Document:

Document

EXHIBIT 10.2

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.        

CONFIDENTIAL

GLOBAL LONG TERM AGREEMENT

This Global Long Term Agreement is made as of September 4, 2020, and effective as of May 1, 2020 (the “Effective Date”) among Lonza Ss Ltd., having an address at Münchensteinerstrasse 38, 4002 Basel, Switzerland] (“LONZA SALES”), Lonza Ltd., having an address at Münchensteinerstrasse 38, 4002 Basel, Switzerland (“LONZA LTD”, and together with LONZA SALES, “LONZA”), and ModernaTX, Inc., with an address at 200 Technology Square, Cambridge, MA 02139 USA (“MODERNA” or “CLIENT”) (each, a “Party” and, collectively, the “Parties”).

RECITALS

A.MODERNA possesses extensive intellectual property, proprietary technology and expertise with respect to the research, development, manufacture and formulation of messenger RNA (mRNA) therapeutics and vaccines;

B.LONZA possesses world class manufacturing and process expertise in biologics manufacturing consistent with cGMP (as defined below);

C.MODERNA and LONZA entered into that certain Strategic Collaboration Agreement, dated as of April 30, 2020, pursuant to which the Parties entered into a multi-year global long term strategic collaboration (the “SCA”);

D.The SCA contemplates that the Parties will enter into this Agreement, pursuant to which MODERNA will engage LONZA to perform process development work and to manufacture and supply the Products at the LONZA facilities for clinical and commercial supply;

E.The Parties (or their respective Affiliates) desire to enter into individual Statements of Work for various workstreams, as further defined below.

NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, LONZA and MODERNA, intending to be legally bound, hereby agree as follows:

AGREEMENT

1.DEFINITIONS

When used in this Agreement, capitalized terms will have the meanings as defined below and throughout the Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.

a.“Additional Products” means any products owned or controlled by MODERNA or its Affiliates (other than the Covid Products) that are mutually agreed by the Parties and identified in the relevant Statement of Work.

a.“Affiliate” means, with respect to either Party, any other corporation, partnership or business entity that directly, or indirectly through one or more intermediaries, controls, is controlled by   or is under common control with such Party. For purposes of this definition, the term “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means direct or indirect ownership of at least fifty percent (50%) of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the ownership of voting securities, by contract, by corporate governance, resolution, regulation or otherwise.

b.“Agreement” means this Global Long Term Agreement, together with all Exhibits, Schedules and Appendices attached hereto, and all Statements of Work issued in connection therewith,   in each case as amended or restated from time to time by the Parties.

c.“Applicable Laws” means all relevant international, federal, provincial, state and local laws, statutes, rules, regulations, directives, ordinances, codes and guidelines promulgated by any  relevant Governmental Authority, whether currently in existence or hereafter promulgated, that are applicable to a Party’s activities hereunder, including the Services performed under the relevant Statement of Work (including cGMP, if applicable to such Services) together with amendments thereto.

d.“BARDA” has the meaning set forth in Section 2.6.2.

e.“BARDA Contract” has the meaning set forth in Section 2.6.2.

f.“Batch” means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

g.“Batch Record” means the production record pertaining to a Batch.

h.“Business Continuity Plans” has the meaning set forth in Section 17.2.

i.“Business Day” means any day other than a Saturday or Sunday on which banking institutions in New York, NY and Visp, Switzerland are open for business.

j.“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided, however, that (a) the first Calendar Quarter of this Agreement shall commence on the Effective Date and end at the end of the Calendar Quarter in which the Effective Date occurs and (b) the last Calendar Quarter of this Agreement shall commence at the commencement of such Calendar Quarter and end on the expiration of the Term.

k.“Calendar Year” means each twelve (12) month period beginning on January 1st; provided, however, that (a) the first Calendar Year of this Agreement shall commence on the Effective Date and end on December 31 of the same year and (b) the last Calendar Year of this Agreement shall commence on January 1 of the Calendar Year in which this Agreement expires and end on the expiration of the Term.

a.“Certificate of Analysis” means a document signed by an authorized representative of LONZA, certifying that a particular Batch of Product was Manufactured in accordance with the Quality Agreement, Applicable Law and the Specifications.

b.“Certificate of Testing” means a document signed by an authorized representative of LONZA, certifying that certain tests identified by MODERNA or mutually agreed upon in writing by the Parties and conducted by LONZA on a Batch of Product meets all Specifications.

c.“cGMP” or “GMP” means the then-current good manufacturing practices, standards, guidelines and regulations promulgated and published by the FDA, EMA and such other jurisdiction agreed upon by the Parties in writing, relating to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs including any standards, guidelines and regulations as promulgated by, as applicable: (a) the FDA under and in accordance with the U.S. Federal Food, Drug and Cosmetic Act and Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations, (b) the EMA and the EU Commission under European Directive 2003/94/EC, and/or (c) the ICH Harmonised Tripartite Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients (ICH Q7), as such standards, guidelines and regulations may be amended from time to time.

d.“cGMP Batch” means any Batch which is required under the relevant Statement of Work to be Manufactured in accordance with cGMP.

e.“Change Order” has the meaning set forth in Section 2.2.

f.“CMC” means chemistry, manufacturing and control.

g.“Commencement Date” means the date set forth in the relevant Statement of Work for the commencement of Services, including the Manufacture of the Product.

h.“Confidential Information” has the meaning set forth in Section 10.1.

i.“Controlled” means, with respect to any Know-How, patent or other intellectual property right, the possession (whether by ownership, license or sublicense, other than by a license, sublicense or other right granted (but not assignment) pursuant to this Agreement) by a Party (or its Affiliate) of the ability to assign or grant to the other Party the licenses, sublicenses or rights to access and use such Know- How, patent or other intellectual property right as provided for in this Agreement, without violating the terms of any agreement or other arrangement with any Third Party in existence as of the time such Party would be required hereunder to grant such license, sublicense, or rights of access and use.

j.“Covid Products” means (a) MODERNA’s proprietary mRNA constructs and lipid nanoparticles for a potential vaccine against SARS-CoV-2, including mRNA-1273 (including any  improved or modified version thereof, “mRNA-1273”), and (b) any other mRNA Constructs or lipid nanoparticles (i) for the treatment or prevention of infection by SARS-CoV-2 and (ii) identified as “Covid Products” in the relevant Statement of Work.

k.“DMF” means any drug master file filed with the FDA, and equivalent filing in other countries or jurisdictions.

a.“EMA” means the Regulatory Authority known as the European Medicines Agency and any successor agency thereto.

b.“Engineering Batch” means any Batch Manufactured under the relevant Statement of Work that is intended to demonstrate the transfer of the Process to the Facility.

c.“Environmental, Health and Safety Laws” or “EHS Laws” means all applicable environmental and similar Applicable Laws, including those relating to (a) safety (including occupational health and safety); protection of human health and the environment; (b) the introduction of any chemical substances into the stream of commerce; and (c) the generation, use, storage, handling, treatment, transportation or disposal of waste.

d.“EUA” means an Emergency Use Authorization, which is an authorization issued by the FDA allowing use of an unapproved medical product or unapproved use of an approved medical product during a declared emergency as determined by the Secretary of the Department of Health and Human Services pursuant to Section 564(b)(1) of the FD&C Act, or a comparable accelerated, conditional or temporary Regulatory Approval.

e.“Equipment” means the MODERNA Equipment or LONZA Equipment, as the context requires.

f.“Exclusivity Term” means, [***].

g.“Executive Officers” means, with respect to MODERNA, its Chief Executive Officer, and, with respect to LONZA, its Chief Executive Officer.

h.“Existing SOWs” means any Statements of Work entered into by the Parties prior to the execution of this Agreement, including (a) Statement of Work Nr. 1, effective as of April 20, 2020, attached hereto as Appendix A-1, (b) Statement of Work Nr. 2, effective as of May 13, 2020, attached hereto as Appendix A-2, and (c) Statement of Work Nr. 3, effective as of May 13, 2020, attached hereto as Appendix A-3.

i.“Facility” means any of LONZA’s facilities located in [***], or such additional facilities that the Parties may mutually agree upon, as

identified in the relevant Statement of Work. In all cases, the Facility(ies) to be utilized for performing Services or Manufacturing Product under this Agreement related to a specific Statement of Work shall be designated in such Statement of Work.

a.“FD&C Act” means the United States Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

b.“FDA” means the U.S. Food and Drug Administration, and any successor agency thereof.

c.“Flow-Down Provisions” has the meaning set forth in Section 2.6.

d.“Force Majeure Event” has the meaning set forth in Section 18.2.

e.“Governmental Authority” means any applicable government authority, court, tribunal, agency, department, legislative body, commission, authority, or other instrumentality of any national, supra-national, state, county, city, or other political subdivision.

f.“Indemnitee” has the meaning set forth in Section 16.3.1.

g.“Indemnitor” has the meaning set forth in Section 16.3.1.

h.“JMT” has the meaning set forth in Section 3.2.1.

i.“JSC” has the meaning set forth in Section 3.1.1.

j.“Know-How” means all non-public technical, scientific, and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, designs, drawings, assembly procedures, software, computer programs, apparatuses, specifications, data, results and materials, including: biological, chemical, vaccine-related, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays, and biological methodology, in all cases, whether or not  copyrightable or patentable, in written, electronic or any other form now known or hereafter developed.

k.“Lien” means any legal charge, debenture, mortgage, deed of trust, security interest, pledge, lien, assignment, or other encumbrance of any kind whether imposed by contract, Applicable Law or otherwise, whether fixed or floating, or conferring priority of payment.

l.“Lipid Nanoparticle” means any delivery technology for mRNA or other nucleic acids using solid particles at room temperature, of 50-1,000 nm size, consisting of solid lipids or a mixture of a solid lipid and a liquid lipid.

m.“LONZA” except where otherwise mentioned in the relevant SOW means [***] and Lonza Ltd [***].

a.“LONZA Equipment” means all equipment and machinery for which LONZA or its Affiliates shall hold title and that is used by LONZA or its Affiliates to (or otherwise necessary for), directly or indirectly, Manufacture Product or perform any Services.

b.“LONZA Improvement” means all Technology conceived, discovered, invented, developed, created, made or reduced to practice in connection with this Agreement that is [***].

c.“LONZA Operating Documents” means the standard operating procedures, standard manufacturing procedures, raw material specifications, protocols, validation documentation, and supporting documentation used by LONZA, such as environmental monitoring, for operation and maintenance of the Facility and LONZA Equipment used in the process of producing the Product, and any other LONZA documents containing information required to be provided to a Regulatory Authority in connection with obtaining Regulatory Approval of a Product, excluding any of the foregoing that are unique to the Manufacture of Product.

d.“LONZA Parties” has the meaning set forth in Section 16.2.

e.“LONZA Personnel” has the meaning set forth in Section 7.12.

f.“LONZA Process Equipment” all LONZA Equipment that is process equipment and is designated by the Parties as “LONZA Process Equipment” in the relevant Statement of Work or other written agreement by the Parties, or in the list of equipment maintained by the JMT as set forth in Section 3.2.2(f). For clarity, Lonza Process Equipment excludes process equipment that is customized or proprietary to Moderna.

g.“LONZA Technology” means all Technology of LONZA (a) existing prior to the effective date of this Agreement; or (b) developed or obtained by or on behalf of LONZA independent of this Agreement and without the use or reference to any confidential information of MODERNA (including the MODERNA Manufacturing Know-How, Products (or components thereof) or any manufacturing  equipment for the Products (or components thereof)).

h.“Losses” has the meaning set forth in Section 16.1.

i.“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce Product, including the production, manufacture, synthesis, processing, packaging, labeling, quality control testing, release, storage, shipping or supply of Product or any intermediate or component thereof. To the extent set forth in the relevant Statement of Work, “Manufacturing” could include process development, process qualification and validation, scale-up, analytic development, product characterization, stability testing, filling, finishing, quality assurance and quality control and supply. “Manufacturing” refers to Manufacturing of Product for pre-clinical, clinical and commercial purposes. “Manufacture” and “Manufactured” will have corresponding meanings.

a.“Materials” means all raw materials, components (including packaging materials), and other potential materials, supplies, consumables or similar items reasonably necessary for, or otherwise used in, the Manufacture of Product.

b.“Member” has the meaning set forth in Section 3.1.1.

c.“MODERNA Equipment” means all equipment or machinery designated by the Parties as “MODERNA Equipment” in the relevant Statement of Work or other written agreement by the Parties, or in the list of equipment maintained by the JMT as set forth in Section 3.2.2(f).

d.“MODERNA Improvement” means all Technology conceived, discovered, invented, developed, created, made or reduced to practice in connection with this Agreement [***].

e.“MODERNA Manufacturing Know-How” means Know-How Controlled by MODERNA or its Affiliates, which is maintained in confidence by MODERNA or its Affiliates, relating to the manufacturing of a given Product, including documentation constituting material support, performance advice, shop practice, specifications as to materials to be used, control methods, standard operating procedures, protocols, descriptions of the manufacturing process and related know-how, development reports, analytical methods, equipment size/name/customizations/components, validation reports, cleaning methods and batch records and any other information, in each case, that is (a) necessary or reasonably useful to manufacture such Product in accordance with the applicable Specifications or (b) disclosed to LONZA or its Affiliates by or on behalf of MODERNA or its Affiliates in connection with this Agreement, including any Statement of Work.

f.“MODERNA Materials” has the meaning set forth in Section 7.1.

g.“MODERNA Personnel” has the meaning set forth in Section 7.11.1.

h.“MODERNA Technology” means all Technology Controlled by MODERNA or its Affiliates
(a) existing prior to the effective date of this Agreement; or (b) developed or obtained by or on behalf of MODERNA or its Affiliates independent of this Agreement and without the use or reference to any confidential information of LONZA. For clarity, the MODERNA Technology includes (i)  the  Product  and any Product-intermediates, components or derivatives of Product, (ii) starting materials and any intermediates, components or derivatives of starting materials, (iii) Specifications, (iv) Test Methods and
(v) Process.

i.“mRNA-1273” has the meaning set forth in the definition of “Covid Products”.

j.“mRNA Construct” means a messenger RNA construct (modified or unmodified) for the expression of a polypeptide, including the sequence of such construct (which may include a cap, 5’ UTR, the associated open reading frame, 3’ UTR and a poly A tail), the chemistry of natural and non-natural nucleic acids, and the other chemical elements contained in such construct.

a.“mRNA Product” means a pharmaceutical or vaccine product that includes, incorporates or contains as an active ingredient one (1) or more mRNA Constructs (whether alone or in combination with one or more other active ingredients).

b.“OFAC” has the meaning set forth in Section 17.4.2.

c.“Person” means any natural person, corporation, unincorporated organization, partnership, association, sole proprietorship, joint stock company, joint venture, limited liability company, trust or government, or Governmental Authority, or any other similar entity.

d.“Process” means any and all processes and activities (or any step in any process or activity) specified by MODERNA that is to be used by LONZA to Manufacture the Product.

e.“Product” has the meaning set forth in the relevant Statement of Work. Product includes the Covid Products and any Additional Products.

f.“Project Documentation” means the compilation of documentation generated or to be generated by LONZA in preparation of and during the performance of the relevant Statement of Work, including, without limitation, executed Batch Records, component records, test records and test record forms, Certificates of Analysis, Certificate of Testing, release documentation, study protocols, study summary reports, deviation reports, laboratory investigations, environment excursions, formulation records, and other related documents, which show that the Product was Manufactured in accordance with the Quality Agreement, Applicable Law and the Specifications, or that Services were otherwise performed in accordance with the requirements of this Agreement.

g.“Quality Agreement” means the document established by MODERNA and LONZA in conjunction with this Agreement to establish the quality requirements applicable to Manufacture in accordance with applicable guidelines issued by the Regulatory Authorities that control authorization and licensing for manufacture and sale of pharmaceutical or medicinal products.

h.“Regulatory Approval” means the approval by any Regulatory Authority to market and sell the Products in the respective markets, including any pricing approval. For clarity, Regulatory Approvals include EUAs and other accelerated, conditional or temporary authorizations or approvals.

i.“Regulatory Authority” means the Service and Product relevant international, federal, provincial, state or local governmental or regulatory bodies, agencies, departments, bureaus, courts or other entities responsible for (a) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use, including the FDA, EMA, United States Drug Enforcement Agency or any other international, federal, state or local regulatory bodies, agencies, departments, bureaus, courts or other entities responsible for the regulation of drugs, (b) granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the manufacturing or use of products, or (c) health, safety or environmental matters generally.

j.“Sanctions” has the meaning set forth in Section 17.4.3.

a.“SARS-CoV-2” means the novel coronavirus known as SARS-CoV-2, including any subtypes or strains thereof.

b.“Services” means the activities to be performed by LONZA hereunder that are agreed to by the Parties and set forth in the relevant Statement of Work. The Statement of Work shall indicate whether the applicable Services are cGMP services or non-cGMP services.

c.“SOP” means a standard operating procedure.

d.“Specifications” means, for a given Product, the list of tests, references to any analytical procedures and acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which final Product should conform to be considered acceptable for its intended use that are provided by MODERNA in a Statement of Work or otherwise approved by MODERNA in writing, as well as dispensing and labeling information, as such specifications are amended or supplemented from time to time by MODERNA in writing.

e.“Statement of Work” or “SOW” means any written plan to perform Services that has been agreed to by the Parties and executed by an authorized representative of each Party. Each Statement of Work will be in the form of the template attached hereto as Appendix B (“SOW Template”), and will include, at a minimum, a reference to this Agreement, a description of the nature and scope of the Services to be performed, a timetable for the performance of the Services, the fees to be charged for such Services, and any other relevant items set forth in the SOW Template.  An initial Statement of Work  is attached hereto as Appendix A. Each Existing SOW shall be deemed a Statement of Work under this Agreement and is hereby governed by, subject to, and incorporated into this Agreement. Each  subsequent Statement of Work shall be governed by, subject to, and incorporated into this Agreement, although the terms in the relevant Statement of Work will apply only to Services described in that Statement of Work.

f.“Taxes” means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature (including any related fine, penalty, surcharge or interest) imposed by, or payable to, a Tax Authority, and has the additional meaning set forth in Section 9.4.

g.“Technology” means all patents, patent applications, inventions, trade secrets, copyrights, know-how, methods, processes, techniques, improvements, data, technical documentation, manuals, regulatory submissions, specifications, SOPs, instructions, and other intellectual property of any kind (whether or not protected or protectable under patent, trademark, copyright or similar laws).

h.“Technology Transfer” means the transfer of Know-How, documentation, specifications, SOPs, analytical methods and process validation documents related to MODERNA’s Process or Product by MODERNA to LONZA for the development of the Project Documentation for the Manufacture of the Product specifically for MODERNA or its Affiliates.

i.“Test Methods” means any assays or other test methods identified by MODERNA in the relevant Statement of Work, or as amended or modified in any Change Order.

j.“Third Party” means any party other than LONZA, MODERNA or their respective Affiliates.

a.“United States” or “U.S.” means the United States of America, including its territories and possessions.

b.“U.S. Government Supply Agreement” means an agreement between Moderna and the United States Department of Defense or other U.S. government agency pursuant to which the U.S. government procures supplies of mRNA-1273 from Moderna, as may be amended or supplemented.

c.“Waste” means all waste material generated from or in connection with any Services.

1.STATEMENTS OF WORK - PROCESS AND PRODUCT DEVELOPMENT; PROCESS OR PRODUCT MANUFACTURE; FLOW-DOWN PROVISIONS; QUALITY AGREEMENT

a.Statement of Work. Prior to performing any Process or Product  development, Technology Transfer, or Product Manufacture, the Parties will collaborate to prepare a Statement of Work describing the activities to be performed by the Parties (or to be subcontracted by LONZA to one or more Third Parties in accordance with Section 2.5). In the event of a conflict between the terms and conditions of this Agreement and any Statement of Work, the terms and conditions of this Agreement shall control.

b.Modification of Statement of Work. Should MODERNA want to change a Statement of Work or to include additional Services to be provided by LONZA, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA may propose to LONZA (including via the JSC or JMT) an amendment to such Statement of Work with the desired changes or additional Services (each a “Change Order”). LONZA will provide MODERNA with a Change Order containing a description of the required modifications to the relevant Statement of Work, and any proposed changes to the pricing  or other fees as well as impact on timelines as a result of such modifications, and will use diligent efforts to do so within [***] of receiving such notice from MODERNA.  LONZA may also propose a Change Order to MODERNA, and MODERNA will use diligent efforts to answer to such proposal within [***] of receiving such proposal. If the proposed Change Order is not acceptable to the receiving Party, the Parties will promptly negotiate in good faith a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under the existing Statement of Work) during any such negotiations. LONZA shall use commercially reasonable efforts to accommodate any of MODERNA’s requested changes, provided if a change is required by any Regulatory Authority on   or after the Commencement Date for a Product, such change shall be included in a Change Order. The modified Statement of Work shall be binding on the Parties only if it is signed by both Parties. Thereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of Work. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to by both Parties, the existing Statement of Work shall remain in effect, unless terminated by MODERNA in accordance with this Agreement or the existing Statement of Work.

c.Performance by LONZA. Subject to the provision by MODERNA of the MODERNA Materials pursuant to Section 7.1, LONZA (directly or through one or more Third Parties in accordance with Section 2.5) will use diligent efforts to perform, subject to the terms of the relevant Statement of Work, the work described in such Statement of Work in a professional manner in accordance with prevailing industry standards, the terms of this Agreement, the terms of the relevant Statement of Work (including the estimated timelines set forth therein), and all Applicable Laws. LONZA will promptly notify

MODERNA of any material potential or actual delays that arise or are anticipated during the performance of the Statement of Work, and will diligently work to mitigate any such delays.

a.Affiliates. Each Party shall have the right to extend the rights, licenses, immunities and obligations granted or imposed under this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to the applicable Party. Each Party shall however remain primarily liable for any acts or omissions, including financial liabilities, of its Affiliates. In addition, an Affiliate of a Party may execute a Statement of Work pursuant to this Agreement and submit or pay invoices (as applicable) under such Statement of Work. In such circumstances, all references in this Agreement to a Party shall be deemed to be to the applicable Affiliate of such Party with respect to (i) the relevant Statement of Work or (ii) the relevant portions of the relevant Statement of Work under which the Affiliate will be performing specified Services or obligations. The Affiliate shall be entitled to enforce this Agreement with respect to such Statement of Work, or as applicable the relevant portions of such Statement of Work, in its own name as an intended third party beneficiary and the Affiliate shall be liable to the other Party for any obligations and liabilities undertaken pursuant to such Statement of Work and subject to the terms and conditions of this Agreement. Without limiting the foregoing, all Statements of Work will be executed by the appropriate legal entities of the Parties, including as may be required to comply with any specific requirements of governments, governmental agencies or other Third Parties that are funding, purchasing or distributing the Covid Products.

b.Subcontracting. With MODERNA’s prior written consent, LONZA may subcontract the performance of specific obligations of LONZA under this Agreement or a Statement of Work to an Affiliate or to a qualified Third Party contractor; provided that (a) the relevant Statement of Work identifies the subcontractor and the specific Services to be performed by the subcontractor or MODERNA separately approves such Third Party contractor in writing, and (b) the subcontractor performs such Services or obligations under the relevant Statement of Work in a manner consistent with the terms and conditions  of this Agreement and such Statement of Work. Except as otherwise agreed upon in a Statement of Work, LONZA will be solely responsible for the performance of any permitted subcontractor, and for Losses arising out of such performance as if such performance had been provided by LONZA itself under this Agreement or the relevant Statement of Work. LONZA will cause any such permitted subcontractor to be bound by, and to comply with, the terms of this Agreement or the relevant Statement of Work, including all confidentiality, intellectual property, recordkeeping, audit and inspection, quality  assurance,  regulatory and other obligations and requirements of LONZA set forth in this Agreement or the relevant Statement of Work. For clarity and notwithstanding anything to the contrary in this Section 2.5, [***].

c.Flow-Down Provisions.

i.The Parties acknowledge and agree that the Manufacturing of certain Products  or the performance of certain Services may be subject to restrictions or requirements based upon funding or grants received by or on behalf of MODERNA or its Affiliates from governments, governmental agencies or other funding sources [***]. The Statements of Work will include appropriate mandatory flow-down provisions (the “Flow-Down Provisions”) that are required to be incorporated as a result of any funding, grants or other funding sources for the Products or Services strictly for the purpose of ensuring MODERNA’s performance of its obligations under such Flow-Down Provisions as incorporated in its prime contract.

ii.Without limiting the generality of the foregoing, the Parties acknowledge and agree that certain Services may include work under one or more prime contracts between the Biomedical Advanced Research and Development Authority (“BARDA”) and MODERNA (or its Affiliate), including the contract dated April 16, 2020 (NO. HHSO75A50120C00034) as may be amended, supplemented or replaced (each, a “BARDA Contract”). Additionally, the Parties acknowledge and agree that Services regarding the Manufacture of mRNA-1273 in the United States will be subject to the terms required under the U.S. Government Supply Agreement.

iii.If a Statement of Work includes Flow-Down Provisions, LONZA hereby covenants that LONZA and its Affiliates will comply with the Flow-Down Provisions set forth in such Statement of Work. If the relevant Statement of Work indicates that the Services are being performed in connection with a BARDA Contract, the Flow-Down Provisions included in Attachment C hereto shall apply with respect to such Services. [***].

a.Quality Agreement. Promptly following the Effective Date, the Parties shall negotiate in good faith and enter into a Quality Agreement on terms to be mutually agreed by the Parties. If reasonably determined necessary by LONZA, the parties shall enter into separate Quality Agreements for different Facilities. LONZA shall Manufacture and supply the Product in accordance with the Quality Agreement as reasonably updated by the Parties from time to time, notably to take into consideration any marketing authorization(s) for Product. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.

1.GOVERNANCE

a.Joint Steering Committee.

i.Immediately following the Effective Date, the Parties shall establish a joint steering committee (“JSC”) to oversee, review, approve and coordinate the activities of the Parties under this Agreement, including each Statement of Work. Each Party shall appoint three (3) members to the JSC (each a “Member”). Each Party may change one or more of its Members by written notice to the other Party.

ii.The JSC shall be responsible for:

        [***] 

iii.The JSC shall meet [***] 

i.[***]

a.Joint Manufacturing Team.

i.Within [***] of the Effective Date, the JSC shall establish a joint manufacturing team  (the “JMT”) to oversee the Services under each Statement of Work.  The JMT shall  be composed of a mutually agreed number of members, with an equal number appointed by each of MODERNA and LONZA. The JMT shall include individuals with expertise and responsibilities appropriate  (in terms of their seniority, availability, function in their respective organizations, training and experience) for the tasks then being undertaken. Each Party shall designate one of its representatives as its primary contact for JMT matters (such Party’s “Team Co-Leader”). A Party may replace any or all of its representatives (and designated Team Co-Leader) at any time by informing the other Team Co-Leader in advance, in writing (which may be by email).

ii.The JMT shall be responsible for:

[***]

i.The JMT shall meet [***].

ii.The Parties acknowledge and agree that the JMT is intended to act as a body solely overseeing and deciding upon items within the scope of work defined and agreed upon in writing  by the Parties in the relevant SOWs, as well as a discussion forum, and not a decision-making body for any items outside of the agreed upon scope of work. Other than with respect to questions regarding the JMT’s authority to review and approve modifications to Statements of Work within parameters prescribed by the JSC, the JMT’s responsibilities are not subject to the oversight of, or escalation to, the JSC in the event of any dispute or disagreement between the Parties.

a.Limitations of Authority. Each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers, or discretion will be delegated to or vested in the JSC or JMT, unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. Except as provided in Section 3.1.2 and Section 3.2.2(f), the JSC and the JMT will not have the power to (a) amend, modify or waive compliance with this Agreement, including any Statement of Work, (b) alter, increase or expand the Parties’ rights or obligations under this Agreement, including any Statement of Work, beyond those explicitly set forth in this Agreement, including any Statement of Work, (c) determine that a Party has fulfilled any obligations under this Agreement or that a Party has breached any obligation under this Agreement, including any Statement of Work, or (d) make a decision that is expressly stated to require the mutual  agreement of the Parties or  for which MODERNA or LONZA have final decision making authority.

1.TECHNOLOGY TRANSFER

a.Based on the information provided by MODERNA and including process definition or changes mutually agreed by the Parties pursuant to the relevant Statement of Work, LONZA will prepare the Project Documentation for the applicable Process in accordance with the schedule set forth in the relevant Statement of Work and the Specifications, the LONZA Operating Documents and any written instructions provided by MODERNA (provided that LONZA shall be required to comply with such written instructions only if such instructions comply with cGMP requirements, data integrity specifications or commitments made by MODERNA to the applicable Regulatory Authorities). MODERNA will  inform LONZA of any specific requirements MODERNA may have relating to the Project Documentation,  including, without limitation, any information or procedures MODERNA wishes to have incorporated therein. The applicable Project Documentation, as set forth in the relevant Statement of Work, shall be completed and delivered by LONZA at completion of a Batch.

b.LONZA will not use or incorporate any non-commercially available materials, Technology, LONZA Technology or LONZA Improvements in connection with the performance of any Services or the

Process, unless such non-commercially available materials, Technology, LONZA Technology or LONZA Improvements are specifically agreed to by the Parties and identified in the relevant Statement of Work, including the applicable terms and conditions of the use or incorporation of such non-commercially available materials, Technology, LONZA Technology or LONZA Improvements. [***].

c.As set forth in the relevant Statement of Work, MODERNA will cooperate with LONZA to assist LONZA to develop the Project Documentation and Process, including, without limitation, by providing LONZA with additional information and procedures as may be required to create the Project Documentation, Process, and/or any of the following: (a) manufacturing process information, SOPs, development reports, (b) quality control assays and related method validation reports, (c) raw material specifications (including vendor, grade and sampling/testing requirements), (d) Product and sample packing and shipping instructions, and (e) Product-specific cleaning and decontamination information.

d.LONZA will deliver a draft version of the applicable portions of the Project Documentation to MODERNA for its review and approval in accordance with the timeline set forth in the relevant Statement of Work. MODERNA will notify LONZA in writing of any objections it has to the draft Project Documentation, and upon such notification, representatives of LONZA and MODERNA will meet promptly in good faith to resolve such objections. LONZA will incorporate all reasonable comments from MODERNA in the Project Documentation. Upon MODERNA’s written acceptance of the draft Project Documentation, such draft will be deemed approved by MODERNA. Any failure by MODERNA to accept in writing any agreed-upon Project Documentation within [***] of receipt will be promptly be escalated to the JSC.

e.The Process, Project Documentation, Specifications, and any improvements or modifications thereto developed during the Term, but excluding any LONZA Operating Documents, LONZA Technology, LONZA Improvements or LONZA Confidential Information included in any of the foregoing, will be deemed MODERNA Confidential Information and subject to the provisions set forth in Article 10.

f.For clarity, LONZA will use the LONZA Operating Documents in the Process or the Project Documentation, but LONZA represents and warrants that LONZA Operating Documents are not necessary for MODERNA or a Third Party contract manufacturer to Manufacture Product as it is assumed that MODERNA or a Third Party contract manufacturer would have its own operating documents and SOPs. LONZA shall make LONZA Operating Documents available to support MODERNA or its Third Party contract manufacturer [***].

1.MODERNA EQUIPMENT.

a.Relevant Terms. Each Statement of Work shall include the terms and conditions applicable to the MODERNA Equipment to be used by LONZA to perform the Services set forth in such Statement of Work.

2.[INTENTIONALLY  LEFT BLANK]

3.MANUFACTURE  OF PRODUCT

a.MODERNA Materials. Within the time period agreed to in the relevant Statement of Work, MODERNA will ensure that LONZA is provided with the materials listed in such Statement of Work required to be supplied by MODERNA for the production of the Product, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Services (collectively, the “MODERNA Materials”). The MODERNA Materials are the Confidential Information of MODERNA and shall be used by LONZA solely for purposes of this Agreement and the relevant Statement of Work. MODERNA will promptly inform LONZA of any delays in providing MODERNA Materials that would prevent LONZA from performing the Services or in accordance with the timeline set forth in the relevant Statement of Work, and, in the event of any such delay, LONZA will use commercially reasonable efforts to accommodate any requests by MODERNA to adjust the timeline for the Services to compensate for such delay.  LONZA shall ensure that the MODERNA Materials is secure  and safe from loss, damage or misuse.

b.LONZA Materials. Except for the MODERNA Materials and as otherwise agreed in the relevant Statement of Work, LONZA shall supply, at its sole cost and expense and accordance with the relevant approved specifications, all materials in adequate quantities to be used by LONZA for the Manufacture of the Product and the performance of Services (“LONZA Supplied Materials”). The Parties agree that LONZA is responsible for the procurement of LONZA Supplied Materials, including with respect to transporting, testing, inspecting and storing the LONZA Supplied Materials; maintaining systems for management of LONZA Supplied Materials; and maintaining adequate supplies of LONZA Supplied Materials based on binding forecasts. LONZA shall not be responsible for raw material shortages or supplier delays outside of its control to the extent it diligently complied with its duties to procure and maintain adequate LONZA supplies Supplied Materials.

c.Commencement Date. Each Statement of Work governing the Manufacture of Product will include a Commencement Date agreed upon by the Parties. Subject to the terms of the relevant Statement of Work, LONZA will commence Manufacture of the Product on or before the Commencement Date.

d.Manufacture by LONZA. During the time period specified in the relevant Statement of Work, LONZA will Manufacture, package, ship, handle quality assurance and quality control for the Product exclusively at the applicable Facility, all as set forth in such Statement of Work, and will deliver to MODERNA the Product requested by MODERNA in such Statement of Work in accordance with the estimated timelines set forth in such Statement of Work, all in accordance with the terms set forth in Section 7.6 below. LONZA shall, at its own cost and expense, ensure that at all times the applicable Facility is in a qualified and validated state appropriate for inclusion as a Manufacturing site for the Products, as

required by the applicable Regulatory Authorities, Applicable Laws and the Specifications for the Products. Any costs or expenses related to bringing a Facility or any LONZA Equipment needed to Manufacture Products or to perform the Services into compliance with any applicable regulatory requirements of a Regulatory Authority at any time shall be borne exclusively by LONZA subject however to changes required solely based on the Products as well as change of Applicable Laws or cGMP requirements. Notwithstanding the foregoing, a Statement of Work may include terms and conditions relating to delays of the Commencement Date for a Product or other delays, including discounts, cancellation rights and other terms and conditions relating to any such delay.

a.Maintenance and Operation. LONZA agrees to  operate and maintain the Facilities and  all LONZA Equipment used, directly or indirectly, to Manufacture Products, or, if applicable, to  perform the Services, in accordance with the applicable Specifications and all Applicable Laws, as well as for the MODERNA Equipment in accordance with mutually agreed upon standards which are to be discussed based on MODERNA's maintenance standards, and to maintain the Facility and LONZA Equipment in an acceptable state of repair and operating efficiency.

b.Qualification and Validation. LONZA shall be responsible for validating the LONZA Equipment used for supply of Product or, if applicable, performance of the Services (including conducting installation, operational and performance qualification), and the production, cleaning and, to the extent applicable, packaging processes, as well as all other appropriate steps performed at the Facilities. All activities and procedures must: (i) meet applicable regulatory requirements; and (ii) be found acceptable by Regulatory Authority inspectors, if applicable. If any Regulatory Authority finds LONZA’s validation procedures to be unacceptable, then LONZA will take (or have taken) appropriate remedial measures, including repeating the validation as necessary, such that the validation procedures meet all applicable regulatory requirements and guidelines, including those necessary to receive all Regulatory Authority approvals. If any of LONZA’s validation procedures fail to comply with cGMP or the Specifications, LONZA shall promptly remedy such failure in order to comply with all cGMP and Specifications. Furthermore, LONZA shall also be responsible for validating the MODERNA Equipment under the terms set forth above when agreed upon in the relevant Statement of Work.

c.Cancellation of a Statement of Work. Each Statement of Work shall provide the termination or cancellation fees for such Statement of Work, if any (the “Cancellation Fees”).

d.Payment of Cancellation Fee and Costs. Each Statement of Work shall provide the payment terms for any applicable Cancellation Fees.

e.Packaging and Shipping. LONZA will package and label the Product for shipment in accordance with the relevant Statement of Work,  the Quality Agreement  and any  instructions provided in writing (e.g. storage and transport conditions). In no event will LONZA or its Affiliates ship, or be instructed to ship, to the United States any Product Manufactured at any Facility outside of the United States.

f.Records. LONZA will maintain complete and accurate records relating to the Services, the Manufacture of each Batch of the Product or the development of any Process, including as required by Applicable Laws (including cGMP, as applicable). LONZA will retain possession of the Project

Documentation, LONZA Operating Documents and all other records, and will promptly provide copies of the Project Documentation and all other records other than the LONZA Operating Documents to MODERNA upon MODERNA’s request and at MODERNA’s expense; provided, however, that LONZA shall provide electronic copies thereof at MODERNA’s request at no cost to MODERNA. [***]. LONZA shall not transfer, deliver or otherwise provide any Project Documentation or other records to any Third Party without the prior written approval of MODERNA. LONZA Operating Documents will remain LONZA Confidential Information. [***]. LONZA shall also provide such other information and assistance as MODERNA may reasonably request in connection with the completion of and submission of applications for Regulatory Approvals for Products and the maintenance thereof. MODERNA has the right to use and reference any of the foregoing, or any DMF covering the foregoing, in connection with any request from any Regulatory Authorities or with a regulatory filing or Regulatory Approval for the Product, to authorize release and final acceptance of Product or as otherwise authorized by the Agreement, including any Statement of Work. LONZA will, on written request by MODERNA or its Affiliate or  Sublicensee, provide  to the requesting party and to any specified Regulatory Authority a letter, in the form reasonably required by the requesting party, acknowledging that the requesting party has the foregoing right of reference.

a.MODERNA Access.

i.Pursuant to and as set forth further in the applicable Statement of Work, [***] MODERNA’s employees, consultants and agents (including its independent contractors or designees) (collectively, “MODERNA Personnel”) in each Facility may participate in the Manufacture of the Product only in such capacities as set forth in the relevant Statement of Work or as may be approved in writing in advance by LONZA, such approval not to be unreasonably withheld, conditioned or delayed; provided, however, that, upon [***] prior written notice to LONZA, MODERNA Personnel shall have the right to be present at the Facility to observe the Manufacture of Product or performance

of Services and for quality or technical reference purposes. MODERNA Personnel working at the Facility are required to comply with LONZA’s Operating Documents and any other applicable LONZA cGMP or safety policies. LONZA shall make available office space to the MODERNA Personnel on-site at the applicable Facility, and shall also provide any reasonable and customary related office resources and support services for such on-site MODERNA Personnel. For the avoidance of doubt, unless otherwise agreed to by LONZA, following completion of technology transfer and stabilization of Manufacturing activities, MODERNA Personnel may not physically participate in the production or Manufacture of any Product that may be used in or on humans.

i.MODERNA Personnel working at the Facility will be and remain employees, consultants or agents of MODERNA, and MODERNA will be solely responsible for the payment of compensation for such MODERNA Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensation insurance, health insurance, and other similar statutory and fringe benefits). MODERNA covenants and agrees to maintain workers’ compensation benefits and employers’ liability insurance as required by Applicable Laws with respect to all MODERNA Personnel working at the Facility.

ii.MODERNA will pay for the actual cost of repairing or replacing to its previous status (to the extent that LONZA determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of LONZA damaged or destroyed by MODERNA Personnel, provided MODERNA shall not be liable for repair or replacement costs resulting from ordinary wear and tear.

iii.MODERNA Personnel visiting or having access to the Facility will abide by LONZA standard policies, operating procedures and the security procedures established by LONZA and provided to such MODERNA Personnel prior to any visits or access to the Facility. MODERNA will be liable for any breaches of security by MODERNA Personnel.  In addition, MODERNA will reimburse LONZA for the cost  of any lost security cards issued to MODERNA Personnel, at the rate of [***] per security card. All MODERNA Personnel will agree to abide by LONZA policies and SOPs established by LONZA, and will sign an appropriate confidentiality agreement.

iv.MODERNA will indemnify and hold harmless LONZA from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) arising out of any injuries suffered by MODERNA Personnel while at the Facility or elsewhere, except to the extent caused by the negligence, gross negligence or willful misconduct on the part of any LONZA Party or resulting from a breach of this Agreement, including any Statement of Work, by LONZA.

a.LONZA Access. If provided for in a Statement of Work, LONZA employees and agents (“LONZA Personnel”) visiting or having access to any MODERNA facility will abide by MODERNA standard policies, operating procedures and the security procedures established by MODERNA and  provided to such LONZA Personnel prior to any visits or access to such facility.  LONZA will be liable for any breaches  of security by LONZA Personnel. In addition, LONZA will reimburse MODERNA for the cost of any lost security cards issued to LONZA Personnel, at the rate of [***] per security card. All LONZA Personnel will agree to abide by MODERNA policies and SOPs established by MODERNA, and will sign an appropriate confidentiality agreement.

a.Disclaimers. The LONZA Parties will not engage in any Product  improvement, modification or refinement, or Manufacturing or development of the Product, other than as expressly set forth in this Agreement and each relevant Statement of Work. Except as set forth in a relevant Statement of Work, each Party acknowledges and agrees that the LONZA Parties have not participated in the invention or testing of any Product, and have not evaluated its safety or suitability for use in humans or otherwise.

1.REGULATORY MATTERS

a.Permits and Approvals. LONZA will ensure that any and all permits,  licenses, registrations, and approvals required by Applicable Law have been obtained in connection with each Facility and LONZA Equipment used in connection with the Manufacture by or on behalf of LONZA hereunder. LONZA will maintain each Facility and the LONZA Equipment in a state of repair and operating efficiency consistent with industry standard practices and all Applicable Law. LONZA will only use disposal services or sites that have appropriate environmental permits and are in compliance with Applicable Law.

b.Regulatory Approvals. MODERNA shall own all Regulatory Approvals, permits, authorizations and certificates necessary for the use of Products.  All DMFs for the Products will be filed   in MODERNA’s (or its designee’s) name and will be owned by MODERNA (or its designee). LONZA shall assist MODERNA in the preparation of such regulatory filings, Regulatory Approvals, permits, authorizations and certificates necessary for the use of Products or DMFs, including providing such information and data, including CMC information and data, as may reasonably be requested by MODERNA, as further detailed in the relevant Statement of Work or as agreed by the Parties in writing. The DMF for the Facility shall be owned by LONZA.

c.Inspections.

i.Subject to the terms of the Quality Agreement with respect to Services and Product and upon not less than [***] prior written notice, or shorter period of time as may be reasonable given the circumstances, LONZA will permit MODERNA or its representatives or designees to inspect and audit the parts of the Facility where LONZA performs the Services, including the parts of the Facility where the Manufacture of the Product is carried out, and to review documents, operations, procedures, and records as they pertain to the Manufacture of Product or performance of any Services,   in order to assess LONZA’s compliance with Applicable Law (including cGMP, as applicable), this Agreement or any relevant Statement of Work, and to perform risk and loss control assessments to support MODERNA’s insurance and self-insurance programs, and to discuss any related issues with LONZA’s management personnel. Such audit shall not last for more than [***] (unless otherwise agreed by the Parties). MODERNA Personnel engaged in such inspection will abide by the terms and conditions set forth in Sections 7.11 and Article 10. As part of MODERNA’s audit of a Facility, MODERNA’s audit may include audit of any of LONZA’s suppliers’ (including suppliers of Materials) qualification procedures, risk assessments, audit reports or supplier questionnaires, and associated corrective actions; provided that in the event LONZA is prohibited from providing such supplier audit, at MODERNA’s request, LONZA will provide an audit summary of a supplier containing all information necessary for MODERNA’s regulatory filings with respect to the Product or confirmation that such an audit

has  been  performed.    LONZA’s quality assurance department shall cooperate with MODERNA, as necessary or useful, in any such inspection conducted pursuant to this Section 8.3.

i.In addition to the foregoing, MODERNA and/or its representatives shall have the right to perform “For Cause” audits as often as required at any time upon not less than [***] advance notice, or shorter period of time as may be reasonable given the circumstances, and during regular business hours. If a For Cause audit confirms that LONZA did not comply with its obligations in compliance with cGMP, this Agreement or any relevant Statement of Work, the audit shall not be charged by LONZA; in all other cases LONZA's standard hourly rates apply (not to exceed [***]). Notwithstanding the foregoing, a For Cause audit shall also be at no cost for MODERNA if it is MODERNA’s sole audit in such Calendar Year.

ii.In addition to those audit rights of MODERNA under this Section 8.3, LONZA shall permit audits to be conducted by or on behalf of a bona fide actual or prospective Third Party collaborator or customer of MODERNA; provided that MODERNA (a) pays a fee of [***] to LONZA for each such audit; and (b) has one or more MODERNA employees accompany the representatives of such Third Party during such audit.

iii.In the event MODERNA identifies any deficiency with respect to LONZA’s operations or activities related to or affecting the Services, Product or the Manufacture of Product or performance of any Services during any such inspection, audit, or review, MODERNA shall have the right to notify LONZA of such deficiency, and, in such case, (a) the Parties will discuss in good faith suitable approaches for correcting such observations, and (b) LONZA shall, within [***] from the date of receipt of such notice, deliver to MODERNA a corrective action plan, addressing each such deficiency (including timelines therefor). Upon acceptance of the corrective action plan by MODERNA (which acceptance shall not be unreasonably withheld), LONZA shall fully implement such corrective action plan to the reasonable satisfaction of MODERNA. MODERNA shall have the right to review all relevant documentation in connection with such deficiency and corrective action.

iv.LONZA shall ensure that its Affiliates involved in the Manufacture of Product (or any component thereof including Material suppliers) permit and afford MODERNA the same rights as set forth above, and LONZA shall use diligent efforts to procure for MODERNA similar rights with respect to any subcontractors involved in the Manufacture of Product on behalf of LONZA.

v.For clarity, any such inspection (or failure to inspect) shall not relieve LONZA of  its obligation to comply with Applicable Laws and the provisions this Agreement, the relevant Statement of Work and the Quality Agreement and does not constitute a waiver of any right otherwise available to MODERNA. In addition, for critical raw material suppliers for Product, LONZA shall be required to audit each and MODERNA shall have the right to review the audit reports and findings and LONZA’s procedures for auditing such suppliers; provided that in the event LONZA is prohibited from providing such reports, findings or procedures, at MODERNA’s request, LONZA will provide confirmation that an audit took place and a summary of findings.

i.For each Facility, in addition to the audit rights above, MODERNA shall have the right to audit the Facility when such Facility is ready for and prior to initiation of cGMP Manufacturing for MODERNA hereunder.

a.Notification of Regulatory Authority Action. Each Party shall promptly notify the other Party of any notice such Party receives regarding any threatened or pending action by any Regulatory Authority regarding the Manufacture of Product, including any Regulatory Authority non-approval or regulatory action. Upon receipt of any such information, the Parties shall consult in an effort to arrive at   a mutually acceptable procedure for taking appropriate action; provided, however, that nothing  contained herein shall be construed as restricting the right of either Party to make a timely report of such matter to any Regulatory Authority or take other action that it deems to be appropriate or required by Applicable Law.

b.Complaints. LONZA shall immediately notify MODERNA of any complaints received by LONZA concerning a Product supplied hereunder. LONZA shall investigate complaints as requested by MODERNA and shall take corrective action to avoid future occurrences.

c.Regulatory Authority Inspections. LONZA shall advise MODERNA immediately (but in no event less than [***] prior to a pre-notified or scheduled visit or inspection) of any Regulatory Authority visit or inspection that relates to Product or the Manufacture thereof at any Facility, or any written or oral inquiries by such Regulatory Authority concerning Product (including safety and efficacy claims) or the Manufacture thereof at any Facility. LONZA will permit representatives of any Regulatory Authority to inspect and audit the parts of each Facility where LONZA performs the Services, including the parts of the Facility where the Manufacture of the Product is carried out, and to inspect or audit the Project Documentation, Batch Records or other records to verify compliance with cGMP and other Applicable Laws and will promptly notify MODERNA of the scheduling of any such inspection relating to the Services, including Manufacture of Product. MODERNA shall be permitted to be on site and available for questions regarding the Product during any such inspection or audit. LONZA shall promptly (and in no event later than [***]) notify MODERNA of the results of any such inspection, and furnish MODERNA summaries of all reports, documents and correspondence with respect to any Regulatory Authority inquiries, visits or inspections, as well as a copy of each report, document and correspondence issued by or provided to any Regulatory Authority in connection with such request, visit or inquiry to the extent  such documents relate to or affect the Services, Product or Manufacture of the Product. LONZA and MODERNA shall consult with one another in an effort to arrive at a mutually acceptable response to the extent related to Product, provided that if the Parties fail to timely arrive at a mutually acceptable response, LONZA shall not be required to delay or risk prejudice to LONZA’s compliance with its legal requirements. Without limiting the foregoing, LONZA shall furnish to MODERNA, (a) within [***] after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit, inspection or inquiry, including any FDA Form 483, Establishment Inspection Report, or warning  letter, and (b) copies of any and all responses or explanations to any Regulatory Authority relating to items set forth above prior to the submission of such responses or explanations to any Regulatory Authority by LONZA. LONZA shall comply with all reasonable requests and comments by MODERNA with respect to all responses or explanations to, or contacts and communications, with any Regulatory Authority relating in any way to the Products or Services, and shall immediately inform MODERNA in the event any Regulatory

Authority takes any regulatory action against LONZA that could have an effect on LONZA’s performance   of the Services or the Manufacture of the Product.

a.Recall; Withdrawal. As may be further set forth in the Quality Agreement, in the event that either Party determines an event, incident or circumstance has occurred which may result in the need for a “recall”, “market withdrawal” or “field alert” of Product, as such terms are defined in the United States Code of Federal Regulations 21 CFR § 7.3 and 21 CFR§ 314, or other Applicable Law or regulation   of a country (a “Recall”), such Party shall advise and consult with the other Party regarding such event. MODERNA shall be responsible for implementing and administering any Recall, in its sole discretion [***]. LONZA shall provide reasonable assistance to MODERNA  in conducting a recall or withdrawal, including providing MODERNA with all reasonably pertinent records and information. If the parties dispute whether such Recall was primarily due to LONZA providing defective Product, then either party may seek the determination of whether the Product was defective Product in accordance with the relevant Statement of Work.

b.Waste. In connection with the Manufacture of Product hereunder or the performance of the Services, LONZA shall be solely responsible, at its cost and expense, for maintaining safety procedures in connection with the Manufacture of Product (or the performance of the Services, as applicable) and for the generation, treatment, storage and/or disposal of Waste relating thereto, all of which shall comply with all Applicable Law, including all applicable environmental and occupational safety and health requirements in the jurisdiction of the Facility.

1.FINANCIAL TERMS

a.Pricing. [***].

b.Payments. MODERNA will make payments to LONZA in the amounts and on the dates set forth in the relevant Statement of Work upon receipt of an invoice from LONZA.

c.Invoices and Pricing. LONZA will charge for the Services in accordance with the price schedule in the relevant Statement of Work. LONZA will invoice MODERNA according to the schedule set forth in the relevant Statement of Work.  LONZA will deliver invoices electronically by email, which shall  be       considered       to       be       an     original      invoice.    Invoices shall be e-mailed to

[***], and/or to such other e-mail address(es) as MODERNA may stipulate from time to time. LONZA will not deliver a paper invoice. Payment of each invoice is due within [***] after MODERNA’s receipt of such invoice. Unless otherwise provided in the relevant Statement of Work, all pricing excludes taxes and costs relating to shipping, validation and regulatory filings. The price shall be invoiced to MODERNA in U.S. Dollars or such other currency as agreed upon in the relevant Statement of Work.

a.Taxes. All amounts mentioned in this Agreement are exclusive of indirect taxes which, where applicable, will be paid by MODERNA on receipt of a valid indirect tax invoice. If MODERNA is required by law to deduct or withhold any taxes from any amount payable under this agreement, the amount payable hereunder shall be increased so that after making all required deductions and/or withholdings, LONZA receives an amount equal to the amount it would have received had no such deductions or withholdings been made. Notwithstanding anything to the contrary herein, if there should be any withholding tax imposed by the applicable jurisdictions on LONZA with respect to any payments to be made by MODERNA to LONZA under or in connection with this Agreement, MODERNA is allowed to deduct such withholding taxes from the payments to LONZA and pay such withholding taxes to the appropriate tax authorities on behalf of LONZA. Regarding the discharged withholding tax, MODERNA will submit to LONZA the corresponding original tax certificates or original tax receipts stamped by the receiving local tax authority within [***] after such withholding obligation is discharged. Notwithstanding the foregoing, upon presentation by LONZA to MODERNA of the relevant tax documentation indicating a reduction in or exemption from withholding tax for LONZA in such taxing jurisdiction pursuant to the provisions of the relevant double taxation treaty, MODERNA shall withhold such tax at the reduced rate (or not withhold any tax if there is an exemption) applicable to such payment in such taxing jurisdiction. .

b.Interest. Any undisputed fee, charge or other payment due to LONZA by MODERNA  under this Agreement that is not paid within [***] after it is due will accrue interest on a daily basis at   a rate of [***] (or the maximum legal interest rate allowed by applicable law, if less) from and [***] after MODERNA receives a notice from LONZA that such fee, charge or other payment has not been paid.

c.Method of Payment. Except as otherwise set forth in Section 9.2 or the relevant Statement of Work, all payments to LONZA hereunder by MODERNA will be in United States currency or such other currency agreed upon by the Parties in the relevant Statement of Work and will be by check, wire transfer, money order, or other method of payment approved by LONZA. Bank information for wire transfers will be provided in the relevant Statement of Work.

d.Cost Improvements. Promptly after a Product has been launched, LONZA will in good faith continuously seek to improve and reduce direct material costs, direct operating labor costs and indirect expenses attributable to the manufacture of the Product throughout the term of this Agreement and, at the request of MODERNA, provide MODERNA with written evidence demonstrating the efforts  and activities undertaken by LONZA in furtherance thereof. LONZA and MODERNA agree to periodically, but not less than [***], review the cost of materials, labor, expenses and other matters

that influence the price MODERNA pays for the Product and determine whether any price decreases may be appropriate. Upon the request of MODERNA, LONZA will provide  to MODERNA reasonable  evidence of any and all improvements as they are achieved and of the availability of any potential improvements hereunder. LONZA agrees to reflect and incorporate into this Agreement achieved price reductions realized by LONZA after the effective date of such price change.  MODERNA and LONZA will set specific  key performance indicators defining timing and percent reduction for the manufacture of the Product (“KPIs”) once a Product has been launched. KPIs may include, but are not limited to, manufacturing operations (including inventory reductions, process improvement, and  lead-times),  sourcing, international operations and logistics, and business practices. Progress of these goals will be reviewed periodically, but in any case no less than [***]. All savings achieved through these cost improvements by LONZA will be [***].

1.CONFIDENTIAL INFORMATION

a.Definition. “Confidential Information” means all technical, scientific and other know- how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, specifications, data, results and other material, pre- clinical and clinical trial results, manufacturing procedures, test procedures and purification and isolation techniques, and any tangible embodiments of any of the foregoing, and any scientific, manufacturing, marketing and business plans, any financial and personnel matters relating to a Party or its present or future products, sales, suppliers, customers, employees, investors or business, that has been disclosed by or on behalf of such Party or such Party’s Affiliates to the other Party or the other Party’s Affiliates either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing this Agreement. Without limiting the foregoing, (a) the terms of this Agreement as well as all information pertaining to the relationship between the Parties will be deemed “Confidential Information” of both Parties, and as such both Parties will be treated as the receiving Party, (b) the Products, all MODERNA Technology, MODERNA Manufacturing Know-How, MODERNA Improvements, MODERNA Equipment, MODERNA Materials, Project Documentation, Specifications, all Regulatory Approvals for the Products and all DMFs for the Products are Confidential Information of MODERNA, (c) all LONZA Technology, LONZA Operating Documents and LONZA Improvements are Confidential Information of LONZA, and, in each case, will be subject to the terms and conditions set forth in this Article 10 (except to the extent necessary for MODERNA to exercise its rights or obligations under this Agreement, including any relevant Statement of Work, including in connection with the licenses granted by LONZA to MODERNA in Section 11.2).

b.Exclusions. Notwithstanding the foregoing Section 10.1, any information disclosed by a Party to the other Party will not be deemed “Confidential Information” of the disclosing Party to the extent that such information:

(a)at the time of disclosure is in the public domain;

(b)becomes part of the public domain, by publication or otherwise, through no fault of the receiving Party or its Affiliates;

a.at the time of disclosure is already in possession of the receiving Party or its Affiliates on a non-confidential basis, as established by contemporaneous written records;

b.is lawfully provided to a Party, without restriction as to confidentiality or use, by a Third Party lawfully entitled to possession of such Confidential Information; or

c.is independently developed by a Party without use of, reliance upon or reference to the other Party’s Confidential Information, as established by contemporaneous written records.

a.Disclosure and Use Restriction. Except as expressly provided herein, the Parties agree that for the Term and the ten (10)-year period following any expiration or termination of the Agreement, each Party and its Affiliates will keep completely confidential and will not publish or otherwise disclose  any Confidential Information of the other Party, its Affiliates or sublicensees, except in accordance with Section 10.4; provided, however, that the obligations under Section 10.5 with respect to MODERNA Manufacturing Know-How or any other trade secret information in the MODERNA Confidential Information or LONZA Confidential Information will survive in perpetuity. Neither Party will use Confidential Information of the other Party except as necessary to perform its obligations, or in the case  of MODERNA to exercise its rights, under this Agreement.

b.Permitted Disclosures. Subject to Section 10.5, each receiving Party agrees to (i) institute and maintain security procedures to identify and account for all copies of Confidential Information of the disclosing Party and (ii) limit disclosure of the disclosing Party’s Confidential Information to its Affiliates and each of its and their respective officers, directors, employees, agents, consultants and independent contractors having a need to know such Confidential Information for purposes of this Agreement, including, with respect to MODERNA, to subcontractors and other Third Parties as necessary or reasonably useful for the purpose of performing MODERNA’s obligations or exercising its rights hereunder in filing or requesting Regulatory Approvals or communications with Regulatory Authorities as set forth in Section 7.10; provided that such Affiliates and each of its and their respective officers, directors, employees, agents, consultants and independent contractors are informed of the terms of this Agreement and are subject to obligations of confidentiality, non-disclosure and non-use similar to those set forth herein. Notwithstanding the foregoing, (a) such Confidential Information may be disclosed to (1) actual (sub)licensees, collaborators or partners, and its and their directors, officers, employees, agents or advisors (including accountants, attorneys, consultants, bankers, financial advisors and members of advisory boards), or (2) any bona fide potential or actual financing sources, investors, underwriters or acquisition partners (including attorneys, accountants, consultants, bankers or financial advisors of the foregoing), in each case ((1)-(2)) who reasonably require such information, who are informed of the confidential nature of such information and are bound by non-use and confidentiality obligations with respect to such information (which may include, solely with respect to attorneys and accountants, professional ethical obligations); and [***].

a.MODERNA Manufacturing Know-How. Notwithstanding anything herein to the contrary, the Parties recognize that maintaining the confidentiality and trade secret nature of the MODERNA Manufacturing Know-How requires an even higher level of vigilance than other Confidential Information. LONZA shall: (i) maintain MODERNA Manufacturing Know-How in confidence with the same degree of  care with which LONZA holds its own like confidential manufacturing information, (ii) disclose the MODERNA Manufacturing Know-How only to those employees of LONZA or its Affiliates who have a need to know such MODERNA Manufacturing Know-How to conduct activities for the Products under this Agreement, including any relevant Statement of Work, and (iii) use the MODERNA Manufacturing Know- How only for Manufacturing and supplying the applicable Product under the relevant Statement of Work and for no other purpose. LONZA will apply appropriate firewall protections and safeguards for all MODERNA Manufacturing Know-How to prevent the MODERNA Manufacturing Know-How from being disclosed, transferred or used to or by any LONZA personnel that are not conducting activities relating to the Products under the relevant Statement of Work. LONZA will not disclose, transfer or use any MODERNA Manufacturing Know-How to any Third Party without the prior written consent of MODERNA, which consent will be at MODERNA’s sole discretion. For clarity, Section 10.4 will not apply to any MODERNA Manufacturing Know-How.

b.Government-Required Disclosure. If a duly  constituted Governmental Authority, court  or Regulatory Authority orders that a Party hereto disclose information subject to an obligation of confidentiality under this Agreement, such Party shall comply with the order, but shall notify the other Party as soon as possible, so as to provide the other Party a reasonable opportunity to apply to a court of record for relief from the order or for confidential treatment thereof, and thereafter such Party shall disclose only the minimum information required to be disclosed in order to comply.

c.Publicity.

i.Neither Party will refer to, display or use the other’s name, trademarks or trade names confusingly similar thereto, alone or in conjunction with any other words or names, in any manner or connection whatsoever, including any publication, article, or any form of advertising or publicity, except with the prior written consent of the other Party or as otherwise set forth in this Section 10.7.

ii.Neither Party may issue any press release or make any other public announcement or statement concerning this Agreement, the transactions contemplated hereby or the terms hereof, without the prior written approval of the other Party, except as may be required by Applicable Law. In the event either Party (the “Issuing Party”) desires to issue a press release or other public statement disclosing information relating to this Agreement, the transactions contemplated hereby or the terms hereof, the Issuing Party will provide the other Party (the “Reviewing Party”) with a copy of the proposed press release or public statement (the “Release”) and seek the Reviewing Party’s prior written consent; provided that no such consent shall be required for press releases or other public statements required by Applicable  Law (but the Issuing Party shall still provide the Reviewing Party with   a copy of the Release for comment in accordance with this Section 10.7). The Issuing Party will specify  with each such Release, taking into account the urgency of the matter being disclosed, a reasonable period of time within which the Reviewing Party may provide any comments on such Release and if the Reviewing Party fails to provide any comments during the response period called for by the Issuing Party, the Reviewing Party will be deemed to have not consented to the issuance of such Release. If the Reviewing

Party provides any comments, the Parties will consult on such Release and work in good faith to prepare   a mutually acceptable Release. Either Party may subsequently publicly disclose  any  information previously contained in any Release so consented to.

i.Notwithstanding Section 10.7.2 or anything herein to the contrary, MODERNA’s obligation to submit any press release or other public announcement or statement concerning this Agreement to LONZA for prior written approval will not apply to any press release or other public announcement or statement regarding the achievement of any milestone identified in a Statement of Work, including regarding Process or Product development, Technology Transfer, or Process or Product Manufacture.

a.Securities Filings; Law. Each Party acknowledges and agrees that the other Party may submit this Agreement to the United States Securities and Exchange Commission (the “SEC”) or any other securities exchange and if a Party does submit this Agreement to the SEC or any other securities exchange, such Party agrees to consult with the other Party with respect to the preparation and submission of, a confidential treatment request for this Agreement. If a Party is required by Applicable Law to make a disclosure of the terms of this Agreement in a filing with or other submission to the SEC or any other securities exchange or otherwise to comply with Applicable Law, and (i) such Party has provided copies of the disclosure to the other Party as far in advance of such filing or other disclosure as is reasonably practicable under the circumstances, (ii) such Party has promptly notified the other Party in writing of  such requirement and any respective timing constraints, and (iii) such Party has given the other Party a reasonable amount of time under the circumstances from the date of notice by such Party of the required disclosure to comment upon, request confidential treatment or approve such disclosure, then such Party will have the right to make such public disclosure at the time and in the manner reasonably determined  by its counsel to be required by Applicable Law. Notwithstanding anything to the contrary herein, it is hereby understood and agreed that if a Party is seeking to make a disclosure as set forth in this Section 10.8, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the  case may be, will in good faith consider incorporating such comments.

1.INTELLECTUAL PROPERTY

a.Ownership.

i.Except as expressly otherwise provided herein, neither Party will, as a result of this Agreement, acquire any right, title, or interest in any Technology of the other Party. Except as expressly otherwise provided herein, ownership of any Technology that is developed,  conceived, invented, first reduced to practice or made in connection with the performance under this Agreement shall follow inventorship all as determined under Applicable Laws.

ii.Subject to LONZA’s right, title and interest in and to any and all LONZA Improvements, MODERNA shall own all right, title, and interest in and to any and all MODERNA Improvements. LONZA hereby assigns to MODERNA (or its designee), without additional compensation,  all of LONZA’s right, title and interest in and to such MODERNA Improvements. LONZA shall promptly disclose to MODERNA in writing all MODERNA Improvements. LONZA shall execute, and shall require its

personnel as well as its Affiliates, or other contractors or agents and their personnel involved in the performance of this Agreement to execute, any documents reasonably required to confirm MODERNA’s ownership of MODERNA Improvements, and any documents required to apply for, maintain and enforce any patent or other right in the MODERNA Improvements. Notwithstanding the foregoing, and subject to the license granted in Section 11.2.2, LONZA shall own all right, title and interest in and to any and all LONZA Improvements.

a.License Grants.

i.During the Term, MODERNA hereby grants to LONZA a fully paid-up, non- exclusive license, without the right to grant sublicenses, under any and all MODERNA Technology, MODERNA Manufacturing Know-How, and MODERNA Improvements that are necessary for LONZA to perform its obligations under this Agreement for the sole and limited purpose of LONZA’s performance of its obligations under this Agreement and the relevant Statements of Work, including, without limitation, the development of the Process (if and to the extent applicable in the relevant Statements of Work) and the Manufacture of Product for MODERNA as set forth in the relevant Statements of Work. Except as set forth in this Section 11.2.1, Lonza shall not by virtue of this Agreement acquire any right, license or title in or to any MODERNA Technology, MODERNA Manufacturing Know-How, MODERNA Improvements, Products or Process.

ii.LONZA hereby grants to MODERNA a non-exclusive, world-wide, fully paid-up, perpetual, transferable (subject to the assignment provisions) license, including the right to grant sublicenses, under the LONZA Technology and LONZA Improvements, to use, sell, offer to sell, import and export the Product Manufactured under this Agreement, including any Statement of Work. In the event and to the extent that the Services or the Process incorporates, uses or contains non-commercially available LONZA Technology or LONZA Improvements that are not specifically agreed to by MODERNA in the relevant Statement of Work and that would be necessary for MODERNA or a Third Party contract manufacturer to Manufacture Products or would otherwise require MODERNA to obtain a license to the non-commercially available LONZA Technology or LONZA Improvements , LONZA hereby grants to MODERNA and its Affiliates a non-exclusive, worldwide, fully paid-up, perpetual, irrevocable, transferable license (subject to the assignment provisions), including the right to grant sublicenses, under such non- commercially available LONZA Technology or LONZA Improvements that are incorporated, used or contained in the Services or Process to Manufacture (or have Manufactured) Products (but no other products). For clarity LONZA will use its operating documents and standard operating procedures (“LONZA Operating Documents”) in performing the Services but LONZA Operating Documents are not necessary   for MODERNA or a third party contract manufacturer to manufacture Product as it is assumed that MODERNA or a third party contract manufacturer would have its own operating documents and standard operating procedures. LONZA Operating Documents will not be provided in a technology transfer to MODERNA or a third party contract manufacturer for manufacturing Product.

b.Further Assurances. Each Party agrees to take all necessary and proper acts, and will cause its employees, Affiliates, contractors, and consultants to take such necessary and proper acts, to effectuate the ownership provisions set forth in this Article 11.

c.Prosecution of Patents.

i.LONZA will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming LONZA Technology or LONZA Improvements at LONZA’s expense.

ii.MODERNA will have the sole right and discretion to file, prosecute and maintain patent applications and patents claiming MODERNA Technology or MODERNA Improvements at MODERNA’s expense. LONZA will cooperate with MODERNA to file, prosecute and maintain patent applications and patents claiming MODERNA Technology or MODERNA Improvements.

1.EXCLUSIVITY [***]

a.LONZA. LONZA and its Affiliates will not, during the applicable Exclusivity Term, [***].

b.MODERNA. MODERNA and its Affiliates agree that, during the applicable  Exclusivity Term, [***]. For clarity, the foregoing exclusivity shall not preclude MODERNA or its Affiliates from: [***].

12.3    [***]

2.REPRESENTATIONS, WARRANTIES AND COVENANTS

a.By MODERNA. MODERNA hereby represents and warrants to LONZA as of the Effective Date that, to the best of its knowledge, ((a)) it has the requisite intellectual property related to the MODERNA Technology and MODERNA Manufacturing Know-How to enable the performance of LONZA’s obligations under this Agreement, and ((b)) the performance of the Services and the production by LONZA of the Product as contemplated in this Agreement will not infringe the intellectual property rights of any Third Party. Such representation and warranty will not apply to any LONZA Equipment to the extent that such LONZA Equipment is the sole basis for the infringement of the intellectual property rights of a Third Party.

b.By LONZA.

i.LONZA hereby represents and warrants to MODERNA that, to the best of its knowledge, as of the Effective Date ((a)) it or its Affiliates have the requisite intellectual property rights in LONZA Equipment and Facility and the LONZA Technology to be able to perform its obligations under this Agreement, and ((b)) that LONZA’s or its Affiliates’ use of the LONZA Equipment, Facility and the LONZA Technology as contemplated in this Agreement and independent of any infringement caused solely by the use of such LONZA Equipment, Facility and the LONZA Technology in combination with the MODERNA Technology, MODERNA Manufacturing Know-How and Product, will not infringe the intellectual property rights of any Third Party.

ii.LONZA further represents and warrants that it has not and will not to its knowledge use in any capacity in connection with this Agreement the services of any individual, corporation, partnership, or association which has been debarred, excluded, or disqualified by the FDA or any other applicable Regulatory Authority. In the event that LONZA receives notice of the debarment or

threatened debarment, exclusion or disqualification or threatened disqualification, of any individual, corporation, partnership or association providing services to LONZA, which relate to its activities under this Agreement, including any Statement of Work, LONZA shall notify MODERNA in writing as soon as practicable.

i.LONZA represents, warrants and covenants that, save for security interests expressly given in favor of MODERNA or its Affiliates, it will have good and marketable title, free and clear of any pledge, lien, restriction, claim, charge, security interest and/or other encumbrance, to all Product  to be delivered under this Agreement (including any Statement of Work), and all Product supplied to MODERNA shall be free and clear of all pledges, liens, restrictions, claims, charges, security interests and/or other encumbrances at the time of delivery.

1.DISCLAIMER; LIMITATION OF LIABILITY

a.DISCLAIMER. EXCEPT FOR THE EXPRESS REPRESENTATIONS AND  WARRANTIES  SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, WITH RESPECT TO THE PRODUCTS, MATERIALS, AND SERVICES PROVIDED UNDER THIS AGREEMENT, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE WITH RESPECT TO SUCH PRODUCTS, MATERIALS, OR SERVICES.

b.Disclaimer of Consequential Damages. EXCEPT [***], IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

c.Limitation of Liability. BOTH PARTIES HEREBY AGREE THAT TO THE FULLEST EXTENT PERMITTED BY LAW, EACH PARTY’S LIABILITY TO THE OTHER PARTY, FOR ANY AND ALL INJURIES, CLAIMS, LOSSES, EXPENSES, OR DAMAGES, WHATSOEVER, ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT FROM ANY CAUSE OR CAUSES, INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE, ERRORS, OMISSIONS OR STRICT LIABILITY, SHALL NOT EXCEED [***]. TO THE EXTENT THAT THIS CLAUSE CONFLICTS WITH ANY OTHER CLAUSE, THIS CLAUSE SHALL TAKE PRECEDENCE OVER SUCH CONFLICTING CLAUSE. IF APPLICABLE LAW PREVENTS ENFORCEMENT OF THIS CLAUSE, THEN THIS CLAUSE SHALL BE DEEMED

MODIFIED TO PROVIDE THE MAXIMUM PROTECTION FOR LONZA AS IS ALLOWABLE UNDER APPLICABLE LAW.

1.TERM AND TERMINATION

a.Term. The term of this Agreement will commence on the Effective Date and will continue until the tenth (10th) anniversary of the Effective Date unless terminated prior to that time or extended   by the Parties (the “Initial Term”). This Agreement will automatically renew for successive additional periods of two (2) years (collectively with the Initial Term, the “Term”) unless MODERNA provides written notice to LONZA at least [***] prior to the end of the then-current Term that it declines to extend the Term. The term of each SOW shall be set forth in such SOW.

b.Termination for Material Breach. Either Party may terminate this Agreement, by written notice to the other Party, for any material breach of this Agreement by the other Party, if such breach is not cured within [***] after the breaching Party receives written notice of such breach from the non-breaching Party; provided, however, that if such breach is not capable of being cured within such thirty-day period and the breaching Party has commenced and diligently continued actions to cure such breach within such thirty-day period, except in the case of a payment default, the cure period shall be extended to 90 days, so long as the breaching Party is making diligent efforts to do so. Such termination shall be effective upon expiration of such cure period; provided that in the event that the breaching Party disputes in good faith the non-breaching Party’s grounds for terminating this Agreement pursuant to this Section 15.2, then the Parties shall refer such dispute for resolution in accordance with Section 18.14, and the provisions therein shall apply. To the extent any material breach by a Party relates specifically to an SOW, the non-breaching Party may elect to have the termination rights set forth in this Section 15.2 apply to just such SOW, rather than to this Agreement generally.

c.Termination Without Cause. MODERNA may terminate any SOW by providing written notice of termination no less than [***] in advance of the date of termination. For the avoidance of doubt, in the event of termination of any SOW by MODERNA under this Section 15.3, MODERNA shall remain liable for all fees owed pursuant to such Statement of Work.

d.Termination by Insolvency. Either Party may terminate this Agreement upon notice to  the other Party, upon (a) the dissolution, termination of existence, liquidation or business failure of the other Party; (b) the appointment of a custodian or receiver for the other Party who has not been terminated or dismissed within [***] of such appointment; (c) the institution by the other Party of any proceeding under national, federal or state bankruptcy, reorganization, receivership or other similar laws affecting the rights of creditors generally or the making by such Party of a composition or any assignment for the benefit of creditors under any national, federal or state bankruptcy, reorganization, receivership or other similar law affecting the rights of creditors generally, which proceeding is not dismissed within [***] of filing. All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code, licenses of rights of “intellectual property” as defined therein.

e.Effects of Termination.

i.Accrued Rights. Termination of this Agreement or any SOW for any reason will  be without prejudice to any rights that will have accrued to the benefit of a Party prior to such termination. Such termination will not relieve a Party of obligations that are expressly indicated to survive the termination of this Agreement or such SOW. Without limitation of the foregoing, in the event of termination of this Agreement or an SOW, LONZA shall be compensated for any Cancellation Fees (if any) in accordance with the relevant Statements of Work. In the case of termination by LONZA for MODERNA’s material breach in accordance with Section 15.2, all scheduled Services and Batches shall be deemed cancelled by MODERNA, and Cancellation Fees set forth in the relevant Statements of Work shall be calculated as of the date of written notice of termination.

ii.Disposition of Remaining MODERNA Property and Confidential Information. Upon termination or expiration of this Agreement, LONZA will, at MODERNA’s option, return or destroy any MODERNA Confidential Information in the possession or control of LONZA. Likewise, MODERNA will, at LONZA’s option, return or destroy any LONZA Confidential Information in the possession or control of MODERNA. Notwithstanding the foregoing provisions: (i) LONZA may retain and preserve, in a secure manner, at its sole cost and expense, samples and standards of each Product following termination or expiration of this Agreement as required by Applicable Law solely for use in determining LONZA’s rights and obligations hereunder; (ii) MODERNA may retain and preserve, in a secure manner, any LONZA Confidential Information following termination or expiration of this Agreement (A) for use in determining MODERNA’s rights and obligations hereunder, (B) as necessary, in connection with MODERNA’s regulatory filings or Regulatory Approvals, or (C) as required by Applicable Law and (iii) each Party may retain a single copy of the other Party’s Confidential Information for documentation purposes only and which shall remain subject to the obligations of nonuse and confidentiality set forth in this Agreement.

15.5.3 Survival. Sections 1, 4.2, 4.5, 4.6, 5.1, 7.8, 7.10, 7.13, 8.2, 8.4, 8.5, 8.6, 8.7, 9.4,
9.5, 9.6, 10, 11, 13, 14, 15, 16, 17.1 and 18 of this Agreement, together with any appendices referenced therein, will survive any expiration or termination of this Agreement.

1.INDEMNIFICATION; INSURANCE

a.Indemnification of MODERNA. LONZA will indemnify MODERNA, its Affiliates, and their respective directors, officers, employees and agents, and defend and hold each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) in connection with any and all actual or alleged liability suits, investigations, claims or demands (collectively, “Losses”) to the extent such Losses arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of: [***].

b.Indemnification of LONZA. MODERNA will indemnify LONZA and its Affiliates, and their respective directors, officers, employees and agents (the “LONZA Parties”), and defend and hold each of them harmless, from and against any and all Losses to the extent such Losses arise out of or result from

any claim, lawsuit or other action or threat by a Third Party arising out of: [***].

a.Indemnification Procedure.

i.An “Indemnitor” means the indemnifying Party. An “Indemnitee” means the indemnified Party, its Affiliates, and their respective directors, officers, employees and agents.

ii.An Indemnitee which intends to claim indemnification under Section 16.1 or Section 16.2 hereof shall promptly notify the Indemnitor in writing of any claim, lawsuit or other action in respect of which the Indemnitee, its Affiliates, or any of their respective directors, officers, employees and agents intend to claim such indemnification.  The Indemnitee shall permit, and shall cause its Affiliates  and their respective directors, officers, employees and agents to permit, the Indemnitor, at its discretion, to settle any such claim, lawsuit or other action and agrees to the complete control of such defense or settlement by the Indemnitor; provided, however, that in order for the Indemnitor to exercise such rights, such settlement shall not adversely affect the Indemnitee’s rights under this Agreement or impose any obligations on the Indemnitee in addition to those set forth herein. No such claim, lawsuit or other action shall be settled without the prior written consent of the Indemnitor and the Indemnitor shall not be responsible for any legal fees or other costs incurred other than as provided herein. The Indemnitee, its Affiliates and their respective directors, officers, employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any claim, lawsuit or other action covered by this indemnification, all at the reasonable expense of the Indemnitor. The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and expense.

b.Insurance. Each Party shall, during the term and for [***] after the expiration of the last Product delivered under this Agreement (including any Statement of Work), obtain and maintain, at its own cost and expense and from a qualified insurance company, comprehensive general liability insurance including, but not limited to, contractual liability coverage and standard product liability coverage in an amount commensurate with industry standards. These insurance requirements are not intended to limit a party’s indemnification obligations hereunder. Coverage types and limits shall be  global for occurrences and claims made and shall include: (a) Commercial General Liability insurance, including contractual liability and products/completed operations coverage – limits of [***]; (b) Workers Compensation/Employers Liability – statutory with minimum Employers Liability limit of [***]; (c) Commercial Umbrella Liability - [***]; and (d) Network Security/Cyber Liability - [***]. Each Party will provide the other Party with at least [***] written notice prior to termination or amendment of such any applicable insurance policy.

1.ADDITIONAL COVENANTS

a.Non-Solicitation. Each Party will agree not to solicit for employment (or for use as an independent contractor) employees of the other Party during the Term and for a period of [***] thereafter; provided that nothing herein will prevent the employment by a Party of individuals who initiate contact with such Party, and  such Party will not be in violation of the non-solicitation restriction  as a result of making a general solicitation for employees or independent contractors or employing individuals who respond to such solicitations. For the avoidance of doubt, the publication of an advertisement will not constitute solicitation or inducement.

b.Business Continuity Plan. LONZA acknowledges the importance to MODERNA of an uninterrupted supply of Products. Based on the information available at the Effective Date, LONZA has, and reasonably expects that despite the COVID-19 Pandemic it will continue to have the available capacity and staff designated “essential workers” under Applicable Laws to perform Services and Manufacture and supply Product under this Agreement. Further, LONZA has a formal business continuity plan detailing LONZA’s plans, procedures and designated resources for timely response to and recovery from potential civil, natural, and physical plant disasters that could reasonably be expected to disrupt LONZA’s performance of services, including Services under this Agreement, and additional plans covering potential disruption that might arise in connection with the COVID-19 Pandemic (“Business Continuity Plans”). During the Term, LONZA will promptly notify MODERNA in writing of any potential disruption to the performance of the Services or the Manufacturing and supply of the Products.

c.Anti-Corruption and Trade Compliance.

i.Each party to this Agreement warrants that none of its employees, agents, officers or other members of its management are officials, officers, agents, or representatives of any government or international public organization. Each party to this Agreement further agrees that it shall not make any payment, either directly or indirectly through agents or otherwise, of money, assets, or anything of value, including the compensation derived from this Agreement, to government or political party officials, officials of international public organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing where such payment would constitute a violation of any Applicable Laws, whether by LONZA, MODERNA, or any other party.

ii.Each Party to this Agreement shall comply with all applicable laws relating to the import, export, reexport, and transfer of items and technologies subject to the Scope of Work of this Agreement, including without limitation the U.S. Export Administration Regulations of the Bureau of Industry and Security of the U.S. Department of Commerce, the U.S. economic sanctions administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”), the import and customs laws of the United States, and all trade laws of any other Governmental Authority of competent jurisdiction.

iii.None of the Parties to this Agreement, including their respective Affiliates, nor any Person or entity acting on behalf of any of the foregoing, (a) is currently the subject or the target of any Sanctions, (b) is located, organized or resident in a country, territory or geographical region that is

itself the subject of Sanctions (including, without limitation, Cuba, Iran, North Korea, Sudan, Syria, and the Crimea region of Ukraine) or whose government is the subject or target of Sanctions, (c) is named in any Sanctions-related list maintained by the U.S. Department of State, the U.S. Department of Commerce, or the U.S. Department of the Treasury, including but not limited to the Specially Designated Nationals and Blocked Persons List maintained by OFAC and the Denied Persons, Entity, and Unverified Lists maintained by the Bureau of Industry and Security, (d) is, otherwise, by public designation of the United Nations Security Council, the European Union, Her Majesty’s Treasury, or other equivalent, applicable Governmental Authority, the subject or target of any Sanctions, (e) is a Person with which any United States person is prohibited from dealing or otherwise engaging in any transaction  by any applicable  law or regulation, (f) is owned or controlled by Persons described in clauses (a) through (e) or is otherwise the subject of Sanctions, or (g) conducts any business or engages in, or has conducted any business or engaged in, making or receiving any contribution of goods, services or money to or for the benefit of any Person,  or in any country or territory that is the subject of Sanctions, other than in compliance with Sanctions laws and regulations. “Sanctions” means any economic or financial sanctions or trade embargoes imposed, administered or enforced from time to time by any United States Governmental Authority (including but not limited to OFAC), the United Nations Security Council, the European Union, Her Majesty’s Treasury,   or other Governmental Authority of competent jurisdiction.

i.None of the materials (including Products) to be supplied under this Agreement originated, in whole or in part, in Cuba, Iran, North Korea, Sudan, Syria, or the Crimea region of Ukraine.

ii.None of the Parties to this Agreement nor their respective officers, directors, employees, or agents are or have been the subject of any actual or threatened allegation, investigation, voluntary disclosure, investigation, prosecution or other enforcement action related to Sanctions, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or any other sanctions, trade, or anti-corruption laws.

iii.All Parties to this Agreement have developed and maintain in effect policies and procedures specifically designed to achieve compliance with the requirements of this Section 17.4, including compliance by their respective authorized agents and other Third Parties acting on their behalf. In construing the compliance obligations under U.S. law with regard to the scope of this Agreement , each Party shall regard itself as a United States person. The Parties to this Agreement shall undertake to cooperate in good faith, to the extent permitted by law and in accordance with applicable legal privilege  in connection with any investigation, by a party to this Agreement or any Governmental  Authority, relating to compliance with this Section 17.4.

1.MISCELLANEOUS

a.Independent Contractors. Each of the Parties is an independent contractor and nothing herein contained shall be deemed to create or constitute the relationship of partners, joint venturers, co- partners, employer/employee, nor of principal and agent between the Parties. Neither Party shall at any time enter into, incur, or hold itself out as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever.

b.Force Majeure.  Neither Party shall be in breach of this Agreement if there is any failure  of performance under this Agreement (except for payment of any amounts due under this Agreement)

occasioned by any reason beyond the reasonable control that is not reasonably foreseeable or avoidance and without the fault or negligence of the Party affected thereby, including, without limitation, an act of God, fire, flood, act of government or state, war, civil commotion, insurrection, acts of terrorism, embargo, sabotage, prevention from or hindrance in obtaining energy or other utilities, labor disputes of whatever nature, or any other reason beyond the reasonable control that is not reasonably foreseeable  or avoidable and without the fault or negligence of the Party affected thereby (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues. Upon cessation of such Force Majeure Event, the affected Party shall promptly resume performance under this Agreement as soon as    it is commercially reasonable for the Party to do so. Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event, the nature thereof, and the extent to which the affected Party will be unable to fully perform its obligations under this Agreement. Each Party further agrees to use diligent efforts to mitigate the effect of such Force Majeure Event as quickly as practicable (provided that in no event shall a Party be required to settle any labor dispute) and to give the other Party prompt written notice when it is again fully able to perform such obligations. If the failure to perform due to such Force Majeure Event continues for a period of [***] or more, then the unaffected Party may terminate this Agreement.

a.[intentionally left blank]

b.Notices. Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier service guaranteeing next-day or second day delivery, charges prepaid, or (d) delivered by facsimile (with documented evidence of transmission), to the addresses or facsimile numbers of the other Party set forth below or at such other addresses as may from time to time be furnished by similar notice by any Party. The effective date of any notice under this Agreement shall be the date of receipt by the receiving Party.

If to LONZA:

LONZA SALES LTD.
Attn: Business Head Münchensteinerstrasse 38
4002 Basel, Switzerland

With a copy to:

Group General Counsel LONZA Sales Ltd.
Münchensteinerstrasse 38

4002 Basel, Switzerland

If to MODERNA:

ModernaTx, Inc.
Attn: General Counsel 200 Technology Square
Cambridge, MA 02139 USA

Either Party may change its address for notice by giving notice thereof in the manner set forth in this Section 18.4.

a.Entire Agreement; Amendments. This Agreement, including the Appendices attached hereto and referenced herein, constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement with respect to the specific subject matter  hereof and supersedes all prior agreements and understandings, oral and written, among the Parties with respect to the subject matter hereof, including, without limitation, the SCA. No terms, conditions, understandings or agreements purporting to amend, modify or vary the terms of this Agreement (including any Appendix hereto) shall be binding unless hereafter made in a written instrument referencing this Agreement and signed by each of the Parties.

b.Governing Law. The construction, validity and performance of the Agreement shall be governed by and construed in accordance with the internal laws of the State of New York, without giving effect to its conflicts of laws provisions. The United Nations Convention on Contracts for the International Sale of Goods and the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980 shall not apply to this Agreement.  The Parties hereby submit to and consent to the exclusive jurisdiction of the federal and state courts sitting in the State of New York and waive any objection to the laying of venue in, and any claim of inconvenient forum with respect to, these courts.

c.Counterparts. This Agreement and any amendment hereto may be executed in any number of counterparts, each of which shall for all purposes be deemed an original and all of which shall constitute the same instrument. This Agreement shall be effective upon full execution by facsimile, PDF, electronic reproduction or original, and a facsimile, PDF or electronic signature shall be deemed to be and shall be as effective as an original signature.

d.Severability. If any part of this Agreement shall be found to be invalid or unenforceable under Applicable Law in any jurisdiction, such part shall be ineffective only to the extent of such invalidity or unenforceability in such jurisdiction, without in any way affecting the remaining parts of this Agreement in that jurisdiction or the validity or enforceability of the Agreement as a whole in any other jurisdiction.  In addition, the part that is ineffective shall be reformed in a mutually agreeable manner so as to as nearly approximate the intent of the Parties as possible.

e.Titles and Subtitles. All headings, titles and subtitles used in this Agreement (including any Appendix hereto) are for convenience only and are not to be considered in construing or interpreting any term or provision of this Agreement (or any Appendix hereto).

f.Exhibits. All “RECITALS”, “DEFINITIONS”, exhibits and appendices referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.

a.Pronouns. Where the context requires, (i) all pronouns used herein will be deemed to refer to the masculine, feminine or neuter gender as the context requires, and (ii) the singular context will include the plural and vice versa.

b.Assignment. This Agreement shall be binding upon the successors and assigns of the Parties and the name of a Party appearing herein shall be deemed to include the names of its successors and assigns. Neither Party may assign its interest under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed; provided, however, a Party shall be entitled without the prior written consent of the other Party to assign this Agreement to an Affiliate or to any company to which such Party may transfer all or substantially all of its assets or capital stock relating to the activities contemplated under this Agreement, whether through purchase, acquisition, merger, consolidation, reorganization or otherwise. Any permitted assignment of this Agreement by either Party will be conditioned upon such Party’s permitted assignee agreeing in writing to comply with all the terms and conditions contained in this Agreement. Any purported assignment without a required consent shall be null and void. No assignment shall relieve any Party of responsibility for the performance of any obligation that accrued prior to the effective date of such assignment.

c.Waiver. No waiver hereunder shall be effective unless signed by the Party granting the waiver. The failure of any Party at any time or times to require performance of any provision of this Agreement (including any Appendix hereto) will in no manner affect its rights at a later time to  enforce the same. No waiver by any Party of any term, provision or condition contained in this Agreement (including any Appendix hereto), whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or  of any other term, provision or condition of this Agreement (including any Appendix hereto).

d.Dispute Resolution.

i.Disputes; Dispute Escalation. Except as expressly set forth otherwise in this Agreement, disputes of any nature arising under, relating to, or in connection with this Agreement  will be exclusively resolved pursuant to this Section 18.14. If the Parties are unable to resolve a dispute, despite their good faith efforts, either Party may, by written notice to the other, have such dispute referred to the Executive Officers (or their designees, which designee is required to have decision-making authority on behalf of such Party), who will attempt to resolve such dispute by negotiation and consultation for a [***] period following receipt of such written notice. Notwithstanding the dispute resolution procedures set forth in this Section 18, in the event of an actual or threatened breach of this Agreement, the aggrieved Party may seek provisional equitable relief (including restraining orders, specific performance or other injunctive relief), without first submitting to any dispute resolution procedures hereunder.

ii.Full Arbitration. In the event that no agreement is reached by the Executive Officers (or other designees) with respect to a dispute within [***] after its referral to them, either Party may at any time after such [***] period submit such dispute to be finally settled by arbitration administered in accordance with the procedural rules of the American Arbitration Association (“AAA”) in effect at the time of submission, as modified by this Section 18.14. The arbitration

will be heard and determined by three (3) arbitrators who are retired judges or attorneys with at least ten
(10) years of relevant experience in the pharmaceutical and biotechnology industry, each of whom will be impartial and independent. Each Party will appoint one arbitrator and the third arbitrator will be selected by the two Party-appointed arbitrators, or, failing agreement within [***] following appointment of the second arbitrator, by AAA. The arbitration shall be held in New York, New York. The arbitration proceedings shall be conducted, and the award shall be rendered, in the English language. Fees, costs and expenses of arbitration are to be divided by the Parties in the following manner: [***].

i.Expedited Arbitration. Notwithstanding Section 18.14.2 the Parties may agree to refer a dispute to expedited arbitration (an “Expedited Dispute”) rather than resolve the same pursuant to Section 18.14.2. Any such Expedited Dispute shall be finally settled by arbitration under the Commercial Arbitration Rules (Expedited Rules) of the American Arbitration Association (“AAA Expedited Rules”). Arbitration will be conducted in New York, New York by one (1) arbitrator who shall be reasonably acceptable to the Parties and who shall be appointed in accordance with the AAA Expedited Rules. If the Parties are unable to select an arbitrator within [***] of the notice that initiated the arbitration, then the arbitrator shall be appointed in accordance with the AAA Expedited Rules. Any arbitrator chosen hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical and industry knowledge relevant to the particular dispute. [***].

ii.Arbitration Award. The arbitrator(s) shall issue their decision in writing, setting forth the basis for such decision. The arbitration award so given will be a final and binding determination of the dispute, will be fully enforceable in any court of competent jurisdiction. Except in a proceeding to enforce the results of the arbitration or as otherwise required by law, neither Party nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both Parties (each such consent not to be unreasonably withheld, delayed or conditioned).

iii.Tolling. The Parties agree that all applicable statutes of limitation and time-based defenses (such as estoppel and laches) shall be tolled while the dispute resolution procedures set forth in this Section 18.14 are pending, and the Parties shall cooperate in taking all actions reasonably necessary to achieve such a result. In addition, during the pendency of any dispute under this Agreement initiated before the end of the cure period under Section 15.2, this Agreement shall remain in full force and effect, and the time periods for cure under Section 15.2 shall be tolled. Notwithstanding the dispute resolution procedures set forth in this Section 18.14, in the event of an actual or threatened breach of this Agreement, the aggrieved Party may seek provisional equitable relief (including restraining orders,  specific performance or other injunctive relief), without first submitting to any dispute resolution procedures hereunder.

iv.Confidentiality. Any and all activities conducted under this Section 18.14, including any and all non-public proceedings and decisions under Section 18.14.2, will be deemed Confidential Information of each of the Parties, and will be subject to the terms of 10.

a.No Presumption Against Drafter. For purposes of this Agreement, each Party hereby waives any rule of construction that requires that ambiguities in this Agreement (including any Appendix hereto) be construed against the drafter.

b.No Third Party Beneficiaries. The representations, warranties, covenants  and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other persons other than MODERNA Indemnitees and LONZA Indemnitees pursuant to the indemnification provisions of Sections 16.1 and 16.2.

c.Further Assurances. The Parties shall execute, acknowledge and deliver such further instruments and shall take all such other incidental  acts as may be reasonably necessary or appropriate  to carry out the purpose and intent of this Agreement.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

MODERNATX, INC.

By:     /s/ Stephane Bancel     Name: Stephane Bancel
Title: CEO

                            LONZA SALES LTD.

By:  /s/ Albert M. Baehny    /s/ Daniel Blaettler

Name: Title:
Albert M. Baehny    Daniel Blaettler CEO a.i. and Chairman    General Counsel

LONZA LTD.

By:   /s/ Albert M. Baehny    /s/ Daniel Blaettler

Name: Title:
Albert M. Baehny    Daniel Blaettler CEO a.i. and Chairman    General Counsel

CONFIDENTIAL

APPENDIX A-1 STATEMENT OF WORK NR. 1

[TO BE ATTACHED]

CONFIDENTIAL

APPENDIX A-2 STATEMENT OF WORK NR. 2

[TO BE ATTACHED]

CONFIDENTIAL

APPENDIX A-3 STATEMENT OF WORK NR. 3

[TO BE ATTACHED]

CONFIDENTIAL

APPENDIX  B TEMPLATE STATEMENT OF WORK
[***]

CONFIDENTIAL

APPENDIX C

[***]

[***]exhibit103

                                                                                                                                                                                                         EXHIBIT 10.3  CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS  BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF  DISCLOSED.                                                                    1. THIS CONTRACT IS A RATED ORDER                                                                            RATING                       PAGE OF PAGES             AWARD/CONTRACT                                            UNDER DPAS (15 CFR 700)                                                                                                                      1             53      2. CONTRACT (Proc. Inst. Ident.) NO.                          3. EFFECTIVE DATE                                                       4. REQUISITION/PURCHASE REQUEST/PROJECT NO.     W911QY20C0100                                                                                 09 Aug 2020                             0011534693      5.  ISSUED BY                                      CODE       W911QY                                    6. ADMINIST ERED BY   (If other than Item 5)                                         CODE      S2206A      W6QK ACC-APG NATICK                                                                                     DEFENSE CONTRACT MANAGEMENT AGENCY      CONTRACTING DIVISION                                                                                    DCMA BOSTON      BLDG 1 GENERAL GREENE AVENUE                                                                            495 SUMMER STREET      NATICK MA 01760-5011                                                                                    BOSTON MA 02210-2138        7.  NAME  AND ADDRESS OF CONTRACTOR                                     (No., street, city, county, state and zip code)                             8.  DELIVERY     MODERNATX, INC.                                                                                                                                         [     ]  FOB ORIGIN              [ X ] OTHER (See below)     [***]                                                                                                                                                          9. DISCOUNT FOR PROMPT PAYMENT     200 TECHNOLOGY SQ      CAMBRIDGE MA 02139-3578                                                                                                                                                           10. SUBMIT INVOICES                   1             ITEM                                                                                                                                                           (4 copies unless otherwise specified)                                                                                                                                                           TO THE ADDRESS                                             Section G      CODE 6RP85                                                   FACILITY CODE                                                                           SHOWN IN:      11.  SHIP TO/MARK FOR                             CODE                                                   12.  PAYMENT WILL BE MADE BY                                                       CODE       HQ0337                                                                                                               DEFENSE FINANCE AND ACCOUNTING SERVICE                                                                                                              DFAS - COLUMBUS CENTER (HQ0337)                                                                                                               NORTH ENTITLEMENT OPERATIONS                                                                                                               P.O. BOX 182317                                 See Schedule                                                                  COLUMBUS OH 43218-2266       13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN                                                         14.  ACCOUNTING AND APPROPRIATION DATA           COMPETITION:                                                                                       See Schedule       [  X ] 10 U.S.C. 2304(c)(   2    )  [                ] 41 U.S.C. 253(c)(               )     15A. ITEM NO.                                   15B. SUPPLIES/ SERVICES                                  15C. QUANTITY                  15D. UNIT                      15E. UNIT PRICE                       15F. AMOUNT                                               SEE SCHEDULE                                                                                                                                    15G. TO TAL AMOUNT OF CONTRACT                                               $1,525,000,000.00                                                                                         16.  TABLE OF CONTENTS    (X)    SEC.                               DESCRIPTION                                      PAGE(S)        (X)    SEC.                                                 DESCRIPTION                                          PAGE(S)                                      PART I - THE SCHEDULE                                                                                         PART II - CONTRACT CLAUSES       X       A     SOLICITATION/ CONTRACT FORM                                                 1 - 2           X       I     CONTRACT CLAUSES                                                                                 45 - 51       X       B     SUPPLIES OR SERVICES AND PRICES/ COSTS                                      3 - 18                 PART III – LIST OF DOCUMENTS, EXHIBITS AND O THER ATTACH.       X       C     DESCRIPTION/ SPECS./ WORK STATEMENT                                         19 - 27         X       J     LIST OF ATTACHMENTS                                                                              52 - 53       X       D     PACKAGING AND MARKING                                                       28                                 PART IV - REPRESENTATIONS AND INSTRUCTIONS       X       E     INSPECT ION AND ACCEPTANCE                                                  29 - 30                       REPRESENTATIONS, CERTIFICATIONS AND                                                                                                                         K       X       F     DELIVERIES OR PERFORMANCE                                                   31 - 33                       OTHER STATEMENTS OF OFFERORS       X       G     CONTRACT ADMINISTRATION DATA                                                34 - 38                 L     INST RS., CONDS., AND NOTICES TO OFFERORS       X       H     SPECIAL CONTRACT REQUIREMENTS                                               39 - 44                 M     EVALUATION FACTORS FOR AWARD                    CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE     17. [    ] CONTRACTOR'S NEGOTIATED AGREEMENT                    Contractor is required to sign this      18. [ ] SEALED-BID AWARD (Contractor is not required to sign this document.)      document and return1      copies to  issuing office.)   Contractor agrees to furnish and deliver all     Your bid on Solicitation Number    W911QY20R0043     items or perform all the services set forth or otherwise identified above and on any continuation      sheets for the consideration stated herein. The rights and obligations of the parties to this      contract shall be subject to and governed by the following documents: (a) this award/contract,           including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as      (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, to the terms listed above and on any continuation sheets. This award consummates the contract which consists of the      as are attached or incorporated by reference herein.                                                     following documents: (a) the Government's solicitation and your bid, and (b) this award/contract. No further contractual      (Attachments are listed herein.)                                                                         document is necessary. (Block 18 should be checked only when awarding a sealed-bid contract.)      19A. NAME AND TITLE OF SIGNER ( Type or print)                                                          20A. NAME OF CONTRACTING OFFICER                                                                                                               CONNELL-MAGAW, CAMILLE / BRANCH CHIEF      Stéphane Bancel, CEO                                                                                                               TEL:                                                       EMAIL: [***]      19B. NAME OF CONTRACTOR                                                  19C. DATE SIGNED               20B. UNITED STATES OF AMERICA                                                                 20C. DATE SIGNED                                                                                                                                                                                                                11-Aug-2020     BY  /s/ Stéphane Bancel                                                  8/11/2020                      BY  /s/ Camille B. Connell-Magaw                    (Signature of person authorized to sign)                                                                                  (Signature of Contracting Officer)      AUTHORIZED FOR LOCAL REPRODUCTION                                                                                                                                                                STANDARD FORM 26 (REV. 5/2011)     Previous edition is NOT usable                                                                                                                                                           Prescribed by GSA – FAR (48 CFR) 53.214(a) 

 

                                                                                           W911QY20C0100                                                                                          Page 2 of 53            Section A - Solicitation/Contract Form                     A.1    The U.S. Army Contracting Command - Aberdeen Proving Ground (ACC-APG), Natick Division has a  requirement for up to 500 million SARS-CoV-2 mRNA-1273 Vaccine doses (100 μg) in support of Joint Program  Executive Office - Chemical Biological Radiological Nuclear Defense (JPEO-CBRND), the Assistant Secretary for  Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA).  All doses of mRNA-1273 Vaccine referenced herein are 100 μg doses. All doses will be delivered in a multi- dose  vial with a volume sufficient for 10 doses per vial. 

 

                                                                                               W911QY20C0100                                                                                              Page 3 of 53                Section B - Supplies or Services and Prices                                       ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  0001                                                                                                     $0.00              SARS-CoV-2 mRNA-1273 Vaccine              FFP              The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-              1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work              (SOW) and CDRLs (Exhibit A) on this contract.              PROJECT: Operation Warp Speed                                                                                                       NET AMT                                 $0.00                                                                                    ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0001AA                               15,000,000     Each             $12.25                     $183,750,000.00              15M Doses              FFP              FOB: Origin (Shipping Point)              PURCHASE REQUEST NUMBER: 0011534693              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $183,750,000.00                       ACRN AA                                                                            $183,750,000.00              CIN: GFEBS001153469300001 

 

                                                                                               W911QY20C0100                                                                                              Page 4 of 53           ITEM NO     SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                        AMOUNT  0001AB                              22,000,000       Each           $12.25                     $269,500,000.00              22M Doses              FFP                                FOB: Origin (Shipping Point)              PURCHASE REQUEST NUMBER: 0011534693              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $269,500,000.00                       ACRN AB                                                                            $269,500,000.00              CIN: GFEBS001153469300002                                                          ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0001AC                               30,000,000     Each             $12.25                     $367,500,000.00              30M Doses              FFP              FOB: Destination              PURCHASE REQUEST NUMBER: 0011534693              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $367,500,000.00                       ACRN AA                                                                            $367,500,000.00              CIN: GFEBS001153469300003 

 

                                                                                               W911QY20C0100                                                                                              Page 5 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0001AD                               33,000,000     Each             $12.25                     $404,250,000.00              33M Doses              FFP              FOB: Destination              PURCHASE REQUEST NUMBER: 0011534693              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $404,250,000.00                       ACRN AA                                                                            $404,250,000.00              CIN: GFEBS001153469300004                                                          ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  0002                                    1            Job                                            $0.00 TBN              Vendor Managed Inventory              FFP              a. The contractor shall secure, manage and maintain storage for up to 100M doses              of mRNA-1273 vaccine and deliver to the designated government facility in              accordance with Section F.              b. [***]               FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                                 $0.00 

 

                                                                                               W911QY20C0100                                                                                              Page 6 of 53            ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  0003                                                                                                     $0.00              EUA or BLA Incentive              FFP              This is an incentive CLIN and will be earned only if an Emergency Use              Authorization (EUA) or Biologics License Application (BLA) is obtained no later              than 31 January 2021.              PROJECT: Operation Warp Speed                                                                                                       NET AMT                                 $0.00                                                                                    ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0003AA                               15,000,000     Each             $3.00                       $45,000,000.00              EUA or BLA Incentive              FFP              If earned, this incentive shall be paid at final acceptance of subCLIN 0001AA.              FOB: Destination              PSC CD: 6505                                                                                                       NET AMT                        $45,000,000.00 

 

                                                                                               W911QY20C0100                                                                                              Page 7 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0003AB                               22,000,000     Each             $3.00                       $66,000,000.00              EUA or BLA Incentive              FFP              If earned, this incentive shall be paid at final acceptance of subCLIN 0001AB.              FOB: Destination              PSC CD: 6505                                                                                                       NET AMT                        $66,000,000.00                                                                  ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0003AC                               30,000,000     Each             $3.00                       $90,000,000.00              EUA or BLA Incentive              FFP              If earned, this incentive shall be paid at final acceptance of subCLIN 0001AC.              FOB: Destination              PSC CD: 6505                                                                                                       NET AMT                        $90,000,000.00                                                                                    ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  0003AD                               33,000,000     Each             $3.00                       $99,000,000.00              EUA or BLA Incentive              FFP              If earned, this incentive shall be paid at final acceptance of subCLIN 0001AD.              FOB: Destination              PSC CD: 6505                                                                                                       NET AMT                        $99,000,000.00 

 

                                                                                               W911QY20C0100                                                                                              Page 8 of 53                                                ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  0004                                    1            Job                                                  NSP              Technical Data              FFP              The contractor shall deliver technical Data IAW Contract Data Requirements List              (CDRL) IAW deliveries in Section C.4 and Section J, Exhibit A.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                                                                  ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  1001                                                                                                     $0.00  OPTION      SARS-CoV-2 mRNA-1273 Vaccine              FFP              The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-              1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work              (SOW) and CDRLs (Exhibit A) on this contract.              PROJECT: Operation Warp Speed                                                                                                       NET AMT                                 $0.00 

 

                                                                                               W911QY20C0100                                                                                              Page 9 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  1001AA                               33,200,000     Each             $16.50                     $547,800,000.00  OPTION      33.2M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.                       FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $547,800,000.00                                                                  ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  1001AB                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.                       FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00 

 

                                                                                               W911QY20C0100                                                                                             Page 10 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  1001AC                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00                                                                                    ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  1002                                    1            Job                                            $0.00 TBN  OPTION      Vendor Managed Inventory              FFP              a. The contractor shall secure, manage and maintain storage for up to 100M doses              of mRNA-1273 vaccine and deliver to the designated government facility in              accordance with Section F.              b. [***]               FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                                 $0.00 

 

                                                                                               W911QY20C0100                                                                                             Page 11 of 53            ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  2001                                                                                                     $0.00  OPTION      SARS-CoV-2 mRNA-1273 Vaccine              FFP              The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-              1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work              (SOW) and CDRLs (Exhibit A) on this contract.              PROJECT: Operation Warp Speed                                                                                                       NET AMT                                 $0.00                                                                  ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  2001AA                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00 

 

                                                                                               W911QY20C0100                                                                                             Page 12 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  2001AB                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00                                                                  ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  2001AC                               33,200,000     Each             $16.50                     $547,800,000.00  OPTION      33.2M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $547,800,000.00 

 

                                                                                               W911QY20C0100                                                                                             Page 13 of 53            ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  2002                                    1            Job                                            $0.00 TBN  OPTION      Vendor Managed Inventory              FFP              a. The contractor shall secure, manage and maintain storage for up to 100M doses              of mRNA-1273 vaccine and deliver to the designated government facility in              accordance with Section F.              b. [***]               FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                                 $0.00                                                                                    ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  3001                                                                                                     $0.00  OPTION      SARS-CoV-2 mRNA-1273 Vaccine              FFP              The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-              1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work              (SOW) and CDRLs (Exhibit A) on this contract.              PROJECT: Operation Warp Speed                                                                                                       NET AMT                                 $0.00 

 

                                                                                               W911QY20C0100                                                                                             Page 14 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  3001AA                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00                                                                  ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  3001AB                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00 

 

                                                                                               W911QY20C0100                                                                                             Page 15 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  3001AC                               33,200,000     Each             $16.50                     $547,800,000.00  OPTION      33.2M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $547,800,000.00                                                                  ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  3002                                    1            Job                                            $0.00 TBN  OPTION      Vendor Managed Inventory              FFP              The contractor shall secure, manage and maintain storage for up to 100M doses of              mRNA-1273 vaccine and deliver to the designated government facility in              accordance with Section F.              b. [***]               FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                                 $0.00 

 

                                                                                               W911QY20C0100                                                                                             Page 16 of 53            ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  4001                                                                                                     $0.00  OPTION      SARS-CoV-2 mRNA-1273 Vaccine              FFP              The contractor shall produce and deliver 100M doses of the SARS-CoV-2 mRNA-              1273 Vaccine filled drug product (FDP), IAW Section C, Statement of Work              (SOW) and CDRLs (Exhibit A) on this contract.                       PROJECT: Operation Warp Speed                                                                                                       NET AMT                                 $0.00                                                                                    ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  4001AA                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00 

 

                                                                                               W911QY20C0100                                                                                             Page 17 of 53            ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  4001AB                               33,400,000     Each             $16.50                     $551,100,000.00  OPTION      33.4M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $551,100,000.00                                                                  ITEM NO    SUPPLIES/SERVICES       QUANTITY        UNIT          UNIT PRICE                         AMOUNT  4001AC                               33,200,000     Each             $16.50                     $547,800,000.00  OPTION      33.2M Doses              FFP              a. If executed, the option shall be awarded upon EUA or no later than [***].              b. The government shall provide [***] notification to exercise the option.              FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                       $547,800,000.00 

 

                                                                                               W911QY20C0100                                                                                             Page 18 of 53            ITEM NO    SUPPLIES/SERVICES      QUANTITY         UNIT          UNIT PRICE                         AMOUNT  4002                                    1            Job                                            $0.00 TBN  OPTION      Vendor Managed Inventory              FFP              The contractor shall secure, manage and maintain storage for up to 100M doses of              mRNA-1273 vaccine and deliver to the designated government facility in              accordance with Section F.              b. [***]               FOB: Destination              PROJECT: Operation Warp Speed              PSC CD: 6505                                                                                                       NET AMT                                 $0.00 

 

                                                                                           W911QY20C0100                                                                                         Page 19 of 53            Section C - Descriptions and Specifications                                                         STATEMENT OF WORK                       LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE                     C.1    SCOPE. The Department of Defense and Health and Human Services (HHS) require large scale  manufacturing of vaccine doses in support of the national emergency response to the Coronavirus Disease 2019  (COVID-19) for the United States Government (USG) and the US population.            C.1.1  Background. In December 2019, a novel coronavirus now known as SARS-CoV-2 was first detected in   Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID-19 that   has now spread globally. The Secretary of Health and Human Service declared a public health emergency on   January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19.   On March 1, 2020, the President of the United States, pursuant to sections 01 and 301 of the National Emergencies   Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42   U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.            C.1.1.1 Under Operation Warp Speed (OWS), the Department of Defense and HHS are leading a whole of nation   effort to ensure development of promising vaccine, diagnostic and therapeutic candidates and ensure that these   medical countermeasures are available in the quantities required to reduce SARS-CoV-2 transmission, identify prior   and/or current infection, and improve patient care, thereby mitigating the impact of COVID-19 on the nation and its  people. The DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense  (JPEO-CBRD) is providing expertise and contracting support to HHS, in compliance with PL 115-92 Authorization  Letter for DoD Medical Priorities, through an Interagency Agreement, signed April 23, 2020. As OWS products  progress to clinical trials to evaluate the safety and efficacy of vaccines and therapeutics, it is critical that, in  parallel, the USG supports large scale manufacturing so that vaccine doses or therapeutic treatment courses are  immediately available for nationwide access as soon as a positive efficacy signal is obtained and the medical  countermeasures are authorized for widespread use.            C.1.2  Objective: The objective of this effort is to obtain the following:                   a. Base Period: Large scale manufacturing of 100 million vaccine doses          b. Option Period 1: Large scale manufacturing of 100 million vaccine doses          c. Option Period 2: Large scale manufacturing of 100 million vaccine doses          d. Option Period 3: Large scale manufacturing of 100 million vaccine doses          e. Option Period 4: Large scale manufacturing of 100 million vaccine doses  The Base Period is 9 months, with overlapping options for a total of 20 months if all options are exercised.            C.2    APPLICABLE DOCUMENTS.            C.2.1  Federal Documents:            C.2.1.1 Title 21 Code of Federal Regulations (CFR), Food and Drugs: Part 210, Current Good Manufacturing  Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; and, Part 211, Current Good  Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General.  (https://www.ecfr.gov/cgi-bin/text-  idx?SID=a95cab20f443897a400bb7e44a27cf4c&mc=true&tpl=/ecfrbrowse/Title21/21cfrv4_02.tpl#0)            C.3     REQUIREMENTS. Independently, and not as an agent of the USG, in accordance with the Proposal   submitted by ModernaTX, Inc. in response to Solicitation Number W911QY20R0043, Titled, “Advanced   Procurement of mRNA-1273 Vaccine for Prevention of SARS-CoV-2 Coronavirus (COVID-19)”), dated July 10,   2020 (and any subsequent USG-approved revisions thereto), the contractor shall provide all necessary services, 

 

                                                                                           W911QY20C0100                                                                                         Page 20 of 53            qualified personnel, material, equipment and facilities (not otherwise provided by the USG under the terms of this   contract) to perform the specific tasks set forth below.            C.3.1   C ontract Line Item Number (CLIN) 0001 - Base Period: Large Scale Manufacturing of 100 Million   V accine Doses.            C.3.1.1  The contractor shall complete all scope required for the production, release and delivery use of 100   million Final Drug Product (FDP) doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include, the following   tasks and other activities reasonably contemplated by such task:            C.3.1.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.            C.3.1.1.2 cGMP manufacturing of 100 million doses fully compliant with 21 CFR 210 and 211.            C.3.1.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated as appropriate.            C.3.1.1.4 Coordinating with FDA to establish an approved commercial vial label, carton and packaging insert  (printed or electronic).            C.3.1.1.5 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response  requirements, subject to any exceptions established by or the enforcement discretion of the FDA, including  “Exemption from Certain Product Tracing and Product Identification Requirements Under Section 582 of the FD&C  Act” (April 2020).            C.3.1.1.6 In coordination with the USG, the contractor shall conduct a demonstration of the vaccine shipping  process prior to the first delivery of FDP doses at a time mutually agreed to by the contractor and the USG.  Moderna shall provide specifications and details associated with the shipping process and containers (IAW CDRL  A005) to enable the USG to adequately plan and prepare for potential distribution of the vaccine.            C.3.1.1.7 Following release of product the contractor shall, promptly deliver product to the designated delivery site  via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. In the unforeseen event  that a designated delivery site cannot receive product and the contractor provides storage beyond 20 days of product  release, the contract will be subject to modification for acceptance purposes.            C.3.1.2   Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and  FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.1.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing  the finding and corrective action(s) in accordance with CDRL A001.            C.3.1.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and Contracting Officer’s  Representative (COR) within [***] of a scheduled FDA audit or within [***] of an ad hoc site visit or audit if the  FDA does not provide advance notice. The contractor shall provide copies of any FDA Audit Report received from  subcontractors that occur as a result of this contract or for this product within [***] of receiving correspondence  from the FDA or third party in accordance with CDRL A002. The Contractor shall 

 

                                                                                           W911QY20C0100                                                                                         Page 21 of 53            provide the Contracting Officer with a plan for addressing areas of nonconformance, if any are identified, within   [***] of submittal of the audit report in accordance with CDRL A002.            C.3.1.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the USG  has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not  limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement  documentation in accordance with CDRL A002.            C.3.2  C LIN 1001 - Option Period 1: Large Scale Manufacturing of 100 Million Vaccine Doses.            C.3.2.1  The contractor shall complete all scope required for the production, release and delivery use of 100  million FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other  activities reasonably contemplated by such tasks:            C.3.2.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.            C.3.2.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.            C.3.2.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated.            C.3.2.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response  requirements subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.2.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site   via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural   disaster or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the   Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed   Inventory (VMI) at the contractor site.            C.3.2.2  Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and   FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.2.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.            C.3.2.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled   FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The   contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this   contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance   with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas of   nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            C.3.2.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the  USG has visibility and input on all FDA communications regarding the drugs and biologics for the following, but 

 

                                                                                           W911QY20C0100                                                                                         Page 22 of 53            not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement   documentation in accordance with CDRL A002.            C.3.3  C LIN 2001 - Option Period 2: Large Scale Manufacturing of 100 Million Vaccine Doses.            C.3.3.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million   FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other activities  reasonably contemplated by such tasks:            C.3.3.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.            C.3.3.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.            C.3.3.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated as appropriate.            C.3.3.1.4 Ensuring that the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-  585 of PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and  response requirements, subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.3.1.5 Following release the contractor shall deliver product to the nearest designated distribution site via a  qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural disaster  or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the Contractor  and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed Inventory  (VMI) at the contractor site.            C.3.3.2  Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and   FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.3.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.            C.3.3.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled   FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The   contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this   contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance   with CDRL A002. The Contractor shall provide the Contracting Officer with a plan for addressing areas of   nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            C.3.3.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the USG  has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not  limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement  documentation in accordance with CDRL A002.            C.3.4  C LIN 3001 - Option Period 3: Large Scale Manufacturing of 100 Million Vaccine Doses. 

 

                                                                                           W911QY20C0100                                                                                         Page 23 of 53            C.3.4.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million  FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other activities  reasonably contemplated by such tasks:            C.3.4.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.            C.3.4.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.            C.3.4.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated.            C.3.4.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response  requirements subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.4.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site   via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural   disaster or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the   Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed   Inventory (VMI) at the contractor site.            C.3.4.2  Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and   FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.4.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.            C.3.4.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled   FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The   contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this   contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance  with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas of   nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            C.3.4.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the  USG has visibility and input on all FDA communications regarding mRNA-1273 for the following, but not limited  to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement documentation in  accordance with CDRL A002.            C.3.5  C LIN 4001 - Option Period 4: Large Scale Manufacturing of 100 Million Vaccine Doses.            C.3.5.1  The contractor shall complete all scope required for the production, release and delivery use of 100  million FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other  activities reasonably contemplated by such tasks: 

 

                                                                                           W911QY20C0100                                                                                         Page 24 of 53            C.3.5.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.            C.3.5.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.            C.3.5.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated.            C.3.5.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 22013), including product verification, serialization, traceability and detection and response  requirements subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.5.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site   via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural   disaster or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the   Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed   Inventory (VMI) at the contractor site.            C.3.5.2  Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and   FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.5.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.            C.3.5.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled   FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The   contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this   contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance   with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas of   nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            C.3.5.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the  USG has visibility and input on all FDA communications regarding the drugs and biologics for the following, but   not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement   documentation in accordance with CDRL A002.            C.4    C LIN 0002: Data Deliverables. The contractor shall provide the following in accordance with the   Contract Data Requirements List (CDRL), DD Forms 1423, provided at Appendix A.            C.4.1  Monthly Inventory Report (CDRL A003), detailing at a minimum, raw materials, Bulk mRNA, formulated  LNPs, and the fill, finish, and released product.            C.4.2   Quality Management Plan. The contractor shall provide a Quality Management Plan, in accordance with   CDRL A004, describing the quality policy and objectives, management review, competencies and training, process   document control, feedback, evaluation, corrective action and preventive action, process improvement,   measurement, and data analysis processes. The framework is normally divided into infrastructure, senior 

 

                                                                                           W911QY20C0100                                                                                         Page 25 of 53            management responsibility, resource management, lifecycle management, and quality management system   evaluation.            C.4.3  Shipping Documentation (CDRL A005) for all Finished Drug Product (FDP) transferring from the   contractor’s fill/finish facility to a USG facility. The contractor shall obtain concurrence on planned shipment   protocols prior to transport.            C.4.4  Expiring Items Report (CDRL A006) for all FDP in the USG’s possession.            C.4.5  Key Personnel Listing (CDRL A007).            C.4.6  Monthly Technical Progress Report (CDRL A008), to include an Integrated Master Schedule, identifying  key activities and contract status.            C.4.7  Final Technical Report (CDRL A009), documenting the work performed and results obtained for the entire   contract period of performance.            C.4.8  Supply Chain Resiliency Plan (SCRP). The contractor shall provide, in accordance with CDRL A010 and   CDRL Attachment 0001, a comprehensive SCRP that provides for identification and reporting of critical   components associated with the secure supply of drug substance, drug product, and work-in-process through to  finished goods, and key equipment suppliers and their locations, including addresses, points of contact, and work  performed per location, to include subcontractors.            C.4.9  Risk Management Plan (RMP). The Contractor shall provide an RMP in accordance with CDRL A011 that   outlines the impacts of each risk in relation to the cost, schedule, and performance objectives. The plan shall include   risk mitigation strategies. Each risk mitigation strategy shall capture how the corrective action will reduce impacts   on cost, schedule and performance.            C.4.10 Manufacturing Reports and Dose Tracking. The Contractor shall provide, in accordance with CDRL A013,   manufacturing reports and manufacturing dose tracking projections and actuals utilizing the USG-provided  “COVID-19 Dose Tracking Template” (CDRL Attachment 0003).            C.4.11 Product Acceptance Report (for each lot of Drug Product). The contractor shall provide, in accordance   with CDRL A014, pictures of the drug product with lot number, drug product lot tree, list of associated deviations  (from drug substance and product), and a Certificate of Analysis.            C.4.12 Incident Report. The contractor shall communicate to BARDA and document all critical programmatic  concerns, issues, or probable risks that have or are likely to significantly impact project schedule and/or cost and/or  performance in accordance with CDRL A016. “Significant” is frequently defined as a 10% or greater cost or  schedule variance within a control account, but should be confirmed in consultation with the COR. Incidents that  present liability to the project even without cost/schedule impact, such as breach of GCP during a clinical study,  shall also be reported.            C.4.13 FDA Correspondence. The contractor shall provide any correspondence between Contractor and FDA  relevant to the scope of this contract and submit in accordance with CDRL A017.            C.4.14 Press Releases. The contractor shall accurately and factually represent the work conducted under this  contract in all press releases. The contractor shall provide an advance copy of any press release in accordance with  CDRL A018.            C.4.15 Manufacturing Development Plan. The contractor shall provide a Manufacturing Development Plan, in  accordance with CDRL A025, describing the manufacturing process for the drug/biologic product to ensure  conformity with §501(a)(2)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code  (USC) §351 (a)(2)(B)), regarding good manufacturing practices (GMP). 

 

                                                                                           W911QY20C0100                                                                                         Page 26 of 53            C.5 Administration.            C.5.1 Post Award Teleconference. The contractor shall host a Post Award Teleconference within 7 calendar days   after contract award.            C.5.1.1 The contractor shall provide an Agenda, IAW CDRL A020, detailing the planned activities for the  subsequent 30 calendar days and shall discuss agenda items for the Post Award Kickoff Meeting.            C.5.1.2 The contractor shall provide Meeting Minutes IAW CDRL A021.            C.5.2 Post Award Kickoff Meeting. The contracting officer may request the contractor host a contract Kick-Off   Meeting within 30 calendar days after contract award via teleconference. The contracting officer shall establish the  date and time of the conference and prepare the agenda to include discussion on contract activities and schedule.            C.5.3 Bi-Weekly Teleconference. The contractor shall participate in bi-weekly teleconferences (or more frequent   meetings required by the USG if warranted based on contract activities) to discuss performance on the contract.            C.5.4 The contractor shall provide an Agenda, IAW CDRL A020; Meeting Minutes in accordance with CDRL  A021; and, Presentation Material in accordance with CDRL A022 for each of the aforementioned teleconferences or   meetings throughout the contract period of performance.            C.5.5 Daily “Check-In”. The contractor shall participate in a daily “check-in” (via teleconference or email) to   address key cost, schedule and technical updates. Daily updates may be shared with senior USG leaders during the   COVID- 19 response and should be provided on a non-confidential basis, unless the update includes confidential  information in which case, the contractor shall provide the update in both confidential and non-confidential formats.   Daily check-ins may occur on weekdays, excluding federal holidays. Upon request of the USG, check-ins may also   occur on weekends and on federal holidays, provided at least 24 hours’ notice.            C.6 Security.            C.6.1 Access and General Protection/Security Policy and Procedures. The contractor shall provide all information   required for background checks necessary to access critical information related to OWS, and to meet USG   installation access requirements to be accomplished by the installation Director of Emergency Services or Security   Office. The contractor employees shall comply with all personnel identity verification requirements as directed by   the USG and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract,  should the security status of OWS change the USG may require changes in the contractor’s security matters or  processes. In addition to the industry standards for employment background checks, the contractor shall be willing  to have key individuals, in exceptionally sensitive positions, identified for additional vetting by the United States  USG.            C.6.2 Security Program and Plan. The contractor shall implement a comprehensive security program that provides   overall protection of personnel, information, data, and facilities associated with fulfilling the USG’s requirement.  The contractor’s security practices and procedures shall be detailed in a Security Plan, in accordance with CDRL  A019, and shall demonstrate how the contractor shall meet and adhere to the security requirements outlined in  CDRL Attachment 0002. This plan shall be delivered to the USG within 45 days of award, and the USG will review  in detail and submit comments within ten (10) business days to the Contracting Officer (CO) to be forwarded to the  Contractor. The Contractor shall review the Security Plan comments, and, submit a final Security Plan to the U.S.  USG within thirty (30) calendar days after receipt of the comments. The Security Plan shall include a timeline for  compliance of all the required security measures outlined in CDRL Attachment 0002.            C.6.3 Operational Security (OPSEC). The contractor shall develop and submit an OPSEC Standard Operating   Procedure (SOP)/Plan IAW CDRL A024. The contractor shall identify in the SOP/Plan critical information related   to this contract, why it needs to be protected, where it is located, who is responsible for it, and how to protect it. 

 

                                                                                           W911QY20C0100                                                                                         Page 27 of 53            C.7 C LIN 0002 Vendor Managed Inventory (VMI). The Contractor shall provide the capability to store the   vaccine for up to 52 weeks, up to 100M doses of mRNA-1273 vaccine, in accordance with product labeling. The  contractor shall, in accordance with paragraph C.3.1.1.6, ensure the product storage of FDP doses for up to 12  months prior to delivery consistent with all FDA requirements to ensure that the product remains available for use in  target populations. [***]. The contractor shall store the product to insure product quality with audible alarms and  contacting. The contractor shall notify the USG within [***] of detection of an incident with the potential to impact  product quality, and implement corrective actions to mitigate the incident. . BARDA/JPEO- CBRND personnel may  conduct Quality Audits of the storage facility, when deemed necessary. The contractor shall notify the USG of  Corrective/Preventive actions within [***] of detection of an incident with potential to impacts product quality.  BARDA/JPEO-CBRND personnel may conduct Quality Audits of the storage facility, when deemed necessary.           C.7.1  The USG will provide the contractor advance notice of the required delivery locations for the vaccine. The contractor shall  ship mRNA-1273 vaccines to designated locations [***] in the United States. The contractor shall be responsible for shipment of  all vaccine product whether acceptance is conducted at origin or destination. [***].    C.7.2 The vaccine product shall be shipped and tracked by the distribution vendor’s shipping tracking number, to   the USG-designated sites within the continental United States.            C.7.3 [***]. Implementation of a Vendor Managed Inventory Plan/SOP (CDRL A012) shall be provided to the   USG. [***]. Notwithstanding either of the foregoing sentences, the contractor shall not be liable for loss of or   damage to supplies caused by the negligence of officers, agents, or employees of the USG acting within the scope   of their employment. 

 

                                                                                          W911QY20C0100                                                                                        Page 28 of 53           Section D - Packaging and Marking                     D.1    Vaccine markings and labeling will be in accordance with FDA and will be finalized through a contract  modification. 

 

                                                                                          W911QY20C0100                                                                                        Page 29 of 53           Section E - Inspection and Acceptance                                      INSPECTION AND ACCEPTANCE TERMS           Supplies/services will be inspected/accepted at:           CLIN        INSPECT AT                 INSPECT BY     ACCEPT AT                      ACCEPT BY  0001        N/A                        N/A            N/A                             N/A  0001AA      Origin                     Government     Origin                         Government  0001AB      Origin                     Government     Origin                         Government  0001AC      Destination                Government     Destination                    Government  0001AD      Destination                Government     Destination                    Government  0002        Destination                Government     Destination                    Government  0003        N/A                        N/A            N/A                             N/A  0003AA      Destination                Government     Destination                    Government  0003AB      Destination                Government     Destination                    Government  0003AC      Destination                Government     Destination                    Government  0003AD      Destination                Government     Destination                    Government  0004        Destination                Government     Destination                    Government  1001        N/A                        N/A            N/A                             N/A  1001AA      Destination                Government     Destination                    Government  1001AB      Destination                Government     Destination                    Government  1001AC      Destination                Government     Destination                    Government  1002        Destination                Government     Destination                    Government  2001        N/A                        N/A            N/A                             N/A  2001AA      Destination                Government     Destination                    Government  2001AB      Destination                Government     Destination                    Government  2001AC      Destination                Government     Destination                    Government  2002        Destination                Government     Destination                    Government  3001        N/A                        N/A            N/A                             N/A  3001AA      Destination                Government     Destination                    Government  3001AB      Destination                Government     Destination                    Government  3001AC      Destination                Government     Destination                    Government  3002        Destination                Government     Destination                    Government  4001        N/A                        N/A            N/A                             N/A  4001AA      Destination                Government     Destination                    Government  4001AB      Destination                Government     Destination                    Government  4001AC      Destination                Government     Destination                    Government  4002        Destination                Government     Destination                    Government                    CLAUSES INCORPORATED BY REFERENCE                    52.246-16        Responsibility For Supplies                         APR 1984                     E1. Inspection: 

 

                                                                                           W911QY20C0100                                                                                         Page 30 of 53            Initial quality inspection of Filled Drug Product (FDP) shall occur when the Contractor performs release testing to   confirm that products complies with Contractor’s release specifications and criteria. Contractor will submit in   WAWF to the Contracting Officer or the duly authorized representative of the Government with a Certificate of   Analysis for quality inspection of all deliverables. Initial Inspection under this contract will be performed at the   Contractor’s facility, or the subcontractor facility, by the BARDA Contracting Officer Technical Representative   (COTR).            Final inspection of product shall occur when the Government inspects each shipment of product delivered to it   hereunder for visible damage and quantity within [***] of such delivery. In the event Contractor supplies any   product to the Government and it is established that such Product was damaged or does not include the required   quantities at the time of delivery, the Government shall promptly notify Contractor in writing within [***]. Final   inspection shall be conducted at the CDC location identified as destination.            In the event the USG requires storage of the FDP to a Vendor Managed Inventory (VMI) location, final quantity   inspection shall be conducted by submission into WAWF of shipping or other documentation confirming quantity   to VMI location. Final physical inspection of the FDP shall be conducted upon receipt of product to USG location.            Inspection of all reports and Contract Data Requirement List (CDRL) under this contract will be performed at   Destination by duly authorized representative of the Government.                     E.2 Acceptance            a. Acceptance at origin shall occur at [***]. Acceptance at destination shall occur [***]. Regardless of where   acceptance occurs, the contractor is responsible for final delivery of Filled Drug Product (FDP) to a government  designated CDC location.            b. Acceptance under this agreement will be performed by Army Contracting Command Aberdeen Proving Ground  (ACC-APG) Natick Contracting Division (NCD) Contracting Officer.            c. Acceptance of services under VMI SubCLINs ( List CLINS) shall occur upon satisfactory physical and quantity   inspection of FDP upon delivery at USG designated CDC location.            d. The parties acknowledge that acceptance may depend on the compliance with the Contractor’s product   specifications. The KO and COR may prior to acceptance consult with FDA under its authority under Public Law   115-92 to determine whether the material to be delivered meets the Contractor’s product specifications. To this   end, Contractor agrees to provide a letter to FDA authorizing the Government to engage in dialog with FDA about   the ultimate compliance of this product with the Contractor’s product specifications prior to acceptance.   BARDA/COR will accept product according to the approved Product Acceptance Procedure. 

 

                                                                                          W911QY20C0100                                                                                        Page 31 of 53           Section F - Deliveries or Performance                                      DELIVERY INFORMATION           CLIN         DELIVERY DATE     QUANTITY         SHIP    TO ADDRESS                    DODAAC /                                                                                        CAGE                                                                                        [***]        [***]             [***]            N/A                                   N/A                                                                                        [***]        [***]             [***]            N/A                                                          Origin (Shipping Point)                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Origin (Shipping Point)                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:                                                           [***]        [***]             [***]            N/A                                   N/A                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:                                                                                        [***]        [***]             [***]            N/A                                                          Destination                                                  FOB:  [***]        [***]             [***]            [***]                                                                                                                       [***]                                                                                                                                                                                                                                                                                                            FOB: Destination   [***]        [***]             [***]            N/A                                   N/A                                                                                        [***]        [***]             [***]            N/A                                                  FOB: Destination 

 

                                                                                          W911QY20C0100                                                                                        Page 32 of 53                    [***]        [***]             [***]                                                                                       Destination     N/A FOB:                                                 [***]        [***]             [***]                                                                        Destination     N/A FOB:                                                 [***]        [***]             [***]                                                                        Destination     N/A FOB:   [***]        [***]             [***]         N/A                                        N/A                                                                                [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination   [***]        [***]             [***]         N/A                                        N/A                                                                                [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination   [***]        [***]             [***]         N/A                                        N/A                                                                                [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                                                                                 [***]        [***]             [***]         N/A FOB:        Destination                     CLAUSES INCORPORATED BY REFERENCE 

 

                                                                                          W911QY20C0100                                                                                        Page 33 of 53                    52.211-17        Delivery of Excess Quantities                       SEP 1989  52.242-15        Stop-Work Order                                     AUG 1989  52.247-34        F.O.B. Destination                                  NOV 1991                             F.1 The contractor shall ship mRNA-1273 vaccines to designated locations [***] in the United States. The contractor  shall be responsible for secure shipment of all vaccine product whether acceptance is conducted at origin or  destination. 

 

                                                                                           W911QY20C0100                                                                                         Page 34 of 53            Section G - Contract Administration Data                                       ACCOUNTING AND APPROPRIATION DATA            AA: 0212020202120400000664643255 S.0074658.5.6 6100.9000021001   COST CODE: A5XAH   AMOUNT: $955,500,000.00                           AB: 0212020202120400000664643255 S.0074658.5.6.1 6100.9000021001   COST CODE: A5XAH   AMOUNT: $269,500,000.00    ACRN   CLIN/SLIN       CIN                            AMOUNT    AA     0001AA          GFEBS001153469300001           $183,750,000.00           0001AC         GFEBS001153469300003           $367,500,000.00           0001AD         GFEBS001153469300004           $404,250,000.00   AB     0001AB          GFEBS001153469300002           $269,500,000.00            CLAUSES INCORPORATED BY REFERENCE                     252.204-7006     Billing Instructions                                OCT 2005   252.232-7003     Electronic Submission of Payment Requests and Receiving DEC 2018                    Reports                                                                 CLAUSES INCORPORATED BY FULL TEXT                     252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)                     (a) Definitions. As used in this clause—            “Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit,   activity, or organization.            “Document type” means the type of payment request or receiving report available for creation in Wide Area   WorkFlow (WAWF).            “Local processing office (LPO)” is the office responsible for payment certification when payment certification is   done external to the entitlement system.            “Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of  Payment Requests and Receiving Reports.            (b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests  and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-  7003, Electronic Submission of Payment Requests and Receiving Reports.            (c) WAWF access. To access WAWF, the Contractor shall— 

 

                                                                                           W911QY20C0100                                                                                         Page 35 of 53                     (1) Have a designated electronic business point of contact in the System for Award Management at   https://www.sam.gov; and            (2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration   available at this web site.            (d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training  Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be  accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.            (e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data   Interchange, or File Transfer Protocol.            (f) WAWF payment instructions. The Contractor shall use the following information when submitting payment   requests and receiving reports in WAWF for this contract or task or delivery order:            (1) Document type. The Contractor shall submit payment requests using the following document type(s):   COMBO    (ii) For fixed price line items—            (A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting  Officer.            Invoice and receiving report document type                     (B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the   requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the   Contracting Officer.            N/A            (iii) For customary progress payments based on costs incurred, submit a progress payment request.            (iv) For performance based payments, submit a performance based payment request.            (v) For commercial item financing, submit a commercial item financing request.            (2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the   contract.            (3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in   applicable fields in WAWF when creating payment requests and receiving reports in the system.                                                    Routing Data Table            Field Name in WAWF                      Data to be entered in WAWF   Pay Official DoDAAC                     HQ0337   Issue By DoDAAC                         W911QY   Admin DoDAAC**                          S2206A 

 

                                                                                           W911QY20C0100                                                                                         Page 36 of 53            Inspect By DoDAAC                       S2206A / BARDA   Acceptor                                W911QY   Ship To                                 TDB                     (4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type  of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition  Regulation 52.216-7, Allowable Cost and Payment, as applicable.            (5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.            (g) WAWF point of contact.            (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s  WAWF point of contact.            [***] / DCMA Boston-AFAW, Administrative Contracting Officer / [***]            (2) Contact the WAWF helpdesk at [***], if assistance is needed.                                                      (End of clause)                              FOR REFERANCE:            DFARS PGI 204.7108 Payment Instructions Table            https://www.acq.osd.mil/dpap/dars/pgi/pgi_htm/current/PGI204_71.htm#payment_instructions                                                                                    G.1 GOVERNMENT CONTRACT ADMINISTRATION            In no event shall any understanding or agreement, contract modification, change order, or other matter in deviation   from the terms of this contract between the Contractor and a person other than the Contracting Officer be effective   or binding upon the Government. All such actions must be formalized by a proper contractual document executed by  the Contracting Officer.                   Procuring Contracting Officer:          [***]          Bldg. 1, General Green Avenue          Natick, MA 017650-5011                   Contract Specialist: 

 

                                                                                           W911QY20C0100                                                                                         Page 37 of 53                    [***]           Bldg. 1, General Green Avenue          Natick, MA 017650-5011            G.2 GOVERNMENT TECHNICAL POINT OF CONTACT                   [***]           Biologist/Project Officer          200 C Street, NW          Washington, DC 20201            G.3 CONTRACTOR’S CONTRACT ADMINISTRATION                   [***]           ModernaTX, Inc.          200 Technology SQ.          Cambridge, MA 02139-3578            G.4 PLACES OF PERFORMANCE                   ModernaTX, Inc.          200 Technology SQ.          Cambridge, MA 02139-3578            G.5 NOTIFICATION OF REVISIONS AND CHANGE            Notification of revision or changes to names or email addresses will be provided by official correspondence from the  PCO/ACO or office of the PCO/ACO in lieu of a contract modification. This does not apply to any such revisions or  changes in the event this contract includes a key personnel clause.            G.6 PERFORMANCE BASED PAYMENT            Performance-based payments (PBP) are authorized under this contract in accordance with FAR 52.232-32. The  contractor shall bill for the PBP upon achievement of the completion criteria identified in Attachment 0008,  Performance-based Payment Milestone Table. Upon achievement of the completion criteria, the contractor shall bill  for the PBP for the base and each option IAW the following schedule:                CLIN       PERIOD            AMOUNT   0001AA       BASE              $        90,210,000   0001AA       BASE              $       132,308,000   0001AA       BASE              $       180,420,000   0001AA       BASE              $       198,462,000   TOTAL                          $       601,400,000      [***]        [***]                           [***]   [***]        [***]                           [***]   [***]        [***]                           [***]   [***]                                        [***]      [***]        [***]                           [***]   [***]        [***]                           [***] 

 

                                                                                           W911QY20C0100                                                                                         Page 38 of 53            [***]        [***]                           [***]   [***]                                        [***]            Delivery Invoicing: PBPs are a type of contract financing and are recouped by the Government through deductions   of payments otherwise due to the contractor for the partial or complete delivery of contract items. The deductions   are made by applying a liquidation rate to the price of delivered contract items. Attachment 0009, Performance-  based Payment Milestone Billing Plan, identifies the contractor invoicing schedule for liquidation. The contractor  shall submit all invoices IAW Attachment 0009. 

 

                                                                                           W911QY20C0100                                                                                         Page 39 of 53            Section H - Special Contract Requirements                     H.1    Key Personnel            Any key personnel specified in this contract are considered to be essential to work performance. At least thirty (30)   calendar days prior to the Contractor voluntarily diverting any of the specified individuals to other programs or   contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or   replacement and a request to replace the individual. The request must identify the proposed replacement and provide   an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the   contract (including, when applicable, Human Subjects Testing requirements). If the employee of the Contractor is   terminated for cause or separates from the Contractor voluntarily with less than thirty (30) calendar-day notice, the   Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert,   replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The   contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The   following individuals are determined to be key personnel:             Name                                    Title    [***]                                   [***]    [***]                                   [***]    [***]                                   [***]    [***]                                   [***]    [***]                                   [***]    [***]                                   [***]    [***]                                   [***]            H.2    Substitution of Key Personnel            The Contractor agrees to assign to the contract those persons whose resumes/CVs were submitted with the proposal  who are necessary to fill the requirements of the contract. No substitutions shall be made except in accordance with  this clause.            All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed   substitution, a complete resume for the proposed substitute and any other information requested by the contracting   officer to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that are   equal to or higher than the qualifications of the person to be replaced. The contracting officer or authorized   representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.            H.3    Disclosure of Information:            Performance under this contract may require the Contractor to access non-public data and information proprietary   to a Government agency, another Government Contractor or of such nature that its dissemination or use other than   as specified in the work statement would be adverse to the interests of the Government or others. Neither the   Contractor, nor Contractor personnel, shall divulge nor release data nor information developed or obtained under   performance of this contract, except authorized by Government personnel or upon written approval of the CO which   the KO will provide in accordance with OWS or other Government policies and/or guidance. The Contractor shall  not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as specified in this contract,  or any information at all regarding this agency.            The Contractor shall comply with all applicable Government requirements for protection of non-public information.  Unauthorized disclosure of nonpublic information is prohibited by the Government’s rules. Unauthorized disclosure  may result in termination of the contract, replacement of a Contractor employee, or other appropriate redress.  Neither the Contractor nor the Contractor‘s employees shall disclose or cause to be disseminated, any information  concerning the operations of the activity, which could result in, or increase the likelihood of, the possibility of a  breach of the activity‘s security or interrupt the continuity of its operations. 

 

                                                                                           W911QY20C0100                                                                                         Page 40 of 53                     No information related to data obtained under this contract shall be released or publicized without the prior written   consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no   such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any  government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s)  securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining  regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions,  or other business transactions. The exceptions identified in this paragraph apply to all disclosures under this Section   H.3 except to the extent that a disclosure is otherwise prohibited by law.            H.4    Publication and Publicity            The contractor shall not release any reports, manuscripts, press releases, or abstracts about the work being performed   under this contract without written notice in advance to the Government.            (a) Unless otherwise specified in this contract, the contractor may publish the results of its work under this contract.   The contractor shall promptly send a copy of each submission to the COR for security review prior to submission.   The contractor shall also inform the COR when the abstract article or other publication is published, and furnish a   copy of it as finally published.            (b) Unless authorized in writing by the CO, the contractor shall not display the DoD logo including Operating   Division or Staff Division logos on any publications.            (c) The contractor shall not reference the products(s) or services(s) awarded under this contract in commercial   advertising, as defined in FAR 31.205-1, in any manner which states or implies DoD approval or endorsement of the   product(s) or service(s) provided.            (d) The contractor shall include this clause, including this section (d) in all subcontracts where the subcontractor  may propose publishing the results of its work under the subcontract. The contractor shall acknowledge the support  of the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response,   Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in   any media by including an acknowledgement substantially as follows:            "This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for   Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract Number   W911QY-20-C-0100.”            H.5    Confidentiality of Information            a.  Confidential information, as used in this article, means non-public information or data of a personal nature  about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.            b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific   information and/or categories of information which the Government will furnish to the Contractor or that the   Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may,   by mutual consent, identify such confidential information from time to time during the performance of the contract.   Failure to agree will be settled pursuant to the "Disputes" clause.            c.  If it is established elsewhere in this contract that information to be utilized under this contract, or a portion  thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in  the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of  records determined to be subject to the Privacy Act.            d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior   written consent of the individual, institution, or organization. 

 

                                                                                           W911QY20C0100                                                                                         Page 41 of 53                     e.  Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the  material in question is subject to the Privacy Act or is confidential information subject to the provisions of this  article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release,  disclosure, dissemination, or publication.            f. Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and   legal officials.            g.  The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other  Federal, State or local laws.           ALL REQUIREMENTS OF THIS SECTION H.5 MUST BE PASSED TO ALL SUB-CONTRACTOR.            H.6    Regulatory Rights            This contract involves supply of a product that requires FDA pre-market approval or clearance before commercial   authorization. Contractor is seeking FDA authorization or clearance for the commercialization of mRNA-1273,  Moderna vaccine for SARS-CoV-2 Coronavirus (the “Technology”). The Contractor is the Sponsor of the  Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE),  emergency use authorization (EUA), new drug application (NDA), biologics license application (BLA), premarket  approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted  to FDA) for the technology. As the Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and  “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the  Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory  Application.           Accordingly, the Contractor and the Government agree to the following:            a. DoD Medical Product Priority. PL 115-92 allows the DoD to request, and FDA to provide, assistance to expedite  development of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing  American military personnel. The contractor recognizes that only the DoD can utilize PL 115-92. As such, the  contractor will work proactively with the Government to leverage this law to its maximum potential under this  contract. The contractor shall submit Public Law 115-92 Sponsor Authorization Letter that will be delivered to the  designated OWS POC(s) within 30 days of award.           [***]            H.7 Performance Based Payment Liquidated under Termination 

 

                                                                                           W911QY20C0100                                                                                         Page 42 of 53                     Performance Based Payments (PBPs) have been authorized as a method of financing under this contract. In the   event the Moderna’s mRNA-1273 COVID Vaccine is unsuccessful in its bid to obtain EUA or FDA approval, the  Government may issue a Termination for Convenience (T4C) in whole or in part, on this contract. Upon notice of a   T4C, the contractor shall submit a termination settlement proposal, IAW FAR 52.249-2, Termination for  Convenience of the Government (Fixed-Price).            H.8    Public Readiness and Emergency Preparedness (PREP) Act:            In accordance with the Public Readiness and Emergency Preparedness Act (“PREP Act”), Pub. L. No. 109-148,   Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as well as the  Secretary of HHS’s Declaration Under the Public Readiness and Emergency Preparedness Act for Medical  Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), and amended on  April 15, 2020, 85 Fed. Reg. 21012 (together, the “Prep Act Declaration”):            (i)    This Agreement is being entered into for purposes of facilitating the manufacture, testing, development,   distribution, administration, and use of “Covered Countermeasures” for responding to the COVID-19 public health   emergency, in accordance with Section VI of the PREP Act Declaration;            (ii)   Contractor’s performance of this Agreement falls within the scope of the “Recommended Activities” for   responding to the COVID-19 public health emergency, to the extent it is in accordance with Section III of the PREP   Act Declaration; and            (iii)  Contractor is a “Covered Person” to the extent it is a person defined in Section V of the PREP Act   Declaration.   Therefore, in accordance with Sections IV and VII of the PREP Act Declaration as well as the PREP Act (42 U.S.C.  § 247d-6d), the Department of Defense contracting via assisted acquisition on behalf of the HHS, expressly  acknowledges and agrees that the HHS Declaration cited above, specifically its language providing immunity from  suit and liability is applicable to this acquisition as long as Contractors activities fall within the terms and conditions  of the PREP Act and the PREP Act Declaration.            The Government may not use, or authorize the use of, any products or materials provided under this contract, unless   such use occurs in the United States (or a U.S. territory where U.S. law applies such as embassies, military and   NATO installations) and is protected from liability under a declaration issued under the PREP Act, or a successor   COVID-19 PREP Act Declaration of equal or greater scope. Any use where the application of the PREP Act is in   question will be discussed with Moderna prior to use and, if the parties disagree on such use, the dispute will be   resolved according to the “Disputes Clause” (52.233-1)            The items and technology covered by this Contract are being developed for both civil and military applications.           [***]

 

                                                                                           W911QY20C0100                                                                                         Page 43 of 53                     H.10   Ensuring Sufficient Supply of the Product            1.     In recognition of the Government’s significant funding for the development and manufacturing of the  product in this contract and the Government’s need to provide sufficient quantities of a COVID-19 vaccine to  protect the United States population, the Government shall have the remedy described in this section to ensure  sufficient supply of the product to meet the needs of the public health or national security. This remedy is not  available to the Government unless and until both of the following conditions ((a) and (b)) are met:            a. Moderna gives written notice, required to be submitted to the Government no later than [***], of:            i. any formal management decision to terminate manufacturing of this product vaccine prior to delivery of any   doses to USG under this contract, including all exercised options, other than as a result of clinical failure, or serious   technical or safety reasons or;            ii. any formal management decision to discontinue sale of this product vaccine to the Government prior to delivery  of any doses to USG under this contract, including all exercised options, other than as a result of clinical failure, or  serious technical or safety reasons; or            iii. any filing that anticipates Federal bankruptcy protection; and            b. Moderna has submitted an Emergency Use Authorization application under §564 of the FD&C Act or a biologics   license application provisions of §351(a) of the Public Health Service Act (PHSA).            2. If both conditions listed in section 1 occur, Moderna, upon the request of the Government, shall provide the   following items necessary for the Government to pursue manufacturing of this product vaccine with a third party for   exclusive sale to the U.S. Government:            a. a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royalty-free paid-up license   to practice or have practiced for or on behalf of the U.S. Government any Moderna Background Patent, Copyright,   other Moderna Intellectual Property, Moderna Know-How, Moderna Technical Data rights necessary to   manufacture doses of the mRNA-1273 vaccine;            b. necessary FDA regulatory filings or authorizations owned or controlled by Moderna related to this product   vaccine and any confirmatory instrument pertaining thereto; and            c. any outstanding Deliverables contemplated or materials purchased under this contract.            3. This remedy will remain available until the end of the contract.           [***]                               

 

                                                                                          W911QY20C0100                                                                                        Page 44 of 53             H.12   Transportation to Final Destination           During the course of performance under this contract, the Government may require storage of the filled drug product  (FDP) before delivery to the final government location. In these circumstances, the Government will accept FDP at  the contractor facility (Origin). The contractor; however, shall continue to be responsible for secure delivery of the  vaccine to its final destination as identified on this contract. [***].           H.13   Validation of IP/Data           The Parties acknowledge that background intellectual property and technical data assertions have been made and  evaluated by the parties. The parties agree that, should additional information relevant to these assertions become  available, the parties will reevaluate said assertions as necessary in the future.           H.14   Novation           Upon Moderna, US, Inc.'s registration in the System for Award Management, the Government will, at the  Contractor's request, complete a novation of this Contract to recognize Moderna US, Inc. as a counterparty instead  of Moderna TX, Inc. This novation will be completed through a modification executed by the Government that  identifies Moderna US, Inc. as the contracting party for all purposes as if it had originally executed the Contract. 

 

                                                                                          W911QY20C0100                                                                                        Page 45 of 53           Section I - Contract Clauses           CLAUSES INCORPORATED BY REFERENCE                    52.202-1         Definitions                                         JUN 2020  52.203-3         Gratuities                                          APR 1984  52.203-5         Covenant Against Contingent Fees                    MAY 2014  52.203-6         Restrictions On Subcontractor Sales To The Government JUN 2020  52.203-7         Anti-Kickback Procedures                            JUN 2020  52.203-8         Cancellation, Rescission, and Recovery of Funds for Illegal or MAY 2014                   Improper Activity                                     52.203-10        Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014  52.203-12        Limitation On Payments To Influence Certain Federal JUN 2020                   Transactions                                          52.203-13        Contractor Code of Business Ethics and Conduct      JUN 2020  52.203-17        Contractor Employee Whistleblower Rights and Requirement JUN 2020                   To Inform Employees of Whistleblower Rights           52.204-1         Approval of Contract                                DEC 1989  52.204-4         Printed or Copied Double-Sided on Postconsumer Fiber MAY 2011                   Content Paper                                         52.204-10        Reporting Executive Compensation and First-Tier     JUN 2020                   Subcontract Awards                                    52.204-13        System for Award Management Maintenance             OCT 2018  52.204-18        Commercial and Government Entity Code Maintenance   JUL 2016  52.204-19        Incorporation by Reference of Representations and   DEC 2014                   Certifications.                                       52.204-23        Prohibition on Contracting for Hardware, Software, and JUL 2018                   Services Developed or Provided by Kaspersky Lab and Other                    Covered Entities.                                     52.204-25        Prohibition on Contracting for Certain Telecommunications AUG 2019                   and Video Surveillance Services or Equipment.         52.209-6         Protecting the Government's Interest When Subcontracting JUN 2020                   With Contractors Debarred, Suspended, or Proposed for                    Debarment                                             52.209-10        Prohibition on Contracting With Inverted Domestic   NOV 2015                   Corporations                                          52.210-1         Market Research                                     JUN 2020  52.215-2         Audit and Records--Negotiation                      JUN 2020  52.215-8         Order of Precedence--Uniform Contract Format        OCT 1997  52.215-11        Price Reduction for Defective Certified Cost or Pricing Data-- JUN 2020                   Modifications                                         52.215-13        Subcontractor Certified Cost or Pricing Data--Modifications JUN 2020  52.215-14        Integrity of Unit Prices                            JUN 2020  52.215-15        Pension Adjustments and Asset Reversions            OCT 2010  52.215-18        Reversion or Adjustment of Plans for Postretirement Benefits JUL 2005                   (PRB) Other than Pensions                             52.215-19        Notification of Ownership Changes                   OCT 1997  52.215-21        Requirements for Certified Cost or Pricing Data and Data JUN 2020                   Other Than Certified Cost or Pricing Data -- Modifications   52.217-4         Evaluation Of Options Exercised At The Time Of Contract JUN 1988                   Award                                                 52.217-7         Option For Increased Quantity-Separately Priced Line Item MAR 1989  52.217-8         Option To Extend Services                           NOV 1999  52.219-8         Utilization of Small Business Concerns              OCT 2018 

 

                                                                                          W911QY20C0100                                                                                        Page 46 of 53           52.219-28        Post-Award Small Business Program Rerepresentation  MAY 2020  52.222-1         Notice To The Government Of Labor Disputes          FEB 1997  52.222-3         Convict Labor                                       JUN 2003  52.222-19        Child Labor -- Cooperation with Authorities and Remedies JAN 2020  52.222-21        Prohibition Of Segregated Facilities                APR 2015  52.222-26        Equal Opportunity                                   SEP 2016  52.222-35        Equal Opportunity for Veterans                      JUN 2020  52.222-36        Equal Opportunity for Workers with Disabilities     JUN 2020  52.222-37        Employment Reports on Veterans                      JUN 2020  52.222-40        Notification of Employee Rights Under the National Labor DEC 2010                   Relations Act                                         52.222-50        Combating Trafficking in Persons                    JAN 2019  52.222-54        Employment Eligibility Verification                 OCT 2015  52.223-6         Drug-Free Workplace                                 MAY 2001  52.223-18        Encouraging Contractor Policies To Ban Text Messaging JUN 2020                   While Driving                                         52.225-13        Restrictions on Certain Foreign Purchases           JUN 2008  52.227-1         Authorization and Consent                           JUN 2020  52.227-1 Alt I   Authorization And Consent (JUN 2020) - Alternate I  APR 1984  52.227-2         Notice And Assistance Regarding Patent And Copyright JUN 2020                   Infringement                                          52.227-11        Patent Rights--Ownership By The Contractor          MAY 2014  52.232-9         Limitation On Withholding Of Payments               APR 1984  52.232-17        Interest                                            MAY 2014  52.232-23        Assignment Of Claims                                MAY 2014  52.232-25        Prompt Payment                                      JAN 2017  52.232-33        Payment by Electronic Funds Transfer--System for Award OCT 2018                   Management                                            52.232-39        Unenforceability of Unauthorized Obligations        JUN 2013  52.232-40        Providing Accelerated Payments to Small Business    DEC 2013                   Subcontractors                                        52.233-1         Disputes                                            MAY 2014  52.233-3         Protest After Award                                 AUG 1996  52.233-4         Applicable Law for Breach of Contract Claim         OCT 2004  52.242-13        Bankruptcy                                          JUL 1995  52.243-1         Changes--Fixed Price                                AUG 1987  52.243-7         Notification Of Changes                             JAN 2017  52.244-5         Competition In Subcontracting                       DEC 1996  52.245-9         Use And Charges                                     APR 2012  52.249-2         Termination For Convenience Of The Government (Fixed- APR 2012                   Price)                                                52.249-8         Default (Fixed-Price Supply & Service)              APR 1984  52.249-14        Excusable Delays                                    APR 1984  252.203-7000     Requirements Relating to Compensation of Former DoD SEP 2011                   Officials                                             252.203-7002     Requirement to Inform Employees of Whistleblower Rights SEP 2013  252.203-7003     Agency Office of the Inspector General              AUG 2019  252.211-7003     Item Unique Identification and Valuation            MAR 2016  252.222-7006     Restrictions on the Use of Mandatory Arbitration Agreements DEC 2010  252.225-7048     Export-Controlled Items                             JUN 2013  252.227-7013     Rights in Technical Data--Noncommercial Items       FEB 2014  252.227-7014     Rights in Noncommercial Computer Software and       FEB 2014                   Noncommercial Computer Software Documentation         252.227-7016     Rights in Bid or Proposal Information               JAN 2011 

 

                                                                                           W911QY20C0100                                                                                         Page 47 of 53            252.227-7017     Identification and Assertion of Use, Release, or Disclosure JAN 2011                    Restrictions                                          252.227-7019     Validation of Asserted Restrictions--Computer Software SEP 2016   252.227-7028     Technical Data or Computer Software Previously Delivered JUN 1995                    to the Government                                     252.227-7030     Technical Data--Withholding Of Payment              MAR 2000   252.227-7037     Validation of Restrictive Markings on Technical Data SEP 2016   252.232-7007     Limitation Of Government's Obligation               APR 2014   252.244-7000     Subcontracts for Commercial Items                   JUN 2013                     CLAUSES INCORPORATED BY FULL TEXT                     52.217-9  OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)            (a) The Government may extend the term of this contract by written notice to the Contractor within 5 days for;   provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30   days for Options 1 and 2, 60 days for Option 3 and 4 before the contract expires. The preliminary notice does not   commit the Government to an extension.            (b) If the Government exercises this option, the extended contract shall be considered to include this option clause.            (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 20  months.           (End of clause)                      52.232-32  PERFORMANCE-BASED PAYMENTS (APR 2012)            (a) Amount of payments and limitations on payments. Subject to such other limitations and conditions as are   specified in this contract and this clause, the amount of payments and limitations on payments shall be specified in   the contract's description of the basis for payment.            (b) Contractor request for performance-based payment. The Contractor may submit requests for payment of  performance-based payments not more frequently than monthly, in a form and manner acceptable to the Contracting   Officer. Unless otherwise authorized by the Contracting Officer, all performance-based payments in any period for   which payment is being requested shall be included in a single request, appropriately itemized and totaled. The   Contractor's request shall contain the information and certification detailed in paragraphs (l) and (m) of this clause.            (c) Approval and payment of requests.            (1) The Contractor shall not be entitled to payment of a request for performance-based payment prior to successful  accomplishment of the event or performance criterion for which payment is requested. The Contracting Officer shall   determine whether the event or performance criterion for which payment is requested has been successfully   accomplished in accordance with the terms of the contract. The Contracting Officer may, at any time, require the   Contractor to substantiate the successful performance of any event or performance criterion which has been or is   represented as being payable.            (2) A payment under this performance-based payment clause is a contract financing payment under the Prompt  Payment clause of this contract and not subject to the interest penalty provisions of the Prompt Payment Act. The  designated payment office will pay approved requests on the 30th day after receipt of the request for performance-  based payment by the designated payment office. However, the designated payment office is not required to provide 

 

                                                                                           W911QY20C0100                                                                                         Page 48 of 53            payment if the Contracting Officer requires substantiation as provided in paragraph (c)(1) of this clause, or inquiries   into the status of an event or performance criterion, or into any of the conditions listed in paragraph (e) of this   clause, or into the Contractor certification. The payment period will not begin until the Contracting Officer approves   the request.            (3) The approval by the Contracting Officer of a request for performance-based payment does not constitute an  acceptance by the Government and does not excuse the Contractor from performance of obligations under this  contract.            (d) Liquidation of performance-based payments.            (1) Performance-based finance amounts paid prior to payment for delivery of an item shall be liquidated by  deducting a percentage or a designated dollar amount from the delivery payment. If the performance-based finance  payments are on a delivery item basis, the liquidation amount for each such line item shall be the percent of that  delivery item price that was previously paid under performance-based finance payments or the designated dollar  amount. If the performance-based finance payments are on a whole contract basis, liquidation shall be by either  predesignated liquidation amounts or a liquidation percentage.            (2) If at any time the amount of payments under this contract exceeds any limitation in this contract, the Contractor  shall repay to the Government the excess. Unless otherwise determined by the Contracting Officer, such excess shall   be credited as a reduction in the unliquidated performance-based payment balance(s), after adjustment of invoice   payments and balances for any retroactive price adjustments.            (e) Reduction or suspension of performance-based payments. The Contracting Officer may reduce or suspend  performance-based payments, liquidate performance-based payments by deduction from any payment under the  contract, or take a combination of these actions after finding upon substantial evidence any of the following  conditions:            (1) The Contractor failed to comply with any material requirement of this contract (which includes paragraphs (h)  and (i) of this clause).            (2) Performance of this contract is endangered by the Contractor's --            (i) Failure to make progress; or            (ii) Unsatisfactory financial condition.            (3) The Contractor is delinquent in payment of any subcontractor or supplier under this contract in the ordinary  course of business.            (f) Title.            (1) Title to the property described in this paragraph (f) shall vest in the Government. Vestiture shall be immediately  upon the date of the first performance-based payment under this contract, for property acquired or produced before  that date. Otherwise, vestiture shall occur when the property is or should have been allocable or properly chargeable  to this contract            (2) "Property," as used in this clause, includes all of the following described items acquired or produced by the  Contractor that are or should be allocable or properly chargeable to this contract under sound and generally accepted   accounting principles and practices:            (i) Parts, materials, inventories, and work in process;            (ii) Special tooling and special test equipment to which the Government is to acquire title; 

 

                                                                                           W911QY20C0100                                                                                         Page 49 of 53            (iii) Nondurable (i.e., noncapital) tools, jigs, dies, fixtures, molds, patterns, taps, gauges, test equipment and other   similar manufacturing aids, title to which would not be obtained as special tooling under subparagraph (f)(2)(ii) of  this clause; and            (iv) Drawings and technical data, to the extent the Contractor or subcontractors are required to deliver them to the  Government by other clauses of this contract.            (3) Although title to property is in the Government under this clause, other applicable clauses of this contract (e.g.,   the termination or clauses) shall determine the handling and disposition of the property.            (4) The Contractor may sell any scrap resulting from production under this contract, without requesting the  Contracting Officer's approval, provided that any significant reduction in the value of the property to which the   Government has title under this clause is reported in writing to the Contracting Officer.            (5) In order to acquire for its own use or dispose of property to which title is vested in the Government under this  clause, the Contractor shall obtain the Contracting Officer's advance approval of the action and the terms. If  approved, the basis for payment (the events or performance criteria) to which the property is related shall be deemed   to be not in compliance with the terms of the contract and not payable (if the property is part of or needed for   performance), and the Contractor shall refund the related performance-based payments in accordance with   paragraph (d) of this clause.            (6) When the Contractor completes all of the obligations under this contract, including liquidation of all  performance-based payments, title shall vest in the Contractor for all property (or the proceeds thereof) not --            (i) Delivered to, and accepted by, the Government under this contract; or            (ii) Incorporated in supplies delivered to, and accepted by, the Government under this contract and to which title is  vested in the Government under this clause.            (7) The terms of this contract concerning liability for Government-furnished property shall not apply to property to   which the Government acquired title solely under this clause.            (g) Risk of loss. Before delivery to and acceptance by the Government, the Contractor shall bear the risk of loss for  property, the title to which vests in the Government under this clause, except to the extent the Government expressly  assumes the risk. If any property is lost (see 45.101), the basis of payment (the events or performance criteria) to  which the property is related shall be deemed to be not in compliance with the terms of the contract and not payable  (if the property is part of or needed for performance), and the Contractor shall refund the related  performance-based payments in accordance with paragraph (d) of this clause.            (h) Records and controls. The Contractor shall maintain records and controls adequate for administration of this  clause. The Contractor shall have no entitlement to performance-based payments during any time the Contractor's   records or controls are determined by the Contracting Officer to be inadequate for administration of this clause.            (i) Reports and Government access. The Contractor shall promptly furnish reports, certificates, financial statements,  and other pertinent information requested by the Contracting Officer for the administration of this clause and to  determine that an event or other criterion prompting a financing payment has been successfully accomplished. The  Contractor shall give the Government reasonable opportunity to examine and verify the Contractor's records and to  examine and verify the Contractor's performance of this contract for administration of this clause.            (j) Special terms regarding default. If this contract is terminated under the Default clause,            (1) the Contractor shall, on demand, repay to the Government the amount of unliquidated performance-based   payments, and            (2) title shall vest in the Contractor, on full liquidation of all performance-based payments, for all property for which 

 

                                                                                           W911QY20C0100                                                                                         Page 50 of 53            the Government elects not to require delivery under the Default clause of this contract. The Government shall be   liable for no payment except as provided by the Default clause.            (k) Reservation of rights.            (1) No payment or vesting of title under this clause shall --            (i) Excuse the Contractor from performance of obligations under this contract; or            (ii) Constitute a waiver of any of the rights or remedies of the parties under the contract.            (2) The Government's rights and remedies under this clause --            (i) Shall not be exclusive, but rather shall be in addition to any other rights and remedies provided by law or this  contract; and            (ii) Shall not be affected by delayed, partial, or omitted exercise of any right, remedy, power, or privilege, nor shall  such exercise or any single exercise preclude or impair any further exercise under this clause or the exercise of any  other right, power, or privilege of the Government.            (l) Content of Contractor's request for performance-based payment. The Contractor's request for performance-based  payment shall contain the following:            (1) The name and address of the Contractor;            (2) The date of the request for performance-based payment;            (3) The contract number and/or other identifier of the contract or order under which the request is made;            (4) Such information and documentation as is required by the contract's description of the basis for payment; and            (5) A certification by a Contractor official authorized to bind the Contractor, as specified in paragraph (m) of this  clause.            (m) Content of Contractor's certification. As required in paragraph (l)(5) of this clause, the Contractor shall make the  following certification in each request for performance-based payment:           I certify to the best of my knowledge and belief that --            (1) This request for performance-based payment is true and correct; this request (and attachments) has been prepared  from the books and records of the Contractor, in accordance with the contract and the instructions of the Contracting  Officer;            (2) (Except as reported in writing on    ), all payments to subcontractors and suppliers under this contract   have been paid, or will be paid, currently, when due in the ordinary course of business;            (3) There are no encumbrances (except as reported in writing on  ) against the property acquired or   produced for, and allocated or properly chargeable to, the contract which would affect or impair the Government's   title;            (4) There has been no materially adverse change in the financial condition of the Contractor since the submission by  the Contractor to the Government of the most recent written information dated   ; and            (5) After the making of this requested performance-based payment, the amount of all payments for each deliverable  item for which performance-based payments have been requested will not exceed any limitation in the contract, and 

 

                                                                                           W911QY20C0100                                                                                         Page 51 of 53            the amount of all payments under the contract will not exceed any limitation in the contract.    (End of Clause)                       52.252-2  CLAUSES INCORPORATED BY REFERENCE (FEB 1998)           This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in  full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may  be accessed electronically at this/these address(es):            https://www.acquisition.gov/content/regulations            (End of clause)                      52.252-6  AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)            (a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an  authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.            (b) The use in this solicitation or contract of any Defense Federal Acquisition Regulation Supplement (48 CFR  Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the   regulation.            (End of clause) 

 

                                                                                          W911QY20C0100                                                                                        Page 52 of 53           Section J - List of Documents, Exhibits and Other Attachments                               Document Type                        Description                     Page #         Date   Exhibit A          CDRLs                                                14       18 July 2020   Attachment 0001    Supply Chain Resiliency Plan for CDRL A010           2        23 July 2020   Attachment 0002    Security Plan                                        6        23 July 2020   Attachment 0003    Dose Tracking Template Draft Moderna               Excel      15 July 2020   Attachment 0004    Data Rights                                          1        7 August 2020   Attachment 0005    [***]                                                1        7 August 2020   Attachment 0006    ModernaTx, Inc. Background Intellectual Property     2        6 August 2020   Attachment 0007    Performance Base Payment Milestone Schedule          1        7 August 2020   Attachment 0008    Performance Base Payment Milestone Billing Plan      15       7 August 2020                                                                                  Exhibit A                               Contract Data Requirements List (CDRL)   Data Item #   Title of Data Item                Subtitle                               Date   A001          Quality Audit Finding and Response BARDA Audit Findings Report           18-Jul-20                 Record (QAFRR)   A002          Quality Audit Finding and Response FDA Audit Findings Report             18-Jul-20                 Record (QAFRR)   A003          Contractor Furnished Material (CFM) Monthly Inventory Report             18-Jul-20                 Report   A004          Quality Program Plan              Quality Program Plan                   18-Jul-20   A005          Task Directive Documentation      Shipping Documentation - Finished      18-Jul-20                                                   Drag Products (FDP)   A006          Task Directive Documentation      Expiring Item Report                   18-Jul-20   A007          Contractor's Personnel Roster     Key Personnel Listing                  18-Jul-20   A008          Status Report                     Monthly Technical Progress Report      18-Jul-20   A009          Contract Summary Report           Final Technical Report                 18-Jul-20   A010          Supply Chain Risk Management Plan Supply Chain Resiliency Plan (SCRP)    18-Jul-20   A011          Contractor's Risk Management Plan Risk Management Plan (RMP)             18-Jul-20   A012          Research and Development of       Vendor Managed Inventory Plan/SOP     18 Jul 20                 Medical Products Regulated by the                 U.S. Food and Drug Administration   A013          Internal Contractor Technical Data Manufacturing Reports and Dose        18-Jul-20                                                   Tracking Projections/Actuals   A014          Certificate of Compliance (Analysis) Product Acceptance Report           18-Jul-20   A015          N/A                                                -                       -   A016          Accident Incident Report          Incident Report                        18-Jul-20   A017          Internal Contractor Technical Data FDA Correspondence                    18-Jul-20                 Report   A018          Acquisition Support Documentation Press Releases                         18-Jul-20   A019          Contractor's Standard Operating   Security Plan                          18-Jul-20                 Procedures   A020          Conference Agenda                 Conference Agenda                      18-Jul-20 

 

                                                                                         W911QY20C0100                                                                                       Page 53 of 53           A021          Report, Record of Meeting/Minutes Meeting Minutes                        18-Jul-20  A022          Presentation Material             Presentation Material                  18-Jul-20  A023          N/A                                                -                       -  A024          Operations Security (OPSEC) Plan  Operational Security (OPSEC)           18 Jul 20                                                  SOP/Plan  A025          Research and Development of       Manufacturing Development Plan         18 Jul 20                Medical Products Regulated by the                U.S. Food & Drug Administration                (FDA)          

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH  IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD  LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                                Section J                  Title                     Description               Page       Date          Exhibit A        Contract Data Requirement List (CDRL)     15     18 July 2020          Attachment 0001  Supply Chain Resiliency Plan for CDRL A010 2     23 July 2020          Attachment 0002  Security Plan                              6     23 July 2020          Attachment 0003  Dose Tracking Template Draft Moderna     Excel   15 July 2020          Attachment 0004  Data Rights                                2     7 August 2020          Attachment 0005  [***]                                      1     7 August 2020          Attachment 0006  ModernaTx, Inc. Background Intellectual    2     6 August 2020                           Property          Attachment 0007  Performance Based Payment                  1     7 August 2020                           Milestone Schedule          Attachment 0008  Performance Based Payment Milestone       15     7 August 2020                           Billing Plan                                                                                                                                         W911QY-20-C-0100                                                                                 Section J 

 

                                                                           Contract Data Requirements List (CDRLs)               Exhibit A                          As of 18 July 2020 

 

                 CONTRACT DATA REQUIREMENTS LIST                               Form Approved                                                                                                                                                   (2 Data Items)                                   OMB No. 0704-0188  The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,  gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this  collection of information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that   notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control  number. Please do not return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                                                                                                      0002                             A             TDP_____ TM ____ Other General/Admin Data                                        E. CONTRACT/PR NO.               F. CONTRACTOR  D. SYSTEM/ITEM                                                                                                     LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE W911QY-20-C-0100          Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                                                                                                   17. Price Group  A001                   Quality Audit Finding and Response Record (QAFRR) BARDA Audit Findings Report  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE  DI-SESS-81923                                C.3.1.2.1, C.3.2.2.1, C.3.3.2.1 ASPR BARDA                                                       12. DATE OF FIRST                                           18. Estimated  7. DD 250 REQ                    10. FREQUENCY                                                       SUBMISSION             14. DISTRIBUTION                        Total Price  N/A                              ASREQ                  9. DIST                              Refer to Block 16                  STATEMENT                                                       13. DATE OF                           b. COPIES                  REQUIRED  8. APP CODE                      11. AS OF DATE      SUBSEQUENT                  C                                                           a. ADDRESSEE           Final           A                                0                   SUBMISSION                            Draft                                                       Refer to Block 16                             Reg   Repro     16. REMARKS                                                                 ASPR BARDA*    1       1     0         4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. The CCAP-SCN** LT 1 0         contractor shall detail the findings and corrective action(s).                                                     8. The US Government (USG) will respond with comments or approval within 10 calendar                               days after receipt.                                                                                                9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                        Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                 Distribution guidance is included in DoD Instruction 5230.24.                                                      12. Submit within 10 business days of an Audit.                                                                    13. The contractor shall incorporate USG comments and provide a final report to the USG                            upon completion of corrective action.                                                                              14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                  the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                          Soto ([***]).                                                                                                      LT:  Letter of Transmittal (via email).                                     15. TOTAL →                                                   2. TITLE OF DATA ITEM  1. DATA ITEM NO.                                                       3. SUBTITLE                         Research and Development of Medical Products                                              17. Price Group          A002                                                           FDA Interactions and Inspections Documents                         Regulated by the U.S. Food & Drug Administration  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE  DI-TCSP-82040 (Tailored)                     C.3.1.2.2, C.3.2.2.2, C.3.3.2.2 ASPR BARDA                                                       12. DATE OF FIRST                                           18. Estimated  7. DD 250 REQ                    10. FREQUENCY                                                       SUBMISSION             14. DISTRIBUTION                     Total Price        N/A                              ASREQ                  9. DIST                              Refer to Block 16                  STATEMENT                                                       13. DATE OF                           b. COPIES                  REQUIRED  8. APP CODE                      11. AS OF DATE      SUBSEQUENT                         C                                                    a. ADDRESSEE           Final                  A                                  0          SUBMISSION                            Draft                                                       Refer to Block 16                             Reg   Repro     16. REMARKS                                                                 ASPR BARDA*    1       1     0         4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. The CCAP-SCN** 1 1  0         contractor shall detail the findings and corrective action(s).                                                     8. The US Government (USG) will respond with comments or approval within 10 calendar                               days after receipt.                                                                                                9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                        Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                 Distribution guidance is included in DoD Instruction 5230.24.                                                      12. Submit within 10 business days of an Audit.                                                                    13. The contractor shall incorporate USG comments and provide a final report to the USG                            upon completion of corrective action.                                                                              14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                  the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                          Soto ([***]).                                                                                                      LT:  Letter of Transmittal (via email).                                                                              15. TOTAL →    2       2     0         G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                                                                                                                     Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020                        

 

                                                                                                                                     CONTRACT DATA REQUIREMENTS LIST                              Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,  gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this   collection of information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that  notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB  control number. Please do not return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.                B. EXHIBIT             C. CATEGORY:                                                        0002                              A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                         E. CONTRACT/PR NO.              F. CONTRACTOR                               LARGE SCALE PRODUCTION OF SARS-CoV-2   W911QY-20-C-0100                Moderna TX, Inc.  VACCINE  1. DATA ITEM NO.      2. TITLE OF DATA ITEM                            3. SUBTITLE                               17. Price Group          A003          Contractor Furnished Material (CFM) Report       Monthly Inventory Report  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                  18. Estimated  DI-MGMT-82049                                C.4.1                          ASPR BARDA                              Total Price  7. DD 250 REQ  9. DIST STATEMENT  10. FREQUENCY       12. DATE OF FIRST     14. DISTRIBUTION       NO        REQUIRED                 MTHLY         SUBMISSION                        C                               Refer to Block 16  8. APP CODE                       11. AS OF DATE      13. DATE OF                                b. COPIES       NA                                   N           SUBSEQUENT                                                                                a. ADDRESSEE             Final                                                             SUBMISSION                            Draft                                                               Refer to Block 16                      Reg   Repro    16. REMARKS                                                                 ASPR BARDA*       1      1     0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. The CCAP-SCN** 0 LT   0       contractor shall detail the findings and corrective action(s).                                                     8. The US Government (USG) will respond with comments or approval within 10 calendar days                          after receipt.                                                                                                     9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                        Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                 Distribution guidance is included in DoD Instruction 5230.24.                                                      12. Submit within 10 business days of an Audit.                                                                    13. The contractor shall incorporate USG comments and provide a final report to the USG                                                                                                                     upon completion of corrective action.                                                                                                                     14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                     the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny  Soto ([***]).                                                                                                      LT:  Letter of Transmittal (via email).                                                                                                                                                        15. TOTAL →       1      1     0       1. DATA ITEM NO.      2. TITLE OF DATA ITEM                            3. SUBTITLE                               17. Price Group          A004          Research and Development of Medical Products     Quality Management Plan                        Regulated by the U.S. Food & Drug Administration  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                  18. Estimated  DI-TCSP-82040 (Tailored)                     C.4.18                         ASPR BARDA                           Total Price  7. DD 250 REQ  9. DIST STATEMENT  10. FREQUENCY       12. DATE OF FIRST     14. DISTRIBUTION       N/A       REQUIRED           ASREQ               SUBMISSION                        C                               Refer to Block 16  8. APP CODE                       11. AS OF DATE      13. DATE OF                                b. COPIES        A                                   0           SUBSEQUENT                                       Final                                                                                    a. ADDRESSEE                                                        SUBMISSION                            Draft   Re                                                                                                                      Repro                                                               Refer to Block 16                       g  16. REMARKS                                                                 ASPR BARDA*       1      1     0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. Page 10, CCAP-SCN** LT LT 0   paragraph f.(2) applies.                                                                                           8. The US Government (USG) will respond with comments or approval within 10 calendar days                          after receipt.                                                                                                     9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                        Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                 Distribution guidance is included in DoD Instruction 5230.24.                                                      12. Submit within 30 calendar days after contract award.                                                           13. The contractor shall incorporate USG comments and resubmit within 10 calendar days                                                                                                                     after receipt.                                                                                                                     14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                     the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny  Soto ([***]).                                                                                                      LT:  Letter of Transmittal (via email).                                                                                                                                                        15. TOTAL →       1      1     0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                 Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020            

 

                                                                                                                                     CONTRACT DATA REQUIREMENTS LIST                              Form Approved                                (1 Data Item)                                    OMB No. 0704-0188  The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources,  gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this   collection of information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports  (0701-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject  to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please DO NOT RETURN your form to the above address.  Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.                B. EXHIBIT             C. CATEGORY:                                                        0002                              A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                         E. CONTRACT/PR NO.              F. CONTRACTOR                               LARGE SCALE PRODUCTION OF SARS-CoV-2   W911QY-20-C-0100                Moderna TX, Inc.  VACCINE  1. DATA ITEM NO. 2. TITLE OF DATA ITEM                                 3. SUBTITLE                               17. Price Group        A005       Research and Development of Medical Products Regulated by the Shipping Documentation-Finished Drug Product                   U.S. Food and Drug Administration (FDA)               (FDP)  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                  18. Estimated  DI-TCSP-82040                                C.4.3                          ASPR BARDA                              Total Price  7. DD 250 REQ  9. DIST STATEMENT  10. FREQUENCY       12. DATE OF FIRST     14. DISTRIBUTION       NA        REQUIRED                 ASREQ         SUBMISSION                        C                               Refer to Block 16  8. APP CODE                       11. AS OF DATE      13. DATE OF                                b. COPIES        A                                   0           SUBSEQUENT                                                                                a. ADDRESSEE             Final                                                             SUBMISSION                            Draft                                                               Refer to Block 16                      Reg   Repro    16. REMARKS                                                                 ASPR BARDA*       1      1     0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. Provide CCAP-SCN** LT LT 0    shipping document for all FDP transferring from the contractor’s facility to a USG facility.                       Provide the following information in order to coordinate the movement and delivery of                              vaccine product from manufacturing locations to USG distribution centers:                                          -Points of Contact information (name, title, phone, email) for manufacturing / supply chain                        personnel for each manufacturing, CMO, storage and distribution locations:                                         - Head of Manufacturing                                                                                            - Production Planning                                                                                              - Logistics                                                                                                                     - Distribution                                                                                                                     - Labeling – Provide vaccine labeling, packaging and distribution information as soon as it                                                                                                                     becomes available. At a minimum, include the following:  a) Primary Container Information; b)  Number of doses per primary container; c) Unit of Sale (carton, box, package, other); d)                           Quantity per Unit of Sale; National Drug Code (NDC) or NDC-like code under EUA; Unit of Sale                       dimensions (H,W,L); e) Unit of Sale weight; f) Intermediate Package; g) Intermediate Package                       dimensions; h) Intermediate Package weight; i) Quantity Unit of Sale per pallet; j) Storage                        Requirements; and k) Stability Information.                                                                        Packaging List:  Include the following DSCSA data elements, TI, TH and TS in packing lists.                        Include the contract number and CDC’s PO number (which BARDA will provide at the time the                          bulk order is submitted) on the packing list for all shipments. Include a copy of the MSDS (with                   QR code) in the packing list envelope with each shipment. Send EDI 856 Advanced Shipment                           Notice for all products shipped to a USG directed location. CDC will provide EDI mapping                           specifications that include the CDC generated PO number. Send electronic/scanned copies of                         all bulk shipment related documents to the COR for three-way matching on the day shipment                          occurs.                                                                                                            8. Shipping Process Demo:  The US Government (USG) will respond within 15 calendar days                            with comments or approval. Subsequent submission (after USG approval of initial shipping                           process demo) within 1 calendar day after receipt of the FDP.                                                      9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                                                                                                                     Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                     Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                     12. 1st Submittal (Demo):  30 calendar days prior to first shipment. Submit concurrent with  each FDP delivery.                                                                                                 13. The contractor shall incorporate USG comments and resubmit to the USG within 1                                 calendar day after receipt.                                                                                        14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) or Adobe                      PDF via email to the BARDA representative:  Marva Taylor                                                           ([***]) and the Contracting Officer** (KO), Danny Soto                                                             ([***]).                                                                                                           LT:  Letter of Transmittal (via email)                                                                                                                                                                                                                                                                            15. TOTAL →       1      1     0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                 Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020             

 

                                                                                                                                     CONTRACT DATA REQUIREMENTS LIST                              Form Approved                                (2 Data Items)                                   OMB No. 0704-0188  The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,  gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this   collection of information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate  (0704-0188). Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if  it does not display a currently valid OMB control number. Please do not return your form to the above organization. Send completed form to the Government Issuing Contracting Officer  for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.                B. EXHIBIT             C. CATEGORY:                                                        0002                              A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                         E. CONTRACT/PR NO.              F. CONTRACTOR                               LARGE SCALE PRODUCTION OF SARS-CoV-2   W911QY-20-C-0100                Moderna TX, Inc.  VACCINE  1. DATA ITEM NO.      2. TITLE OF DATA ITEM                            3. SUBTITLE                               17. Price Group          A006          Task Directive Documentation                     Expiring Items Report  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                  18. Estimated  DI-SESS-82206 (Tailored)                     C.4.3                          ASPR BARDA                              Total Price  7. DD 250 REQ  9. DIST STATEMENT  10. FREQUENCY       12. DATE OF FIRST       NA        REQUIRED                 ASREQ         SUBMISSION                      14. DISTRIBUTION                        C                               Refer to Block 16  8. APP CODE                       11. AS OF DATE      13. DATE OF                                b. COPIES       NO                                  NA           SUBSEQUENT                                                                                a. ADDRESSEE             Final                                                             SUBMISSION                            Draft                                                               Refer to Block 16                      Reg   Repro    16. REMARKS                                                                 ASPR BARDA*       0      1     0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. Only CCAP-SCN** 0 LT  0       paragraph cc applies.                                                                                              9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                        Contractors (Administrative or Operational Use).                                                                   Determination made July 18, 2020. Distribution guidance is included in DoD Instruction                             5230.24.                                                                                                           12. & 13. Submit 30 calendar days prior to product expiration throughout contract period of                        performance.                                                                                                       14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                     the BARDA representative:  Marva Taylor                                                                                                                     ([***]) and the Contracting Officer** (KO), Danny Soto                                                                                                                     ([***]).  LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                           15. TOTAL →       0      1     0       1. DATA ITEM NO.      2. TITLE OF DATA ITEM                            3. SUBTITLE                               17. Price Group          A007          Contractor’s Personnel Roster                    Key Personnel Listing  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                  18. Estimated  DI-MGMT-81834A                               C.4.5                          ASPR BARDA                           Total Price  7. DD 250 REQ  9. DIST STATEMENT  10. FREQUENCY       12. DATE OF FIRST     14. DISTRIBUTION       N/A       REQUIRED           ASREQ               SUBMISSION                        C                               Refer to Block 16  8. APP CODE                       11. AS OF DATE      13. DATE OF                                b. COPIES        A                                   0           SUBSEQUENT                                       Final                                                                                    a. ADDRESSEE                                                        SUBMISSION                            Draft   Re                                                                                                                      Repro                                                               Refer to Block 16                       g  16. REMARKS                                                                 ASPR BARDA*       1      1     0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** 0    LT    0       8. The US Government (USG) will respond with comments or approval within 10 calendar days                          after receipt.                                                                                                     9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                        Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                 Distribution guidance is included in DoD Instruction 5230.24.                                                      12. Submit with Technical Proposal.                                                                                13. The contractor shall incorporate USG comments and resubmit to the USG within 10                                calendar days after receipt. Resubmit for any changes to key personnel.                                                                                                                     14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                     the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                                                                                                                     Soto ([***]).  LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                           15. TOTAL →       1      1     0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                 Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020            

 

                              CONTRACT DATA REQUIREMENTS LIST                                                                             Form Approved                                                                                                    (1 Data Item)                                                                         OMB No. 0704-0188  The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources,  gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this                        collection of information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports  (0701-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject  to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please DO NOT RETURN your form to the above address.  Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.                                             B. EXHIBIT                               C. CATEGORY:                                                                                                         0002                                                      A                         TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                                                     E. CONTRACT/PR NO.                                       F. CONTRACTOR                                                              LARGE SCALE PRODUCTION OF SARS-CoV-2                               W911QY-20-C-0100                                         Moderna TX, Inc.  VACCINE  1. DATA ITEM NO.                     2. TITLE OF DATA ITEM                                                                  3. SUBTITLE                                                              17. Price Group               A008                    Status Report                                                                          Monthly Technical Progress Report  4. AUTHORITY (Data Acquisition Document No.)                                  5. CONTRACT REFERENCE                                  6. REQUIRING OFFICE                                             18. Estimated  DI-MGMT-80368A (Tailored)                                                     C.4.6                                                  ASPR BARDA                                                           Total Price  7. DD 250 REQ            9. DIST STATEMENT                10. FREQUENCY                      12. DATE OF FIRST                       14. DISTRIBUTION          NA               REQUIRED                                    MTHLY                   SUBMISSION                                        C                                                      Refer to Block 16  8. APP CODE                                               11. AS OF DATE                     13. DATE OF                                                                 b. COPIES           A                                                               0                   SUBSEQUENT                                                                                                                                         a. ADDRESSEE                                 Final                                                                                                           SUBMISSION                                                          Draft                                                                                                           Refer to Block 16                                                     Reg       Repro         16. REMARKS                                                                                                                          ASPR BARDA*                    1           1          0           4.             The DID may be obtained from http://quicksearch.dla.mil/. The Monthly Progress report shall address each of           CCAP-SCN**                     1           1          0           the below items and be cross-referenced to the Statement of Work (SOW), Product Delivery Table, and an Integrated Master  Schedule (IMS), and detail the following:                                                                                                                                                              ●  A cover page that includes the contract number and title; the type of report and period that it covers; the Contractor’s                                                                            name, address, telephone number, fax number, and e-mail address; and the date of submission;  ●  SECTION I-EXECUTIVE SUMMARY                                                                                                                                                                         ●  SECTION II - PROGRESS                                                                                                                                                                               ●  SECTION II Part A:  OVERALL PROGRESS - A description of overall progress.                                                                                                                           ●  SECTION II part B:  MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all meetings, conference calls, etc. that  have taken place during the reporting period. Include progress on administration and management issues (e.g., evaluating,                                                                              and managing subcontractor performance, and personnel changes).                                                                                                                                        ●  SECTION II Part C:  TECHNICAL PROGRESS - For each activity related to Gantt chart, document the results of work completed  and cost incurred during the period covered in relation to proposed progress, effort and budget. The report shall be in                                                                                sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in                                                                       sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific                                                                       evaluation of data accumulated to date under the contract. The report shall include a description of problems encountered  and proposed corrective action; differences between planned and actual progress, why the differences have occurred and                                                                                 what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data                                                                                 accumulated to date under the project.  ●  SECTION II Part D:  PROPOSED WORK - A summary of work proposed related to Gantt chart for the next reporting period                                                                                 and preprints/reprints of papers and abstracts.                                                                                                                                                        ●  SECTION III:  Estimated and Actual Expenses.                                                                                                                                                             a.        This section of the report shall contain a narrative or table detailing whether there is a significant discrepancy  (>10%) at this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual                                                                                      expenses should be broken down to the appropriate WBS level.                                                                                                                                                b.        This section of the report should also contain estimates for the Subcontractors’ expenses from the previous  month if the Subcontractor did not submit a bill in the previous month. If the subcontractor(s) was not working or did not                                                                             incur any costs in the previous month, then a statement to this effect should be included in this report for those respective                                                                          subcontractors.                                                                                                                                                                                        Additionally, the report shall detail the following:  ●  Storage/inventory of ancillary materials (vials, needles, syringes, etc.)                                                                                                                           ●  Shipment and receipt of ancillary materials (vials, needles, syringes, etc.)                                                                                                                        ●  Disposal of ancillary materials (vials, needles, syringes, etc.)  ●  Bulk drug substance production                                                                                                                                                                      ●  Fill, finish, and release of product                                                                                                                                                                ●  Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant                                                                                                        ●  Stability information of intermediates, bulk substance and/or finished product  ●  Shipment of bulk substance of final product                                                                                                                                                         ●  Disposition of bulk substance or final product                                                                                                                                                      ●  Identify doses accepted by the Government in previous submissions  8.             The USG will review the monthly reports with the Contractor and provided feedback with 10 calendar days                                                                                 after receipt.                                                                                                                                                                                         9.             Distribution Statement C:  Distribution authorized to U.S. Government agencies and their Contractors                                                                                    (Administrative or Operational Use). Determination made July 18, 2020. Distribution guidance is included in DoD Instruction  5230.24.                                                                                                                                                                                               12.            Submit on the 20th day of the month covering the preceding month. (A Monthly progress report is not due                                                                                 required during the month when the Final Report )final version, not draft) is due (see CDRL A009)  13.            The contractor shall incorporate USG comments and resubmit to the USG within 10 calendar days after receipt.                                                                            Resubmit for any changes to key personnel.                                                                                                                                                             14.            Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to the BARDA                                                                                 representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny Soto ([***]).  LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   15. TOTAL →                    2           2          0           G. PREPARED BY                                                             H. DATE                         I. APPROVED BY                                      J. DATE                                 Pamela Serra                                                               July 18, 2020                   Marva Taylor                                        July 18, 2020                                                       

 

                                                                                                                                                                                                                                        CONTRACT DATA REQUIREMENTS LIST                                                                             Form Approved                                                     (2 Data Items)                                                                        OMB No. 0704-0188  The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,             gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.                                             B. EXHIBIT                              C. CATEGORY:                                                                                                              0002                                                      A                        TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                                                    E. CONTRACT/PR NO.                                       F. CONTRACTOR                                                                   LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE                                   W911QY-20-C-0100                            Moderna TX, Inc.  1. DATA ITEM NO.                       2. TITLE OF DATA ITEM                                                               3. SUBTITLE                                                                   17. Price Group                A009                     Contract Summary Report                                                             Final Technical Report  4. AUTHORITY (Data Acquisition Document No.)                                 5. CONTRACT REFERENCE                                 6. REQUIRING OFFICE                                                   18. Estimated                                                                                                                                                                                                                Total Price  DI-ADMN-80447A                                                               C.4.7                                                 ASPR BARDA  7. DD 250 REQ               9. DIST                       10. FREQUENCY                      12. DATE OF FIRST SUBMISSION          14. DISTRIBUTION           N/A                STATEMENT                                R/ASR                   Refer to Block 16                              REQUIRED  8. APP CODE                                               11. AS OF DATE                     13. DATE OF SUBSEQUENT                                                         b. COPIES                                          C                                                    SUBMISSION                                a. ADDRESSEE                                   Final                           A                                                            0                                                                                       Draft                                                                                               Refer to Block 16                                                                 Reg          Repro          16. REMARKS                                                                                                                        ASPR BARDA*                    1             1             0            4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. The final report shall be marked as           CCAP-SCN**                     1             1             0            'Final’.  A cover letter with the report shall contain a summary (not to exceed 200 words) of salient results achieved during  the performance of the contract and be structured in the following format:  Include the following:  Identify doses accepted                                                                                by the Government in previous submissions.                                                                                                                                                                                                             a. Cover page to include the contract number, contract title, performance period covered, Contractor's name and address,                                                                    telephone number, fax number, email address and submission date.                                                                                                                                           b. SECTION I:  EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the                                                                        major accomplishments relative to the specific activities set forth in the Statement of Work.                                                                                                              c. SECTION II:  RESULTS - A detailed description of the work performed related to WBS and Gantt chart, the results obtained,  and the impact of the results on the scientific and/or public health community including a listing of all manuscripts                                                                                      (published and in preparation) and abstracts presented during the entire period of performance and a summary of all                                                                                                                                                                                                             inventions.                                                                                                                                                                                 8. The US Government (USG) will respond with comments or approval within 30 calendar days after receipt of first draft                                                                                     report and within 15 calendar days of second submission.                                                                                                                                    9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their Contractors (Administrative or                                                                                 Operational Use). Determination made July 18, 2020. Distribution guidance is included in DoD Instruction 5230.24.  12. Submit Draft Report 75 calendar days prior to end of contract. Submit Final Report 30 calendar days after contract                                                                                     award.                                                                                                                                                                                                     13. The contractor shall incorporate USG comments and resubmit to the USG within 30 calendar days after receipt for first                                                                   submission and within 10 calendars days after second submission.                                                                                                                                           14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to the BARDA representative:                                                                 Marva Taylor ([***]) and the Contracting Officer** (KO), Danny Soto ([***]).                                                                                                                               LT:  Letter of Transmittal (via email).                                                                                                                                     15. TOTAL →                    2             2             0            1. DATA ITEM NO.                       2. TITLE OF DATA ITEM                                                               3. SUBTITLE                                                                   17. Price Group                A010                     Supply Chain Risk Management Plan                                                   Supply Chain Resiliency Plan (SCRP)  4. AUTHORITY (Data Acquisition Document No.)                                 5. CONTRACT REFERENCE                                 6. REQUIRING OFFICE                                                   18. Estimated                                                                                                                                                                                                           Total Price  DI-MGMT-82256                                                                C.4.8                                                 ASPR BARDA  7. DD 250 REQ               9. DIST                       10. FREQUENCY                      12. DATE OF FIRST SUBMISSION          14. DISTRIBUTION           N/A                STATEMENT                               ASREQ                    Refer to Block 16                              REQUIRED  8. APP CODE                                               11. AS OF DATE                     13. DATE OF SUBSEQUENT                                                         b. COPIES                                          C                                                    SUBMISSION                                a. ADDRESSEE                                   Final                           A                                                            0                                                                                       Draft                                                                                               Refer to Block 16                                                                 Reg          Repro                                                                                                                                             ASPR BARDA*                    1             1             0            16. REMARKS                                                                                                                                     CCAP-SCN**                    LT             LT            0            4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/.                                                                                                                                                                                                             SPECIFIC CONTENT INSTRUCTIONS ARE PROVIDED AT ATTACHMENT 0001 TO THIS CDRL.                                                                                                                                                                                                             8. The US Government (USG) will respond with comments or approval within 10 calendar                                                                                                        days after receipt.                                                                                                                                                                                        9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                                                                                                                Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                         Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                                              12. Submit with 30 Calendar days after contract award.                                                                                                                                                                                                             13. The contractor shall incorporate USG comments and resubmit to the USG within 7                                                                                                                                                                                                             calendar days after receipt. Submit any and all proposed revisions to the Plan for USG                                                                                                      approval 10 calendar days prior to implementation.                                                                                                                                                         14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                          the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                                                                                                                  Soto ([***]).                                                                                                                                                                                              LT:  Letter of Transmittal (via email).                                                                                                                                     15. TOTAL →                    1             1             0            G. PREPARED BY                                                            H. DATE                         I. APPROVED BY                                      J. DATE                                      Pamela Serra                                                              July 18, 2020                   Marva Taylor                                        July 18, 2020                   

 

                                                                                                                                          CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A011           Research and Development of Medical Products    Risk Management Plan (RMP)                         Regulated by the U.S. Food and Drug Administration  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price  DI-TCSP-82040 (Tailored)                     C.4.9                          ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               R/ASR        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. Page CCAP-SCN** 1 1     0       29, Paragraph (4) applies.                                                                                           8. The US Government (USG) will respond with comments or approval within 7 calendar days                             after receipt.                                                                                                       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                                                                                                                       Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                12. Submit within XX calendar days after contract award.                                                             13. The contractor shall incorporate USG comments and resubmit to the USG within 20                                  calendar days after receipt. Submit updates to the RMP concurrent with Monthly Progress                              Report. (CDRL A008). The contractor may choose to notify the USG up to two times every                               three months if there are no changes from the prior submission, and not submit an update.                                                                                                                       14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                       the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                    Soto ([***]).                                                                                                        LT:  Letter of Transmittal (via email).                                     15. TOTAL →      2       2       0                              2. TITLE OF DATA ITEM                                                                       17. Price Group  1. DATA ITEM NO.                                                       3. SUBTITLE                         Research and Development of Medical Products          A012                                                           Vendor Managed Inventory Plan/SOP                         Regulated by the U.S. Food and Drug Administration  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-TCSP-82040 (Tailored)                     C.7.1                          ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               R/ASR        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** 1    1       0       Page 11, paragraph (13) applies and Page 29, Paragraph (4) applies. (Subparagraphs (a)                               through (c) do not apply.)                                                                                           8. The US Government (USG) will respond with comments or approval within 7                                           calendar days after receipt.                                                                                                                       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                                                                                                                       Contractors (Administrative or Operational Use). Determination made July 18, 2020.                           Distribution guidance is included in DoD Instruction 5230.24.                                                        12. Submit within 45 calendar days after contract award.                                                             13. The contractor shall incorporate USG comments and resubmit to the USG within 20                                  calendar days after receipt. Resubmit for any changes to the USG-approved Plan/SOP.                                  14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                       the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                                                                                                                       Soto ([***]).                                                                                                LT:  Letter of Transmittal (via email).                                                                                                                                                          15. TOTAL →      2       2       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020            

 

                                                                                                                                                     CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A013           Research and Development of Medical Products    Manufacturing Reports and Dose Tracking                         Regulated by the U.S. Food and Drug Administration Projections/Actuals  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price  DI-SESS-81309                                C.4.10                         ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                 N/A                                                Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. Pg. 10, CCAP-SCN** 1 LT 0       paragraph e applies. The contractor shall complete the Dose Tracking Template provided at                            Attachment 0003.                                                                                                     8. The US Government (USG) will respond with comments or approval within 15 business                                 days after receipt.                                                                                                                       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                                                                                                                       Contractors (Administrative or Operational Use). Determination made July 18, 2020.                           Distribution guidance is included in DoD Instruction 5230.24.                                                        12. Submit Manufacturing Reports 15 business days prior to FDA submission. Submit the                                Dose Tracking Template within 15 calendar days after contract award and daily thereafter.                            13. The contractor shall incorporate USG comments and resubmit to the USG within 5                                   business days after receipt.                                                                                                                       14. Submit as an electronic file in Microsoft Excel via email to the BARDA representative:                                                                                                                        Marva Taylor ([***]) and the Contracting Officer** (KO), Danny Soto ([***]).                                 LT:  Letter of Transmittal (via email).                                                                                                                                                          15. TOTAL →      0       1       0                              2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group  1. DATA ITEM NO.                         Research and Development of Medical Products    Product Acceptance Report and Certificates of          A014                         Regulated by the U.S. Food and Drug Administration Analyses/Compliance  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-TCSP-82040                                C.4.11                         ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                 N/A                                                Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. The CCAP-SCN** LT LT    0       contractor shall provide:  pictures of the drug product with lot number, drug product lot tree,                      list of associated deviations (from drug substance and product), and a Certificate of                                Analysis/Compliance.                                                                                                 8. The US Government (USG) will respond with comments or approval within 5 calendar days                                                                                                                       after receipt.                                                                                                                       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                  Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                   Distribution guidance is included in DoD Instruction 5230.24.                                                        12. Submit for each lot of FDP delivered.                                                                            13. The contractor shall incorporate USG comments and resubmit to the USG within 3                                   calendar days after receipt.                                                                                                                       14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                       the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                                                                                                                                         Soto ([***]).                                                                                                LT:  Letter of Transmittal (via email).                                     15. TOTAL →      1       1       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020 

 

                                                                                                                                                     CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A015           NOT USED                                          4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price                                                                              A  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION                  STATEMENT                                              REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                                                       SUBMISSION               a. ADDRESSEE              Final                                                                                                    Draft                                                                                                       Reg    Repro    16. REMARKS                                                                                                                                                                                                                               NOT USED                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                15. TOTAL →                              1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A016           Accident Incident Report                        Incident Report  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-MGMT-82188                                C.4.12                         ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                 N/A                                                Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** 1    LT      0       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                   Distribution guidance is included in DoD Instruction 5230.24.                                                        12. Submit with 48 hours of activity or incident or within 24 hours for a security activity or                                                                                                                       incident.                                                                                                                       13. Submit additional updates within 48 hours of additional developments. If corrective                      action is deemed necessary by the USG, the Contractor shall address in writing, its                                  consideration of concerns raised within 5 business days of receipt.                                                  14. Provide via telephone with written follow-ups and corrective actions to the COR and                              Contracting Officer. Provide write-up as an electronic file in Microsoft Office (i.e. Word, Excel,                   Power Point) via email to the BARDA representative:  Marva Taylor ([***]) and the                                                                                                                       Contracting Officer** (KO), Danny Soto ([***]).                                                                                                                       LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                       15. TOTAL →      1       1       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020                       

 

                                                                                                                                          CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A017           Research and Development of Medical Products    FDA Correspondence                         Regulated by the U.S. Food and Drug Administration  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price  DI-TCSP-82040 (Tailored)                     C.4.13                         ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      0       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** 0    LT      0       8. The US Government (USG) will respond with comments or approval within 10 business                                 days after receipt.                                                                                                  9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                       12. Submit within 2 business days of receipt of FDA correspondence.                                          13. The contractor shall incorporate USG comments and resubmit concurrent with FDA                                   submission or no later than 1 calendar day of its submission to FDA.                                                 14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                    the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                            Soto ([***]).                                                                                                                       LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                                                                        15. TOTAL →      0       1       0       1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A018           Acquisition Support Documentation               Press Releases  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-MGMT-81607                                C.4.14                         ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. Only CCAP-SCN** LT LT   0       paragraphs 3.e, 3.f and 3.g apply.                                                                                   9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                   Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                       12. Submit no less than 5 business days prior to the issuance of the press release.                                                                                                                       13. Submit any final press releases no later than one (1) calendar day prior to its release.                 14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                    the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                            Soto ([***]).                                                                                                        LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         15. TOTAL →      1       1       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020            

 

                                                                                                                                          CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A019           Contractor's Standard Operating Procedures      Security Plan  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price  DI-MGMT-81580                                C.6                            ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               R/ASR        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                 N/A                                                Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** 1    1       0       8. The US Government (USG) will respond with comments or approval within 15 calendar                                 days after receipt.                                                                                                  9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                       12. Submit within 45 calendar days after contract award.                                                     13. The contractor shall incorporate USG comments and resubmit to the USG within 10                                  calendar days after receipt. Resubmit for any and all revisions for USG approval.                                    14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                    the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                            Soto ([***]).                                                                                                                       LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                                                                        15. TOTAL →      2       2       2       1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A020           Conference Agenda                               Agenda  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-ADMN-81249B                               C.5.11, C.5.4                  ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** LT   LT      0       8. Post Award Teleconference:  The USG will respond with comments or approval within 1                               calendar days after receipt. Kickoff Meeting:  The USG will respond with comments or                                 approval within 3 calendar days after receipt.                                                                       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                                                                                                                       Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                12. Post Award Teleconference:  Submit at least 3 business days prior to conduct of meeting                          and establish a teleconference number, unless otherwise provided by the USG. Kickoff                                 Meeting:  Submit at least 5 business days prior to conduct of meeting.                                               13. The contractor shall incorporate USG comments and distribute agenda at least 2 business                          days prior to meeting.                                                                                                                       14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                                                                                                                       the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                    Soto ([***]).                                                                                                        LT:  Letter of Transmittal (via email).                                     15. TOTAL →      1       2       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020                        

 

                                                                                                                                          CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A021           Report, Record of Meeting/Minutes               Meeting Minutes  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price  DI-ADMN-81505                                C.4.12, C.5.4                  ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** LT   1       0       8. The US Government (USG) will respond with comments or approval within 10 calendar                                 days after receipt.                                                                                                  9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                       12. Submit within 3 calendar days after conduct of meeting.                                                  13. Post Award Teleconference:  The contractor shall incorporate USG comments and                                    resubmit to the USG within 3 business day after receipt and within 10 business days for                              Kickoff Meeting.                                                                                                     14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                    the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                                                                                                                       Soto ([***]).                                                                                                                       LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                       15. TOTAL →      2       2       0       1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A022           Presentation Material                           Presentation Material  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-ADMN-81373                                C.5.4                          ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                 N/A                                                Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** 1    1       0       8. The US Government (USG) will respond with comments or approval within 5 calendar days                             after receipt.                                                                                                       9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                       12. Submit concurrent with Agenda (CDRL A020).                                                               13. The contractor shall incorporate USG comments and resubmit to the USG within 5                                   calendar days after receipt.                                                                                         14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                    the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                            Soto ([***]).                                                                                                                       LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                                                                        15. TOTAL →      2       2       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020                       

 

                                                                                                                                          CONTRACT DATA REQUIREMENTS LIST                           Form Approved                                (2 Data Items)                                   OMB No. 0704-0188   The public reporting burden for this collection of information is estimated to average 220 hours per response, including the time for reviewing instructions, searching existing data sources,   gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to the Department of Defense, Executive Services Directorate (0704-0188). Respondents should be aware that notwithstanding any  other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. Please do not  return your form to the above organization. Send completed form to the Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.               B. EXHIBIT             C. CATEGORY:                                                           0002                             A             TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                        E. CONTRACT/PR NO.               F. CONTRACTOR                                 LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE  W911QY-20-C-0100         Moderna TX, Inc.  1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A023           NOT USED                                          4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                        Total Price                                                                              A  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION                  STATEMENT                                              REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                                                       SUBMISSION               a. ADDRESSEE              Final                                                                                                    Draft                                                                                                       Reg    Repro    16. REMARKS                                                                                                                                                                                                                               NOT USED                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                15. TOTAL →                              1. DATA ITEM NO.       2. TITLE OF DATA ITEM                           3. SUBTITLE                                 17. Price Group          A024           Operations Security (OPSEC) Plan                Operational Security Plan (OPSEC) SOP/Plan  4. AUTHORITY (Data Acquisition Document No.) 5. CONTRACT REFERENCE          6. REQUIRING OFFICE                    18. Estimated                                                                                                                     Total Price  DI-MGMT-80934C                               C.6.3                          ASPR BARDA  7. DD 250 REQ   9. DIST          10. FREQUENCY       12. DATE OF FIRST SUBMISSION 14. DISTRIBUTION        N/A       STATEMENT               ASREQ        Refer to Block 16                  REQUIRED  8. APP CODE                      11. AS OF DATE      13. DATE OF SUBSEQUENT                        b. COPIES                         C                             SUBMISSION               a. ADDRESSEE              Final               A                                  0                                                 Draft                                                       Refer to Block 16                               Reg    Repro    16. REMARKS                                                                 ASPR BARDA*      1       1       0       4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/. CCAP-SCN** LT   1       0       8. The US Government (USG) will respond with comments or approval within 10 calendar                                 days after receipt.                                                                                                  9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their                          Contractors (Administrative or Operational Use). Determination made July 18, 2020.                                                                                                                       Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                       12. Submit within 90 calendar days of contract award.                                                        13. The contractor shall incorporate USG comments and revisions within 10 calendar days                              after receipt. Resubmit for any revisions to the UGS-approved SOP/Plan.                                              14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to                    the BARDA representative:  Marva Taylor ([***]) and the Contracting Officer** (KO), Danny                            Soto ([***]).                                                                                                                       LT:  Letter of Transmittal (via email).                                                                                                                                                                                                                                                                                                                        15. TOTAL →      1       2       0       G. PREPARED BY                             H. DATE           I. APPROVED BY                J. DATE                   Pamela Serra                               July 18, 2020     Marva Taylor                  July 18, 2020                        

 

 

                              CONTRACT DATA REQUIREMENTS LIST                                                                             Form Approved                                                                                                            (1 Data Item)                                                                        OMB No. 0704-0188  The public reporting burden for this collection of information is estimated to average 110 hours per response, including the time for reviewing instructions, searching existing data sources,                gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of  information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports (0701-0188), 1215  Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing  to comply with a collection of information if it does not display a currently valid OMB control number. Please DO NOT RETURN your form to the above address. Send completed form to the  Government Issuing Contracting Officer for the Contract/PR No. listed in Block E.  A. CONTRACT LINE ITEM NO.                                              B. EXHIBIT                              C. CATEGORY:                                                                                                                 0002                                                      A                        TDP_____ TM ____ Other General/Admin Data  D. SYSTEM/ITEM                                                     E. CONTRACT/PR NO.                                       F. CONTRACTOR                                                                     LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE                                    W911QY-20-C-0100                            Moderna TX, Inc.  1. DATA ITEM NO.                      2. TITLE OF DATA ITEM                                                                 3. SUBTITLE                                                                     17. Price Group               A025                     Research and Development of Medical Products Regulated                                Monthly Technical Progress Report                                        by the U.S. Food & Drug Administration  4. AUTHORITY (Data Acquisition Document No.)                                  5. CONTRACT REFERENCE                                            6. REQUIRING OFFICE                                          18. Estimated  DI-MGMT-80368A (Tailored)                                                     C.4.6                                                            ASPR BARDA                                                   Total Price  7. DD 250 REQ             9. DIST STATEMENT               10. FREQUENCY                       12. DATE OF FIRST SUBMISSION                     14. DISTRIBUTION           NA               REQUIRED                                   MTHLY                    Refer to Block 16  8. APP CODE                            C                  11. AS OF DATE                      13. DATE OF SUBSEQUENT SUBMISSION                                                     b. COPIES                                                                                                                                                    a. ADDRESSEE                               Final                      A                                                              0                                         Refer to Block 16                                       Draft                                                                                                                                                                                         Reg        Repro       16. REMARKS                                                                                                                                    ASPR BARDA*                   1           1          0                                                                                                                                                        CCAP-SCN**                    1           1          0         4. The Data Item Description (DID) may be obtained from http://quicksearch.dla.mil/.                                                                                                                                                                                                                8. The US Government (USG) will respond with comments or approval within 10 calendar days after receipt.                                                                                                                                                                                                                                                                                                                    9. Distribution Statement C:  Distribution authorized to U.S. Government agencies and their Contractors (Administrative or Operational                                                                 Use). Determination made July 18, 2020. Distribution guidance is included in DoD Instruction 5230.24.                                                                                                                                                                                                                                                                                                                       12. Submit within 30 calendar days of contract award.                                                                                                                                                                                                                                                                                                                                                                13. The contractor shall incorporate USG comments and revisions within 10 calendar days after receipt. Resubmit for any revisions to                                                                                                                                                                                                                the UGS-approved Plan.                                                                                                                                                                                                                                                                                                                                                                                               14. Submit as an electronic file in Microsoft Office (i.e. Word, Excel, Power Point) via email to the BARDA representative:  Marva Taylor                                                                                                                                                                                                                ([***]) and the Contracting Officer** (KO), Danny Soto ([***]).                                                                                                                                        LT:  Letter of Transmittal (via email)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   

 

                                                                                                                                                                                                                                                                                                                             15. TOTAL →      2      2     0      G. PREPARED BY                            H. DATE            I. APPROVED BY                     J. DATE               Pamela Serra                              July 18, 2020      Marva Taylor                       July 18, 2020                                                      INSTRUCTIONS FOR COMPLETING DD FORM 1423                                                 (See DoD 5010.12-M for detailed instructions.)                          FOR GOVERNMENT PERSONNEL                                            FOR THE CONTRACTOR    Item A. Self-explanatory.                                           Item 17. Specify appropriate price group from one of the following groups                                                                        of effort in developing estimated prices for each data item listed on the DD    Item B. Self-explanatory.                                           Form 1423.    Item C. Mark (X) appropriate category:  TDP - Technical Data Package; TM - a. Group I. Definition - Data which is not otherwise essential to the    Technical Manual; Other - other category of data, such as “Provisioning,"  contractor's performance of the primary contracted effort    "Configuration Management," etc.                                           (production, development, testing, and administration) but which                                                                               is required by DD Form 1423.    Item D. Enter name of system/item being acquired that data will support.    Item E. Self-explanatory (to be filled in after contract award).         Estimated Price - Costs to be included under Group I are those                                                                        applicable to preparing and assembling the data item in conformance with    Item F. Self-explanatory (to be filled in after contract award).    Government requirements, and the administration and other expenses    Item G. Signature of preparer of CDRL.                              related to reproducing and delivering such data items to the Government.     Item H. Date CDRL was prepared.                                        b.  Group II. Definition - Data which is essential to the performance of                                                                               the primary contracted effort but the contractor is required to    Item I. Signature of CDRL approval authority.                                                                               perform additional work to conform to Government requirements    Item J. Date CDRL was approved.                                            with regard to depth of content, format, frequency of submittal,                                                                               preparation, control, or quality of the data item.    Item 1. See DoD FAR Supplement Subpart 4.71 for proper numbering.    Item 2. Enter title as it appears on data acquisition document cited in Item Estimated Price - Costs to be included under Group II are those    4.                                                                  incurred over and above the cost of the essential data item without                                                                        conforming to Government requirements, and the administrative and    Item 3. Enter subtitle of data item for further definition of data item other expenses related to reproducing and delivering such data item to the    (optional entry).                                                   Government.          Enter Data Item Description (DID) number, military specification    Item 4.                                                                c.  Group III. Definition - Data which the contractor must develop for    number, or military standard number listed in DoD 5010.12-L (AMSDL), or    his internal use in performance of the primary contracted effort    one-time DID number, that defines data content and format requirements.    and does not require any substantial change to conform to    Item 5. Enter reference to tasking in contract that generates requirement  Government requirements with regard to depth of content,    for the data item (e.g., Statement of Work paragraph number).              format, frequency of submittal, preparation, control, and quality                                                                               of the data item.    Item 6. Enter technical office responsible for ensuring adequacy of the data    item.                                                                     Estimated Price - Costs to be included under Group III are the                                                                        administrative and other expenses related to reproducing and delivering    Item 7. Specify requirement for inspection/acceptance of the data item by such data item to the Government.    the Government.    Item 8. Specify requirement for approval of a draft before preparation of d. Group IV. Definition - Data which is developed by the contractor as    the final data item.                                                       part of his normal operating procedures and his effort in supplying                                                                               these data to the Government is minimal.    Item 9. For technical data, specify requirement for contractor to mark the    appropriate distribution statement on the data (ref. DoDD 5230.24).       Estimated Price - Group IV items should normally be shown on the    Item 10. Specify number of times data items are to be delivered.    DD Form 1423 at no cost.    Item 11. Specify as-of date of data item, when applicable.    Item 12. Specify when first submittal is required.                  Item 18. For each data item, enter an amount equal to that portion of the                                                                        total price which is estimated to be attributable to the production or    Item 13. Specify when subsequent submittals are required, when applicable. development for the Government of that item of data. These estimated                                                                        data prices shall be developed only from those costs which will be incurred    Item 14. Enter addressees and number of draft/final copies to be delivered as a direct result of the requirement to supply the data, over and above                                                                                                                               

 

to each addressee. Explain reproducible copies in Item 16.          those costs which would otherwise be incurred in performance of the                                                                      contract if no data were required. The estimated data prices shall not  Item 15. Enter total number of draft/final copies to be delivered.  include any amount for rights in data. The Government's right to use the  Item 16. Use for additional/clarifying information for Items 1 through 15. data shall be governed by the pertinent provisions of the contract.  Examples are:  Tailoring of documents cited in Item 4; Clarification of  submittal dates in Items 12 and 13; Explanation of reproducible copies in  Item 14.; Desired medium for delivery of the data item.          

 

 

                                                                                                                Supply Chain Resiliency Plan for CDRL A010                  Attachment 0001                                       As of 23 July 2020                                                                          W911QY-20-C-0100                                                                  Supply Chain Resiliency Plan                                                                           Attachment 0001                                                                                Page 1 of 3        

 

                                       ATTACHMENT 0001                                                  TO                                 CONTRACT DATA REQUIREMENTS                                              LIST A010          Supply Chain Resiliency Plan          The contractor shall provide a comprehensive Supply Chain Resiliency Plan that provides for identification and   reporting of critical components associated with the secure supply of drug substance, drug product, and work-in-  process through to finished goods.          1. A critical component is defined as any material that is essential to the product or the manufacturing process   associated with that product. Included in the definition are consumables and disposables associated with   manufacturing. NOT included in the definition are facility and capital equipment.          Consideration of critical components includes the evaluation and potential impact of raw materials, excipients,   active ingredients, substances, pieces, parts, software, firmware, labeling, assembly, testing, analytical and   environmental componentry, reagents, or utility materials which are used in the manufacturing of a drug, cell banks,   seed stocks, devices and key processing components and equipment. A clear example of a critical component is one   where a sole supplier is utilized.          2. The contractor shall identify key equipment suppliers, their locations, local resources, and the associated control   processes at the time of award. This document shall address planning and scheduling for active pharmaceutical   ingredients, upstream, downstream, component assembly, finished drug product and delivery events as necessary for   the delivery of product.             a)  Communication for these requirements shall be updated as part of an annual review, or as necessary, as part          of regular contractual communications.      b)  For upstream and downstream processing, both single-use and re-usable in-place processing equipment,          and manufacturing disposables also shall be addressed. For finished goods, the inspection, labeling,          packaging, and associated machinery shall be addressed taking into account capacity capabilities.      c)  The focus on the aspects of resiliency shall be on critical components and aspects of complying with the          contractual delivery schedule. Delivery methods shall be addressed, inclusive of items that are foreign-          sourced, both high and low volume, which would significantly affect throughput and adherence to the          contractually agreed deliveries.          3. The contractor shall articulate in the plan, the methodology for inventory control, production planning, scheduling   processes and ordering mechanisms, as part of those agreed deliveries.             a)  Production rates and lead times shall be understood and communicated to the HHS/ASPR/BARDA          Contracting Officer or the Contracting Officer's Representative as necessary.      b)  Production throughput critical constraints should be well understood by activity and by design, and          communicated to contractual personnel. As necessary, communication should focus on identification,          exploitation, elevation, and secondary constraints of throughput, as appropriate.          4. Reports for critical items should include the following information:             a)  Critical Material      b)  Primary vendor and secondary vendor, if applicable      c)  Supplier, Manufacturing / Distribution Location      d)  Supplier Lead Time      e)  Shelf Life      f)  Transportation / Shipping restrictions                                                                                                            W911QY-20-C-0100                                                                                       Supply Chain Resiliency Plan                                                                                                  Attachment 0001                                                                                                       Page 2 of 3                                                                                                      

 

g)  Comparability studies, if applicable  h)  Amount of material (dose equivalent) in inventory                                                                                              W911QY-20-C-0100                                                                                      Supply Chain Resiliency Plan                                                                                               Attachment 0001                                                                                                    Page 3 of 3        

 

 

                                                                                Security Plan   Attachment 0002                        As of 23 July 2020                                                         W911QY-20-C-0100                                                                     Security Plan                                                           Attachment 0002                                                                Page 1 of 7 

 

                                      ATTACHMENT 0002                                       CONTRACT DATA REQUIREMENTS                                             LIST A019                                       BARDA SECURITY REQUIREMENTS         The contractor shall provide a Security Plan which shall address the following:         [***]                                                                                            W911QY-20-C-0100                                                                                                  Security Plan                                                                                               Attachment 0002                                                                                                    Page 2 of 7 

 

                                                                                  Data Rights     Attachment 0004                        As of 7 August 2020                                                                                                                                                                                                                                                                          Data Rights                                                           Attachment 0004                                                                Page 1 of 3 

 

                       Data Rights Restrictions         Limited Rights Data         The following are Modern’s technical data assertions required by DFAR   252.227-7017 (“Identification and assertion of use, release, or disclosure   restrictions”). Notwithstanding any contrary representation by the   Contractor on the System for Award Management or any contrary   provision in the contract, the following categories of information   developed exclusively at private expense will, if provided to the   Government, be considered limited rights data subject to the restrictions   specified in DFAR 227.7013. These restrictions apply to any component   of information covered by this provision, regardless of whether a   component is included in a contract deliverable. The Government will, as   applicable, retain government purpose rights or unlimited rights in   technical data generated in performance or included in a deliverable as  required by DFARS 252.227-7013 or another applicable data rights clause  to the extent that any component of such technical data (i) was  developed in whole or in part with Government funds, (ii) pertains to an  item developed in whole in part with Government funds, or (iii) was first  produced in performance of a Government contract subject to FAR  52.227-14. Nothing in this Contract or this Attachment affects any data  rights that the Government may already have under prior agreements  between Moderna and the Government, including with respect to  Agreement Nos. [***] The Government will not reverse engineer or  otherwise evaluate materials provided under this Contract to reproduce  the type of information described below without Moderna’s prior  written consent.                [***]               [***]            [***]               [***]     [***]               [***]            [***]              [***]    [***]               [***]                                   [***]               [***]                                   [***]               [***]                                   [***]               [***]                                   [***]               [***]                                    [***]               [***]            [***]              [***]                                                                                   W911QY-20-C-0100                                                                           Data Rights                            August 7, 2020                              Attachment 0004                                                                             Page 2 of 3       

 

                                [***]                                   [***]               [***]           [***]               [***]    [***]               [***]           [***]               [***]    [***]               [***]           [***]               [***]    [***]               [***]           [***]               [***]    [***]               [***]           [***]               [***]                                                August 7, 2020                         W911QYData-20-C Rights-0100                                                                      Attachment 0004                                                                         Page 3 of 3 

 

 

                                                                                                                         [***]      Attachment 0005                        As of 7 August 2020                                                                                                                                                                                                                                W911QY-20-C-0100                                                                     [***]                                                           Attachment 0005                                                                 Page 1 of 2        

 

       [***]                                                                                                                                                                                                                                                                                                                                                                                                                                                    August 7, 2020                                      W911QY-20-C-0100                                                                                                     [***]                                                                                           Attachment 0005                                                                                                 Page 2 of 2        

 

                                                                             Moderna Tx, Inc. Background Intellectual Property                       Attachment 0006                                          As of 6 August 2020                                                                            W911QY-20-C-0100                                                 ModernaTx, Inc. Background Intellectual Property                                                                             Attachment 0006                                                                                  Page 1 of 3 

 

       Description of Moderna, Inc. Representative Intellectual Property       [***]                                                                                                                                                                                                                                     W911QY-20-C-0100                                            ModernaTx, Inc. Background Intellectual Property                                                             Attachment 0006                                                                  Page 2 of 3      

 

             Description of Moderna, Inc. Representative Intellectual Property                [***]                                                                                                 W911QY-20-C-0100                                                                       ModernaTx, Inc. Background Intellectual Property                                                                                                   Attachment 0006                                                                                                        Page 3 of 3 

 

                                                       Performance Based Payment (PBP) Milestone Schedule              Attachment 0007                               As of 7 August                                                                                                                                                 W911QY-20-C-0100 PBP                                           Milestone Schedule                                            Attachment 0007                                               Page 1 of 2        

 

                   Severable/          Milestone                Price    Milestone Completion Verification Method   CLIN             Cumulative                                           Moderna shall provide: 1) written confirmation                                           from the CMO network that sufficient capacity has         Capacity                                           been reserved; and, 2) written confirmation of         and Raw   Severable    $601,400,000 reservation of sufficient raw materials along with a   001   Material                          manufacturing schedule.         Reservation  [***]   [***]    [***]               [***] [***]            [***]    [***]               [***] [***]  [***]                                                                                                                                                                                                                                                                       W911QY-20-C-0100 PBP                                                                         Milestone Schedule                                                                           Attachment 0007       

 

Page 2 of 2          

 

                                                                             Performance Base Payment (PBP) Milestone Billing Plan                      Attachment 0008                                         As of 7 August 2020                                                                                                                                                                                                                                                                                     W911QY-20-C-0100                                                                     PBP Milestone Billing Plan                                                                              Attachment 0008        

 

Page 1 of 16          

 

                                                                                                                                                                                                                                                                      Page 2 of 16      [***]                                                                                                                                                                                                                                                                                                                                                                     W911QY-20-C-0100                                                                                                                                                                                                                            PBP Milestone Billing Plan                                                                                                                                                                                                                                      Attachment 0008   

 

 

[***]                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               W911QY-20-C-0100                                                                                                                                                                                                                                                                PBP Milestone Billing Plan                                                                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                                                                                 Page 3 of   16     

 

                  [***]                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                                                    PBP Milestone Billing Plan                                                                                                                                                                                                                                                             Attachment 0008                                                                                                                                                                                                                                                                 Page 4 of 16                     

 

[***]                                                                                                                                                                                                                                                                                                                                                                                                                   W911QY-20-C-0100                                                                                                                                                                                                                                                     PBP Milestone Billing Plan                                                                                                                                                                                                                                                              Attachment 0008                                                                                                                                                                                                                                                                  Page 5 of 16   

 

                                                                                                                                                                                                                                                                                [***]                                                                                                                                                                                                                                                                                                                                                                                                              W911QY-20-C-0100                                                                                                                                                                                                                                                     PBP Milestone Billing Plan                                                                                                                                                                                                                                                              Attachment 0008                                                                                                                                                                                                                                                                  Page 6 of 16     

 

  [***]                                       

 

[***]                                                                                                                                                                                                                                                                                                                                                                                                          W911QY-20-C-0100                                                                                                                                                                                                                                                     PBP Milestone Billing Plan                                                                                                                                                                                                                                                              Attachment 0008                                                                                                                                                                                                                                                                  Page 7 of 16     

 

[***]                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 W911QY-20-C-0100                                                                                                                                                           PBP Milestone Billing Plan                                                                                                                                                                  Attachment 0008    ACTIVE/105609918.3     

 

Page 8 of 16                         

 

[***]                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   W911QY-20-C-0100                                                                                                                                                           PBP Milestone Billing Plan                                                                                                                                                                  Attachment 0008                                                                                                                                                                     Page 9 of 16    ACTIVE/105609918.3     

 

[***]                                                                                                                                                                                                                                                                                                                                                                                                     W911QY-20-C-0100                                                                                                                                                                                                                                                      PBP Milestone Billing Plan                                                                                                                                                                                                                                                               Attachment 0008                                                                                                                                                                                                                                                                  Page 10 of 16     

 

[***]                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                   PBP Milestone Billing Plan                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                               Page 11 of 16       

 

[***]                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                   PBP Milestone Billing Plan                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                               Page 12 of 16    

 

[***]                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                   PBP Milestone Billing Plan                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                               Page 13 of 16                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            

 

[***]                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                   PBP Milestone Billing Plan                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                               Page 14 of 16    

 

[***]                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                   PBP Milestone Billing Plan                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                               Page 15 of 16        

 

[***]                                                                                                                                                                                                                                                                                                                                                                  W911QY-20-C-0100                                                                                                                                                                                                                   PBP Milestone Billing Plan                                                                                                                                                                                                                            Attachment 0008                                                                                                                                                                                                                               Page 16 of 16                                                                                                                                                                                                                                                 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS  BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF  DISCLOSED.                                                                                                                                                      1. CONTRACT ID CODE    PAGE OF PAGES        AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT                                                                1       16                                     2. AMENDMENT/MODIFICATION NO.           3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO.                5. PROJECT NO.(If applicable)                                                                                                                                                                      0011534693                                                                                                            6. ISSUED BY                   CODE     W911QY            7. ADMINISTERED BY (If other than item 6)   CODE    S2206A                                                                DEFENSE CONTRACT MANAGEMENT AGENCY     W6QK ACC-APG NATICK DIVISION                               DCMA BOSTON     BLDG 1 GENERAL GREENE AVENUE                               495 SUMMER STREET     NATICK MA 01760-5011                                       BOSTON MA 02210-2138       8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)                 9A. AMENDMENT OF SOLICIT AT ION NO.      MODERNA US INC                                                                             [***]                                                                                     9B. DATED (SEE ITEM 11)      200 TECHNOLOGY SQ                                                                          CAMBRIDGE MA 02139-3578                                                                   10A. MOD. OF CONTRACT/ORDER NO.                                                                                             X  W911QY20C0100                                                                                                10B. DATED (SEE ITEM 13)    CODE   8PTM0                               FACILITY CODE                                 X 09-Aug-2020                                         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 must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:       (a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;       or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR 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 telegramor letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.    12. ACCOUNT ING AND APPROPRIATION DATA (If required)                                  13. THIS ITEM APPLIES ONLY TO MODIFICAT IONS OF CONTRACT S/ORDERS.                                   IT MODIFIES THE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.      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).    X C. THIS SUPPLEMENT AL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:      Mutual Agreement of the parties, FAR 43.103(a)(3) & H.14, Novation      D. OTHER (Specify type of modification and authority)      E. IMPORTANT: Contractor is not,       X    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 solicitat ion/contract subject matter       where feasible.)       Modification Control Number:          dsoto202575       The purpose of this modification is to     1. Novation Change from Moderna TX to Moderna US     2. Section C make administrative revisions to correct type-o and update company name     3. Section G update company name, correct type-o in subCLINs, and revise WAWF Clause inspect by from S2206A to W911QY     4. Section I add FAR 52.204-25 and update information in FAR 252.232-7007     5. Section J revised page number on Exhibits and Attachments       The total obligated amount and contract price remains the unchanged.    Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.    15A. NAME AND TITLE OF SIGNER (Type or print)                16A. NAME AND TITLE OF CONT RACTING OFFICER (Type or print)                                                                    CAMILLE B. CONNELL-MAGAW                                                                                                       [***]    Stephane   Bancel, CEO                                       TEL: [***]                      EMAIL:                                                  (Signature of   15C. DATE SIGNED                                   16B. UNITED    15B. CONTRACTOR/OFFEROR                      person                                                                                                                    STATES OF     /s/ Stephane Bancel                         authorized to    9/4/2020                                                 sign)                                                              AMERICA BY 

 

         /s/ Camille B. Connell-Magaw        16C. DATE                                      SIGNED     (Signature of Contracting Officer) 9/08/2020   EXCEPTION TO SF 30                        30-105-04                                 STANDARD FORM 30 (Rev. 10-83)  APPROVED BY OIRM 11-84                                                              Prescribed by GSA FAR (48                                                                                      CFR) 53.243                                                                                                                                                                                                                                                             

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 2 of 16           SECTION SF 30 BLOCK 14 CONTINUATION PAGE           SUMMARY OF CHANGES                    SECTION C - DESCRIPTIONS AND SPECIFICATIONS                     The following have been modified:                                                STATEMENT OF WORK                       LARGE SCALE PRODUCTION OF SARS-CoV-2 VACCINE                     C.1    SCOPE. The Department of Defense and Health and Human Services (HHS) require large scale   manufacturing of vaccine doses in support of the national emergency response to the Coronavirus Disease 2019   (COVID-19) for the United States Government (USG) and the US population.           C.1.1   Background. In December 2019, a novel coronavirus now known as SARS-CoV-2 was first detected in  Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID-19 that  has now spread globally. The Secretary of Health and Human Service declared a public health emergency on  January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19.  On March 1, 2020, the President of the United States, pursuant to sections 01 and 301 of the National Emergencies  Act (50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social Security Act (SSA), as amended (42  U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.           C.1.1.1 Under Operation Warp Speed (OWS), the Department of Defense and HHS are leading a whole of nation  effort to ensure development of promising vaccine, diagnostic and therapeutic candidates and ensure that these  medical countermeasures are available in the quantities required to reduce SARS-CoV-2 transmission, identify prior  and/or current infection, and improve patient care, thereby mitigating the impact of COVID-19 on the nation and its  people. The DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense  (JPEO-CBRD) is providing expertise and contracting support to HHS, in compliance with PL 115-92 Authorization  Letter for DoD Medical Priorities, through an Interagency Agreement, signed April 23, 2020. As OWS products  progress to clinical trials to evaluate the safety and efficacy of vaccines and therapeutics, it is critical that, in  parallel, the USG supports large scale manufacturing so that vaccine doses or therapeutic treatment courses are  immediately available for nationwide access as soon as a positive efficacy signal is obtained and the medical  countermeasures are authorized for widespread use.           C.1.2   Objective: The objective of this effort is to obtain the following:                   a. Base Period: Large scale manufacturing of 100 million vaccine doses          b. Option Period 1: Large scale manufacturing of 100 million vaccine doses          c. Option Period 2: Large scale manufacturing of 100 million vaccine doses          d. Option Period 3: Large scale manufacturing of 100 million vaccine doses          e. Option Period 4: Large scale manufacturing of 100 million vaccine doses   The Base Period is 9 months, with overlapping options for a total of 20 months if all options are exercised.            C.2    APPLICABLE DOCUMENTS.           C.2.1   Federal Documents:           C.2.1.1 Title 21 Code of Federal Regulations (CFR), Food and Drugs: Part 210, Current Good Manufacturing  Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; and, Part 211, Current Good  Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General.            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 3 of 16           (https://www.ecfr.gov/cgi-bin/text-  idx?SID=a95cab20f443897a400bb7e44a27cf4c&mc=true&tpl=/ecfrbrowse/Title21/21cfrv4_02.tpl#0)           C.3      REQUIREMENTS. Independently, and not as an agent of the USG, in accordance with the Proposal   submitted by Moderna US, Inc. in response to Solicitation Number W911QY20R0043, Titled, “Advanced   Procurement of mRNA-1273 Vaccine for Prevention of SARS-CoV-2 Coronavirus (COVID-19)”), dated July 10,   2020 (and any subsequent USG-approved revisions thereto), the contractor shall provide all necessary services,   qualified personnel, material, equipment and facilities (not otherwise provided by the USG under the terms of this   contract) to perform the specific tasks set forth below.            C.3.1   Contract Line Item Number (CLIN) 0001 - Base Period: Large Scale Manufacturing of 100 Million   Vaccine Doses.            C.3.1.1  The contractor shall complete all scope required for the production, release and delivery use of 100   million Final Drug Product (FDP) doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include, the following   tasks and other activities reasonably contemplated by such task:           C.3.1.1.1  Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.           C.3.1.1.2  cGMP manufacturing of 100 million doses fully compliant with 21 CFR 210 and 211.           C.3.1.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations   and that labeling is updated as appropriate.            C.3.1.1.4 Coordinating with FDA to establish an approved commercial vial label, carton and packaging insert   (printed or electronic).           C.3.1.1.5 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and response  requirements, subject to any exceptions established by or the enforcement discretion of the FDA, including  “Exemption from Certain Product Tracing and Product Identification Requirements Under Section 582 of the FD&C  Act” (April 2020).           C.3.1.1.6  In coordination with the USG, the contractor shall conduct a demonstration of the vaccine shipping  process prior to the first delivery of FDP doses at a time mutually agreed to by the contractor and the USG.  Moderna shall provide specifications and details associated with the shipping process and containers (IAW CDRL  A005) to enable the USG to adequately plan and prepare for potential distribution of the vaccine.            C.3.1.1.7 Following release of product the contractor shall, promptly deliver product to the designated delivery site   via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. In the unforeseen event   that a designated delivery site cannot receive product and the contractor provides storage beyond 20 days of product   release, the contract will be subject to modification for acceptance purposes.            C.3.1.2   Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and   FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.1.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing   the finding and corrective action(s) in accordance with CDRL A001.            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 4 of 16                    C.3.1.2.2  FDA Audits. The Contractor shall notify the Contracting Officer and Contracting Officer’s  Representative (COR) within [***] of a scheduled FDA audit or within [***] of an ad hoc site visit or audit if the  FDA does not provide advance notice. The contractor shall provide copies of any FDA Audit Report received from  subcontractors that occur as a result of this contract or for this product within [***] of receiving correspondence  from the FDA or third party in accordance with CDRL A002. The Contractor shall provide the Contracting Officer  with a plan for addressing areas of nonconformance, if any are identified, within [***] of submittal of the audit  report in accordance with CDRL A002.           C.3.1.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the USG  has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not  limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement  documentation in accordance with CDRL A002.           C.3.2   CLIN 1001 - Option Period 1: Large Scale Manufacturing of 100 Million Vaccine Doses.            C.3.2.1  The contractor shall complete all scope required for the production, release and delivery use of 100  million FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other  activities reasonably contemplated by such tasks:           C.3.2.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.           C.3.2.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.           C.3.2.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated.           C.3.2.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of   PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and response   requirements subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.2.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site  via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural  disaster or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the  Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed  Inventory (VMI) at the contractor site.           C.3.2.2   Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and  FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.2.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.            C.3.2.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled   FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The contractor   shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this contract or   for this product within [***] of receiving correspondence from the FDA or third party in            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 5 of 16           accordance with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas  of nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.           C.3.2.2.3  FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the  USG has visibility and input on all FDA communications regarding the drugs and biologics for the following, but  not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement  documentation in accordance with CDRL A002.           C.3.3   CLIN 2001 - Option Period 2: Large Scale Manufacturing of 100 Million Vaccine Doses.           C.3.3.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million  FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other activities  reasonably contemplated by such tasks:           C.3.3.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.           C.3.3.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.            C.3.3.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations   and that labeling is updated as appropriate.            C.3.3.1.4 Ensuring that the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-   585 of PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and   response requirements, subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.3.1.5 Following release the contractor shall deliver product to the nearest designated distribution site via a   qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural disaster   or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the Contractor   and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed Inventory   (VMI) at the contractor site.            C.3.3.2  Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and   FDA representatives for required site visits and audits at facilities used to support this contract throughout the period   of performance of the contract.            C.3.3.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.            C.3.3.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled   FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The   contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this   contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance   with CDRL A002. The Contractor shall provide the Contracting Officer with a plan for addressing areas of   nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 6 of 16           C.3.3.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the USG  has visibility and input on all FDA communications regarding the drugs and biologics for the following, but not  limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement  documentation in accordance with CDRL A002.           C.3.4   CLIN 3001 - Option Period 3: Large Scale Manufacturing of 100 Million Vaccine Doses.            C.3.4.1 The contractor shall complete all scope required for the production, release and delivery use of 100 million  FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other activities  reasonably contemplated by such tasks:           C.3.4.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.           C.3.4.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.           C.3.4.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated.           C.3.4.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and response  requirements subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.4.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site   via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural   disaster or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the   Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed   Inventory (VMI) at the contractor site.           C.3.4.2   Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and  FDA representatives for required site visits and audits at facilities used to support this contract throughout the period  of performance of the contract.            C.3.4.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.           C.3.4.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled  FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The  contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this  contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance  with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas of  nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            C.3.4.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the   USG has visibility and input on all FDA communications regarding mRNA-1273 for the following, but not limited   to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement documentation in   accordance with CDRL A002.            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 7 of 16           C.3.5   CLIN 4001 - Option Period 4: Large Scale Manufacturing of 100 Million Vaccine Doses.            C.3.5.1  The contractor shall complete all scope required for the production, release and delivery use of 100  million FDP doses of a SARS-CoV-2 mRNA-1273 vaccine. This shall include the following tasks and other  activities reasonably contemplated by such tasks:           C.3.5.1.1 Storage of FDP doses prior to delivery consistent with all FDA requirements to ensure that the product  remains available for use in target populations. Storage and maintenance of the vaccine prior to delivery shall be  under conditions and at temperatures necessary to retain stability for use as prescribed in this contract for a period of  12 months. (Based on FDP stability data that supports a 12-month shelf-life, subject to FDA confirmation of the  assigned shelf-life.) Ensure requirements of 21CFR207, Registration of Producers of Drugs and Listing of Drugs in  Commercial Distribution are met prior to distribution to the CDC. Documents shall be provided under CDRL A002,  FDA Interactions and Inspections Documentation.           C.3.5.1.2 cGMP manufacturing of 100 million doses, subject to any exceptions established by or the enforcement  discretion of the FDA.           C.3.5.1.3 Ensuring that vial labeling and packaging is consistent with FDA guidance for use in target populations  and that labeling is updated.           C.3.5.1.4 Ensuring the product complies with the Drug Supply Chain Security Act (DSCSA), Sections 581-585 of  PL 113-54 (Nov. 27, 2013), including product verification, serialization, traceability and detection and response  requirements subject to any exceptions established by or the enforcement discretion of the FDA.            C.3.5.1.5 Following release of the product the contractor shall deliver the product to the designated distribution site   via a qualified distribution vendor in accordance with Section F and paragraph C.7 below. To the extent a natural   disaster or other emergency affecting a designated delivery site restricts such site’s ability to receive product, the   Contractor and the USG will promptly agree on an alternate USG delivery location, or storage as Vendor Managed   Inventory (VMI) at the contractor site.           C.3.5.2   Site Visits and Audits. The contractor shall accommodate periodic or ad hoc site visits by BARDA and  FDA representatives for required site visits and audits at facilities used to support this contract throughout the period  of performance of the contract.            C.3.5.2.1 BARDA Audits. If issues are identified during an audit, the contractor shall submit a report detailing the   finding and corrective action(s) in accordance with CDRL A001.           C.3.5.2.2 FDA Audits. The Contractor shall notify the Contracting Officer and COR within [***] of a scheduled  FDA audit or within [***] of an ad hoc site visit or audit if the FDA does not provide advance notice. The  contractor shall provide copies of any FDA Audit Report received from subcontractors that occur as a result of this  contract or for this product within [***] of receiving correspondence from the FDA or third party in accordance  with CDRL A015. The Contractor shall provide the Contracting Officer with a plan for addressing areas of  nonconformance, if any are identified, within [***] of submittal of the audit report in accordance with CDRL A002.            C.3.5.2.3 FDA Interactions. The contractor shall provide copies of the plan and processes that will ensure the   USG has visibility and input on all FDA communications regarding the drugs and biologics for the following, but   not limited to: FDA interactions, FDA meetings, communications, submissions, inspections, and enforcement   documentation in accordance with CDRL A002.            C.4    CLIN 0002: Data Deliverables. The contractor shall provide the following in accordance with the   Contract Data Requirements List (CDRL), DD Forms 1423, provided at Appendix A.            C.4.1  Monthly Inventory Report (CDRL A003), detailing at a minimum, raw materials, Bulk mRNA, formulated   LNPs, and the fill, finish, and released product.            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 8 of 16                    C.4.2    Quality Management Plan. The contractor shall provide a Quality Management Plan, in accordance with  CDRL A004, describing the quality policy and objectives, management review, competencies and training, process  document control, feedback, evaluation, corrective action and preventive action, process improvement,  measurement, and data analysis processes. The framework is normally divided into infrastructure, senior  management responsibility, resource management, lifecycle management, and quality management system  evaluation.           C.4.3   Shipping Documentation (CDRL A005) for all Finished Drug Product (FDP) transferring from the  contractor’s fill/finish facility to a USG facility. The contractor shall obtain concurrence on planned shipment  protocols prior to transport.           C.4.4   Expiring Items Report (CDRL A006) for all FDP in the USG’s possession.           C.4.5   Key Personnel Listing (CDRL A007).           C.4.6   Monthly Technical Progress Report (CDRL A008), to include an Integrated Master Schedule, identifying  key activities and contract status.           C.4.7   Final Technical Report (CDRL A009), documenting the work performed and results obtained for the entire  contract period of performance.           C.4.8   Supply Chain Resiliency Plan (SCRP). The contractor shall provide, in accordance with CDRL A010 and  CDRL Attachment 0001, a comprehensive SCRP that provides for identification and reporting of critical  components associated with the secure supply of drug substance, drug product, and work-in-process through to  finished goods, and key equipment suppliers and their locations, including addresses, points of contact, and work  performed per location, to include subcontractors.           C.4.9   Risk Management Plan (RMP). The Contractor shall provide an RMP in accordance with CDRL A011 that  outlines the impacts of each risk in relation to the cost, schedule, and performance objectives. The plan shall include  risk mitigation strategies. Each risk mitigation strategy shall capture how the corrective action will reduce impacts  on cost, schedule and performance.           C.4.10  Manufacturing Reports and Dose Tracking. The Contractor shall provide, in accordance with CDRL A013,  manufacturing reports and manufacturing dose tracking projections and actuals utilizing the USG-provided  “COVID-19 Dose Tracking Template” (CDRL Attachment 0003).           C.4.11  Product Acceptance Report (for each lot of Drug Product). The contractor shall provide, in accordance  with CDRL A014, pictures of the drug product with lot number, drug product lot tree, list of associated deviations  (from drug substance and product), and a Certificate of Analysis.           C.4.12 Incident Report. The contractor shall communicate to BARDA and document all critical programmatic  concerns, issues, or probable risks that have or are likely to significantly impact project schedule and/or cost and/or  performance in accordance with CDRL A016. “Significant” is frequently defined as a 10% or greater cost or  schedule variance within a control account, but should be confirmed in consultation with the COR. Incidents that  present liability to the project even without cost/schedule impact, such as breach of GCP during a clinical study,  shall also be reported.           C.4.13 FDA Correspondence. The contractor shall provide any correspondence between Contractor and FDA  relevant to the scope of this contract and submit in accordance with CDRL A017.           C.4.14 Press Releases. The contractor shall accurately and factually represent the work conducted under this  contract in all press releases. The contractor shall provide an advance copy of any press release in accordance with  CDRL A018.            

 

                                                                                       W911QY20C0100                                                                                             (dsoto202575)                                                                                              Page 9 of 16           C.4.15  Manufacturing Development Plan. The contractor shall provide a Manufacturing Development Plan, in  accordance with CDRL A025, describing the manufacturing process for the drug/biologic product to ensure  conformity with §501(a)(2)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code  (USC) §351 (a)(2)(B)), regarding good manufacturing practices (GMP).           C.5  Administration.            C.5.1 Post Award Teleconference. The contractor shall host a Post Award Teleconference within 15 7 calendar   days after contract award.           C.5.1.1 The contractor shall provide an Agenda, IAW CDRL A020, detailing the planned activities for the  subsequent 30 calendar days and shall discuss agenda items for the Post Award Kickoff Meeting.           C.5.1.2 The contractor shall provide Meeting Minutes IAW CDRL A021.            C.5.2 Post Award Kickoff Meeting. The contracting officer may request the contractor host a contract Kick-Off   Meeting within 30 calendar days after contract award via teleconference. The contracting officer shall establish the   date and time of the conference and prepare the agenda to include discussion on contract activities and schedule.            C.5.3 Bi-Weekly Teleconference. The contractor shall participate in bi-weekly teleconferences (or more frequent   meetings required by the USG if warranted based on contract activities) to discuss performance on the contract.           C.5.4 The contractor shall provide an Agenda, IAW CDRL A020; Meeting Minutes in accordance with CDRL  A021; and, Presentation Material in accordance with CDRL A022 for each of the aforementioned teleconferences or   meetings throughout the contract period of performance.           C.5.5 Daily “Check-In”. The contractor shall participate in a daily “check-in” (via teleconference or email) to  address key cost, schedule and technical updates. Daily updates may be shared with senior USG leaders during the  COVID- 19 response and should be provided on a non-confidential basis, unless the update includes confidential  information in which case, the contractor shall provide the update in both confidential and non-confidential formats.  Daily check-ins may occur on weekdays, excluding federal holidays. Upon request of the USG, check-ins may also  occur on weekends and on federal holidays, provided at least 24 hours’  notice.           C.6 Security.            C.6.1 Access and General Protection/Security Policy and Procedures. The contractor shall provide all information   required for background checks necessary to access critical information related to OWS, and to meet USG   installation access requirements to be accomplished by the installation Director of Emergency Services or Security   Office. The contractor employees shall comply with all personnel identity verification requirements as directed by   the USG and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract,   should the security status of OWS change the USG may require changes in the contractor’s security matters or   processes. In addition to the industry standards for employment background checks, the contractor shall be willing   to have key individuals, in exceptionally sensitive positions, identified for additional vetting by the United States   USG.            C.6.2 Security Program and Plan. The contractor shall implement a comprehensive security program that provides   overall protection of personnel, information, data, and facilities associated with fulfilling the USG’s requirement. The   contractor’s security practices and procedures shall be detailed in a Security Plan, in accordance with CDRL A019,   and shall demonstrate how the contractor shall meet and adhere to the security requirements outlined in CDRL   Attachment 0002. This plan shall be delivered to the USG within 45 days of award, and the USG will review in   detail and submit comments within ten (10) business days to the Contracting Officer (CO) to be forwarded to the   Contractor. The Contractor shall review the Security Plan comments, and, submit a final Security Plan to the U.S.   USG within thirty (30) calendar days after receipt of the comments. The Security Plan shall include a timeline for   compliance of all the required security measures outlined in CDRL Attachment 0002.            

 

                                                                                                     W911QY20C0100                                                                                        (dsoto202575)                                                                                         Page 10 of 16             C.6.3 Operational Security (OPSEC). The contractor shall develop and submit an OPSEC Standard Operating   Procedure (SOP)/Plan IAW CDRL A024. The contractor shall identify in the SOP/Plan critical information related   to this contract, why it needs to be protected, where it is located, who is responsible for it, and how to protect it.           C.7  CLIN 0002 Vendor Managed Inventory (VMI). The Contractor shall provide the capability to store the  vaccine for up to 52 weeks, up to 100M doses of mRNA-1273 vaccine, in accordance with product labeling. The  contractor shall, in accordance with paragraph C.3.1.1.6, ensure the product storage of FDP doses for up to 12  months prior to delivery consistent with all FDA requirements to ensure that the product remains available for use in  target populations . [***] The contractor shall store the product to insure product quality with audible alarms and  contacting. The contractor shall notify the USG within [***] of detection of an incident with the potential to impact  product quality, and implement corrective actions to mitigate the incident. . BARDA/JPEO- CBRND personnel may  conduct Quality Audits of the storage facility, when deemed necessary. The contractor shall notify the USG of  Corrective/Preventive actions within [***] of detection of an incident with potential to impacts product quality.  BARDA/JPEO-CBRND personnel may conduct Quality Audits of the storage facility, when deemed necessary.           C.7.1  The USG will provide the contractor advance notice of the required delivery locations for the vaccine. The  contractor shall ship mRNA-1273 vaccines to designated locations in up to [***] in the United States. The  contractor shall be responsible for shipment of all vaccine product whether acceptance is conducted at origin or  destination. [***]                  C.7.2 The vaccine product shall be shipped and tracked by the distribution vendor’s shipping tracking number, to   the USG-designated sites within the continental United States.            C.7.3 [***] Implementation of a Vendor Managed Inventory Plan/SOP (CDRL A012) shall be provided to the   USG. [***] Notwithstanding either of the foregoing sentences, the contractor shall not be liable for loss of or   damage to supplies caused by the negligence of officers, agents, or employees of the USG acting within the scope   of their employment.                                       SECTION G - CONTRACT ADMINISTRATION DATA                      The following have been modified:           G.1  GOVERNMENT CONTRACT ADMINISTRATION           In no event shall any understanding or agreement, contract modification, change order, or other matter in deviation  from the terms of this contract between the Contractor and a person other than the Contracting Officer be effective  or binding upon the Government. All such actions must be formalized by a proper contractual document executed by  the Contracting Officer.                   Procuring Contracting Officer:          Camille Connell-Magaw / [***] / [***]          [***]          [***]            

 

                                                                                                     W911QY20C0100                                                                                        (dsoto202575)                                                                                         Page 11 of 16                    Contract Specialist:          Danny Soto / [***] / [***]          [***]          [***]             G.2 GOVERNMENT TECHNICAL POINT OF CONTACT                   Marva Taylor / [***] / [***]          Biologist/Project Officer          [***]          [***]           G.3  CONTRACTOR’S CONTRACT ADMINISTRATION                   [***]           ModernaTX, Inc.          200 Technology SQ.          Cambridge, MA 02139-3578           G.4  PLACES OF PERFORMANCE                   Moderna US, Inc.          200 Technology SQ.          Cambridge, MA 02139-3578           G.5  NOTIFICATION OF REVISIONS AND CHANGE           Notification of revision or changes to names or email addresses will be provided by official correspondence from the  PCO/ACO or office of the PCO/ACO in lieu of a contract modification. This does not apply to any such revisions or  changes in the event this contract includes a key personnel clause.           G.6 PERFORMANCE BASED PAYMENT           Performance-based payments (PBP) are authorized under this contract in accordance with FAR 52.232-32. The  contractor shall bill for the PBP upon achievement of the completion criteria identified in Attachment 0007,  Performance-based Payment Milestone Table. Upon achievement of the completion criteria, the contractor shall bill  for the PBP for the base and each option IAW the following schedule:                CLIN        PERIOD           AMOUNT    0001AA      BASE              $        90,210,000    0001AB      BASE              $       132,308,000    0001AC      BASE              $       180,420,000    0001AD      BASE              $       198,462,000    TOTAL                         $       601,400,000       [***]       [***]                           [***]    [***]       [***]                           [***]    [***]       [***]                           [***]    [***]                                       [***]       [***]       [***]                           [***]           

 

                                                                                                     W911QY20C0100                                                                                        (dsoto202575)                                                                                         Page 12 of 16                     [***]       [***]                           [***]   [***]       [***]                           [***]   [***]                                       [***]           Delivery Invoicing: PBPs are a type of contract financing and are recouped by the Government through deductions  of payments otherwise due to the contractor for the partial or complete delivery of contract items. The deductions  are made by applying a liquidation rate to the price of delivered contract items. Attachment 0008, Performance-  based Payment Milestone Billing Plan, identifies the contractor invoicing schedule for liquidation. The contractor  shall submit all invoices IAW Attachment 0008.                     252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)                    (a) Definitions. As used in this clause--           “Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit,   activity, or organization.            “Document type” means the type of payment request or receiving report available for creation in Wide Area   WorkFlow (WAWF).            “Local processing office (LPO)” is the office responsible for payment certification when payment certification is   done external to the entitlement system.            “Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of  Payment Requests and Receiving Reports.           (b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests  and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-  7003, Electronic Submission of Payment Requests and Receiving Reports.           (c) WAWF access. To access WAWF, the Contractor shall—            (1) Have a designated electronic business point of contact in the System for Award Management at   https://www.sam.gov; and            (2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration   available at this web site.            (d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training   Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be   accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.            (e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data   Interchange, or File Transfer Protocol.            (f) WAWF payment instructions. The Contractor shall use the following information when submitting payment   requests and receiving reports in WAWF for this contract or task or delivery order:            (1) Document type. The Contractor shall submit payment requests using the following document type(s):    COMBO            

 

                                                                                                     W911QY20C0100                                                                                        (dsoto202575)                                                                                         Page 13 of 16           (ii) For fixed price line items—            (A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting  Officer.           Invoice and receiving report document type                    (B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the  requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the  Contracting Officer.           N/A           (iii) For customary progress payments based on costs incurred, submit a progress payment request.           (iv) For performance based payments, submit a performance based payment request.           (v) For commercial item financing, submit a commercial item financing request.           (2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the  contract.           (3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in   applicable fields in WAWF when creating payment requests and receiving reports in the system.                                                    Routing Data Table             Field Name in WAWF                     Data to be entered in WAWF    Pay Official DoDAAC                     HQ0337    Issue By DoDAAC                         W911QY    Admin DoDAAC**                          S2206A    Inspect By DoDAAC                       W911QY / BARDA    Acceptor                                W911QY    Ship To                                 TDB                     (4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type   of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition   Regulation 52.216-7, Allowable Cost and Payment, as applicable.           (5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.           (g) WAWF point of contact.            (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s  WAWF point of contact.            Orlando Ortiz / DCMA Boston-AFAW, Administrative Contracting Officer / [***]            

 

                                                                                  W911QY20C0100                                                                       (dsoto202575)                                                                        Page 14 of 16          (2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.                                            (End of clause)                           FOR REFERANCE:           DFARS PGI 204.7108 Payment Instructions Table           https://www.acq.osd.mil/dpap/dars/pgi/pgi_htm/current/PGI204_71.htm#payment_instructions                                                                          SECTION I - CONTRACT CLAUSES                    The following have been added by reference:          52.204-25      Prohibition on Contracting for            AUG 2020                 Certain Telecommunications                 and Video Surveillance Services                 or Equipment.                    The following have been modified:           252.232 7007 LIMITATION OF GOVERNMENT'S OBLIGATION (APR 2014)           (a) Contract line item 0003 is incrementally funded. For this item, the sum of $0.00 of the total price is   presently available for payment and allotted to this contract. An allotment schedule is set forth in   paragraph (j) of this clause.           (b) For items(s) identified in paragraph (a) of this clause, the Contractor agrees to perform up to the   point at which the total amount payable by the Government, including reimbursement in the event of   termination of those item(s) for the Government's convenience, approximates the total amount   currently allotted to the contract. The Contractor is not authorized to continue work on those item(s)   beyond that point. The Government will not be obligated in any event to reimburse the Contractor in   excess of the amount allotted to the contract for those item(s) regardless of anything to the contrary in   the clause entitled "TERMINATION FOR THE CONVENIENCE OF THE GOVERNMENT." As used in this   clause, the total amount payable by the Government in the event of termination of applicable contract   line item(s) for convenience includes costs, profit and estimated termination settlement costs for those   item(s).          

 

                                                                                  W911QY20C0100                                                                       (dsoto202575)                                                                        Page 15 of 16                   (c) Notwithstanding the dates specified in the allotment schedule in paragraph (j) of this clause, the   Contractor will notify the Contracting Officer in writing at least ninety days prior to the date when, in   the Contractor's best judgment, the work will reach the point at which the total amount payable by the   Government, including any cost for termination for convenience, will approximate 85 percent of the   total amount then allotted to the contract for performance of the applicable item(s). The notification   will state (1) the estimated date when that point will be reached and (2) an estimate of additional   funding, if any, needed to continue performance of applicable line items up to the next scheduled date   for allotment of funds identified in paragraph (j) of this clause, or to a mutually agreed upon substitute   date. The notification will also advise the Contracting Officer of the estimated amount of additional   funds that will be required for the timely performance of the item(s) funded pursuant to this clause, for   subsequent period as may be specified in the allotment schedule in paragraph (j) of this clause, or   otherwise agreed to by the parties. If after such notification additional funds are not allotted by the   date identified in the Contractor's notification, or by an agreed substitute date, the Contracting Officer   will terminate any item(s) for which additional funds have not been allotted, pursuant to the clause of   this contract entitled "TERMINATION FOR THE CONVENIENCE OF THE GOVERNMENT".           (d) When additional funds are allotted for continued performance of the contract line item(s) identified  in paragraph (a) of this clause, the parties will agree as to the period of contract performance which will  be covered by the funds. The provisions of paragraph (b) through (d) of this clause will apply in like  manner to the additional allotted funds and agreed substitute date, and the contract will be modified  accordingly.           (e) If, solely by reason of failure of the Government to allot additional funds, by the dates indicated  below, in amounts sufficient for timely performance of the contract line item(s) identified in paragraph  (a) of this clause, the Contractor incurs additional costs or is delayed in the performance of the work  under this contract and if additional funds are allotted, an equitable adjustment will be made in the  price or prices (including appropriate target, billing, and ceiling prices where applicable) of the item(s),  or in the time of delivery, or both. Failure to agree to any such equitable adjustment hereunder will be a  dispute concerning a question of fact within the meaning of the clause entitled "disputes."           (f) The Government may at any time prior to termination allot additional funds for the performance of   the contract line item(s) identified in paragraph (a) of this clause.           (g) The termination provisions of this clause do not limit the rights of the Government under the clause  entitled "DEFAULT." The provisions of this clause are limited to work and allotment of funds for the  contract line item(s) set forth in paragraph (a) of this clause. This clause no longer applies once the  contract if fully funded except with regard to the rights or obligations of the parties concerning  equitable adjustments negotiated under paragraphs (d) or (e) of this clause.           (h) Nothing in this clause affects the right of the Government to this contract pursuant to the clause of  this contract entitled "TERMINATION FOR CONVENIENCE OF THE GOVERNMENT."           (i) Nothing in this clause shall be construed as authorization of voluntary services whose acceptance is  otherwise prohibited under 31 U.S.C. 1342.           

 

                                                                                                     W911QY20C0100                                                                                        (dsoto202575)                                                                                         Page 16 of 16            (j) The parties contemplate that the Government will allot funds to this contract in accordance with the   following schedule:            On execution of contract $0.00           Upon successful completion of CLIN 0003 $300,000,000    (End of clause)     SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS                      The following have been modified:                        Document Type                       Description                     Page #         Date    Exhibit A          CDRLs                                                15        18 July 2020    Attachment 0001    Supply Chain Resiliency Plan for CDRL A010           3         23 July 2020    Attachment 0002    Security Plan                                        7         23 July 2020    Attachment 0003    Dose Tracking Template Draft Moderna                Excel     15 July 2020    Attachment 0004    Data Rights                                          3        7 August 2020    Attachment 0005    [***]                                                2        7 August 2020    Attachment 0006    ModernaTx, Inc. Background Intellectual Property     3        6 August 2020    Attachment 0007    Performance Base Payment Milestone Schedule          2        7 August 2020    Attachment 0008    Performance Base Payment Milestone Billing Plan      16       7 August 2020                              (End of Summary of Changes)            

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM  THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.                                                                                                     1. CONTRACT ID CODE    PAGE OF PAGES        AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT                                                                1        3                                      2. AMENDMENT/MODIFICATION NO.            EFFECTIVE        4. REQUISITION/PURCHASE REQ. NO.                5. PROJECT NO.(If applicable)                                                                             DATE                                                                                                                      0011534693                                            11-Sep-2020                                                     6. ISSUED BY                   CODE     W911QY            7. ADMINISTERED BY (If other than item 6)   CODE    S2206A                                                                DEFENSE CONTRACT MANAGEMENT AGENCY     W6QK ACC-APG NATICK DIVISION                               DCMA BOSTON     BLDG 1 GENERAL GREENE AVENUE                               495 SUMMER STREET     NATICK MA 01760-5011                                       BOSTON MA 02210-2138       8. NAME AND ADDRESS OF CONTRACTOR      (No., Street, County, State and Zip Code)            9A. AMENDMENT OF SOLICITATION NO.      MODERNA US, INC.                                                                           [***]                                                                                     9B. DATED (SEE ITEM 11)      200 TECHNOLOGY SQ      CAMBRIDGE MA 02139-3578                                                                                                                                                              10A. MOD. OF CONTRACT/ORDER NO.                                                                                             X  W911QY20C0100                                                                                                10B. DATED (SEE ITEM 13)    CODE   8PTM0                               FACILITY CODE                                 X   09-Aug-2020                                         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 must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:       (a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;       or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR 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 telegramor letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.    12. ACCOUNT ING AND APPROPRIAT ION DATA (If required)                                  13. THIS ITEM APPLIES ONLY TO MODIFICAT IONS OF CONTRACT S/ORDERS.                                   IT MODIFIES THE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.      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).    X C. THIS SUPPLEMENT AL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:      45 CFR part 101, Health Resources and Priorities Allocations System (HRPAS)      D. OTHER (Specify type of modification and authority)      E. IMPORTANT: Contractor       is not, X    is required to sign this document and return 1 copies to the issuing office.     14. DESCRIPTION OF AMENDMENT /MODIFICAT ION     (Organized by UCF section headings, including solicitation/contract subject matter       where feasible.)       Modification Control Number: tscott202802       OBLIGATION AMOUNT: $0.00       See Block 14 continuation page      Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.    15A. NAME AND TITLE OF SIGNER (Type or print)                16A. NAME AND TITLE OF CONT RACTING OFFICER (Type or print)                                                                                                    [***]    Stephane BANCEL, CEO                                            Christine F. Sordillo                                                                 TEL: [***]                      EMAIL:    15B. CONTRACTOR/OFFEROR                 15C. DATE SIGNED     16B. UNIT ED STATES OF AMERICA                     16C. DATE SIGNED      /s/ Stephane Bancel                      9/10/2020          BY  /s/ Christine F. Sordillo                         11 Sept 2020     (Signature of person authorized to sign)                         (Signature of Contracting Officer)     EXCEPTION TO SF 30                                      30-105-04                                     STANDARD FORM 30 (Rev. 10-83)    APPROVED BY OIRM 11-84                                                                                Prescribed by GSA                                                                                                          FAR (48 CFR) 53.243 

 

                                                                                                              W911QY20C0100                                                                                        (tscott202802)                                                                                           Page 2 of 3  SECTION SF 30 BLOCK 14 CONTINUATION PAGE           SUMMARY OF CHANGES                    SECTION SF 30 - BLOCK 14 CONTINUATION PAGE                     The following have been added by full text:           The purpose of this modification is to:           1.  Add a Health Resources Priorities and Allocations System (HRPAS) priority rating of DO-HR to this              contract:                       This is a DO rated contract for the purpose of emergency preparedness and the Contractor shall follow              all the provisions of the Health Resources Priorities and Allocations System regulation (45 CFR Part              101). If the contractor needs to utilize industrial resources to fulfill this rated order for a health              resource, it is authorized pursuant to 45 CFR §101.36(b) to place the same priority rating and program              identification symbol for health resources on its orders for industrial resources with its suppliers.                   2.  Add a Defense Priorites and Allocation System (DPAS) priority rating of DO-C9 to this contract to act              as the equivalent to the HRPAS priority rating of DO-HR.                   3.  Add FAR 52.211-15, Defense Priority and Allocation Requirements                       This is a rated order certified for national defense, emergency preparedness, and energy program use,              and the Contractor shall follow all the requirements of the Defense Priorities and Allocations System              regulation (15 CFR 700).                   4.  Add Attachment 0009 - HRPAS Moderna Letter to Section J           The total funded amount and total contract price remain unchanged.                      SECTION A - SOLICITATION/CONTRACT FORM           The DPAS code DO-C9 has been added.           The contractor organization has changed from                   MODERNATX, INC.                   [***]                    200 TECHNOLOGY SQ                   CAMBRIDGE MA 02139-3578                    to                   MODERNA US, INC.                   [***]                    200 TECHNOLOGY SQ                   CAMBRIDGE MA 02139-3578                      SECTION I - CONTRACT CLAUSES 

 

                                                                                                              W911QY20C0100                                                                                        (tscott202802)                                                                                           Page 3 of 3           The following have been added by full text:           52.211-15   DEFENSE PRIORITY AND ALLOCATION REQUIREMENTS (APR 2008)            This is a rated order certified for national defense, emergency preparedness, and energy program use, and the  Contractor shall follow all the requirements of the Defense Priorities and Allocations System regulation (15 CFR  700).           (End of clause)                     SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS                     The following have been modified:                        Document Type                        Description                      Page #         Date    Exhibit A           CDRLs                                                 15        18 July 2020    Attachment 0001     Supply Chain Resiliency Plan for CDRL A010            3         23 July 2020    Attachment 0002     Security Plan                                         7         23 July 2020    Attachment 0003     Dose Tracking Template Draft Moderna                 Excel      15 July 2020    Attachment 0004     Data Rights                                           3        7 August 2020    Attachment 0005     [***]                                                 2        7 August 2020    Attachment 0006     ModernaTx, Inc. Background Intellectual Property      3        6 August 2020    Attachment 0007     Performance Base Payment Milestone Schedule           2        7 August 2020    Attachment 0008     Performance Base Payment Milestone Billing Plan       16       7 August 2020    Attachment 0009     HRPAS Moderna Letter                                  1       3 September 2020                              (End of Summary of Changes)

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00316-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00316-of-00352.parquet"}]]