lung pathology upon wild- type SARS-CoV-2 infection. This model should facilitate evaluation of wild-type SARS-CoV-2 virus and will also be used to evaluation protection from mRNA-1273 vaccination. This model is however still under development and data are unlikely to become available before June/July 2020.

Finally, Vincent Munster (NIH/NIAID) has developed a Rhesus macaque model of SARS-CoV infection. After challenge animals get sick but infection is not lethal. Decreased respiration and irregular breathing, weight loss, fever spike at day 1 and evidence of pneumonia are all observed. In addition, hematological evidence of disease is seen, as well as viremia and shedding in nose, throat, and rectum up to day 10. Unlike what is observed clinically a high challenge dose of virus is required, and animals recover without intervention. Animals will be immunized with limiting doses of mRNA-1273 to allow breakthrough infection and endpoints relevant for disease enhancement will be collected. Results from these challenge studies may become available by end of June 2020.

Establish a Surrogate of Protection (WBS 1.3.3.2)
The primary endpoint for accelerated approval of a SARS-CoV-2 vaccine would be a neutralization assay. This endpoint must be supported with a body of pre-clinical work that demonstrates a correlation between neutralizing titers and efficacy and that quantifies a protective serologic threshold titer using the same neutralization assay. Murine and NHP efficacy models are being developed in parallel to the Phase 1 clinical study. Building on data from these preliminary models and studies, Moderna will conduct NHP efficacy and murine passive transfer studies to confirm and refine the surrogate of protection.

Clinical (WBS 1.4)
A Phase 1 study of mRNA-1273 in 120 healthy subjects 18-55 years of age will evaluate the safety and immunogenicity of two injections (28 days apart) at four dose levels (25, 50, 100 and 250 μg). The proposed Phase 2 study will enroll n=600 healthy subjects (>18 years) to receive two injections, 28 days apart, of placebo or 50 or 100 μg mRNA-1273, at 1:1:1, age stratified (18-55 yrs; >55 yrs).

The total safety database from the mRNA-1273 Phase 1 and Phase 2 studies will be approximately 445 adult participants exposed and approximately 245 adult participants at the highest dose level. The proposed Phase 2 study (synopsis included below) is intended to support entry to subsequent Phase 3 study(ies). [***].

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	Contract #75A50120C00034		Modification P00012

Phase 2 Safety and Immunogenicity Study (WBS 1.4.2.1)
Immediately following dose selection in the initial Phase 1 study the program will initiate a Phase 2 clinical study. The P201 study will confirm the safety and immunogenicity results from the open-label Phase 1, again testing a two-dose administration series 28d apart. Its assumed that 600 participants, randomized 1:1:1 active: placebo, testing a two dose levels of mRNA-1273. Enrollment will be age-stratified participants 18 year of age and above into two age cohorts. Primary objectives will include standard clinical safety evaluation with conventional safety and SARS-CoV-2-specific IgG endpoints though a neutralizing antibody assay would be preferred if available. Secondary objectives will evaluate of the specific humoral response against SARS-CoV-2 by binding and neutralizing antibody (nAb) response. Safety will be followed through 6 months post-last vaccination and primary immunogenicity endpoint will be measured at D57. The study will enroll in the US under IND. The study will assess COVID-19 as exploratory endpoint which may extend the duration of follow-up accordingly. Clinical trial assessments will include measurement of SARS-CoV-2 S-specific binding antibody and neutralizing activity in sera. This will provide an indication of vaccine-induced antibody quality and relative potency. Historically, immune-complex mediated lung pathology has been associated with a high ratio of binding to functional antibody activity. In addition, vaccine-induced T cell responses will be evaluated by peptide pool stimulation to define the pattern of cytokine production. [***]. To support the EUA, an interim clinical study synopsis will be drafted based on D57 safety and immunogenicity data.
Adolescent Study (WBS 1.4.2.3) – Updated with Mod P00012 – P203

Moderna will conduct an initial pediatric study plan (PSP) under Pediatric Research Equity Act requirements during the IND phase. A deferral will be requested for children less than 6 months of age at the time of initial BLA approval. Having demonstrated the mRNA-1273 is safe, tolerated, and effective in adults, Moderna will test the safety and immunogenicity of mRNA-1273 in a pediatric population with an aged-based step-down design.

The P203 study is a Phase 2/3, randomized, observer-blind, placebo controlled, study to evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 SARS-CoV-2 vaccine in 3000 3,740 healthy adolescents 12 to < 18 years of age. Participants will be randomly assigned to receive injections of either 100 μg of mRNA-1273 vaccine or a placebo control in a 2:1 randomization ratio. The goal of the study is to seek an indication for use of mRNA 1273 (100 μg IM, given as 2 injections, 28 days apart) in the 12 to < 18 year age group. The basis for demonstrating vaccine effectiveness is proposed to be met by serum antibody (Ab) response measured in this adolescent age group. The approach to inferring vaccine effectiveness will depend on whether or not an accepted serum Ab threshold conferring protection against COVID-19 has been established. If an Ab threshold of protection has been established, effectiveness will be inferred based on the proportion of adolescent study participants with serum Ab levels (on study Day 57) meeting or exceeding the Ab threshold. If an Ab threshold of protection has not been established, effectiveness will be inferred based on demonstrating non-inferiority of the geometric mean value of serum nAb from adolescent participants compared to the geometric mean value of serum nAb from adults enrolled in the ongoing clinical endpoint efficacy trial (Study P301).

This adolescent study will monitor all participants for a total of 12 months following the second dose of vaccine or placebo. Safety assessments will include solicited ARs (7 days post each injection), unsolicited AEs (28 days post each injection), medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse event of special interest (AESI) (pediatric MIS C) throughout the study period. Upon authorization of a vaccine in this age group, participants will be invited to cross over into an Open-Label Part B at which time they will be informed of their vaccination status and participants originally randomized to placebo will be offered mRNA-1273.

Pediatrics (WBS 1.4.2.4) – Updated with Mod P00012 – P204

mRNA-1273-P204 is a Phase 2/3, 2-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo- controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to < 12 years. The study population will be divided into 3 age groups (6 to < 12 years, 2 to < 6 years, and 6 months to < 2 years) and up to 3 dose levels (25, 50, and 100 μg) of mRNA-1273 will be evaluated.

The study will be conducted in 2 parts. Part 1 of the study will be open label and consist of dose-escalation, age de-escalation in 1,275 participants (see Table below for the number of participants in each age group) to select the dose for each age group. Part 2 of the study will be placebo-controlled, observer-blind evaluation of the selected dose in up to 12,000 participants (up to 4,000 participants in each age group). No participants in Part 1 will participate in Part 2 of the study.

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	Contract #75A50120C00034		Modification P00012

The study will begin with the oldest age group (6 to < 12 year) and age de-escalate. Each age group will begin with Part 1 and advance to Part 2. The mRNA-1273 investigational vaccine or placebo will be administered as 2 intramuscular (IM) injections, approximately 28 days apart.

The mRNA-1273 dose levels that will be evaluated in each age group in Part 1 and Part 2 of the study are given in the Table below. The 6-month to < 2 yr and the 2 to <6 year old age groups will receive the 25 μg dose level.

																		
	

Age Group
	Part
1
	Part
2

	mRNA- 1273
25 μg
	mRNA- 1273
50 μg
	mRNA- 1273
100 μg
	Selected Dose Level of mRNA-1273 From Part 1
	

Placebo

	6 to < 12years
		Study Arm 1(n=375)
	Study Arm 2(n=375)
	Study Arm 8 (n=
3,000)50 μg
	Study Arm 9(n=
1,000)

	2 to < 6 years
	Study Arm 7(Optional) (n=75)
	Study Arm 3(n=75)
Study Arm 4(n=75)
		Study Arm 10 (n= up to 3,000) 25 μg
	Study Arm 11(n=up to 1,000)

	6 months to
< 2 years
	Study Arm 5(n=150)
	Study Arm 6(n=150)
		Study Arm 12 (n= up to 3,000) 25 μg
	Study Arm 13(n=up to 1,000)

The study will enroll in the US and Canada.

Phase 3 Pivotal Study (WBS 1.4.3.1) – Updated with Mod P00012 – P301

Phase 3 Pivotal Study (WBS 1.4.3.1). The Phase 3 mRNA-1273-P301 study will confirm the trends observed during the Phase 1 and 2 trials, evaluating safety and efficacy in a larger number of subjects aged 18 and above. Approximately 30,000 subjects will be enrolled according to 1:1 randomization (active: placebo). Primary objectives will be 1) to demonstrate the efficacy of mRNA-1273 to prevent COVID-19 and 2) to evaluate the safety and reactogenicity of 2 injections of the mRNA-1273 vaccine given 28 days apart. Secondary objectives will evaluate: the efficacy of mRNA-1273 to prevent severe COVID-19; the efficacy of mRNA-1273 to prevent virologically confirmed SARS-CoV-2 infection or COVID-19 regardless of symptomatology or severity; VE against a broad definition of COVID-19 disease; VE to prevent death due to COVID-19 disease; VE against all- cause mortality; the efficacy of mRNA-1273 to prevent COVID-19 after the first dose of investigational product (IP); the efficacy of mRNA-1273 to prevent COVID-19 in all study participants, regardless of evidence of prior SARS-CoV-2 infection; the efficacy of mRNA-1273 to prevent asymptomatic SARS-CoV-2 infection.

The sample size of this Phase 3 is driven by the total number of cases to demonstrate VE (mRNA-1273 vs. placebo) to prevent COVID-19. [***].

[***].

On issuance of the EUA, in agreement with the FDA and OWS, the P301 study will offer vaccine to participants that were randomized to receive placebo and the study will transition to an open label study. All 30K participants will return for a Participant Decision Visit. Participants will complete an updated ICF, a sera and NP swab sample will be collected to test for asymptomatic infection, and participants randomized to the placebo arm will be offered vaccine. After unblinding the sponsor will continue to leverage the clinical trial infrastructure. Doubling the exposed population will reduce the incidence of rare events potentially detectable with high confidence in the trial to approximately 1/10,000 or 0.01%.

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	Contract #75A50120C00034		Modification P00012

In anticipation of FDA authorization of booster vaccination in September 2021, Moderna offered a booster dose of 50 μg mRNA-1273 (in Part C of the trial) to the approximately 25,000 participants in P301. Part C will facilitate the retention of study participants and is being conducted with minimal disruption to the original study. Safety and immunogenicity of the booster as well as the impact of the booster on the incidence rates of COVID-19 in the mRNA 1273 and Placebo-mRNA 1273 groups will be evaluated.

Part C Visit 1 will include an optional NP swab. Post-dosing safety calls will include passive solicitation for myocarditis and pericarditis, and myocarditis and pericarditis adjudication committee (AC) will be included. Covid-19 surveillance and case reporting/AC will continue for all. Original SOA Safety Calls post M13 (V5) to drop from monthly to every 2 months.

An interim database lock to support an sBLA will occur based on data generated from Protocol Amendment 9 that cover the addition of boosting and associated data for all eligible subjects.

Lot to Lot Consistency (WBS 1.4.3.2)

Based on FDA feedback received on 27 Aug 2020 this study is no longer required for licensure.

Regulatory (WBS 1.5)
IND Preparation and Filing (WBS 1.5.1.1)
Moderna’s Regulatory Affairs group, in close collaboration with BARDA, will work to draft a comprehensive regulatory master plan to guide the preclinical, CMC and clinical development of mRNA-1273 within the first 90 days of the contract. An original investigational new drug application (IND) will be filed with the United States Food and Drug Administration (FDA) to support the clinical development of the Moderna product from Phase 2 onwards.

IND Maintenance (WBS 1.5.1.2)
The Moderna-owned IND will be maintained to support the desired clinical development plan. As needed, meetings will be conducted to receive feedback and gain concurrence on the specifics of the development activities with the FDA. Moderna will file for Emergency Use Authorization, following the FDA guidance of EUA for COVID-19 vaccines. A product-specific VRBPAC will be held.

BLA Submission (WBS 1.5.2.1)
Moderna will submit a Biologics License Application (BLA) and seek approval for the mRNA-1273 vaccine.

CMC (WBS 1.6)
CTM Manufacture for Phase 2 (WBS 1.6.3.2)
Clinical trial materials for the P201 study will be supplied using the AMP process. The target yield of each lot is approximately [***] vials; consequently, manufacture of up to five drug product (DP) lots is expected to deliver [***] total vials. The DP will be a frozen liquid stored at [***]. The DP vials will be labeled and packaged by Moderna to support clinical testing in the US.

Process Development for Late Stage Clinical Supply (WBS 1.6.3.3) mRNA Process Development
Technical Development will confirm and optimize the process parameters for mRNA manufacture. [***].

[***].

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	Contract #75A50120C00034		Modification P00012

BLA Readiness (WBS 1.6.3.8)
In support of the Biologics License Application (BLA) due to the nature of the proposed timeline, it is likely that Moderna will need to complete some of process validation activities, primarily process characterization, after the completion of process performance qualification and before BLA filing. Moderna intends to rapidly develop a robust process for clinical manufacturing and PPQ, and then fully describe the acceptable design space for the process prior to BLA filing. Other activities to support this BLA filing, such as completing raw material qualification activities; if not included in the BLA

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	Contract #75A50120C00034		Modification P00012

submission, will require a supplement to the initial BLA. In the initial BLA filing Moderna will describe its control strategy to cover the gap between initial BLA filing and the BLA supplement.

Process Development for Full Commercial Scale (WBS 1.6.4.1)
The following section outlines the process development activities [***]. The goal of this work is to demonstrate the capability to produce mRNA-1273 at a scale that can support clinical demand.

[***].

Controls (Analytical and Validation) (WBS 1.6.5)

Potency Assay Development and Implementation (WBS 1.6.5.1)
[***].

Analytical Method Development and Validation (WBS 1.6.5.2)
Moderna has established a set of analytical methods that are applied to the release and stability testing of intermediates and DP. These methods are sufficient to assure the identity, strength, quality, purity and potency of the final product, and will have been qualified for use for mRNA-1273 as part of the Phase 2 CTM campaign. Robustness of product release and stability methods, structural characterization and identification of impurities to further support product specifications, product comparability assessment will continue to support Phase 3 development and licensure.

Characterization Assay Development and Implementation (WBS 1.6.5.3)
A heightened characterization panel of analytical techniques will be used to assess any process modifications and to confirm process reproducibility for both drug substance and drug product during process development and scale up. As the applicability of the methods used in the heightened panel to elucidate quality attributes of drug substance and drug product is determined, these methods may be elevated to the respective release panel.

Stability Studies (WBS 1.6.5.4)
Throughout the program, many studies will be undertaken [***]. This includes studies using development bench scale material, engineering lot material, and GMP material. This body of data will be used to apply interim and long-term shelf life to the drug product and process intermediates.
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