Exhibit 10.13
LICENSE AGREEMENT
This License Agreement (this “Agreement”) is effective
as of November 15, 2013 (the “Effective Date”), by and between Angion Biomedica Corp., a Delaware corporation (“Angion”),
and Ohr Cosmetics LLC, a Delaware corporation (“Ohr”). Angion and Ohr are sometimes referred to herein individually
as a “Party” and collectively as the “Parties”.
WHEREAS, Angion owns Licensed Patent Rights (as hereinafter
defined), relating to inhibition of CYP26 activity and desires to make ANG-3522 available for the development and commercialization
of certain dermatological products and methods for public use and benefit; and
WHEREAS, Ohr is a company engaged in the research, development,
manufacturing and commercialization of dermatological products;
WHEREAS, Ohr desires to obtain from Angion and Angion has
agreed to grant to Ohr, an exclusive license under the Licensed Patent Rights with respect to the development of Licensed Products
in the Licensed Field; all in accordance with the terms and conditions set forth herein; and
NOW, THEREFORE, the Parties in consideration of the mutual
representations, warranties and covenants contained herein and for other good and valuable consideration, hereby agree as follows:
ARTICLE 1
DEFINITIONS
When capitalized in this Agreement, the following terms shall have
the meanings set forth below:
1.1 “Affiliate”
means (a) any entity directly or indirectly controlling, controlled by or under common control with a Party; (b) any entity owning
or controlling more than fifty percent (50%) of the outstanding voting rights or securities of a Party; or (c) any entity whose
outstanding voting rights or securities are owned more than fifty percent (50%) by a Party.
1.2 “Best
Efforts” means the level of efforts required to diligently and effectively develop, manufacture and commercialize a Licensed Product,
including but not limited to the performance of all testing and other studies and all other activities necessary to for the production,
use and sale of the Licensed Products in the Territory in which Ohr intends to produce, use and/or sell the Licensed Products provided
that applicable laws, rules and regulations require that the performance of such testing and other studies and other activities
specified above shall be carried out with respect to Licensed Products.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
1.3 “Confidential
Information” means the terms and conditions of this Agreement and all proprietary information and materials (whether or not
patentable) communicated to either Party by or on the behalf of the other Party in the course of negotiating this Agreement and/or
in the course of performing each Party’s obligations under this Agreement, including, but not limited to: formulations, techniques,
methodology, equipment, instrumentation, data, reports, sales information, know-how, sources of supply, patent positioning, business
and/or product plans and projections, sublicense terms, other communications made under Section 2.3 of this Agreement, Ohr’s royalty
reports, Ohr’s other reports to Angion under this Agreement, and strategy and other information about prosecution and/or enforcement
of the Licensed Patent Rights.
1.4 “First
Commercial Sale” shall mean, with respect to any Licensed Product, the first sale on a commercial basis in an arm’s length
transaction for end use of such Licensed Product in a country. Licensed Product distributed or used for clinical trial purposes
shall not be considered sold, marketed or made publicly available for sale and shall not constitute first commercial sale.
l.5 “Gross Revenue” means the gross invoiced sales
prices charged for all Licensed Products sold by or for Ohr, its Affiliates and sublicensees in arm’s-length transactions to Third
Parties (including sales relating to transactions between Ohr, its Affiliates, and/or their respective sublicensees and agents)
and any other payment or other consideration charged by Ohr and its Affiliates from a sublicense or other Third Parties in consideration
for a sublicense, such as milestone payments, license fees, license maintenance fee and equity . For clarity, no deductions
are permitted for any of the following estimated and/or incurred charges or expenses:
(a) Trade,
cash, prompt payment and/or quantity discounts;
(b) Returns,
allowances, rebates, chargebacks, other allowances or payments to government agencies;
(c) Retroactive
price reductions applicable to sales of such product;
(d) Fees
paid to distributors, selling agents (excluding any sales representatives of a Party or any of its Affiliates), group purchasing
organizations and managed care entities;
(e) Credits
or allowances (actually paid or allowed) for wastage replacement, whether cash or trade;
(f) Non-recoverable
sales taxes, excise taxes, tariffs and duties (excluding taxes when assessed on income derived from sales); and
(g) Bad
debt, freight or other transportation charges, insurance charges, additional special packaging, and other governmental charges.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
1.6 “Licensed
Field” means any and all uses of Licensed Product for conditions of the skin or hair, by any route of administration.
1.7 “Licensed
Patent Rights” means (i) the patents and pending patent applications set forth on Schedule 1 attached hereto, as updated
from time to time, including, without limitation, all substitutions, reissues, renewals, reexaminations, supplementary protection
certificates, extensions, registrations and confirmations thereof, (ii) all patent applications, if any, owned or controlled by
Angion, with the right to grant rights to Ohr as provided in this Agreement, which claim priority from the patent applications
that resulted in the patents described on Schedule 1 (including provisional, continuation, divisional and continuation-in-part
applications) and any patents issuing therefrom; and (iii) all foreign counterparts of any of the foregoing in clause (i) or (ii).
1.8 “Licensed
Product” means any product that incorporates Angion compound ANG-3522 for use in conditions of the skin or hair, or whose
making, use, manufacture or sale, but for the licenses granted to Ohr in this Agreement, would infringe at least one Valid Patent
Claim.
1.9 “Territory”
means the entire world in which a Valid Claim exists.
1.10 “Third
Party” means a person or entity other than (a) Ohr, (b) Angion, or (c) an Affiliate of either Ohr or Angion.
1.11 “Valid
Patent Claim” means any issued and unexpired patent claim within the Licensed Patent Rights, which has not been adjudged invalid
or unenforceable unless and until such claim has been disclaimed, denied or admitted to be unpatentable, invalid or unenforceable
through reissue, reexamination, or disclaimer; or been found to be unpatentable, invalid or unenforceable by a court or other authority
in the country in which the patent is issued; or a patent application that is pending for less than 5 years.
ARTICLE 2
LICENSES
2.1 Grant
of License. Angion hereby grants to Ohr an exclusive license, including the right to grant sublicenses pursuant to Section
2.2 of this Agreement, under all the Licensed Patent Rights to make, have made, use, sell, offer for sale, import and otherwise
exploit Licensed Products in the Territory in the Licensed Field until the expiration of the last to expire of the Licensed Patent
Rights.
2.2 Sublicenses.
Ohr shall have the right to grant to others nonassignable (except as expressly permitted hereunder) sublicenses under the Licensed
Patent Rights commensurate in scope to the license and rights granted under Section 2.1; provided that each sublicense granted
by Ohr hereunder shall be in an arm’s length transaction, comply with the terms of this Agreement and
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
shall prohibit the granting by the sublicensee of further sublicenses
under the Licensed Patent Rights, except that such sublicensees shall be permitted to grant sublicenses to Affiliates of such sublicensees,
for so long as they remain Affiliates of such sublicensees, and entities with which such sublicensees are collaborating for the
research, development, manufacture and commercialization of Licensed Products. Ohr’s right to grant sublicenses shall be in effect
only during the time that the license to Ohr under the Licensed Patent Rights is in effect. Ohr shall promptly notify Angion in
writing of the grant of any sublicenses under this Agreement and shall provide Angion with the name of each sublicensee, and the
field and the territory of each such sublicense.
2.3 License
to Intellectual Property. The Parties acknowledge that this Agreement constitutes a license to “intellectual property”
as such term is used in 11 U.S.C. § 365(n).
2.4 No
Further Rights. Except as explicitly provided in thus Article I, no further or different license or right, express or implied
is granted by either Party.
ARTICLE 3
FEES AND ROYALTIES
3.1 Upfront
and Expense Reimbursement Payments. Ohr shall reimburse Angion for all expenses associated with the ANG-3522 human topical
irritation study, and expenses associated with patent protection for the Licensed Patent Rights, and all expenses related to the
review of any agreements between the Parties. For patent expenses related to Licensed Patent Rights, if a patent application covers
only subject matter in the Licensed Field, Ohr shall reimburse Angion 100% of the expenses. If a patent application includes, but
does not only cover, the Licensed Field, Ohr shall reimburse Angion [***] ([***]%) of the expenses related thereto.
3.2 Milestone
Fees. Ohr will pay to Angion the following milestone payments within thirty (30) days after the occurrence of the following
events:
| (a) | [***] dollars ($[***]) when Ohr, its Affiliates and sublicensees
[***] dollars ($[***]) in Gross Revenues; |
| (b) | An additional [***] dollars ($[***]) when Ohr its Affiliates and sublicensees invoice a
cumulative total of [***] dollars ($[***]) in Gross Revenues; |
| (c) | An additional [***] dollars ($[***]) when Ohr, its Affiliates
and sublicensees invoice a cumulative total of [***] dollars ($[***]) in Gross Revenues; and |
| (d) | An additional [***] dollars ($[***]) when Ohr, its Affiliates
and sublicensees invoice a cumulative total of [***] dollars ($[***]) in Gross Revenues. |
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
3.3 Royalties.
Ohr shall pay to Angion a royalty of [***] percent ([***]%) of the Gross Revenue.
3.4 Patent
Challenge. If Ohr, its Affiliate or a sublicensee commences an action in which it challenges the validity, enforceability or
scope of any of the Licensed Patent Rights (a “Challenge Proceeding”), the royalty rate specified in Section 3.4 will
be doubled with respect to Gross Revenues invoiced during the pendency of such Challenge Proceeding, and the amounts due to Angion
pursuant to Section 3.2 above shall be doubled. If the outcome of such Challenge Proceeding is a determination in favor of Angion,
(a) the royalty rate specified in Section 3.4 and the amounts due under Section 3.2 shall remain at such doubled rate and (b) Ohr
shall reimburse Angion for all expenses incurred by the Angion (including reasonable attorneys’ fees) in connection with
such Challenge Proceeding. If the outcome of such Challenge Proceeding is a determination in favor of Ohr, Ohr will have no right
to recoup any royalties or milestone payments paid before or during the pendency of such Challenge Proceeding.
3.5 Withholding
of Taxes. If the taxing authority of any government imposes a tax on the royalties to be paid under this Agreement or requires
Ohr, its Affiliates and/or sublicensees to withhold amounts from royalties payable to Angion to ensure payment of such taxes, Ohr
shall so notify Angion in each instance and shall reasonably cooperate with Angion in Angion’s efforts to obtain exemption from
payment of such taxes, a refund of taxes withheld, or credits with respect to such taxes paid. In the event Ohr pays such withholding
taxes to such tax authority, it will send evidence of the obligation together with proof of payment to Angion within sixty (60)
days of such payment.
3.6 No
Other Payments. Except as expressly set forth in this Section 4, neither Ohr nor any of its Affiliates or sublicensees shall
have any obligation to pay Angion any royalty, milestone payment or fee or payment of any kind under this Agreement or with respect
to the Licensed Patent Rights.
3.7 Term.
Royalties and Milestone Payments will be paid until the later of: (i) 15 years from the First Commercial Sale of a Licensed Product,
or (ii) the last to expire Licensed Patent Rights.
3.8 Exchange
Rate; Manner and Place of Payment. All payments hereunder shall be payable in U.S. dollars. For payments made on Gross Revenues
with respect to each quarter, for countries other than the U.S., whenever conversion of payments from any foreign currency shall
be required, such conversion shall be made at a rate of exchange equal to the rate of exchange for the currency of the country
from which payments are payable as published in The Wall Street Journal, Western Edition, on the last business day of the calendar
quarter for which a payment is due. All payments owed under this Agreement shall be made by wire transfer to a bank and account
designated in writing by Angion, unless otherwise specified in writing by Angion.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
3.9 Late
Payment. Ohr shall pay interest to Angion on the aggregate amount of any payments that are not paid on or before the date such
payments are due under this Agreement at a rate per annum equal to the lesser of the prime rate, as published in The Xxxx Xxxxxx
Xxxxxxx, Xxxxxxx Xxxxxx Xxxxxx Edition, plus [***] ([***]%), on the date on which any such payment is due, calculated on the number
of days such payment is delinquent. No interest shall be payable on the amount of any overpaid royalties to be re-paid by Angion.
3.10 Delayed
Payment. Ohr may delay making the first milestone payment in 3.2(a) herein without causing Monetary Default in accordance with
Section 7.4, by paying Angion [***]% of the payment per consecutive quarter starting in the first quarter the milestone payment
is due. Unpaid remaining amounts of the milestone payment will accrue interest in accordance with Section 3.9 herein.
ARTICLE 4
REPORTS, PAYMENTS AND RECORDS
4.1 Reports.
After the First Commercial Sale of a Licensed Product in the Territory during the term of this Agreement, Ohr shall deliver to
Angion quarterly written reports of Ohr’s and Affiliates’ and sublicensees’ sales of Licensed Products in the Territory during
the immediately preceding calendar quarter. Each report shall be accompanied by payment of all royalties and other monies due and
shall be certified by Ohr’s Chief Financial Officer.
4.2 Timing
of Reports. A report shall be due sixty (60) days following the end of each calendar quarter (“Report Date”). The
first report shall be due on the first Report Date following the end of the calendar quarter in which the First Commercial Sale
of Licensed Products under this Agreement takes place.
4.3 Content
of Report. Each report shall show:
(a) the
actual xxxxxxxx of Licensed Products sold by Ohr, its Affiliates and sublicensees in the Territory; and
(b) the
computation of royalties due.
(c) amounts
paid under Section 4.6 that are claimed as a deduction against the royalties due.
4.4 Sublicense
Reports. Ohr shall require each sublicensee to make appropriate reports to Ohr to enable Angion to comply with this Article
4. Ohr shall endeavor to require each sublicensee to provide to Ohr its respective reports in a timely manner so as to enable Ohr
to include such sublicensee’s report in Ohr’s report for the quarter that is the subject of the sublicensee’s report.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
4.5 Books
and Records. Ohr shall keep complete and accurate records of the underlying revenue and expense data relating to the calculations
of Gross Revenues and payments required under this Agreement. Ohr shall keep such records at its principal place of business for
three (3) years following the end of the calendar year to which they pertain.
4.6 Audit.
Angion shall have the right, at its own expense and not more than once in any four consecutive calendar quarters during the term
of this Agreement (except for one (1) post-termination audit), to have an independent, certified public accountant, selected by
Angion and reasonably acceptable to Ohr, review the records of Ohr, its Affiliates and sublicensees, in the location(s) where such
records are maintained by Ohr upon reasonable notice (which shall be no less than forty five (45) days prior written notice) and
during regular business hours and under obligations of strict confidence, for the sole purpose of verifying the basis and accuracy
of payments required and made under this Agreement. The independent public accountants selected by Angion and agreed to by Ohr
will be required to sign Ohr’s confidential disclosure agreement prior to performing any audit procedures or receiving any information
from Ohr. The report and communication of such accountant shall be limited to a certificate stating whether any report made or
payment submitted by Ohr during such period is accurate or inaccurate and the amount of any payment discrepancy, regardless if
the discrepancy is favorable or unfavorable to Angion. Ohr shall receive a copy of each such report concurrently with receipt by
Angion. Should the inspection lead to the discovery of a discrepancy to Angion’s detriment, Ohr shall pay the amount of the discrepancy
(without interest) within thirty (30) days of Ohr’s agreement with the findings of the inspection. Should the inspection lead to
the discovery of a discrepancy to Ohr’s detriment, Ohr will have the right to deduct such amount (without interest) from any future
royalty payment obligations; to the extent that no or insufficient future royalty obligations are due to Angion, Angion agrees
to pay such amount to Ohr within thirty (30) days of receiving an invoice from Angion. Angion shall pay the full cost of the inspection
unless the discrepancy is greater than five percent (5%) to Angion’s detriment, in which case Ohr shall pay the reasonable cost
charged by such accountant for such inspection.
4.7 W-9
Forms. Angion shall provide to Ohr a completed IRS Form W9 within five (5) days after the Effective Date.
ARTICLE 5
OHR’S DILIGENCE
5.1 Diligence. Ohr shall exercise Best Efforts to develop,
manufacture, and commercialize Licensed Products. Notwithstanding the foregoing, Ohr does not represent or warrant to Angion that
any commercializable product will be developed hereunder or that any Licensed Product will be commercially exploitable or of any
commercial value.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
5.2 Dormant
Program. In the event that Ohr ceases all development and commercialization of all Licensed Products for twelve (12) consecutive
months or longer, Angion shall have the right, at its sole discretion, to render the license set forth in Section 2.1 of this Agreement
non-exclusive or terminate this Agreement, upon providing Ohr with sixty (60) days’ written notice of its intent to do so,
provided, however, that upon receiving such notice, Ohr shall have the right for the duration of such sixty (60) days to provide
Angion with evidence that Ohr had not ceased development of all Licensed Products for twelve (12) consecutive months or longer,
and provided, further that Ohr will use reasonable efforts to provide such evidence promptly after receiving such notice from Angion.
Notwithstanding the foregoing, in the event that Angion renders the license set forth in Section 2.1 of this Agreement non-exclusive,
the remaining provisions, including, without limitation, Ohr’s obligation to pay milestones and royalties hereunder, shall remain
in full force and effect.
5.3 Progress
Reports. Until First Commercial Sale of the first Licensed Product, upon the written request of Angion, Ohr shall provide to
Angion a written report summarizing its progress in the development of such Licensed Product and summarizing its projected efforts
for the current year of such Licensed Product, provided that Ohr shall not be required to provide more than one such report per
calendar year.
5.4 Manufacturing.
Ohr hereby covenants that all Licensed Products produced for commercial distribution shall be manufactured in accordance with then
applicable regulations.
ARTICLE 6
INTELLECTUAL PROPERTY
6.1 Validity
and Enforceability. Angion represents that it owns its Licensed Patent Rights, and that to Angion’s knowledge, the Licensed
Patent Rights, once patented, is valid and enforceable.
6.2 Prosecution.
Angion will control and be responsible for all patent prosecution and enforcement of Licensed Patent Rights. Ohr will reimburse
Angion for those expenses in accordance with Section 2.2 herein.
6.3 Notice
of Third Party Infringement. Ohr and Angion shall each promptly inform the other in writing of any infringement by a Third
Party of any of the Licensed Patent Rights within or outside the Licensed Field of which they have notice or reasonable suspicion,
as well as any declaratory Judgment action alleging invalidity or non-infringement of any of the Licensed Patent Rights. Angion
shall have the first right, but not the obligation, to bring claim against such Third Party infringer and to enforce the Licensed
Patent Rights.
6.4 Awards.
Any recovery in proceedings brought by either party shall first be used to reimburse such party for all of its actual costs and
expenses, including legal expenses, incurred to
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
conduct such proceedings. Out of any amount relating to infringement
of the Licensed Patent Rights remaining, Ohr shall treat such remaining amount as Gross Revenues and pay to Angion a royalty thereon
pursuant to Section 3.4 of this agreement.
6.5 Discontinuance
or Settlement. Angion shall not enter into a settlement or consent judgment or other voluntary and final disposition of any
suit affecting Licensed Products without the prior written consent of Ohr. Ohr agrees it shall not enter into any settlement, consent
judgment or other voluntary final disposition of any infringement action under this Article 7 that (i) is materially prejudicial
to Angion’s rights in the Licensed Patent Rights without Angion’s prior written consent, such consent not to be unreasonably withheld
or delayed or (ii) incurs any financial liability on the part of Angion or requires an admission of liability on the part of Angion,
without Angion’s prior written consent, such consent not to be unreasonably withheld or delayed.
ARTICLE 7
EXPIRATION AND TERMINATION
7.1 Expiration.
The term of this Agreement shall commence on the Effective Date and expire upon Angion’s termination of this Agreement in accordance
with the terms of this Agreement or on the later of: (i) 15 years from the First Commercial Sale of a Licensed Product, or (ii)
the last to expire Licensed Patent Rights.
7.2 Termination.
Ohr shall have no right to terminate the Agreement. Angion shall have right to terminate the Agreement upon bankruptcy or dissolution
of Ohr. In the event Angion terminates the Agreement and later commercializes a Licensed Product incorporating Licensed Patent
Rights, and prior to termination Ohr had successfully demonstrated therapeutic activity of a Licensed Product in two different
skin conditions, Angion will pay Ohr or its successors [***]% of the net revenue received by Angion from such commercialization,
after all outstanding Licensed Product related debts have been satisfied, and provided, further, that Ohr transfers to Angion the
entire know how, data and information relating to the Licensed Product and grants Angion the exclusive right to use them. “Net
revenues” shall mean amount charged for all Licensed Products sold by Angion less:
(a) Trade,
cash, prompt payment and/or quantity discounts;
(b) Returns,
allowances, rebates, chargebacks, other allowances or payments to government agencies;
(c) Retroactive
price reductions applicable to sales of such product;
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
(d) Fees
paid to distributors, selling agents (excluding any sales representatives of a Party or any of its Affiliates), group purchasing
organizations and managed care entities;
(e) Credits
or allowances (actually paid or allowed) for wastage replacement, whether cash or trade;
(f) Non-recoverable
sales taxes, excise taxes, tariffs and duties (excluding taxes when assessed on income derived from sales); and
(g) Bad
debt, freight or other transportation charges, insurance charges, additional special packaging, and other governmental charges.
7.3 Remedy.
Ohr’s only remedy for breach of the Agreement by Angion shall be damages limited to the royalties and milestone payments
previously paid to Angion by Ohr.
7.4 Monetary
Default. Upon any failure by Ohr to timely pay undisputed amounts due to Angion required to be paid under this Agreement, Angion,
in addition to any other remedy available at law or equity, shall have the right to elect to terminate this Agreement by giving
Ohr thirty days’ written notice of Angion’s election to terminate. This Agreement shall terminate upon the expiration of such thirty
(30) day period, unless Ohr has cured such breach on or before such date, in which case it shall continue unaffected.
7.5 Abandonment.
In the event that Ohr determines to abandon all work on Licensed Products, Ohr shall notify Angion of such determination in writing,
and upon such notice, this Agreement shall automatically terminate and all rights licensed hereunder will revert to Angion.
7.6 Effect
of Termination of this Agreement. Termination of this Agreement for any reason shall effect the immediate and simultaneous
termination of all licenses granted under this Agreement, including sublicenses and all rights extended to Ohr’s Affiliates.
7.7 Surviving
Obligations and Provisions. Ohr’s obligations to pay, and report to Angion on, the sale of any Licensed Product sold before
expiration or termination of this Agreement shall survive such expiration or termination. In addition to any provision of this
Agreement that expressly survives the expiration or termination of this Agreement, Article 9 of this Agreement shall survive the
expiration or termination of this Agreement.
ARTICLE 8
FURTHER DEVELOPMENT ACTIVITIES
8.1 Further
Development by Angion. Any further research conducted by Angion on CPY26 inhibitors for potential use in the Licensed Field
will be for the exclusive benefit of Ohr. Angion
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
and Ohr will agree on a budget and goals for such research.
Ohr will reimburse Angion for its reasonable expenses directly associated with such research according to the budget. All patentable
and proprietary technology developed in the course of such funded research will be owned solely and exclusively by Angion and licensed
to Ohr pursuant to the Agreement and only in the Licensed Field.
8.2 Further
Development by Ohr. Ohr shall own all intellectual property and clinical trial data it develops independently. Ohr grants Angion
an option to an exclusive, worldwide, sub-licensable and transferable license to any uses of Ohr’s intellectual property
outside the Licensed Field for further development and to make, have made, use, sell, offer for sale, import and otherwise exploit
products. The option shall extend for [***] ([***]) days after Angion’s receipt of a disclosure of the intellectual property (the
“Option Period”). If Angion notifies Ohr in writing of its exercise of the option within the Option Period, then the
parties will proceed in good faith to negotiate a license agreement within [***] ([***]) days after notification of exercise (“Negotiation
Period”). If Angion does not exercise its option, or notifies Ohr that it will not exercise its option, or the parties fail
to sign a license agreement within the Negotiation Period, then Angion shall no longer have any claim to Ohr’s disclosed
intellectual property outside the Licensed Field, except that if the parties are unable to agree on licensing terms during the
Negotiation Period, then for a period of [***] ([***])[***] thereafter Ohr shall not license the intellectual property to a third
party on financial terms more favorable to the licensee than those last offered to Angion without first giving Angion an opportunity
to license the intellectual property or data on those more favorable terms. Upon Notification, Angion will have [***] ([***]) days
to accept the licensing terms deemed more favorable.
ARTICLE 9
GENERAL
9.1 Integration.
This Agreement and all schedules attached to this Agreement constitute the entire agreement between the Parties as to the subject
matter of such documents. All prior and contemporaneous negotiations, representations, warranties, agreements, statements, promises
and understandings are superseded and merged into, extinguished by and completely expressed by such documents. No Party shall be
bound by or charged with any written or oral agreements, representations, warranties, statements, promises or understandings not
specifically set forth in such documents.
9.2 Addresses
and Notices. All notices, requests, reports and other communications provided in this Agreement shall be in writing and shall
be deemed to have been made or given: (a) when delivered, if delivered by hand or sent by facsimile or the like; (b) on the day
following deposit with an overnight courier: or (c) on the third business day following deposit in the US Mail, certified or registered
with return receipt requested:
If to Ohr:
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
Ohr Cosmetics LLC
000 Xxxxx Xxxxxx
Xxxx Xxx XX 00000
With a copy to:
If to Angion:
Angion Biomedica Corp.
00 Xxxxxxx Xxxxxxxxx Xxxx.
Xxxxxxxxx XX 00000
With a copy for Notice purposes only to:
Xxxxx Xxxxx Zedek Xxxxxx Xxxxxx, LLP
Att: Xxxx Xxxxx
0000 Xxxxxxxx, Xxx Xxxx, XX 00000
Such addresses may be altered by notice so given.
9.3 Applicable
Law. This Agreement and its effect are subject to and shall be construed and enforced in accordance with the law of the State
of New York, without regard to the laws of New York concerning the conflicts of laws, except as to any issue which depends upon
the validity, scope or enforceability of any Licensed Patent, which issue shall be determined in accordance with the laws of the
United States of America.
9.4 Performance
by Affiliates. Ohr shall have the right to perform its obligations hereunder through Affiliates, provided it shall remain responsible
for and guarantee such performance.
9.5 Confidential
Information.
9.5.1 Obligations
and Restrictions. A Party receiving Confidential Information under this Agreement shall maintain such Confidential Information
in confidence, and shall not disclose, divulge or otherwise communicate such Confidential Information to others, except to employees
and/or consultants who are bound by like terms of confidentiality, nor use it for any purpose, except pursuant to, and in order
to carry out, the terms and objectives of this Agreement. The receiving Party further agrees to exercise reasonable precautions
to prevent and restrain the unauthorized disclosure of such Confidential Information by any of its directors, officers, employees,
consultants, subcontractors, sublicensees and agents. The terms of this Agreement will be held in confidence by the Parties until
three (3) years following the expiration or termination of this Agreement, except (i) to the extent necessary in order to enforce
its rights under this Agreement, (ii) to prospective investors and acquirors or companies with which it is negotiating a merger,
under reasonable obligations of confidentiality, and (iii) as required by the rules of any securities exchange or automated quotation
system or to the extent such terms are
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
required to be disclosed without an obligation of confidence
to a governmental agency or in response to involuntary compulsory process issued by a court, administrative agency or any governmental
body having apparent jurisdiction provided the Party subject to such process first provides notice to the other Party hereto (to
the extent practicable) and reasonably cooperates with efforts by the notified Party to secure confidential protection of such
terms.
9.5.2 Release
from Restrictions. The provisions of Section 9.5.1 shall not apply to any Confidential Information that:
| (a) | at the time of receipt by a Party was independently known to such Party without obligation of confidentiality from a source
other than the other Party to this Agreement or anyone acting on behalf of any of them; |
| (b) | is generally known to the public through no fault of
such Party; |
| (c) | has been published in any form (abstracts, papers, etc.) so as to become part of the public domain through no fault of the
receiving Party; |
| (d) | has been made available to such Party without obligation of confidentiality by a Third Party having the lawful right to do
so without breaching any such obligation of nonuse or confidentiality to any Xxxxx to this Agreement; or |
| (e) | is shown to have been independently developed by the receiving Party without use or reliance upon the Confidential Information. |
9.5.3 Publicity.
Neither Party shall make any public statement, press releases or other public announcements relating to this Agreement without
the prior written consent of the other Party, except that Angion shall have the right to make a single press release, provided,
however, that Angion provides to Ohr a copy of such final release at least five (5) days prior to its release.
9.6 Dispute
Resolution. The Parties shall make all reasonable efforts to resolve any dispute concerning this Agreement, its construction
or its actual or alleged breach, by face-to-face negotiations between senior executives. Should such negotiation fail to resolve
the matter in 90 days from the first meeting of the executives, the Parties shall proceed to binding arbitration under the rules
of the American Arbitration Association (“AAA”) and in accordance with the applicable rules of the AAA. Nothing in
this section shall be construed to waive any rights or timely performance of any obligations existing under this Agreement.
9.7 Compliance
With Law; Severability. Nothing in this Agreement shall be construed to require the commission of any act contrary to law.
If this Agreement conflicts with any statute, law, ordinance or treaty concerning the legal right of the parties to contract, the
latter shall prevail. In such event, the affected provisions of this Agreement shall be curtailed and limited
| 13 |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
only to the extent necessary to bring it within the applicable
legal requirements and the validity, legality and enforceability of the remaining provisions of this Agreement shall not in any
way be affected or impaired thereby.
9.8 Representations,
Warranties and Disclaimers.
9.8.1 Representations
and Warranties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, as follows:
(a) Such
Party is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated;
(b) Such
Party (i) has the corporate power and authority and legal right to enter into this Agreement, to perform its obligations and to
grant the licenses hereunder, and (ii) has taken all necessary corporate action on its own to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder;
(c) This
Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal and valid obligation binding upon
such Party and enforceable against it in accordance with its terms;
(d) The
execution, delivery and performance of this Agreement by such Party do not conflict with any agreement, instrument or understanding,
oral or written, to which it is a party or by which it is bound, nor violate any applicable law or regulation of any governmental
body or administrative or other agency having jurisdiction over it;
(e) Such
Party is aware of no action, suit, inquiry or investigation instituted by any Third Party that questions or threatens the validity
of this Agreement; and
(f) All
necessary consents, approvals and authorizations of all governmental authorities and other persons required to be obtained by such
Party in connection with this Agreement have been obtained.
9.8.2 Other
Representations and Warranties of Angion. Angion hereby further represents and warrants as follows:
(a) Licensed
Patent Rights. As of the Effective Date, Angion is the exclusive owner of the Licensed Patent Rights, free and clear of all
Liens and has sufficient rights to license the Licensed Patent Rights as are necessary to grant the licenses to Ohr pursuant to
this Agreement without breach or violation of, or conflict with any right of or contract with any Third Party. As of the Effective
Date Angion has not granted, and shall not during the term of this Agreement grant, any right, license, covenant, consent or privilege
to any Third Party or otherwise undertake any action which would conflict in any respect with the rights granted to Ohr set forth
in this Agreement.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
(b) No
Claims. Angion has not received, nor is aware, of any claims or allegations that a Third Party has any right or interest in
or to the Licensed Patent Rights or that any of the Licensed Patent Rights are invalid or unenforceable.
(c) Validity
and Enforceability. Angion is not aware of the existence of any facts that form the basis for the invalidation or unenforceability
of the Licensed Patent Rights.
9.8.3 Disclaimers.
Angion makes no representation or warranty whatsoever with respect to any Licensed Product. Angion further disclaims:
(a) Any
representation or warranty that anything made, used, sold or otherwise disposed of under a license granted in this Agreement is,
or will be, free from infringement of patents of third parties;
(b) Any
obligation to bring or prosecute any action or suit against third parties for infringement of any patent subject to the provisions
of Article 6.
9.9 Waiver.
A Party’s consent to or waiver, express or implied, of the other Party’s breach of its obligations hereunder shall not be deemed
to be or construed as a consent to or waiver of any other breach of the same or any other obligations of the other Party. A Party’s
failure to complain of any act, or failure to act, by the other Party, to declare the other Party in default, to insist upon the
strict performance of any obligation or condition of this Agreement or to exercise any right or remedy consequent upon a breach
thereof, no matter how long such failure continues, shall not constitute a waiver by such Party of its rights hereunder, of any
such breach, or of any other obligation or condition. A Party’s consent in any one instance shall not limit or waive the necessity
to obtain such Party’s consent in any future instance and in any event no consent or waiver shall be effective for any purpose
hereunder unless such consent or waiver is in writing and signed by the Party granting such consent or waiver.
9.10 Indemnity.
Ohr agrees to indemnify, defend and hold harmless (“Indemnify”) Angion, and all of its officers, directors, employees
and agents (collectively, the “Indemnitees”) from and against any and all claims, damages and liabilities, including
reasonable legal costs and fees (in each such case, a “Loss”), asserted by Ohr, its Affiliates, sublicensees and/or Third
Parties (whether governmental or private) or arising from the design, manufacture, use, promotion or sale of any Licensed Product
by or for Ohr, its Affiliate or sublicensee, or arising from the use of any such Licensed Product or Licensed IP by any Third Party
including any consumer or any customer of Ohr, its Affiliate or sublicensee. Ohr will provide Angion with proof of product liability
and other insurances.
9.10.1 No
Liability. Ohr shall not assume or be liable for any Losses (whether by way of indemnity or otherwise) resulting from or arising
in connection with the acts or omissions of Angion (or any agent, independent contractor or Third Party engaged by Angion) prior
to the Effective Date of this Agreement.
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Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
9.10.2 Indemnification
Procedure. To be eligible to be so Indemnified as described in this Section 9.10, each of the Indemnitees seeking to be Indemnified
shall provide Ohr (the “Indemnifying Party”) with prompt notice of any claim (with a description of the claim and the nature
and amount of any such Loss) giving rise to the indemnification obligation pursuant to Section 9.10, as the case may be, and the
exclusive ability to defend such claim (with the reasonable cooperation of Indemnitee(s)). Each Indemnitee(s) shall have the right
to retain its own counsel, at its own expense, if representation of the counsel of the Indemnifying Party would be inappropriate
due to actual or potential differing interests between such Indemnitee(s) and the Indemnifying Party. Neither the Indemnitee(s)
nor the Indemnifying Party shall settle or consent to the entry of any judgment with respect to any claim for Losses for which
indemnification is sought, without the prior written consent of the other Party (not to be unreasonably withheld or delayed); provided
however, that the Indemnifying Party shall have the right to settle or compromise any claim for losses without such prior written
consent if the settlement or compromise provides for a full and unconditional release of the Indemnitee(s) and is not materially
prejudicial to any Indemnitee’s rights. The Indemnifying Party’s obligation to Indemnify the lndemnitee(s) pursuant to this Section
9.10 shall not apply to the extent of any Losses (a) that arise from the gross negligence or intentional misconduct of any Indemnitee;
or (b) that arise from the breach by any Indemnitee of this Agreement.
9.11 LIMITATION
OF DAMAGES. EXCEPT FOR BREACHES OF SECTION 9.5 (CONFIDENTIALITY), IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOST REVENUE, LOST PROFITS, OR LOST SAVINGS), EVEN IF IT HAS NOTICE OF THE POSSIBILITY
OF SUCH DAMAGES. IN NO EVENT OR EVENTS SHALL ANGION’S AGGREGATE LIABILITY TO OHR UNDER OR IN RELATION TO THIS AGREEMENT EXCEED
THE AMOUNTS PAID OR PAYABLE BY OHR TO ANGION UNDER THIS AGREEMENT.
9.12 Assignment.
This Agreement, and the license, rights and duties contained in this Agreement, shall not be assigned by either Party except as
part of a sale of its business related to the subject matter of this Agreement, and, in such event, only collectively and in their
entirety. In the case of assignment by Ohr, the assignee, purchaser or merger partner must demonstrate sufficient financial resources
and experience to continue commercialization of the Licensed Patent Rights. The assigning Party shall give the other prompt written
notice of such assignment and obtain the agreement of the assignee to abide by the terms of this Agreement and to assume all of
the assignor’s obligations under this Agreement. Upon such assignment, the defined term for such assignor as used in this Agreement
shall thereafter mean the assignee.
9.13 Non-Use
of Names. Ohr shall not use the name, trademark, logo, physical likeness or name of any employee of Angion, its officers, directors
or employees, or any adaptation of any of them, in any advertising, promotional or sales literature, other than, subject to Section
9.5, an
| 16 |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
objective statement of fact by a representative of such Party
at a scientific conference, analyst call, outreach program or the like, without Angion’s prior written consent. Ohr shall require
its Affiliates and sublicensees to comply with the foregoing. Angion shall not use the name, trademark, logo, physical likeness
or name of any employee of Ohr, its officers, directors or employees, or any adaptation of any of them, in any advertising, promotional
or sales literature, without Ohr’s prior written consent.
9.14 Construction.
The parties agree that each Party has reviewed this Agreement and that any rule of construction to the effect that ambiguities
arc to be resolved against the drafting Party shall not apply to the interpretation of this Agreement. As used herein, the term
“including” shall mean “including, without limitation.”
9.15 Headings.
The headings for each Article and Section in this Agreement have been inserted for convenience of reference only and arc not intended
to limit or expand on the meaning of the language contained in the particular Article or Section. Unless otherwise specified, (a)
references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of
this Agreement, (b) references in any Section to any clause are references to such clause of such Section, and (c) references to
any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally
executed or, if subsequently varied, replaced or supplemented from time to time, as so varied, replaced or supplemented and in
effect at the relevant time of reference thereto.
9.16 Further
Actions. Each Party agrees to execute, acknowledge and deliver such further instruments and to do all such other acts as may
be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
9.17 Independent
Contractors. The relationship between Angion and Ohr created by this Agreement is solely that of independent contractors. This
Agreement does not create any agency, distributorship, employee-employer, partnership, joint venture or similar business relationship
between the Parties. Neither Party is a legal representative of the other Party, and neither Party can assume or create any obligation,
representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever. Each Party
shall use its own discretion and shall have complete and authoritative control over its employees and the details of performing
its obligations under this Agreement.
9.18 No
Benefit of Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement arc for the
sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any
rights on any Third Parties.
9.19 Insurance.
Upon and after the first commercial sale or distribution or the Licensed Products, and for so long as such Licensed Products are
sold by or on behalf of Ohr, Ohr shall maintain comprehensive general liability, product liability and broad form contractual liability
| 17 |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
insurance in amounts and with coverage conditions customary
for like products naming Angion as additional insured.
IN WITNESS WHEREOF, the parties hereto have each caused a duly
authorized officer to sign this Agreement to be effective the Effective Date.
| ANGION BIOMEDICA CORP. |
OHR COSMETICS LLC |
| |
|
|
|
| |
|
|
|
| By: |
Xxxxxx X. Xxxxxxxx, M.D. |
By: |
Xxxxxx X. Xxxxxxxx, M.D. |
| |
President |
|
Member |
| 18 |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
Schedule l
| Docket Number and Associate | |
Filing Details and Comments |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
| [***] | |
[***] |
[***]
[***]
| 19 |
Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. |
