Exhibit 10.2
EXECUTION COPY
CONFIDENTIAL
REDACTED
Certain identified information, indicated
by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive
harm if publicly disclosed.
DEVELOPMENT
AND LICENSE AGREEMENT
This DEVELOPMENT
AND LICENSE AGREEMENT (“Agreement”), effective as of November 9, 2017 (the “Effective Date”),
is made by and between CureVac AG, a German stock corporation organized under the laws of Germany, having its principal place of
business at Xxxx-Xxxxxxx-Xxxxxxx 00, 00000 Xxxxxxxxx, Xxxxxxx (“CureVac”), and CRISPR Therapeutics AG, a Swiss
corporation organized under the laws of Switzerland (“CRISPR”), having its principal place of business at Xxxxxxxxxxxxx
00, 0000 Xxx, Xxxxxxxxxxx. CureVac and CRISPR are each sometimes referred to herein as a “Party” and collectively
as the “Parties.”
RECITALS
A. WHEREAS,
CRISPR has an interest in developing and accessing Cas9 mRNA Constructs (as defined below) for use in gene editing therapeutics.
B. WHEREAS,
CureVac has a proprietary mRNA technology platform, and an interest in developing Cas9 mRNA Constructs for CRISPR for gene editing
applications;
C. WHEREAS,
the Parties intend to collaborate with the goals of identifying and optimizing Cas9 mRNA Constructs for certain Programs (as defined
below); and
D WHEREAS,
CRISPR and CureVac will enter into a supply agreement, under which CureVac will supply CRISPR such optimized Cas9 mRNA Constructs
for use in gene editing applications in certain Programs.
NOW, THEREFORE,
the Parties hereby agree as follows:
Article 1
DEFINITIONS
1.1 “Affiliate”
means any Person that directly or indirectly is controlled by, controls or is under common control with another Person. For the
purposes of this definition, the term “control” (including with correlative meanings, the terms “controlled by”
and “under common control with”) as used with respect to a Person means (a) in the case of a corporate entity, direct
or indirect ownership of voting securities entitled to cast 50% or more of the votes in the election of directors, (b) in the case
of a non-corporate entity, direct or indirect ownership of 50% or more of the equity interests with the power to direct the management
and policies of such entity, or (c) any other arrangement whereby a Person controls or has the right to control the board of directors
or equivalent governing body or management of a corporation or other entity. For the avoidance of doubt, on the Effective Date
Casebia Therapeutics LLP (“Casebia”) is an Affiliate of CRISPR for all purposes under this Agreement. Regarding
CureVac, Affiliate shall not include Mr. Xxxxxxx Xxxx and dievini Xxxx BioTech holding GmbH & Co. KG and/or any other entity
controlled by Xx. Xxxx and/or dievini Xxxx BioTech holding GmbH & Co. KG. Any such Person shall only be an Affiliate for purposes
of this Agreement when and as long as it meets the requirements of this Section 1.1.
1.2 “Applicable
Law” means any federal, state, local or foreign law (including, common law), statute or ordinance, or any rule, regulation,
judgment, order, writ or decree of or from any court, Regulatory Authority or other governmental authority having jurisdiction
over or related to the subject item that may be in effect from time to time.
1.3 “Background
Intellectual Property” shall mean, as applicable, CRISPR Background Intellectual Property or CureVac Background Intellectual
Property.
1.4 “Calendar
Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30,
and December 31; provided, however, that (a) the first Calendar Quarter of any particular period shall extend from the commencement
of such period to the end of the first complete Calendar Quarter thereafter, and (b) the last Calendar Quarter shall end upon the
expiration or termination of this Agreement.
1.5 “Calendar
Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.6 “Cas9
mRNA Construct” [*****].
1.7 “Combination
Product” shall have the meaning set forth in Section 1.60 below.
1.8 “Commercial
Supply Agreement” means an agreement for the supply of Cas9 mRNA Constructs for use by CRISPR, its Affiliates and Sublicensees
in Pivotal Clinical Trials and Commercialization.
1.9 "Commercially
Reasonable Efforts" shall mean, with respect to the efforts to be expended by a Party with respect to any objective, the
reasonable, diligent, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar
objective under similar circumstances. It is understood and agreed that with respect to the Development and Commercialization of
Licensed Products by CRISPR, such efforts shall be substantially equivalent to those efforts and resources commonly used by similarly
situated biotechnology companies with resources similar to CRISPR in the European Union and the United States for products owned
by them or to which they have rights, which products are at a similar stage in its Development or product life and are of similar
market potential taking into account all scientific, commercial and other factors that such pharmaceutical company would take into
account, including efficacy, safety, approved labelling, the competitiveness of alternative products in the marketplace, the expected
and actual market exclusivity of the Licensed Products, and the likelihood of receipt of a Regulatory Approval given the Regulatory
Authority involved.
1.10 “Commercialization”
shall mean any and all activities directed to the preparation for sale of, offering for sale of, or sale of Licensed Products,
including activities related to marketing, promoting, labelling, packaging, distributing, importing and exporting such Licensed
Products, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, to “Commercialize”
and “Commercializing” shall mean to engage in Commercialization, and “Commercialized” has
a correlative meaning.
1.11 “Competitive
Infringement” shall have the meaning set forth in Section 8.4(b).
1.12 “Confidential
Information” means subject to the exceptions in Section 6.2, the information of any nature and in any form that
a Party may learn of (including, but not limited to, all documents and/or all data, nucleic acid and protein sequences, chemical
structures, software and/or hardware samples, models, methods, descriptions, Know-How, processes, applications and/or knowledge,
whether patentable or not), in the performance of the Agreement, and in particular any confidential information relating to the
Licensed Intellectual Property, Licensed Products, names of business partners, business strategy, developing strategy, data regarding
Licensed Products, their prices and markets, that a Party may receive in the performance of this Agreement. The Know-How within
the Licensed Intellectual Property for use in the Field and the terms and conditions of this Agreement are Confidential Information
of both Parties.
1.13 “Controlled”
or “Controls” means, when used in reference to a subject item or a right, the legal authority or right of a
Party (or any of its Affiliates) (whether by ownership or license, other than pursuant to this Agreement) to grant the right to
use such item or right to the other Party, or to otherwise disclose proprietary or trade secret information to such other Party,
without violating the terms of any agreement or other arrangement by which such Party is bound.
1.14 “Cover”
means, with respect to a particular subject matter at issue and the relevant Patent Rights and Know-How, that, but for a license
granted to a Party under a claim included in such Patent Rights or under the Know-How, or such Party’s ownership or Control
of such Patent Rights or Know-How, the manufacture, use, sale, offer or sale or importation by such Party of the subject matter
at issue would infringe such claim or exploit or otherwise use such Know-How or, in the case of a Patent Right that is a patent
application, would infringe a claim in such patent application if it were to issue as a patent in a particular country or countries.
1.15 “CRISPR
Background Intellectual Property” means CRISPR Background Know-How and CRISPR Background Patent Rights and that is not
Foreground Intellectual Property. The CRISPR Background Intellectual Property as of the Effective Date is identified in Attachment
A hereto.
1.16 “CRISPR
Background Know-How” means any Know-How Controlled by CRISPR as of the Effective Date or thereafter during the Term that
is reasonably necessary or useful for the Parties to conduct activities under the Development Program and/or to Develop, Manufacture
and Commercialize Licensed Products in accordance with this Agreement.
1.17 “CRISPR
Background Patent Rights” means any Patent Rights Controlled by CRISPR as of the Effective Date or thereafter during
the Term that are reasonably necessary or useful for the Parties to conduct the activities under the Development Program and/or
to Develop, Manufacture and Commercialize Licensed Products in accordance with this Agreement.
1.18 “CRISPR
Improvement” means any improvement, change, modification, variation, revision, update or enhancement to the CRISPR Background
Intellectual Property.
1.19 “CRISPR
System” means a system comprising one or more of the following:
(a) [*****]
(b) [*****] and
(c)
[*****]
1.20 “CureVac
Background Intellectual Property” means the CureVac Background Patent Rights and CureVac Background Know-How, and that
is not Foreground Intellectual Property. The CureVac Background Intellectual Property is identified in Attachment B hereto.
For clarity, CureVac Background Intellectual Property does not include Patent Rights and Know-How in-licensed by CureVac from Acuitas
Therapeutics, Inc. and from PharmaJet, Inc.
1.21 “CureVac
Background Know-How” means all Know-How Controlled by CureVac or its Affiliates as of the Effective Date or thereafter
during the Term that is reasonably necessary or useful for Parties to conduct the activities under the Development Program and/or
to Develop, Manufacture and Commercialize Licensed Products.
1.22 “CureVac
Background Patent Rights” means all Patent Rights Controlled by CureVac or its Affiliates as of the Effective Date or
thereafter during the Term that are reasonably necessary or useful for the Parties to conduct the activities under the Development
Program and/or to Develop, Manufacture and Commercialize Licensed Products.
1.23 “CureVac
Competitor” means a pharmaceutical and/or biotechnological company that has a primary focus of its business in the development,
manufacture (for its own account) or commercialization of therapeutic products or services (for its own account) in the field of
pDNA and/or mRNA provided that the Parties acknowledge and agree that the term “CureVac Competitor” does not include
contract manufacturing organizations, contract research organizations, or entities that do work on a fee-for-services basis as
contract manufacturers for others. For clarity, Boehringer Ingelheim’s contract manufacturing organization would not be deemed
a “CureVac Competitor,” even if a Boehringer Ingelheim affiliate (including a parent entity) is developing or commercializing
therapeutic products in the field of pNDA and/or mRNA).
1.24 “CureVac
Improvement” means any improvement, change, modification, variation, revision, update or enhancement to the CureVac Background
Intellectual Property.
1.25 “Development”
shall mean all research, non-clinical, and clinical testing and drug development activities conducted in respect of the Licensed
Products for use in the Field, including those reasonably necessary or useful or required by a Regulatory Authority in support
of obtaining Regulatory Approvals. “Development” shall include generation, validation and optimization, formulation
development, delivery system development, non-clinical testing, mechanism studies, toxicology, pharmacokinetics, clinical studies,
regulatory affairs activities, statistical analysis and report writing, submission of documents, market research, pharmacoeconomic
studies, and epidemiological/real world data studies. “Develop” and "Developed" have a correlative
meaning.
1.26 “Development
Program” means the research and development program regarding the identification, optimization and selection of Cas9
mRNA Constructs funded as agreed in this Agreement and to be conducted in accordance with the Work Plan and this Agreement. For
clarity, all activities conducted under the Development Program shall be distinct from the Development of the Licensed Products
and shall not extend to any activities which shall be conducted under the Manufacturing Services Agreement.
1.27 “Development
Term” means the period set forth in the Work Plan to perform all of the activities of the Work Plan.
1.28 “Dual
Improvement Intellectual Property” shall have the meaning set forth in Section 7.1(d)(iii)(C).
1.29 “EMA”
means European Medicines Agency and any successor agency or authority thereto.
1.30 “Executive
Officer” means (a) in the case of CureVac, the Chief Corporate Officer, and (b) in the case of CRISPR, the Chief Business
Officer, neither of which may be a member of the JSC. Each Party may change its Executive Officer from time to time by providing
written notice to the other Party in accordance with the terms of this Agreement.
1.31 “FDA”
means the United States Food and Drug Administration or its successor.
1.32 “Field”
means all human therapeutic applications in the Programs that make use of a CRISPR System.
1.33 “First
Commercial Sale” means on a Licensed Product-by-Licensed Product and country-by-country basis, the first arm’s-length
transaction, transfer or disposition for value by or on behalf of CRISPR or any Affiliate or Sublicensee of CRISPR to a Third Party
of such Licensed Product for end use or consumption of such Licensed Product. First Commercial Sale excludes (a) the distribution
of reasonable quantities of promotional samples of Licensed Products, or (b) the transfer of Licensed Product to a Third Party
to use Licensed Product for the sole purpose of performing preclinical or clinical studies or (c) the transfer of Licensed Product
to a Third Party solely for charitable or compassionate use purposes on a named patient basis if the Selling Party transfers Licensed
Product at cost of goods or below.
1.34 “First
Exercise Period” has the meaning set forth in Section 7.4.
1.35 “Foreground
Intellectual Property” means the Foreground Patent Rights and the Foreground Know-How.
1.36 “Foreground
Know-How” means the Know-How first conceived, discovered, developed, reduced to practice or generated by either Party
or jointly by the Parties under this Agreement.
1.37 “Foreground
Patent Rights” means all Patent Rights that arise from the Foreground Know-How.
1.38 “FTE”
means one employee working full-time for one year, or more than one person working the equivalent of a full-time person,
working directly on performing activities under the Development Program, as applicable, where “full-time” is
considered [*****] hours for one Calendar Year. No additional payment will be made with respect to any individual who works
more than [*****] hours per Calendar Year and any individual who devotes less than [*****] hours per Calendar Year
will be treated as an FTE on a pro rata basis based upon the actuâ] number of hours worked divided by [*****].
1.39 “FTE
Costs” means the product of (a) the number of FTEs (proportionately, on a per-FTE basis) used by CureVac or its Affiliates
in directly performing activities assigned to CureVac under and in accordance with the Development Program, and (b) the FTE Rate.
1.40 “FTE
Rate” means € [*****].
1.41 “Full
Sublicense Rate” has the meaning set forth in Section 5.3.
1.42 “GLP”
means the then-current practices and procedures set forth in Xxxxx 00, Xxxxxx Xxxxxx Code of Federal Regulations, Part 58 (as amended),
and any other regulations, guidelines or guidance documents relating to good laboratory practices, or any foreign equivalents thereof
in the country in which such studies or clinical trials are conducted or that are otherwise applicable.
1.43 “GLP
Toxicology Study” means, with respect to a Licensed Product, a study conducted in a species, in compliance with GLP,
for the purposes of assessing the efficacy, safety or the onset, severity, and duration of toxic effects and their dose dependency
with the goal of establishing a profile sufficient to support the filing of an IND.
1.44 “IND”
means any Investigational New Drug application, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal
Regulations, including any supplements or amendments thereto. References herein to IND will include, to the extent applicable,
any comparable filings outside the United States.
1.45 “Infringement
Action” shall have the meaning set forth in Section 8.4(c).
1.46 “Joint
Steering Committee” shall have the meaning set forth in Section 3.1(a).
1.47 “Jointly-Owned
Foreground Intellectual Property” shall have the meaning set forth in Section 7.1(d)(ii).
1.48 “Jointly-Owned
Foreground Know-How” shall have the meaning set forth in Section 7.1(d)(ii).
1.49 “Jointly-Owned
Foreground Patent Rights” shall have the meaning set forth in Section 7.1(d)(ii).
1.50 “Know-How”
means any and all proprietary data, inventions, methods, information, processes, trade secrets, techniques and technology, whether
patentable or not, including discoveries, formulae, practices, biological sequences, test data, analytical and quality control
data, manufacturing technology and data, registration dossiers and specifications. Know-How includes any such information comprised
or embodied in the Materials, if any.
1.51 "Licensed
Intellectual Property" means the CureVac Background Intellectual Property and any Foreground Intellectual Property solely
or jointly owned by CureVac.
1.52 "Licensed
Patent Rights" means any Patent Right which is part of the Licensed Intellectual Property.
1.53 “Licensed
Product” means any product comprising a Cas9 mRNA Construct, where such Cas9 mRNA Construct (a) the research,
Development, Manufacture, use, sale, offer for sale or importation of which relies on the use of Know-How within the Licensed
Intellectual Property, or (b) the research, Development,
Manufacture, use, sale, offer for sale or importation of which in or into a country is Covered by a Valid Claim of a Patent Right
or by Know-How within the Licensed Intellectual Property.
1.54 “Losses”
shall have the meaning set forth in Section 9.1.
1.55 “Manufacture”
means all manufacturing operations for Cas9 mRNA Constructs and Licensed Products, including all activities related to the synthesis,
making, production, processing, purifying, of the Cas9 mRNA Constructs, or any intermediate thereof, including process development,
process qualification and validation, scale-up, pre-clinical, clinical and Commercial production and analytic development, product
characterization, stability testing, quality assurance, and quality control. “Manufacturing” has a correlative
meaning.
1.56 “Manufacturing
Services Agreement” means the Manufacturing Services Agreement between the Parties, dated as of the Effective Date for
the pre-clinical and clinical (up to Pivotal Clinical Trials) Manufacture of Cas9 mRNA Constructs.
1.57 “Marketing
Authorization Application” or “MAA” means an application for Regulatory Approval in a country, territory
or possession.
1.58 “Materials”
means the biological materials set forth on Attachment C hereto, whether by themselves or incorporated into another material,
and any progeny, modifications, mutants, components or derivatives thereof. Attachment C may be amended upon the mutual
written agreement by the Parties.
1.59 “NDA”
means a new drug application that is submitted to the FDA for marketing approval for a Licensed Product, pursuant to 21 C.F.R.
§ 314.3, or any foreign equivalent.
1.60 “Net
Sales” means with respect to any Licensed Product, the gross amounts received by CRISPR, its Affiliates, distributors
and Sublicensees (each, a “Selling Party”) from Third Party customers for sales of such Licensed Product, less
the following deductions actually incurred, allowed, paid, accrued or specifically allocated in its financial statements in accordance
with such Selling Party’s accounting principles, for:
(a) [*****]
(b) [*****]
(c) [*****] and
(d) [*****]
1.61 “Non-Royalty
Sublicense Income” means any payments, including upfront and milestone payments, that CRISPR or its Affiliate receives
in consideration of CRISPR, its Affiliate or Sublicensees granting any sublicense to a Third Party under any Licensed Intellectual
Property to a Sublicensee, other than: [*****].
1.62 “Patent
Rights” means patents and patent applications, together with any unlisted patents and patent applications claiming priority
thereto, and any continuations, continuations-in-part, reissues, reexamination certificates, substitutions, divisionals, supplementary
protection certificates, renewals, registrations, extensions including all confirmations, revalidations, patents of addition, PCTs,
and pediatric and other exclusivity periods and all foreign counterparts thereof, and any patents issued or issuing with respect
to any of the foregoing.
1.63 “Person”
means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, governmental
authority, association or other entity.
1.64 “Phase
1 Clinical Trial” means a clinical study of a drug candidate in patients with the primary objective of characterizing
its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in
21 C.F.R. 312.21(a), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the
United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational
or marketed agents.
1.65 “Phase
2 Clinical Trial” means a clinical study of a drug candidate in patients with the primary objective of characterizing
its activity in a specific disease state as well as generating more detailed safety, tolerability, and pharmacokinetics information
as described in 21 C.F.R. 312.21(b), or a comparable clinical study prescribed by the relevant regulatory authority in a country
other than the United States including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a)
or corresponding foreign regulations and is subsequently optimized or expanded
to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Phase 3 Clinical
Trial (e.g., a phase 1/2 trial). The relevant drug candidate may be administered to patients as a single agent or in combination
with other investigational or marketed agents.
1.66 “Phase
3 Clinical Trial” means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation
of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21
C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United
States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational
or marketed agents
1.67 “Pivotal
Clinical Trial” means a clinical study of a drug candidate in patients, performed after preliminary evidence suggesting
efficacy of such product has been obtained, conducted for inclusion in (a) that portion of the FDA submission and approval process
that provides for the continued trials of such product in sufficient numbers of human patients to confirm with statistical significance
the safety and efficacy of such Licensed Product sufficient to support Regulatory Approval in the proposed indication, as more
fully defined in 21 C.F.R. §312.21(c) or (b) equivalent Regulatory Authority submissions in a country other than the United
States.
1.68 “Program”
means applying the CRISPR System and using a Cas9 mRNA Construct for the following programs: (i) the [*****], in accordance
with Section 4.2(a). below, [*****] being set forth on Attachment G, or as substituted in accordance with Section
4.2(b) ("Program 1"); (ii) [*****] or (iii) [*****] or as
substituted in accordance with Section 4.3 (“[*****]”).
1.69 “Reduced
Sublicense Rate” has the meaning set forth in Section 5.3.
1.70 “Regulatory
Approval” means any and all approvals (including pricing and reimbursement approvals, if any), licenses, registrations
or authorizations of any national or international or local Regulatory Authority, department, bureau or other governmental entity,
necessary for the Manufacture and Commercialization of a Licensed Product in any regulatory jurisdiction. Regulatory Approvals
include approvals by Regulatory Authorities of XXXx.
1.71 “Regulatory
Authority” means, with respect to a country or region, any national (e.g., the FDA for the United States, EMA for the
European Union), supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental
authority involved in the granting of any approval required by Applicable Laws to Manufacture and Commercialize a relevant Licensed
Product in such country or region or, to the extent required in such country or region, price approval, for pharmaceutical products
in such country or region.
1.72 “Regulatory
Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with
respect to a Licensed Product.
1.73 “Reserved
Program” shall mean any program that is the subject of a signed agreement between CureVac and a Third Party, or the
subject of bona fide ongoing research, development or commercialization activities by CureVac, in each case, that would be breached
if such proposed [*****] under this Agreement at the time CRISPR provides the written notice to CureVac as described in Section
4.3(b).
1.74 “Royalty
Term” on a Licensed-Product by Licensed-Product, and country-by-country basis, the period commencing on the First Commercial
Sale of a Licensed Product and ending upon the later of (i) the date on which there is no Valid Claim that would be infringed,
absent a license, by the Development, Manufacture or Commercialization of such Licensed Product in such country,(ii) the date
on which the Regulatory Exclusivity in such country for such Licensed Product expires; or (iii) ten (10) years after the
First Commercial Sale of such Licensed Product in such country.
1.75 “Solely-Owned
Foreground Intellectual Property” shall have the meaning set forth in Section 7.1(d)(i).
1.76 “Solely-Owned
Foreground Know-How” shall have the meaning set forth in Section 7.1(d)(i).
1.77 “Solely-Owned
Foreground Patent Rights” shall have the meaning set forth in Section 7.1(d)(i).
1.78 “Sublicensee”
means an Affiliate or any Third Party that is granted a sublicense as permitted under Section 7.2, either directly by CRISPR
or indirectly by any other Sublicensee hereunder.
1.79 “Term”
means the period of time beginning on the Effective Date and ending on the expiration of the Royalty Term for all Licensed Products,
unless sooner terminated in accordance with the provision of this Agreement.
1.80 “Territory”
means worldwide.
1.81 “Third
Party” means any Person other than CRISPR, CureVac and their respective Affiliates.
1.82 “Third
Party Agreement” has the meaning set forth in Section 7.4
1.83 “Valid
Claim” means (a) a claim of an issued and unexpired patent which has not been revoked or held unenforceable or invalid
by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or (b)
a claim of a pending patent application that was filed and has been prosecuted in good faith and has not been (i) cancelled, withdrawn,
abandoned or finally disallowed without the possibility of appeal or refiling of such application, or (ii) pending for more than
[*****] years since such claim was first presented or is the result of amending another claim pending for more than [*****] years
(either in the same application or in another application in the same jurisdiction) so as to add or delete an obvious limitation,
so as to make a trivial or non-substantive change, or so as to change a matter of form.
1.84 “Work
Plan” means the plan setting forth (a) the activities to be undertaken as part of the Development Program, (b) the
Party responsible for each such activity, (c) the deliverables, (d) the budget, and (e) timeline for performance, as set
forth in Attachment D hereto, and as may be amended from time to time with written approval of the JSC during the
Development Term. For clarity, on a Program-by-Program basis, the Work Plans shall be limited to the identification,
optimization and selection of Cas9 mRNA Constructs and shall not extend to any activities which shall be conducted under the
Manufacturing Services Agreement.
Article 2
CAS9 mRNA DEVELOPMENT PROGRAM
2.1 Purpose
and Term. The Parties have agreed to engage in the Development Program on the terms and conditions set forth in this Agreement.
As part of the Development Program, the Parties will work together to identify and optimize Cas9 mRNA Constructs for use in gene
editing therapeutics. The Development Program will be undertaken and performed during the Development Term.
2.2 Diligence;
Standards of Conduct with respect to the Work Plan. Each Party agrees to use Commercially Reasonable Efforts to perform the
tasks assigned to such Party under the Work Plan in a timely and effective manner, and each Party further agrees to conduct its
activities under the Work Plan in a good scientific manner and in compliance in all material respects with Applicable Law. In the
event of any inconsistency between the Work Plan and this Agreement, the terms of this Agreement will prevail. Without limiting
the foregoing, in all events, both Parties will provide all resources necessary to support the Development Program, including providing
the appropriate technical resources and personnel with the appropriate skill, training and expertise. All disputes regarding the
level of efforts and resources dedicated by a Party to the performance of the Development Program will be escalated to the JSC.
2.3 Amendments
to the Work Plan. During the Development Term, each Party will have the right to propose modifications or amendments to the
Work Plan; provided, however, that any modifications or amendments to the Work Plan that are proposed by either Party will be subject
to review and prior written approval by the JSC pursuant to Section 3.1(b)(ii) and subject to Section 3.2.
2.4 Decision
Making. Except as otherwise expressly provided in this Agreement, all matters regarding the Work Plan will be decided by consensus
by the JSC pursuant to Section 3.1(d) and subject to Section 3.2.
2.5 Progress.
During the Development Term each Party will keep the other Party reasonably informed regarding the progress and results of performance
of the Development Program. Without limiting the foregoing, following the end of each Calendar Quarter, each Party will prepare
a summary of all work performed to date, such summary to include a discussion of progress against goals set forth in the Work Plan.
The Parties will discuss such summary at the next JSC meeting.
2.6 Records.
CureVac will maintain complete and accurate records (in the form of technical notebooks or electronic files where appropriate)
of all work conducted by it under the Work Plan and all Know-How resulting from such work. Such records will fully and properly
reflect all work done and results achieved in the performance of the Work Plan in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes. CRISPR will have the right to receive copies of such records maintained by CureVac,
including in electronic format if maintained in such format, at reasonable times to the extent reasonably necessary to perform
obligations or exercise rights under this Agreement. Promptly following completion of the Work Plan, CureVac will deliver a final
report to CRISPR summarizing all work performed pursuant to the Work Plan, the results thereof and comparing the results
thereof against any goals set forth in the Work Plan.
2.7 Subcontracts.
Except as outlined in the Work Plan, CureVac may not subcontract any of its obligations under this Agreement absent CRISPR’s
prior written consent.
2.8 Manufacture
and Supply. All Cas9 mRNA Constructs required for use by CRISPR, its Affiliates and Sublicensees in accordance with this Agreement
for the non-clinical and Phase 1 Clinical Trial and Phase 2 Clinical Trial Development of the Licensed Products shall comport with
or incorporate CureVac’s most advanced required Manufacturing technology, methods and materials and shall be Manufactured
by or on behalf of CureVac in accordance with Applicable Laws and the terms and conditions of the Manufacturing Services Agreement
attached hereto as Attachment E. The potential supply of Cas9 mRNA Constructs required for use by CRISPR its Affiliates
and Sublicensees for Pivotal Clinical Trials and Commercial supply and a technology transfer in the event CureVac will not supply
such Cas9 mRNA Constructs is set forth in the Manufacturing Services Agreement.
2.9 Supply
of Material. CureVac will use Commercially Reasonable Efforts to supply to CRISPR, its Affiliates and Sublicensees the Materials
set forth in Attachment C hereof. CRISPR will use such Materials only in accordance with the Work Plan as set forth in Attachment
D and otherwise in accordance with the terms and conditions of this Agreement and will not reverse engineer or chemically analyze
the Material except as expressly provided for in the Work Plan.
2.10 Regulatory
Filings. CureVac hereby grants to CRISPR and its Affiliates, the right of cross-reference in any regulatory filing, Regulatory
Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) Controlled by
CureVac or its Affiliates in any country in the Territory that relate to any Licensed Product to permit CRISPR or its Affiliates
to comply with its regulatory obligations with respect to the Licensed Product in the Field in the Territory, or to exercise CRISPR’s
or its Affiliate’s rights hereunder or under the Manufacturing Services Agreement or the Commercial Supply Agreement. CureVac
shall do and cause to be done such reasonable acts and things, as may be necessary under, or as CRISPR may reasonably request,
to effectuate the rights of cross-reference contemplated in this Section 2.10. The foregoing grant is sublicenseable (through
multiple tiers) by CRISPR and its Affiliates. Notwithstanding anything to the contrary in this Agreement, unless required by any
Applicable Law or Regulatory Authority, CureVac shall not withdraw or inactivate any regulatory filing that CRISPR references or
otherwise uses pursuant to this Section 2.10.
Article 3
GOVERNANCE
3.1 Joint
Steering Committee.
(a) Formation;
Composition. Within [*****] days following the Effective Date, the Parties will establish a joint steering committee (the
“Joint Steering Committee” or “JSC”) comprised of two (2) representatives from each
Party (or appointed representatives of an Affiliate of such Party) with sufficient seniority within the applicable Party to
make decisions arising within the scope of the JSC’s responsibilities and each Party will appoint one of its
representatives to the JSC as such Party’s “Work Plan Leader”. The Parties’ initial
representatives to the JSC, and Work Plan Leaders, are set forth on Attachment F hereto. The JSC may change its size
from time to time by mutual consent of its members; provided that the JSC will consist at all times of an equal number
of representatives of each of CureVac and CRISPR. Each Party may replace any or all of its JSC representatives at any time
upon written notice to the other Party. The JSC may invite non-members to participate in the discussions and meetings of the
JSC; provided that such participants (i) will have no voting authority at the JSC and (ii) are bound under written
obligations of confidentiality no less protective of the other Party’s Confidential Information than those set forth in
this Agreement. Each meeting of the JSC will be co-chaired by a representative of each Party. The role of the chairpersons
will be to convene and preside at meetings of the JSC. The chairpersons will have no additional powers or rights beyond those
held by the other JSC representatives. Each Party’s Work Plan Leader will be the primary point of contact for the other
Party on all matters relating to the activities of the Work Plan.
(b) Specific
Responsibilities. The JSC will:
(i) oversee
the performance of the Work Plan;
(ii) review
the progress of activities under the Work Plan, all reports submitted by the Parties in accordance with Section 2.5, and
review and approve any amendments thereto, including any necessary amendments to the Work Plan budget as a result of any amendment
to the Work Plan, any other amendment to the Work Plan budget and any amendment to the timelines or activities under the Work Plan;
(iii) agree
on amendments of the Work Plan;
(iv) work
to resolve any disagreement between the Parties relating to the Work Plan;
(v) coordinate
Patent Right applications regarding Foreground Intellectual Property; and
(vi) perform
such other functions as appropriate, to further the purposes of this Agreement, in each case as agreed in writing by the Parties.
(c) Meetings.
During the Development Term, the JSC will meet at least quarterly for the first year, and at least twice a year thereafter. Following
the expiration of the Development Term, the Parties may agree to reduce the number of meetings to at least twice a year until
all [*****] Programs have initiated a Phase 1 Clinical Trial, unless otherwise agreed by the Parties. The JSC may meet in person,
by videoconference or by teleconference. Notwithstanding the foregoing, at least [*****] per year will be in person unless
the Parties mutually agree in writing to waive such requirement. In-person JSC meetings will be held at locations alternately
selected by CureVac and by CRISPR. Each Party will bear the expense of its respective JSC members’ participation in JSC
meetings. Meetings of the JSC will be effective only if at least [*****] of each Party is present or participating
in such meeting. Prior to each meeting of the JSC, CureVac and CRISPR will take turns to (i) prepare a written report detailing
the work performed to date under the Work Plan and evaluating such work in relation to the goals of the Work Plan and (ii) provide
such other information as is reasonably requested by the JSC. On a Program-by-Program basis, after each Program has initiated
a Phase 1 Clinical Trial, CRISPR shall provide CureVac with bi-annual reports summarizing all material matters and data relating
to the Programs, the results achieved in performance of the Development and outlining its further Development activities with
respect to such Program. Furthermore, CRISPR will, subject to confidentiality obligations, provide to CureVac copies of Final
Study Reports, once they are available, and will respond to any reasonable request from CureVac to obtain information on the status
of the Programs. Such reporting shall be available on a Program-by-Program basis until the date of the First Commercial Sale of
a Licensed Product for such Program.
(d) Decision
Making. The representatives from each Party on the JSC will have, collectively, [*****] on behalf of that Party, and all decision
making will be by consensus. Disputes at the JSC will be handled in accordance with Section 3.2.
3.2 Resolution
of JSC Disputes.
(a) Within
the JSC. Subject to the exception specified below in this Section 3.2, all decisions within the JSC will be made by
consensus. If the JSC is unable to reach consensus on any issue for which it is responsible, within [*****] days after a Party
affirmatively states that a decision needs to be made, either Party may elect to submit such issue to the Parties’ Executive
Officers, in accordance with Section 3.2(b).
(b) Referral
to Executive Officers. If a Party makes an election under Section 3.2(a) to refer a matter to the Executive Officers,
the JSC will submit in writing the respective positions of the Parties to the Executive Officers. The Executive Officers will use
good faith efforts in compliance with Section 3.3, which will include at least one in person meeting between such Executive Officers
within [*****] days after the JSC’s submission of such matter to them. If the Executive Officers are unable to reach unanimous
agreement on any such matter, CRISPR will decide such matter, provided that no exercise of such CRISPR’s decisionmaking authority
on any matter may, without CureVac’s prior written consent, not to be unreasonably withheld, conditioned or delayed, (i)
result in a material change to the Work Plan that significantly accelerates or decelerates the planned activities or requires allocation
by CureVac of personnel significantly greater than or less than those provided for in the Work Plan “significantly”to
include anything beyond [*****] percent of the agreed scope, (ii) result in a reduction of CRISPRs diligence obligations under this
Agreement, or (iii) otherwise conflict with this Agreement.
3.3 Good
Faith. In conducting themselves on the JSC, and in exercising their rights under Section 3.2, all representatives of
each Party will consider reasonably and in good faith all input received from the other Party. In exercising any decision making
authority granted to it under Section 3.2, each Party will act based on its good faith judgment taking into consideration
the best interests of the Development Program
Article 4
DEVELOPMENT AND COMMERCIALIZATION OF
LICENSED PRODUCTS
4.1 Development
and Commercialization. CRISPR shall have the sole right and responsibility for Developing and Commercializing Licensed Products
in the Field, including obtaining necessary Regulatory Approvals, at its sole cost and expense.
4.2 Back-up
Approach and Substitution for Program 1.
(a) CRISPR
will pursue the primary gene (as set forth in Attachment G) under Program 1. In the event the results of the Development show that
the primary gene should not be further pursued, such results to be discussed within the JSC, and CRISPR may select one of the back-up
genes in Attachment G to replace the primary gene.
(b) With
respect to Program 1, during the [*****] commencing on the Effective Date, CRISPR shall be permitted once to substitute the treatment
of [*****] upon notice to CureVac, at no additional cost.
4.3 Program
Substitution [*****]
(a) Substitution.
With respect to the [*****] Program, during the first [*****] years of this Agreement, CRISPR shall be permitted once to substitute
an alternative program for [*****] using the procedures set forth in Section 4.3(b), provided the intended indication has
an incidence approximately the same or less than the indication [*****]. The substitution is subject to the substitution fee
set forth below, and the milestones set forth in Section 5.4(c) shall not be adjusted for any [*****] Program substitution. For
clarity, even if the [*****] Program had already achieved several milestones, the substitution program would have to pay those
milestones again.
(b) [*****]
Program Substitution Process. CRISPR shall provide CureVac written notice of its request to substitute a target for the [*****]
Program within the [*****] years of the Effective Date. If CureVac provides CRISPR notice that a proposed substitution for the
[*****] Program is a Reserved Program, CureVac shall notify CRISPR within [*****] days after the date on which CureVac receives
notice of the proposed substitution if such proposed substitution is a Reserved Program. CureVac shall, if requested by CRISPR
in writing, provide CRISPR with such evidence to support that such proposed substitution is a Reserved Program. If after providing
such evidence, CRISPR concludes that such a substitution is not a Reserved Program, CRISPR will so notify CureVac, CureVac will
provide such evidence as CureVac believes is reasonably required to establish that such substitution is a Reserved Program to an
independent attorney or other expert with experience that is relevant to the dispute and reasonably acceptable to both Parties.
Such independent expert will review and make a determination in accordance with this Agreement regarding whether such proposed
substitution is a Reserved Program. The independent expert shall promptly notify the Parties of its determination as to whether
a proposed substitution is a Reserved Program, but shall not disclose to CRISPR information provided by CureVac in connection with
such determination. The independent expert’s determination shall be binding on the Parties, absent a manifest error of such
expert’s determination. If the independent expert determines such proposed substitution is a Reserved Program, CRISPR shall
be permitted to select another target for the [*****] Program; if the independent expert determines such proposed substitution
is not a Reserved Program, such proposed substitution shall become the target for the [*****] Program.
(c) Substitution
Fee. In the event CRISPR choses to substitute the [*****] Program a Substitution Fee of [*****] US dollars (US$ [*****]) is
due within [*****] days of confirmation of the new target by CureVac, or once the target is confirmed not to be a Reserved
Program in accordance with Section 4.3(b) above.
4.4 Diligence.
Subject to the terms of this Agreement, CRISPR shall use its Commercially Reasonable Efforts to progress the Development and Commercialization
of the Licensed Products in all three Programs in the Field in the Territory. CRISPR shall, inter alia,
(a) conduct
all non-clinical and clinical Development activities in a timely manner, and allocate such Development budgets as are commercially
reasonable and adequate to progress the non-clinical and clinical Development of Licensed Products hereunder;
(b) when
appropriate based on satisfactory data obtained during the nonclinical and clinical Development, use its Commercially Reasonable
Efforts to secure all required Regulatory Approvals in at least the EU, the US and Japan (with respect to Japan only, after taking
into account, among other things, commercial considerations and disease prevalence of a Program in Japan), following completion
of all appropriate clinical trials; and
(c) use
its Commercially Reasonable Efforts to make the First Commercial Sale of the Licensed Products in each country following the issuance
of the Regulatory Approvals for such country.
The diligence obligations set forth in this Section 4.4
may be satisfied by CRISPR, an Affiliate, or its or their Sublicensees.
Article 5
PAYMENTS; PAYMENT TERMS
5.1 Technology
Access Fee. Within [*****] business days following the Effective Date, CRISPR shall pay to CureVac a one-time payment of three million
US dollars (US$ 3,000,000).
5.2 Research
Support Payments. On a quarterly basis, CureVac shall provide an invoice to CRISPR setting forth the total FTE Costs (including
the amount of time actually spent by CureVac’s FTEs on activities under the Work Plan and a brief description of the work
performed by such FTEs), and any reasonable and documented out-of-pocket expenses incurred by CureVac in the performance of the
CureVac activities under the Work Plan until the date of such invoice, and CRISPR shall, within [*****] days after receiving such
invoice, reimburse CureVac for the full amount of such FTE Costs and reasonable out-of-pocket expenses incurred by CureVac; provided
that, CRISPR shall not be responsible for the payment of any costs and expenses (including FTE Costs) that are incurred by CureVac
for any activities that are not set forth in the then-current Work Plan, and such costs and expenses will be borne entirely by
CureVac unless otherwise approved by CRISPR in writing.
5.3 Non-Royalty
Sublicense Income.
(a) On
a Sublicensee-by-Sublicensee basis, CRISPR will, in addition to Development and Commercial Milestones in accordance with Section
5.4 and royalties on Net Sales in accordance with Section 5.5, pay CureVac the percentage set forth below of Non-Royalty
Sublicense Income received by CRISPR or its Affiliates in accordance with the following table:
| Stage at which sublicense is granted by |
% of Non-Royalty |
% of Non-Royalty |
| CRISPR |
Sublicense Income |
Sublicense Income |
| |
Payable to CureVac for |
from Casebia Payable |
| |
Such Sublicense (“Full |
to CureVac for Such |
| |
Sublicense Rate”) |
Sublicense (“Reduced |
| |
|
Sublicense Rate”) |
| [*****] |
[*****] |
[*****] |
| |
|
|
| |
|
|
| |
|
|
| [*****] |
|
|
| |
|
|
| [*****] |
[*****] |
[*****] |
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| [*****] |
[*****] |
[*****] |
| |
|
|
| |
|
|
In the event CRISPR receives the Non-Royalty
Sublicense Income at the Reduced Sublicense Rate from Casebia, CRISPR shall pay the difference to the Non-Royalty Sublicense Income
at the Full Sublicense Rate once and if the Third Party who obtained the sublicense from Casebia grants a sub-sublicense to another
Third Party. For illustration purposes: If Casebia receives an upfront payment from its Sublicensee in the amount of [*****] US
dollars (US$ [*****]), CRISPR shall pay [*****] US dollars (US$ [*****] rather than [*****] US dollars (US$ [*****]) to CureVac.
The difference between the Non-Royalty Sublicense Income calculated at the Full Sublicense Rate and the Non-Royalty Sublicense
Income calculated at the Reduced Sublicense Rate [*****] shall be paid if and once Casebia’s Sublicensee grants a sub-sublicense
to a Third Party and makes a first upfront or milestone payment to Casebia. For clarity, no license or sublicenses between CRISPR
and any of its Affiliates shall give rise to any payments under this Agreement.
5.4 Development
& Commercial Milestones. In consideration of the performance of the Development Program and the licenses granted under
this Agreement, CRISPR will pay to CureVac the amounts set forth below within [*****] calendar days following achievement
of the applicable milestone by a Licensed Product. Milestones listed below shall be paid one time per Program under this Agreement,
and can be satisfied anywhere in the Territory. In the event a milestone event is being skipped, the respective milestone payment
is payable once the next consecutive milestone has been achieved, jointly with the milestone payment for such consecutive milestone.
(a) The
first achievement of any of the following milestones by a Licensed Product Developed by or on behalf of CRISPR, any of its Affiliates
or any Sublicensee in connection with the Program 1:
[*****]
(b) The
first achievement of any of the following milestones by a Licensed Product Developed by or on behalf of CRISPR, any of its Affiliates
or any Sublicensee in connection with the [*****] Program:
[*****]
(c) The
first achievement of any of the following milestones by a Licensed Product Developed by or on behalf of CRISPR, any of its Affiliates
or any Sublicensee in connection with the [*****]:
[*****]
5.5 Running
Royalties.
(a) Subject
to the terms and conditions of this Agreement, on a country-by-country and Licensed Product-by-Licensed Product basis, CRISPR
will pay to CureVac a royalty equal to [*****] percent ([*****]%) of Net Sales of Licensed Products sold or transferred by CRISPR, its
Affiliates and its Sublicensees in those countries during the Royalty Term applicable to such Licensed Product.
(b) On
a country-by-country and Licensed Product-by-Licensed Product basis, the royalty rate that CRISPR shall pay CureVac pursuant to
Section 5.5(a) shall be reduced by [*****] percent ([*****]%) if at the time of sale (i) no Valid Claims
exist and (ii) Regulatory Exclusivity has expired.
(c) No
Multiple Royalties. If the Development, Manufacture, Commercialization or other use of any Licensed Product is (i) Covered
in a given country by more than one Patent Right or by a Patent Right and Know-How within the Licensed Intellectual Property, multiple
royalties with respect to Net Sales of that Licensed Product in that country shall not be due.
(d) Blended
Royalties. With respect to a potential step down in royalty rates to account for the expiry of certain Patent Rights, the
Parties acknowledge and agree that the Licensed Intellectual Property licensed under this Agreement may justify royalty rates
and/or royalty terms of differing amounts for sales of Licensed Products in the Territory, which rates could be applied
separately to Licensed Products involving the exercise of Licensed Patent Rights in the Territory and/or the incorporation of
Know How comprised in the Licensed Intellectual Property, and that if such royalties were calculated separately, royalties
relating to the Licensed Patent Rights in the Territory and royalties relating to the Know How comprised in the Licensed
Intellectual Property would last for different terms. For practicality reasons the Parties have agreed on a blended royalty
rate. For clarity, this Section 5.5(d) solely explains the rationale behind the royalty rates agreed by the Parties
and does not modify any of the other provisions of this Agreement.
(e) Fully
Paid-Up Licenses. With respect to a Licensed Product in a given country, as of the date on which the Royalty Term applicable
to such Licensed Product ends, the license grants contained in Section 7.1(a) shall become fully paid-up, royalty-free,
perpetual and irrevocable for such Licensed Product in such country.
(f) Timing
of Royalty Payments. CRISPR shall make royalty payments owed to CureVac hereunder in arrears, within [*****] days after the end
of each Calendar Quarter in which such payment accrues. Each royalty payment shall be accompanied by a report for each country
in which sales of Licensed Products occurred in the Calendar Quarter. Such report shall describe the Net Sales of each Licensed
Product sold by or on behalf of CRISPR, its Affiliates or Sublicensees during the applicable Calendar Quarter for each country
in which sales of any Licensed Product occurred, specifying: the gross sales (if available) and Net Sales in each country’s
currency, including an accounting of deductions taken in the calculation of Net Sales; the applicable exchange rate to convert
from each country’s currency to US Dollars; and the royalties payable in US Dollars.
5.6 Royalty
Records. CRISPR and its Affiliates and Sublicensees shall keep, for at least [*****] years from the end of the Calendar Year
to which they pertain, complete and accurate records of sales by CRISPR, its Affiliates and Sublicensees, as the case may be, of
each Licensed Product, in sufficient detail to allow the accuracy of the payments hereunder to be confirmed.
5.7 Third
Party Payments. To the extent CRISPR enters into a Third Party Agreement pursuant to Section 7.4, CRISPR shall be entitled
to deduct from the then-current sales milestone and royalty payments due to CureVac under this Article 5 the amounts paid
(including milestone payments, royalties or other license fees) by CRISPR to such Third Party under such Third Party Agreement;
provided, however, that in no event shall the amounts due to CureVac from CRISPR in any Calendar Quarter be reduced by more than
[*****]. Any amount that CRISPR is entitled to deduct that is reduced by the foregoing limitation on the deduction, or is otherwise
not deducted in a particular Calendar Quarter (for example, if the amount due to CureVac is less than the amount due to such Third
Party during such Calendar Quarter), such amount that was not deducted shall be carried forward and CRISPR may deduct such amount
from subsequent amounts due to CureVac until the full amount that CRISPR was entitled to deduct is deducted. CureVac agrees to
fully cooperate with CRISPR to acquire such rights.
5.8 Review.
Subject to the other terms of this Section 5.8, at the request of CureVac, which shall not be made more frequently
than once per Calendar Year during the Term, upon at least [*****] days’ prior written notice, and at CureVac’s
expense, CRISPR shall permit an independent certified public accountant selected by CureVac and reasonably acceptable to
CRISPR to inspect (during regular business hours) the records required to be maintained by CRISPR relating to royalties
payable pursuant to this Agreement. In every case the accountant must have previously entered into a confidentiality
agreement with all Parties substantially similar to the provisions of Article 6 and limiting the disclosure and use of
such information by such accountant to authorized representatives of the Parties and the purposes germane to this Section
5.8. The Parties shall treat the results of any such accountant’s review of such records under this Section
5.8 as Confidential Information of the applicable Party subject to the terms of Article 6. If any such review
reveals a deficiency in the calculation and/or payment of royalties by CRISPR, then CRISPR shall promptly reimburse CureVac
for such accountant’s fees and pay CureVac the revealed amount remaining to be paid.
5.9 Method
of Payment. All payments under this Agreement will be transferred to the following CureVac account:
[*****]
5.10 Accounting.
All payments due under this Agreement will be made in United States dollars. Conversion of foreign currency to United States Dollars
shall be made at the average monthly rate of exchange, using Bloomberg foreign exchange rates, using the conversion rates beginning
the second to last business Day of the month preceding the month in which such sales are recorded and ending on the second to last
business day of the month in which the sales are recorded.
5.11 Interest.
Payments not paid within [*****] business days after the due date under this Agreement shall bear interest at an annual rate
of [*****] percent ([*****]%) above the three-month-LIBOR rate of the respective currency for the time period in which such
amount is outstanding. If CRISPR disputes the amount of a payment hereunder and does make such payment nonetheless, CRISPR
shall be reimbursed the payment plus statutory interest as of the date of CureVac’s receipt of CRISPR’s notice
disputing such payment, once the Parties agree or it is finally adjudicated that CRISPR was not obligated to make such
payment.
5.12 Tax
Withholding; Restrictions on Payment. All payments under or in connection with this Agreement shall be inclusive of any income
taxes and each Party shall be responsible for its own income taxes assessed by a tax or other authority. If laws, regulations or
rules require that taxes be withheld with respect to any payments by CRISPR to CureVac under this Agreement, CRISPR will: (a) deduct
those taxes from the remittable payment as required by law from, (b) pay the taxes to the proper taxing authority, and (c) send
evidence of the obligation together with proof of tax payment to CureVac on a timely basis following that tax payment. Each Party
agrees to cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant
agreement or treaty which is in effect, and CRISPR shall forward any refund payments to CureVac without undue delay. The Parties
shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance with Applicable Laws, regulations
and rules.
5.13 VAT.
All payments due to the terms of this Agreement are expressed to be exclusive of value added tax (VAT) or similar indirect taxes
(e.g., Goods and Service tax). VAT/indirect taxes shall be added to the payments due to the terms if legally applicable.
5.13 Refund;
Offset. The payments made under this Article 5 are in no event refundable or creditable.
Article 6
CONFIDENTIALITY
6.1 Confidential
Obligations. Each Party agrees that a Party (the “Receiving Party”) receiving Confidential Information of
the other Party (the “Disclosing Party”) (or that has received any such Confidential Information from the other
Party prior to the Effective Date) in connection with this Agreement shall, subject to Section 6.2 and Section 6.3,
(a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain
in confidence its own proprietary industrial information of similar kind and value, but in no circumstances less than a reasonable
standard of care, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing
Party, except for disclosures expressly permitted below, and (c) not use such Confidential Information for any purpose except those
expressly permitted by this Agreement, including the exercise of rights and satisfaction of obligations under this Agreement.
6.2 Exceptions.
The obligations in Section 6.1 shall not apply with respect to any portion of the Confidential Information that the Receiving
Party can show by competent written proof:
(a) is
publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party by or on behalf of the
Disclosing Party;
(b) was
known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its
use, prior to disclosure by the Disclosing Party;
(c) is
subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without
any obligation to keep it confidential or any restriction on its use;
(d) is
published by a Third Party or otherwise becomes publicly available or enters the public domain without violation of this Agreement
by the Receiving Party or any person for whom the Receiving Party is responsible pursuant to Section 6.3(c), either before
or after it is disclosed to the Receiving Party; or
(e) is
independently Developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Disclosing Party’s
Confidential Information.
6.3 Authorized
Disclosure. The Receiving Party may disclose Confidential Information belonging to the Disclosing Party, and Confidential Information
deemed to belong to both Parties under the terms of this Agreement, to the extent (and only to the extent) such disclosure is reasonably
necessary in the following instances:
(a) subject
to Section 6.4, complying with Applicable Laws (including the rules and regulations of the Securities and Exchange Commission
or any national securities exchange) and with judicial or administrative process, if in the reasonable opinion of the Receiving
Party’s counsel, such disclosure is necessary for such compliance, provided that the Disclosing Party is informed,
to the extent practicable, of the obligation of disclosure, so that the Disclosing Party may oppose or limit such disclosure obligation
and provided the Receiving Party limits the disclosure to the strict minimum in order to comply with its obligations;
(b) disclosure
by the Parties of the existence of this Agreement in any annual report to stockholders, filings with the Securities and Exchange
Commission and other Regulatory Authorities and communications with securities analysts and stockholders; and
(c) disclosure,
solely on a “need to know basis,” to Affiliates, potential or actual research and development collaborators, subcontractors,
investment bankers, investors, lenders, shareholders, or other potential or actual financial or strategic partners, and each of
the Parties’ respective directors, employees, contractors, agents, legal counsel and accountants, each of whom prior to disclosure
must be bound by obligations of confidentiality and non-use no less restrictive than the obligations set forth in this Article
6, which for avoidance of doubt, will not permit use of such Confidential Information for any purpose except those permitted
by this Agreement, including the exercise of rights and satisfaction of obligations under this Agreement; provided, however,
that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives
Confidential Information pursuant to this Section 6.3 to treat such Confidential Information as required under this Article
6.
If and whenever any Confidential Information
is disclosed in accordance with this Section 6.3, such disclosure shall not cause any such information to cease to be Confidential
Information except to the extent that such disclosure results in a public disclosure of such information (otherwise than by breach
of this Agreement). Where reasonably possible and subject to Section 6.4, the Receiving Party shall notify the Disclosing
Party of the Receiving Party’s intent to make any disclosures pursuant to Section 6.3(a) or 6.3(b) sufficiently
prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate
to protect the confidentiality of the information, and the Receiving Party will provide reasonable assistance to the Disclosing
Party with respect thereto; provided that, in any event, the Receiving Party will use reasonable measures to ensure confidential
treatment of such information and shall only disclose such Confidential Information of the Disclosing Party as is necessary to
comply with such Applicable Laws or judicial process.
6.4 Securities
Filings. If either Party proposes to file with the Securities and Exchange Commission or the securities regulators of any state
or other jurisdiction a registration statement or any other disclosure document that describes or refers to the terms and conditions
of this Agreement under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other Applicable
Law, the Party shall notify the other Party of such intention and shall provide such other Party with a copy of relevant portions
of the proposed filing prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior
to the filing thereof), including any exhibits thereto relating to the terms and conditions of this Agreement, and shall use reasonable
and diligent efforts to obtain confidential treatment of the terms and conditions of this Agreement that such other Party requests
be kept confidential, and shall only disclose Confidential Information that is requested by the Securities and Exchange Commission
or legally required to be disclosed. No such notice shall be required under this Section 6.4 if the description of or reference
to this Agreement contained in the proposed filing has been included in the press release or in any previous filing made by the
either Party hereunder or otherwise approved by the other Party.
6.5 Publicity.
Except as otherwise provided herein, each Party agrees not to issue any other press release or other public statement disclosing
terms of this Agreement or using the name or trademark of the other Party, its Affiliates or its employees, in either case, without
the prior written consent of such other Party.
6.6 Existing
Confidentiality Agreement. The Parties hereby agree that all confidential information disclosed by one Party to the other pursuant
to that certain Confidentiality Agreement, by and between the Parties, dated February 26, 2017, will be governed by the terms of
this Agreement.
6.7 Return
of Confidential Information. Upon expiry or earlier termination of the Agreement, upon written request of a Party (such request,
if made, to be made within three (3) months of such expiry or termination) the other Party will destroy or return (as shall be
specified in such request) to the requesting Party all copies of the Confidential Information of the requesting Party; provided
that the Party may retain: (i) one copy of such Confidential Information for recordkeeping purposes, for the sole purpose of ensuring
compliance with this Agreement; (ii) any copies of such Confidential Information as is required to be retained under Applicable
Law; (iii) any copies of such Confidential Information as is necessary or useful for such Party to exercise a right or fulfill
an obligation towards a Sublicensee, if any, or as set forth in this Agreement; and (iv) any copies of any computer records and
files containing Confidential Information that have been created by such Party’s routine archiving/backup procedures.
Article 7
INTELLECTUAL PROPERTY
7.1 Ownership;
License Grants.
(a) Exclusive
License. CureVac hereby grants to CRISPR, and CRISPR hereby accepts, an exclusive (even as to CureVac and its Affiliates),
sublicenseable (in accordance with Section 7.2), worldwide, royalty-bearing license under the Licensed Intellectual Property
to Develop, Manufacture, Commercialize and otherwise use, including, but not limited to the right to research, have researched,
develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import, have
imported, export, otherwise exploit and otherwise have exploited, Licensed Products in the Field in the Territory, in accordance
with the terms and conditions, and subject to the limitations of this Agreement, the Manufacturing Services Agreement and the Commercial
Supply Agreement.
(b) Exclusive
Back License. On a Licensed Product-by-Licensed Product basis, as so long as CureVac is supplying Cas9 mRNA Constructs to CRISPR
for a Licensed Product under the Manufacturing Services Agreement or any Commercial Supply Agreement, and on a Licensed Product-by-Licensed
Product basis, CRISPR hereby grants to CureVac, and CureVac hereby accepts, an exclusive (even as to CRISPR and its Affiliates)
worldwide, cost-free sublicense of the rights granted to CRISPR under Section 7.1(a), to Manufacture and have Manufactured
Licensed Products in the Field in the Territory. For clarity, CureVac has no license to use, sell or otherwise exploit such Licensed
Products and consequently will Manufacture such Licensed Products solely to supply to CRISPR, its Affiliates and their respective
Sublicensees under such agreements.
(c) Background
Intellectual Property. CureVac acknowledges and agrees that with signing this Agreement it does not acquire a license or any
other right to CRISPR Background Intellectual Property except for the limited purpose of carrying out its duties and obligations
under this Agreement and that such limited, non-exclusive, cost-free license will expire upon the completion of such duties and
obligations or the termination or expiration of this Agreement, whichever is the first to occur. CRISPR acknowledges and agrees
that CureVac retains all rights to the CureVac Background Intellectual Property, subject only to the licenses granted hereunder.
(d) Ownership
of Foreground Intellectual Property.
(i) Except
as set forth in subsection (iii) below, each Party will solely own all right, title and interest in and to all Foreground
Intellectual Property that is discovered, created, conceived or reduced to practice solely by or on behalf of such Party
(“Solely-Owned Foreground Know-How”) and all Patent
Rights arising therefrom that Cover such Solely-Owned Foreground Know-How (“Solely-Owned Foreground Patent Rights”),
and together with the Solely-Owned Foreground Know-How, the “Solely-Owned Foreground Intellectual Property”.
All right, title and interest in and to all Solely-Owned Foreground Intellectual Property will automatically vest solely in such
Party.
(ii) Except
as set forth in subsection (iii) below, the Parties will jointly own all right, title and interest in and to all Foreground Intellectual
Property that is discovered, created, conceived or reduced to practice jointly by or on behalf of the Parties (“Jointly-Owned
Foreground Know-How”) and all Patent Rights arising therefrom that Cover such Jointly-Owned Foreground Know-How (“Jointly-Owned
Foreground Patent Rights”), and together with the Jointly-Owned Foreground Know-How, the “Jointly-Owned Foreground
Intellectual Property”. Each Party will have an undivided one-half interest in and to such Jointly-Owned Foreground Intellectual
Property. CRISPR will have a right to grant non-exclusive licenses (with the right to grant sublicenses through multiple tiers)
to CureVac’s share in such Jointly-Owned Foreground Intellectual Property to the extent such license is required to exercise
or exploit CRISPR Background Intellectual Property; and CureVac will have a right to grant non-exclusive licenses (with the right
to grant sublicenses through multiple tiers) to CRISPR’s share in such Jointly-Owned Foreground Intellectual Property to
the extent such license is required to exercise or exploit CureVac Background Intellectual Property; i.e., neither Party is to
be blocked in the use of its Background Intellectual Property. Subject to the licenses granted herein, any further license to Jointly-Owned
Foreground Intellectual Property requires the prior written consent of the other Party. Each Party, for itself and on behalf of
its and its Affiliates’ employees, subcontractors, consultant and agents, hereby assigns and agrees to assign, without additional
consideration, to the other Party a joint and undivided interest in and to all Jointly-Owned Foreground Intellectual Property to
effect such joint ownership, which assignment such other Party hereby accepts.
(iii) Notwithstanding
subsections (i) and (ii) above,
(A) CRISPR
will solely own any Foreground Intellectual Property that is a CRISPR Improvement and that is not also a CureVac Improvement at
the time such CRISPR Improvement is discovered, created, conceived, developed or reduced to practice, regardless of the Party or
Parties such Foreground Intellectual Property was discovered, created, conceived, developed or reduced to practice by or on behalf
of, and CureVac, for itself and on behalf of its and its Affiliates’ employees, subcontractors, consultants and agents hereby
assigns and agrees to assign, all of its rights, title and interest in such Intellectual Property to CRISPR. CureVac shall execute
and deliver to CRISPR, to the extent necessary, any deed(s) of such assignment, in a mutually agreeable form and will take whatever
actions reasonably necessary, including the appointment of CureVac as its attorney in fact solely to make such assignment, to effect
such assignment.
(B) CureVac
will solely own any Foreground Intellectual Property that is a CureVac Improvement that is not also a CRISPR Improvement at the
time such CureVac Improvement is discovered, created, conceived, developed or reduced to practice, regardless of the Party or Parties
such Foreground Intellectual Property was discovered, created, conceived, developed or reduced to practice by or on behalf of,
and CRISPR, for itself and on behalf of its and its Affiliates’ employees, subcontractors, consultants and agents hereby
assigns and agrees to assign, all of its rights, title and interest in such Intellectual Property to CureVac. CRISPR shall execute
and deliver to CureVac, to the extent necessary, any deed(s) of such assignment, in a mutually agreeable form and will take whatever
actions reasonably necessary, including the appointment of CRISPR as its attorney in fact solely to make such assignment, to effect
such assignment.
(C) To
the extent a particular item of Foreground Intellectual Property constitutes both a CRISPR Improvement and a CureVac Improvement,
(“Dual Improvement Intellectual Property”), the Parties shall discuss in good faith whether any such Foreground
Intellectual Property can be divided and owned in accordance with subsections (A) and (B) above, made subject to separate patent
filings to be assigned accordingly; and to the extent no such division is possible, such Dual Improvement Intellectual Property
shall be treated as part of the Jointly-Owned Foreground Intellectual Property for all purposes under this Agreement.
7.2 Right
to Sublicense. CRISPR shall be entitled to sublicense (through multiple tiers) its rights under Section 7.1(a) to any
Affiliates and to any Third Parties, provided that sublicenses to Third Parties require CureVac’s prior written consent which
CureVac will not unreasonably withhold, condition or delay and that such sublicenses are subject to the Non-Royalty Sublicense
Income in accordance with Section 5.3 above. For any sublicense it must be provided that the respective sublicense agreement
contains terms and conditions that are not inconsistent with those contained in this Agreement, and shall include provisions regarding
confidentiality, indemnification, audit, record-keeping and termination. CRISPR shall remain liable to CureVac for all obligations
under this Agreement. CRISPR shall furnish CureVac with a fully executed copy of any sublicense agreement promptly after its execution,
subject to reasonable redactions to the extent not necessary for CureVac to understand the scope of such sublicense, to calculate
the Non-Royalty Sublicense Income and to determine if CRISPR is in compliance with this Section 7.2, and subject to the
confidentiality provisions therein. The terms of any such sublicense agreement shall be Confidential Information of CRISPR.
7.3 Disclosure.
Each Party will promptly disclose to the other Party all Foreground Know-How that is discovered, created, conceived or reduced
to practice by or on behalf of such Party, and will provide documentation regarding the same as the other Party may reasonably
request, including, information obtained by CureVac relating to CureVac’s proprietary mRNA technology platform generally
that would reasonably have an impact on any Cas9 mRNA Constructs or Licensed Products.
7.4 Third
Party Licenses. To the extent CRISPR identifies any Patent Rights controlled by a Third Party that are reasonably
necessary for a Party to freely exercise, practice or otherwise use the CureVac Background Patent Rights or the Foreground
Patent Rights solely owned by CureVac, in each case, in connection with a Party’s direct or indirect performance of its
rights or obligations under this Agreement, and with respect to CRISPR’s exploitation of Cas9 mRNA Constructs included
in a Licensed Product in accordance with this Agreement, only if such Cas9 mRNA Constructs are defined by CureVac, CRISPR
will promptly notify CureVac of such Patent Rights, Know-How or other intellectual property and CureVac will have the first
right to negotiate for and enter into a license agreement (“Third Party Agreement”) with respect to such
Patent Rights, Know-How, or other intellectual property, provided that CureVac will notify CRISPR if CureVac wishes to
exercise such right within [*****] days of CRISPR’s notice, and such first right will continue until the earlier of (x)
[*****] days after the date of CureVac’s notice to CRISPR exercising such right or (y) CureVac is no longer actively
negotiating such agreement, in which case CureVac will so notify CRISPR (such period is referred to the “First
Exercise Period”), and CureVac will keep CRISPR reasonably informed as to the status of such negotiations. If
CureVac does not notify CRISPR of its intent to exercise such right or the First Exercise Period expires, CRISPR will have
the right to negotiate for and enter into a Third Party Agreement with respect to such Patent Rights, Know-How or other
intellectual property.
Article 8
PROSECUTION AND ENFORCEMENT
8.1 Patent
Prosecution. As between the Parties, each Party will have the sole right, but not the obligation, to file, prosecute and maintain
the Patent Rights owned solely by such Party. During the Term, CureVac will consult with CRISPR as to the preparation, filing,
prosecution, and maintenance of any of its Foreground Patent Rights reasonably prior to any deadline or action with the United
States Patent & Trademark Office or any foreign patent office and will furnish CRISPR with copies of all relevant documents
reasonably in advance of consultation. CureVac will reasonably consider any of CRISPR’s reasonable comments on any documents
to be submitted to such patent offices. In the event CureVac (i) decides not to file a patent application pertaining to any Foreground
Know-How in any given country or countries, or (ii) desires to abandon any patent or patent application within the Foreground Patent
Rights, then, in each case, CureVac shall provide CRISPR with reasonable prior written notice of such intended decision not to
file or such intended decision of abandonment or decline of responsibility. If CRISPR elects to file any such patent application
on behalf of CureVac, or if CRISPR elects to continue such patent or patent application on behalf of CureVac, the Parties shall
promptly consult and CureVac may elect to retain responsibility therefor provided that any such decision shall be made in a sufficiently
prompt time so as not to jeopardize CRISPR’s ability to file such patent application or its ability to pursue or maintain
such patent or patent application. Otherwise, CRISPR shall have the right, but not the obligation, to prepare, file, prosecute
and maintain the relevant Foreground Patent Rights, as applicable, or seek patent protection in the first instance, on behalf of
CureVac and at CRISPR’s expense.
8.2 Prosecution
of Jointly-Owned Foreground Patent Rights. CRISPR will have the first right, but not the obligation to file, prosecute and
maintain Jointly-Owned Foreground Patent Rights, and will bear the costs incurred by CRISPR in connection with such efforts. CRISPR
will consult with CureVac as to the preparation, filing, prosecution and maintenance of the Jointly-Owned Foreground Patent Rights
reasonably prior to any deadline or action with any patent office and will furnish CureVac with copies of all relevant documents
reasonably in advance of consultation. CRISPR will reasonably consider any of CureVac’s reasonable comments on any documents
to be submitted to such patent offices. In the event CRISPR (i) decides not to file a patent application pertaining to any Jointly-Owned
Foreground Know-How in any given country or countries, or (ii) desires to abandon any patent or patent application within the Jointly-Owned
Foreground Patent Rights, then, in each case, CRISPR shall provide CureVac with reasonable prior written notice of such intended
decision not to file or such intended decision of abandonment or decline of responsibility. If CureVac elects to file any such
patent application, or if CureVac elects to continue such patent or patent application, the Parties shall promptly consult and
CRISPR may elect to retain responsibility therefor provided that any such decision shall be made in a sufficiently prompt time
so as not to jeopardize CureVac’s ability to file such patent application or its ability to pursue or maintain such patent
or patent application. Otherwise, CureVac shall have the right, but not the obligation, to prepare, file, prosecute and maintain
the relevant Foreground Patent Rights, as applicable, or seek patent protection in the first instance, at CureVac’s expense.
8.3 Cooperation.
Each Party will provide the other Party, at the other Party’s request and expense, all reasonable assistance and cooperation
in connection with this Article 8, including providing any necessary powers of attorney and executing any
other required documents or instruments for such filing, prosecution or maintenance, and joining any lawsuit as needed for standing.
8.4 Third
Party Actions.
(a) Patent
Infringement Claims Against a Party. Each Party shall notify the other if it is aware of any claim that the Development, Manufacture,
Commercialization or other use of a Licensed Product in the Field infringes a Patent Right Controlled by a Third Party, setting
forth the facts of such claim in reasonable detail. CRISPR shall have the first right, but not the obligation, at its own expense,
to defend and control the defense of any such claim, by counsel of its own choice. CRISPR shall not enter into a settlement that
imposes a financial obligation upon CureVac or which limits the scope or invalidates any CureVac’s intellectual property
rights without CureVac’s prior written consent and in any settlement CRISPR shall always take into consideration the interest
of CureVac. In case CRISPR elects not to defend and control the defense of any such claim, it shall notify CureVac of such election
within due term to allow CureVac to defend and control the defense of any such claim.
(b) Notice.
If either Party learns of any (i) actual, alleged or threatened infringement or misappropriation of any of the Licensed Patent
Rights in the Field, including based on the Development or Commercialization of a product that competes with a Licensed Product;
(ii) declaratory judgment initiated by a Third Party naming a Party, or a Party’s Affiliate or a Sublicensee as a defendant
and alleging invalidity, unenforceability or non-infringement of any of the Licensed Patent Rights Covering the Development or
Commercialization of a Licensed Product in the Field (“Competitive Infringement”), or (iii) declaratory judgment
initiated by a Third Party naming a Party or a Party’s Affiliate or Sublicensee as a defendant and alleging invalidity, unenforceability
or non-infringement of any Licensed Patent Rights Covering the Manufacture of a Licensed Product in the Field, such Party shall
promptly notify the other Party and shall provide the other Party with available evidence of such infringement or declaratory action.
(c) Enforcement
and Defense. CRISPR shall have the first and exclusive right, but not the obligation, to take any reasonable measures it
deems appropriate with respect to any Competitive Infringement in the Territory of any Licensed Patent Rights. Such measures
may include (a) initiating or prosecuting an infringement, misappropriation or other appropriate suit or action (each an
“Infringement Action”) in the Territory, or (b) granting adequate rights and licenses to any Third Party
necessary to render continued Competitive Infringement in the Territory non-infringing. Notwithstanding the foregoing, if
CRISPR does not inform CureVac that it intends to either initiate such an Infringement Action or grant adequate rights and
licenses to such Third Party within [*****] after CRISPR’s receipt of a notice of infringement, then CureVac will have
the second right, but not the obligation, to initiate such Infringement Action with respect to such Licensed Patent Rights.
For any infringement other than a Competitive Infringement, and except as set forth below, each Party will have the first
right, but not the obligation to enforce and defend the Licensed Patent Rights owned solely by such Party, and CRISPR will
have the first right, but not the obligation to enforce and defend the Jointly Owned Foreground Patent Rights, with the
exception only of Jointly-Owned Foreground Patent Rights which solely Cover the Manufacture of the Licensed Products, for
which CureVac will have the first right, but not the obligation to enforce and defend. If within [*****] after having been
notified of any alleged Third Party infringement of any Licensed Patent Right or any declaratory action contemplated by Section
8.4(d), in each case, in the Field, the Party enforcing or defending the Patent Right is unsuccessful in persuading the
alleged infringer to desist, or the respective competent Party shall not have brought an infringement action within such
[*****] period, or if the respective competent Party has not responded to such declaratory action, then, in
any such event the other Party shall have the right, but not the obligation, to prosecute and defend the respective Licensed
Patent Rights in connection with any such matter. The Party taking action to enforce and defend under this Section
8.4(c) shall bear all of its costs related to such enforcement and defense, including any costs incurred by the other
Party providing support to such enforcement and defense at the request of the enforcing and defending Party.
(d) Standing
to Xxx; Collaboration. In any litigation brought by either Party pursuant to this Section 8.4, the enforcing Party shall
notify the non-enforcing Party of the commencement of that litigation and shall have the right and standing to use and xxx in the
other Party’s name. Irrespective of which Party brings the infringement action hereunder, (i) the Parties shall collaborate
with respect to such action; (ii) the non-enforcing Party shall have the right, at its own expense, to be represented by independent
counsel in any such litigation; and (iii) the Parties shall consult with each other regarding and agree on strategic decisions
and their implementation in connection with such action. The Party bringing the infringement action hereunder shall bear all the
expenses of any suit brought by it claiming infringement of any Licensed Patent Right.
(e) Recovery.
In the event that either Party exercises the rights conferred in this Article 8 and recovers any damages or other sums in such
action, such damages or other sums recovered shall first be applied to all out-of-pocket costs and expenses incurred by the Parties
in connection therewith (including, without limitation, attorneys’ fees). If such recovery is insufficient to cover all such
costs and expenses of both Parties, the Parties’ costs shall be paid on a pro-rated basis. If after such reimbursement any
funds shall remain from such damages or other sums recovered, such funds shall be [*****] the Parties
Article 9
INDEMNIFICATION
9.1 Indemnification
by CRISPR. Subject to the terms and conditions hereof, CRISPR shall indemnify CureVac, its Affiliates, and its and their directors,
officers, employees, approved subcontractors and agents (“CureVac Indemnitees”) and defend and hold each of
them harmless, from and against any and all Third Party claims and all losses, damages, liabilities, costs and expenses (including
reasonable attorneys’ fees and expenses) (collectively, “Losses”) that such CureVac Indemnitees may be
required to pay to one or more Third Parties to the extent arising from or occurring as a result of (a) an uncured material breach
of any of CRISPR’s representations, warranties or covenants set forth in this Agreement, (b) the exercise by CRISPR and/or
any of its Affiliates or Sublicensees of the rights granted to CRISPR pursuant to Sections 4.1 and 7.1 (including
the Development, Manufacture, Commercialization or other use of Licensed Products), except to the extent such Losses are in connection
with the CureVac Background Intellectual Property or the Foreground Intellectual Property solely owned by CureVac; or (c) the negligence,
recklessness, or willful misconduct by CRISPR or its Affiliates. Notwithstanding the foregoing, CRISPR will have no obligations
under this Section to the extent Losses arise from or occur as a result of (i) gross negligence or willful misconduct (including
noncompliance with any Applicable Laws, regulations, or rules) on the part of a CureVac Indemnitee, or (ii) a breach by CureVac
of any representations, warranties or covenants set forth in this Agreement.
9.2 Indemnification
by CureVac. Subject to the terms and conditions hereof, CureVac shall indemnify CRISPR, its Affiliates, and its and their directors,
officers, employees, subcontractors, and agents (“CRISPR Indemnitees”), and defend and hold each of them harmless,
from and against any Third Party claims and all Losses that such CRISPR Indemnitees may be required to pay one or more Third Parties to the extent
arising from or occurring as a result of (a) an uncured material breach of any of CureVac’s representations, warranties or
covenants set forth in this Agreement, or (b) the negligence, recklessness, or willful misconduct by CureVac or its Affiliates.
Notwithstanding the foregoing, CureVac will have no obligations under this Section to the extent Losses arise from or occur as
a result of (i) gross negligence or willful misconduct (including non-compliance with any Applicable Laws, regulations, or rules)
on the part of a CRISPR Indemnitee, or (ii) a breach by CRISPR of any representations, warranties or covenants set forth in this
Agreement.
9.3 Indemnification
Procedures. Except as set forth in Section 8.4(a), the person claiming indemnity under this Article 9 (the “Indemnified
Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”)
promptly after learning of any claim, provided, that the failure to provide such notice shall not affect the Indemnifying
Party’s obligations hereunder, except to the extent it is materially prejudiced thereby. The Indemnified Party shall provide
the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of
the claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of
its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct
the defense of the claim with counsel of its choice. The Indemnifying Party shall not settle a claim in any manner that would require
payment by the Indemnified Party, or would materially adversely affect the rights granted to the Indemnified Party hereunder, or
would materially conflict with the terms of this Agreement, or adversely affect such Party or its products, without first obtaining
the indemnified Party’s prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed.
So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle or compromise
any such claim without the prior written consent of the Indemnifying Party, such consent not to be unreasonably withheld, conditioned
or delayed. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (a) the Indemnified
Party may defend against, consent to the entry of any judgment, or enter into any settlement with respect to such claim in any
manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent
from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the
Indemnified Party as provided in this Article 9.
Article 10
REPRESENTATIONS AND WARRANTIES
10.1 CureVac
Representations. Subject to the disclosures in Attachment H hereto, CureVac represents, warrants and covenants to CRISPR,
on the Effective Date, as follows.
(a) CureVac
is a stock corporation, validly existing and in good standing under the laws of Germany, with full power and authority to operate
its properties and to carry on its business as presently conducted.
(b) CureVac
has full power and authority to execute, deliver and perform this Agreement. This Agreement constitutes legally binding and valid
obligations of CureVac, enforceable in accordance with their terms;
(c) The
execution and delivery of this Agreement and the performance of the obligations contemplated hereby have been duly authorized by
all appropriate CureVac corporate action;
(d) The
execution, delivery and performance by CureVac of this Agreement and the consummation of the transactions contemplated hereby will
not result in any violation of, conflict with, result in a breach of or constitute a default under any contract or agreement to
which CureVac is a party or by which it is bound.
(e) To
the knowledge of CureVac, no consent, approval, order or authorization of, or registration, qualification, designation, declaration
or filing with, any federal, state or local governmental authority on the part of CureVac is required in connection with the execution,
delivery and performance of this Agreement.
(f) There
is no action, suit, proceeding or investigation pending or, to the knowledge of CureVac, currently threatened in writing against
or affecting CureVac that questions the validity of this Agreement or the right of CureVac to enter into this Agreement or perform
CureVac’s obligations hereunder.
(g) There
are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial, administrative or legal proceedings
pending or, to the knowledge of CureVac, threatened, against CureVac, including with respect to administrative or other governmental
investigations, which would (a) be reasonably expected to affect or restrict the ability of CureVac to perform its obligations
under this Agreement, or (b) affect in any manner the Licensed Intellectual Property or CureVac’s Control thereof.
(h) To
the knowledge of CureVac, no Third Party is conducting or engaging in any activity that would constitute infringement or misappropriation
of the Licensed Intellectual Property; and to the knowledge of CureVac, the performance of activities contemplated by this Agreement
(including the practice of the Licensed Intellectual property in accordance with the terms and conditions of this Agreement) would
not itself constitute infringement or misappropriation of Third party’s intellectual property rights in existence on the
Effective Date.
(i) To
CureVac’s knowledge, no objection or proceeding is pending or threatened that questions the validity or enforceability of
the CureVac Background Intellectual Property or the issuance of any patent applications included therein.
(j) As
of and following the Effective Date, CureVac has undertaken reasonable efforts to secure and will continue to use reasonable efforts
to secure from all employees, consultants, contractors and other Persons who have contributed or will contribute to the development,
creation, conception or invention of any of the Licensed Intellectual Property a written agreement assigning to CureVac or its
Affiliates all rights to such developments, creations, conceptions or inventions and such Affiliates have assigned such rights
to CureVac, and, to CureVac’s knowledge, neither CureVac nor any of its Affiliates has received any written communication
challenging CureVac’s ownership or right to such Licensed Intellectual Property, unless such an agreement with the inventor
is not required under Applicable Law for ownership in such Licensed Intellectual Property to vest in CureVac.
10.2 CRISPR’s
Representations. CRISPR represents and warrants to CureVac, on and as of the Effective Date, that:
(a) CRISPR
is a corporation, duly incorporated, validly existing and in good standing under the laws of Switzerland, with full corporate power
and authority to operate its properties and to carry on its business as presently conducted;
(b) CRISPR
has full power and authority to execute, deliver and perform this Agreement. This Agreement constitutes the legally binding and
valid obligations of CRISPR, enforceable in accordance with their terms;
(c) the
execution, delivery and performance by CRISPR of this Agreement and the consummation of the transactions contemplated thereby will
not result in any violation of, conflict with, result in a breach of or constitute a default under any contract or agreement to
which CRISPR is a party or by which it is bound, its business or assets;
(d) no
consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal,
state or local governmental authority on the part of CRISPR is required in connection with the execution, delivery and performance
of this Agreement; and
(e) there
is no action, suit, proceeding or investigation pending or, to the knowledge of CRISPR, currently threatened against or affecting
CRISPR or that questions the validity of this Agreement, or the right of CRISPR to enter into this Agreement or consummate the
transactions contemplated hereby.
10.3 Covenants.
Each Party covenants and agrees that during the Term, neither it, nor its Affiliates, will take any action or cause or permit the
taking of any action that would have the effect of invalidating or breaching any of the representations or warranties contained
in Section 10.1 or 10.2, including, without limitation, any action that would result in any invalidity of any of
the Licensed Patent Rights. Without limiting the foregoing, CureVac covenants and agrees that during the Term, neither it, nor
its Affiliates, will take any action or cause or permit the taking of any action that would materially adversely affect the rights
of CRISPR under this Agreement. For clarity, CureVac cannot and will not grant a license to any Third Party to the extent CRISPR
has obtained exclusive rights under this Agreement.
10.4 Disclaimer
of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER WARRANTIES CONCERNING
PATENT RIGHTS OR ANY OTHER MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR ARISING OUT OF COURSE OF CONDUCT OR TRADE CUSTOM OR
USAGE, AND EACH PARTY DISCLAIMS ALL SUCH EXPRESS OR IMPLIED WARRANTIES.
Article 11
INSURANCE; LIMITATION OF LIABILITY
11.1 Insurance.
CRISPR shall maintain, at its own cost, a program of insurance and/or self-insurance against liability (including product
liability) and any other risks associated with its activities and obligations under this Agreement, the Commercialization of
any Licensed Products, and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on
such terms as are customary for companies similar to CRISPR for the activities to be conducted by them under this Agreement.
Such insurance coverage shall be kept as long as any Licensed Product is Commercialized. CureVac shall maintain, at its own
cost, a program of insurance and/or self-insurance against liability and any other risks associated with its activities and
obligations under this Agreement, and its indemnification obligations hereunder, in such amounts, subject to such deductibles
and on such terms as are customary for companies similar to CureVac for the activities to be conducted by CureVac under this
Agreement. Such insurance coverage shall be kept as long as any Licensed Product is commercialized.
11.2 Consequential
Damages. EXCEPT WITH RESPECT TO WILLFUL MISCONDUCT, GROSS NEGLIGENCE, ANY BREACH OF ARTICLE 6 (CONFIDENTIALITY), OR
ANY INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 9, TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAWS, IN NO EVENT WILL
EITHER PARTY OR ITS AFFILIATES OR ITS OR THEIR OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES
FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) ARISING FROM OR RELATED TO THIS AGREEMENT.
Article 12
GENERAL COMPLIANCE WITH LAW
Each Party will use reasonable commercial
efforts to comply with all Applicable Law relating to the exercise of rights and satisfaction of obligations under this Agreement.
Article 13
TERM AND TERMINATION
13.1 Term.
The Term will commence as of the Effective Date, and unless earlier terminated in accordance with this Section 13, will
expire on a Licensed Product-by-Licensed Product and country-by-country basis, upon such time as the Royalty Term with respect
to the sale of such Licensed Product in such country expires.
13.2 Termination
for Breach.
(a) Material
Breach. Subject to the other terms of this Agreement, this Agreement may be terminated, on a Program-by-Program basis, by either
Party for a material breach by the other Party to this Agreement, provided that the breaching Party has not cured such breach
within [*****] after the date of written notice to the breaching Party, which notice shall describe such breachnn reasonable
detail and shall state the non-breaching Party’s intention to terminate this Agreement pursuant to this Section, provided
further that in no event will the failure of CRISPR to pay a disputed amount under this Agreement, the Manufacturing Services Agreement
or any Commercial Supply Agreement be considered a material breach of this Agreement.
(b) Program
by Program; Development Program. In the event the facts giving rise to termination under Section 13.2(a) relate to one
or more Programs but not all Programs, such termination, if any, will relate only to the affected Program(s) and this Agreement
will otherwise continue with respect to all other Programs in all respects. Further, if CRISPR exercises any of its termination
rights under this Article 13, CRISPR may terminate the Development Program without terminating the remainder of this Agreement.
13.3 Voluntary
Termination by CRISPR. CRISPR may terminate this Agreement, in its entirety or on a Program-by-Program basis, at any time upon
[*****] prior written notice to CureVac.
13.4 Termination
for Bankruptcy. If any Party hereto files for protection under bankruptcy laws, makes an assignment for the benefit of creditors,
appoints or suffers appointment of a receiver or trustee over its property, files a petition under any bankruptcy or insolvency
act or has any such petition filed against it which is not discharged within [*****] of the filing thereof, then the respective
other Party may terminate this Agreement effective immediately upon written notice to the insolvent Party.
13.5 Change
of Control of CRISPR. In the event of (i) a direct or indirect acquisition of beneficial ownership of fifty percent (50%) or
more of the voting power in CRISPR by a CureVac Competitor; or (ii) the sale or other disposition of all or substantially all of
the assets of CRISPR to a CureVac Competitor; or (iii) the merger, amalgamation or other form of business combination or similar
transaction between CRISPR and a CureVac Competitor (“Change of Control”) the following shall apply:
(a) CRISPR
shall promptly give written notice of such Change of Control to CureVac; and
(b) CureVac
shall have the right to be released of any or all of its ongoing obligations under the Development Program, and of its obligations
of disclosure and information exchange relating solely thereto. In addition, the JSC shall be dissolved upon CureVac’s request.
For clarity, CureVac shall not have the right to be released from any obligations under this Agreement, the Manufacturing Services
Agreement, or the Commercial Supply Agreement relating to the Programs or Licensed Products outside of the Development Program.
For further clarity, CRISPR shall retain all rights hereunder to all Cas9 mRNA Constructs and any other deliverables delivered
to CRISPR under the Development Program prior to such Change of Control, and CRISPR shall have the right to exploit such Cas9 mRNA
Constructs and any other deliverables in accordance with the license grant set forth in Section 7.1.
(c) In
addition to the confidentiality obligations according to Article 6, CRISPR shall take reasonable steps to ensure that any
Confidential Information of CureVac provided under this Agreement is not shared with any others within CRISPR that are not required
to manage, perform and exercise CRISPR’s rights and obligations under this Agreement.
13.6 Termination
for Challenge of CureVac Licensed Patent Rights. CureVac may terminate this Agreement by providing [*****] prior written notice
to CRISPR in the event CRISPR or any of its Affiliates directly or indirectly challenges the validity of the Licensed Patent Rights
in a legal proceeding or supports a Third Party in the challenge of a Licensed Patent Right in a legal proceeding (in each case
before a court of competent jurisdiction). Any such termination shall only become effective if CRISPR or its Affiliate has not
withdrawn such action before the end of the above notice period. In the event a Sublicensee of CRISPR challenges the validity of
a CureVac Licensed Patent Right, CureVac may terminate this Agreement hereunder, if CRISPR does not terminate such sublicense agreement
within the [*****] notice period.
13.7 Remedies.
Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 13 are in addition
to any other relief and remedies available to either Party under this Agreement and at law.
13.8 Effects
of Expiration or Termination.
(a) License
Upon Expiration. Upon expiration, but not upon earlier termination of this Agreement, the licenses granted to CRISPR in Section
7.1 shall automatically covert to the license set forth in Section 5.5(e).
(b) Termination
of Licenses. Upon any termination of this Agreement by a Party prior to expiration, except as otherwise provided in Section
13.5, as of the effective date of such termination, all licenses granted by CureVac to CRISPR under this Agreement shall terminate
automatically, and the Licensed Intellectual Property shall automatically revert back to CureVac.
(c) Notwithstanding
the foregoing, no termination of this Agreement shall be construed as a termination of any sublicense of any Sublicensee hereunder,
and thereafter each such Sublicensee shall be considered a direct licensee of CureVac, provided (i) CureVac has approved such sublicense
in accordance with Section 7.2; (ii) CureVac does not assume undertakings and liabilities towards the Sublicensee beyond
those stipulated herein; and (iii) the Sublicensee is then in full compliance with all terms and conditions of its sublicense.
(d) Post-Termination
Activities. Upon termination of this Agreement CRISPR shall provide CureVac with a written inventory of all Licensed Products
that are in the process of Manufacture, in use or in stock; provided, however, that if CRISPR terminates this Agreement
in part under Section 13.3, such inventory shall only apply to the Licensed Products subject to such partial termination.
All Licensed Products that are not disposed of as provided above shall be delivered to CureVac or otherwise disposed of in CureVac’s
sole discretion and at CRISPR’s sole expense.
(e) Accrued
Payment Claims. Termination of this Agreement for any reason whatsoever shall not relieve CRISPR of its obligations to pay
all royalties, milestones and other amounts payable to CureVac which have accrued prior to, but remain unpaid as of, the date of
expiration or termination hereof.
(f) Reversion.
In the event of termination of this Agreement by CRISPR pursuant to Section 13.3 or by CureVac pursuant to Section 13.2
or 13.4, CureVac shall be entitled to demand from CRISPR the transfer and/or assignment, as applicable, of all right, title
and interest in and to any Cas9 mRNA Constructs, and all data related thereto. Under no circumstance shall CureVac be entitled
to any CRISPR Background Intellectual Property, CRISPR Improvement, CRISPR’s Solely-Owned Foreground Intellectual Property,
CRISPR’s interest in and to any Jointly-Owned Foreground Intellectual Property, or to any CRISPR Drug Product (as defined
in the Manufacturing Services Agreement) or any data related to or generated through the use of or reference to a CRISPR Drug Product.
13.9 Surviving
Provisions. Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Article
6 (Confidentiality), Article 7 (Intellectual Property) (provided that Sections 7.1(a), 7.1(c), 7.2, and 7.3
shall not survive termination by CRISPR under Section 13.3 (Voluntary Termination by CRISPR) or any termination by CureVac
under Article 13), Article 8 (with respect to Patent Rights Covering Know-How developed prior to Termination), Article
9 (Indemnification), Section 11 (Insurance, Limitation of Liability), Section 13.7 (Remedies), Section 13.8
(Effects of Expiration or Termination), Section 13.9 (Surviving Provisions), Article 14 (Dispute Resolution) and
Article 15 (Miscellaneous, to the extent applicable), as well as any rights or obligations otherwise accrued hereunder (including
any accrued payment obligations), shall survive the expiration or termination of this Agreement. Termination shall not relieve any Party from any liability which
has accrued prior to such termination.
Article 14
DISPUTE RESOLUTION
14.1 Mandatory
Procedures. The Parties agree that any dispute arising out of or relating to this Agreement will be resolved solely by means
of the procedures set forth in this Article 14, and that such procedures constitute legally binding obligations that are
an essential provision of this Agreement. If either Party fails to observe the procedures of this Article 14, as may be
modified by their written agreement, the other Party may bring an action for specific performance of these procedures in any court
of competent jurisdiction.
14.2 Dispute
Resolution Procedures. In the event of a dispute between the Parties (other than disputes arising out of the JSC), relating
to the validity performance, construction or interpretation of this Agreement, upon the request of either Party by written notice,
the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least
one in-person meeting between the Executive Officers of each Party. If the matter is not resolved within [*****] following
the written request for discussions, either Party may then invoke the provisions of Section 14.3.
14.3 Any
dispute (other than disputes arising from the JSC) relating to the validity performance, construction or interpretation of this
Agreement, which cannot be resolved amicably between the Parties after following the procedure set forth in Section 14.2,
shall be submitted to arbitration in accordance with the Arbitration Rules of WIPO in effect on the date of the commencement of
the arbitration proceedings. The location of the arbitration proceedings will be London, England. The number of arbitrators will
be three (3). The language of the arbitration proceeding will be English. The decision of the arbitrators shall be final and binding
upon the Parties (absent manifest error on the part of the arbitrator(s)) and enforceable in any court of competent jurisdiction.
14.4 Performance
to Continue. Each Party will continue to perform its undisputed obligations under this Agreement pending final resolution of
any dispute arising out of or relating to this Agreement; provided, however, that a Party may suspend performance of its
undisputed obligations during any period in which the other Party fails or refuses to perform its undisputed obligations.
14.5 Tolling.
The Parties agree that all applicable statutes of limitation and time-based defenses, as well as all time periods in which a
Party must exercise rights or perform obligation hereunder, will be tolled once the dispute resolution procedures set forth
in this Section 14.5 have been initiated and for so long as they are pending, and the Parties will cooperate in taking
all actions reasonably necessary to achieve such a result. In addition, during the pendency of any dispute under this
Agreement initiated before the end of any applicable cure period, (a) this Agreement will remain in full force and effect,
(b) the provisions of this Agreement relating to termination for material breach with respect to such dispute will not be
effective, (c) the time period for cure as to any termination notice given prior to the initiation of arbitration will be
tolled, (d) any time periods to exercise rights or perform obligations will be tolled; and (e) neither Party will issue a
notice of termination pursuant to this Agreement based on the subject matter of the arbitration, until the arbitral tribunal
has confirmed the material breach and the existence of the facts claimed by a Party to be the basis for the asserted material
breach; provided, that if such breach can be cured by (i) the payment of money, the defaulting Party will have an
additional [*****] within its receipt of the arbitral tribunal’s decision to pay such amount or (ii) the taking of
specific remedial actions, the defaulting Party will have a reasonably necessary period to diligently undertake and complete
such remedial actions within such reasonably necessary period or any specific timeframe established by such arbitral
tribunal’s decision before any such notice of termination can be issued. Further, with respect to any time periods that
have run during the pendency of the dispute, the applicable Party will have a reasonable period of time or any specific
timeframe established by such arbitral tribunal’s decision to exercise any rights or perform any obligations affected
by the running of such time periods.
Article 15
MISCELLANEOUS
15.1 Severability.
If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision shall be considered
severed from this Agreement and shall not serve to invalidate any remaining provisions hereof, unless the invalid or unenforceable
provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have
entered into this Agreement without the invalid or unenforceable provision. The Parties shall make a good faith effort to replace
any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when
entering this Agreement may be realized.
15.2 Notices.
Any notice required or permitted to be given by this Agreement shall be in writing and shall be (a) delivered by hand or by FedEx,
UPS or any other similar service with tracking capabilities, (b) registered mail, or (c) delivered by facsimile followed by delivery
via any of the methods set forth in this Section 15.2, in each case, addressed as set forth below unless changed by notice
so given:
| If to CRISPR: |
| | | |
| | | CRISPR Therapeutics AG |
| | | Xxxxxxxxxxxxx 00 |
| | | 0000 Xxx |
| | | Xxxxxxxxxxx |
| | | Attention: Chief Executive Officer |
| | | |
| | | and |
| | | |
| | | CRISPR Therapeutics Limited |
| | | 00 Xxxxxxxxx Xxxxx Xxxx |
| | | Xxxxxx X0X 0XX |
| | | Xxxxxx Xxxxxxx |
| | | Attention: Chief Legal Officer |
| | | |
| | with copies (which shall not constitute notice) to: |
| | | |
| | | Xxxxxxx Procter LLP |
| | | 000 Xxxxxxxx Xxxxxx |
| | | Xxxxxx, XX 00000 |
| | | Attention: |
[*****] |
| | | Facsimile: |
[*****] |
| | | Telephone: |
[*****] |
| | | |
| | | and |
| | | |
| | | |
[*****] |
| | | |
| If to CureVac: |
| | | |
| | | CureVac XX |
| | | Xxxx-Xxxxxxx-Xxx. 00 |
| | | 00000 Xxxxxxxx |
| | | Xxxxxxx |
| | | Attention: CEO and General Counsel |
Any such notice shall be deemed given on
the date received. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written
notice delivered to the Party’s notices in accordance with this Section 15.2.
15.3 Assignment.
Neither Party may, without the consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed,
assign or transfer any of its rights and obligations hereunder; provided that no such consent is required for an assignment
or transfer (in whole or in part) by either Party (a) to an Affiliate or (b) to a successor-in-interest by reason of merger or
consolidation or sale of all or substantially all of the respective Party’s assets to which this Agreement relates; provided
further that, with respect to an assignment or transfer by a Party in accordance with the prior provisions, (i) with respect
to an assignment to a successor-in-interest, such assignment includes all relevant rights and obligations under this Agreement,
and (ii) any assignee or transferee shall have agreed as of such assignment or transfer to be bound by the terms of this Agreement
in a writing provided to the other Party. Subject to the foregoing, this Agreement shall inure to the benefit of and be binding
on the Parties’ successors and permitted assigns. Any assignment or transfer in violation of the foregoing shall be null
and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever,
and the non-assigning, non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer.
Upon request by CRISPR, the Parties shall cooperate to enter into a separate agreement or agreements with respect to one or more
Programs covered under this Agreement (i.e. severing such Program(s) from this Agreement and covering them instead in a separate
agreement having the same terms as this one but being limited to such Program or Programs), which separate agreement(s) may be
assigned in accordance with the foregoing provisions of this Section 15.3.
15.4 Waivers
and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to
be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach
of such provision or any other provision on such occasion or any succeeding occasion. No, modification, release, or amendment of
any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by both Parties.
15.5 Governing
Law. This Agreement shall be governed by and construed and interpreted in accordance with the laws of Switzerland; irrespective
of the choice of laws principles of the laws of Switzerland, as to all matters, including matters of validity, construction, effect,
enforceability, performance and remedies, provided, that questions affecting the construction and effect of any Patent Rights shall
be determined by the law of the country in which the Patent Rights have been filed, granted or issued.
15.6 Relationship
of the Parties. Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to
be construed so as to constitute CureVac and CRISPR as partners, agents, or joint venturers. Neither Party shall have any express
or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the
other Party to any contract, agreement, or undertaking with any Third Party. There are no express or implied third party beneficiaries
hereunder.
15.7 Entire
Agreement. This Agreement and the attached attachments constitutes the entire agreement between the Parties as to the subject
matter of this Agreement and, as of the Effective Date, supersedes and merges all prior and contemporaneous negotiations, representations,
agreements, and understandings regarding the same. The Material Transfer Agreement between the Parties dated June 13, 2016, as
amended from time to time, and the Confidentiality Agreement between the Parties dated February 26, 2016 are being replaced as
of the Effective Date, provided that the ownership rights with respect to any Intellectual Property (as defined in the Material
Transfer Agreement) discovered, created, conceived or reduced to practice under the Material Transfer Agreement prior to the Effective
Date will remain to be governed by the Material Transfer Agreement. This Agreement, and its attachments, may not be amended except
in a writing signed by duly authorized representatives of the Parties expressly stating that it is amending this Agreement and
identifying each provision being amended.
15.8 Counterparts.
This Agreement may be executed in counterparts (whether delivered by facsimile or otherwise) with the same effect as if both Parties
had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute
one and the same instrument.
15.9 Interpretation.
(a) Each
of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them,
that in such negotiations each of them has been represented by competent counsel, and that the final agreement contained herein,
including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly,
in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the
wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed
against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
(b) The
definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the context
may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. The word “will” shall
be construed to have the same meaning and effect as the word “shall.” The word “any” shall mean “any
and all” unless otherwise clearly indicated by context. The word “including” will be construed as “including
without limitation.” The word “or” will be interpreted in the inclusive sense commonly associated with the term
“and/or”.
(c) Unless
the context requires otherwise, (a) any definition of or reference to any agreement, instrument, or other document herein
shall be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented,
or otherwise modified (subject to any restrictions on such amendments, supplements, or modifications set forth herein or
therein), (b) any reference to any Applicable Laws herein shall be construed as referring to such Applicable Laws as from
time to time enacted, repealed, or amended, (c) any reference herein to any Person shall be construed to include the
Person’s successors and assigns, (d) all references herein to Articles, Sections, or Attachments, unless otherwise
specifically provided, shall be construed to refer to Articles, Sections, and Attachments of this Agreement, and references
to this Agreement includes all Articles, Sections, and Attachments hereof, (e) the words “herein”,
“hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement
in each of their entirety, as the context requires, and not to any particular provision hereof, (f) the word
“notice” means notice in writing (whether or not specifically stated) and will include notices, consents,
approvals and other written communications contemplated under this Agreement, and (g) provisions that require that a Party,
the Parties or any committee hereunder “agree,” “consent” or “approve” or the like will
require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved
minutes or otherwise (but excluding e-mail and instant messaging).
(d) Headings
and captions are for convenience only and are not be used in the interpretation of this Agreement.
15.10 Section
365(n).
(a) All
licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of
right to “intellectual property” as defined in Section 101 of such Code. Each Party, as licensee, may fully exercise
all of its rights and elections under the U.S. Bankruptcy Code and any foreign equivalent thereto in any country having jurisdiction
over a Party or its assets. The Parties further agree that, if a Party elects to retain its rights as a licensee under such Code,
such Party shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology.
Such embodiments of the technology shall be delivered to the licensee Party not later than:
(i) the
commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations
under the Agreement, or
(ii) if
not delivered under Section 15.10(a)(i), upon the rejection of this Agreement by or on behalf of the licensor, upon written
request.
(b) Any
agreements supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section
365(n) of the Bankruptcy Code.
[Signature page follows.]
CONFIDENTIAL
IN WITNESS WHEREOF, the Parties hereto have
executed this Agreement effective as of the Effective Date.
| CureVac AG |
CRISPR Therapeutics AG |
| By: |
/s/ Xx. Xxxxxx Xxxxx |
By: |
|
| Name: |
Xx. Xxxxxx Xxxxx |
Name: |
|
| Title: |
Chief Executive Officer |
Title: |
|
CONFIDENTIAL
IN WITNESS WHEREOF, the Parties hereto have
executed this Agreement effective as of the Effective Date.
| CureVac AG |
CRISPR Therapeutics AG |
| By: |
|
By: |
/s/ Xxxxxx Xxxxx |
| Name: |
|
Name: |
Xxxxxx
Xxxxx |
| Title: |
|
Title: |
Chief Executive Officer |
EXECUTION COPY
CONFIDENTIAL
ATTACHMENT A
CRISPR Background Intellectual Property
A. [*****]
ATTACHMENT B
CureVac Background Intellectual Property
[*****]
ATTACHMENT C
Materials
Cas9 mRNA Constructs developed under this Agreement
ATTACHMENT D
Work Plan
[*****]
ATTACHMENT E
Manufacturing
Services Agreement
[*****]
ATTACHMENT
F
JSC Participants
[*****]
ATTACHMENT G
Alternative Program 1 Target List
[*****]
ATTACHMENT H
Disclosure Letter
[*****]
