Exhibit 10.28
CONFIDENTIAL
PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO REGULATION S-K ITEM 601(b)(10)(iv) OF THE SECURITIES ACT OF 1933,
AS AMENDED. CERTAIN CONFIDENTIAL INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT (i) IS NOT MATERIAL AND
(ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO EYENOVIA, INC. IF PUBLICLY DISCLOSED. THE REDACTED TERMS HAVE BEEN MARKED
IN THIS EXHIBIT AT THE APPROPRIATE PLACES WITH EMPTY BRACKETS INDICATED BY [
].
LICENSE AGREEMENT
This License
Agreement (the “Agreement”) is entered into on August 10, 2020 (the “Effective Date”)
between Eyenovia, Inc., a Delaware corporation with a place of business
at 295 Madison Ave., New York, NY 10017 (“Eyenovia”), and Arctic Vision
(Hong Kong) Limited, a Hong Kong company with a registered office at 23/F Nan Fung Tower 88 Connaught Road C &
173 Des Voeux Road C, Central, Hong Kong (“Arctic Vision”). Eyenovia and Arctic Vision may be referred to herein
individually as a “Party” and collectively as the “Parties”.
Recitals
Whereas,
Eyenovia, a clinical stage biopharmaceutical company, is developing ophthalmic therapeutic products, and owns or controls certain
patent, know-how, and other intellectual property rights relating to such products; and
Whereas,
Arctic Vision wishes to obtain from Eyenovia, and Eyenovia is willing to grant to Arctic Vision, an exclusive license to research,
develop, manufacture, and commercialize such products in the Territory (as defined below), all on the terms and conditions set
forth herein.
Now
Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency
of which are hereby acknowledged, Arctic Vision and Eyenovia hereby agree as follows:
Article 1
DEFINITIONS
Unless the context otherwise
requires, the terms in this Agreement with initial letters capitalized, have the meanings set forth below, or the meaning as designated
in the indicated places throughout this Agreement.
1.1 “1st
Generation Device” has the meaning set forth in Section 5.2(c)(i).
1.2 “2nd
Generation Device” has the meaning set forth in Section 5.2(c)(ii).
1.3 “Accounting
Standards” means, with respect to a Party and its Affiliates, either (a) International Financial Reporting Standards
(“IFRS”) or (b) United States generally accepted accounting principles (“GAAP”), in
either case ((a) or (b)) that are used at the applicable time, and as consistently applied across its business, by such Party
or any of its Affiliates.
1.4 “Additional
Indication” means any Indication other than (a) presbyopia with respect to the MicroLine Product and (b) myopia
with respect to the MicroPine Product.
1.5 “Additional
Indication Plan” has the meaning set forth in Section 4.3(a).
1.6 “Additional
Indication Registration Trial” has the meaning set forth in Section 4.3(a).
1.7 “Affiliate”
means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the
purpose of this definition, “control” (including, with correlative meaning, the terms “controlled by” and
“under the common control”) means the actual power, either directly or indirectly through one or more intermediaries,
to direct or cause the direction of the management and policies of such Person, whether by the ownership of fifty percent (50%)
or more of the voting stocking of such Person, by contract or otherwise.
1.8 “Alliance
Manager” has the meaning set forth in Section 3.6.
1.9 “Arctic
Vision Indemnitees” has the meaning set forth in Section 9.1.
1.10 “AV
Know-How” means, subject to Section 11.2(b), all Know-How that (a) is Controlled by Arctic Vision or any of
its Affiliates at any time during the Term and (b) is necessary or reasonably useful for the Development, manufacture, use,
importation, offer for sale, sale, or other Commercialization of any Product or any component thereof.
1.11 “AV
Patents” means, subject to Section 11.2(b), all Patents that Arctic Vision or any of its Affiliates Control at any
time during the Term that (a) Cover any (i) AV Know-How or (ii) Product or any component thereof, or (b) are
necessary or reasonably useful for the Development, manufacture, use, importation, offer for sale, sale, or other Commercialization
of any Product or component thereof.
1.12 “AV
Product Contracts” means, with respect to any Terminated Product or Terminated Jurisdiction, as applicable, any manufacturing,
supplier, distributor, Development, clinical study, or other agreement between Arctic Vision or any of its Affiliates and a Third
Party, other than any agreement with a Sublicensee pursuant to which rights to Products are sublicensed hereunder, that is solely
related to the Development, manufacture, or Commercialization of such Terminated Product or a Product in such Terminated Jurisdiction,
as applicable.
1.13 “AV
Product-Related Materials” means, with respect to a Terminated Product or Terminated Jurisdiction, as applicable, all
advertising and promotional materials (including but not limited to flyers, brochures, pamphlets and electronic media) and labeling
and packaging materials, in each case, that (a) pertain solely to such Terminated Product or a Product in such Terminated
Jurisdiction, as applicable, and (b) Arctic Vision or any of its Affiliates possess as of the effective date of termination
for such Termination Product or Terminated Jurisdiction, as applicable.
1.14 “AV
Technology” means the AV Patents, AV Know-How, and Arctic Vision’s interest in any Joint Inventions and Joint Patents.
1.15 “Business
Day” means a day, other than a Saturday or Sunday, on which banking institutions in Hong Kong, China and New York, New
York, U.S. are open for business.
1.16 “Calendar
Quarter” means each of the three (3) month periods ending March 31, June 30, September 30, and December 31,
provided that: (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first complete
such three (3)-month period thereafter and (b) the final Calendar Quarter of the Term shall end on the last day of the Term.
1.17 “Calendar
Year” means (a) the period beginning on the Effective Date and ending on December 31 of the calendar year in
which the Effective Date falls, and (b) thereafter each successive period of twelve (12) consecutive calendar months beginning
on January 1 and ending on December 31, provided that the final Calendar Year of the Term shall end on the last day of
the Term.
1.18 “China”
or “PRC” means the People’s Republic of China, which for the purpose of this Agreement does not include
Taiwan, Hong Kong, and Macao.
1.19 “Change
of Control” means, with respect to a Party, (a) a merger, consolidation, recapitalization, or reorganization of
such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any
securities into which such voting securities have been converted or exchanged, ceasing to represent at least fifty percent (50%)
of the combined voting power of the voting securities of the surviving entity or the parent of the surviving entity outstanding
immediately after such merger, consolidation, recapitalization, or reorganization, (b) a transaction or series of related
transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of fifty percent
(50%) or more of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer
to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets (or that portion
thereof related to the subject matter of this Agreement). Notwithstanding the foregoing, any transaction or series of transactions
effected for the purpose of financing the operations of the applicable Party or changing the form or jurisdiction of organization
of such Party (such as an initial public offering or other offering of equity securities to non-strategic investors or corporate
reorganization) will not be deemed a “Change of Control” for purposes of this Agreement.
1.20 “Claims”
has the meaning set forth in Section 9.1.
1.21 “CMO”
means contract manufacturing organization.
1.22 “Commercialize”
or “Commercialization” means the conduct of all activities undertaken before and after Regulatory Approval
relating to the promotion, sales, marketing, and distribution for sale of Products in the Field in the Territory (including
importing, exporting, transporting, customs clearance, warehousing, invoicing, handling, and delivering Products to customers),
including sales force efforts, detailing, advertising, market research, market access (including price and reimbursement
activities), medical education and information services, publication, scientific and medical affairs, medical support,
advisory and collaborative activities with opinion leaders and professional societies including symposia, marketing, sales
force training, and sales (including receiving, accepting, and filling Product orders) and distribution for sale, and all
activities directed to obtaining pricing and reimbursement approvals for Products.
1.23 “Commercially
Reasonable Efforts” means with respect to a particular activity or Product and a Party, that measure of efforts and resources
that is consistent with the efforts and resources that a similarly-situated biopharmaceutical or biotechnology company commits
to its own activities or products that it is actively developing or commercializing that are at a similar stage of development
or commercialization and have similar market potential, taking into account efficacy, safety, patent and regulatory exclusivity,
anticipated or approved labeling, present and future market potential, competitive market conditions, the profitability of the
product in light of pricing and reimbursement issues, and all other relevant factors. Commercially Reasonable Efforts shall be
determined on a Product-by-Product and Jurisdiction-by-Jurisdiction basis, and it is anticipated that the level of efforts required
may be different for different Products in different countries and may change over time.
1.24 “Competitive
Combination Product” means (a) for the MicroLine Product, pilocarpine
and [ ].
1.25 “Competitive
Senju Product” means a Senju Product for the treatment of (i) myopia (in the case of a MicroPine Product) or (ii) improvement
in near vision or presbyopia (in the case of a MicroLine Product).
1.26 “Confidential
Information” of a Party means all Know-How, unpublished patent applications, and other information and data of a financial,
commercial, business, operational, or technical nature of such Party that is: (a) disclosed or otherwise made available by
or on behalf of such Party or any of its Affiliates to the other Party or any of its Affiliates, whether made available orally,
in writing, or in electronic form, or (b) learned from a Party or any of its Affiliates by the other Party or any Affiliate
thereof pursuant to this Agreement or the Supply Agreement; provided that the terms of this Agreement and all Joint Inventions
will be deemed both Parties’ Confidential Information.
1.27 “Control”
or “Controlled” means, with respect to any Know-How, Patents, or other intellectual property rights, that a
Party or an Affiliate thereof has the legal authority or right (whether by ownership, license, or otherwise) to grant a license,
sublicense, access, or other right (as applicable) under such Know-How, Patents, or other intellectual property rights to the other
Party on the terms and conditions set forth herein, in each case without breaching the terms of any agreement between such Party
or any Affiliate thereof and a Third Party.
1.28 “Cost
of Goods” means, [ ].
1.29 “Cover”
means, with respect to a particular subject matter at issue and a relevant Patent, that the manufacture, use, sale, offer for sale,
or importation of such subject matter would fall within the scope of a pending or issued claim in such Patent.
1.30 “Data”
means, with respect to a Product, any and all scientific or technical data directly pertaining to such Product that is generated
by or on behalf of a Party, their respective Affiliates and, to the extent Controlled by such Party or its Affiliates, licensees,
sublicensees, including such research data, clinical pharmacology data, pre-clinical data, clinical data, clinical study reports,
or submissions made in association with any Regulatory Materials for such Product.
1.31 “Develop”
or “Development” means all development activities for any Product that are directed to obtaining Regulatory
Approval(s) of such Product and lifecycle management of such Product in any country or Jurisdiction in the world, including
all non-clinical, preclinical, and clinical testing and studies of such Product; toxicology, pharmacokinetic, and pharmacological
studies; statistical analyses; assay development; protocol design and development; the preparation, filing, and prosecution of
any MAA for such Product; development activities directed to label expansion and/or obtaining Regulatory Approval for one or more
additional indications following initial Regulatory Approval; development activities conducted after receipt of Regulatory Approval;
and all regulatory affairs related to any of the foregoing.
1.32 “Development
Costs” means the costs incurred by a Party or its Affiliate that are specifically directed (or reasonably allocable)
to the Development of a Product or a component thereof, including amounts that a Party pays to Third Parties involved in the Development
of such Product or component (at cost), and all internal costs (calculated on an FTE basis) and out-of-pocket costs incurred by
or on account of a Party in conducting Development activities with respect to such Product or component.
1.33 “Development
Plan” has the meaning set forth in Section 4.2(b).
1.34 “Dollar”
means U.S. dollars, and “$” shall be interpreted accordingly.
1.35 “Eyenovia
Indemnitees” has the meaning set forth in Section 9.2.
1.36 “FDA”
means the U.S. Food and Drug Administration, or its successor.
1.37 “Field”
means the Initial Indications.
1.38 “First
Commercial Sale” means the first sale of a Product in a Jurisdiction by Arctic Vision, its Affiliates, or Sublicensees
to a Third Party for end use of such Product after Regulatory Approval of such Product has been granted in such Jurisdiction. For
clarity, First Commercial Sale does not include the supply or transfer of Product to an Affiliate or Sublicensee or for clinical
trials or compassionate use.
1.39 “FTE”
means the equivalent of a full-time individual’s work for a twelve (12) month period, consisting of a total of
[ ] hours per year of dedicated effort. Any person who
devotes more or less than [ ] hours per year on the
applicable activities shall be treated as an FTE on a pro-rata basis, based upon the actual number of hours worked by such
person on such activities, divided by [ ]. For clarity, the hours spent by temporary workers and contractors on applicable
activities may be treated as FTE on a pro-rata basis.
1.40 “FTE
Costs” means the FTE Rate multiplied by the number of FTEs applied by Eyenovia or any of its Affiliates to the relevant
activity.
1.41 “FTE
Rate” means a rate of [ ] Dollars ($[ ]) per FTE per year.
1.42 “Generic
Product” means, with respect to a Product in a Jurisdiction, any combination of pharmaceutical and medical device product
that (a) contains (i) the same active pharmaceutical ingredient(s) as such Product and (ii) either the Optejet
Dispenser Base or a similar medical device that is intended to deliver such active pharmaceutical ingredient(s) in substantially
the same manner as such Product; (b) is approved by the Regulatory Authority in such regulatory jurisdiction as a freely substitutable
generic for such Product on an expedited or abbreviated basis based on bioequivalence or interchangeability with the Product; and
(c) is sold in such jurisdiction by a Third Party that is not a Sublicensee and did not purchase such product in a chain of
distribution that included any of Arctic Vision or its Affiliates or Sublicensees.
1.43 “Government
Authority” means any federal, state, national, state, provincial, or local government, or political subdivision thereof,
or any multinational organization or any authority, agency, or commission entitled to exercise any administrative, executive, judicial,
legislative, police, regulatory, or taxing authority or power, any court, or tribunal (or any department, bureau or division thereof,
or any governmental arbitrator or arbitral body).
1.44 “IDE”
means any investigational device exemption or similar or equivalent application filed with the applicable Regulatory Authority
for approval to conduct clinical testing of a medical device in humans in the applicable Jurisdiction.
1.45 “Improvement”
means any modification, addition, improvement, update, or upgrade to a Product, or any component thereof, that is (a) developed
by or on behalf of Eyenovia or any of its Affiliates during the Term, including any alternative or improved dosage forms of a Product,
novel formulation technology Developed for a Product, or modification or improvement to the Optejet Dispenser Base, and (b) incorporated
into a Product that is being Developed or Commercialized outside of the Territory.
1.46 “IND”
means any investigational new drug application, clinical trial application, clinical trial exemption, or similar or equivalent
application filed with the applicable Regulatory Authority for approval to conduct clinical testing of a pharmaceutical product
in humans in the applicable Jurisdiction.
1.47 “Indemnified
Party” has the meaning set forth in Section 9.3.
1.48 “Indemnifying
Party” has the meaning set forth in Section 9.3.
1.49 “Indication”
means, with respect to a Product, a diagnostic, prophylactic, or therapeutic use for a particular disease or condition with respect
to which use at least one human clinical trial is required to support the inclusion of such disease or condition in the indication
statement of a package insert approved by a Regulatory Authority for such Product and for which an MAA (or a supplement, extension,
or amendment thereto) must be filed to obtain such approval by such Regulatory Authority.
1.50 “Initial
Indications” means, with respect to (a) the MicroLine Product, presbyopia and (b) the MicroPine Product, myopia.
1.51 “Invention”
means any discovery, improvement, process, method, composition of matter, article of manufacture, or invention, patentable or otherwise,
that is invented, first reduced to practice, or otherwise first made by either Party or any Affiliate thereof in exercising its
rights or carrying out its obligations under this Agreement, or, in the case of Arctic Vision or any of its Affiliates, as a result
of its or their access to Eyenovia’s Confidential Information, or, in the case of Eyenovia or any of its Affiliates, as a
result of its or their access to Arctic Vision’s Confidential Information, in each case whether directly or via its or its
Affiliates’ employees, directors, officers, agents, other representatives, contractors or, to the extent Controlled by a
Party or its Affiliates, Sublicensees, including all intellectual property rights therein.
1.52 “Joint
Invention” has the meaning set forth in Section 6.1(b)(ii).
1.53 “Joint
Patent” has the meaning set forth in Section 6.1(b)(ii).
1.54 “JSC”
has the meaning set forth in Section 3.1.
1.55 “Jurisdiction”
has the meaning set forth in Section 1.100.
1.56 “Know-How”
means all technical information, know-how, and data, including inventions, discoveries, trade secrets, specifications, instructions,
processes, formulae, compositions of matter, cells, cell lines, assays, animal models, and other physical, biological, or chemical
materials, expertise and other technology, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical,
physical, and analytical, safety, nonclinical, and clinical data, regulatory documents, data and filings, instructions, processes,
formulae, expertise, and information in each case that is relevant to the research, development, use, importation, offering for
sale, or sale of, or which may be useful in studying, testing, or developing, pharmaceutical, biologic, or medical device products
or any combination thereof.
1.57 “Law”
means any federal, state, local, foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution
or promulgation, or any order by any Government Authority, or any license, franchise, permit, or similar right granted under any
of the foregoing, or any similar provision having the force or effect of law.
1.58 “Licensed
Know-How” means, subject to Section 11.2(b), all Know-How that (a) is Controlled by Eyenovia or any of its
Affiliates as of the Effective Date or at any time during the Term and (b) is necessary or reasonably useful for the Development,
manufacture, use, importation, offer for sale, sale, or other Commercialization of any Product in the Field, including, for the
avoidance of doubt, (i) all such Know-How in any and all Improvements and (ii) Eyenovia’s and its Affiliates’
interest in any Joint Invention satisfying clauses (a) and (b) above.
1.59 “Licensed
Patents” means, subject to Section 11.2(b), all Patents that Eyenovia or any of its Affiliates Control as of the
Effective Date or at any time during the Term that (a) Cover any (i) Licensed Know-How or (ii) Product or any component
thereof, or (b) are necessary or reasonably useful for the Development, manufacture, use, importation, offer for sale, sale,
or other Commercialization of any Product in the Field, including Eyenovia’s and its Affiliates’ interest in any such
Joint Patent. The Licensed Patents existing as of the Effective Date are set forth in Exhibit B (such Patents
and all Patents claiming priority thereto, the “Existing Licensed Patents”).
1.60 “Licensed
Technology” means the Licensed Patents, Licensed Know-How, and Eyenovia’s interest in any Joint Inventions and
Joint Patents.
1.61 “Losses”
has the meaning set forth in Section 9.1.
1.62 “MAA”
or “Marketing Authorization Application” means an application to the appropriate Regulatory Authority for approval
or clearance to market and sell any pharmaceutical, biologic, or medical device product, or any combination thereof, for human
use in a particular country or Jurisdiction, and all amendments and supplements thereto.
1.63 “Manufacturing
Territory” means worldwide, but excluding the following countries: Afghanistan, Bahrain, Bangladesh, Bhutan, Brunei,
Burma, Cambodia, Cyprus, East Timor, India, Indonesia, Japan, Laos, Malaysia, Maldives, Mongolia, Myanmar, Nepal, North
Korea, Pakistan, Philippines, Papua New Guinea, Singapore, Sri Lanka, Thailand, Uzbekistan, and Vietnam.
1.64 “MicroLine
Product” means pilocarpine, as the sole active pharmaceutical ingredient,
formulated and loaded into a cartridge for delivery using, and delivered by means of, the Optejet Dispenser Base, as further described
in Part 1 of Exhibit A and including any and all Improvements thereto.
1.65 “MicroPine
Product” means atropine sulfate, as the sole active pharmaceutical ingredient, formulated and loaded into a
cartridge for delivery using, and delivered by means of, the Optejet Dispenser Base, as further described in
Part 2 of Exhibit A and including any and all Improvements thereto.
1.66 “MicroStat
Product” means combination formulation of phenylephrine 2.5%–tropicamide
1% formulated and loaded into a cartridge for delivery using, and delivered by means of, the Optejet Dispenser Base.
1.67 “Milestone
Event” has the meaning set forth in Section 5.2(a).
1.68 “Milestone
Payment” has the meaning set forth in Section 5.2(a).
1.69 “Net
Sales” means [ ]:
(a) [ ];
(b) [ ];
(c) [ ];
(d) [ ];
(e) [ ]; and
(f) [ ].
[ ].
1.70 “NMPA”
means National Medical Products Administration of China (formerly known as the China Food and Drug Administration), or its successor.
1.71 “Optejet
Dispenser Base” means the Optejet Dispenser Base®, as further described in Part 3 of Exhibit A
and including any and all Improvements thereto.
1.72 “Other
Licensee” means a Third Party to whom Eyenovia or an Affiliate thereof has granted rights to Develop, use, make, have
made, sell, offer for sale, have sold, import, or otherwise Commercialize either Product, or any component thereof, outside the
Territory.
1.73 “Patents”
means all patents and patent applications (which for the purpose of this Agreement shall be deemed to include certificates of invention
and applications for certificates of invention), including all divisionals, continuations, substitutions, continuations-in-part,
re-examinations, reissues, additions, renewals, revalidations, extensions, registrations, pediatric exclusivity periods, and supplemental
protection certificates and the like of any such patents and patent applications, and any and all foreign equivalents of the foregoing.
1.74 “Person”
means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization
or other entity.
1.75 “Primary
Royalty Term” means, on a Product-by-Product and Jurisdiction-by-Jurisdiction basis, the period from the Effective Date
until the later of (A) the expiration of the last-to-expire Valid Claim in the Licensed Patents that Cover the composition
of matter or method of use of a particular Product in a particular Jurisdiction and (B) the tenth (10th) anniversary of the
First Commercial Sale of such Product in such Jurisdiction.
1.76 “Product”
means (a) the MicroLine Product and/or (b) the MicroPine Product, as the context dictates.
1.77 “Product
Infringement” has the meaning set forth in Section 6.3(a).
1.78 “Recall”
has the meaning set forth in Section 4.9.
1.79 “Region”
means each of (a) China, Taiwan, Hong Kong, and Macao and (b) South Korea.
1.80 “Registration
Trial” means (a) with respect to a Product, a clinical study of such Product in human patients (i) with a defined
dose or a set of defined doses of such Product designed to establish statistically significant efficacy and safety of such Product
for the purpose of enabling the preparation and submission of an MAA for such Product to the competent Regulatory Authorities in
a country or other jurisdiction, and (ii) that would satisfy the requirements of 21 C.F.R. § 312.21(c), or its foreign
equivalent, and (b) with respect to the Optejet Dispenser Base, a clinical study of such medical device in human subjects
that would satisfy the IDE requirements set forth in 21 C.F.R. Part 812, or its foreign equivalent.
1.81 “Regulatory
Approval” means, with respect to a country or jurisdiction, all approvals of any Regulatory Authority that are necessary
for the use, import, transport, promotion, marketing, distribution, offer for sale, or commercial sale of a pharmaceutical, biologic,
or medical device product or any combination thereof in such country or regulatory jurisdiction, including pricing and reimbursement
approval if required by applicable Law for such purposes.
1.82 “Regulatory
Authority” means any applicable Government Authority responsible for granting Regulatory Approvals for the Product, including
the FDA and NMPA.
1.83 “Regulatory
Material” means any and all regulatory applications, submissions, notifications, communications, correspondences, registrations,
and other filings made to, received from, or otherwise conducted with a Regulatory Authority in order to Develop, manufacture,
market, sell, or otherwise Commercialize a pharmaceutical, biologic, or medical device product or any combination thereof in a
particular country or jurisdiction, including IDEs, INDs, MAAs, and Regulatory Approvals.
1.84 “Safety
Data” means data related solely to any adverse or serious adverse drug experiences, adverse or serious adverse medical
device experiences, and medical device malfunctions, as such information is reportable to Regulatory Authorities. Safety Data also
includes “adverse events”, “adverse drug reactions”, and “unexpected adverse drug reactions”
as defined in the ICH Harmonised Tripartite Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited
Reporting.
1.85 “Safety
Data Exchange Agreement” has the meaning set forth in Section 4.7.
1.86 “Senior
Officer” means, with respect to Eyenovia, the Chief Executive Officer or his/her designee, and with respect to Arctic
Vision, the Chief Executive Officer or his/her designee.
1.87 “Senju
Affiliate” means any corporation or non-corporate business entity, firm, partnership or other entity that controls,
is controlled by, or is under common control with Senju. For purposes of this definition, "control" shall mean the
ownership of at least fifty percent (50%) of the voting stock of such entity or any other comparable equity or ownership
interest, or (a) in the absence of the ownership of a least fifty percent (50%) of the voting stock of a corporation, or (b) in
the case of a non-corporate business entity, if it possesses, directly or indirectly, the power to direct, or cause the
direction of, the management and policies of the corporation whether through the ownership of control of voting securities,
by contract or otherwise.
1.88 “Senju
Competitor” means a pharmaceutical company that, as of the relevant date referenced in this Agreement, holds [ ] percent
([ ]%) of the TRx pharmaceutical topical ophthalmic market in Japan.
1.89 “Senju
Invention” means any discovery, invention, improvement, idea, concept, technique, method, process, formula, or technology
within the field of opthamology, whether patentable or not, generated from Senju’s, Senju Affiliates’, or any Senju
Sublicensee’s activities (or those performed on Senju’s, Senju Affiliates’, or any Senju Sublicensee’s
behalf) under the Senju License Agreement for the Senju Product.
1.90 “Senju
Licensed Know-How” means any and all information, data, clinical studies, instructions, proprietary information, trade
secrets, techniques or materials which are related to and generated by Senju’s, Senju Affiliates’, or any Senju Sublicensee’s
activities (or those performed on Senju’s, Senju Affiliates’, or any Senju Sublicensee’s behalf) under the Senju
License Agreement for the Senju Product.
1.91 “Senju
License Agreement” means that certain Exclusive License Agreement between Eyenovia and Senju Pharmaceutical Co., Ltd.
(“Senju”), dated as of March 18, 2015, as amended April 8, 2020 (the “First Senju Amendment”)
and August 10, 2020 (the “Second Senju Amendment”).
1.92 “Senju
Patents” means Patents owned or controlled by Senju, any Senju Affiliate, or any Senju Sublicensee covering any Senju
Invention or Senju Licensed Know-How.
1.93 “Senju
Product” means Licensed Product (as defined in the Senju License Agreement).
1.94 “Senju
Sublicensee” means a third party (that is not an affiliate
of Senju) granted a license by Senju for the right to manufacture, distribute, or otherwise market one or more Senju Products
under the Senju License Agreement.
1.95 “Senju
Territory” means Afghanistan, Bahrain, Bangladesh, Bhutan, Brunei, Burma, Cambodia, China (including Hong Kong, Macao
and Taiwan), Cyprus, East Timor, India, Indonesia, Japan, Laos, Malaysia, Maldives, Mongolia, Myanmar, Nepal, North Korea,
Pakistan, Philippines, Papua New Guinea, Singapore, Sri Lanka, South Korea, Thailand, Uzbekistan, and Vietnam.
1.96 “Shared
Patents” means Licensed Patents (as defined hereunder) that are also Licensed Patents (as defined under the Senju License
Agreement).
1.97 “Subcontractor”
means a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party
under this Agreement on a fee-for-service basis (including CROs and CMOs), excluding
all Sublicensees and Third Party Distributors.
1.98 “Sublicensee”
means any Third Party to whom Arctic Vision or an Affiliate thereof grants a sublicense under Arctic Vision’s rights to the
Licensed Technology granted pursuant to Section 2.1 to Develop, manufacture, or Commercialize any Product in the Territory.
1.99 “Supply
Agreement” has the meaning of Section 4.10.
1.100 “Term”
has the meaning set forth in Section 10.1.
1.101 “Terminated
Jurisdiction” has the meaning set forth in Section 10.3(a).
1.102 “Terminated
Product” has the meaning set forth in Section 10.3(a).
1.103 “Territory”
means (a) the People’s Republic of China, (b) Taiwan, (c) the Republic of Korea (“South Korea”),
(d) the Hong Kong Special Administrative Region of the People’s Republic of China (“Hong Kong”),
and (e) the Macao Special Administrative Region of the People’s Republic of China (“Macao”) (each
of (a) – (e), a “Jurisdiction”).
1.104 “Third
Party” means any Person other than a Party or an Affiliate of a Party.
1.105 “Third
Party Distributor” means any Third Party that purchases Product from Arctic Vision or its Affiliates or Sublicensees
takes title to such Product, and distributes such Product directly to customers, but does not Develop or manufacture such Product
and does not make any royalty, profit-share, or other payment to Arctic Vision or its Affiliates or Sublicensees, other than payment
for the purchase of such Products for resale.
1.106 “TRx”
means [ ].
1.107 “United
States” or “U.S.” means the United States of America and its territories and possessions.
1.108 “Valid
Claim” means (a) a claim of a pending Patent application that has not been (i) abandoned, finally rejected
or expired without the possibility of appeal or re-filing or (ii) pending for more than [ ] ([ ]) [ ]
since such claim was first presented to the patent authority; and (b) a claim of an issued and unexpired Patent that has
not been dedicated to the public, disclaimed, abandoned, revoked, or held invalid or unenforceable by a court, Governmental Authority,
national or regional patent office, or other body of competent jurisdiction from which no further appeal can be taken, and that
has not been explicitly disclaimed, or admitted in writing to be invalid or unenforceable or of a scope not Covering a particular
product or service through reissue, disclaimer or otherwise.
1.109 Interpretation.
In this Agreement, unless otherwise specified:
(a) The
words “include”, “includes”, and “including” shall be deemed to be followed by the phrase “without
limitation”;
(b) words
denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;
(c) the
word “or” is used in the inclusive sense typically associated with the phrase “and/or” unless the subjects
of the conjunction are, or are intended to be, mutually exclusive;
(d) words
such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely
to the particular provision in which such words appear; and
(e) the
Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall include
references to the Exhibits and attachments.
Article 2
LICENSE
2.1 License
Grant. Eyenovia hereby grants to Arctic Vision and its Affiliates:
(a) an
exclusive (even as to Eyenovia and its Affiliates) license, with the right to grant sublicenses as provided in Section 2.2
and transferable with this Agreement under Section 11.2, under the Licensed Technology to research, Develop, use, sell, offer
for sale, have sold, import, and otherwise Commercialize the Products in the Field in the Territory; and
(b) a
non-exclusive license, with the right to grant sublicenses as provided in Section 2.2 and transferable with this Agreement
under Section 11.2, under the Licensed Technology to make and have made the Products in the Manufacturing Territory solely
for use or sale in the Territory in accordance with the license granted under Section 2.1; provided that, Arctic
Vision acknowledges and agrees that, notwithstanding anything to the contrary,
(i) the
rights granted under clause (a) and (b) above with respect to any Senju Know-How and Senju Inventions are not granted
to any Affiliate of Arctic Vision;
(ii) the
rights granted under clause (b) above outside of the Territory shall not include any Know-How or Patents owned or controlled
by Senju, any Senju Affiliate, or any Senju Sublicensee, but Arctic Vision may, as a third party beneficiary of Section 3
of the Second Senju Amendment, enjoy sublicensable rights under Senju Inventions, Senju Licensed Know-How, and Senju Patents to
manufacture or have manufactured Products in the Manufacturing Territory, provided that such rights shall be limited to Products
for marketing and distributing in the Territory and may be applied only to Products manufactured outside the Territory (which rights
are assignable with this Agreement); and
(iii) the
rights granted in clauses (a) and (b) above shall not include any rights to any Senju Licensed Know-How, Senju
Inventions, or Senju Patents following the expiration or termination of the Senju License Agreement, except to the
extent the Senju License Agreement provides for the survival of such rights following such expiration or termination.
(iv) Eyenovia
will use its best efforts to enforce the rights granted Arctic Vision as written in the Senju License Agreement for the benefit
of Artic Vision and provide all such rights thereunder to Arctic Vision consistent with the terms of this Agreement.
2.2 Sublicenses.
Arctic Vision shall have the right to grant sublicenses (through multiple tiers) to contractors, other Third Parties, and, with
respect to Senju Licensed Know-How, Senju Inventions, and Senju Patents, Arctic Vision’s Affiliates under the licenses granted
in Section 2.1 [ ]; provided, however, that such right shall not include the right to grant any such sublicense to an Affiliate
or Third Party that, at the time such sublicense grant would become effective, is a Senju Competitor or that would enable a Third
Party to directly or indirectly sell or otherwise provide any Product to a Senju Competitor; and provided further that, [ ]. If
Eyenovia does not respond to Arctic Vision within [ ] ([ ]) [ ] after receiving from Arctic
Vision a written request for consent to a proposed sublicense, such consent shall be deemed given. Arctic Vision shall have the
right to request at any time that Eyenovia seek confirmation from Senju whether a Third Party or Affiliate of Arctic Vision is
a Senju Competitor at the time of such inquiry and, following each such request, Eyenovia shall promptly seek Senju’s written
confirmation with respect thereto and provide Arctic Vision with a copy of each such confirmation promptly following its receipt
thereof. Each sublicense shall be subject to and consistent with the terms and conditions under this Agreement and Arctic Vision
shall remain primarily responsible for the performance of its obligations hereunder and for each of its Affiliates’ and
Sublicensees’ compliance with the relevant terms of this Agreement. Arctic Vision shall notify Eyenovia of the grant of
any sublicense within [ ] ([ ]) [ ] after the execution of the applicable sublicense agreement and shall
provide Eyenovia with a copy of such sublicense agreement (in English), provided that Arctic Vision shall have the right to redact
any confidential terms of such copy (other than the name of the applicable sublicensee) that are not necessary for Eyenovia to
confirm compliance with this Agreement. Eyenovia agrees that (a) Subcontractors and Third Party Distributors are not Sublicensees
and (b) the agreements entered into with (i) Subcontractors (including, for the avoidance of doubt, CMOs) that do not
have the right to Commercialize the Product and (ii) Third Party Distributors do not, in either case ((i) or (ii)),
require Eyenovia’s consent.
2.3 Retained
Rights. Eyenovia retains the right to practice the Licensed Technology outside the scope
of the exclusive licenses granted to Arctic Vision under Section 2.1 and to fulfill its rights and obligations under this
Agreement.
2.4 No
Implied License. Except as expressly set forth herein, neither Party shall acquire any
license, right, or other interest, by implication or otherwise, under any intellectual property rights of the other Party.
2.5 Technology
Transfer.
(a) Initial
Disclosure of Licensed Know-How. Within [ ] ([ ]) [ ] after the Effective Date, Eyenovia shall, at Eyenovia’s
cost, (i) provide Arctic Vision with all Licensed Know-How that exists as of the Effective Date and is possessed by Eyenovia
or an Affiliate thereof in written or electronic form, including those such specific Know-How items set forth in Exhibit B
and (ii) ensure that any Licensed Know-How that is in the possession of a Third Party (and not Eyenovia’s or
any of its Affiliate’s possession) is provided to Arctic Vision by such Third Party. Eyenovia shall confirm in writing to
Arctic Vision that the foregoing transfer of Licensed Know-How is complete after it has disclosed to Arctic Vision all of such
Licensed Know-How. Arctic Vision may request, from time to time, any additional Licensed Know-How that was not provided by Eyenovia
to Arctic Vision as above within such initial [ ] ([ ]) [ ] period, and Eyenovia shall provide
such additional Licensed Know-How as soon as reasonably practicable.
(b) Disclosure
of Additional Know-How and Improvements.
(i) On
a Calendar Quarterly basis during the Term, Eyenovia shall notify Arctic Vision of any additional Licensed Know-How (including
any Improvement) developed by Eyenovia or its Affiliates, or that otherwise that has come into Eyenovia’s or its Affiliates’
Control, and is material to the Development or Commercialization of Products since the last such disclosure under this Section 2.5.
Upon written request of Arctic Vision, Eyenovia shall promptly provide copies thereof to Arctic Vision, at no additional cost to
Arctic Vision.
(ii) On
a Calendar Quarterly basis during the Term, Arctic Vision shall notify Eyenovia of (1) any AV Know-How developed by or on
behalf of Arctic Vision or its Affiliates, or that otherwise comes into Arctic Vision’s or its Affiliates’ Control,
and is material to the Development or Commercialization of Products, or (2) any Know-How or Patents that are subject to the
licenses granted under Section 2.8(b) arising since, in either case, the last such disclosure under this Section 2.5;
provided, however, that for the purposes of clause (1) above and the licenses granted under Section 2.8(a), Arctic Vision
shall not be deemed to Control any AV Know-How the practice of which by Eyenovia, its Affiliates, or Other Licensees under rights
granted under this Agreement would result in a payment being owed by Arctic Vision or any Affiliate thereof to any Third Party
pursuant to the terms of the agreement between Arctic Vision or any Affiliate thereof and such Third Party pursuant to which rights
in such AV Know-How were acquired. Upon written request of Eyenovia, Arctic Vision shall promptly provide copies thereof to Eyenovia,
at no additional cost to Eyenovia.
(c) Manufacturing
Know-How. With respect to manufacturing-related Licensed Know-How (including
methods, processes, testing/characterization information, and all documentation constituting material support, performance
advice, standard operating procedures, specifications as to materials to be used, and control methods to use and practice the
manufacturing process for each Product and component thereof), Arctic Vision shall have the right to instruct Eyenovia to
provide all or a portion of such Licensed Know-How to one or more of Arctic Vision’s designees to enable such
designee(s) to manufacture each Product, or any of the components thereof, on behalf of Arctic Vision, and Eyenovia
shall ensure that the Licensed Know-How so provided constitutes the Licensed Know-How for the manufacturing process used for
such Product, or component thereof, as of such date. In such case, Eyenovia will, subject to Section 2.5(e), cooperate
with the applicable designee(s), as reasonably requested by Arctic Vision in writing, to complete and implement the
manufacturing-related technology transfer as quickly as reasonably practicable.
(d) Technical
Assistance. Upon Arctic Vision’s written request, Eyenovia shall provide Arctic
Vision or its designee with reasonable technical assistance to enable Arctic Vision or its designee to use and practice the Licensed
Technology in connection with the Development of the Product or any component thereof, including reasonable access to Arctic Vision’s
and its Affiliates’ employees, consultants, and, to the extent Eyenovia is able to provide such access through its Commercially
Reasonable Efforts, contractors, in each case involved in the Development of a Product, or any component thereof (including the
Optejet Dispenser Base®), at no additional cost to Arctic Vision.
(e) Limitations.
Notwithstanding anything to the contrary, Eyenovia’s obligations under Section 2.5(c) with respect to the transfer
of manufacturing-related Licensed Know-How or provision of manufacturing-related assistance shall not be required to exceed, in
the aggregate, a total of [ ] ([ ]) hours. Such assistance shall be provided at times mutually agreed by the Parties so as to accommodate
each Party’s scheduling requirements and the availability of each Party’s relevant employees, consultants, and contractors.
For any such assistance requested by Arctic Vision and provided by Eyenovia in excess of [ ] ([ ]) hours, Arctic Vision shall reimburse
Eyenovia for [ ] percent ([ ]%) of Eyenovia’s reasonable internal costs, at the FTE Rate, and [ ] percent ([ ]%) of the reasonable
out-of-pocket costs, incurred by Eyenovia in providing such additional assistance.
2.6 Exclusivity.
During the Term for a particular Product in a particular Region, Eyenovia and its Affiliates shall not:
(a) grant
to any Third Party any right under the Licensed Technology that would conflict with the rights granted to Arctic Vision under this
Agreement for such Product in such Region;
(b) directly
or indirectly through a Third Party, Develop or Commercialize any pharmaceutical product for the treatment of (i) myopia (in
the case of a MicroPine Product) or (ii) improvement in near vision or presbyopia (in the case of a MicroLine Product), in
each case in such Region, except, in each case, to the extent rights to Develop or Commercialize such product in such Region are
granted under the Senju License Agreement;
(c) directly
or indirectly through a Third Party, Develop or Commercialize any Competitive Combination Product corresponding to such Product
in such Region, except, in each case, to the extent rights to Develop or Commercialize such Competitive Combination Product in
such Region are granted under the Senju License Agreement;
(d) supply
the Optejet Dispenser Base that is compatible for use with the cartridges included as a component in a Product, or the cartridge
included as a component in such Product, to any Third Party in such Region to deliver a pharmaceutical product for the treatment
of (i) myopia (in the case of a MicroPine Product) or (ii) improvement in near vision or presbyopia (in the case of a
MicroLine Product);
(e) supply
to any Third Party in such Region (other than a designee of Arctic Vision) the Optejet Dispenser Base described in Section 2.6(d);
(f) supply
to any Third Party in such Region (other than a designee of Arctic Vision) (i) pilocarpine ([ ]) formulated and loaded into
a cartridge for use in the treatment of improvement in near vision or presbyopia or (ii) atropine sulfate ([ ]) formulated
and loaded into a cartridge for the treatment of myopia; or
(g) supply
such Product, the Optejet Dispenser Base described in Section 2.6(d), or the cartridges described in Section 2.6(d),
to any Third Party outside the Territory if Eyenovia knows or would reasonably be expected to anticipate that such Product or such
components will be used or sold in a Region.
The Parties acknowledge
that Senju has agreed, in Section 1 of the Second Senju Amendment, that it shall not (and that it shall ensure that Senju
Affiliates and Senju Sublicensees do not) develop, have developed, commercialize, have commercialized, import, or have imported
any pharmaceutical product containing atropine for the treatment of myopia or pilocarpine for the improvement in near vision or
presbyopia in the Territory through the exercise of any rights granted under the Senju License Agreement, and Eyenovia shall use
Commercially Reasonable Efforts to enforce such obligation upon Arctic Vision’s reasonable written request.
2.7 Sublicense
under Third Party License. If Eyenovia enters into any agreement with a Third Party
after the Effective Date that includes a license from such Third Party to Eyenovia under any Know-How or Patents that are
necessary to Develop, use, sell, offer for sale, or import the Products in the Territory, then, to the extent such agreement
includes (a) an exclusive license to such rights or (b) a non-exclusive license to such rights and permits the
sublicensing to Arctic Vision of the applicable rights under such Know-How or Patents in the Territory with respect to the
Products on a non-exclusive basis, then in each case ((a) and (b)) Eyenovia shall promptly notify Arctic Vision of such
Third Party license agreement, identify the relevant Know-How or Patents, and provide Arctic Vision with the substantive
terms of the Third Party license agreement applicable to such rights that would be sublicensed to Arctic Vision. Such
Know-How and Patents, to the extent falling within the definition of Licensed Technology, shall be sublicensed to Arctic
Vision under Section 2.1 and/or 2.2 hereof (as applicable) as Licensed Know-How or Licensed Patents, as applicable,
provided that Arctic Vision acknowledges and agrees in writing, in a form of agreement or amendment reasonably acceptable to
both Parties, (i) to add such Patents and Know-How to the definition of Licensed Patents and Licensed Know-How,
respectively, (ii) that its sublicense under such license agreement is subject to the terms and conditions of such
license agreement, (iii) to be responsible, subject to Section 5.6, for the payments that become due under such
Third Party agreement solely and specifically as a result of Arctic Vision’s (or its Affiliate’s or
Sublicensee’s) practice, in the Field in the Territory, of the Know-How and Patent Rights the subject of such Third
Party agreement, and (iv) to comply with the other terms of such license agreement that are applicable to the sublicense
granted to Arctic Vision and its Affiliates thereunder.
2.8 Licenses
to Eyenovia.
(a) General.
Arctic Vision hereby grants to Eyenovia and its Affiliates:
(i) an
exclusive (even as to Arctic Vision and its Affiliates) license, with the right to grant sublicenses through multiple tiers and
transferable with this Agreement under Section 11.2, under the AV Technology to research, Develop, use, sell, offer for sale,
have sold, import, and otherwise Commercialize the Products in the Field outside the Territory; and
(ii) a
non-exclusive, worldwide license, with the right to grant sublicenses through multiple tiers and transferable with this Agreement
under Section 11.2, under the AV Technology to make and have made the Products solely for use or sale (i) by Eyenovia
or its Affiliates or Other Licensees outside the Territory, or (ii) by Arctic Vision or its Affiliates or Sublicensees in
the Territory in accordance with the license granted under Section 2.1;
provided, however,
that for the purposes of this Section 2.8(a), Arctic Vision shall not be deemed to Control any AV Know-How or AV Patents the
practice of which by Eyenovia, its Affiliates, or Other Licensees under the rights granted this Agreement would result in a payment
being owed by Arctic Vision or any Affiliate thereof to any Third Party pursuant to the terms of the agreement between Arctic Vision
or any Affiliate thereof and such Third Party pursuant to which rights in such AV Know-How or AV Patents were acquired.
(b) Senju.
Without limitation of, and in addition to, the rights granted under Section 2.8(a),
Arctic Vision hereby grants to Eyenovia and its Affiliates, solely for purposes of sublicensing such rights to Senju as required
under Section 3(3) of the Second Senju Amendment, a license (which shall be sublicensable by Eyenovia to Senju, and further
sublicensable by Senju pursuant to the Senju License Agreement) under the Licensed Know-How (for purposes
solely of this Section 2.8(b), as defined in the Senju License Agreement) and Inventions (for purposes solely of this Section 2.8(b),
as defined in the Senju License Agreement) with respect to any Product generated from Arctic Vision’s, its Affiliates’,
or Sublicensees’ activities under this Agreement, to research, develop, commercialize, manufacture, or use (a) Senju
Products other than Products in the Field in the Territory and (b) Senju Products in countries of the Senju Territory other
than China and South Korea.
Article 3
GOVERNANCE
3.1 Joint
Steering Committee. Within [ ] ([ ]) [ ] after the Effective Date, the Parties shall establish a joint
steering committee (the “JSC”), composed of two (2) senior employees of each Party, to oversee and guide
the coordination of the Parties under this Agreement. The JSC shall act as a joint consultative body and, to the extent expressly
provided herein, a joint decision-making body. The JSC shall in particular:
(a) review
and discuss the strategy and progress of the Development of the Products in the Territory;
(b) monitor
regulatory actions and pharmacovigilance and safety matters for the Products;
(c) review
and discuss Development of the Products outside the Territory;
(d) review
and discuss Commercialization activities for the Products in the Territory and outside the Territory;
(e) oversee
and facilitate the Parties’ communications and activities with respect to publications under Section 7.4;
(f) establish
joint subcommittees as it deems necessary or advisable to further the purpose of this Agreement; and
(g) perform
such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated
to it by the Parties’ written agreement, including providing financial oversight of the activities conducted pursuant to
this Agreement.
The Parties acknowledge
and agree that, as of the Effective Date and unless and to the extent later agreed in good faith by the Parties in writing, the
JSC’s general purpose shall be for information sharing and advisory purposes, and the JSC shall not have any decision-making
power under this Agreement with respect to either Party’s Development, manufacture, or Commercialization of Products.
3.2 JSC
Membership and Meetings.
(a) Committee
Members. Each JSC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable
Party to make decisions arising within the scope of the JSC’s responsibilities. Each Party may replace its representatives
on the JSC on written notice to the other Party, but each Party shall strive to maintain continuity in the representation of its
JSC members. Each Party shall appoint one of its JSC representatives to be a co-chairperson of the JSC. The co-chairpersons shall
prepare and circulate agendas to JSC members at least [ ] ([ ]) [ ] before each JSC meeting and shall
direct the preparation of reasonably detailed minutes for each JSC meeting, which shall be approved by the co-chairpersons and
circulated to JSC members within [ ] ([ ]) [ ] after such meeting. The Parties shall determine their respective
initial members of the JSC within [ ] ([ ]) [ ] following the Effective Date.
(b) Meetings.
The JSC shall hold meetings at such times as it elects to do so, but in no event shall meetings of the JSC be held less
frequently than once every [ ] ([ ])
[ ] prior to obtaining the first Regulatory Approval
of a Product in the Territory. The first JSC meeting shall be held within
[ ] ([ ])
[ ] after the Effective Date. JSC meetings may be held
in person or by audio or video teleconference, or any combination thereof. In-person JSC meetings shall be held at locations
alternately selected by the Parties. Each Party shall be responsible for all of its own expenses of participating in any JSC
meeting. No action taken at any JSC meeting shall be effective unless at least one (1) representative of each Party is
participating. In addition, upon written notice to the other Party, either Party may request that a special ad hoc meeting of
the JSC be convened for the purpose of resolving any disputes in connection with, or for the purpose of reviewing or making a
decision pertaining to any material subject-matter within the scope of the JSC, the review or resolution of which cannot be
reasonably postponed until the following scheduled JSC meeting. Such ad hoc meeting shall be convened at such time as may be
mutually agreed by the Parties, but no later than [ ]
([ ]) [ ] following the notification date of
request that such meeting be held.
(c) Non-Member
Attendance. Each Party may from time to time invite a reasonable number of participants,
in addition to its representatives, to attend JSC meetings in a non-voting capacity; provided that if either Party intends
to have any Third Party (including any consultant) attend such a meeting, such Party shall provide reasonable prior written notice
to the other Party and obtain the other Party’s approval for such Third Party to attend such meeting, which approval shall
not be unreasonably withheld or delayed. Such Party shall ensure that such Third Party is bound by written confidentiality and
non-use obligations consistent with the terms of this Agreement.
3.3 Decision-Making.
(a) All
decisions of the JSC, with respect to any matter over which the Parties mutually agree in good faith in writing following the
Effective Date the JSC shall have decision-making authority (“JSC Decision Matters”), shall be made by
unanimous vote, with each Party’s representatives collectively having one (1) vote. If after reasonable discussion
and good faith consideration of each Party’s view on a particular matter subject to the decision of the JSC, the
representatives of the Parties cannot reach an agreement as to such matter within
[ ]
([ ]) [ ] after such
matter was brought to the JSC for resolution, then either Party at any time may refer such issue to the Senior Officers for
resolution.
(b) If
the Senior Officers cannot resolve a JSC Decision Matter within
[ ] ([ ])
[ ] after such matter has been referred to them,
then:
(i) Eyenovia
shall have final decision making authority, which shall be exercised in its reasonable discretion, with respect to any JSC Decision
Matter concerning (1) the Development and Commercialization of the Products outside the Territory or (2) any intellectual
property issues directly pertaining to the Products outside the Territory, in each case (1) – (2) provided that
the exercise of such final decision making authority does not have a material adverse effect, and is not reasonably expected to
have a material adverse effect, on the Development or Commercialization of the Products in the Territory;
(ii) Arctic
Vision shall have final decision making authority, which shall be exercised in its reasonable discretion, with respect to any JSC
Decision Matter concerning (1) the Development and Commercialization of the Products in the Territory or (2) any intellectual
property issues directly pertaining to the Products in the Territory, in each case (1) – (2) provided that the
exercise of such final decision making authority does not have a material adverse effect, and is not reasonably expected to have
a material adverse effect, on the Development or Commercialization of the Products outside the Territory.
(iii) Neither
Party shall have final decision making authority with respect to any JSC Decision Matter not covered by Sections 3.3(b)(i) or
3.3(b)(ii), and the status quo shall persist with respect to such JSC Decision Matter unless and until the Parties agree.
3.4 Limitations
on Authority. The JSC shall have only such powers as are expressly assigned to it in this
Agreement, and such powers shall be subject to the terms and conditions of this Agreement. Without limiting the generality of the
foregoing, the JSC will not have the power to amend this Agreement or waive any provision of this Agreement, and no JSC decision
may be in contravention of any terms and conditions of this Agreement.
3.5 Discontinuation
of the JSC. The activities to be performed by the JSC shall solely relate to governance
under this Agreement and are not intended to be or involve the delivery of services. The JSC shall continue to exist until the
termination or expiration of this Agreement or, if earlier, the Parties mutually agree in writing to disband the JSC. Thereafter,
each Party shall designate a contact person for the exchange of information under this Agreement or such exchange of information
shall be made through the Alliance Managers, and decisions of the JSC shall be decisions as between the Parties, subject to the
other terms and conditions of this Agreement.
3.6 Alliance
Managers. Promptly after the Effective Date, each Party shall appoint an individual who
shall be an employee of such Party having appropriate qualification and experience to act as the alliance manager for such Party
(the “Alliance Manager”). Each Alliance Manager shall be responsible for coordinating and managing processes
and interfacing between the Parties on a day-to-day basis throughout the Term. The Alliance Manager will ensure communication to
the JSC of all relevant matters raised at any joint subcommittees and project teams. Each Alliance Manager shall be permitted to
attend meetings of the JSC, as appropriate and as non-voting participants. The Alliance Managers shall be the primary contact for
the Parties regarding the activities contemplated by this Agreement and shall facilitate all such activities hereunder. Each Party
may replace its Alliance Manager with an alternative representative at any time with prior written notice to the other Party. Any
Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager. Each Party shall bear
its own costs of its Alliance Manager.
Article 4
DEVELOPMENT, manufacture, AND COMMERCIALIZATION
4.1 General.
Subject to the terms and conditions of this Agreement, Arctic Vision shall be solely responsible for the Development, manufacture,
and Commercialization of the Products in the Territory, at Arctic Vision’s own cost and expense.
4.2 Development.
(a) General.
Arctic Vision (either itself or through its Affiliates and Sublicensees) shall be responsible for the Development of the Products
in the Field in the Territory, including by conducting all pre-clinical studies and all clinical trials of the Products in the
Territory, at Arctic Vision’s own cost and expense.
(b) Development
Plan. Within
[ ] ([ ])
[ ] after the end of each Calendar Year during the
Term until the first receipt of Regulatory Approval of a Product in the Field in the Territory, Arctic Vision shall provide
Eyenovia with a written plan setting forth a summary and an approximate timeline of the Development activities Arctic Vision
expects to conduct (either itself or through its Affiliates and Sublicensees) in respect of the Products (the
“Development Plan”). Each annual update shall include amendments and revisions to any long term
Development activities, as well as a summary of activities projected to be conducted in the then-current Calendar Year,
including any Development activities to be conducted pursuant to Section 4.3(b), and shall include a good faith estimate
of the timelines for such activities. The initial Development Plan is attached hereto as Exhibit C. If the
terms of the Development Plan contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then
the terms of this Agreement shall govern. For clarity, the Development Plan shall be provided solely for information purposes
and is not binding on Arctic Vision. Arctic Vision shall use Commercially Reasonable Efforts to ensure that no activities
contemplated under any Development Plan, and that the Development of Products under this Agreement, would not reasonably be
anticipated to materially or adversely affect the Development or Commercialization of any Product outside the
Territory.
(c) Reporting.
Within [ ] ([ ])
[ ] days after the end of each Calendar Year, Arctic
Vision shall provide the JSC with a report summarizing in reasonable detail its Development activities in respect of the
Products in the Territory in the previous Calendar Year. The Parties shall review and discuss such report at the JSC
meetings.
4.3 Right
to Co-Develop for Additional Indications.
(a) Additional
Indication Plan. If Eyenovia is interested in Developing a Product for an Additional Indication, then it shall provide Arctic
Vision reasonably promptly with a written reasonably detailed plan and budget for such additional Development work (the “Additional
Indication Plan”). Within [ ] ([ ]) [ ] after Arctic Vision’s receipt of an Additional
Indication Plan, the JSC shall meet to review such Additional Indication Plan and permit Arctic Vision an opportunity to ask questions
and request additional information from Eyenovia related to such Additional Indication Plan. For each Additional Indication Plan,
Arctic Vision shall have the right to request, by written notice to Eyenovia given with [ ] ([ ]) [ ]
following such JSC meeting, that Eyenovia use Commercially Reasonable Efforts to negotiate an amendment of the Senju License Agreement
that would permit the addition of such Additional Indication to the Field for the applicable Product under this Agreement on reasonable
terms acceptable to both Parties (such an amendment, a “Senju Additional Indication Amendment”), provided that
such obligation shall only apply for a period of [ ] ([ ]) [ ] following such request by Arctic
Vision. If a Senju Additional Indication Amendment is signed within such [ ] ([ ]) [ ] period,
Arctic Vision and Senju shall use Commercially Reasonable Efforts to negotiate an amendment to this Agreement adding such Additional
Indication to the Field consistent with the terms of the above-referenced amendment to the Senju License Agreement (such an amendment,
an “Additional Indication Amendment”) and, if the Parties agree upon such an amendment to this Agreement within
[ ] ([ ]) [ ] of the execution of the Senju Additional Indication Amendment, Arctic Vision,
may elect, at its discretion, to collaborate in the conduct of one of the Registration Trials under such Additional Indication
Plan (the “Additional Indication Registration Trial”) by recruiting, in the Territory, up to [ ]
([ ] %), or such other proportion as necessary to ensure statistically meaningful results in the Territory for
submission of an MAA to any applicable Regulatory Authority in the Territory, of the global participants for such Registration
Trial, [ ].
(b) Co-Development.
If, with respect to any Additional Indication that is the subject of an Additional Indication Plan, (i) a Senju
Additional Indication Amendment is executed by Senju and Eyenovia with respect to such Additional Indication by the
applicable date set forth above, (ii) an Additional Indication Amendment adding such Additional Application to the Field
under this Agreement is executed by the Parties by the applicable date set forth above, and (iii) Arctic Vision elects
to collaborate with respect to any Additional Indication Registration Trial by written notice to Eyenovia by the applicable
date set forth above, then, subject to the proviso set forth in the last sentence of Section 4.3(a), the Parties shall
coordinate, through the JSC, on the finalization of the protocol for such Additional Indication Registration Trial and the
selection and engagement of clinical trial sites in the Territory to conduct Arctic Vision’s portion of such Additional
Indication Registration Trial, provided that the Parties shall use Commercially Reasonable Efforts to cause the JSC to meet
to review such Additional Indication Plan within [ ]
([ ]) [ ] of its being provided to the JSC.
In such case, as between the Parties, (i) Arctic Vision shall be solely responsible for (A) overseeing the conduct
of the clinical trial sites for such Additional Indication Registration Trial in the Territory and (B) the Development
Costs incurred in connection with the conduct of such Registration Trial in the Territory and (ii) Eyenovia shall be
solely responsible for (A) overseeing the conduct of the clinical trial sites for such Additional Indication
Registration Trial outside the Territory and (B) the Development Costs incurred in connection with the conduct of such
Registration Trial outside the Territory. In addition, if clauses (i), (ii), and (iii) of the first sentence of this
Section 4.3(b) are satisfied with respect to a particular Additional Indication and Arctic Vision elects in writing
to Eyenovia to collaborate in the corresponding Additional Indication Registration Trial within the above-referenced time
period, the Parties shall discuss and negotiate in good faith to enter into an amendment to this Agreement, or separate
written agreement between the Parties, to further address the Parties’ rights and obligations with respect to the
performance of such Additional Indication Registration Trial.
(c) Eyenovia
Territory Development. For clarity, if (i) Arctic Vision does not request that
Eyenovia attempt to negotiate a Senju Additional Indication Amendment for a particular Additional Indication by the
applicable date set forth above, (ii) a Senju Additional Indication Amendment is not executed by Senju and Eyenovia with
respect to an Additional Indication by the applicable date set forth above, (iii) an Additional Indication Amendment
adding such Additional Application to the Field under this Agreement is not by the applicable date set forth above,
(iv) Arctic Vision does not elect to collaborate with respect to any Additional Indication Registration Trial by written
notice to Eyenovia by the applicable date set forth above, or (v) Arctic Vision does make such an election but the
Parties do not execute, despite Eyenovia’s application of good faith efforts, an agreement or amendment with respect
thereto as referenced in the last sentence of Section 4.3(b) within
[ ] ([ ])
[ ] after such election, Eyenovia may pursue such
Development work outside the Territory, provided that: (1) it shall provide updates to the JSC with respect to such
Additional Indication Registration Trial at each regularly scheduled JSC meeting and (2) it shall not conduct any
Development of the Product in a manner that, as the time such Development is performed, would be reasonably expected to have
any material adverse effect on the Development or Commercialization of such Product in the Field in the Territory.
4.4 Diligence.
(a) Initial
Indications. Arctic Vision (either itself or through its Affiliates and Sublicensees)
shall use Commercially Reasonable Efforts to Develop and Commercialize (a) the MicroLine Product for the treatment of presbyopia
in the Territory and (b) the MicroPine Product for the treatment of myopia in the Territory.
(b) Additional
Indications. If (i) Arctic Vision has the right to, and Arctic Vision does, elect
to collaborate with respect to any Additional Indication Registration Trial pursuant to Section 4.3(b) and (ii) the
Parties execute an agreement or amendment with respect thereto as referenced in the last sentence of Section 4.3(b), the Parties
shall, subject to, and as further described in, such agreement or amendment, each use Commercially Reasonable Efforts to conduct
the Development activities allocated to such Party with respect to such Additional Indication Registration Trial.
(c) No
Guarantee. The Parties acknowledge and agree that no outcome or success is or can be assured
and that failure to achieve desired results will not in and of itself constitute a breach or default of any obligation in this
Agreement.
4.5 Data
Use and Exchange.
(a) Initial
Indications.
(i) Arctic
Vision’s Rights. Arctic Vision shall have the sublicensable right (transferable
with this Agreement pursuant to Section 11.2) to use and reference, without additional consideration, any and all Data generated
by or on behalf of Eyenovia or any of its Affiliates outside the Territory for obtaining and maintaining Regulatory Approval of
the Products for the Initial Indications, and otherwise Commercializing the Products for the Initial Indications, in the Territory
in accordance with the terms of this Agreement.
(ii) Eyenovia’s
Rights. Eyenovia and its Affiliates shall have the sublicensable right (transferable with
this Agreement pursuant to Section 11.2) to use and reference, without additional consideration, any and all Data generated
by or on behalf of Arctic Vision or any of its Affiliates in the Territory for obtaining and maintaining Regulatory Approval of
the Products for the Initial Indications, and otherwise Commercializing the Products for the Initial Indications, outside the Territory
in accordance with the terms of this Agreement.
(b) Additional
Indications.
(i) Rights
to Reference. Each Party shall have the right to use and reference, without additional
consideration, any and all Data generated in the performance of any clinical trial of a Product for any Additional Indication conducted
by or on behalf of the other Party, its Affiliates, or, to the extent Controlled by such other Party or its Affiliates, Sublicensees
(in the case of Arctic Vision) or Other Licensees (in the case of Eyenovia) (including all such Data generated in the performance
of any Additional Indication Registration Trial) to Develop, obtain and maintain Regulatory Approval for, and Commercialize, such
Product for such Additional Indication in the Territory (in the case of Arctic Vision) or outside the Territory (in the case of
Eyenovia) in each case in accordance with the terms of this Agreement. Notwithstanding the foregoing, (i) Arctic Vision shall
only be granted the rights contemplated by the preceding sentence to the extent contemplated by any agreement or amendment executed
by the Parties with respect to such Additional Indication as referenced in the last sentence of Section 4.3(b) and (ii) if
a Party does not Control such use and reference rights with respect to Data generated by any Sublicensee (in the case of Arctic
Vision) or Other Licensee (in the case of Eyenovia), then such Party shall not have the right to grant use and reference rights
to such Sublicensee (in the case of Arctic Vision) or Other Licensee (in the case of Eyenovia) to any Data generated by or on behalf
of the other Party, provided that (1) the foregoing limitation shall not apply to Eyenovia’s rights hereunder to the
extent sublicensed to Senju under the Senju License Agreement and (2) Eyenovia shall be entitled to sublicense such rights
to Senju, its Affiliates, and its and their sublicensees under the Senju License Agreement.
(ii) Data
Exchange. At each regularly scheduled JSC meeting, each Party shall update the JSC regarding
the status, progress, and results of its Development activities in connection with any then-ongoing clinical trial of a Product
in such Party’s territory. In addition, after the completion of any such clinical trial, each Party shall in a timely manner
provide the other Party with a copy of all Data generated from such trial in the Territory (in the case of Arctic Vision) or outside
the Territory (in the case of Eyenovia) for use by the other Party in accordance with this Section 4.5(b).
4.6 Regulatory.
(a) General.
Arctic Vision shall have the sole right to prepare, obtain, and maintain MAAs (including the setting of the overall regulatory
strategy therefor), Regulatory Approvals, and other Regulatory Materials in its own name or in the name of an Affiliate, and to
conduct communications with the applicable Regulatory Authorities, for the Products in the Field in the Territory (which shall
include filings of or with respect to INDs, MAAs, and other filings or communications with the applicable Regulatory Authorities
in the Field in the Territory). At Arctic Vision’s request, Eyenovia shall (i) provide Arctic Vision with any and all
documentation in Eyenovia’s possession and Control not previously provided to Arctic Vision that is requested by a Regulatory
Authority with respect to the foregoing and (ii) review and comment on an English-language summary and original-language copies
of any such Regulatory Materials prior to submission thereof.
(b) Transfer
and Right of Reference. Eyenovia hereby grants to Arctic Vision a right of reference to
all Regulatory Materials pertaining to the Products, and each component thereof, submitted by or on behalf of Eyenovia in and outside
the Territory. Arctic Vision may use such right of reference to seek, obtain, and maintain Regulatory Approval of the Products
in the Field in the Territory. For the purposes of this Agreement, “right of reference” means the “right of reference
or use” as defined in 21 C.F.R. § 314.3(b) and any equivalent regulation outside the US, as each may be amended
from time to time. For clarity, such right shall not include any such right with respect to any Regulatory Materials owned or controlled
by Senju, any Senju Affiliate, or any Senju Sublicensee.
4.7 Adverse
Event Reporting; Safety Data Exchange Agreement. As soon as reasonably practicable
after the Effective Date, the Parties shall enter into a reasonable and customary form of safety data exchange agreement
setting forth the pharmacovigilance and safety data exchange procedures for the Parties with respect to the Products, such as
Safety Data sharing, adverse events reporting, medical device malfunction reporting, and safety signal and risk management
(the “Safety Data Exchange Agreement”), which agreement the Parties shall amend from time to time as
necessary to comply with any changes in applicable Laws or any guidance received from Regulatory Authorities. Such procedures
shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under
applicable Laws to monitor patients’ safety. Eyenovia has established, and shall continue to hold (either by itself or
through an Affiliate, or vendor engaged by Eyenovia or its Affiliate), a global safety database for each of the Products and
for the Optejet Dispenser Base, and shall maintain (or ensure the maintenance of) such global safety databases for so long as
the Products are under Development or Commercialization by the Parties, their respective Affiliates, any Sublicensees, or any
Other Licensees. Eyenovia shall bear the costs associated with maintaining such databases and preparing reports for outside
the Territory. Arctic Vision shall maintain, and bear the costs associated with maintaining, its own safety database for the
Products in the Field in the Territory and shall provide all Safety Data, including adverse event reports and medical device
malfunction reports, in such database to Eyenovia in accordance with the Safety Data Exchange Agreement. Eyenovia shall
ensure that each Party is able to access the data from the global safety database in order to meet legal and regulatory
obligations. Each Party shall, as between the Parties, be primarily responsible for reporting quality complaints, adverse
events, and Safety Data related to the Products in the Field and Optejet Dispenser Base therefor to any necessary Regulatory
Authorities in the Territory (in the case of Arctic Vision) or outside the Territory (in the case of Eyenovia), and
responding to safety issues and to all requests of Regulatory Authorities related to the Products in the Field or the Optejet
Dispenser Base therefor, in each case at its own cost. Each Party agrees to comply with its respective obligations under the
Safety Data Exchange Agreement and to cause its Affiliates, Sublicensees (in the case of Arctic Vision), and Other Licensees
with respect to Products (in the case of Eyenovia) to comply with such obligations, [ ].
4.8 Notification
of Threatened Action. Each Party shall notify the other Party within [ ] ([ ]) [ ] of any information
it receives regarding any threatened or pending action, inspection, or communication by any Regulatory Authority which may adversely
affect the safety or efficacy claims of any Product or the continued Development, manufacture, or Commercialization of any Product.
Upon receipt of such information, the Parties shall promptly consult with each other in an effort to arrive at a mutually acceptable
procedure for taking appropriate action.
4.9 Recalls.
In the event that a recall, withdrawal, or field correction (including the dissemination of relevant information (e.g.,
“Dear Doctor” letter or its equivalent regarding use of a Product)) of any Product (a
“Recall”) in the Field in the Territory (in the case of Arctic Vision) or outside the Territory (in the
case of Eyenovia) is required by a Regulatory Authority of competent jurisdiction therein, or if a Recall of a Product in the
Field in the Territory (in the case of Arctic Vision) or outside the Territory (in the case of Eyenovia) is deemed advisable
by such Party in its reasonable, good faith discretion, such Party shall so notify the other Party in writing no later than
[ ] ([ ]) [ ] in advance of the earlier of
(a) initiation of a Recall or (b) the submission of plans for such an action to a Regulatory Authority.
Promptly after being notified of a Recall by the other Party, each Party shall provide the other Party, at the other
Party’s expense, with such assistance in connection with such Recall as may be reasonably requested by such other
Party. All costs and expenses in connection with a Recall, including the costs and expenses related to the
dissemination of relevant information, in the Territory shall be paid by Arctic Vision (including reimbursement of costs and
expenses incurred by Eyenovia pursuant to the above-referenced assistance); all costs and expenses in connection with a
Recall, including the costs and expenses related to the dissemination of relevant information, outside the Territory shall be
paid by Eyenovia (including reimbursement of costs and expenses incurred by Arctic Vision pursuant to the above-referenced
assistance). Arctic Vision and Eyenovia, respectively, shall handle exclusively the organization and implementation of
all Recalls of Products in the Field in the Territory and outside the Territory, respectively. Notwithstanding the foregoing,
any Recall related to the manufacture and supply of a Product by Eyenovia to Arctic Vision under the Supply Agreement shall
be governed by the terms and conditions of the Supply Agreement.
4.10 Manufacture
and Supply.
(a) Eyenovia
Supply. Except as provided in Section 4.10(c) below, and subject to the
Parties’ execution, and the terms of, the Supply Agreement, Eyenovia shall manufacture and supply, through itself, one
or more of its Affiliates, or one or more Third Party CMO(s), the Products in finished, assembled form for use in the
Development and Commercialization of the Products under this Agreement. Subject to Section 4.10(c), all Products
supplied by Eyenovia to Arctic Vision under the Supply Agreement shall be at a price equal to the Supply Price for such
Product set forth in Section 5.3, and Eyenovia shall source such Products, and the components thereof, from one or more
manufacturers (which may be any combination of Eyenovia, any Affiliates thereof, or Third Party CMOs that Eyenovia or its
Affiliate reasonably determines in good faith to be appropriately qualified for such manufacture), provided that within
[ ] ([ ])
[ ] after submitting the first MAA of a Product in the
U.S., Eyenovia shall have at least two (2) manufacturers (which may be any combination of Eyenovia, any Affiliates
thereof, or Third Parties) able (i.e., with all technology transfer reasonably necessary to be operational completed) to
manufacture and supply for each stage of the manufacturing process of the Products (for example, two (2) manufacturers
providing MicroLine and MicroPine drug substance, two (2) manufacturers manufacturing MicroLine and MicroPine
cartridges, two (2) manufacturers performing drug-cartridge assembly, etc.).
(b) Supply
Agreement. As soon as reasonably practicable after the Effective Date, but in any
event within [ ] ([ ])
[ ] after the Effective Date, the Parties shall enter
into a supply agreement for the manufacture and supply of the Products to Arctic Vision (the “Supply
Agreement”). The Supply Agreement shall provide for a term of supply, on a Product-by-Product basis, that commences
on the effective date of such agreement and continues for an initial term that expires on the earlier of (i) the date
[ ] ([ ])
[ ] after the receipt of the first Regulatory Approval
of such Product in the Territory or (ii) [ ], and thereafter automatically renews for two-year
periods unless terminated by a Party as provided therein.
(c) Arctic
Vision Supply. Subject to the remainder of this Section 4.10(c), Arctic Vision
shall have the right, but not the obligation, to manufacture and supply, itself or through one or more Third Party CMO(s),
the Products for use in the Development and Commercialization of the Products in the Field in the Territory under this
Agreement. If Arctic Vision wishes to so manufacture and supply the Products, it shall terminate the Supply Agreement in
accordance with the terms therein and continue to source Products from Eyenovia until the effective date of such termination.
Following the effective date of termination of the Supply Agreement, (i) Arctic Vision shall be responsible for the
manufacture and supply of the Products for use or sale in the Territory under this Agreement and (ii) in lieu of paying
to Eyenovia the Supply Price for Products set forth in Section 5.3, Arctic Vision shall pay to Eyenovia a royalty on the
Net Sales of the Products in the Territory as set forth in Section 5.5. Upon Arctic Vision’s request, Eyenovia
shall facilitate an introduction to Eyenovia’s Third Party CMO(s) of the Products and reasonably assist Arctic
Vision in negotiating a supply agreement with such CMO(s) for supply of the Products to Arctic Vision, provided such
assistance shall not require the use of counsel, drafting of documents, or any other material dedication of Eyenovia
resources. Arctic Vision shall promptly notify Eyenovia in writing of any Affiliate or Third Party engaged to manufacture any
Product (or portion or component thereof) on behalf of Arctic Vision, any Affiliate thereof, or any Sublicensee (which notice
shall provide the name of such manufacturer).
4.11 Commercialization.
Arctic Vision (itself or through its Affiliates and Sublicensees) shall be responsible for all aspects of the Commercialization
of, and use Commercially Reasonable Efforts to Commercialize, the Products in the Field in the Territory, at Arctic Vision’s
own cost and expense, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating
with applicable Government Authorities regarding the price and reimbursement status of the Products; (c) marketing and promotion;
(d) booking sales, distributing Products, and performing related services; (e) handling all aspects of order processing,
invoicing, and collection, inventory and receivables; and (f) providing customer support, including handling medical queries,
and performing other related functions.
4.12 Commercialization
Cooperation. Eyenovia shall support Arctic Vision’s Commercialization of the Products
in the Field in the Territory as reasonably requested by Arctic Vision and at Arctic Vision’s expense, by providing Arctic
Vision with copies of promotional and other materials used by Eyenovia and its Affiliates to Commercialize the Products outside
of the Territory and by providing Arctic Vision with access and introductions to key opinion leaders with respect to Products outside
of the Territory.
Article 5
PAYMENTS
5.1 Upfront
Payment. Arctic Vision shall pay to Eyenovia a one-time upfront payment of four million
Dollars ($4,000,000) within three (3) Business Days after the Effective Date, with Arctic Vision initiating an irrevocable
wire transfer to Eyenovia therefor, and providing Eyenovia reasonable written evidence thereof, upon the Effective Date.
5.2 Development
and Regulatory Milestone Payments.
(a) Milestone
Events. Subject to the remainder of this Section 5.2, Arctic Vision shall pay to
Eyenovia the one-time, non-creditable payments set forth in the table below (“Milestone Payment”) upon the first
achievement of the corresponding milestone event (“Milestone Event”), whether by or on behalf of Arctic Vision
or its Affiliates or Sublicensees.
|
Development and Regulatory Milestone Events
|
Milestone Payment
|
|
1)
[ ]
|
$[ ]
|
|
2)
[ ]
|
$[ ]
|
|
3)
[ ]
|
$[ ]
|
|
4)
[ ]
|
$[ ]
|
|
5)
[ ]
|
$[ ]
|
|
6)
[ ]
|
$[ ]
|
|
7)
[ ]
|
$[ ]
|
|
8)
[ ]
|
$[ ]
|
|
9)
[ ]
|
$[ ]
|
(b) Milestone
Payment Reduction for Supply Failure. If following a Supply Failure (as defined in the
Supply Agreement), Arctic Vision elects to terminate the Supply Agreement and assume responsibility for the manufacture and supply
of Products under this Agreement as set forth in Section 4.10(c), the Milestone Payment for each Milestone Event that has
not been achieved as of the date of such Supply Failure shall be reduced by [ ] percent ([ ]%).
(c) Milestone
Payment Deferral for 1st Generation Device.
(i) With
respect to Milestone Events #1 through #8, if the first achievement of any such Milestone Event is by a Product that incorporates
the Optejet Dispenser Base having the specifications set forth in Part 3 of Exhibit A (the “1st
Generation Device”), the corresponding Milestone Payment shall be reduced by [ ] percent ([ ]%) (such [ ] ([ ]%), the
“Device Reduction Portion”).
(ii) The
Device Reduction Portion of any Milestone Payment reduced pursuant to Section 5.2(c)(i) shall be paid to Eyenovia upon
the first achievement of the corresponding Milestone Event by a Product that incorporates an Optejet Dispenser Base having the
specifications set forth in Part 3 of Exhibit A by or on behalf of Eyenovia after the Effective Date (the
“2nd Generation Device”).
(iii) For
clarity, if the first achievement of any such Milestone Event is by a Product that incorporates the 2nd Generation Device,
the full amount of the corresponding Milestone Payment shall be paid to Eyenovia.
(iv) For
further clarity, Section 5.2(c)(i) shall not apply to Milestone Event #9.
(d) Notice
and Payment. Arctic Vision shall notify Eyenovia in writing within
[ ] ([ ])
[ ] after (i) the first achievement of any
Milestone Event set forth in this Section 5.2 and (ii) in the event a Milestone Event is first achieved by a
Product incorporating a 1st Generation Device, the first achievement of such Milestone Event by a Product
incorporating a 2nd Generation Device, and shall pay to Eyenovia the corresponding Milestone Payment or Device
Reduction Portion within [ ] ([ ])
[ ] after the applicable achievement of such Milestone
Event.
(e) Payment
Deferral. Notwithstanding anything to the contrary in this Agreement, if Eyenovia
has not (1) executed a reasonable and customary form of safety data exchange, pharmacovigilance, or similar agreement
with Senju that is reasonably consistent with the description of such agreement set forth in Section 4.7 and
(2) provided Arctic Vision written notice (and copy) thereof prior to the date a particular payment under this Agreement
would be due (other than the upfront payment under Section 5.1), such payment (including any development payment or
Milestone Payment) shall not be due until the date [ ]
([ ]) [ ] following Eyenovia’s
execution of such agreement with Senju and notice (and copy) thereof to Arctic Vision. For clarity, all payments due by
Arctic Vision under this Agreement (other than Section 5.1) are expressly subject to the conditions of this
Section 5.2(e) and any payment amount deferred shall not be payable (and forgiven by Eyenovia) upon a termination
of this Agreement if the conditions of this Section 5.2(e) are not met at the time of notice of
termination.
5.3 2nd
Generation Device Development Costs.
(a) Cap.
Arctic Vision shall reimburse Eyenovia for up to [ ] percent ([ ]%) of the Development Costs incurred by Eyenovia or any
Affiliate thereof in connection with the Development of the 2nd Generation Device (“Device Development
Costs”), up to a maximum reimbursement of [ ] Dollars ($[ ]) (the “Cap”). In no event shall
Arctic Vision be obliged pursuant to this Section 5.3 to pay to Eyenovia more than (i) [ ] Dollars ($[ ]) within
the first [ ] ([ ]) [ ] after the Effective Date or (ii) the Cap, regardless of the total
Device Development Costs, provided that, in the event Eyenovia invoices Arctic Vision for payment of Device Development Costs
in excess of [ ] Dollars ($[ ]) during the first [ ] ([ ]) [ ] following the Effective Date,
such excess Device Development Costs shall be due within [ ] ([ ]) [ ] after the first
anniversary of the Effective Date.
(b) Invoice
and Payment. Eyenovia shall, on a Calendar Quarter basis, submit to Arctic Vision a
statement setting forth the total Device Development Costs incurred in the previous Calendar Quarter and the portion of such
Device Development Costs to which Eyenovia is entitled to be reimbursed by Arctic Vision pursuant to Section 5.3(a).
Each such invoice shall include a reasonably detailed report for such Device Development Costs, including reasonable
supporting documents. Arctic Vision shall pay each invoice that is not reasonably disputed in good faith by Arctic Vision
within [ ] ([ ]) [ ] after the receipt of such invoice, and the amount properly due under any
other invoice within [ ] ([ ]) [ ] of the resolution of the dispute concerning such invoice
pursuant to Section 11.7, subject to, in either case, Arctic Vision’s right to audit Eyenovia’s records and
books related to such costs as provided in Section 5.10.
(c) Catch-Up
Milestone. If the total amount reimbursed by Arctic Vision to Eyenovia pursuant to Section 5.3(a) (“Total
Amount Reimbursed”) is an amount less than the Cap, then upon the earliest of (i) [ ], (ii) [ ], (iii) [
], or (iv) [ ], Arctic Vision shall pay to Eyenovia an amount equal to the difference between the Cap and the Total Amount
Reimbursed (i.e., Cap – Total Amount Reimbursed = payment amount).
5.4 Supply
Price.
(a) Product
Supply Prices. Subject to the remainder of this Section 5.4, in consideration
for the units of Product provided by Eyenovia to Arctic Vision under the Supply Agreement, Arctic Vision shall pay to
Eyenovia a supply prices equal to those set forth in the table in Exhibit D (the “Supply
Price”) for all Products provided to Arctic Vision for use or sale by or on behalf of Arctic Vision, its
Affiliates, or Sublicensees; provided that in no case shall the Supply Price for a Product (i) be an amount less than [
] percent ([ ]%) of the Cost of Goods of such Product or (ii) exceed [ ] percent ([ ]%) of the Cost of Goods of such
Product. For clarity, the Supply Price includes transportation costs for the Product when such Product is supplied in bulk
(i.e., at least one pallet in a shipment). During the Term, Eyenovia shall use Commercially Reasonable Efforts to maintain,
or reduce, the Cost of Goods in effect as of the Effective Date. From time to time during the Term, upon Arctic
Vision’s request, the Parties shall discuss in good faith strategies to reduce the Cost of Goods.
(b) Supply
Price Reduction for Generic Entry. If one or more Generic Products with respect to a Product
is sold in a Jurisdiction in the Territory by a Third Party, the Supply Price for such Product purchased for sale in such Jurisdiction
shall, for Product ordered by Arctic Vision for sale in such Jurisdiction in such Calendar Quarter and each Calendar Quarter thereafter,
be reduced by [ ] percent ([ ]%) of the Supply Price set forth on Exhibit D therefor (as modified by Section 5.4(c),
if applicable), provided, however, that such reduction, the deduction contemplated by Section 5.6, and any reduction pursuant
to Section 10.4 shall not in any event collectively reduce the amount due Eyenovia for the purchase of any such Product to
an amount less than the greater of (i) [ ] percent ([ ]%) of the Supply Price set forth therefor on Exhibit D or
(ii) [ ] percent ([ ]%) of Cost of Goods for such Product.
(c) Competitive
Combination Products and Competitive Senju Products. If (1) any Competitive Combination
Product with respect to a Product is sold in a Jurisdiction by Eyenovia, any Affiliate thereof, or any Third Party to whom Eyenovia
or an Affiliate thereof has granted rights in such Jurisdiction to Commercialize such Competitive Combination Product or (2) any
Competitive Senju Product with respect to a Product is sold in a Jurisdiction by Senju, a Senju Affiliate, or a Senju Sublicensee,
then the Supply Price for such Product for such Jurisdiction shall be reduced to the greater of (i) [ ] percent ([ ]%) of
the Supply Price set forth therefor on Exhibit D (as modified by Section 5.4(b), if applicable) or (ii) [
] percent ([ ]%) of Cost of Goods for such Product, provided, however, that, (a) in such case, any additional reduction pursuant
to Section 5.4(b), the deduction contemplated by Section 5.6, and any reduction pursuant to Section 10.4, shall
apply and be taken to the extent such reductions do not collectively reduce the amount due Eyenovia for the purchase of any such
Product to an amount less than [ ] percent ([ ]%) of Cost of Goods for such Product and (b) only one reduction shall be applied
under this Section 5.4(c), even if both clause (1) and (2) apply with respect to a particular Product in a particular
Jurisdiction.
(d) Invoice
and Payment. Concurrently with delivery of Product to Arctic Vision, Eyenovia shall
submit to Arctic Vision an invoice for payment, in U.S. Dollars, of the payment for such delivery. Arctic Vision shall pay
each invoice that is not reasonably disputed in good faith, in U.S. Dollars, within [ ] ([ ])
[ ] after receipt of such invoice by wire transfer of immediately available funds into an account designated by
Eyenovia.
5.5 Royalties.
(a) Royalty
Rate. Subject to the remainder of this Section 5.5, with respect to any unit of
MicroPine Product or MicroLine Product, respectively, not supplied by Eyenovia under the Supply Agreement, Arctic Vision
shall make quarterly non-refundable royalty payments to Eyenovia on the Net Sales of such MicroPine Products or MicroLine
Products, respectively, sold in the Territory, as calculated by multiplying the applicable royalty rate set forth in the
table below by the corresponding amounts of Net Sales of such MicroPine Products or MicroLine Products, respectively, sold in
the Territory in the applicable Calendar Year. For clarity, no royalty under this Section 5.5 shall be owed for
any unit of Product for which Arctic Vision paid to Eyenovia the Supply Price under the Supply Agreement and sales of all
such units shall be excluded from the computation of Net Sales.
|
For
that portion of Net Sales of MicroPine Products or MicroLine Products in the Territory in a particular Calendar Year
|
Royalty
Rate
|
|
1) less
than or equal to
|
$[
]
|
[
]%
|
|
2) greater
than
|
$[
]
|
[
]%
|
|
but
less than or equal to
|
$[
]
|
|
|
3) greater
than
|
$[
]
|
[
]%
|
|
but
less than or equal to
|
$[
]
|
|
|
4) greater
than
|
$[
]
|
[
]%
|
As examples of the
royalties contemplated by this Section 5.5(a), if (i) Net Sales of MicroPine Products in a particular Calendar Year total
$[ ], (ii) Net Sales of MicroLine Products in such Calendar Year total $[ ], (iii) none of such Products were supplied
under the Supply Agreement, and (iv) none of the adjustments set forth in Section 5.5(c) or 5.6 apply, then (1) royalties
due Eyenovia on such Net Sales of MicroPine Products shall equal $[ ] and (2) royalties due Eyenovia on such Net Sales of
MicroLine Products $[ ].
(b) Royalty
Term. Arctic Vision’s obligation to pay royalties pursuant to this Section 5.5
shall (i) commence, on a Product-by-Product and Jurisdiction-by-Jurisdiction basis, following the termination of the Supply
Agreement with respect to such Product and apply to any unit of such Product sold by Arctic Vision, its Affiliates, or Sublicensees
in such Jurisdiction that is not supplied by Eyenovia under the Supply Agreement and (ii) expire upon termination of this
Agreement.
(c) Royalty
Reductions.
(i) Generic
Entry. If a Generic Product is sold in a Jurisdiction by a Third Party during any Calendar
Quarter in the Primary Royalty Term of a Product, the royalty rate set forth in Section 5.5(a) above shall be reduced
by [ ] percent ([ ]%) for such Product in such Jurisdiction for such Calendar Quarter and each Calendar Quarter thereafter during
the remainder of the Primary Royalty Term.
(ii) Patent
Expiry. If the Primary Royalty Term for a particular Product in a Jurisdiction extends
beyond the expiration of the last to expire Valid Claim of a Licensed Patent in such Jurisdiction that Covers the composition of
matter or use of such Product, then the royalty rate set forth in Section 5.5(a) above shall, for all sales of such Product
following such expiration in such Jurisdiction, be reduced by [ ] percent ([ ]%) for such Product in such Jurisdiction.
(iii) Competitive
Combination Products and Competitive Senju Products. If (1) any Competitive
Combination Product is sold for human therapeutic use in a Jurisdiction during any Calendar Quarter of the Primary Royalty
Term of the Product corresponding to such Competitive Combination Product by Eyenovia, any Affiliate thereof, or any
Third Party to whom Eyenovia or an Affiliate thereof has granted rights in such Jurisdiction to Commercialize such
Competitive Combination Product or (2) any Competitive Senju Product is sold for the applicable Initial Indication in a
Jurisdiction during any Calendar Quarter of the Primary Royalty Term of the Product corresponding to such Competitive Senju
Product by Senju, any Senju Affiliate, or any Senju Sublicensee, then the royalty rate set forth in
Section 5.5(a) above, as it may be adjusted pursuant to Sections 5.5(c)(i) and 5.5(c)(ii) (with such
adjustment being calculated for purposes hereof subject to Section 5.5(c)(iv) below), shall be reduced by [ ]
percent ([ ]%) for such Product in such Jurisdiction for such Calendar Quarter and each Calendar Quarter thereafter during
the remainder of the Primary Royalty Term, provided that only one reduction shall be applied
under this Section 5.5(c)(iii), even if both subclauses (1) and (2) apply with respect to a particular Product
in a particular Jurisdiction.
(iv) Royalty
Floor. Notwithstanding the foregoing Sections 5.5(c)(i)and 5.5(c)(ii), with respect to
any Product in any Calendar Quarter, the operation of subsections (i) and (ii) above, individually or in combination,
shall not reduce by more than [ ] percent ([ ]%) the royalties that would otherwise have been due under Section 5.5 with respect
to Net Sales of such Product in the applicable Jurisdiction during the period during which such adjustments apply.
(d) Expiration
of Primary Royalty Term. Upon the expiration of the Primary Royalty Term for a particular
Product in a particular Jurisdiction, (i) the royalty rate applicable to all Net Sales of such Product in such Jurisdiction
shall be reduced to [ ] percent ([ ]%), and, notwithstanding anything to the contrary, such royalty shall not be subject to further
reduction pursuant to Section 5.5(c), 5.6, or 10.4 and (ii) Sections 4.1, 4.2, 4.3, 4.4, 4.11, and 4.12 shall no longer
apply with respect to such Product in such Jurisdiction.
(e) Report
and Payment. Within [ ] ([ ]) [ ] after the end of each Calendar Quarter during which Net
Sales occur on which Arctic Vision is required to pay to Eyenovia royalties under this Section 5.5, Arctic Vision shall provide
Eyenovia with a royalty report that contains the following information for the applicable Calendar Quarter, on a Product-by-Product
and Jurisdiction-by-Jurisdiction basis: (i) the amount of gross sales of the Product, (ii) a calculation of Net Sales
of the Product (include a reasonably detailed accounting of any deductions from gross sales), (iii) a calculation of the
royalty payment due on such Net Sales, including the application of any reduction made in accordance with Section 5.5(c) or
5.6, (iv) the exchange rate for such Jurisdiction, and (v) the aggregate annual Net Sales of each Product. Concurrent
with the delivery of the applicable quarterly royalty report, Arctic Vision shall pay Eyenovia in Dollars the royalties owed with
respect to Net Sales for such Calendar Quarter.
5.6 Third
Party Payment Stacking. If (a) Arctic Vision enters into an agreement with a
Third Party under which it obtains a license or other right to a Third Party’s Patents or Know-How with respect to the
Development, manufacture, or Commercialization of a Product in one or more Jurisdictions in the Territory without which the
sale, offering for sale, use, or import of such Product would not be (i) possible without infringing a Valid Claim of
such Patents in such Jurisdiction or (ii) commercially practicable or (b) Arctic Vision is required to make
payments to Eyenovia pursuant to Section 2.7(iii), Arctic Vision shall be entitled to, as applicable:
(i) deduct from any Supply Price payments payable under the Supply Agreement with respect to such Product purchased for
use or sale in such Jurisdiction [ ] percent ([ ]%) of all royalties and other amounts paid to such Third Party with respect
to such Product in such Jurisdiction pursuant to the terms of such agreement; provided, however, that such deduction together
with any reduction contemplated by Section 5.4(b) or 10.4 shall not in any event collectively reduce the amount due
to Eyenovia for the purchase of any such Product for such Jurisdiction to an amount less than the greater of (A) [ ]
percent ([ ]%) of the Supply Price set forth therefor on Exhibit D and (B) [ ] percent ([ ]%) of Cost of
Goods for such Product, or (ii) deduct from any royalties payable under Section 5.5 with respect to such Product [
] percent ([ ]%) of all royalties and other amounts paid to such Third Party with respect to such Product in such
Jurisdiction pursuant to the terms of such agreement; provided, however, that such deduction together with any reductions
taken pursuant to Section 5.5(c) shall not in any event collectively reduce by more than [ ] percent ([ ]%) the
royalty payment under Section 5.5(a) that would otherwise be due in any Calendar Quarter. Arctic Vision shall have
the right to carry forward to subsequent Calendar Quarters any deductions it is not allowed to take because of the
limitations set forth in the foregoing provisos (in each of subsection (i) and (ii)), subject to such limitations in
each such subsequent Calendar Quarter. Notwithstanding anything to the contrary, none of the adjustments described above
shall apply to any royalties due pursuant to Section 5.5(d).
5.7 Currency;
Exchange Rate. All payments to be made by Arctic Vision to Eyenovia under this Agreement
shall be made in Dollars by bank wire transfer in immediately available funds to a bank account designated by written notice from
Eyenovia. The rate of exchange to be used in computing the amount of currency equivalent in Dollars shall be made at the average
of the closing exchange rates reported in The Wall Street Journal (U.S., Eastern Edition) for the first, middle, and last
Business Days of the applicable reporting period for the payment due.
5.8 Late
Payments. If Eyenovia does not receive payment of any sum due to it on or before the due date therefor, simple interest shall
thereafter accrue on the sum due from the due date until the date of payment at a per-annum rate of prime (as reported in The
Wall Street Journal (U.S., Eastern Edition)) plus [ ] percentage points ([ ] pp) or the maximum rate allowable by applicable
Law, whichever is less.
5.9 Taxes.
(a) Taxes
on Income. Each Party shall be solely responsible for all income taxes imposed on payments
received from the other Party under this Agreement.
(b) Tax
Cooperation. The Parties agree to reasonably cooperate with one another and use
reasonable efforts, to the extent permitted by applicable Law, to avoid or reduce tax withholding or similar obligations in
respect of the milestone payments, royalty payments, and other payments made by one Party (the “Paying
Party”) to the other Party (the “Paid Party”) under this Agreement. To the extent that a Paying
Party is required by applicable Laws to deduct and withhold taxes on any payment to the other Party, the Paying Party shall
pay the amounts of such taxes to the proper Government Authority in a timely manner and promptly transmit to the other
Party an official tax certificate or other evidence of such payment sufficient to enable Eyenovia to claim such payment of
taxes. The Paid Party shall provide the Paying Party any tax forms that may be reasonably necessary in order for the Paid
Party to not withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty or other
applicable Law, to the extent legally able to do so, and the Paid Party shall use reasonable efforts to provide any such tax
forms to the Paying Party reasonably in advance of any applicable due date. The Paying Party shall provide the Paid Party
with reasonable assistance to enable the Paid Party’s recovery, refund, or credit, as permitted by applicable Laws, of
withholding taxes or similar obligations resulting from payments made under this Agreement, such recovery to be for the
benefit of the Paid Party. The Paying Party shall have the right to deduct any such tax, levy, or charge actually paid from
any payment due to the Paid Party. Each Party agrees to use reasonable efforts to assist the other Party in claiming
exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in
force and in minimizing the amount required to be so withheld or deducted.
5.10 Financial
Records; Audits. Each Party shall maintain complete and accurate records in sufficient
detail in relation to this Agreement to permit the other Party to confirm the accuracy of the amount of Device Development Costs
to be reimbursed, and the amount of royalty and other payments payable under this Agreement. Each Party shall keep such books and
records for at least five (5) years following the Calendar Year to which they pertain. Upon reasonable prior written
notice, such records shall be inspected during regular business hours at such place or places where such records are customarily
kept by an internationally-recognized (i.e., “Big Four”) independent certified public accountant (the “Auditor”)
selected by the auditing Party and reasonably acceptable to the audited Party for the sole purpose of verifying for the auditing
Party the accuracy of the financial reports furnished by the audited Party pursuant to this Agreement or of any payments made,
or required to be made, by the audited Party pursuant to this Agreement. Before beginning its audit, the Auditor shall execute
an undertaking reasonably acceptable to each Party by which the Auditor agrees to keep confidential all information reviewed during
the audit. Such audits may occur no more often than once each Calendar Year and not more frequently than once with respect to records
covering any specific period of time. Each Party shall only be entitled to audit the books and records from the five (5) Calendar
Years prior to the Calendar Year in which the audit request is made. The Auditor shall not disclose the audited Party’s Confidential
Information to the auditing Party, and shall only verify the accuracy or inaccuracy of the financial reports furnished by the audited
Party or the amount of payments by such Party under this Agreement, and, in the case of any inaccuracy, the amount of such inaccuracy.
In the event that the final result of the inspection reveals an underpayment or overpayment, the underpaid or overpaid amount shall
be settled within thirty (30) days after the Auditor’s report by payment thereof to, or credit against future amounts owed
hereunder by (or reimbursement if no future amounts will be owed hereunder), the Party owed such payment, as promptly elected thereby
in writing. The auditing Party shall bear the reasonable, documented cost of such audit unless such audit reveals an overpayment
to, or an underpayment by, the audited Party, which underpayment or overpayment was more than five percent (5%) of the amount properly
payable with respect to the period covered by such report, in which case the audited Party shall reimburse the auditing Party for
the reasonable, documented costs for such audit.
Article 6
INTELLECTUAL PROPERTY RIGHTS
6.1 Inventions.
(a) Data.
All Data generated solely by or on behalf of a Party in connection with the Development, Commercialization, manufacture, and other
exploitation of the Products shall be, in each case, the exclusive property of such Party. For clarity, each Party shall have access
and right to use and reference the Data Controlled by the other Party or its Affiliates as set forth in Section 4.5.
(b) Inventions.
Inventorship of all Inventions made under this Agreement shall be determined in accordance with U.S. patent laws.
(i) Each
Party shall, as between the Parties, own any Inventions made solely by such Party or its Affiliates, including its or their employees,
agents, or independent contractors, in the course of conducting its activities under this Agreement. For clarity, any Inventions
pertaining to a Product, or any component thereof, Controlled by Eyenovia, including Know-How in such Inventions and Patents that
Cover such Inventions, are and shall be included in the Licensed Technology.
(ii) The
Parties shall jointly own any Inventions that are made jointly by a Party or its Affiliates or its or their employees, agents,
or independent contractors, on the one hand, and the other Party or its Affiliate or its or their employees, agents, or independent
contractors on the other hand, in the course of performing activities under this Agreement (“Joint Inventions”).
All Patents Covering patentable Joint Inventions shall be referred to herein as “Joint Patents”. Except to the
extent a Party is restricted by the licenses granted to the other Party herein, each Party shall be entitled to practice, exploit,
and sublicense its rights in Joint Inventions and Joint Patents without the duty of accounting or payment to, or seeking consent
from, the other Party.
6.2 Patent
Prosecution.
(a) Licensed
Patents. As between the Parties, Arctic Vision shall have the first right to file,
prosecute, and maintain the Licensed Patents in the Territory, at Arctic Vision’s cost and expense, provided that
Arctic Vision shall use Commercially Reasonable Efforts in exercising such right and shall use Commercially Reasonable
Efforts to not take any actions with respect thereto that would reasonably be anticipated, at the time such decision is made,
to adversely affect any Patents owned or Controlled by Eyenovia or any Affiliate thereof outside the Territory that Cover any
Product or component thereof. In furtherance of the foregoing, (i) upon Arctic Vision’s request, Eyenovia shall
provide Arctic Vision any files and documents in Eyenovia’s or its Affiliates’ possession and Control that are
necessary or materially useful in the prosecution or maintenance of the Licensed Patents in the Territory and (ii) the
Parties shall cooperate in good faith to exchange information on a reasonably periodic basis with respect to the prosecution
and maintenance of the Licensed Patents and the corresponding Patents owned or Controlled by Eyenovia outside the
Territory. Promptly after the Effective Date, Eyenovia shall transfer the prosecution and maintenance of the Licensed Patents
in the Territory to Arctic Vision or its counsel. Without limiting the generality of the foregoing, Arctic Vision shall, on a
reasonably periodic basis, consult with Eyenovia and keep Eyenovia reasonably informed of the status of the Licensed Patents
and shall promptly provide Eyenovia with an English language and, if in a language other than English, original copy of any
material correspondence received from any patent authority in the Territory in connection therewith. In addition, Arctic
Vision shall provide Eyenovia with English language and, if in a language other than English, original drafts of proposed
material filings and correspondence to any patent authority in the Territory with respect to the Licensed Patents to provide
Eyenovia a reasonable opportunity to review and comment thereon prior to submission. Arctic Vision shall notify Eyenovia in
writing of any decision to not file, or to cease prosecution or maintenance of, any Licensed Patents in the Territory. Arctic
Vision shall provide such notice at least [ ] ([ ]) [ ] prior to any filing or payment due
date, or any other due date that requires action, in connection with such Licensed Patent. In such event, upon
Eyenovia’s request, (i) Arctic Vision shall provide Eyenovia any files and documents in Arctic Vision’s or
its Affiliates’ possession and Control that are necessary or materially useful in the prosecution or maintenance of
such Licensed Patent and (ii) Arctic Vision shall transfer the prosecution and maintenance of such Licensed Patent to
Eyenovia, and thereafter Eyenovia shall have the right to file, prosecute, maintain, and defend such Licensed Patent in the
Territory at Eyenovia’s cost and expense and (ii) such Patent, and any Patents
claiming priority thereto, shall no longer be included in the Licensed Patents for purposes of this Agreement.
(b) Joint
Patents. The Parties shall mutually agree on which Party will prepare, file, prosecute,
and maintain Joint Patents which are not Licensed Patents based on the contribution of each Party to such Joint Invention and each
Party’s potential interest in products based upon such Joint Invention.
(c) Shared
Patents. Notwithstanding anything to the contrary, and without limitation of AV’s
obligations, or Eyenovia’s obligations under Section 6.2(a) or 6.2(b), AV shall, to the extent it has the right
to file, prosecute, and maintain Licensed Patents and Joint Patents in the Territory under Section 6.2(a) or 6.2(b),
file, prosecute and maintain the Licensed Patents and Joint Patents in the Territory, and shall be responsible for all material
actions relating to the filing, prosecution and maintenance thereof, including, without limitation, patent interference, reexaminations,
reissuances, appeals, oppositions and revocation proceedings. AV shall not knowingly take any action during the filing, prosecution
and maintenance of any Licensed Patent or Joint Patents in the Territory that would adversely affect Senju or any corresponding
Patent outside the Territory (including any reduction in claim scope), without Eyenovia’s prior written consent.
(d) Cooperation.
Each Party shall provide the other Party reasonable assistance and cooperation in the patent prosecution efforts under this Section 6.2,
including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.
6.3 Patent
Enforcement.
(a) Notice.
Each Party shall promptly notify the other Party if it becomes aware of any alleged, threatened, or actual infringement by a Third
Party of the rights granted under Section 2.1(a) to any Licensed Patent (including any Joint Patents which are Licensed
Patents), including such infringement arising by the manufacture, use, import, or sale of a Product, any product substantially
similar to a Product, or, to the extent used or incorporated into a pharmaceutical product delivering the same API as a Product
in substantially the same manner as a Product, any component of any of the foregoing, in each case in the Territory (a “Product
Infringement”).
(b) Enforcement.
(i) [ ]
shall have, as between the Parties, the sole right to bring and control any legal action to enforce the Licensed Patents
against a Product Infringement, or negotiate and enter into any settlement with respect thereto, at its own expense;
provided, however, that (1) [ ], (2) [ ], and (3) [ ]. In the event
that [ ] enforces the Licensed Patents against a Product Infringement (either on its own behalf or at
[ ] request), [ ] shall have the right to participate, at its own expense and with counsel of its
choice, in such enforcement of the Licensed Patents, provided that [ ] acknowledges that [ ] shall be
the controlling party in such action. If [ ] does not bring such legal action or commence negotiations to
enter into a settlement with respect to such Product Infringement, either on its own behalf or at [ ] request,
prior to the earlier of the date that is (i) [ ] ([ ]) [ ] after the notice provided
pursuant to Section 6.3(a) or (ii) [ ] ([ ]) [ ] prior to the applicable
expiration date for the initiation of such action under applicable Law, then [ ] acknowledges that [ ]
shall have the right to bring and control any legal action to enforce the Licensed Patents against such Product Infringement,
or enter into any settlement thereof, at its own expense. In such case, [ ] shall use Commercially Reasonable
Efforts to (i) provide [ ] a reasonable opportunity to consult with [ ] with respect thereto and
(ii) [ ] ensure that does not enter into any settlement of any Product Infringement, or make any admissions
or assert any position in such claim, suit, proceeding, or threat of any of the foregoing with respect to any Product
Infringement, in a manner that would materially and adversely affect the manufacture, use, or sale of any Product in the
Field in the Territory, without [ ] prior written consent.
(ii) Notwithstanding
Section 6.3(b)(i), upon [ ] written request with respect to any Product Infringement, [ ] shall
use Commercially Reasonable Efforts to obtain [ ] to have the right to bring and control any legal action to
enforce the Licensed Patents against such Product Infringement, or negotiate and enter into any settlement with respect
thereto, at its own expense and as it reasonably and in good faith determines appropriate. If such permission or
amendment is obtained from [ ] and [ ] does not bring such legal action, or commence negotiations to
enter into a settlement with respect to such Product Infringement, by a date to be reasonably negotiated and agreed upon in
good by the Parties in conjunction with the negotiation of [ ], which date shall not be any later than the earlier
of (i) the date that is [ ] ([ ]) [ ] after the notice provided pursuant to
Section 6.3(a) or (ii) the date that is [ ] ([ ]) [ ] prior to the applicable
expiration date for the initiation of such action under applicable Law, [ ] acknowledges that either
[ ] shall have the right to bring and control any legal action to enforce the Licensed Patents against such
Product Infringement, or enter into any settlement thereof, at its own expense as it reasonably determines appropriate after
providing [ ] a reasonable opportunity for consultation with respect thereto, provided that in such event
[ ] shall not, and shall use Commercially Reasonable Efforts to ensure that [ ] does not, enter into
any settlement of any Product Infringement, or make any admissions or assert any position in such claim, suit, proceeding, or
threat of any of the foregoing with respect to any Product Infringement, in a manner that would materially and adversely
affect the manufacture, use, or sale of any Product in the Field in the Territory, without [ ] prior written
consent. [ ] agrees not to enter into any settlement of any Product Infringement, or make any admissions or assert
any position in such claim, suit, proceeding, or threat of any of the foregoing with respect to any Product Infringement, in
a manner that would adversely affect any Product or [ ] , or the manufacture, use, or sale of any Product or
[ ], within or outside the Territory, without the prior written consent of [ ].
(c) Cooperation.
At the request and, subject to the cost-sharing obligation set forth in Section 6.3(b)(i), if applicable, expense of the
Party bringing the action under Section 6.3(b) above (or, in the case of any such action brought by [ ],
[ ]), the other Party shall provide reasonable assistance in connection therewith, including by executing
appropriate documents, cooperating in discovery and joining as a party to the action if required. In connection with any such
proceeding, the Party bringing the action under Section 6.3(b) (or, in the case of any such action brought by
[ ], [ ]) shall keep the other Party reasonably informed on the status of such action and shall not
enter into any settlement (i) admitting the invalidity of, or otherwise impairing the other Party’s rights in, any
Licensed Patent without the prior written consent of the other Party (not to be unreasonably withheld), provided that the
foregoing shall not apply to any Product Infringement action or settlement brought or entered into by [ ], or
(ii) admitting the invalidity of, or that would reasonably be anticipated, at the time such decision is made, to
otherwise impair [ ] rights in, any corresponding Patent outside the Territory without [ ] prior
written consent. In furtherance of the foregoing, the Parties shall cooperate in good faith to exchange information on a
reasonably periodic basis with respect to the prosecution and maintenance of the Licensed Patents and the corresponding
Patents owned or Controlled by Eyenovia outside the Territory.
(d) Recovery.
The enforcing Party shall be solely responsible for any cost and expenses incurred by such Party or, pursuant to the first
sentence of Section 6.3(c), the other Party, as a result of such enforcement action. If Eyenovia recovers monetary
damages in any enforcement action with respect to, or receives any amounts in settlement of, any Product Infringement, such
recovery shall first be allocated to reimbursing the Parties’ costs and expenses incurred with respect thereto on a pro
rata basis, with the remaining portion thereof being allocated [ ] percent ([ ]%) to Eyenovia and [ ] percent ([ ]%) to
Arctic Vision, with Arctic Vision being paid such amount within [ ] ([ ]) [ ] after
Eyenovia’s receipt thereof, provided that, for clarity, Eyenovia shall not receive, nor be obligated to share with
Arctic Vision, any amounts recovered or received by [ ] with respect to any Product Infringement. If Arctic Vision
is the enforcing Party and recovers monetary damages in any enforcement action with respect to, or receives any amounts in
settlement of, any Product Infringement under Section 6.2(b)(ii), such recovery shall first be allocated to reimbursing
the Parties’ costs and expenses incurred with respect thereto on a pro rata basis, with the remaining portion thereof
being allocated [ ] percent ([ ]%) to Arctic Vision and [ ] percent ([ ]%) to Eyenovia, with Eyenovia being paid such amount
within [ ] ([ ]) [ ] after Arctic Vision’s receipt thereof.
(e) Other
Infringement. Except for Product Infringement as set forth above, each Party shall have
the exclusive right to enforce its own Patents against any infringement anywhere in the world.
6.4 Defense
of Licensed Patents. In the event that a Party receives notice of any claim alleging the invalidity or unenforceability of
any Licensed Patent in the Territory, such Party shall bring such claim to the attention of the other Party, including all relevant
information in its possession related to such claim. The Parties, through the JSC, shall discuss such claim. Where such allegation
is made in an opposition, reexamination, interference, or other patent office proceeding or a declaratory judgement action, then
the provisions of Section 6.2 shall apply to determine the Parties’ respective rights and obligations with respect
to such allegation; provided however that if a Party wishes to bring an infringement claim to enforce the Licensed Patent with
respect to a Product Infringement, then the provisions of Section 6.3 shall apply to determine the Parties’ respective
rights and obligations with respect thereto. Each Party shall provide to the Party defending any Licensed Patent in the Territory
under this Section 6.4 reasonable assistance in such defense, at such defending Party’s request and expense. The defending
Party shall keep the other Party reasonably informed of the status and progress of such efforts and shall reasonably consider
the other Party’s comments on any such efforts. Without the prior written consent of the other Party (not to be unreasonably
withheld), neither Party shall enter into any settlement of any claim, suit, or action that it defended under this Section 6.4
that admits the invalidity or unenforceability of any Licensed Patent or otherwise materially adversely impacts the other Party’s
interest therein. Notwithstanding anything to the contrary, Arctic Vision shall not (i) have any rights to defend any Licensed
Patent, except to the extent provided in Section 6.2, or (ii) enter into any settlement of any claim, suit, or action
that it defended under this Section 6.4 that admits the invalidity or unenforceability of any Patent outside the Territory
which corresponds to any Licensed Patent, or otherwise adversely impacts [ ] or any Licensed Patent or corresponding Patent outside
the Territory (including any reduction in claim scope), without, in the case of clause (ii), Eyenovia’s prior written consent.
In furtherance of the foregoing, the Parties shall cooperate in good faith to exchange information on a reasonably periodic basis
with respect to the prosecution and maintenance of the Licensed Patents and the corresponding Patents owned or controlled by Eyenovia
outside the Territory.
6.5 Defense
of Third Party Claims. If a claim is brought against a Party or an Affiliate thereof by
a Third Party alleging infringement of a Patent of such Third Party by the Development, manufacture, or Commercialization of the
Product in the Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, the Parties
shall use reasonable good faith efforts to agree on and enter into an “common interest agreement” wherein the Parties
agree to their shared, mutual interest in the outcome of such potential dispute, and thereafter, the Parties shall promptly meet
to consider the claim or assertion and the appropriate course of action. Each Party shall be entitled to represent itself in any
litigation to which it is a party, at its own expense, unless otherwise agreed upon by the Parties or as otherwise set forth in
this Agreement.
6.6 Trademarks.
(a) Product
Trademarks. Eyenovia or its Affiliates may develop and adopt trademarks, including
trade names, trade dresses, branding, and logos, to be used with respect to the Products (such trademarks, trade names, trade
dresses, branding, and logos developed thereby, other than those representing Eyenovia or its Affiliates generally, including
those set forth on Exhibit E, “Eyenovia Product Marks”), and Eyenovia and its Affiliates shall
own all Eyenovia Product Marks throughout the world and all goodwill in the Eyenovia Product Marks shall accrue to Eyenovia
and its Affiliates. If Arctic Vision wishes to develop its own trademarks, including trade names, trade dresses, branding,
and logos, for any Products in the Territory that are not Eyenovia Product Marks (such trademarks, trade names, trade
dresses, branding, and logos, other than those representing Arctic Vision or its Affiliates generally, the “AV
Product Marks”; the Eyenovia Product Marks and/or AV Product Marks, “Product Marks”), Arctic
Vision shall have the right to develop and select such AV Product Marks as may be available for registration and marketing of
such Product(s) in the Territory. Eyenovia shall be responsible for, but prior to the initiation of the first
Registration Trial of a Product in the Territory shall not have any obligation with respect to, the registration,
maintenance, defense and enforcement of the Eyenovia Product Marks in the Territory using counsel reasonably acceptable to
Arctic Vision at Arctic Vision’s expense (and Arctic Vision shall reimburse Eyenovia for any such expense within
[ ] ([ ]) [ ] after any invoice received therefor from Eyenovia that is not reasonably
disputed in good faith), and Arctic Vision shall be responsible for the registration, maintenance, defense and enforcement of
the AV Product Marks in the Territory using counsel mutually reasonably acceptable to Eyenovia. Following the initiation of
the first Registration Trial of a Product in the Territory, Eyenovia shall, upon written notice from Arctic Vision with
respect to any Eyenovia Product Mark reasonably selected by Arctic Vision for use in the Territory with respect to such
Product, use Commercially Reasonable Efforts to register, maintain, and defend such Eyenovia Product Mark, at Arctic
Vision’s expense. Each Party shall keep the other Party informed of material progress with regard to the registration,
prosecution, maintenance and defense, if any, of such Party’s Product Marks in the Territory, including content,
timing, and jurisdiction of the filing of such Product Marks in the Territory, sufficiently in advance for the other Party to
be able to review any material documents, and the filing Party shall consult with, and consider in good faith the requests and
suggestions of, the other Party with respect to strategies for filing, prosecuting and defending such Product Marks in the
Territory.
(b) Trademark
License.
(i) Arctic
Vision shall have the right, but not the obligation, to use the Eyenovia Product Marks to Commercialize the Products in the Territory.
Eyenovia hereby grants to Arctic Vision a limited, royalty-free license to use the Eyenovia Product Marks in connection with the
Commercialization of the Products in the Territory under this Agreement. All use of the Eyenovia Product Marks shall comply with
applicable Laws and shall be subject to Eyenovia’s prior review and approval, such approval not to be unreasonably withheld,
conditioned, or delayed.
(ii) Arctic
Vision shall comply with all applicable Laws and regulations pertaining to the proper use and designation of the Eyenovia Product
Marks in connection with the Commercialization of the Products in the Territory. Additionally, Arctic Vision shall use Commercially
Reasonable Efforts to:
(1) after
receipt of a written request from Eyenovia, comply with the reasonable requirements of Eyenovia as to the form, manner, scale and
context of use of the Eyenovia Product Marks, the use of the statements to accompany them, as well as the appearance of the Eyenovia
Product Marks
(2) on
containers, packaging and related marketing and promotional materials to be used for Product; and
(3) include,
on any item which bears an Eyenovia Product Mark, a statement identifying Eyenovia as the owner of such Eyenovia Product Mark and
stating that Arctic Vision is an authorized user of such Eyenovia Product Mark;
(iii) Arctic
Vision shall not take any action that it knows is, or would reasonably be anticipated to be, inconsistent with Eyenovia’s
or its Affiliates’ ownership of the Eyenovia Product Marks. Any benefits (including good will) accruing from the use of the
Eyenovia Product Marks under this Agreement shall automatically vest in Eyenovia and its Affiliates. Arctic Vision shall not form
any combination trademarks or trade names with any Eyenovia Product Marks.
Article 7
CONFIDENTIALITY
7.1 Confidentiality
Obligations. Except to the extent expressly authorized by this Agreement or
otherwise agreed in writing by the Parties, each Party agrees that, during the Term of this Agreement and for
[ ] ([ ]) [ ] thereafter, it shall keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any
rights or the performance of any obligations hereunder) any Confidential Information of the other Party.
7.2 Exceptions.
The obligations set forth in Section 7.1 shall not apply to any information that the receiving Party can demonstrate that
such information:
(a) is
known by the receiving Party at the time of its receipt without an obligation of confidentiality, and not through a prior disclosure
by the disclosing Party, as documented by the receiving Party’s business records;
(b) is
in the public domain before its receipt from the disclosing Party, or thereafter enters the public domain other than through the
receiving Party’s breach of the confidentiality obligations set forth herein;
(c) is
subsequently disclosed to the receiving Party, without obligation of confidentiality, by a Third Party who may lawfully do so and
is not under an obligation of confidentiality to the disclosing Party; or
(d) is
developed by the receiving Party independently and without use of, or reference to, any Confidential Information of the disclosing
Party, as documented by the receiving Party’s business records.
Any combination of features
or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or
available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle
of operation are published or available to the general public or in the rightful possession of the receiving Party.
7.3 Authorized
Disclosures. Notwithstanding anything to the contrary herein, a Party may disclose the
other Party’s Confidential Information to the extent:
(a) such
disclosure is reasonably necessary: (i) for the filing, prosecution, enforcement, and defense of Patents as contemplated by
this Agreement; (ii) in connection with regulatory filings for a Product or any component thereof; (iii) for prosecuting
or defending litigation as contemplated by this Agreement; or (iv) to its and its Affiliates’ employees, consultants,
contractors, and agents, in each case on a need-to-know basis in connection with the exercise of its rights or the performance
of its obligations under this Agreement, including the Development, manufacture, or Commercialization of any Product, or any component
thereof, in accordance with the terms of this Agreement;
(b) such
disclosure is reasonably necessary: (i) to such Party’s or its Affiliates’ directors, attorneys, independent
accountants, or financial advisors for the purpose of enabling such directors, attorneys, independent accountants, or
financial advisors to provide advice to such Party; or (ii) to actual or potential investors, lenders, investment
bankers, acquirors, acquisition or merger targets, Sublicensees, Subcontractors, Third Party Distributors, Other
Licensees, and other financial or business partners for the purpose of evaluating or carrying out an actual or potential
investment, loan, acquisition, merger, collaboration, license, strategic partnership, or other business relationship;
provided that in each such case on the condition that such recipients are bound by confidentiality and non-use obligations
substantially consistent with those contained in this Agreement;
(c) such
disclosure is required by applicable Laws or judicial or administrative process (including regulations promulgated by securities
exchanges), provided that in such event such Party shall, except where impracticable, give reasonable advance notice to the other
Party of such disclosure, use diligent efforts to secure confidential or protective treatment of such Confidential Information
reasonably consistent to those such Party would use to protect its own confidential information of a similar nature, but in no
event less than reasonable efforts, and cooperate with the other Party, as reasonably requested thereby, in seeking confidential
or protective treatment of such information.
Any information disclosed
pursuant to Section 7.3 shall remain Confidential Information and subject to the restrictions set forth in this Agreement,
including the foregoing provisions of this Article 7.
7.4 Publications.
(a) Review.
Each Party shall have the right to review and comment on any material proposed for presentation or publication by the other
Party regarding results of such other Party’s Development activities during the Term with respect to the Products,
whether by oral presentation, manuscript, or abstract. Before any such material is submitted for publication, or presentation
of any such material is made, the publishing Party shall deliver an English-language summary, and an original-language
original, of the material proposed for disclosure to the other Party, at least [ ] ([ ]) [ ]
for oral presentations or abstracts or [ ] ([ ]) [ ] for manuscripts, prior to submitting the
material to a publisher or initiating any other disclosure, or as close to these time frames as reasonably possible. The
reviewing Party shall review any such material and give its comments to the publishing Party within [ ]
([ ]) [ ] for oral presentations or abstracts and [ ] ([ ]) [ ] for
manuscripts after the receipt of such material, provided that the reviewing Party shall make reasonable efforts to review
such materials and abstracts and return such items as soon as practicable to the publishing Party with appropriate comments,
if any. Subject to Section 7.4(b), and without limitation of a Party’s obligations under Section 7.1, as
modified by Sections 7.2 and 7.3, following the expiration of the applicable time period for review, the publishing Party
shall be free to submit such proposed manuscript for publication or presentation materials for public disclosure, and does
not need to follow this process for subsequent publications or presentations of the same data or other
information.
(b) Delays
in Publication. If the reviewing Party notifies the publishing Party within the
applicable time period set forth in subsection (a) above that such publication or presentation, in the reviewing
Party’s reasonable judgment (i) contains an Invention for which the reviewing Party desires to obtain patent
protection, the publishing Party shall delay such publication or presentation for a period of up to [ ]
([ ]) [ ] (or such other time period agreed by the Parties in writing) to permit the preparation and
filing of a patent application for such Invention, or (ii) contains any Confidential Information of the reviewing Party,
or could be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by
the reviewing Party to the publishing Party, the Parties shall attempt to agree on revisions to the applicable disclosure so
as to preserve both the commercial value of such Confidential Information and the scientific merit of such disclosure, and no
publication or presentation shall be made by the publishing Party until the Parties agree on such revisions (such agreement
not to be unreasonably withheld, conditioned, or delayed) or the Confidential Information of the reviewing Party is
removed.
7.5 Publicity.
(a) The
Parties have agreed on language of a joint press release announcing this Agreement, which is attached hereto as Exhibit F,
to be issued by the Parties promptly after the Effective Date. Subject to the rest of this Section 7.5, no disclosure of the
terms of this Agreement may be made by either Party, and, except as permitted under Section 6.6 or 10.3(d), neither Party
shall use the name, trademark, trade name, or logo of the other Party, its Affiliates, or their respective employee(s) in
any publicity, promotion, news release, or disclosure relating to this Agreement or its subject matter, without the prior express
written permission of the other Party, except that is, based on the advice of the disclosing Party’s counsel, required by
Law (including the rules of a securities exchange on which the securities of the disclosing entity are listed or to which
an application for listing has been submitted). Following the initial joint press release announcing this Agreement, either Party
shall be free to disclose or publicize, without the other Party’s prior written consent, the existence of this Agreement,
the identity of the other Party, and those terms of the Agreement which have already been publicly disclosed in accordance herewith.
(b) A
Party may disclose this Agreement and its terms in securities filings with the Securities Exchange Commission or other
Government Authorities to the extent, based on the advice of the disclosing Party’s counsel, such disclosure is
required by Law (or rules of a securities exchange on which the securities of the disclosing entity are listed or to
which an application for listing has been submitted) after complying with the procedure set forth in this Section 7.5.
In such event, the Party seeking such disclosure will prepare a proposed redacted version of this Agreement, and the other
Party agrees to promptly (and in any event, no less than [ ] ([ ]) [ ] after receipt of such
proposed redactions) give its input in a reasonable manner in order to allow the Party seeking disclosure to file the
redacted version of the Agreement within the time lines proscribed by applicable Laws.
(c) Each
Party acknowledges that the other Party may be legally required to make public disclosures of certain material developments or
material information generated under this Agreement and agrees that each Party may make such disclosures as required by Law or
rules of a securities exchange on which the securities of the disclosing entity are listed (or to which an application for
listing has been submitted).
7.6 Prior
CDA. This Agreement supersedes the Confidentiality Agreement between the Parties
dated [ ] (the “Prior CDA”) with respect to information disclosed thereunder, provided that,
notwithstanding anything to the contrary, the standstill restrictions in Section 6 of the Prior CDA shall remain in
effect in accordance with the terms therein. All information disclosed by a Party or its Affiliate under the Prior CDA shall
be deemed Confidential Information of such Party under this Agreement and shall be subject to the terms of this
Article 7.
7.7 Equitable
Relief. Each Party acknowledges that a breach of this Article 7 may not reasonably
or adequately be compensated in damages in an action at law and that such a breach may cause the other Party irreparable injury
and damage. Therefore each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under
this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any breach
of the obligations relating to Confidential Information set forth in this Agreement.
Article 8
REPRESENTATIONS AND WARRANTIES
8.1 Mutual
Representations and Warranties. Each Party hereby represents, warrants, and covenants
(as applicable) to the other Party, as of the Effective Date, as follows:
(a) it
is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which
it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and
to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the
right to grant the licenses granted by it hereunder;
(b) (i) it
has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, including,
without limitation, the right to grant the licenses granted by it hereunder; (ii) it has taken all necessary corporate action
on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder;
and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and
binding obligation of such Party that is enforceable against it in accordance with its terms;
(c) the
execution, delivery and performance of this Agreement will not cause or result in a violation of any applicable Law or of its charter
documents, and it is not a party to any agreement that would materially prevent it from granting the rights granted to the other
Party under this Agreement or performing its obligations under the Agreement; and
(d) it
shall comply in all material aspects with all applicable Laws in the course of performing its obligations and exercising its rights
under this Agreement.
8.2 Additional
Representations and Warranties of Eyenovia. Eyenovia hereby represents and warrants to
Arctic Vision that, as of the Effective Date:
(a) Eyenovia
solely owns, or is the sole and exclusive licensee of, the entire right, title, and interest in and to the Licensed Technology
in the Territory in the Field with respect to the Products and the components thereof, free and clear of all liens, except as otherwise
set forth in the Senju License Agreement or this Agreement, and has the right to grant to Arctic Vision the licenses and rights
as purported to be granted hereunder;
(b) Eyenovia
has not granted, and will not grant during the Term, any license or right in the Licensed Technology that are inconsistent with
the licenses and rights granted to Arctic Vision under this Agreement;
(c) Eyenovia
and its Affiliates have not received any written notice from any Third Party asserting or alleging that the research, Development,
or manufacture of either Product infringed or misappropriated the intellectual property rights of such Third Party;
(d) to
Eyenovia’s knowledge, the Development, manufacture, and Commercialization of the Products in the Territory can be carried
out as contemplated by this Agreement without infringing or misappropriating any intellectual property rights of any Third Party,
provided that, for purposes of this clause (d), Arctic Vision acknowledges that Eyenovia has not performed (or had performed on
its behalf) any patent or freedom to operate searches or analyses with respect to the Development, manufacture, and Commercialization
of the Products in the Territory and there shall be no implied duty to have performed any such search or analysis for purposes
hereof;
(e) there
are no pending or, to the knowledge of Eyenovia and its Affiliates, alleged or threatened, adverse actions, suits, proceedings,
or claims against Eyenovia or its Affiliates involving the Licensed Technology, either Product, or any component of either Product;
(f) Eyenovia
and its Affiliates are not aware of any infringement or misappropriation of any Licensed Technology by any Third Party;
(g) Exhibit B
includes all Patents Controlled by Eyenovia and its Affiliates as of the Effective Date that Cover the Products in the Territory
(including composition of matter and methods of making and using the Products);
(h) Eyenovia
or its Affiliates possess (either directly or via a Third Party that Eyenovia or its Affiliate has the right to require to provide
to Arctic Vision) the Licensed Know-How that is necessary or reasonably useful to Develop, manufacture, and Commercialize each
Product as such activity is being conducted by Eyenovia or its Affiliates as of the Effective Date outside the Territory;
(i) there
is no pending or, or to the knowledge of Eyenovia and its Affiliates, alleged or threatened, re-examination, opposition, interference,
or litigation, or any written communication alleging that any Licensed Patent is invalid or unenforceable anywhere in the world;
(j) all
application, registration, maintenance, and renewal fees in respect of the Licensed Patents due prior to the Effective Date have
been paid and all necessary documents and certificates for the purpose of maintaining the issued Patents within the Licensed Patents
due prior to the Effective Date have been filed with the applicable Government Authority;
(k) Eyenovia
and its Affiliates (including, to the knowledge of Eyenovia and its Affiliates, their contractors) have complied with all applicable
Laws in connection with the Development of the Products, and have not used any employee, consultant, or contractor who has been
debarred by any Regulatory Authority, or to its knowledge, is the subject of a debarment proceeding by any Regulatory Authority;
and
(l) Eyenovia
has provided Arctic Vision with complete and accurate copies of all Regulatory Materials, including INDs and device master files,
held by Eyenovia in the Territory for each Product and the Optejet Dispenser Base, respectively;
(m) all
Regulatory Materials filed in the Territory by Eyenovia with respect to each Product and the Optejet Dispenser Base were, at the
time of filing, true, complete, and accurate;
(n) neither
Eyenovia, any Affiliate thereof, nor, to Eyenovia’s and its Affiliates’ knowledge, any Third Party holds any IND or
Regulatory Approval in the Territory for any Product or any component thereof, nor submitted an application for any of the foregoing
to any Regulatory Authority in the Territory;
(o) Eyenovia
has not received any written notice from any Regulatory Authority or other Government Authority commencing or threatening withdrawal
of any active IND for either Product held by Eyenovia;
(p) all
Products manufactured by Eyenovia for use in clinical trials of such Product in the Territory have been manufactured in accordance
with cGMPs;
(q) all
information provided by Eyenovia or its Affiliates to Arctic Vision for due diligence purposes in relation to this Agreement is,
to the knowledge of Eyenovia and its Affiliates with respect to all Licensed Know-How generated by Third Parties, complete and
accurate in all material respects. Without limiting the foregoing, Eyenovia and its Affiliates have made available to Arctic Vision
for review all material Data for each Product and all other material information (including relevant correspondence with Regulatory
Authorities) in the possession and Control of Eyenovia or its Affiliates relating to each Product; and
(r) it
does not plan to file for insolvency protection under Bankruptcy Laws for at least [ ] ([ ])
[ ] after the Effective Date and it is not aware of any fact that would cause a Third Party to initiate any such
proceedings against it.
8.3 Eyenovia
Representations, Warranties, and Covenants Regarding the Senju License Agreement.
(a) Eyenovia
shall make any and all payments that become due under the Senju License Agreement as a result of any activity under this Agreement,
whether by or on behalf of Eyenovia or by Arctic Vision or its Affiliate or Sublicensee, in each case in accordance with the terms
of the Senju License Agreement.
(b) Eyenovia
is, as of the Effective Date, in compliance in all material respects with the Senju License Agreement, and, to Eyenovia’s
knowledge, the other party to the Senju License Agreement is, as of the Effective Date, not in breach or default in any respect
of the Senju License Agreement pertaining to the Product.
(c) In
the event that Eyenovia receives a notice or other communication alleging it is in breach (including a notice or other
communication threatening termination) of the Senju License Agreement, Eyenovia shall promptly Arctic Vision with a copy of
such notice. Without limiting any other right or remedy of Arctic Vision under this Agreement and in order to prevent,
ameliorate, mitigate, or cure a breach of the Senju License Agreement, in the event that Eyenovia fails to perform any of its
obligations under the Senju License Agreement, which failure is not cured within [ ] ([ ]) [ ]
after written notice thereof from Arctic Vision, Arctic Vision may perform such obligation on behalf of Eyenovia, provided
that Arctic Vision shall be entitled to credit any reasonable, documented out-of-pocket costs it incurs in performing any
such obligation against any future payments otherwise owed to Eyenovia under this Agreement. This Agreement sets forth the
obligations of the Parties inter se, and nothing in this Agreement (including any standard of effort set forth herein)
shall limit or modify the obligations of Eyenovia under the Senju License Agreement.
(d) Eyenovia
shall not agree to any amendment or other modification (including termination) to the Senju License Agreement in a manner that
would, at the time of such amendment, modification, or termination, reasonably be anticipated to adversely affect the rights sublicensed
to Arctic Vision under this Agreement without Arctic Vision’s prior written consent, such consent not to be unreasonably
withheld or delayed.
8.4 Arctic
Vision Representations, Warranties, and Covenants Regarding the Senju License Agreement.
Arctic Vision represents and warrants that, as of the Effective Date, neither it nor any of its Affiliates is a Senju Competitor.
Notwithstanding anything to the contrary, Arctic Vision shall not, and shall ensure that Sublicensees and its Affiliates do not,
(i) sublicense any rights granted hereunder to any Third Party that is a Senju Competitor at the time such sublicense is granted,
(ii) permit any Sublicensee to sublicense its rights to any Third Party that is a Senju Competitor at the time such sublicense
is granted, or (iii) indirectly or directly sell or otherwise provide, or permit any Affiliate of Arctic Vision or Sublicensee
to indirectly or directly sell or otherwise provide, any Product to any Third Party that is a Senju Competitor.
8.5 Disclaimer.
EXCEPT AS EXPRESSLY STATED HEREIN, NO OTHER REPRESENTATIONS OR WARRANTIES WHATSOEVER, INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH OTHER
REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. BOTH PARTIES
UNDERSTAND THAT THE PRODUCTS ARE THE SUBJECT OF ONGOING RESEARCH AND DEVELOPMENT AND NEITHER PARTY CAN ASSURE THAT ANY
PRODUCT CAN BE SUCCESSFULLY DEVELOPED AND COMMERCIALIZED.
Article 9
INDEMNIFICATION; LIABILITY
9.1 Indemnification
by Eyenovia. Eyenovia shall indemnify, defend, and hold harmless Arctic Vision, its Affiliates,
and their respective officers, directors, agents and employees (“Arctic Vision Indemnitees”) from and against
any and all Third Party suits, claims, actions, or demands (each, a “Claim”) against an Arctic Vision Indemnitee,
and all associated liabilities, expenses, and/or losses, including reasonable legal expenses and attorneys’ fees (collectively
“Losses”), in each case arising out of or caused by:
(a) the
negligence, willful misconduct, or failure to comply with applicable Law of any Eyenovia Indemnitee;
(b) Eyenovia’s
or any of the Eyenovia Indemnitees’ breach of this Agreement, including any representation, warranty, or covenant made by
Eyenovia hereunder; or
(c) the
Development, manufacture, or Commercialization of any Product by or on behalf of Eyenovia or its Affiliates or Other Licensees,
including any Claim alleging that any of such activities infringes or misappropriates any Third Party’s intellectual property
or other rights;
except in each
case to the extent (i) such Claims result from any circumstances set forth in clause (a), (b), or (c) of Section 9.2
or (ii) Arctic Vision is obligated to indemnify the Eyenovia Indemnitee for such Claim.
9.2 Indemnification
by Arctic Vision. Arctic Vision shall indemnify and hold Eyenovia, its Affiliates, and
their respective officers, directors, agents and employees (“Eyenovia Indemnitees”) from and against any and
all Losses in each case resulting from any Third Party Claims against an Eyenovia Indemnitee arising out of or caused by:
(a) the
negligence or willful misconduct, or failure to comply with applicable Law of any Arctic Vision Indemnitee;
(b) Arctic
Vision’s or any of the Arctic Vision Indemnitees’ breach of this Agreement, including any representation, warranty,
or covenant made by Arctic Vision hereunder; or
(c) the
Development, manufacture, or Commercialization of any Product by or on behalf of Arctic Vision, its
Affiliates, or Sublicensees, including any Claim alleging that any of such activities infringes or misappropriates any Third
Party’s intellectual property or other rights;
except in each case, to the extent (i) such Claims result
from any circumstances set forth in clause (a), (b), or (c) of Section 9.1 or (ii) Eyenovia is obligated to
indemnify the Arctic Vision Indemnitee for such Claim.
9.3 Indemnification
Procedure. If either Party is seeking indemnification under Sections 9.1 or 9.2 (the “Indemnified
Party”), it shall inform the other Party (the “Indemnifying Party”) in writing of the Claim giving
rise to the obligation to indemnify pursuant to such Section as soon as reasonably practicable after receiving notice of the
Claim. The Indemnifying Party shall have the right to assume the defense of any such Claim for which it is obligated to indemnify
the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party and the Indemnifying Party’s insurer
as the Indemnifying Party may reasonably request, and at the Indemnifying Party’s cost and expense. The Indemnified Party
shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any Claim that has been
assumed by the Indemnifying Party. Neither Party shall have the obligation to indemnify the other Party in connection with any
settlement made without the Indemnifying Party’s written consent, which consent shall not be unreasonably withheld or delayed.
The Indemnifying Party may not settle any Claim without the prior written consent of the Indemnified Party, such consent shall
not be unreasonably withheld, conditioned, or delayed; provided, however, that the Indemnifying Party shall not be required to
obtain such consent if the settlement: (a) involves only the payment of money and does not cause the Indemnified Party to
be subject to any non-indemnified liability or injunctive or other similar type of relief; (b) does not require an admission
by the Indemnified Party; and (c) does not adversely affect the intellectual property rights Controlled by, or the rights
or licenses granted under this Agreement to, the Indemnified Party (or its Affiliate). If the Parties cannot agree as to the application
of Section 9.1 or 9.2 as to any Claim, pending resolution of the dispute pursuant to Section 11.7, the Parties may conduct
separate defenses of such Claims, with each Party retaining the right to claim indemnification from the other Party in accordance
with Section 9.1 or 9.2 upon resolution of the underlying Claim.
9.4 Mitigation
of Loss. Each Indemnified Party shall use Commercially Reasonable Efforts to take, and
shall procure that its Affiliates use Commercially Reasonable Efforts to take, such reasonable steps and action as are reasonably
necessary, or as the Indemnifying Party may reasonably request in writing, in order to mitigate any Claims (or potential associated
Losses) subject to indemnification under this Article 9, provided that the Indemnifying Party shall bear any material, reasonable,
documented costs incurred by the Indemnified Party with respect to any such steps or actions to the extent such costs constitute
Losses subject to indemnification pursuant to Section 9.1 or 9.2. Nothing in this Agreement shall or shall be deemed to relieve
any Party of any common law or other duty under applicable Law to mitigate any losses incurred by it.
9.5 Limitation
of Liability. NEITHER PARTY SHALL BE LIABLE
TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO THIS
AGREEMENT, OR DAMAGES FOR LOSS OF PROFIT, LOST SALES, OR LOST OPPORTUNITY IN CONNECTION WITH THIS AGREEMENT, IN
EACH CASE REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 9.1 OR 9.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF
CONFIDENTIALITY OBLIGATIONS IN Article 7 OR EXCLUSIVITY OBLIGATIONS UNDER SECTION 2.6.
9.6 Insurance.
Each Party, at its own expense, shall maintain commercial general liability insurance and product liability and other
appropriate insurance, in amounts consistent with sound business practice in its respective territory and reasonable in light
of its obligations under this Agreement. Each Party shall maintain such insurance for the period commencing promptly after
the Effective Date until [ ] ([ ]) [ ] after the Term. Each Party shall provide a certificate
of insurance evidencing such coverage to the other Party upon request. It is understood that such insurance shall not be
construed to create any limit of either Party’s obligations or liabilities with respect to its indemnification
obligations under this Agreement.
Article 10
TERM AND TERMINATION
10.1 Term.
The term of this Agreement (“Term”) shall commence upon the Effective Date and continue until terminated pursuant
to Section 10.2.
10.2 Termination.
(a) Termination
by Arctic Vision for Convenience. At any time during the Term, Arctic Vision may terminate
this Agreement in its entirety or on a Product-by-Product or Jurisdiction-by-Jurisdiction basis, for any or no reason, upon ninety
(90) days’ written notice to Eyenovia, provided that, if Arctic Vision terminates this Agreement prior to its payment of
the amount due under Section 5.1, Arctic Vision shall, notwithstanding anything to the contrary, remain liable for such payment.
(b) Termination
for Material Breach.
(i) Each
Party shall have the right to terminate this Agreement immediately upon written notice to the other Party if such other Party materially
breaches this Agreement and has not cured such breach within ninety (90) days (or, in the event of a failure to pay, thirty (30)
days) after receipt from the non-breaching Party of written notice specifying the breach and requesting its cure; provided, however,
that if such breach (other than a payment breach) cannot be cured within such ninety (90)-day period, a Party will not have the
right to terminate pursuant to this Section 10.2(b)(i) if the breaching Party commences Commercially Reasonable Efforts
to cure such breach within such ninety (90)-day period and cures such breach within ninety (90) days after the initial ninety (90)
day period; and provided further that if the breaching Party is Arctic Vision and such material breach relates solely to one Product
under the Agreement (but not to all Products), then Eyenovia shall have the right to terminate this Agreement pursuant to this
Section 10.2(b) solely with respect to the Product to which such material breach relates.
(ii) If
the alleged breaching Party disputes in good faith the existence or materiality of a breach specified in a notice provided by the
other Party, and such alleged breaching Party provides the other Party notice of such dispute within thirty (30) days of notice
from the other Party of such breach, then the other Party shall not have the right to terminate this Agreement under Section 10.2(b) unless
and until an arbitral tribunal, in accordance with Section 11.7, has determined that the alleged breaching Party has materially
breached the Agreement and such Party fails to cure such breach within the applicable cure period set forth above following such
decision.
(c) Termination
for Insolvency.
(i) In
the event that either Party (i) files for protection under bankruptcy or insolvency laws, (ii) makes an assignment for
the benefit of creditors, (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property
that is not discharged within sixty (60) days after such filing, (iv) proposes or is a party to any dissolution or liquidation,
(v) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged
within sixty (60) days of the filing thereof, or (vi) admits in writing its inability generally to meet its obligations as
they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon
written notice to such Party.
(ii) All
rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of
Title 11 of the United States Code and other similar laws in any other jurisdiction outside of the Territory (collectively,
the “Bankruptcy Laws”), licenses of rights to “intellectual property” as defined under the
Bankruptcy Laws. If a case is commenced during the Term by or against a Party under Bankruptcy Laws then, unless and until this
Agreement is rejected as provided pursuant to such Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession)
and its successors and assigns (including a Title 11 trustee) shall perform all of the obligations in this Agreement intended
to be performed by such Party. If a case is commenced during the Term by or against a Party under the Bankruptcy Laws, this Agreement
is rejected as provided for under the Bankruptcy Laws, and the non-bankrupt Party elects to retain its rights hereunder as provided
for under the Bankruptcy Laws, then the Party subject to such case under the Bankruptcy Laws (in any capacity, including debtor-in-possession)
and its successors and assigns (including a Title 11 trustee), shall provide to the non-bankrupt Party copies of all Patents
and Know-How Controlled by the bankrupt Party necessary for the non-bankrupt Party to prosecute, maintain and enjoy its rights
under the terms of this Agreement. All rights, powers and remedies of the non-bankrupt Party as provided herein are in addition
to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including
the Bankruptcy Laws) in the event of the commencement of a case by or against a Party under the Bankruptcy Laws. In particular,
it is the intention and understanding of the Parties to this Agreement that the rights granted to the Parties under this Section 10.2
are essential to the Parties’ respective businesses and the Parties acknowledge that damages are not an adequate remedy.
10.3 Effect
of Termination. Upon termination of this Agreement, the following terms will apply (for
clarity, during the pendency of any dispute regarding material breach and/or any termination notice period with respect to such
Product, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all
of their respective obligations hereunder):
(a) Licenses.
Upon termination of this Agreement in its entirety, Arctic Vision’s licenses under Section 2.1 shall terminate. Upon
termination of this Agreement solely with respect to a Product (the “Terminated Product”) or Jurisdiction (the
“Terminated Jurisdiction”), Arctic Vision’s license under Section 2.1 shall terminate with respect
to such Terminated Product or Terminated Jurisdiction and this Agreement shall continue in full force and effect with respect to
all other Products and other Jurisdictions not subject to termination.
(b) Sublicenses.
Upon any termination of this Agreement, whether in its entirety or with respect to a Product or Jurisdiction, all rights granted
to any Sublicensee under any rights subject to such termination (including any sublicenses thereto) shall, notwithstanding anything
to the contrary, terminate.
(c) Development
Wind-Down or Transition. If any clinical trials that were initiated by or on behalf of
Arctic Vision, any Affiliate thereof, or any Sublicensee prior to the termination of this Agreement are on-going as of the effective
date of termination of this Agreement in its entirety or with respect to a Product, Arctic Vision shall cooperate with Eyenovia
as reasonably requested thereby to wind-down such clinical trial(s) in an orderly fashion at the cost and expense of Arctic
Vision, unless terminated by Arctic Vision pursuant to Section 10.2(b); provided, however, that Arctic Vision shall consider
in good faith any request by Eyenovia to transition the sponsorship of any such ongoing clinical trial to Eyenovia or its designee.
If the Parties agree to transition sponsorship of any clinical trial of a Terminated Product(s) to Eyenovia or its designee,
Arctic Vision shall provide reasonable cooperation to Eyenovia and its designee(s) to facilitate, and the Parties shall use
reasonable efforts to effect, a reasonable, orderly, and prompt transition of the Development activities relating to the Terminated
Product(s) to Eyenovia and/or its designee(s) so that Eyenovia or its designee is able to assume responsibility for same
as of the effective date of termination. If this Agreement is terminated solely with respect to a Product or a Jurisdiction, then
the foregoing shall apply with respect to such Terminated Product or Terminated Jurisdiction. For clarity, nothing in this Section 10.3(c) shall
require Arctic Vision to create any new Know-How.
(d) Reversion.
Upon termination of this Agreement, in whole or in part, for any reason, the following shall apply with respect to the Product(s) and/or
Jurisdiction(s) subject to such termination:
(i) Eyenovia
shall have the right, exercisable within [ ] ([ ]) [ ] after termination, to request that
Arctic Vision provide Eyenovia with a list of all of the material information in Arctic Vision’s or its
Affiliates’ possession or control, and not previously provided to Eyenovia, concerning: AV Patents, AV Know-How, AV
Product Marks, Regulatory Approvals, MAAs, Regulatory Materials, AV Product-Related Materials, and AV Product Contracts, and
Arctic Vision’s and its Affiliates inventory of Products and components thereof (the “Reversion
List”). Arctic Vision shall provide the Reversion List to Eyenovia within [ ] ([ ]) [ ]after
receiving Eyenovia’s request therefor;
(ii) Within
[ ] ([ ]) [ ] after Arctic Vision’s provision to Eyenovia of the Reversion List, Eyenovia
shall indicate to Arctic Vision, in writing, which items of the Reversion List Eyenovia wishes to review in further detail
(the “Data Room Request”). Within [ ] ([ ]) [ ] after Arctic Vision’s
receipt of Eyenovia’s Data Room Request, Arctic Vision shall create a data room including the items specified in the
Data Room Request (the “Reversion Data Room”) and provide Eyenovia with reasonable access to such data
room.
(iii) To
the extent permitted by applicable Laws and the applicable Regulatory Authority(ies) and requested by Eyenovia in writing
within [ ] ([ ]) [ ] after Eyenovia receives access to the Reversion Data Room, Arctic Vision
shall transfer and assign to Eyenovia or its designee, at Eyenovia’s expense, all Regulatory Approvals, MAAs, and other
Regulatory Materials solely pertaining to the Products in the Territory, and all Data generated by Arctic Vision solely
pertaining to the Products, in each case, in Arctic Vision’s or its Affiliates’ Control and possession as of the
effective date of applicable termination. To the extent any Regulatory Approvals, MAAs, and other Regulatory Materials for,
in each case, the Products cannot be so transferred or do not solely relate to the Products, (A) Arctic Vision shall
cooperate with Eyenovia, as reasonably requested thereby and at Eyenovia’s expense, in preparing, filing, and obtaining
Regulatory Approvals, MAAs, and/or Regulatory Materials for the Products in the name of Eyenovia or its designee that are
equivalent to those that could not be so transferred and (B) the licenses granted under
Section 10.3(d)(iv) shall include a right of reference to all such Regulatory Approvals, MAAs, and/or Regulatory
Materials that could not be so transferred or do not solely relate to the Products (but such right of reference shall be
limited solely to reference in respect of the Products).
(iv) Effective
upon the effective date of termination of this Agreement in part or in its entirety, but subject to Section 2.6, Arctic
Vision shall grant, and hereby grants, to Eyenovia and its Affiliates a non-exclusive, royalty-bearing license under
(A) all AV Know-How actually incorporated by Arctic Vision into a Terminated Product, or any Product in the Terminated
Jurisdiction, as it exists as of the effective date of termination or otherwise necessary for the Development, manufacture
and/or Commercialization of a Terminated Product, or a Product in the Terminated Jurisdiction, as it exists as of the
effective date of termination, (B) all AV Patents necessary for the Development, manufacturing, and Commercialization of
each Terminated Product, or any Product in the Terminated Jurisdiction, as it exists as of the effective date of termination,
and (C) all AV Product Marks actually used in the Commercialization of any Terminated Product or in any Terminated
Jurisdiction as of the effective date of termination, in each case (A) (B), and (C) Controlled by Arctic Vision or
its Affiliates as of the effective date of such termination, to make, have made, use, sell, offer for sale, import, Develop,
and Commercialize the Terminated Products in the Territory or Products in the Terminated Jurisdiction, as applicable;
provided, however, that for the purposes of this Section 10.3(d)(iv), Arctic Vision shall not be deemed to Control any
AV Know-How or AV Patents the practice of which by Eyenovia, its Affiliates, or Other Licensees under the rights granted
under this Agreement would result in a payment being owed by Arctic Vision or any Affiliate thereof to any Third Party
pursuant to the terms of the agreement between Arctic Vision or any Affiliate thereof and such Third Party pursuant to which
rights in such AV Know-How or AV Patents were acquired, unless Eyenovia agrees, pursuant to the Reversion Terms, to be
responsible for such payments.
(v) To
the extent requested by Eyenovia in writing within [ ] ([ ]) [ ] after Eyenovia receives
access to the Reversion Data Room, Arctic Vision shall use Commercially Reasonable Efforts to assign AV Product Contracts to
Eyenovia, to the extent not prohibited by the terms thereof, or otherwise reasonably facilitate introductions between
Eyenovia and the applicable Third Party(ies).
(vi) To
the extent requested by Eyenovia in writing within [ ] ([ ]) [ ] after the effective date of
termination, Eyenovia shall have the right, but not the obligation, to purchase from Arctic Vision any or all usable
inventory of Products or components thereof in Arctic Vision’s or its Affiliates’ possession or control as of the
date of termination, at a transfer price equal to Arctic Vision’s and its Affiliates’ fully-burdened costs to
acquire such inventory plus shipping, handling, and storage costs incurred by Arctic Vision and its Affiliates with respect
thereto.
(vii) Reversion-Based
Consideration.
(1) In
exchange for Arctic Vision’s obligations set forth in Sections 10.3(d)(iii) and 10.3(d)(iv) above, Eyenovia
shall pay Arctic Vision milestones and/or royalties on sales of the Terminated Products on or after the effective date of
termination by Eyenovia or any of its Affiliates or (sub)licensees. The Parties shall use good faith efforts to negotiate and
agree upon commercially reasonable economic terms for such royalties and/or milestones, taking into account the circumstances
of termination (including any breach of this Agreement by Arctic Vision) and then current stage of the applicable Terminated
Product in the Territory (the “Reversion Terms”), within [ ] ([ ]) [ ] (or
such longer period of time agreed by the Parties) following the effective date of termination. If the Parties are unable to
agree on the Reversion Terms within such [ ] ([ ])-[ ] period (or such longer period agreed by
the Parties), such dispute shall be finally resolved pursuant to the dispute resolution procedures set forth on Exhibit G
pursuant to which the Expert (as defined therein) shall select the entirety of one Party’s proposed Reversion Terms to
the extent reasonably practicable, taking into consideration the circumstances of termination (including, if applicable any
uncured material breach of this Agreement by Arctic Vision or Eyenovia) and then current stage of the applicable Terminated
Product(s) in the applicable Jurisdiction(s) of the Territory. Notwithstanding anything to the contrary, in the
event the Reversion Terms are determined pursuant to Exhibit G and the Expert selects the Reversion Terms
proposed by Arctic Vision, Eyenovia shall have the right, upon written notice to Arctic Vision given within [ ]
([ ]) [ ] of the final determination of the Reversion Terms pursuant to Exhibit G, to
reject such terms. If Eyenovia provides such a written rejection within such time period, the licenses granted under
Section 10.3(d)(iv) shall automatically terminate, Arctic Vision shall not have any obligations under
Section 10.3(d)(iii), 10.3(d)(v), and 10.3(d)(vi), all assignments made to Eyenovia pursuant to Sections 10.3(d)(iii),
10.3(d)(v), and 10.3(d)(vi) shall be deemed null and avoid, and Eyenovia shall reimburse Arctic Vision for any
reasonable, documented, out-of-pocket and internal expenses incurred by Arctic Vision with respect to the process set forth
on Exhibit G that resulted in the selection of such Reversion Terms and any other reasonable, documented expenses
incurred by Arctic Vision pursuant to Sections 10.3(d)(iii), 10.3(d)(v), and 10.3(d)(vi).
(2) Notwithstanding
Section 10.3(d)(vii)(1) above, Eyenovia shall not have any payment obligations to Arctic Vision of any kind with respect
to Arctic Vision’s obligations, or any grant of rights or transfer of assets, under Sections 10.3(d)(iii) and 10.3(d)(iv),
and the proviso set forth in Section 10.3(d)(iv) shall not apply, to the extent necessary to enable Eyenovia to comply
with the last sentence of Section 4 of the First Senju Amendment without incurring any costs or expenses, provided that, notwithstanding
the foregoing, if Senju is granted any rights or assigned any assets that are granted or assigned under Sections 10.3(d)(iii) and
10.3(d)(iv), Eyenovia shall pay Arctic Vision [ ] percent ([ ]%) of the royalties paid to Eyenovia under the Senju License Agreement
with respect to sales of Products in the Field in the Territory following the grant of such rights or transfer of such assets.
(viii) Upon
termination of this Agreement solely with respect to a Product or a Jurisdiction and not in its entirety, the foregoing Sections
10.3(d)(iii)-10.3(d)(viii) shall apply with respect to the Terminated Product or Terminated Jurisdiction only.
10.4 Right
to Maintain License. Notwithstanding the foregoing, if, at any time following Arctic
Vision’s payment to Eyenovia of amounts totaling [ ] Dollars ($[ ]) or more under Section 5.2, Arctic Vision would
otherwise have the right to terminate this Agreement pursuant to Section 10.2(b) for Eyenovia’s uncured
material breach, then in lieu of such termination, Arctic Vision may elect, as its sole and exclusive remedy with respect to
such breach by Eyenovia (and in lieu of its right to terminate this Agreement with respect to such uncured breach), to
continue this Agreement in full force and effect upon written notice to Eyenovia given within [ ] ([ ])
[ ] after the cure period applicable under Section 10.2(b) with respect to such breach by Eyenovia, that
(a) Arctic Vision’s diligence obligations under Section 4.4 shall be deemed fully satisfied with respect to
such Product in such Jurisdiction, (b) any Milestone Payments under Section 5.2 that would have been due to
Eyenovia by Arctic Vision as a result of the achievement of a Milestone after such termination with respect to such Product
in such Jurisdiction shall each be reduced by [ ] percent ([ ]%), and (c) the Supply Price under Section 5.4, and
the royalty rates under Section 5.5(a), applicable to such Product in such Jurisdiction shall thereafter be reduced by [
] percent ([ ]%), provided that such reduction shall not in any event reduce the amount due to Eyenovia for the purchase of
such Product for such Jurisdiction to an amount less than [ ] percent ([ ]%) of Cost of Goods therefor.
10.5 Return
of Confidential Information. Upon expiration or termination of this Agreement in its
entirety for any reason, except to the extent that a Party obtains or retains the right to use the other Party’s
Confidential Information, each Party shall return or cause to be returned to the other Party or destroy (and certify such
destruction to such other Party) all Confidential Information and all substances or compositions of the other Party or its
Affiliates delivered or provided by or on behalf of such other Party, as well as any other material provided by or on behalf
of such other Party in any medium, in connection with this Agreement, except that each Party may retain one (1) copy of
all Confidential Information for its legal records.
10.6 Survival.
Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or
termination. Without limiting the foregoing, the following provisions shall survive the expiration or termination of this Agreement:
Articles 1, 7, 9, and 11 and Sections 2.3, 2.4, 2.8, 4.5(a)(ii), 4.5(b)(i) (with respect to the rights of Eyenovia), 5.8,
5.9, 5.10, 6.1, 8.4(b), 8.5, 10.3, 10.4, 10.5, 10.6, and 10.7.
10.7 Termination
Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether
or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies shall
remain available except as agreed to otherwise herein.
Article 11
GENERAL PROVISIONS
11.1 Force
Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted
under or breached this Agreement for failure or delay in performing any obligation under this Agreement, other than any failure
to pay (unless the force majeure directly affects the method of payment), to the extent such failure or delay is caused by or results
from causes beyond the reasonable control of the affected Party, which may include embargoes, war, acts of war (whether war be
declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire,
floods, earthquakes or other acts of God, or acts, omissions, or delays in acting by any Government Authority or the other Party.
The affected Party shall notify the other Party in writing of such force majeure circumstances as soon as reasonably practical
and shall promptly undertake and continue diligently all reasonable efforts necessary to cure such force majeure circumstances
or to perform its obligations in spite of the ongoing circumstances.
11.2 Assignment.
(a) Except
as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred
by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld, conditioned,
or delayed); provided, however, that either Party may assign or otherwise transfer this Agreement and its rights and obligations
hereunder without the other Party’s consent:
(i) in
connection with the transfer or sale of all or substantially all of the business or assets of such Party (or that portion thereof
relating to this Agreement) to a Third Party, whether by merger, consolidation, divesture, restructure, sale of stock, sale of
assets, or otherwise; or
(ii) to
an Affiliate, provided that if the entity to which this Agreement is assigned ceases to be an Affiliate of the assigning
Party, other than in connection with the transfer or sale of all or substantially all of the business or assets of such
Affiliate (or that portion thereof relating to this Agreement) to a Third Party, whether by merger, divesture, sale of stock,
sale of assets, or otherwise, the Agreement shall be automatically assigned back to the assigning Party or its successor
unless otherwise consented to in writing by the other Party (which consent shall not be unreasonably withheld, conditioned,
or delayed);
provided that, notwithstanding
anything to the contrary, Arctic Vision shall not be entitled to assign this Agreement to any Senju Competitor (as determined at
the time of the proposed assignment) without Eyenovia’s prior written consent to the extent expressly prohibited by the terms
of the Senju License Agreement. Arctic Vision shall promptly notify Eyenovia in writing of any Affiliate or Third Party to whom
this Agreement is assigned (which notice shall include the name of such assignee).
(b) Notwithstanding
anything to the contrary, all rights to Know-How, Patents, materials, and other intellectual property or assets (i) owned
or otherwise controlled by (A) a Third Party permitted assignee of a Party (or any of such Third Party’s pre-existing
affiliates) immediately prior to such assignment or (B) any Third Party that otherwise acquires all or substantially all of
the stock, assets, or business of a Party (or all or substantially all of the assets or business of a Party related, in either
case, to this Agreement) or otherwise obtains control of a Party (with “control”, for purposes of this definition,
having the meaning set forth in the definition of Affiliate above) (or any of such Third Party’s affiliates) immediately
prior to such acquisition or obtaining of control or (ii) independently developed by a Third Party described in clause (i) (or
any of its affiliates existing prior to such assignment, acquisition, or obtaining of control) following the applicable assignment,
acquisition, or change of control, other than in the exercise of rights or performance of obligations under this Agreement and
without reference to, or use or benefit of, the other Party’s Confidential Information shall, in the case of (i) and
(ii), be automatically excluded from the rights licensed or granted to the other Party under this Agreement, except to the extent
(1) immediately prior to the consummation of such assignment, acquisition, or obtaining of control, such Know-How, Patents,
materials, or other intellectual property or assets were already Controlled by such Party and included in the rights granted to
the other Party under this Agreement or (2) after the consummation of such assignment, acquisition, or obtaining of control,
any of such Third Party’s (or its pre-existing affiliates’) Patent Rights, Know-How, or other intellectual property
rights are used in the performance of such Party’s obligations or exercise of its rights under this Agreement, in each of
which cases ((1) and (2)) such Patent Right, Know-How, or other intellectual property right will be deemed to be “Controlled”
by such Party for the purposes of this Agreement.
(c) The
rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and
permitted assigns of the Parties, and the name of a Party appearing herein will be deemed to include the name of such Party’s
successors and permitted assigns to the extent necessary to carry out the intent of this Section 11.2. Any assignment not
in accordance with this Section 11.2 shall be null and void and of no legal effect.
11.3 Change
of Control. If there is a Change of Control of Eyenovia, then Eyenovia shall provide
written notice to Arctic Vision at least [ ] ([ ]) [ ] prior to the closing date of
such Change of Control, subject to any confidentiality or other legal obligations of Eyenovia then in effect (but in any
event Eyenovia shall notify Arctic Vision within [ ] ([ ]) [ ] after the closing date
of such Change of Control).
11.4 Severability.
If any one or more of the provisions contained in this Agreement is held invalid, illegal, or unenforceable in any respect, the
validity, legality, and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired
thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties
shall in such an instance negotiate in good faith to promptly replace the invalid, illegal, or unenforceable provision(s) with
valid, legal, and enforceable provision(s) which, insofar as practical, implement the original intent of the Parties.
11.5 Notices.
All notices which are required or permitted hereunder shall be in writing, in English, and sufficient if delivered personally,
sent by registered or certified mail or overnight courier, sent by nationally-recognized overnight courier or sent by registered
or certified mail, postage prepaid, return receipt requested, addressed as follows:
If to Eyenovia:
Eyenovia, Inc
295 Madison Ave
Suite 2400
NY, NY 10017
USA
Attn: John Gandolfo, CFO
with a copy (which shall not
constitute notice) to:
Wyrick Robbins Yates & Ponton LLP
4101 Lake Boone Trail, Suite 300
Raleigh, NC 27613
USA
Attn: Jason S. Wood
Fax: 919-781-4865
If to Arctic Vision:
23rd Floor, Nan Fung Tower,
88 Connaught Road C & 173 Des Voeux Road
C, Central,
Hong Kong, China
Attn: CEO
or to such other address(es) as the Party to whom notice is
to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been
given: (a) when delivered if personally delivered on a Business Day (or if delivered on a non-Business Day, then on the next
Business Day); (b) on the fifth Business Day after dispatch if sent by internationally-recognized overnight courier; or (c) on
the tenth (10th) Business Day following the date of mailing, if sent by mail.
11.6 Governing
Law. This Agreement shall be governed by and construed in accordance with the laws of
the State of Delaware, U.S., without reference to any rules of conflict of laws that may require the application of the laws
of a different jurisdiction.
11.7 Dispute
Resolution.
(a) General.
Any dispute between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection
herewith, other than as set forth in Section 3.3 and Section 10.3(d)(vii), (a “Dispute”), shall be resolved
pursuant to this Section 11.7.
(b) Senior
Officers. Any Dispute shall first be referred to the Senior Officers of the Parties, who
shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Officers shall be
conclusive and binding on the Parties.
(c) Intellectual
Property Disputes. If the Senior Officers are not able to agree on the resolution of
a Dispute within [ ] ([ ]) [ ] (or such other period of time as mutually agreed by the
Senior Officers) after such Dispute was first referred to them and such Dispute is with respect to the validity, scope,
enforceability, inventorship, or ownership of any Patent, or trademark right (“IP Dispute”), then, if a Party
wishes to pursue further resolution of such IP Dispute, an action, claim, or proceeding to resolve such IP Dispute shall be
brought in any court of competent jurisdiction in any country or jurisdiction in which such intellectual property rights
apply.
(d) Arbitration.
If the Senior Officers are not able to agree on the resolution of a Dispute within [ ] ([ ])
[ ] (or such other period of time as mutually agreed in writing by the Senior Officers) after such Dispute was
first referred to them, then, except as otherwise set forth in subsection (c) above, if a Party wishes to pursue further
resolution of such Dispute, such Dispute shall be finally resolved by binding arbitration in accordance with this
Section 11.7(d). Such Dispute shall be referred to and finally resolved by arbitration administered by the International
Chamber of Commerce (“ICC”) pursuant to the Rules of Arbitration of the ICC then in effect (the
“Rules”), except as otherwise provided herein and applying the substantive law specified in
Section 11.6. The arbitration will be conducted in London, England, by a panel of three (3) independent, neutral
arbitrators appointed in accordance with the Rules; provided that each Party will, within [ ]
([ ]) [ ] after the institution of the arbitration proceedings, nominate such an arbitrator, and such
arbitrators will together, within [ ] ([ ]) [ ], select a third (3rd) such arbitrator to
serve as the chairperson of the arbitration panel. Each arbitrator must have significant business or legal experience in the
pharmaceutical business. If the two (2) initial arbitrators are unable to select a third (3rd) arbitrator within such
[ ] ([ ]) [ ] period, the third (3rd) arbitrator will be appointed in accordance with Rules.
After conducting any hearing and taking any evidence deemed appropriate for consideration, the arbitrators will be requested
to render their opinion within [ ] ([ ]) [ ] of the final arbitration hearing. The
arbitration shall be conducted, and all documents submitted to the arbitrators shall be, in English. No panel of arbitrators
will have the power to award damages excluded pursuant to Section 9.4 under this Agreement and any arbitral award that
purports to award such damages is expressly prohibited and void ab initio. Each Party shall bear its own legal costs for its
counsel and other expenses, and the Parties shall equally share the costs of the arbitration; provided that the arbitral
tribunal shall have the discretion to provide that the losing Party is responsible for all or a portion of such arbitration
and legal costs, in such case the arbitral award will so provide. Decisions of the panel of arbitrators that conform to the
terms of this Section 11.7(d) shall be final and binding upon the Parties and the Parties undertake to carry out
any award without delay. Judgment on the award may be entered in any court of competent jurisdiction. Except to the extent
necessary to confirm, enforce, or challenge an award of the arbitration, to protect or pursue a legal right, or as otherwise
required by applicable Law or regulation or securities exchange, neither Party nor any arbitrator may disclose the existence,
content, or results of any arbitration hereunder without the prior written consent of both Parties. Notwithstanding anything
to the contrary in the foregoing, in no event shall an arbitration be initiated after the date when commencement of a legal
or equitable proceeding based on the dispute, controversy, or claim would be barred by the applicable Delaware statute of
limitations. Any disputes concerning the propriety of the commencement of the arbitration shall be finally settled by the
arbitral tribunal.
(e) Injunctive
Relief. Notwithstanding anything herein to the contrary, nothing in this Section 11.7
shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction,
or other interim equitable relief concerning a Dispute in any court of competent jurisdiction before or after the initiation of
an arbitration as set forth in Section 11.7(d), if necessary to protect the interests of such Party. This Section shall
be specifically enforceable.
11.8 Entire
Agreement; Amendments. This Agreement, together with the Exhibits hereto and, if and when
executed by the Parties, the Supply Agreement and Safety Data Exchange Agreement, contains the entire understanding of the Parties
with respect to the subject matter hereof. Any other express or implied agreements and understandings, negotiations, writings and
commitments, either oral or written, with respect to the subject matter hereof are superseded by the terms of this Agreement and,
if and when executed by the Parties, the Supply Agreement and Safety Data Exchange Agreement. The Exhibits to this Agreement are
incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by authorized representative(s) of both Parties.
11.9 Headings;
Language. The captions to the several Articles, Sections, and subsections hereof are not
a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.
This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding,
the terms of this Agreement. Any data or other documents required to be shared with the other Party shall be provided in the original
language such data or document is generated. In the event the receiving Party requests a translation of such data or document,
the cost of translation shall be borne by the requesting Party.
11.10 Independent
Contractors. It is expressly agreed that Eyenovia and Arctic Vision shall be independent
contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture, agency, employer-employee
or similar business relationship, including for all tax purposes. Neither Eyenovia nor Arctic Vision shall have the authority to
make any statements, representations, or commitments of any kind, or to take any action, which shall be binding on the other Party,
without the prior written consent of the other Party.
11.11 Waiver.
The waiver by either Party of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other
Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party whether
of a similar nature or otherwise.
11.12 Cumulative
Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each
shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.
11.13 Further
Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other Party may reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other
Party its rights and remedies under this Agreement.
11.14 Waiver
of Rule of Construction. Each Party has had the opportunity to consult with counsel
in connection with the review, drafting, and negotiation of this Agreement. Accordingly, the rule of construction that any
ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
11.15 Counterparts.
This Agreement may be executed in two or more counterparts by original signature, facsimile or PDF files, each of which shall be
deemed an original, but all of which together shall constitute one and the same instrument.
11.16 Recordal
of this Agreement. Eyenovia shall provide Arctic Vision with the necessary
assistance to record this Agreement with the State Intellectual Property Office of the PRC, including the execution of a
short form license agreement in Chinese to effect such recordal. In the event of any conflict between such license
agreement and this Agreement, the terms of this Agreement shall prevail.
{Signature
Page Follows}
IN WITNESS WHEREOF, the Parties intending
to be bound have caused this License Agreement to be executed by their duly authorized representatives as of the Effective
Date.
|
|
Eyenovia, Inc.
|
|
Arctic Vision (Hong Kong) Limited
|
|
|
|
|
|
|
|
|
By:
|
/s/ Tsontcho Ianchulev
|
|
By:
|
/s/ Hoi Ti Wu
|
|
|
|
|
|
|
|
|
|
Name:
|
Tsontcho Ianchulev
|
|
Name:
|
Hoi Ti Wu
|
|
|
|
|
|
|
|
|
|
Title:
|
CEO
|
|
Title:
|
CEO
|
|
List
of Exhibits
|
Exhibit A:
|
|
Part 1: MicroLine, Part 2: MicroPine, Part 3: Optejet
Dispenser Base
|
|
|
|
|
|
Exhibit B:
|
|
Licensed Patents and Specified Licensed Know-How
|
|
|
|
|
|
Exhibit C:
|
|
Initial Development Plan
|
|
|
|
|
|
Exhibit D:
|
|
Supply Price
|
|
|
|
|
|
Exhibit E:
|
|
Initial Eyenovia Product Marks
|
|
|
|
|
|
Exhibit F:
|
|
Joint Press Release
|
|
|
|
|
|
Exhibit G:
|
|
Reversion Terms Resolution Procedure
|
Exhibit F
Eyenovia and Arctic Vision Announce Exclusive
Collaboration and License Agreement to Develop and Commercialize MicroPine and MicroLine in Greater China and South Korea
Eyenovia Eligible to Receive up to a
Total of $45.75 million in Upfront Payments and Development and Commercialization Milestones and Development Costs
Arctic Vision to Lead Expansion of Novel
Approach to Treating Myopia and Presbyopia in Greater China and South Korea
New York, NY and Shanghai, China
– August 11, 2020 – Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company
developing a pipeline of microdose array print (MAP™) therapeutics and Arctic Vision, a clinical stage biotech company focused
on developing and commercializing innovative ophthalmology therapies in China and Asia, today announced that they have entered
into an exclusive license agreement for Arctic Vision to develop and commercialize MicroPine for the treatment of progressive myopia
and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.
Under the terms of the agreement, Eyenovia
may receive up to a total of $45.75 million in upfront payments as well as additional payments, based on various development and
regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development
costs. In addition, Arctic Vision will purchase its supply of MicroPine and MicroLine from Eyenovia or, for such products
not supplied by Eyenovia, pay Eyenovia a mid-single digit percentage royalty on net sales of such products, subject to certain
adjustments. Eyenovia will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply
to its Asian licensee pursuant to the arrangement by which Eyenovia reacquired rights to such products in Greater China and
South Korea from the original licensee.
“This licensing agreement with
Arctic Vision grows our commercial reach to address some of the largest progressive myopia markets in the world,” commented
Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. "With the continued validation
of our therapeutic approach, the agreement also provides non-dilutive capital to further support our planned launch of MicroStat
in the United States next year, as well as the ongoing development of our late stage ophthalmology pipeline including MicroPine
for progressive myopia and MicroLine for improvement in near vision.”
Eddy (Hoi Ti) Wu, Ph.D., Founder
and CEO, Arctic Vision added, “Eyenovia is a leader in the field of novel microdosing technology to treat myopia and
presbyopia and we are committed to accelerating the development of MicroPine and MicroLine in Greater China and South Korea.
In Asia, it is estimated that up to 50% of children in some regions are myopic, and the figure is increasing. On the other
end of the spectrum, many people over the age of 40 are gradually suffering from age related presbyopia, which is currently
corrected exclusively with medical devices or surgery-based modalities. We believe MicroPine and MicroLine have the potential
to address the needs unmet by conventional eye drops and can play an important role in growing Arctic Vision’s
innovative pipeline. Through this new partnership, we believe we can lead the Chinese ophthalmology market into the
future.”
About MicroPine for Progressive
Myopia
MicroPine (atropine ophthalmic solution) is for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness.
Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial
elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy,
macular staphylomas, retinal detachment and visual impairment. MicroPine has been developed for comfort and ease-of-use in children.
Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic
evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the
role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).
Feasibility Dose-finding Atropine Studies: ATOM
1; ATOM 2; LAMP (Independent Collaborative Group Trials)
About MicroLine for Presbyopia
MicroLine
is a pharmacologic treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes
a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans.
Current treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution
is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture
effect. Eyenovia believes that its administration of pilocarpine using the company’s high precision microdosing technology
could provide a meaningful improvement in near vision while enhancing tolerability and usability.
About Optejet® and MicroRx
Ocular Therapeutics
Eyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision
piezo-print technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. We believe the
volume of ophthalmic solution administered with the Optejet is less than 75% of that delivered using conventional eyedroppers,
thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology is designed
for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds,
beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training
in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers. Additionally, its smart electronics
and mobile e-health technology are designed to track and enhance patient compliance.
About Eyenovia
Eyenovia, Inc. (NASDAQ:
EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™)
therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for
presbyopia, myopia progression and mydriasis. For more Information, please visit www.eyenovia.com.
About Arctic Vision
Arctic Vision is a China-based clinical
stage specialty ophthalmology company with a leading portfolio of breakthrough technologies. The company’s vision is to
address ophthalmology’s unmet needs through innovative therapies in China, Asia and globally. Arctic Vision is established
by top-tier life sciences investors, and led by an elite team of ophthalmic industry veterans with substantial and compelling
China and global experiences in R&D and commercialization of eye care products. For more information, please visit www.arcticvision.com.
Forward Looking Statements
Except
for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking
statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations,
strategies, predictions or any other statements relating to our future activities or other future events or conditions, including
estimated market opportunities in the United States for our product candidates. These statements are based on current expectations,
estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees
of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes
and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due
to numerous factors discussed from time to time in documents which we file with the SEC. In addition, such statements could be
affected by risks and uncertainties related to, among other things: our ability to timely develop, implement and maintain manufacturing,
commercialization and marketing capabilities and strategies for our product candidates; our estimates regarding the potential
market opportunity for our product candidates; the potential advantages of our product candidates; the rate and degree of market
acceptance and clinical utility of our product candidates; impacts of and uncertainty related to COVID-19; fluctuations in our
financial results, particularly given market conditions and the potential economic impact of COVID-19; our need to raise additional
money to fund our operations for at least the next 12 months as a going concern; the potential impacts of COVID-19 on our supply
chain; risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could
still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the timing
and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; the potential
success of our reprioritized pipeline; any cost savings related to our reprioritized pipeline; our ability to attract and retain
key personnel; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which
we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive
position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under
applicable securities laws, we do not undertake any obligation to update any forward-looking statements.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
The Ruth Group
Alexander Lobo
Phone: 646-536-7037
alobo@theruthgroup.com
Eyenovia Media Contact:
Pazanga Health Communications
Diana Soltesz
Phone: 818-618-5634
dsoltesz@pazangahealth.com
Arctic Vision Contact:
Ms. Chris Fang
Senior Director, Corporate Development & Investor Relations
chrisfang@arcticvision.com / communications@arcticvision.com
