Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 1 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 1 of 73
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`E X HI BI T A
`EXHIBIT A
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`

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`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 2 of 73
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`[* * * ] I n di c at es r e d a cti o ns
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`N O N -E X C L U SI V E L I C E N S E A G R E E
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`M E N T B E T
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`W E E N B I ON T E C H A G A N D A C UI T A S T H E R A P E U TI C S IN C
`E X E C U TI O N C O P Y C O VI D -1 9 V A C CI N E
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`N O N -E X C L U SI V E L I C E N S E A G R E E
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`M E N T
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`b y a n d b et w e e n
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`A C UI T A S T H E R A P E U TI C S , I N C .
`
`a n d
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`B I ON T E C H R N A P H A R
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`M A C E U T I C A L S G M B H
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`d at e d
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`A p ril 7 , 2 0 2 0
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`

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`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 3 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 3 of 73
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`Table of Contents
`
`Page
`
`DEFINITIONS...
`
`gir
`
`EAEeee nL
`
`1,
`
`2,
`
`3,
`
`4,
`
`7,
`
`a.
`
`LICENSE GRANTS; TECHNOLOGY TRANSFER...
`
`sa tiesessnsasascenaneassesansassescescasesceacass Eh
`
`Option to Convert Mor-ewelusive Limengeee
`
`Licenses iyor sosassesansasseectseasesenanaea
`
`
`21
`
`22
`
`BQ
`
`24
`25
`2.6
`
`SUBMOONSH RIQINSoo ceca scenessuusevasesussssiuestuisnsseuiseataeseusascnueasesenseoss 8
`
`Tacha logy Transtar. .....ccscsessesccecsssssnecssvenssesaveesetsasesseresnessesnsransatneransnssersnsecneenarens
`Wprddates to Appendix Led oo. cecsescececessssseeesssecaescesavenssnsasececeenacsssieeeeaesaueanansneaseseseasereneeses
`FEACOCLapeea RTDeae ne eee seeenreeseese cence epetee enanenntennge muececen eanee enengserenenenemenenser
`
`oowwOWoO
`
`LICENSE LIMITATIONSoe cee
`
`PAYMENTS AND ROYALT IES ccc ccc ccceceee cer cece sens ee eeceeeee ee ceeece ae sanree ae saeeeenscneeeenerees
`
`41
`
`4.2
`
`MiDESEOME PAINTS .......cccccccceseesecessnseeessstcaseserasasnaneesasnenecunsecrseeraetneserapenuserenseasarenaceea 9
`
`FATDE, ana teens yrate mange geceua snp anignan pain snunmnemitn aera sennginieeonens eouavnn mr carseaicanrseeae en one 11
`
`PayITIETt TRPITIS ....csesceccessrsecrscasseer senses eieeecssaseseonsaoasrenea in prenemneesertieasierteraeisterenscarererses 1?
`4.3
`OWNERSHIP AND INVENTORSHIP OF IPL cece cece ee cettetect ee eter en eceteeeneee
`
`
`
`
`
`PATENT PROSECUTION AND MAINTENANCE oocece eee ee cere ee eee dt
`
`6.1
`6.2
`
`6.3
`
`(CSTEares goceseareesenercczapi same geracouspsatnnmnsanbnissictesiarpi piasuinaaianaieseeneanoea peas venenioemmetenerctl
`Election Not te Prosecute or Maintain or Pay Patent Costs .......scsessseersssrsrsesereas 14
`
`Regulatory Exclusivity Periods ........0.ccccccccececsaseesteaseessrsosesesstrsneeeserenaesseeesescacesenars id
`
`Cooperation....... sete ueevauvvasvamssuausansgoasvsnvavec:evavereravavurwnsatrevewsevavereeraneanses dete tuereeieevtnenees 15
`6,4
`PATENT ENFORCEMENT AND DEFENSE... cccsce ceceteuseecerseseserseeenseesesenaee DE
`
`7.2
`
`Enforperment eid Defense......c:cenccecsececseese sence ve cnseeecntenencneae enererante ee
`
`
`
`15
`
`CONAIBENTAL¥vccssccarancsaeacissincmanarmuniunaseccraianiewarauiaremeninennenigernerenn iy
`
`8.1
`
`cnnFartLa nse niescaiannwenecneneneenteanseeiiecivantneay sm mimadearetamel
`
`jiu enacmecia iaor eb hl date aie ets Weerawarana nee ere aU
`Exceptions...
`4.3
`
`a4 Petriathed! DISCOSBSio02vicar creasnncuneecrerwannmenacnrianneannmnenamema nee ae
`
`8.5
`
`8.6
`
`Return of Confidential Information...
`
`raga RR MN
`
`aRReE aERTE UTTe ERM TeaeetaaEeE eee eer
`
`LED
`
`PUTPE arora spocepcieeras sence ncenreceenne cae meueanerentouenacne aerate cepaeu ues ean araee een ee dampers 18
`
`ewiwisaiwcieamnetanie Lo
`Terms ofthis License Agreement; Publicity. ...............
`a7
`WARRANTIES; LIMITATIONS OF LIABILITY; INDEMNIFICATION...
`wid
`
`9,
`
`g1
`
`Rep reserrations And VWWAPTEMIES .c.cccccsetsesecscasssssesacesseseasessseoesniesavenvansavssiabsotsssenssasesensie LO
`
`
`
`

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`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 4 of 73
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`Table cf Contents
`(continued)
`
`Page
`
`g.2
`
`9.3
`
`9.4
`9.5
`
`9.6
`
`a7
`
`10.1
`10.2
`
`10.3
`
`10.4
`
`10.5
`
`10.
`
`Additional Representations Of ACuUItaS ....ccccccssscesssssnses scence seseesansosssanasesaraesens een
`DUDSIIVETS 20. o.cece sees eecesceces ee ceecaeseeeeceeaceceeccscacaeecesacaseeneasassceeeuetecsseeeaesacsesansassesceacasaseess
`
`Na Consequential DAM@QeS...ccccecssesecasseserasessseeesssessssesesssscnsesssvensnsnsssnenseassseests
`Performance ty OMS oo ce eee cece cece nee ene ae ee tesetre teetnunteesettnseesatenoe
`
`PROPIPICATION eee cceccsceesenaosuasesesasessoaneueesceueueasessvasaesassusbseesesseseveesenes BRBNESRBBE
`
`Se
`
`Tarmination by BioMTech...eeeee cece er cene ne treeeen ee reseraeserantaereeeninerer cree el
`
`Termination Wor Bankruptcy oo... ccc ccccecccuecesescnecasscesesnsectscsesssesseranenrseransarserenseesascnans 24
`Effects Of Terrmimetion eo... ccece ecccecesessas ssasssenuseessecnussassecaeassasscsunsassevaesousasciuee 25
`
`10.6
`SUPTVAL, cece se csercesceserererevsezcravasssessenstseseeesacavenseasavaereneasapecerenees
`GENERAL PROVISIONS oocece ee cee reer eente ee seonee ae seeneesceeeecescaeeeeeee eed
`
`eS
`
`11.
`
`11.1
`
`Dispute FesOlutioneeeecece cece cere cee ca ee nee te ee neeun ee egeeeneeateeeneeseereeceseaeeecenee ed
`
`Cumulative Remedies and Inreparabile Har i,........cccscececcecceeessseseeeeessessersecessesensessesee eee OE
`11.3
`FRBLerEcars Path PTDRN acts ienesavinctse ve ppcnr pins avnnpms ava pcastantvacania uviseyeaicarwstinncenaacs OD
`114
`
`COMPUT AIIGE WITH LEV... cee ccs ssesnceesseensecusecasserasasneesusnsietsosnssesseranentseransarsarerseesasenans 26
`
`iF
`
`GOVEITI II LAW ooocsceceseassteserarestemienssviereemsncaiaresa:sutarsnuatateotenseeneateermeenees se ssrnavensevaveetae 27
`CCOUMMMERDANTS: FACSITIIBS oo...ccc eects ccesecucecasescesassceesseseeesouesesesserassesserapsesseeenseasesensee 2
`
`Waiver of Rule of Corsiruchiom .....2... ecceccccessececececeseneeceeencerecnees
`
`a
`
`
`
`27
`
`aT
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`11.5
`
`11.6
`
`117
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`11.8
`
`11.9
`11.10
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`11.11
`
`Lii2
`
`NCCE ccsieersiectieheraniniaar aiiades iadeinaadeRNC aTERRAener
`
`11.13
`
`SPTTEaE VET ia ccc ccc cceccneciccatcecterenaeareie ener nancrecases mnineuaw aatiwa etaneT aera eae 28
`
`11.14
`
`11.15
`
`11.16
`
`SSSA sscce scasinmieenetamscatacnsnevinen vanciamimannatetenamenin toa buisieimieania emUaNA TETRA Te aeTaSNRTaRRIS
`
`EDU PUTIN se escves oc eres ee es scctourarauccueeye cadena uqavdtbe ae Meccanadceeome ctieteidenecame A
`
`Fea OARA csncaa cance caancnerenseaceausunaincnnimimacadenitdenaiinctaiinnadeinnaaieR imei 28
`
`

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`List ot Appendices
`
`Appendix 1.4
`
`Patents within the Acuitas LMP Technology as of the License Agreement Effective
`Date
`
`Appendix 1.17
`
`Qual Improvement Patents
`
`Appendiw 1.73
`
`Jointly Quined Patents
`
`Appendix 1.53
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`Description of the Target{s)
`
`Appendix 2.4
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`Appendix 9.2
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`Technology Transtar Agreement
`
`Exceptions to Acuitas’ Representations and Warranties in Section 9.2
`
`

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`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 6 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 6 of 73
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`License Agreement
`
`This Lidense Agreement ("License Sgraemeant"), dated as ot April 7, 2020 (the "License Agreement
`Effective Date"),
`is made by and between Acuitas Therapeutics Inc., a British Columbia corporation
`(‘Acuitas"), and BioNTech RA Pharmaceuticals GmbH, a German corporation ("BioNTech'). Each of
`Acuitas and BioNTech may be referred to herein as a "Party" or together as the "Parties."
`
`WHEREAS,Acuitas has proprietary LWP Technology (as defined below);
`
`WHERESS, BioTech has expertise and intellectual property relating to MRNA Constructs (as
`defined below) as well as to formulation development
`including non-clinical
`testing and GMP
`manufacturing;
`
`WHEREAS, Acuitas and BioNTech are parties to that certain Development and Qotion Agreement
`(dated Juby 10, 7017) (the “Development.and Option Agreement”) pursuant to which BioNTech has options
`to take licenses under the 4cuitas LP Technology (as defined below) with respect to BioNTech’s MRNA
`Conctructs; and
`
`WHEREAS,pursuant to the terms of the Development and Option Agreement, BioTech has
`exercised an option with respect to the Target (as defined below) and the Parties are now entering into a
`licensing arrangement whereby BioNTech will have @ license under the Acuitas LNP Technology to
`develop and commercialize Licensed Prociucts (as defined below) based on such Target
`
`NOW, THEREFORE,in consideration of the mutual covenants contained herein, and for other
`good and valuable consideration, the amount and sufficiency of which are hereby acknowledged, the Parties
`hereby agree as follows:
`
`1.
`
`Definitions.
`
`The following ters and their correlatives will have the following meanings:
`1.1
`“Acuitas LWP Technology" means any and all LWP Technology Controlled by Acuitas or
`any of its Affiliates as of the License Agreement Effective Date or at any time during the Terr, including
`Acuitas right and interest
`in amy Technology created, conceived or
`reduced to practice under the
`Development and Option Agreement anc necessary or useful for the research, development, manufacturing
`and commercialization of Licensed Products, Unless otherwise set forth herein, Acuitas LWP Technology
`will axclude Jointhy Owned Patents and Dual Improvement Patents.
`
`L2="“VAcuitas Incemnitiess" has the meaning set forth in Section 9. 6/a).
`
`“Affiliate” of a person or entity means any other entity which (directly or indirectly) is
`1.3
`controlled by, controls or is under common control with such person or entity. For tha purgoses of this
`definition, the term “control” (including, with correlative meanings, the terms “controlled by" and “under
`common control with") as used with respect to an entity will mean (i) in the case of 2 corporate entity, cirect
`or indirect ownership of voting securities entitled to cast at least fifty percent (50) of the votes in the
`election of directors or (i) in the case of a non-conporate entity, direct or indirect ownership of at least fifty
`percent (50%) of the equity interests with the voting power to direct the management anc policies of such
`entity, provided that if local Law restricts foreign ownership, control will be established by direct or incirect
`ownership of the maximum ovvnership percentage that may, undar such local Law, be owned by foreign
`interests.
`
`

`

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`14
`
`[#4]
`
`“CGMP” means current Good Manufacturing Practices as specified inthe U.S. C.F.R., ICH
`1.5
`Guideline O7.A, or equivalent Laws of an apalicabla Regulatory Authority at the time of manufacture.
`
`"Calendar Quarter" means the respective periods of three (3) consecutive calendar months
`1.6
`ending on March 31, June 30, September 30 and December 31.
`
`i “Change of Control" with respect to Acuitas, shall be deemed to have occurred if during
`the Term [i) any person or entity is or becomes the “beneficial owner”, directly or indirectly, of shares of
`capital stock or other interests (including partnership interests) of Acuitas then outstanding and normally
`entitled (without regard to the occurrence of any contingency) to vote in the election of the directors,
`managers or similar supervisory positions of Acuitas representing fifty percent (50%) or mare of the total
`voting power of all outstanding classes of voting stock of Acuitas or has the power, directly or indirectly,
`to elect a majority of the members of the Acuitas’ board of directors, or similar governing body: or (ii)
`Acuitas enters into a merger, consolidation or similar transaction with another person or entity; or (iii)
`Acuitas sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets
`representing all or substantially all of Acuitas’ consolidated total assets to which this Agreement relates; or
`(iv) the holders of capital stock of Acuitas aogrove a plan or proposal for the liquidation or dissolution of
`Acuitas.”
`
`“Combination Product” means a Licensed Product that is combined and sold together (but
`18
`not, for avoidance of doubt, formulated tagether) with at least one additional active ingredient/product other
`than a Licensed Product. Drug delivery vehicles, adjuvants, and excipients shall not oe desmed to be "active
`ingredients", except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an
`active
`ingredient
`in
`accordance with
`21 C.F.R.
`210.5(b)(7) or
`equivalent Laws
`in other
`jurisdictions, provided however, [***|]
`
`“Competitive Product” shall mean a product that is, or can reasonably be, used for the same
`1.9
`Indication as @ Licersed Product.
`
`1.109“Indication” shall mean an individual disease or clinical condition with respect to which at
`least one adequate and well controlled study is required to support inclusion of such disease or condition in
`the indication statement of an FDA approved package insert for a Licensed Product.
`
`L110
`
`“Confidential Information’ has the meaning set forth in Section 8.1.
`
`

`

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`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 8 of 73
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`“Control” or “Controlled” means, with respect to any Know-How or Patent, the possession
`1.12
`(whether by ownership of license, other than by a license or sublicense granted pursuant to this License
`Agreement or the Development and Option Agreement) by Acuitas or its Affiliates of the ability to grant
`to BioNTech a license or access to such Know-How or Patent as provided herein to such item, without
`violating the tems of any agreement or other arrangement with any Third Party and without owing any
`thilestene, royalty or other monetary obligations toa Third Party.
`
`“Covered Product” means a Licensed Product aovered by one or more Valid Claims of the
`1.13
`Acuitas LNP Technology.
`
`“Covers”, with reference to (a) a Patent, means that the manufacture, development or
`1.14
`commercialization of a Licensed Product would infringe a Vali¢ Claim of such Patent in the country in
`which such activity occurs;
`and [b) Know-How, means that
`the manufacture, development or
`commercialization of a Licensed Product incorporates or embodies such Know-How.
`
`1.15
`
`“Development and Option
`
`Agreement” has the meaning set forth in the Preamble.
`
`1.16
`
`“Disclosing Party"has the meaning set forth in Section 8.1
`
`1.170“Dual [mprovenvent Patents” mocans the Patents listed in Appendix 1.17 hereto, as
`
`amended fram time to time.
`
`L.18=“Field of Lise means use of Licensed Product for human therapeutic and prophylactic
`applications.
`
`“First Commercial Sale" means the first sale for use or consumption of any Licensed
`1.19
`Product ina country after all required Requlatory Approvals for commercialsale of such Licensed Product
`have been obtained in such country.
`
`1.20
`
`“Fusion Protein® [***)
`
`
`
`L210 “IndemnificationClaim Notice” has the meaning set forth in Section 9.6(c).
`
`
`
`1.22
`
`“Indemnified Party” hes the meaning set forth in Section 9.6(c).
`
`“Jointly OwnedPatents” means the Patents listed in Appendix 1.23 hereto, as amended
`1.23
`from time to time.
`
`technical, scientific and other know-how and
`“Koow-How" means all commercial,
`L244
`information, trade secrets. Knowledge, technology, methods, processes, practices, formulae, instructions,
`skills, Techniques, procedures, experiences,
`ideas,
`technical assistance, designs, drawings, assembly
`procedures, computer programs,
`specifications, data and results
`(including biological, chemical,
`
`a
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 9 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 9 of 73
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`toxicological, pharmaceutical, physical anc analytical, preclinical, clinical, safety,
`pharmacological,
`manufacturing and quality control data and know-how, including study designs and protocols), in all cases,
`provided it is confidential and proprietary, and regardless of whether patentable, in written, electronic or
`any other form.
`
`jucignents, or
`regulations, orders,
`rules,
`laws, statutes,
`“Law” of "Laws" means all
`1.25
`ordinances having the effect of lawof any federal, national, multinational, state, provincial, county. city or
`other political subdivision,
`
`1.26
`
`“License Agreement”has tha meaning sat forth in the Preambla.
`
`Ley
`
`“License Agreement Effective Date" has the meaning set forth in the Preamble.
`
`1.288©6“Licensed Product(s)" means [***] product(s) consisting of Lipid Nanoparticles
`(LMF) containing [***] MRNA Constructs [***] where such product is derived from.
`is based on, or
`utilizes any Acuitas LMP Technology. For the avoidance of doubt,
`the term “Licensed Product” in
`respect of the Target [***].
`
`“LNPTechnology” mean Techoology that claims, embodies or incorporates delivery
`129
`systems (and components thereof) based on of incorporating lipid nanoparticles (LMF).
`
`“LNP Technology Patent(s}" means Patents comprised in the Acuitas LNP Technology,
`1.30
`including any future Patent which will become part of the Acurtas LNP Technology during the Term and
`further including Acuitas’ rights in the Joimly Owned Patents, unless otherwise set forth herein.
`
`L310
`
`“Losses” has the meaning set forth in Section 9.6[4).
`
`“Major Market Countries” means Canada, United States, Japan, France, Germany, Spain,
`1.32
`Italy, or United Kingcom.
`
`1.33
`
`"mRNA Construct" [**"]
`
`"mRNA Technology” means Technology that claims, embodies or incorporates exprassian
`1.34
`systems (and companents thereof), based on or incorporating mRNA.
`
`1.35
`
`"Milestones" means the milestones payable pursuant to Section 4,
`
`1.36=“MilestoneEvent” has the meaning set forth in Section 4.1,
`
`L370
`
`“Milestone Payment” has the meaning set forth in Section 4.1.
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 10 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 10 of 73
`
`1.38
`
`“Nel Sales means, with respect
`
`to any Licensed Product,
`
`[***]
`
`da}
`
`(b}
`
`[***]
`
`[***]
`
`ic)
`
`[* **]
`
`(d}
`
`[* ¥ *]
`
`ic}
`
`[* + ¥]
`
`()
`
`[***]
`
`@ [***)
`
`ml
`“*]
`
`[=**]
`
`[***]
`1.9
`“Patent(s)" means an (i) issued patent, a patent application, and a future patent issued
`from any such patent application, (il) @ future patent
`issued from @ patent application filed in any
`country workchvide which claims priority from a patent or patent application of (7), and (iii) any additions,
`divisions, continuations,
` continuations-in-part,
`invention
`certificates,
`substitutions,
`reissues,
`reexaminations, extansions,
`registrations, utility models, supplementary protection certificates and
`renewals based on any patent or patert application under (i) or (ii), but not including any rights that
`give rise to regulatory
`
`

`

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`
`exclusivity periods (other than supplementary protection certificates, which will be treated es “Patents”
`hereunder).
`
`“Patent Costs" means the reasonable, docurnented, out-of-pocket costs and expenses paid
`140
`to outside legal counsel, and filing and maintenance exoenses, actually and reasonably incurred by a Party
`in prosecuting and maintaining Patents and enforcing and defending them.
`
`“Phase 1 Study" means a fumanclinical ial of a Licensed Product in any country, the
`141
`primary purpose of which is the determination of safery and which may include the determination of
`pharmacokinetic ancfor pharmacodynarnic profiles in healthy individuals or a diseased patient population.
`A, Phase 1 Study ina diseased patient population may include,
`in addition to primary determination of
`safety, dose exploration and a determination of preliminary efficacy of a product in the target patient
`population. For clarity, a particular human clinical trial of a Licensed Product will not be considered bath
`a Phase 1 Study anda Phase? Study for the ounposes of Milastone payments under Section 4.1.
`
`“Phase 2 Study” means a human clinical trial of a Licensed Product in any country, and
`L.d2
`which is: (a) a human clinical trial (other than a Phase 1 Stucy) in which the primary purpose is dose
`exploration, dose response, duration of effect, kinetics or preliminary efficacy and safety of a product in
`the target patient population. or (b) a controlled dose-ranging clinical triél to evaluate further the efficacy
`and safety of such product in the target patient population and to define the optimal dosing regimen.
`
`“Phase 3 Study" means a human clinical trial of a Licensed Product in any country, and
`1.43
`whieh is: (a) a controlled study of a product in the target patient population of the efficacy and safety of
`SUCH product which is prospectively designed to demonstrate statistically whether such product 1s effective
`and safe for use in a particular indication in a manner sufficient to obtain Requlatory Approvel to market
`such product.
`
`“Pre-Existing Restrictions” means, with respect to a Target, that (a)
`1d400
`Third Party Restrictions”), or (b) [®**)| (Pre-existing Internal Restrictions”),
`
`[***] (“Pre-Existing
`
`145
`
`“Receiving Party” has the meaning set forth in Section 8.1.
`
`“RequlatoryApproval" means, with respect to a country or extra-national territory, any and
`1.46000
`all approvals (including BLAs and MAAs), licenses, registrations or authorizations of any Regulatory
`Authority necessary in order to commercially distripute, sell or market a product in such country or some
`or all of such extra-national territory.
`including any pricing or reimbursement approvals,
`
`1.47=“Regulatory Authority” means any national (ag. the FDA), supra-national (e.g. the
`
`EMA),
`regional, state or local regulatory agency, department, bureau, commission, council or other
`governmental authority,
`in any jurisdiction in the world, invelved in the granting of Regulatory Approval.
`
`1.46
`
`“[**"] Target” means the
`
`[***]
`
`149
`
`“Royalty Tern" has the meaning set forth in Section 4.2(d).
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 12 of 73
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`
`1.508“BioNTech Indemnitees* has the meaning set forth in Section 9.6(b).
`
`L510
`
`“Solely Qumed IP" has the meaning set forth in Article 5.
`
`is granted a sublicense as permitted by
`"“Sublicensee" meant any Third Party that
`1.52
`Section 2.2, either directhy by BioNTech or its Affiliates or indirectly by any other Sublicensee hereunder.
`
`“Target” means the proteins described in Appendi« 1.53 and includes: (a)
`153)
`occurring human protein [***],
`
`[***] naturally
`
`1.54
`
`1.55
`
`"Technology" means collectively Patents and Know-How.
`
`“Term” has the meaning set forth in Section 10.1.
`
`1.56=“Territory” means worlewide.
`
`L570
`Affiliates.
`
`“Third Party" means any person or entity other than BioNTech, Acuitas and their respective
`
`L.580“Third Party Claims” has the meaning set forth in Section 9.G(a).
`
`to elicit an adaplive immune
`“Vaceine” means any product primarily infeided (i)
`1.59
`response in the recipient against a specific disease-causing organism or malignancy as the result of
`presentation of antigen|s} associated with the dissase-causing organism or malignancy; or (ii) to provide
`Passive immune protection against a specific disease-causing organism.
`
`1.60
`
`“Vaccine Target” means Covid-19 Target a5 described in Appendix 1.53.
`
`"Walid Claim" means, with respect to a particular country, any claim of (i) an issued and
`L.61
`unexpired Patent: or (i) a pending Patent claim,
`[***]
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 13 of 73
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`
`2.
`
`License Grants; Technology Transter.
`
`Licenses by Acuitas. Subject to the terms and conditions of this License Agreement,
`21
`Acuitas hereby grants to BioTech and its AAfiliates (i) a non-exclusive, non-transferrable license, with the
`right to sublicense only as permitted by Section 2.3(b), under the Acuitas LWP Technology, to develop,
`have developed, make, have made, use and have used, sell, offer for sale, have sold and import and have
`imported Licensed Products in the Field of Lise in the Territory and (il) an exclusive, non-transferrable
`license, with the right to sublicense only as permitted by Section 2.3(h), under the Jointly Qwned Program
`Patents, and any Dual Imorovement Patents owned by Acurtas, to develop, have developed, make, have
`made, use and have used, sell, offer for sale, have sold and import and have imported Licensed Products
`within the scope of allowed ancfor issued claims within any Major Market Country (whether or not
`expired) within the BioNTech mRNA Technology in the Field of Use in the Territory. [**]
`
`BioNTech will have a limited option
`Option to Convert Non-exclusive License.
`22
`to convert the non-exclusive license granted pursuant to Section 2.1 to an exclusive license. BioTech
`will notify Acuitas and the Escrow Agent in writing of its desire to exercise the exclusive license
`option (Conversion Option Notice”) and pay to Acuilas an escrow fee of
`[***] dollars (U.S.5 [***]).
`The Escrow Agent - on behalf of Acuitas - will review the Conversion Option Notice provided by
`BioNTech hereunder to determine whether or not any such proposed Target is on the Restricted Target
`List as of the date of such Option Conversion Notice.
`If
`the Target
`is subject
`to Pre-existing
`Restrictions,
`the Escrow Agent will notify BioTech that the license set forth in Section 2.1 may not be
`converted to an exclusive license. If the Target is not subject to Pre-existing Restrictions, the Escrow
`Agent will notify BioTech that the license set forth in Sectiod 2.1 may be converted to an exclusive
`license upon BioNTech’s delivery of a signed Exclusive License Agreement
`in the form attached
`hereto as Exhibit 2.2 and payment of a conversion fee equal
`to [the difference between the
`nonexclusive and exclusive option fee under the Development and Option Agreement ([***| dollars
`(U.S. [***]}) plus (the difference between any milestone fees paid under the nonexclusive license prior
`to the Conversion Option Notice and the milestone fees for such events under an exclusive license).
`
`23
`
`Sublicensing Rights.
`
`Transter. The license granted in Section 2.1 [and option set forth in Saction 2.2] is
`(a)
`transferable only upon a permitted assignment of this License Agreement in accordance with Saction 11.11.
`
`BioTech Sublicenses, The licenses granted in Section 2.1 may be sublicensed
`(b)
`(with the right to sublicense through multiple tiers),
`in full or in part, by BioNTech,
`its Affiliates or
`Sublicensees to Third Parties provided, that for any sublicense to Third Parties:
`
`Each sublicense wall be in writing and on terms consistent with and subject to the
`(i)
`terms of this License Agreement,
`
`BioNTech will provide Acuitas with a copy of any sublicense agreement with a
`(ii)
`Sublicensee within [***] days of execution thereof, which sublicense agreement may be redacted as
`
`a
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 14 of 73
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`
`necessary tO protect commercially sensitive information and shall be treated as BioNTech Canfidential
`Information hereunder,
`
`BioNTech will be responsible for any and all obligations of such Sublicensee as if
`(iii)
`such Sublicensee were BioNTech hereunder; and
`
`Any sublicense granted by BioNTech to any rights licensed to it hereunder
`liv)
`terminate immediately upon the termination of the license from Acuitas to BioNTech and ils
`Shall
`Affiliates with respect to such rights, provided that such sublicensed rights shall not terminate if, as of the
`effective date of such tarmination pursuant to Sections 10.2, 10.3{a) or 10.4, a Sublicensae is not in
`material default of its obligations under
`its sublicense agreement, and within
`[***] days of such
`termination and a written notice by Acuitas and disclosure of this License Agreement to the Sublicensee,
`the Sublicensee agrees in writing to be bound directly to Acuitas under a
`license agreement
`subsiantially similar
`to this License Agreement with respect
`to the rights sublicensed hereunder,
`Substituting such Sublicenses for BioNTech.
`
`For clarity purposes, BioNTech is entitled to engage contract
`Subcontractors.
`(c}
`research organizations and contract manufacturing organizations for the develooment and manufacture of
`Licensed Products an behalf of BioNTech. To the extent such contract organizations require a license
`to perform such subcontracted activities under applicable Laws, BioNTech is entitled to grant a limited
`linense without an obligation to meet the conditions of Section 2.2 (bjt) and (iv).
`
`Technology Transtar. After tha Licanse Agraemant Effective Date Acuitas will conduct
`24
`a single full transtar of Acuitas LNP Technology to BioNTech andor its desiqnee(s) (which designee(s)
`may be an Affiliate or a Third Party cGMP manufacturer) es required for the applicable transferee of the
`then-current
`process. The
`technology transfer
`activities,
`the
`rights
`and
`obligations of
`the
`Parties,
`the reimbursement of Acuitas for the technology transfer activities, and the rights and
`licenses to any Tachnology generated in the course of the technology transfer will be as set forth in the
`Technology Transfer “Agreement becoming effective on the License Agreement Effective Date and
`included in Aopendix 2.4.
`
`Updates to Appendix 1.1. Acuitas shall notify BioNTech at least once every [***]
`25
`months of Patents that are added to the Acuitas LP Technology following the License Agreement
`Effective Date or any Patents that have been abandoned or discontinued in accordance with the terms of
`this License Agreement. Appendix 1.1 shall be automatically updated to include any such added or deleted
`Patents.
`
`Documents and Declarations. Acuitas shall execute all documents, give all declarations
`2.6
`licenses granted hereunder and reasonably cooperate with BioNTech to the extent
`regarding the
`such documents, declarations ancfor cooperation are required for the recording of registration of the
`licenses granted hereunder at the various patent offices in the Territory for the benefit of BioN Tech,
`its
`Affiliates or their Sublicensees.
`
`License Limitations. No licenses or other rights are granted by Acuitas hereunder to use any
`3.
`trademark, trade name, trade dress or service mark owned or otherwise Controlled by Acuitas or any of its
`Affiliates. All licenses and other rights are or shall be granted only as expressly provided in this
`License Agreement, and no other licenses or other rights is or shall be created or granted by either Party
`hereunder by implication, estoppel or otherwise,
`
`4,
`
`Payments and Royalties.
`
`Payment’) to Acuitas upon the first occurrence of each of the milestone events (each, a “MilestoneEvent’)
`by a Licensed Product as set forth below in this Section 4.1. BioNTech wall notify Acuitas of the
`
`4.1 Milestone Payments. BioNTech will make"milestone payments (each, a “Milestone
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 15 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 15 of 73
`
`achievernent of each Milestone Event within [***] business days of such achievement. Each Milestone
`Payment will be payable to Acuitas by BioNTech within (***| days of the achievement of the specified
`Milestone Event and such payments when owed or paid will be non-refundable and non-creditable. If one
`or more of the Milestone Events set forth below are not achieved or not required for any reason, the payment
`for such skipped Milestone Event will be due at the same time as the payment for the next achieved
`Milestone Event.
`
`Milestone Payment For Covered
`Products
`
`[***]
`
`Milestone Event
`
`[r? |
`
`[* * |
`
`al
`
`[***]
`
`[r" *]
`
`10
`
`

`

`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 16 of 73
`Case 1:22-cv-02229-MKV Document 49-1 Filed 11/01/22 Page 16 of 73
`
`[***]
`
`42
`
`Royalties.
`
`Royalty. Subject to the remainder of this Section 4.2, on a country-by-country basis
`(a)
`and a Licensed Product-ty-Licensed Procuct basis,
`
`(i)
`
`(***| BioNTech will pay to Acuitas a royalty of [***)o Net Sales.
`
`*)
`
`tf BioTech or its Affiliate or Sublicensea, in its
`Third Party Royalty Payments.
`(b)
`reasonable judgment, considers it necessary or useful te obtain a license from any Third Party that Covers a
`Licensed Product in order to develop, manufacture or commercialize such Licensed Product the amount of
`BioNTech'’s royalty obligations under Sections 4.1{a) will be reduced by [***] percent ([**"]%6) of the
`amount of the royalty payments made to such Third Party ("Third Party Royalty Payments"), provided,
`however,
`[***] For avoidance of doubt, Third Party Royalty Payments will
`include payments by
`RioNTec