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EX-10.2 3 lonzamodernagltafullye.htm EX-10.2
EXHIBIT 10.2
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THISEXHIBIT 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 eﬀec ve as of May 1, 2020 (the “Eﬀec ve 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”), andModernaTX, Inc., with an address at 200 Technology Square, Cambridge, MA 02139 USA (“MODERNA” or “CLIENT”) (each, a “Party”
and, collec vely, the “Par es”).
RECITALSA.
MODERNA possesses extensive intellectual property, proprietary technology and exper se with respect to theresearch, development, manufacture and formula on of messenger RNA (mRNA) therapeu cs and vaccines;
B.
LONZA possesses world class manufacturing and process exper se in biologics manufacturing consistent with cGMP
(as deﬁned below);C.
MODERNA and LONZA entered into that certain Strategic Collabora on Agreement, dated as of April 30, 2020,
pursuant to which the Par es entered into a mul -year global long term strategic collabora on (the “SCA”);
D.
The SCA contemplates that the Par es 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 facili es for clinical and commercial
supply;E.
The Par es (or their respec ve Aﬃliates) desire to enter into individual Statements of Work for various workstreams,
as further deﬁned below.
NOW, THEREFORE, in considera on of the foregoing and the mutual promises and covenants hereina er set forth, LONZA and
MODERNA, intending to be legally bound, hereby agree as follows:
AGREEMENT1.

DEFINITIONSWhen 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. “Addi onal Products” means any products owned or controlled by MODERNA or its Aﬃliates (other than the Covid
Products) that are mutually agreed by the Par es and iden ﬁed in the relevant Statement of Work.

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“Aﬃliate” means, with respect to either Party, any other corpora on, partnership or business en ty that directly, or
indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes ofthis deﬁni on, the term “control” and, with correla ve meanings, the terms “controlled by” and “under common control with” means
direct or indirect ownership of at least ﬁ y percent (50%) of the securi es or other ownership interests represen ng the equity vo ng
stock or general partnership or membership interest of such en ty or the power to direct or cause the direc on of the management or
policies of such en ty, whether through the ownership of vo ng securi es, by contract, by corporate governance, resolu on,
regula on or otherwise.
b.
“Agreement” means this Global Long Term Agreement, together with all Exhibits, Schedules and Appendices a achedhereto, and all Statements of Work issued in connec on therewith, in each case as amended or restated from me to me by the
Par es.
c.
“Applicable Laws” means all relevant interna onal, federal, provincial, state and local laws, statutes, rules, regula ons,
direc ves, ordinances, codes and guidelines promulgated by any relevant Governmental Authority, whether currently in existence orherea er promulgated, that are applicable to a Party’s ac vi es 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 Sec on 2.6.2.

e.

“BARDA Contract” has the meaning set forth in Sec on 2.6.2.

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

“Batch Record” means the produc on record pertaining to a Batch.

h.

“Business Con nuity Plans” has the meaning set forth in Sec on 17.2.

i.
“Business Day” means any day other than a Saturday or Sunday on which banking ins tu ons in New York, NY and
Visp, Switzerland are open for business.
j.
“Calendar Quarter” means the respec ve periods of three (3) consecu ve 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 theEﬀec ve Date and end at the end of the Calendar Quarter in which the Eﬀec ve Date occurs and (b) the last Calendar Quarter of thisAgreement shall commence at the commencement of such Calendar Quarter and end on the expira on 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 Eﬀec ve 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
expira on of the Term.

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Documenta.
“Cer ﬁcate of Analysis” means a document signed by an authorized representa ve of LONZA, cer fying that a
par cular Batch of Product was Manufactured in accordance with the Quality Agreement, Applicable Law and the Speciﬁca ons.
b.
“Cer ﬁcate of Tes ng” means a document signed by an authorized representa ve of LONZA, cer fying that certain
tests iden ﬁed by MODERNA or mutually agreed upon in wri ng by the Par es and conducted by LONZA on a Batch of Product meetsall Speciﬁca ons.
c.
“cGMP” or “GMP” means the then-current good manufacturing prac ces, standards, guidelines and regula ons
promulgated and published by the FDA, EMA and such other jurisdic on agreed upon by the Par es in wri ng, rela ng to the tes ng,
manufacturing, processing, packaging, holding or distribu on of drug substances and ﬁnished drugs including any standards, guidelines
and regula ons as promulgated by, as applicable: (a) the FDA under and in accordance with the U.S. Federal Food, Drug and Cosme c
Act and Title 21, Parts 210 and 211 of the U.S. Code of Federal Regula ons, (b) the EMA and the EU Commission under European
Direc ve 2003/94/EC, and/or (c) the ICH Harmonised Tripar te Good Manufacturing Prac ce Guide For Ac ve Pharmaceu cal
Ingredients (ICH Q7), as such standards, guidelines and regula ons may be amended from me to me.
d.
“cGMP Batch” means any Batch which is required under the relevant Statement of Work to be Manufactured inaccordance with cGMP.
e.

“Change Order” has the meaning set forth in Sec on 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 ofServices, including the Manufacture of the Product.
h.

“Conﬁden al Informa on” has the meaning set forth in Sec on 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 toaccess and use such Know- How, patent or other intellectual property right as provided for in this Agreement, without viola ng theterms of any agreement or other arrangement with any Third Party in existence as of the me such Party would be required hereunderto grant such license, sublicense, or rights of access and use.
j.
“Covid Products” means (a) MODERNA’s proprietary mRNA constructs and lipid nanopar cles for a poten al vaccine
against SARS-CoV-2, including mRNA-1273 (including any improved or modiﬁed version thereof, “mRNA-1273”), and (b) any othermRNA Constructs or lipid nanopar cles (i) for the treatment or preven on of infec on by SARS-CoV-2 and (ii) iden ﬁed 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 jurisdic ons.

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Documenta.

“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 todemonstrate 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 rela ng to (a) safety (including occupa onal health and safety); protec on of human health and theenvironment; (b) the introduc on of any chemical substances into the stream of commerce; and (c) the genera on, use, storage,
handling, treatment, transporta on or disposal of waste.
d.
“EUA” means an Emergency Use Authoriza on, which is an authoriza on 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 Sec on 564(b)(1) of the FD&C Act, or a comparable
accelerated, condi onal or temporary Regulatory Approval.
e.

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

f.

“Exclusivity Term” means, [***].

g.
“Execu ve Oﬃcers” means, with respect to MODERNA, its Chief Execu ve Oﬃcer, and, with respect to LONZA, itsChief Execu ve Oﬃcer.
h.
“Exis ng SOWs” means any Statements of Work entered into by the Par es prior to the execu on of this Agreement,
including (a) Statement of Work Nr. 1, eﬀec ve as of April 20, 2020, a ached hereto as Appendix A-1, (b) Statement of Work Nr. 2,
eﬀec ve as of May 13, 2020, a ached hereto as Appendix A-2, and (c) Statement of Work Nr. 3, eﬀec ve as of May 13, 2020, a achedhereto as Appendix A-3.
i.
“Facility” means any of LONZA’s facili es located in [***], or such addi onal facili es that the Par es may mutuallyagree upon, as

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iden ﬁed in the relevant Statement of Work. In all cases, the Facility(ies) to be u lized 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 Cosme c Act (21 U.S.C. § 301 et seq.), as amended from me tome, together with any rules, regula ons and requirements promulgated thereunder (including all addi ons, supplements, extensions,and modiﬁca ons thereto).
b.

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

c.

“Flow-Down Provisions” has the meaning set forth in Sec on 2.6.

d.

“Force Majeure Event” has the meaning set forth in Sec on 18.2.

e.
“Governmental Authority” means any applicable government authority, court, tribunal, agency, department,
legisla ve body, commission, authority, or other instrumentality of any na onal, supra-na onal, state, county, city, or other poli cal
subdivision.
f.

“Indemnitee” has the meaning set forth in Sec on 16.3.1.

g.

“Indemnitor” has the meaning set forth in Sec on 16.3.1.

h.

“JMT” has the meaning set forth in Sec on 3.2.1.

i.

“JSC” has the meaning set forth in Sec on 3.1.1.

j.
“Know-How” means all non-public technical, scien ﬁc, and other know-how and informa on, trade secrets,knowledge, technology, means, methods, processes, prac ces, formulae, instruc ons, skills, techniques, procedures, experiences,
ideas, designs, drawings, assembly procedures, so ware, computer programs, apparatuses, speciﬁca ons, data, results and materials,
including: biological, chemical, vaccine-related, pharmacological, toxicological, pharmaceu cal, physical and analy cal, pre-clinical,
clinical, safety, manufacturing and quality control data and informa on, including study designs and protocols, assays, and biologicalmethodology, in all cases, whether or not copyrightable or patentable, in wri en, electronic or any other form now known or herea erdeveloped.
k.
“Lien” means any legal charge, debenture, mortgage, deed of trust, security interest, pledge, lien, assignment, or otherencumbrance of any kind whether imposed by contract, Applicable Law or otherwise, whether ﬁxed or ﬂoa ng, or conferring priorityof payment.

l.
“Lipid Nanopar cle” means any delivery technology for mRNA or other nucleic acids using solid par cles at room
temperature, of 50-1,000 nm size, consis ng of solid lipids or a mixture of a solid lipid and a liquid lipid.
m.

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

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Documenta.
“LONZA Equipment” means all equipment and machinery for which LONZA or its Aﬃliates shall hold tle and that isused 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 prac ce in connec on with this Agreement that is [***].
c.
“LONZA Opera ng Documents” means the standard opera ng procedures, standard manufacturing procedures, rawmaterial speciﬁca ons, protocols, valida on documenta on, and suppor ng documenta on used by LONZA, such as environmental
monitoring, for opera on and maintenance of the Facility and LONZA Equipment used in the process of producing the Product, and anyother LONZA documents containing informa on required to be provided to a Regulatory Authority in connec on with obtaining
Regulatory Approval of a Product, excluding any of the foregoing that are unique to the Manufacture of Product.
d.

“LONZA Par es” has the meaning set forth in Sec on 16.2.

e.

“LONZA Personnel” has the meaning set forth in Sec on 7.12.

f.
“LONZA Process Equipment” all LONZA Equipment that is process equipment and is designated by the Par es as“LONZA Process Equipment” in the relevant Statement of Work or other wri en agreement by the Par es, or in the list of equipment
maintained by the JMT as set forth in Sec on 3.2.2(f). For clarity, Lonza Process Equipment excludes process equipment that iscustomized or proprietary to Moderna.
g.
“LONZA Technology” means all Technology of LONZA (a) exis ng prior to the eﬀec ve 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 conﬁden al
informa on 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 Sec on 16.1.

i.
“Manufacture” and “Manufacturing” means any steps, processes and ac vi es necessary to produce Product,
including the produc on, manufacture, synthesis, processing, packaging, labeling, quality control tes ng, 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 qualiﬁca on and valida on, scale-up, analy c development, productcharacteriza on, stability tes ng, 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 havecorresponding meanings.

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“Materials” means all raw materials, components (including packaging materials), and other poten al 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 Sec on 3.1.1.

c.
“MODERNA Equipment” means all equipment or machinery designated by the Par es as “MODERNA Equipment” inthe relevant Statement of Work or other wri en agreement by the Par es, or in the list of equipment maintained by the JMT as set
forth in Sec on 3.2.2(f).
d.
“MODERNA Improvement” means all Technology conceived, discovered, invented, developed, created, made or
reduced to prac ce in connec on with this Agreement [***].
e.
“MODERNA Manufacturing Know-How” means Know-How Controlled by MODERNA or its Aﬃliates, which ismaintained in conﬁdence by MODERNA or its Aﬃliates, rela ng to the manufacturing of a given Product, including documenta oncons tu ng material support, performance advice, shop prac ce, speciﬁca ons as to materials to be used, control methods, standard
opera ng procedures, protocols, descrip ons of the manufacturing process and related know-how, development reports, analy cal
methods, equipment size/name/customiza ons/components, valida on reports, cleaning methods and batch records and any otherinforma on, in each case, that is (a) necessary or reasonably useful to manufacture such Product in accordance with the applicableSpeciﬁca ons or (b) disclosed to LONZA or its Aﬃliates by or on behalf of MODERNA or its Aﬃliates in connec on with this Agreement,
including any Statement of Work.
f.

“MODERNA Materials” has the meaning set forth in Sec on 7.1.

g.

“MODERNA Personnel” has the meaning set forth in Sec on 7.11.1.

h.
“MODERNA Technology” means all Technology Controlled by MODERNA or its Aﬃliates(a) exis ng prior to the eﬀec ve 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 conﬁden al informa on of LONZA. For clarity, the MODERNA
Technology includes (i) the Product and any Product-intermediates, components or deriva ves of Product, (ii) star ng materials andany intermediates, components or deriva ves of star ng materials, (iii) Speciﬁca ons, (iv) Test Methods and(v) Process.
i.

“mRNA-1273” has the meaning set forth in the deﬁni on of “Covid Products”.

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

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“mRNA Product” means a pharmaceu cal or vaccine product that includes, incorporates or contains as an ac ve
ingredient one (1) or more mRNA Constructs (whether alone or in combina on with one or more other ac ve ingredients).
b.

“OFAC” has the meaning set forth in Sec on 17.4.2.

c.
“Person” means any natural person, corpora on, unincorporated organiza on, partnership, associa on, sole
proprietorship, joint stock company, joint venture, limited liability company, trust or government, or Governmental Authority, or any
other similar en ty.
d.
“Process” means any and all processes and ac vi es (or any step in any process or ac vity) 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
Addi onal Products.
f.
“Project Documenta on” means the compila on of documenta on generated or to be generated by LONZA in
prepara on of and during the performance of the relevant Statement of Work, including, without limita on, executed Batch Records,
component records, test records and test record forms, Cer ﬁcates of Analysis, Cer ﬁcate of Tes ng, release documenta on, study
protocols, study summary reports, devia on reports, laboratory inves ga ons, environment excursions, formula on records, and otherrelated documents, which show that the Product was Manufactured in accordance with the Quality Agreement, Applicable Law and theSpeciﬁca ons, 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 conjunc on with this Agreement
to establish the quality requirements applicable to Manufacture in accordance with applicable guidelines issued by the Regulatory
Authori es that control authoriza on and licensing for manufacture and sale of pharmaceu cal or medicinal products.
h.
“Regulatory Approval” means the approval by any Regulatory Authority to market and sell the Products in therespec ve markets, including any pricing approval. For clarity, Regulatory Approvals include EUAs and other accelerated, condi onal or
temporary authoriza ons or approvals.
i.
“Regulatory Authority” means the Service and Product relevant interna onal, federal, provincial, state or local
governmental or regulatory bodies, agencies, departments, bureaus, courts or other en es responsible for (a) the regula on(including pricing) of any aspect of pharmaceu cal or medicinal products intended for human use, including the FDA, EMA, UnitedStates Drug Enforcement Agency or any other interna onal, federal, state or local regulatory bodies, agencies, departments, bureaus,
courts or other en es responsible for the regula on of drugs, (b) gran ng approvals for the performance of Services under thisAgreement or for issuing regula ons pertaining to the manufacturing or use of products, or (c) health, safety or environmental ma ers
generally.
j.

“Sanc ons” has the meaning set forth in Sec on 17.4.3.

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

b.
“Services” means the ac vi es to be performed by LONZA hereunder that are agreed to by the Par es 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 opera ng procedure.

d.
“Speciﬁca ons” means, for a given Product, the list of tests, references to any analy cal procedures and acceptancecriteria 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 orotherwise approved by MODERNA in wri ng, as well as dispensing and labeling informa on, as such speciﬁca ons are amended or
supplemented from me to me by MODERNA in wri ng.
e.
“Statement of Work” or “SOW” means any wri en plan to perform Services that has been agreed to by the Par es
and executed by an authorized representa ve of each Party. Each Statement of Work will be in the form of the template a achedhereto as Appendix B (“SOW Template”), and will include, at a minimum, a reference to this Agreement, a descrip on of the natureand scope of the Services to be performed, a metable 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 ini al Statement of Work is a ached hereto as Appendix A. Each
Exis ng 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 taxa on, levy, duty, charge, social security charge, contribu on or withholding ofwhatever nature (including any related ﬁne, penalty, surcharge or interest) imposed by, or payable to, a Tax Authority, and has theaddi onal meaning set forth in Sec on 9.4.
g.
“Technology” means all patents, patent applica ons, inven ons, trade secrets, copyrights, know-how, methods,
processes, techniques, improvements, data, technical documenta on, manuals, regulatory submissions, speciﬁca ons, SOPs,
instruc ons, and other intellectual property of any kind (whether or not protected or protectable under patent, trademark, copyrightor similar laws).
h.
“Technology Transfer” means the transfer of Know-How, documenta on, speciﬁca ons, SOPs, analy cal methods andprocess valida on documents related to MODERNA’s Process or Product by MODERNA to LONZA for the development of the Project
Documenta on for the Manufacture of the Product speciﬁcally for MODERNA or its Aﬃliates.
i.
“Test Methods” means any assays or other test methods iden ﬁed by MODERNA in the relevant Statement of Work, oras amended or modiﬁed in any Change Order.
j.

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

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Documenta.

“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 connec on with any Services.

1.
STATEMENTS OF WORK - PROCESS AND PRODUCT DEVELOPMENT; PROCESS OR PRODUCT MANUFACTURE; FLOW-DOWN PROVISIONS; QUALITYAGREEMENTa.
Statement of Work. Prior to performing any Process or Product development, Technology Transfer, or Product
Manufacture, the Par es will collaborate to prepare a Statement of Work describing the ac vi es to be performed by the Par es (or tobe subcontracted by LONZA to one or more Third Par es in accordance with Sec on 2.5). In the event of a conﬂict between the terms
and condi ons of this Agreement and any Statement of Work, the terms and condi ons of this Agreement shall control.
b.
Modiﬁca on of Statement of Work. Should MODERNA want to change a Statement of Work or to include addi onal
Services to be provided by LONZA, including any changes to the Speciﬁca ons, 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 addi onal
Services (each a “Change Order”). LONZA will provide MODERNA with a Change Order containing a descrip on of the required
modiﬁca ons to the relevant Statement of Work, and any proposed changes to the pricing or other fees as well as impact on melines
as a result of such modiﬁca ons, and will use diligent eﬀorts to do so within [***] of receiving such no ce from MODERNA. LONZA may
also propose a Change Order to MODERNA, and MODERNA will use diligent eﬀorts to answer to such proposal within [***] of receivingsuch proposal. If the proposed Change Order is not acceptable to the receiving Party, the Par es will promptly nego ate in good faith a
Change Order that is mutually acceptable. LONZA shall con nue to work under this Agreement (including under the exis ng Statementof Work) during any such nego a ons. LONZA shall use commercially reasonable eﬀorts to accommodate any of MODERNA’srequested changes, provided if a change is required by any Regulatory Authority on or a er 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 Par es only if it is signed byboth Par es. Therea er such modiﬁed version of the Statement of Work will be deemed to have replaced the prior version of theStatement of Work. Notwithstanding the foregoing, if a modiﬁed version of the Statement of Work is not agreed to by both Par es, theexis ng Statement of Work shall remain in eﬀect, unless terminated by MODERNA in accordance with this Agreement or the exis ng
Statement of Work.
c.
Performance by LONZA. Subject to the provision by MODERNA of the MODERNA Materials pursuant to Sec on 7.1,
LONZA (directly or through one or more Third Par es in accordance with Sec on 2.5) will use diligent eﬀorts to perform, subject to theterms of the relevant Statement of Work, the work described in such Statement of Work in a professional manner in accordance withprevailing industry standards, the terms of this Agreement, the terms of the relevant Statement of Work (including the es matedmelines set forth therein), and all Applicable Laws. LONZA will promptly no fy

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MODERNA of any material poten al or actual delays that arise or are an cipated during the performance of the Statement of Work,and will diligently work to mi gate any such delays.
a.
Aﬃliates. Each Party shall have the right to extend the rights, licenses, immuni es and obliga ons 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 liabili es, of its Aﬃliates. In addi on, anAﬃliate 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 por ons of the relevant Statement of Work underwhich the Aﬃliate will be performing speciﬁed Services or obliga ons. The Aﬃliate shall be en tled to enforce this Agreement withrespect to such Statement of Work, or as applicable the relevant por ons 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 obliga ons and liabili es undertaken pursuant to such
Statement of Work and subject to the terms and condi ons of this Agreement. Without limi ng the foregoing, all Statements of Workwill be executed by the appropriate legal en es of the Par es, including as may be required to comply with any speciﬁc requirementsof governments, governmental agencies or other Third Par es that are funding, purchasing or distribu ng the Covid Products.
b.
Subcontrac ng. With MODERNA’s prior wri en consent, LONZA may subcontract the performance of speciﬁc
obliga ons 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 iden ﬁes the subcontractor and the speciﬁc Services to be performed by the subcontractor or
MODERNA separately approves such Third Party contractor in wri ng, and (b) the subcontractor performs such Services or obliga ons
under the relevant Statement of Work in a manner consistent with the terms and condi ons of this Agreement and such Statement ofWork. Except as otherwise agreed upon in a Statement of Work, LONZA will be solely responsible for the performance of any permi ed
subcontractor, and for Losses arising out of such performance as if such performance had been provided by LONZA itself under thisAgreement or the relevant Statement of Work. LONZA will cause any such permi ed subcontractor to be bound by, and to comply with,the terms of this Agreement or the relevant Statement of Work, including all conﬁden ality, intellectual property, recordkeeping, audit
and inspec on, quality assurance, regulatory and other obliga ons 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 Sec on 2.5, [***].
c.

Flow-Down Provisions.

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The Par es acknowledge and agree that the Manufacturing of certain Products or the performance of certain
Services may be subject to restric ons 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 obliga ons
under such Flow-Down Provisions as incorporated in its prime contract.
ii.
Without limi ng the generality of the foregoing, the Par es 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”). Addi onally, the Par es 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 theServices are being performed in connec on with a BARDA Contract, the Flow-Down Provisions included in A achment C hereto shallapply with respect to such Services. [***].
a.
Quality Agreement. Promptly following the Eﬀec ve Date, the Par es shall nego ate in good faith and enter into a
Quality Agreement on terms to be mutually agreed by the Par es. If reasonably determined necessary by LONZA, the par es shallenter into separate Quality Agreements for diﬀerent Facili es. LONZA shall Manufacture and supply the Product in accordance with the
Quality Agreement as reasonably updated by the Par es from me to me, notably to take into considera on any marke ng
authoriza on(s) for Product. In the event of a conﬂict between any of the provisions of this Agreement and the Quality Agreement withrespect to quality-related ac vi es, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the eventof a conﬂict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial ma ers,
including alloca on of risk, liability and ﬁnancial responsibility, the provisions of this Agreement shall govern.
1.

GOVERNANCE

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Joint Steering Commi ee.

i.
Immediately following the Eﬀec ve Date, the Par es shall establish a joint steering commi ee (“JSC”) to
oversee, review, approve and coordinate the ac vi es of the Par es 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 wri enno ce to the other Party.
ii.

The JSC shall be responsible for:iii.

The JSC shall meet [***][***]

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i.
a.

[***]

Joint Manufacturing Team.

i.
Within [***] of the Eﬀec ve 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 exper se and responsibili es appropriate(in terms of their seniority, availability, func on in their respec ve organiza ons, training and experience) for the tasks then being
undertaken. Each Party shall designate one of its representa ves as its primary contact for JMT ma ers (such Party’s “Team CoLeader”). A Party may replace any or all of its representa ves (and designated Team Co-Leader) at any me by informing the other
Team Co-Leader in advance, in wri ng (which may be by email).
ii.

The JMT shall be responsible for:[***]https://www.sec.gov/Archives/edgar/data/1682852/000168285220000023/lonzamodernagltafullye.htm

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The JMT shall meet [***].

ii.
The Par es 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 wri ng by the Par es 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 ques ons
regarding the JMT’s authority to review and approve modiﬁca ons to Statements of Work within parameters prescribed by the JSC, theJMT’s responsibili es are not subject to the oversight of, or escala on to, the JSC in the event of any dispute or disagreement between
the Par es.
a.
Limita ons of Authority. Each Party will retain the rights, powers and discre on granted to it under this Agreement
and no such rights, powers, or discre on will be delegated to or vested in the JSC or JMT, unless such delega on or ves ng of rights isexpressly provided for in this Agreement or the Par es expressly so agree in wri ng. Except as provided in Sec on 3.1.2 and Sec on
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 Par es’ rights or obliga ons under this Agreement, including any Statement ofWork, beyond those explicitly set forth in this Agreement, including any Statement of Work, (c) determine that a Party has fulﬁlled any
obliga ons under this Agreement or that a Party has breached any obliga on under this Agreement, including any Statement of Work,or (d) make a decision that is expressly stated to require the mutual agreement of the Par es or for which MODERNA or LONZA haveﬁnal decision making authority.
1.

TECHNOLOGY TRANSFERa.
Based on the informa on provided by MODERNA and including process deﬁni on or changes mutually agreed by the
Par es pursuant to the relevant Statement of Work, LONZA will prepare the Project Documenta on for the applicable Process inaccordance with the schedule set forth in the relevant Statement of Work and the Speciﬁca ons, the LONZA Opera ng Documents andany wri en instruc ons provided by MODERNA (provided that LONZA shall be required to comply with such wri en instruc ons only ifsuch instruc ons comply with cGMP requirements, data integrity speciﬁca ons or commitments made by MODERNA to the applicable
Regulatory Authori es). MODERNA will inform LONZA of any speciﬁc requirements MODERNA may have rela ng to the Project
Documenta on, including, without limita on, any informa on or procedures MODERNA wishes to have incorporated therein. The
applicable Project Documenta on, as set forth in the relevant Statement of Work, shall be completed and delivered by LONZA at
comple on of a Batch.
b.
LONZA will not use or incorporate any non-commercially available materials, Technology, LONZA Technology or LONZA
Improvements in connec on with the performance of any Services or the

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Process, unless such non-commercially available materials, Technology, LONZA Technology or LONZA Improvements are speciﬁcally agreed
to by the Par es and iden ﬁed in the relevant Statement of Work, including the applicable terms and condi ons of the use orincorpora on 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 Documenta on and Process, including, without limita on, by providing LONZA with addi onal informa on and procedures as
may be required to create the Project Documenta on, Process, and/or any of the following: (a) manufacturing process informa on,
SOPs, development reports, (b) quality control assays and related method valida on reports, (c) raw material speciﬁca ons (including
vendor, grade and sampling/tes ng requirements), (d) Product and sample packing and shipping instruc ons, and (e) Product-speciﬁccleaning and decontamina on informa on.
d.
LONZA will deliver a dra version of the applicable por ons of the Project Documenta on to MODERNA for its review
and approval in accordance with the meline set forth in the relevant Statement of Work. MODERNA will no fy LONZA in wri ng of any
objec ons it has to the dra Project Documenta on, and upon such no ﬁca on, representa ves of LONZA and MODERNA will meet
promptly in good faith to resolve such objec ons. LONZA will incorporate all reasonable comments from MODERNA in the Project
Documenta on. Upon MODERNA’s wri en acceptance of the dra Project Documenta on, such dra will be deemed approved by
MODERNA. Any failure by MODERNA to accept in wri ng any agreed-upon Project Documenta on within [***] of receipt will bepromptly be escalated to the JSC.
e.
The Process, Project Documenta on, Speciﬁca ons, and any improvements or modiﬁca ons thereto developed during
the Term, but excluding any LONZA Opera ng Documents, LONZA Technology, LONZA Improvements or LONZA Conﬁden al
Informa on included in any of the foregoing, will be deemed MODERNA Conﬁden al Informa on and subject to the provisions set
forth in Ar cle 10.
f.
For clarity, LONZA will use the LONZA Opera ng Documents in the Process or the Project Documenta on, but LONZA
represents and warrants that LONZA Opera ng Documents are not necessary for MODERNA or a Third Party contract manufacturer toManufacture Product as it is assumed that MODERNA or a Third Party contract manufacturer would have its own opera ng documents
and SOPs. LONZA shall make LONZA Opera ng Documents available to support MODERNA or its Third Party contract manufacturer[***].

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Document

MODERNA EQUIPMENT.

a.
Relevant Terms. Each Statement of Work shall include the terms and condi ons 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 PRODUCTa.
MODERNA Materials. Within the me 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 produc on of the
Product, and any handling instruc ons, protocols, SOPs and other documenta on necessary to maintain the proper es of suchmaterials for the performance of the Services (collec vely, the “MODERNA Materials”). The MODERNA Materials are the Conﬁden al
Informa on 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 theServices or in accordance with the meline set forth in the relevant Statement of Work, and, in the event of any such delay, LONZA willuse commercially reasonable eﬀorts to accommodate any requests by MODERNA to adjust the meline 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 speciﬁca ons, all materials in adequate
quan es to be used by LONZA for the Manufacture of the Product and the performance of Services (“LONZA Supplied Materials”).
The Par es agree that LONZA is responsible for the procurement of LONZA Supplied Materials, including with respect to transpor ng,
tes ng, inspec ng and storing the LONZA Supplied Materials; maintaining systems for management of LONZA Supplied Materials; andmaintaining 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 du es to procure and maintainadequate 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 Par es. 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 me 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 withthe es mated melines set forth in such Statement of Work, all in accordance with the terms set forth in Sec on 7.6 below. LONZA
shall, at its own cost and expense, ensure that at all mes the applicable Facility is in a qualiﬁed and validated state appropriate forinclusion as a Manufacturing site for the Products, as

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required by the applicable Regulatory Authori es, Applicable Laws and the Speciﬁca ons 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 compliancewith any applicable regulatory requirements of a Regulatory Authority at any me 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 theforegoing, a Statement of Work may include terms and condi ons rela ng to delays of the Commencement Date for a Product or otherdelays, including discounts, cancella on rights and other terms and condi ons rela ng to any such delay.
a.
Maintenance and Opera on. LONZA agrees to operate and maintain the Facili es and all LONZA Equipment used,directly or indirectly, to Manufacture Products, or, if applicable, to perform the Services, in accordance with the applicableSpeciﬁca ons 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 opera ng eﬃciency.
b.
Qualiﬁca on and Valida on. LONZA shall be responsible for valida ng the LONZA Equipment used for supply of
Product or, if applicable, performance of the Services (including conduc ng installa on, opera onal and performance qualiﬁca on),and the produc on, cleaning and, to the extent applicable, packaging processes, as well as all other appropriate steps performed at the
Facili es. All ac vi es 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 valida on procedures to be unacceptable, then LONZA willtake (or have taken) appropriate remedial measures, including repea ng the valida on as necessary, such that the valida onprocedures meet all applicable regulatory requirements and guidelines, including those necessary to receive all Regulatory Authority
approvals. If any of LONZA’s valida on procedures fail to comply with cGMP or the Speciﬁca ons, LONZA shall promptly remedy such
failure in order to comply with all cGMP and Speciﬁca ons. Furthermore, LONZA shall also be responsible for valida ng the MODERNA
Equipment under the terms set forth above when agreed upon in the relevant Statement of Work.
c.
Cancella on of a Statement of Work. Each Statement of Work shall provide the termina on or cancella on fees forsuch Statement of Work, if any (the “Cancella on Fees”).
d.
Payment of Cancella on Fee and Costs. Each Statement of Work shall provide the payment terms for any applicable
Cancella on 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 instruc ons provided in wri ng (e.g. storage and transport condi ons). 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 theUnited States.
f.
Records. LONZA will maintain complete and accurate records rela ng 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 willretain possession of the Project

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Documenta on, LONZA Opera ng Documents and all other records, and will promptly provide copies of the Project Documenta on
and all other records other than the LONZA Opera ng 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 Documenta on or other records to any Third Party without the prior
wri en approval of MODERNA. LONZA Opera ng Documents will remain LONZA Conﬁden al Informa on. [***]. LONZA shall also
provide such other informa on and assistance as MODERNA may reasonably request in connec on with the comple on of andsubmission of applica ons for Regulatory Approvals for Products and the maintenance thereof. MODERNA has the right to use andreference any of the foregoing, or any DMF covering the foregoing, in connec on with any request from any Regulatory Authori es orwith 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 wri en request by MODERNA or its Aﬃliate or
Sublicensee, provide to the reques ng party and to any speciﬁed Regulatory Authority a le er, in the form reasonably required by thereques ng party, acknowledging that the reques ng 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) (collec vely, “MODERNA Personnel”) in each Facility may
par cipate in the Manufacture of the Product only in such capaci es as set forth in the relevant Statement of Work or as may beapproved in wri ng in advance by LONZA, such approval not to be unreasonably withheld, condi oned or delayed; provided, however,
that, upon [***] prior wri en no ce to LONZA, MODERNA Personnel shall have the right to be present at the Facility to observe the
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LONZA’s Opera ng 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 comple on of technology transfer and stabiliza on of Manufacturing ac vi es, MODERNA Personnel may not physicallypar cipate in the produc on 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 compensa on for such MODERNA Personnel (including
applicable Federal, state and local withholding, FICA and other payroll taxes, workers’ compensa on insurance, health insurance, andother similar statutory and fringe beneﬁts). MODERNA covenants and agrees to maintain workers’ compensa on beneﬁts andemployers’ 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 resul ng from ordinary wear and tear.
iii.
MODERNA Personnel visi ng or having access to the Facility will abide by LONZA standard policies, opera ng
procedures and the security procedures established by LONZA and provided to such MODERNA Personnel prior to any visits or accessto the Facility. MODERNA will be liable for any breaches of security by MODERNA Personnel. In addi on, 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 conﬁden ality agreement.
iv.
MODERNA will indemnify and hold harmless LONZA from and against any and all losses, damages, liabili es,
costs and expenses (including reasonable a orneys’ 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 ofany LONZA Party or resul ng 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”) visi ng or
having access to any MODERNA facility will abide by MODERNA standard policies, opera ng 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 forany breaches of security by LONZA Personnel. In addi on, 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 conﬁden ality agreement.

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Disclaimers. The LONZA Par es will not engage in any Product improvement, modiﬁca on or reﬁnement, orManufacturing or development of the Product, other than as expressly set forth in this Agreement and each relevant Statement ofWork. Except as set forth in a relevant Statement of Work, each Party acknowledges and agrees that the LONZA Par es have notpar cipated in the inven on or tes ng of any Product, and have not evaluated its safety or suitability for use in humans or otherwise.
1.

REGULATORY MATTERSa.
Permits and Approvals. LONZA will ensure that any and all permits, licenses, registra ons, and approvals required by
Applicable Law have been obtained in connec on with each Facility and LONZA Equipment used in connec on 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 opera ng
eﬃciency consistent with industry standard prac ces and all Applicable Law. LONZA will only use disposal services or sites that haveappropriate environmental permits and are in compliance with Applicable Law.
b.
Regulatory Approvals. MODERNA shall own all Regulatory Approvals, permits, authoriza ons and cer ﬁcatesnecessary 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 prepara on of such regulatory ﬁlings, Regulatory Approvals, permits,authoriza ons and cer ﬁcates necessary for the use of Products or DMFs, including providing such informa on and data, including
CMC informa on and data, as may reasonably be requested by MODERNA, as further detailed in the relevant Statement of Work or as
agreed by the Par es in wri ng. The DMF for the Facility shall be owned by LONZA.
c.

Inspec ons.

i.
Subject to the terms of the Quality Agreement with respect to Services and Product and upon not less than[***] prior wri en no ce, or shorter period of me as may be reasonable given the circumstances, LONZA will permit MODERNA or its
representa ves 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, opera ons, 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 Par es). MODERNA Personnel engaged in such inspec on
will abide by the terms and condi ons set forth in Sec ons 7.11 and Ar cle 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) qualiﬁca on procedures, risk assessments, audit
reports or supplier ques onnaires, and associated correc ve ac ons; 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 informa on necessary for
MODERNA’s regulatory ﬁlings with respect to the Product or conﬁrma on that such an audit

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has been performed. LONZA’s quality assurance department shall cooperate with MODERNA, as necessary or useful, in any suchinspec on conducted pursuant to this Sec on 8.3.
i.
In addi on to the foregoing, MODERNA and/or its representa ves shall have the right to perform “For Cause”
audits as o en as required at any me upon not less than [***] advance no ce, or shorter period of me 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 obliga ons incompliance 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 addi on to those audit rights of MODERNA under this Sec on 8.3, LONZA shall permit audits to be
conducted by or on behalf of a bona ﬁde actual or prospec ve 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
representa ves of such Third Party during such audit.
iii.
In the event MODERNA iden ﬁes any deﬁciency with respect to LONZA’s opera ons or ac vi es related to oraﬀec ng the Services, Product or the Manufacture of Product or performance of any Services during any such inspec on, audit, or
review, MODERNA shall have the right to no fy LONZA of such deﬁciency, and, in such case, (a) the Par es will discuss in good faith
suitable approaches for correc ng such observa ons, and (b) LONZA shall, within [***] from the date of receipt of such no ce, deliverto MODERNA a correc ve ac on plan, addressing each such deﬁciency (including melines therefor). Upon acceptance of thecorrec ve ac on plan by MODERNA (which acceptance shall not be unreasonably withheld), LONZA shall fully implement suchcorrec ve ac on plan to the reasonable sa sfac on of MODERNA. MODERNA shall have the right to review all relevant documenta on
in connec on with such deﬁciency and correc ve ac on.
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 inspec on (or failure to inspect) shall not relieve LONZA of its obliga on to comply with
Applicable Laws and the provisions this Agreement, the relevant Statement of Work and the Quality Agreement and does notcons tute a waiver of any right otherwise available to MODERNA. In addi on, for cri cal 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 foraudi ng such suppliers; provided that in the event LONZA is prohibited from providing such reports, ﬁndings or procedures, at
MODERNA’s request, LONZA will provide conﬁrma on that an audit took place and a summary of ﬁndings.

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For each Facility, in addi on to the audit rights above, MODERNA shall have the right to audit the Facility
when such Facility is ready for and prior to ini a on of cGMP Manufacturing for MODERNA hereunder.
a.
No ﬁca on of Regulatory Authority Ac on. Each Party shall promptly no fy the other Party of any no ce such Party
receives regarding any threatened or pending ac on by any Regulatory Authority regarding the Manufacture of Product, including any
Regulatory Authority non-approval or regulatory ac on. Upon receipt of any such informa on, the Par es shall consult in an eﬀort toarrive at a mutually acceptable procedure for taking appropriate ac on; provided, however, that nothing contained herein shall be
construed as restric ng the right of either Party to make a mely report of such ma er to any Regulatory Authority or take other ac onthat it deems to be appropriate or required by Applicable Law.
b.
Complaints. LONZA shall immediately no fy MODERNA of any complaints received by LONZA concerning a Productsupplied hereunder. LONZA shall inves gate complaints as requested by MODERNA and shall take correc ve ac on to avoid future
occurrences.
c.
Regulatory Authority Inspec ons. LONZA shall advise MODERNA immediately (but in no event less than [***] prior toa pre-no ﬁed or scheduled visit or inspec on) of any Regulatory Authority visit or inspec on that relates to Product or the
Manufacture thereof at any Facility, or any wri en or oral inquiries by such Regulatory Authority concerning Product (including safety
and eﬃcacy claims) or the Manufacture thereof at any Facility. LONZA will permit representa ves of any Regulatory Authority toinspect 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 Documenta on, Batch Records or other records to verify
compliance with cGMP and other Applicable Laws and will promptly no fy MODERNA of the scheduling of any such inspec on rela ng
to the Services, including Manufacture of Product. MODERNA shall be permi ed to be on site and available for ques ons regarding the
Product during any such inspec on or audit. LONZA shall promptly (and in no event later than [***]) no fy MODERNA of the results ofany such inspec on, and furnish MODERNA summaries of all reports, documents and correspondence with respect to any Regulatory
Authority inquiries, visits or inspec ons, as well as a copy of each report, document and correspondence issued by or provided to any
Regulatory Authority in connec on 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 mutuallyacceptable response to the extent related to Product, provided that if the Par es fail to mely 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 limi ng
the foregoing, LONZA shall furnish to MODERNA, (a) within [***] a er receipt, any report or correspondence issued by the Regulatory
Authority in connec on with such visit, inspec on or inquiry, including any FDA Form 483, Establishment Inspec on Report, or warning
le er, and (b) copies of any and all responses or explana ons to any Regulatory Authority rela ng to items set forth above prior to thesubmission of such responses or explana ons to any Regulatory Authority by LONZA. LONZA shall comply with all reasonable requests
and comments by MODERNA with respect to all responses or explana ons to, or contacts and communica ons, with any Regulatory
Authority rela ng in any way to the Products or Services, and shall immediately inform MODERNA in the event any Regulatory

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Authority takes any regulatory ac on 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 anevent, incident or circumstance has occurred which may result in the need for a “recall”, “market withdrawal” or “ﬁeld alert” ofProduct, as such terms are deﬁned in the United States Code of Federal Regula ons 21 CFR § 7.3 and 21 CFR§ 314, or other Applicable
Law or regula on of a country (a “Recall”), such Party shall advise and consult with the other Party regarding such event. MODERNA
shall be responsible for implemen ng and administering any Recall, in its sole discre on [***]. LONZA shall provide reasonableassistance to MODERNA in conduc ng a recall or withdrawal, including providing MODERNA with all reasonably per nent records andinforma on. If the par es dispute whether such Recall was primarily due to LONZA providing defec ve Product, then either party may
seek the determina on of whether the Product was defec ve Product in accordance with the relevant Statement of Work.
b.
Waste. In connec on with the Manufacture of Product hereunder or the performance of the Services, LONZA shall besolely responsible, at its cost and expense, for maintaining safety procedures in connec on with the Manufacture of Product (or the
performance of the Services, as applicable) and for the genera on, treatment, storage and/or disposal of Waste rela ng thereto, all ofwhich shall comply with all Applicable Law, including all applicable environmental and occupa onal safety and health requirements inthe jurisdic on of the Facility.
1.

FINANCIAL TERMSa.

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 tohttps://www.sec.gov/Archives/edgar/data/1682852/000168285220000023/lonzamodernagltafullye.htm

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Document[***], and/or to such other e-mail address(es) as MODERNA may s pulate from me to me. LONZA will not deliver a paper invoice.
Payment of each invoice is due within [***] a er MODERNA’s receipt of such invoice. Unless otherwise provided in the relevant
Statement of Work, all pricing excludes taxes and costs rela ng to shipping, valida on 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 men oned 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 amountpayable under this agreement, the amount payable hereunder shall be increased so that a er making all required deduc ons and/or
withholdings, LONZA receives an amount equal to the amount it would have received had no such deduc ons or withholdings beenmade. Notwithstanding anything to the contrary herein, if there should be any withholding tax imposed by the applicable jurisdic ons
on LONZA with respect to any payments to be made by MODERNA to LONZA under or in connec on with this Agreement, MODERNA isallowed to deduct such withholding taxes from the payments to LONZA and pay such withholding taxes to the appropriate tax
authori es on behalf of LONZA. Regarding the discharged withholding tax, MODERNA will submit to LONZA the corresponding original
tax cer ﬁcates or original tax receipts stamped by the receiving local tax authority within [***] a er such withholding obliga on isdischarged. Notwithstanding the foregoing, upon presenta on by LONZA to MODERNA of the relevant tax documenta on indica ng a
reduc on in or exemp on from withholding tax for LONZA in such taxing jurisdic on pursuant to the provisions of the relevant double
taxa on treaty, MODERNA shall withhold such tax at the reduced rate (or not withhold any tax if there is an exemp on) applicable tosuch payment in such taxing jurisdic on. .
b.
Interest. Any undisputed fee, charge or other payment due to LONZA by MODERNA under this Agreement that is not
paid within [***] a er it is due will accrue interest on a daily basis at a rate of [***] (or the maximum legal interest rate allowed byapplicable law, if less) from and [***] a er MODERNA receives a no ce from LONZA that such fee, charge or other payment has notbeen paid.
c.
Method of Payment. Except as otherwise set forth in Sec on 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 Par es in the relevant
Statement of Work and will be by check, wire transfer, money order, or other method of payment approved by LONZA. Bank
informa on for wire transfers will be provided in the relevant Statement of Work.

d.
Cost Improvements. Promptly a er a Product has been launched, LONZA will in good faith con nuously seek toimprove and reduce direct material costs, direct opera ng labor costs and indirect expenses a ributable to the manufacture of the
Product throughout the term of this Agreement and, at the request of MODERNA, provide MODERNA with wri en evidence
demonstra ng the eﬀorts and ac vi es 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 ma ers

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that inﬂuence the price MODERNA pays for the Product and determine whether any price decreases may be appropriate. Upon therequest of MODERNA, LONZA will provide to MODERNA reasonable evidence of any and all improvements as they are achieved and of
the availability of any poten al improvements hereunder. LONZA agrees to reﬂect and incorporate into this Agreement achieved pricereduc ons realized by LONZA a er the eﬀec ve date of such price change. MODERNA and LONZA will set speciﬁc key performanceindicators deﬁning ming and percent reduc on for the manufacture of the Product (“KPIs”) once a Product has been launched. KPIs
may include, but are not limited to, manufacturing opera ons (including inventory reduc ons, process improvement, and lead- mes),sourcing, interna onal opera ons and logis cs, and business prac ces. 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 INFORMATIONa.
Deﬁni on. “Conﬁden al Informa on” means all technical, scien ﬁc and other know- how and informa on, trade
secrets, knowledge, technology, means, methods, processes, prac ces, formulas, instruc ons, skills, techniques, procedures,
speciﬁca ons, data, results and other material, pre- clinical and clinical trial results, manufacturing procedures, test procedures andpuriﬁca on and isola on techniques, and any tangible embodiments of any of the foregoing, and any scien ﬁc, manufacturing,marke ng and business plans, any ﬁnancial and personnel ma ers rela ng 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 otherParty or the other Party’s Aﬃliates either in connec on with the discussions and nego a ons pertaining to this Agreement or in thecourse of performing this Agreement. Without limi ng the foregoing, (a) the terms of this Agreement as well as all informa on
pertaining to the rela onship between the Par es will be deemed “Conﬁden al Informa on” of both Par es, and as such both Par es
will be treated as the receiving Party, (b) the Products, all MODERNA Technology, MODERNA Manufacturing Know-How, MODERNA
Improvements, MODERNA Equipment, MODERNA Materials, Project Documenta on, Speciﬁca ons, all Regulatory Approvals for the
Products and all DMFs for the Products are Conﬁden al Informa on of MODERNA, (c) all LONZA Technology, LONZA Opera ng
Documents and LONZA Improvements are Conﬁden al Informa on of LONZA, and, in each case, will be subject to the terms andcondi ons set forth in this Ar cle 10 (except to the extent necessary for MODERNA to exercise its rights or obliga ons under thisAgreement, including any relevant Statement of Work, including in connec on with the licenses granted by LONZA to MODERNA in
Sec on 11.2).
b.
Exclusions. Notwithstanding the foregoing Sec on 10.1, any informa on disclosed by a Party to the other Party will not
be deemed “Conﬁden al Informa on” of the disclosing Party to the extent that such informa on:(a) at the me of disclosure is in the public domain;(b)

becomes part of the public domain, by publica on or otherwise, through no fault of the receiving

Party or its Aﬃliates;

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at the me of disclosure is already in possession of the receiving Party or its Aﬃliates on a nonconﬁden al basis, as established by contemporaneous wri en records;b.
is lawfully provided to a Party, without restric on as to conﬁden ality or use, by a Third Party
lawfully en tled to possession of such Conﬁden al Informa on; orc.
is independently developed by a Party without use of, reliance upon or reference to the other Party’s
Conﬁden al Informa on, as established by contemporaneous wri en records.
a.
Disclosure and Use Restric on. Except as expressly provided herein, the Par es agree that for the Term and the ten(10)-year period following any expira on or termina on of the Agreement, each Party and its Aﬃliates will keep completely
conﬁden al and will not publish or otherwise disclose any Conﬁden al Informa on of the other Party, its Aﬃliates or sublicensees,
except in accordance with Sec on 10.4; provided, however, that the obliga ons under Sec on 10.5 with respect to MODERNA
Manufacturing Know-How or any other trade secret informa on in the MODERNA Conﬁden al Informa on or LONZA Conﬁden al
Informa on will survive in perpetuity. Neither Party will use Conﬁden al Informa on of the other Party except as necessary to perform
its obliga ons, or in the case of MODERNA to exercise its rights, under this Agreement.
b.
Permi ed Disclosures. Subject to Sec on 10.5, each receiving Party agrees to (i) ins tute and maintain security
procedures to iden fy and account for all copies of Conﬁden al Informa on of the disclosing Party and (ii) limit disclosure of thedisclosing Party’s Conﬁden al Informa on to its Aﬃliates and each of its and their respec ve oﬃcers, directors, employees, agents,
consultants and independent contractors having a need to know such Conﬁden al Informa on for purposes of this Agreement,
including, with respect to MODERNA, to subcontractors and other Third Par es as necessary or reasonably useful for the purpose of
performing MODERNA’s obliga ons or exercising its rights hereunder in ﬁling or reques ng Regulatory Approvals or communica ons
with Regulatory Authori es as set forth in Sec on 7.10; provided that such Aﬃliates and each of its and their respec ve oﬃcers,
directors, employees, agents, consultants and independent contractors are informed of the terms of this Agreement and are subject toobliga ons of conﬁden ality, non-disclosure and non-use similar to those set forth herein. Notwithstanding the foregoing, (a) suchConﬁden al Informa on may be disclosed to (1) actual (sub)licensees, collaborators or partners, and its and their directors, oﬃcers,
employees, agents or advisors (including accountants, a orneys, consultants, bankers, ﬁnancial advisors and members of advisoryboards), or (2) any bona ﬁde poten al or actual ﬁnancing sources, investors, underwriters or acquisi on partners (including a orneys,accountants, consultants, bankers or ﬁnancial advisors of the foregoing), in each case ((1)-(2)) who reasonably require suchinforma on, who are informed of the conﬁden al nature of such informa on and are bound by non-use and conﬁden ality obliga ons
with respect to such informa on (which may include, solely with respect to a orneys and accountants, professional ethicalobliga ons); and [***].

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MODERNA Manufacturing Know-How. Notwithstanding anything herein to the contrary, the Par es recognize thatmaintaining the conﬁden ality and trade secret nature of the MODERNA Manufacturing Know-How requires an even higher level ofvigilance than other Conﬁden al Informa on. LONZA shall: (i) maintain MODERNA Manufacturing Know-How in conﬁdence with thesame degree of care with which LONZA holds its own like conﬁden al manufacturing informa on, (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 ac vi es 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 ofWork and for no other purpose. LONZA will apply appropriate ﬁrewall protec ons 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 conduc ng ac vi es rela ng 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 wri en consent of MODERNA, whichconsent will be at MODERNA’s sole discre on. For clarity, Sec on 10.4 will not apply to any MODERNA Manufacturing Know-How.
b.
Government-Required Disclosure. If a duly cons tuted Governmental Authority, court or Regulatory Authority ordersthat a Party hereto disclose informa on subject to an obliga on of conﬁden ality under this Agreement, such Party shall comply withthe order, but shall no fy 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 conﬁden al treatment thereof, and therea er such Party shall disclose only theminimum informa on 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 conjunc on with any other words or names, in any manner or connec on whatsoever, including any publica on,ar cle, or any form of adver sing or publicity, except with the prior wri en consent of the other Party or as otherwise set forth in thisSec on 10.7.
ii.
Neither Party may issue any press release or make any other public announcement or statement concerning
this Agreement, the transac ons contemplated hereby or the terms hereof, without the prior wri en 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 otherpublic statement disclosing informa on rela ng to this Agreement, the transac ons contemplated hereby or the terms hereof, theIssuing 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 wri en consent; provided that no such consent shall be required for press releases orother public statements required by Applicable Law (but the Issuing Party shall s ll provide the Reviewing Party with a copy of theRelease for comment in accordance with this Sec on 10.7). The Issuing Party will specify with each such Release, taking into accountthe urgency of the ma er being disclosed, a reasonable period of me 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, theReviewing Party will be deemed to have not consented to the issuance of such Release. If the Reviewing

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Party provides any comments, the Par es will consult on such Release and work in good faith to prepare a mutually acceptable
Release. Either Party may subsequently publicly disclose any informa on previously contained in any Release so consented to.
i.
Notwithstanding Sec on 10.7.2 or anything herein to the contrary, MODERNA’s obliga on to submit any press
release or other public announcement or statement concerning this Agreement to LONZA for prior wri en approval will not apply to
any press release or other public announcement or statement regarding the achievement of any milestone iden ﬁed in a Statement ofWork, including regarding Process or Product development, Technology Transfer, or Process or Product Manufacture.
a.
Securi es Filings; Law. Each Party acknowledges and agrees that the other Party may submit this Agreement to theUnited States Securi es and Exchange Commission (the “SEC”) or any other securi es exchange and if a Party does submit thisAgreement to the SEC or any other securi es exchange, such Party agrees to consult with the other Party with respect to the
prepara on and submission of, a conﬁden al treatment request for this Agreement. If a Party is required by Applicable Law to make adisclosure of the terms of this Agreement in a ﬁling with or other submission to the SEC or any other securi es 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 prac cable under the circumstances, (ii) such Party has promptly no ﬁed the other Party in wri ng
of such requirement and any respec ve ming constraints, and (iii) such Party has given the other Party a reasonable amount of me
under the circumstances from the date of no ce by such Party of the required disclosure to comment upon, request conﬁden al
treatment or approve such disclosure, then such Party will have the right to make such public disclosure at the me and in the mannerreasonably 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 Sec on 10.8, and the other Party provides
comments within the respec ve me periods or constraints speciﬁed herein or within the respec ve no ce, the Party seeking to makesuch disclosure or its counsel, as the case may be, will in good faith consider incorpora ng 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, tle, 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 prac ce or made in connec on with the performance under thisAgreement shall follow inventorship all as determined under Applicable Laws.
ii.
Subject to LONZA’s right, tle and interest in and to any and all LONZA Improvements, MODERNA shall own all
right, tle, and interest in and to any and all MODERNA Improvements. LONZA hereby assigns to MODERNA (or its designee), without
addi onal compensa on, all of LONZA’s right, tle and interest in and to such MODERNA Improvements. LONZA shall promptly discloseto MODERNA in wri ng all MODERNA Improvements. LONZA shall execute, and shall require its

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personnel as well as its Aﬃliates, or other contractors or agents and their personnel involved in the performance of this Agreement toexecute, 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 Sec on 11.2.2, LONZA shall own all right, tle 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 rightto grant sublicenses, under any and all MODERNA Technology, MODERNA Manufacturing Know-How, and MODERNA Improvementsthat are necessary for LONZA to perform its obliga ons under this Agreement for the sole and limited purpose of LONZA’s performanceof its obliga ons under this Agreement and the relevant Statements of Work, including, without limita on, the development of theProcess (if and to the extent applicable in the relevant Statements of Work) and the Manufacture of Product for MODERNA as set forthin the relevant Statements of Work. Except as set forth in this Sec on 11.2.1, Lonza shall not by virtue of this Agreement acquire any
right, license or tle in or to any MODERNA Technology, MODERNA Manufacturing Know-How, MODERNA Improvements, Products orProcess.
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 theevent 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 benecessary for MODERNA or a Third Party contract manufacturer to Manufacture Products or would otherwise require MODERNA toobtain 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 opera ng documents and standard opera ng procedures (“LONZA Opera ng
Documents”) in performing the Services but LONZA Opera ng 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
opera ng documents and standard opera ng procedures. LONZA Opera ng 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 Ar cle 11.
c.

Prosecu on of Patents.

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LONZA will have the sole right and discre on to ﬁle, prosecute and maintain patent applica ons and patents
claiming LONZA Technology or LONZA Improvements at LONZA’s expense.
ii.
MODERNA will have the sole right and discre on to ﬁle, prosecute and maintain patent applica ons andpatents claiming MODERNA Technology or MODERNA Improvements at MODERNA’s expense. LONZA will cooperate with MODERNA toﬁle, prosecute and maintain patent applica ons 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, theforegoing exclusivity shall not preclude MODERNA or its Aﬃliates from: [***].
12.3 [***]
2.

REPRESENTATIONS, WARRANTIES AND COVENANTSa.
By MODERNA. MODERNA hereby represents and warrants to LONZA as of the Eﬀec ve Date that, to the best of its
knowledge, ((a)) it has the requisite intellectual property related to the MODERNA Technology and MODERNA Manufacturing KnowHow to enable the performance of LONZA’s obliga ons under this Agreement, and ((b)) the performance of the Services and the
produc on by LONZA of the Product as contemplated in this Agreement will not infringe the intellectual property rights of any Third
Party. Such representa on and warranty will not apply to any LONZA Equipment to the extent that such LONZA Equipment is the solebasis 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 Eﬀec ve
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 obliga ons 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 combina on 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 inconnec on with this Agreement the services of any individual, corpora on, partnership, or associa on which has been debarred,
excluded, or disqualiﬁed by the FDA or any other applicable Regulatory Authority. In the event that LONZA receives no ce of thedebarment or

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threatened debarment, exclusion or disqualiﬁca on or threatened disqualiﬁca on, of any individual, corpora on, partnership or
associa on providing services to LONZA, which relate to its ac vi es under this Agreement, including any Statement of Work, LONZA
shall no fy MODERNA in wri ng as soon as prac cable.
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 tle, free and clear of any pledge, lien, restric on, 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, restric ons, claims, charges, security interests and/or otherencumbrances at the me of delivery.
1.

DISCLAIMER; LIMITATION OF LIABILITYa.
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 RESPECTTO SUCH PRODUCTS, MATERIALS, OR SERVICES.
b.
Disclaimer of Consequen al Damages. EXCEPT [***], IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER ORANY 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 INCONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
c.
Limita on 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 EXTENTTHAT 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

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MODIFIED TO PROVIDE THE MAXIMUM PROTECTION FOR LONZA AS IS ALLOWABLE UNDER APPLICABLE LAW.
1.

TERM AND TERMINATIONa.
Term. The term of this Agreement will commence on the Eﬀec ve Date and will con nue un l the tenth (10th)
anniversary of the Eﬀec ve Date unless terminated prior to that me or extended by the Par es (the “Ini al Term”). This Agreement
will automa cally renew for successive addi onal periods of two (2) years (collec vely with the Ini al Term, the “Term”) unless
MODERNA provides wri en no ce to LONZA at least [***] prior to the end of the then-current Term that it declines to extend theTerm. The term of each SOW shall be set forth in such SOW.
b.
Termina on for Material Breach. Either Party may terminate this Agreement, by wri en no ce to the other Party, forany material breach of this Agreement by the other Party, if such breach is not cured within [***] a er the breaching Party receives
wri en no ce of such breach from the non-breaching Party; provided, however, that if such breach is not capable of being cured withinsuch thirty-day period and the breaching Party has commenced and diligently con nued ac ons to cure such breach within such thirtyday period, except in the case of a payment default, the cure period shall be extended to 90 days, so long as the breaching Party ismaking diligent eﬀorts to do so. Such termina on shall be eﬀec ve upon expira on of such cure period; provided that in the event thatthe breaching Party disputes in good faith the non-breaching Party’s grounds for termina ng this Agreement pursuant to this Sec on
15.2, then the Par es shall refer such dispute for resolu on in accordance with Sec on 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 termina onrights set forth in this Sec on 15.2 apply to just such SOW, rather than to this Agreement generally.
c.
Termina on Without Cause. MODERNA may terminate any SOW by providing wri en no ce of termina on no lessthan [***] in advance of the date of termina on. For the avoidance of doubt, in the event of termina on of any SOW by MODERNA
under this Sec on 15.3, MODERNA shall remain liable for all fees owed pursuant to such Statement of Work.
d.
Termina on by Insolvency. Either Party may terminate this Agreement upon no ce to the other Party, upon (a) the
dissolu on, termina on of existence, liquida on 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 ins tu on by the other Partyof any proceeding under na onal, federal or state bankruptcy, reorganiza on, receivership or other similar laws aﬀec ng the rights ofcreditors generally or the making by such Party of a composi on or any assignment for the beneﬁt of creditors under any na onal,
federal or state bankruptcy, reorganiza on, receivership or other similar law aﬀec ng 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 bedeemed to be, for purposes of Sec on 365(n) of Title 11 of the United States Code, licenses of rights of “intellectual property” asdeﬁned therein.
e.

Eﬀects of Termina on.

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Accrued Rights. Termina on 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 termina on. Such termina on will not relieve a Party of obliga onsthat are expressly indicated to survive the termina on of this Agreement or such SOW. Without limita on of the foregoing, in the eventof termina on of this Agreement or an SOW, LONZA shall be compensated for any Cancella on Fees (if any) in accordance with therelevant Statements of Work. In the case of termina on by LONZA for MODERNA’s material breach in accordance with Sec on 15.2, allscheduled Services and Batches shall be deemed cancelled by MODERNA, and Cancella on Fees set forth in the relevant Statements ofWork shall be calculated as of the date of wri en no ce of termina on.
ii.
Disposi on of Remaining MODERNA Property and Conﬁden al Informa on. Upon termina on or expira onof this Agreement, LONZA will, at MODERNA’s op on, return or destroy any MODERNA Conﬁden al Informa on in the possession orcontrol of LONZA. Likewise, MODERNA will, at LONZA’s op on, return or destroy any LONZA Conﬁden al Informa on in the possession
or control of MODERNA. Notwithstanding the foregoing provisions: (i) LONZA may retain and preserve, in a secure manner, at its solecost and expense, samples and standards of each Product following termina on or expira on of this Agreement as required by
Applicable Law solely for use in determining LONZA’s rights and obliga ons hereunder; (ii) MODERNA may retain and preserve, in asecure manner, any LONZA Conﬁden al Informa on following termina on or expira on of this Agreement (A) for use in determining
MODERNA’s rights and obliga ons hereunder, (B) as necessary, in connec on 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 Conﬁden al
Informa on for documenta on purposes only and which shall remain subject to the obliga ons of nonuse and conﬁden ality set forthin this Agreement.
15.5.3 Survival. Sec ons 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 expira on
or termina on of this Agreement.
1.

INDEMNIFICATION; INSURANCEa.
Indemniﬁca on of MODERNA. LONZA will indemnify MODERNA, its Aﬃliates, and their respec ve directors, oﬃcers,
employees and agents, and defend and hold each of them harmless, from and against any and all losses, damages, liabili es, costs andexpenses (including reasonable a orneys’ fees and expenses) in connec on with any and all actual or alleged liability suits,inves ga ons, claims or demands (collec vely, “Losses”) to the extent such Losses arise out of or result from any claim, lawsuit orother ac on or threat by a Third Party arising out of: [***].
b.
Indemniﬁca on of LONZA. MODERNA will indemnify LONZA and its Aﬃliates, and their respec ve directors, oﬃcers,
employees and agents (the “LONZA Par es”), and defend and hold each of them harmless, from and against any and all Losses to theextent such Losses arise out of or result fromhttps://www.sec.gov/Archives/edgar/data/1682852/000168285220000023/lonzamodernagltafullye.htm

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

Indemniﬁca on Procedure.

i.
An “Indemnitor” means the indemnifying Party. An “Indemnitee” means the indemniﬁed Party, its Aﬃliates,
and their respec ve directors, oﬃcers, employees and agents.
ii.
An Indemnitee which intends to claim indemniﬁca on under Sec on 16.1 or Sec on 16.2 hereof shallpromptly no fy the Indemnitor in wri ng of any claim, lawsuit or other ac on in respect of which the Indemnitee, its Aﬃliates, or anyof their respec ve directors, oﬃcers, employees and agents intend to claim such indemniﬁca on. The Indemnitee shall permit, andshall cause its Aﬃliates and their respec ve directors, oﬃcers, employees and agents to permit, the Indemnitor, at its discre on, tose le any such claim, lawsuit or other ac on and agrees to the complete control of such defense or se lement by the Indemnitor;
provided, however, that in order for the Indemnitor to exercise such rights, such se lement shall not adversely aﬀect the Indemnitee’srights under this Agreement or impose any obliga ons on the Indemnitee in addi on to those set forth herein. No such claim, lawsuitor other ac on shall be se led without the prior wri en 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 respec ve directors, oﬃcers,
employees and agents shall cooperate fully with the Indemnitor and its legal representa ves in the inves ga on and defense of any
claim, lawsuit or other ac on covered by this indemniﬁca on, all at the reasonable expense of the Indemnitor. The Indemnitee shallhave the right, but not the obliga on, to be represented by counsel of its own selec on and expense.

b.
Insurance. Each Party shall, during the term and for [***] a er the expira on of the last Product delivered under thisAgreement (including any Statement of Work), obtain and maintain, at its own cost and expense and from a qualiﬁed insurancecompany, comprehensive general liability insurance including, but not limited to, contractual liability coverage and standard productliability coverage in an amount commensurate with industry standards. These insurance requirements are not intended to limit a
party’s indemniﬁca on obliga ons 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 opera ons coverage – limitsof [***]; (b) Workers Compensa on/Employers Liability – statutory with minimum Employers Liability limit of [***]; (c)Commercial Umbrella Liability - [***]; and (d) Network Security/Cyber Liability - [***]. Each Party will provide the otherParty with at least [***] wri en no ce prior to termina on or amendment of such any applicable insurance policy.

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Document

ADDITIONAL COVENANTS

a.
Non-Solicita on. 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 [***] therea er; provided that nothing herein will prevent theemployment by a Party of individuals who ini ate contact with such Party, and such Party will not be in viola on of the non-solicita on
restric on as a result of making a general solicita on for employees or independent contractors or employing individuals who respondto such solicita ons. For the avoidance of doubt, the publica on of an adver sement will not cons tute solicita on or inducement.
b.
Business Con nuity Plan. LONZA acknowledges the importance to MODERNA of an uninterrupted supply of Products.
Based on the informa on available at the Eﬀec ve Date, LONZA has, and reasonably expects that despite the COVID-19 Pandemic it will
con nue to have the available capacity and staﬀ designated “essen al workers” under Applicable Laws to perform Services andManufacture and supply Product under this Agreement. Further, LONZA has a formal business con nuity plan detailing LONZA’s plans,
procedures and designated resources for mely response to and recovery from poten al civil, natural, and physical plant disasters that
could reasonably be expected to disrupt LONZA’s performance of services, including Services under this Agreement, and addi onal
plans covering poten al disrup on that might arise in connec on with the COVID-19 Pandemic (“Business Con nuity Plans”). During
the Term, LONZA will promptly no fy MODERNA in wri ng of any poten al disrup on to the performance of the Services or the
Manufacturing and supply of the Products.
c.

An -Corrup on 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 representa ves of any government or interna onal public organiza on. Each party to thisAgreement 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 compensa on derived from this Agreement, to government or poli cal party oﬃcials,
oﬃcials of interna onal public organiza ons, candidates for public oﬃce, or representa ves of other businesses or persons ac ng on
behalf of any of the foregoing where such payment would cons tute a viola on of any Applicable Laws, whether by LONZA, MODERNA,
or any other party.
ii.
Each Party to this Agreement shall comply with all applicable laws rela ng to the import, export, reexport,
and transfer of items and technologies subject to the Scope of Work of this Agreement, including without limita on the U.S. Export
Administra on Regula ons of the Bureau of Industry and Security of the U.S. Department of Commerce, the U.S. economic sanc ons
administered by the U.S. Department of the Treasury’s Oﬃce of Foreign Assets Control (“OFAC”), the import and customs laws of theUnited States, and all trade laws of any other Governmental Authority of competent jurisdic on.
iii.
None of the Par es to this Agreement, including their respec ve Aﬃliates, nor any Person or en ty ac ng on
behalf of any of the foregoing, (a) is currently the subject or the target of any Sanc ons, (b) is located, organized or resident in acountry, territory or geographical region that ishttps://www.sec.gov/Archives/edgar/data/1682852/000168285220000023/lonzamodernagltafullye.htm

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itself the subject of Sanc ons (including, without limita on, Cuba, Iran, North Korea, Sudan, Syria, and the Crimea region of Ukraine) or
whose government is the subject or target of Sanc ons, (c) is named in any Sanc ons-related list maintained by the U.S. Department ofState, the U.S. Department of Commerce, or the U.S. Department of the Treasury, including but not limited to the Specially Designated
Na onals and Blocked Persons List maintained by OFAC and the Denied Persons, En ty, and Unveriﬁed Lists maintained by the Bureau
of Industry and Security, (d) is, otherwise, by public designa on of the United Na ons Security Council, the European Union, Her
Majesty’s Treasury, or other equivalent, applicable Governmental Authority, the subject or target of any Sanc ons, (e) is a Person withwhich any United States person is prohibited from dealing or otherwise engaging in any transac on by any applicable law or regula on,(f) is owned or controlled by Persons described in clauses (a) through (e) or is otherwise the subject of Sanc ons, or (g) conducts any
business or engages in, or has conducted any business or engaged in, making or receiving any contribu on of goods, services or money
to or for the beneﬁt of any Person, or in any country or territory that is the subject of Sanc ons, other than in compliance with
Sanc ons laws and regula ons. “Sanc ons” means any economic or ﬁnancial sanc ons or trade embargoes imposed, administered orenforced from me to me by any United States Governmental Authority (including but not limited to OFAC), the United Na ons
Security Council, the European Union, Her Majesty’s Treasury, or other Governmental Authority of competent jurisdic on.
i.
None of the materials (including Products) to be supplied under this Agreement originated, in whole or inpart, in Cuba, Iran, North Korea, Sudan, Syria, or the Crimea region of Ukraine.
ii.
None of the Par es to this Agreement nor their respec ve oﬃcers, directors, employees, or agents are or
have been the subject of any actual or threatened allega on, inves ga on, voluntary disclosure, inves ga on, prosecu on or otherenforcement ac on related to Sanc ons, the U.S. Foreign Corrupt Prac ces Act of 1977, as amended, or any other sanc ons, trade, oran -corrup on laws.
iii.
All Par es to this Agreement have developed and maintain in eﬀect policies and procedures speciﬁcallydesigned to achieve compliance with the requirements of this Sec on 17.4, including compliance by their respec ve authorized agentsand other Third Par es ac ng on their behalf. In construing the compliance obliga ons under U.S. law with regard to the scope of thisAgreement , each Party shall regard itself as a United States person. The Par es to this Agreement shall undertake to cooperate in goodfaith, to the extent permi ed by law and in accordance with applicable legal privilege in connec on with any inves ga on, by a party
to this Agreement or any Governmental Authority, rela ng to compliance with this Sec on 17.4.
1.

MISCELLANEOUSa.
Independent Contractors. Each of the Par es is an independent contractor and nothing herein contained shall bedeemed to create or cons tute the rela onship of partners, joint venturers, co- partners, employer/employee, nor of principal andagent between the Par es. Neither Party shall at any me 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 thisAgreement (except for payment of any amounts due under this Agreement)

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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 limita on, an act of God, ﬁre, ﬂood, act of government or state, war, civilcommo on, insurrec on, acts of terrorism, embargo, sabotage, preven on from or hindrance in obtaining energy or other u li es,
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 con nue as long as theForce Majeure Event con nues. Upon cessa on 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
wri en no ce 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 obliga ons under this Agreement. Each Party further agrees to use diligent eﬀorts to mi gate the eﬀect ofsuch Force Majeure Event as quickly as prac cable (provided that in no event shall a Party be required to se le any labor dispute) andto give the other Party prompt wri en no ce when it is again fully able to perform such obliga ons. If the failure to perform due tosuch Force Majeure Event con nues for a period of [***] or more, then the unaﬀected Party may terminate this Agreement.
a.

[inten onally le blank]b.
No ces. Any no ce required or permi ed to be given under this Agreement by any Party shall be in wri ng and shallbe (a) delivered personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a na onally-recognizedcourier service guaranteeing next-day or second day delivery, charges prepaid, or (d) delivered by facsimile (with documented evidenceof transmission), to the addresses or facsimile numbers of the other Party set forth below or at such other addresses as may from me
to me be furnished by similar no ce by any Party. The eﬀec ve date of any no ce under this Agreement shall be the date of receipt
by the receiving Party.
If to LONZA:LONZA SALES LTD.
A n: 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:

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

Either Party may change its address for no ce by giving no ce thereof in the manner set forth in this Sec on 18.4.
a.
En re Agreement; Amendments. This Agreement, including the Appendices a ached hereto and referenced herein,cons tutes the full understanding of the Par es and a complete and exclusive statement of the terms of their agreement with respect
to the speciﬁc subject ma er hereof and supersedes all prior agreements and understandings, oral and wri en, among the Par es withrespect to the subject ma er hereof, including, without limita on, the SCA. No terms, condi ons, understandings or agreements
purpor ng to amend, modify or vary the terms of this Agreement (including any Appendix hereto) shall be binding unless herea ermade in a wri en instrument referencing this Agreement and signed by each of the Par es.
b.
Governing Law. The construc on, validity and performance of the Agreement shall be governed by and construed inaccordance with the internal laws of the State of New York, without giving eﬀect to its conﬂicts of laws provisions. The United Na ons
Conven on on Contracts for the Interna onal Sale of Goods and the 1974 Conven on on the Limita on Period in the Interna onal Saleof Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980 shall not apply to this Agreement. The Par es hereby
submit to and consent to the exclusive jurisdic on of the federal and state courts si ng in the State of New York and waive any
objec on 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 ofwhich shall for all purposes be deemed an original and all of which shall cons tute the same instrument. This Agreement shall beeﬀec ve upon full execu on by facsimile, PDF, electronic reproduc on or original, and a facsimile, PDF or electronic signature shall bedeemed to be and shall be as eﬀec ve 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
jurisdic on, such part shall be ineﬀec ve only to the extent of such invalidity or unenforceability in such jurisdic on, without in any
way aﬀec ng the remaining parts of this Agreement in that jurisdic on or the validity or enforceability of the Agreement as a whole inany other jurisdic on. In addi on, the part that is ineﬀec ve shall be reformed in a mutually agreeable manner so as to as nearly
approximate the intent of the Par es as possible.
e.
Titles and Sub tles. All headings, tles and sub tles used in this Agreement (including any Appendix hereto) are forconvenience only and are not to be considered in construing or interpre ng 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 thisAgreement and are incorporated into this Agreement by such reference.

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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 Par es 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 thisAgreement without the prior wri en consent of the other Party, such consent not to be unreasonably withheld, condi oned ordelayed; provided, however, a Party shall be en tled without the prior wri en consent of the other Party to assign this Agreement toan Aﬃliate or to any company to which such Party may transfer all or substan ally all of its assets or capital stock rela ng to theac vi es contemplated under this Agreement, whether through purchase, acquisi on, merger, consolida on, reorganiza on orotherwise. Any permi ed assignment of this Agreement by either Party will be condi oned upon such Party’s permi ed assignee
agreeing in wri ng to comply with all the terms and condi ons contained in this Agreement. Any purported assignment without arequired consent shall be null and void. No assignment shall relieve any Party of responsibility for the performance of any obliga onthat accrued prior to the eﬀec ve date of such assignment.
c.
Waiver. No waiver hereunder shall be eﬀec ve unless signed by the Party gran ng the waiver. The failure of any Party
at any me or mes to require performance of any provision of this Agreement (including any Appendix hereto) will in no manneraﬀect its rights at a later me to enforce the same. No waiver by any Party of any term, provision or condi on contained in thisAgreement (including any Appendix hereto), whether by conduct or otherwise, in any one or more instances, shall be deemed to be orconstrued as a further or con nuing waiver of any such term, provision or condi on or of any other term, provision or condi on of thisAgreement (including any Appendix hereto).
d.

Dispute Resolu on.

i.
Disputes; Dispute Escala on. Except as expressly set forth otherwise in this Agreement, disputes of any
nature arising under, rela ng to, or in connec on with this Agreement will be exclusively resolved pursuant to this Sec on 18.14. If the
Par es are unable to resolve a dispute, despite their good faith eﬀorts, either Party may, by wri en no ce to the other, have suchdispute referred to the Execu ve Oﬃcers (or their designees, which designee is required to have decision-making authority on behalfof such Party), who will a empt to resolve such dispute by nego a on and consulta on for a [***] period following receipt of such
wri en no ce. Notwithstanding the dispute resolu on procedures set forth in this Sec on 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 performanceor other injunc ve relief), without ﬁrst submi ng to any dispute resolu on procedures hereunder.
ii.
Full Arbitra on. In the event that no agreement is reached by the Execu ve Oﬃcers (or other designees) withrespect to a dispute within [***] a er its referral to them, either Party may at any me a er such [***] period submit such dispute tobe ﬁnally se led by arbitra on administered in accordance with the procedural rules of the American Arbitra on Associa on (“AAA”)
in eﬀect at the me of submission, as modiﬁed by this Sec on 18.14. The arbitra on

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will be heard and determined by three (3) arbitrators who are re red judges or a orneys with at least ten(10) years of relevant experience in the pharmaceu cal and biotechnology industry, each of whom will be impar al and independent.
Each Party will appoint one arbitrator and the third arbitrator will be selected by the two Party-appointed arbitrators, or, failingagreement within [***] following appointment of the second arbitrator, by AAA. The arbitra on shall be held in New York, New York.
The arbitra on proceedings shall be conducted, and the award shall be rendered, in the English language. Fees, costs and expenses ofarbitra on are to be divided by the Par es in the following manner: [***].
i.
Expedited Arbitra on. Notwithstanding Sec on 18.14.2 the Par es may agree to refer a dispute to expedited
arbitra on (an “Expedited Dispute”) rather than resolve the same pursuant to Sec on 18.14.2. Any such Expedited Dispute shall be
ﬁnally se led by arbitra on under the Commercial Arbitra on Rules (Expedited Rules) of the American Arbitra on Associa on (“AAAExpedited Rules”). Arbitra on will be conducted in New York, New York by one (1) arbitrator who shall be reasonably acceptable to the
Par es and who shall be appointed in accordance with the AAA Expedited Rules. If the Par es are unable to select an arbitrator within[***] of the no ce that ini ated the arbitra on, then the arbitrator shall be appointed in accordance with the AAA Expedited Rules.
Any arbitrator chosen hereunder shall have educa onal training and industry experience suﬃcient to demonstrate a reasonable levelof scien ﬁc, ﬁnancial, medical and industry knowledge relevant to the par cular dispute. [***].
ii.
Arbitra on Award. The arbitrator(s) shall issue their decision in wri ng, se ng forth the basis for suchdecision. The arbitra on award so given will be a ﬁnal and binding determina on of the dispute, will be fully enforceable in any courtof competent jurisdic on. Except in a proceeding to enforce the results of the arbitra on or as otherwise required by law, neither Party
nor any arbitrator may disclose the existence, content or results of any arbitra on hereunder without the prior wri en consent of both
Par es (each such consent not to be unreasonably withheld, delayed or condi oned).
iii.
Tolling. The Par es agree that all applicable statutes of limita on and me-based defenses (such as estoppel
and laches) shall be tolled while the dispute resolu on procedures set forth in this Sec on 18.14 are pending, and the Par es shallcooperate in taking all ac ons reasonably necessary to achieve such a result. In addi on, during the pendency of any dispute under thisAgreement ini ated before the end of the cure period under Sec on 15.2, this Agreement shall remain in full force and eﬀect, and theme periods for cure under Sec on 15.2 shall be tolled. Notwithstanding the dispute resolu on procedures set forth in this Sec on
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 injunc ve relief), without ﬁrst submi ng to any dispute resolu on
procedures hereunder.
iv.
Conﬁden ality. Any and all ac vi es conducted under this Sec on 18.14, including any and all non-public
proceedings and decisions under Sec on 18.14.2, will be deemed Conﬁden al Informa on of each of the Par es, and will be subject tothe terms of 10.

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No Presump on Against Dra er. For purposes of this Agreement, each Party hereby waives any rule of construc onthat requires that ambigui es in this Agreement (including any Appendix hereto) be construed against the dra er.
b.
No Third Party Beneﬁciaries. The representa ons, warran es, covenants and agreements set forth in this Agreement
are for the sole beneﬁt of the Par es hereto and their successors and permi ed 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 indemniﬁca on provisionsof Sec ons 16.1 and 16.2.
c.
Further Assurances. The Par es shall execute, acknowledge and deliver such further instruments and shall take allsuch other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

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IN WITNESS WHEREOF, the Par es have caused this Agreement to be executed by their duly authorized representa ves as of the Eﬀec ve
Date.

MODERNATX, INC.

By:/s/ Stephane Bancel
Title: CEO

Name: Stephane Bancel

LONZA SALES LTD.

By: /s/ Albert M. Baehny /s/ Daniel Blae ler

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Nam
Titl
Albert M. Baehny Daniel Blaettler CEO a.i. andChairman General Counsel

LONZA LTD.

By: /s/ Albert M. Baehny /s/ Daniel Blae ler
Nam
Titl
Albert M. Baehny Daniel Blaettler CEO a.i. andChairman General Counsel

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CONFIDENTIAL

APPENDIX A-1 STATEMENT OF WORK NR. 1[TO BE ATTACHED]

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CONFIDENTIAL

APPENDIX A-2 STATEMENT OF WORK NR. 2[TO BE ATTACHED]

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CONFIDENTIAL

APPENDIX A-3 STATEMENT OF WORK NR. 3[TO BE ATTACHED]

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CONFIDENTIAL

APPENDIX B TEMPLATE STATEMENT OF WORK[***]

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CONFIDENTIAL

APPENDIX C
[***]
[***]

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