Exhibit
10.1


 


The
General Hospital Corporation 


EXCLUSIVE
PATENT LICENSE AGREEMENT


 


MGH
Agreement No: A215841


MGH
Case No: 1416


 


This
License Agreement (“Agreement”) is made as of the 8th day of May, 2013 (“Effective Date”), by and between
VICapsys Inc., a Florida corporation, having a principal place of business at 1234 Airport Road Destin Florida 32541 (“Company”)
and The General Hospital Corporation, d/b/a Massachusetts General Hospital, a not-for-profit Massachusetts corporation,
with a principal place of business at 55 Fruit Street, Boston, Massachusetts 02114 (“Hospital”), each referred to
herein individually as a “Party” and collectively as the “Parties”.


 


RECITALS


 


Hospital,
as a center for patient care, research and education, is the owner of certain Patent Rights (defined below) and desires to grant
a license of those Patent Rights to Company in order to benefit the public by disseminating the results of its research via the
commercial development, manufacture, distribution and use of Products and Processes (defined below).


 


Company
has the capability to commercially develop, manufacture, distribute and use Products and Processes for public use and benefit
and desires to license such Patent Rights.


 


For
good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:


 


1.
CERTAIN DEFINITIONS


 


As
used in this Agreement, the following terms shall have the following meanings, unless the context requires otherwise.


 


1.1
“Affiliate” with respect to either Party shall mean any corporation or other legal entity other than that Party
in whatever country organized, controlling, controlled by or under common control with that Party. The term “control”
shall mean (i) in the case of Company, direct or indirect ownership of fifty percent (50%) or more of the voting securities having
the right to elect directors, and (ii) in the case of Hospital, the power, direct or indirect, to elect or appoint fifty percent
(50%) or more of the directors or trustees, or to cause direction of management and policies, whether through the ownership of
voting securities, by contract or otherwise.


 


1.2
“Claim” shall mean any pending or issued claim of any Patent Right that has not been permanently revoked, nor
held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable
or unappealed in the time allowed for appeal.


 




    	 	 	 



    	 



    

 


1.3
“Distributor” shall mean any third party entity to whom Company, a Company Affiliate or a Sublicensee has granted,
express or implied, the right to distribute any Product or Process pursuant to Section 2.1(b)(ii).


 


1.4
“First Commercial Sale” shall mean the initial Sale anywhere in the applicable License Territory of a Product
or Process.


 


1.5
First License Sub-field shall mean the first sub-field to be developed i.e. therapeutic use to treat disorders of type
1 diabetes.


 


1.6
“License Field” shall mean the field of coating and transplanting cells, tissues and devices for therapeutic
purposes and shall not include diagnostics, or any other field not specifically set forth herein. License Field shall include
the License Sub-Field defined infra and the Identified License Sub-Field defined supra.


 


1.7
“Identified License Sub-Field” shall mean: a) any subfield other than First License Sub-Field that is identified
by either Hospital and/or a third party; and b) of which Company is provided written notice of by Hospital in writing on or after
four (4) years from the Effective Date.


 


1.8
“License Territory” shall mean worldwide.


 


1.9
“Net Sales” shall be calculated as set forth in this Section 1.9.


 


	 	(a)	Subject to the conditions set forth below, “Net
Sales” shall mean:




 


	 	(i)	the
    gross amount billed or invoiced, or if no such bill or invoice is issued the amount received, whichever is greatest, by Company
    and its Affiliates and Sublicensees for or on account of Sales of Products and Processes; 
	 	 	 
	 	(ii)	less
    the following amounts:


 


	 	(A)	to
    the extent separately stated on the bill or invoice, actually paid by Company and its Affiliates in effecting such Sale: 


 


	 	1.	amounts
    repaid or credited by reason of rejection or return of applicable Products or Processes; 
	 	 	 
	 	2.	reasonable
    and customary trade, quantity or cash rebates or discounts to the extent allowed and taken;
	 	 	 
	 	3.	amounts
    for outbound transportation, insurance, handling and shipping, but only to the extent separately invoiced in a manner that
    clearly specifies the charges applicable to the applicable Products; and


 




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	 	4.	taxes,
    customs duties and other governmental charges levied on or measured by Sales of Products or Processes, to the extent separately
    invoiced, whether paid by or on behalf of Company so long as Company’s price is reduced thereby, but not franchise or
    income taxes of any kind whatsoever.


 


	 	(B)	the
    gross amount billed or invoiced, or if no such bill or invoice is issued the amount received, whichever is greatest, by Company
    and its Affiliates and Sublicensees for or on account of Sales of Products and Processes to Hospital and Hospital’s
    Affiliates.


 


	 	(b)	Specifically
    excluded from the definition of “Net Sales” are amounts attributable to any Sale of any Product or Process between
    or among Company and any Company Affiliate and/or Sublicensee, unless the transferee is the end purchaser, user or consumer
    of such Product or Process. 
	 	 	 
	 	(c)	No
    deductions shall be made for any commissions paid to any individuals or for any costs or expenses of collections.
	 	 	 
	 	(d)	Net
    Sales shall be deemed to have occurred and the applicable Product or Process “Sold” on the earliest of the date
    of billing, invoicing, delivery or payment or the due date for payment. 
	 	 	 
	 	(e)	If
    any Product or Process is Sold at a discounted price that is lower than the customary price charged, or for non-cash consideration
    (whether or not at a discount), Net Sales shall be calculated based on the non-discounted cash amount charged to an independent
    third party for the Product or Process during the same Reporting Period or, in the absence of such transaction, on the fair
    market value of the Product or Process. Non-cash consideration that could affect any payment due to Hospital hereunder shall
    not be accepted without the prior written consent of Hospital. 


 


1.10
“Materials” shall mean those biological materials identified in Appendix B2 attached hereto and incorporated
herein, which biological materials shall be transferred to Company to effect the terms of this Agreement.


 


1.11
“Patent Rights” shall mean, inclusively, the PCT Patent Application Serial number PCT/US00/09678, filed on
March 7th, 2000, and/or the equivalent of such application including any division, continuation (but not including
continuation-in-part), U.S. and foreign patent application, Letters Patent, and/or the equivalent thereof issuing thereon, and/or
reissue, reexamination or extension thereof, as may be further described in Appendix A1.


 




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1.12
“Process” shall mean any process, method or service the use or performance of which, in whole or in part:


 


	 	(a)	absent
    the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; and/or
	 	 	 
	 	(b)	employs,
    is based upon or is derived from Technological Information; and/or
	 	 	 
	 	(c)	 makes
    use of in whole or in part, or incorporates, is derived from, is related to, or is a modified form of the Materials.


 


1.13
“Product” shall mean any article, device or composition, the manufacture, use, or sale of which, in whole or
in part:


 


	 	(a)	absent
    the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; and/or
	 	 	 
	 	(b)	employs,
    is based upon or is derived from Technological Information; and/or 
	 	 	 
	 	(c)	makes
    use of in whole or in part, or incorporates, is derived from, is related to, or is a modified form of the Materials.


 


1.14
“Reporting Period” shall mean each three month period ending March 31, June 30, September 30 and December 31.


 


1.15
“Sell” (and “Sale” and “Sold” as the case may be) shall mean to sell or have sold,
to lease or have leased, to import or have imported or otherwise to transfer or have transferred a Product or Process for valuable
consideration (in the form of cash or otherwise), and further in the case of a Process to use or perform such Process for the
benefit of a third party.


 


1.16
“Sublicense Income” shall mean consideration in any form received by Company and/or Company’s Affiliate(s)
in connection with or otherwise attributable to a grant of a sublicense or any other right, license, privilege or immunity (regardless
of whether such grantee is a “Sublicensee” as defined in this Agreement) to make, have made, use, have used, Sell
or have Sold Products or Processes, but excluding consideration included within Net Sales. Sublicense Income shall include without
limitation any license signing fee, license maintenance fee, unearned portion of any minimum royalty payment, distribution or
joint marketing fee, research and development funding in excess of the cost of performing such research and development, and any
consideration received for an equity interest in, extension of credit to or other investment in Company or Company’s Affiliates
to the extent such consideration exceeds the fair market value of the equity or other interest received as determined by agreement
of the Parties or by an independent appraiser mutually agreeable to the Parties.


 


1.17
“Sublicensee” shall mean any sublicensee of rights granted in accordance with Section 2.1(a)(ii). For purpose
of this Agreement, a Distributor of a Product or Process shall not be included in the definition of Sublicensee unless such Distributor
(i) is granted any right to make, have made, use or have used Products or Processes in accordance with Section 2.1(a)(ii), or
(ii) has agreed to pay to Company or its Affiliate(s) royalties on such Distributor’s sales of Products or Processes, in
which case such Distributor shall be a Sublicensee for all purposes of this Agreement. 


 




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1.18
“Technological Information” shall mean research data, designs, formulae, process information and other information
pertaining to the invention(s) claimed in the Patent Rights which is created by Dr. Poznansky and owned by Hospital and is not
confidential information of or otherwise obligated to any third party and which Dr. Poznansky knows as of the Effective Date and
reasonably believes is necessary in order for Company to utilize the licenses granted hereunder, as further described in Appendix
B1. Company agrees to treat all Technological Information in accordance with the provisions of Appendix E.


 


1.19
“Xenotransplantation Patent Rights” shall mean, inclusively, the issued U.S. Patent/s numbered 6,153,428;
6,413,769; 7,547,522 and 7,547,816 and/or the equivalent of such application including any division, continuation (but not including
continuation-in-part), U.S. and foreign patent application, Letters Patent, and/or the equivalent thereof issuing thereon, and/or
reissue, reexamination or extension thereof, as may be further described in Appendix A2.


 


2.
LICENSE


 


2.1
Grant of License.


 


	 	(a)	Subject
    to the terms of this Agreement and Hospital’s rights in Patent Rights, Hospital hereby grants to Company in the License
    Field in the License Territory: 


 


	 	(i)	an
    exclusive, royalty-bearing license under its rights in Patent Rights to make, have made, use, have used, Sell and have Sold
    Products and Processes; 
	 	 	 
	 	(ii)	a
    non-exclusive, royalty-bearing license under its rights in Xenotransplantation Patent Rights to make, have made, use, have
    used, Sell and have Sold Products and Processes; 
	 	 	 
	 	(iii)	a
    non-exclusive, sub-licensable (solely in the License Field and License Territory) royalty-bearing license to MATERIALS and
    to make, have made, use, have used, MATERIALS for only the purpose of creating PRODUCTS, the TRANSFER of PRODUCTS and to use,
    have used and TRANSFER PROCESSES;
	 	 	 
	 	(iii)	the
        right to grant sublicenses under the rights granted in Section 2.1(a)(i) to Sublicensees, provided that in each case Company
        shall be responsible for the performance of any obligations of Sublicensees relevant to this Agreement as if such performance
        were carried out by Company itself, including, without limitation, the payment of any royalties or other payments provided
        for hereunder, regardless of whether the terms of any sublicense provide for such amounts to be paid by the Sublicensee
        directly to Hospital; and

         



 




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	 	(iv)	the
    nonexclusive right to use Technological Information disclosed by Hospital to Company hereunder in accordance with this Agreement.


 


	 	(b)	The
    license granted in Section 2.1(a) above includes: 


 


	 	(i)	the
    right to grant to the final purchaser, user or consumer of Products the right to use such purchased Products in a method coming
    within the scope of Patent Rights within the License Field and License Territory; and 
	 	 	 
	 	(ii)	the
    right to grant a Distributor the right to Sell (but not to make, have made, use or have used) such Products and/or Processes
    for or on behalf of Company, its Affiliates and Sublicensees in a manner consistent with this Agreement.


 


	 	(c)	The
    foregoing license grant shall include the grant of such license to any Affiliate of Company, provided that such Affiliate
    shall assume the same obligations as those of Company and be subject to the same terms and conditions hereunder; and further
    provided that Company shall be responsible for the performance of all of such obligations and for compliance with all of such
    terms and conditions by Affiliate. Company shall provide to Hospital a fully signed, non-redacted copy of each agreement with
    each Affiliate that assumes the aforesaid obligations, including all exhibits, attachments and related documents and any amendments,
    within thirty (30) days of request by Hospital.
	 	 	 
	 	(d)	Notwithstanding
    anything express or implied herein to the contrary, COMPANY shall not transfer MATERIALS to any third party except as set
    forth under Section 2.2 below, which transfer shall only be effected as necessary to create PRODUCTS.


 


2.2
Sublicenses. Each sublicense granted hereunder shall be consistent with and comply with all terms of this Agreement, shall
incorporate terms and conditions sufficient to enable Company to comply with this Agreement, shall prohibit any further sublicense
or assignment by a Sublicensee without Hospital consent and shall provide that Hospital is a third party beneficiary thereof.
Any sublicense granted by Company shall be subject to the prior written approval of Hospital, which approval shall not be unreasonably
withheld. Company shall provide to Hospital a fully signed non-redacted copy of all sublicense agreements and amendments thereto,
including all exhibits, attachments and related documents, within thirty (30) days of executing the same. Upon termination of
this Agreement or any license granted hereunder for any reason, any sublicenses shall be addressed in accordance with Section
10.7. Any sublicense which is not in accordance with the forgoing provisions shall be null and void.


 




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2.3
Retained Rights; Requirements. Any and all licenses granted hereunder are subject to:


 


	 	(a)	the
    right of Hospital and Hospital’s Affiliates and academic, government and not-for-profit institutions to make and to
    use the subject matter described and/or claimed in the Patent Rights; and
	 	 	 
	 	(b)	the
    right of Hospital and Hospital’s Affiliates and academic, government and not-for-profit institutions to make, have made
    and to use and have used the MATERIALS and to permit any other party to make and use the MATERIALS for any purpose (other
    than the TRANSFER of Products and Processes under the PATENT RIGHTS in the LICENSE SUBFIELD); and
	 	 	 
	 	(c)	for
    Patent Rights supported by federal funding, the rights, conditions and limitations imposed by U.S. law (see 35 U.S.C.
    § 202 et seq. and regulations pertaining thereto), including without limitation:


 


	 	(i)	the
    royalty-free non-exclusive license granted to the U.S. government; and
	 	 	 
	 	(ii)	the
    requirement that any Products used or sold in the United States shall be manufactured substantially in the United States.
    


 


2.4
No Additional Rights. It is understood that nothing in this Agreement shall be construed to grant Company or any of its
Affiliates a license, express or implied, under any patent owned solely or jointly by Hospital other than the Patent Rights expressly
licensed hereunder. Hospital shall have the right to license any Patent Rights to any other party for any purpose outside of the
License Field or the License Territory. HOSPITAL shall have the right to license any Materials to any other party for any purpose
whatsoever, other than the TRANSFER of Products and Processes under the PATENT RIGHTS in the LICENSE SUBFIELD.


 


2.5
Disclosure of Technological Information. At Company’s request prior to execution of this Agreement, Hospital (through
Dr. Poznansky) shall use reasonable efforts to disclose in confidence within thirty (30) days after execution of this Agreement
the Technological Information licensed hereunder.


 




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3.
DUE DILIGENCE OBLIGATIONS


 


3.1
Diligence Requirements. Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, best
efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field.
Such efforts shall include achieving the following objectives within the time periods designated below following the Effective
Date:


 


(a)
Pre-Sales Requirements.


 


	 	(i)	Company
    shall provide a detailed business plan or Private Placement document within three (3) months of the Effective Date
	 	(ii)	Company
    shall raise $20 million in a financing round within twelve (12) months of the Effective Date
	 	(iii)	Company
    shall fund the mutually agreed upon collaborative research plan to be undertaken at Hospital (see Collaborative Research Agreement
    attached hereto as Appendix F and incorporated herein).
	 	(iv)	Within
    two years of the Effective Date, Company shall engage a regulatory consultant and a CRO to conduct the first GLP study
	 	(v)	Within
    two years of the Effective Date, Company shall begin contract manufacturing the Product
	 	(vi)	Within
    four years of the Effective Date, Company will file an IND application for the lead indication;
	 	(vii)	Within
    five years of the Effective Date, Company will commence Phase I/II trials;
	 	(viii)	Within
    seven years of the Effective Date, Company will commence Phase III trials for a Product in the U.S.;
	 	(ix)	Within
    nine years of the Effective Date, Company will file a NDA or PMA; and 
	 	(x)	Within
    ten years of the Effective Date, Company will obtain FDA approval for a Product or Process.


 


(b)
Post-Sales Requirements.


 


	 	(i)	Following
    the First Commercial Sale in any country in the License Territory, Company shall itself or through its Affiliates and/or Sublicensees
    make continuing Sales in such country without any elapsed time period of one (1) year or more in which such Sales do not occur.
    
	 	 	 
	 	(ii)	Company
    shall itself or through an Affiliate or Sublicensee make such First Commercial Sale within the following countries and regions
    in the License Territory within ten (10) years after the Effective: USA and/or Europe.


 


Achievement
of the foregoing objectives shall be deemed to satisfy Company’s obligations to use best efforts under this Section 3.1.


 


3.2
Diligence Failures. If Hospital determines that Company has failed to fulfill any of its obligations under Section 3.1,
then Hospital may treat such failure as a default and may terminate this Agreement and/or any license granted hereunder in accordance
with Section 10.4.


 


3.3
Diligence Reports. Company shall provide all reports with respect to its obligations under Section 3.1 as set forth in
Section 5.


 




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3.4
Diligence Requirements for Identified license sub-field. 


 


(a)
If at any time after four (4) years from the Execution Date of the License Agreement, an additional sub-field is identified by
either Hospital or a third party, Company will receive written notification from Hospital of said additional field and shall have
sixty (60) days to provide Hospital with written notification of its intention to develop said sub-field. Should Company decline
to pursue said sub-field, or if Company fails to provide written notification of interest within the sixty (60) day period identified
above, rights to said sub-field shall revert to Hospital.


 


(b)
Company shall itself use, or shall cause its Affiliates or Sublicensees, as applicable, to use, commercially reasonable best
efforts to develop and make available to the public Products and Processes throughout the License Territory and the
Identified License Sub-field. Such efforts shall include providing in writing to Hospital a commercial development plan for
Products and Processes encompassed by the Identified License Sub-field within sixty (60) days from the date of
Company’s receipt of Hospital ’s notice of the Identified License Sub-field in order that Hospital and Company
can agree on appropriate diligence provisions in regard to the aforementioned Products and Processes for incorporation into
the Agreement within three (3) months from the aforementioned date. Achievement of the foregoing objectives shall be deemed
to satisfy Company’s obligations to use commercially reasonable best efforts under this Section 3.4 (b).


 


3.5
Diligence Failures for Identified license sub-field. If Hospital determines that Company has failed to fulfill any of its
obligations under Section 3.4 (b), then Hospital may treat such failure as a default and may terminate the licenses granted hereunder
with respect to the Identified License Sub-field in accordance with Section 10.4.


 


4.
PAYMENTS AND ROYALTIES


 


4.1
Patent Cost Reimbursement. Company shall reimburse Hospital for all costs associated with the preparation, filing, prosecution
and maintenance of all Patent Rights (“Patent Costs”). As of the Effective Date, Hospital has incurred approximately
Ninety Six Thousand Five Hundred Fifty Eight U.S. Dollars ($96,558) in Patent Costs, which amount Company shall pay to Hospital
upon execution of this Agreement. Company shall pay to Hospital, or at Hospital’s request directly to patent counsel, all
other Patent Costs within thirty (30) days of Company’s receipt of an invoice for such Patent Costs either from Hospital
or Hospital’s patent counsel. Company agrees to indemnify, defend and hold Hospital harmless from and against any and all
liabilities, damages, costs and expenses arising from the failure of Company to timely pay such invoices and Patent Costs. Hospital
shall instruct patent counsel to provide copies to Hospital for Hospital’s administrative files of all invoices detailing
Patent Costs which are sent directly to Company. If Company pays any Patent Costs directly, Company shall advise patent counsel
that Hospital is and shall remain patent counsel’s client.


 




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4.3
Annual License Fee; Annual Minimum Royalty.


 


	 	(a)	Before
    First Commercial Sale. 


 


	 	(i)	No
    annual license fee shall be due until the earlier to occur of, the conclusion of all Hospital research and co-developmental
    activities; or the initiation of human clinical studies.
	 	 	 
	 	(ii)	Following
    the earlier to occur of the conclusion of all Hospital research and co-developmental activities, or the initiation of human
    clinical studies, Company shall pay Hospital a nonrefundable annual license fee in the amount of Twenty Five Thousand U.S.
    dollars ($25,000) per year within sixty (60) days after each annual anniversary of the Effective Date. 


 


	 	(b)	After
    First Commercial Sale. Following the First Commercial Sale, Company shall pay Hospital a non-refundable minimum annual
    royalty in the amount of Fifty Thousand U.S. dollars ($50,000) per year within sixty (60) days after each annual anniversary
    of the Effective Date. The annual minimum royalty shall be credited against royalties subsequently due on Net Sales made during
    the same calendar year, if any, but shall not be credited against royalties due on Net Sales made in any other year. 


 


4.4
Milestone Payments. In addition to the payments set forth in Sections 4.1 through 4.3 above, Company shall pay Hospital
milestone payments, as follows:


 


(a)
One Hundred Fifty Thousand U.S. dollars ($150,000) within sixty (60) days of the initiation of a Phase II human clinical trial;
and


 


(b)
Five Hundred Thousand U.S. dollars ($500,000) within sixty (60) days of the initiation of a Phase III human clinical trial; and


 


(c)
Five Hundred Thousand U.S. dollars ($500,000) within sixty (60) days of a New Drug Approval.


 


4.5
Royalties and Sublicense Income.


 


	 	(a)	Royalties


 


	 	(i)	There
    shall be no royalty due on the Net Sales of all Products and Processes in the First License Subfield.
	 	(iii)	Beginning
    with the First Commercial Sale of Products and Processes in additional License Subfields in any country in the License Territory,
    Company shall pay Hospital a royalty rate consistent with industry standards, to be negotiated at such time; and 
	 	(iv)	Company
    acknowledges that Products and/or Processes were or will be developed using, based upon or derived from Technological Information
    and agrees to pay royalties pursuant to this Section 4.5(a)(ii), even after Patent Rights have expired or been abandoned.
    


 


	 	(b)	Sublicense
    Income. Company shall pay Hospital a percentage of any and all Sublicense Income, such percentage to be in proportion
    to Hospital’s ownership interest at the time of such Sublicense. 


 




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	 	(c)	All
    payments due to Hospital under this Section 4.5 shall be due and payable by Company within thirty (30) days after the end
    of each Reporting Period, and shall be accompanied by a report as set forth in Sections 5.3 and 5.4.


 


4.6
Equity. As partial consideration for the rights granted in this Agreement, and in conjunction with the execution of this
Agreement by the Parties, Company shall issue to Hospital (a) on the Effective Date, that number shares of its common stock that
equal forty percent (40%) of Company’s fully-diluted outstanding shares on the Effective Date (the “Shares”),
and (b) at any time during the period commencing on the Effective Date and continuing until the Qualified Financing Date, i.e.,
the date on which Company has raised greater than or equal to twenty million U.S. dollars ($20,000,000.00), Company shall issue
Hospital additional shares of its common stock such that Hospital’s equity ownership shall continue to equal forty percent
(40%) of Company’s outstanding shares on such date. For the avoidance of doubt, (a) Hospital shall continue to receive dilution
protection with respect to the shares issued to Hospital until Company receives $20,000,000 in a Qualified Financing and (b) following
Company’s receipt of $20,000,000 in a Qualified Financing, Hospital’s shares shall be subject to dilution to the same
extent as Company’s other common stockholders.


 


4.7
Board Seat. Hospital shall have a seat on the Company’s Board of Directors.


 


4.8
Form of Payment. All payments due under this Agreement shall be drawn on a United States bank and shall be payable in United
States dollars. Each payment shall reference this Agreement and its Agreement Number and identify the obligation under this Agreement
that the payment satisfies. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the
United States, as reported in The Wall Street Journal, on the last working day of the applicable Reporting Period. Such payments
shall be without deduction of exchange, collection or other charges, and, specifically, without deduction of withholding or similar
taxes or other government imposed fees or taxes, except as permitted in the definition of Net Sales.


 


Checks
for all payments due to the Hospital under this Agreement shall be made payable to the Hospital and addressed as set forth below:


 


Massachusetts
General Hospital


BOA-Lockbox
Services


PCSR
Lockbox #415007


MA5-527-02-07


2
Morrissey Blvd


Dorchester,
MA 02125


Reference
Agreement #: A215841


 




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Payments
via wire transfer should be made as follows:


 


ACH
Credit: ABA # 011-000-138


Federal
Reserve Wire: ABA#026-009-593


SWIFT
Code: BOFAUS3N


Account
#0050169434


Massachusetts
General Hospital


Bank
of America


100
Federal Street


Boston,
MA 02110


Reference
Agreement #: A215841


 


4.9
Overdue Payments. The payments due under this Agreement shall, if overdue, bear interest beginning on the first day following
the Reporting Period to which such payment was incurred and until payment thereof at a per annum rate equal to two percent (2%)
above the prime rate in effect on the due date as reported by The Wall Street Journal, such interest rate being compounded on
the last day of each Reporting Period, not to exceed the maximum permitted by law. Any such overdue payments when made shall be
accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not preclude Hospital from
exercising any other rights it may have as a consequence of the lateness of any payment.


 


5.
REPORTS AND RECORDS


 


5.1
Diligence Reports. Within sixty (60) days after the end of each calendar year, Company shall report in writing to Hospital
on progress made toward the objectives set forth in Section 3.1 during such preceding 12 month period, including, without limitation,
progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing and the number
of sublicenses entered into and marketing.


 


5.2
Milestone Achievement Notification. Company shall report to Hospital the dates on which it achieves the milestones set
forth in Section 4.4 within sixty (60) days of each such occurrence.


 


5.3
Sales Reports. Company shall report to Hospital the date of the First Commercial Sale in each country of the License Territory
within thirty (30) days of each such occurrence. Following the First Commercial Sale, Company shall deliver reports to Hospital
within thirty (30) days after the end of each Reporting Period. Each report under this Section 5.4 shall have substantially the
format outlined in Appendix C, shall be certified as correct by an officer of Company and shall contain at least the following
information as may be pertinent to a royalty accounting hereunder for the immediately preceding Reporting Period:


 


	 	(a)	the
    number of Products and Processes Sold by Company, its Affiliates and Sublicensees in each country;
	 	 	 
	 	(b)	the
    amounts billed, invoiced and received by Company, its Affiliates and Sublicensees for each Product and Process, in each country,
    and total billings or payments due or made for all Products and Processes; 


 




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	 	(c)	calculation
    of Net Sales for the applicable Reporting Period in each country, including an itemized listing of permitted offsets and deductions;
    
	 	 	 
	 	(d)	total
    royalties payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion; and
	 	 	 
	 	(e)	any
    other payments due to Hospital under this Agreement.


 


If
no amounts are due to Hospital for any Reporting Period, the report shall so state.


 


5.4
Sublicense Income Reports. Company shall, along with delivering payment as set forth in Section 4.6, report to Hospital
within thirty (30) days of receipt the amount of all Sublicense Income received by Company, and Company’s calculation of
the amount due and paid to Hospital from such income, including an itemized listing of the source of income comprising such consideration,
and the name and address of each entity making such payments in substantially the format outlined in Appendix D.


 


5.5
Audit Rights. Company shall maintain, and shall cause each of its Affiliates and Sublicensees to maintain, complete and
accurate records relating to the rights and obligations under this Agreement and any amounts payable to Hospital in relation to
this Agreement, which records shall contain sufficient information to permit Hospital and its representatives to confirm the accuracy
of any payments and reports delivered to Hospital and compliance in all other respects with this Agreement. Company shall retain
and make available, and shall cause each of its Affiliates and Sublicensees to retain and make available, such records for at
least five (5) years following the end of the calendar year to which they pertain, to Hospital and/or its representatives and
upon at least fifteen (15) days’ advance written notice, for inspection during normal business hours, to verify any reports
and payments made and/or compliance in other respects under this Agreement. If any examination conducted by Hospital or its representatives
pursuant to the provisions of this Section show an underreporting or underpayment of five percent (5%) or more in any payment
due to Hospital hereunder, Company shall bear the full cost of such audit and shall remit any amounts due to Hospital (including
interest due in accordance with Section 4.7) within thirty (30) days of receiving notice thereof from Hospital.


 


6.
PATENT PROSECUTION AND MAINTENANCE


 


6.1
Prosecution. Hospital shall be responsible for the preparation, filing, prosecution and maintenance of all patent applications
and patents included in Patent Rights. Company shall reimburse Hospital for Patent Costs incurred by Hospital relating thereto
in accordance with Section 4.2.


 


6.2
Copies of Documents. With respect to any Patent Right licensed hereunder, Hospital shall instruct the patent counsel prosecuting
such Patent Right to (i) copy Company on patent prosecution documents that are received from or filed with the United States Patent
and Trademark Office and foreign equivalent, as applicable; (ii) if requested by Company, provide Company with copies of draft
submissions to the USPTO prior to filing; and (iii) give consideration to the comments and requests of Company or its patent counsel.


 




    	 	13	 



    	 



    

 


6.3
Company’s Election Not to Proceed. Company may elect to surrender any patent or patent application in Patent Rights
in any country upon sixty (60) days advance written notice to Hospital. Such notice shall relieve Company from the obligation
to pay for future Patent Costs but shall not relieve Company from responsibility to pay Patent Costs incurred prior to the expiration
of the sixty (60) day notice period. Such U.S. or foreign patent application or patent shall thereupon cease to be a Patent Right
hereunder, Company shall have no further rights therein and Hospital shall be free to license its rights to that particular U.S.
or foreign patent application or patent to any other party on any terms.


 


6.4
Confidentiality of Prosecution and Maintenance Information. Company agrees to treat all information related to prosecution
and maintenance of Patent Rights as Confidential Information in accordance with the provisions of Appendix E.


 


7.
THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS


 


7.1
Hospital Right to Prosecute. Hospital will protect its Patent Rights from infringement and prosecute infringers when, in
its sole judgment, such action may be reasonably necessary, proper and justified. If Company shall have supplied Hospital with
written evidence demonstrating to Hospital’s reasonable satisfaction prima facie infringement of a claim of a Patent Right
in the License Field in the License Territory by a third party which poses a material threat to Company’s rights under this
Agreement, Company may by notice request Hospital to take steps to protect such Patent Right. Hospital shall notify Company within
three (3) months of the receipt of such notice whether Hospital intends to prosecute the alleged infringement. If Hospital notifies
Company that it intends to so prosecute, Hospital shall, within three (3) months of its notice to Company either (i) cause such
infringement to terminate, or (ii) initiate legal proceedings against the infringer.


 


7.2
Company Right to Prosecute. In the event Hospital notifies Company that Hospital does not intend to prosecute infringement
identified under Section 7.1, Company may, upon notice to Hospital, initiate legal proceedings against the infringer at Company’s
expense with respect to a claim of a Patent Right in the License Field in the License Territory. Before commencing such action,
Company and, as applicable, any Affiliate, shall consult with Hospital, concerning, among other things, Company’s standing
to bring suit, the advisability of bringing suit, the selection of counsel and the jurisdiction for such action (provided Company
must have Hospital’s prior written consent with respect to selection of jurisdiction for any action in which Hospital may
be joined as a party-plaintiff) and shall use reasonable efforts to accommodate the views of Hospital regarding the proposed action,
including without limitation with respect to potential effects on the public interest. Company shall be responsible for all costs,
expenses and liabilities in connection with any such action and shall indemnify and hold Hospital harmless therefrom, regardless
of whether Hospital is a party-plaintiff, except for the expense of any independent counsel retained by Hospital in accordance
with Section 7.5 below.


 




    	 	14	 



    	 



    

 


7.3
Hospital Joined as Party-Plaintiff. If Company elects to commence an action as described in Section 7.2 above, Hospital
shall have, in its sole discretion, the option to join such action as a party-plaintiff. If Hospital is required by law to join
such action as a party-plaintiff, Hospital may either, in its sole discretion, permit itself to be joined as a party-plaintiff
at the sole expense of Company, or assign to Company all of Hospital’s right, title and interest in and to the Patent Right
which is the subject of such action (subject to all of Hospital’s obligations to the government under law and any other
rights that others may have in such Patent Right). If Hospital makes such an assignment, such action by Company shall thereafter
be brought or continued without Hospital as a party; provided, however, that Hospital shall continue to have all rights of prosecution
and maintenance with respect to Patent Rights and Company shall continue to meet all of its obligations under this Agreement as
if the assigned Patent Right were still licensed to Company hereunder.


 


7.4
Notice of Actions; Settlement. Company shall promptly inform Hospital of any action or suit relating to Patent Rights and
shall not enter into any settlement, consent judgment or other voluntary final disposition of any action relating to Patent Rights,
including but not limited to appeals, without the prior written consent of Hospital.


 


7.5
Cooperation. Each Party agrees to cooperate reasonably in any action under Section 7 which is controlled by the other Party,
provided that the controlling party reimburses the cooperating party for any costs and expenses incurred by the cooperating party
in connection with providing such assistance, except for the expense of any independent counsel retained by the cooperating party
in accordance with this Section 7.5. Such controlling party shall keep the cooperating party informed of the progress of such
proceedings and shall make its counsel available to the cooperating party. The cooperating party shall also be entitled to independent
counsel in such proceedings but at its own expense, said expense to be offset against any damages received by the Party bringing
suit in accordance with Section 7.6.


 


7.6
Recovery. Any award paid by third parties as the result of such proceedings (whether by way of settlement or otherwise)
shall first be applied to reimbursement of any legal fees and expenses incurred by either Party and then the remainder shall be
divided between the Parties as follows:


 


	 	(a)	(i)	Company
    shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of
    damages the court shall have applied; and


 


	 	(ii)	Hospital
    shall receive an amount equal to the royalties and other amounts that Company would have paid to Hospital if Company had Sold
    the infringing Products and Services rather than the infringer; and


 


	 	(b)	the
    balance, if any, remaining after Company and Hospital have been compensated under Section 7.6(a) shall be shall be shared
    equally by the Parties. 


 




    	 	15	 



    	 



    

 


8.
INDEMNIFICATION AND INSURANCE


 


8.1
Indemnification.


 


	 	(a)	Company
    shall indemnify, defend and hold harmless Hospital and its Affiliates and their respective trustees, directors, officers,
    medical and professional staff, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”),
    against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation) incurred
    by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments
    arising out of COMPANY’s use in any manner hereunder, storage, handling, or other action, of Materials, and/or
    arising out of any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty,
    or strict liability) concerning any product, process or service made, used, or sold or performed pursuant to any right or
    license granted under this Agreement. 
	 	 	 
	 	(b)	Company
    agrees, at its own expense, to provide attorneys reasonably acceptable to the Hospital to defend against any actions brought
    or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not
    such actions are rightfully brought; provided, however, that any Indemnitee shall have the right to retain its own counsel,
    at the expense of Company, if representation of such Indemnitee by counsel retained by Company would be inappropriate because
    of conflict of interests of such Indemnitee and any other party represented by such counsel. Company agrees to keep Hospital
    informed of the progress in the defense and disposition of such claim and to consult with Hospital prior to any proposed settlement.
	 	 	 
	 	(c)	This
    section 8.1 shall survive expiration or termination of this Agreement.


 


8.2
Insurance.


 


	 	(a)	Beginning
    at such time as any such product, process or service is being commercially distributed, sold, leased or otherwise transferred,
    or performed or used (other than for the purpose of obtaining regulatory approvals), by Company, an Affiliate or Sublicensee,
    Company shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less
    than $2,000,000 per incident and $2,000,000 annual aggregate and naming the Indemnitees as additional insureds. Such commercial
    general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage
    for Company’s indemnification under Section 8.1 of this Agreement. If Company elects to self-insure all or part of the
    limits described above (including deductibles or retentions which are in excess of $250,000 annual aggregate) such self-insurance
    program must be acceptable to the Hospital and the Risk Management Foundation. The minimum amounts of insurance coverage required
    under this Section 8.2 shall not be construed to create a limit of Company’s liability with respect to its indemnification
    under Section 8.1 of this Agreement.


 




    	 	16	 



    	 



    

 


	 	(b)	Company
    shall provide Hospital with written evidence of such insurance upon request of Hospital. Company shall provide Hospital with
    written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance; if
    Company does not obtain replacement insurance providing comparable coverage prior to the expiration of such fifteen (15) day
    period, Hospital shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without
    notice or any additional waiting periods.
	 	 	 
	 	(c)	Company
    shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i)
    the period that any such product, process, or service is being commercially distributed, sold, leased or otherwise transferred,
    or performed or used (other than for the purpose of obtaining regulatory approvals), by Company or by a licensee, affiliate
    or agent of Company and (ii) a reasonable period after the period referred to in (c) (i) above which in no event shall be
    less than fifteen (15) years.
	 	 	 
	 	(d)	This
    section 8.2 shall survive expiration or termination of this Agreement.


 


9.
DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY


 


9.1
Title to Patent Rights. To the best knowledge of Hospital’s Office of Research, Ventures and Licensing, Hospital
is the owner by assignment from Drs. Poznansky, Luster and Scadden of the Patent Rights and has the authority to enter into this
Agreement and license the Patent Rights to Company hereunder.


 


9.2
No Warranties. HOSPITAL MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE PATENT RIGHTS
OR MATERIALS AND THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS,
WHETHER OR NOT DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME. SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, HOSPITAL MAKES NO WARRANTY
OR REPRESENTATION (i) REGARDING THE VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE PATENT
RIGHTS, AND (ii) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR MATERIALS OR ANY PRODUCT WILL NOT INFRINGE ANY PATENTS OR OTHER
INTELLECTUAL PROPERTY RIGHTS OF HOSPITAL OR OF ANY THIRD PARTY.


 




    	 	17	 



    	 



    

 


9.3
Limitation of Liability. IN NO EVENT SHALL HOSPITAL OR ANY OF ITS AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS,
OFFICERS, MEDICAL OR PROFESSIONAL STAFF, EMPLOYEES AND AGENTS BE LIABLE TO LICENSEE OR ANY OF ITS AFFILIATES, SUBLICENSEES OR
DISTRIBUTORS FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR
THE LICENSE OR RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, INCLUDING WITHOUT LIMITATION ECONOMIC
DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER HOSPITAL SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW,
OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.


 


10.
TERM AND TERMINATION


 


10.1
Term. The term of this Agreement shall commence on the Effective Date and shall remain in effect until the later of:


 


	 	(a)	the
    date on which all issued patents and filed patent applications within the Patent Rights have expired or been abandoned, and
    
	 	 	 
	 	(b)	one
    (1) year after the last Sale for which a royalty is due under Section 4.5(a)(ii); 


 


unless
this Agreement is terminated earlier in accordance with any of the other provisions of Section 10.


 


10.2
Termination for Failure to Pay. If Company fails to make any payment due hereunder, Hospital shall have the right to terminate
this Agreement upon ten (10) business days written notice, unless Company makes such payments plus any interest due, as set forth
in Section 4.7, within said ten (10) day notice period. If payments are not made, Hospital may immediately terminate this Agreement
at the end of said ten (10) day period. Company shall be entitled to only one such cure period in a calendar year; for a second
failure to make payment on time, Hospital shall have the right to terminate this Agreement immediately upon written notice.


 


10.3
Termination for Insurance and Insolvency.


 


	 	(a)	Insurance.
    Hospital shall have the right to terminate this Agreement in accordance with Section 8.2(b) if Company fails to maintain the
    insurance required by Section 8.2. 
	 	 	 
	 	(b)	Insolvency
    and other Bankruptcy Related Events. Hospital shall have the right to terminate this Agreement immediately upon written
    notice to Company with no further notice obligation or opportunity to cure if Company: (i) shall become insolvent; (ii) shall
    make an assignment for the benefit of creditors; or (iii) or shall have a petition in bankruptcy filed for or against it.
    


 


10.4
Termination for Non-Financial Default. If Company, any of its Affiliates or any Sublicensee shall default in the performance
of any of its other obligations under this Agreement not otherwise covered by the provisions of Section 10.2 and 10.3, and if
such default has not been cured within sixty (60) days after notice by Hospital in writing of such default, Hospital may immediately
terminate this Agreement, and/or any license granted hereunder with respect to the country or countries in which such default
has occurred, at the end of said sixty (60) day cure period. Hospital shall also have the right to terminate this Agreement and/or
any such license immediately, upon written notice, in the event of repeated defaults even if cured within such sixty (60) day
periods.


 




    	 	18	 



    	 



    

 


10.5
Challenging Validity. During the term of this Agreement, Company shall not challenge, and shall restrict Company Affiliates
and Sublicensees from challenging, the validity of the Patent Rights and in the event of any breach of this provision Hospital
shall have the right to terminate this Agreement and any license granted hereunder immediately. In addition, if the Patent Rights
are upheld Company shall reimburse Hospital for its legal costs and expenses incurred in defending any such challenge.


 


10.6
Termination by Company. Company shall have the right to terminate this Agreement by giving ninety (90) days advance written
notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section
10.9.


 


10.7
Effect of Termination on Sublicenses. Any sublicenses granted by Company under this Agreement shall provide for termination
or assignment to Hospital of Company’s interest therein, at the option of Hospital, upon termination of this Agreement or
upon termination of any license hereunder under which such sublicense has been granted.


 


10.8
Effects of Termination of Agreement. Upon termination of this Agreement or any of the licenses hereunder for any reason,
final reports in accordance with Section 5 shall be submitted to Hospital and all royalties and other payments, including without
limitation any unreimbursed Patent Costs, accrued or due to Hospital as of the termination date shall become immediately payable.
Company shall cease, and shall cause its Affiliates and Sublicensees to cease under any sublicense granted by Company, all Sales
and uses of Products and Processes upon such termination, subject to Section 10.9. Company shall cease, and shall cause its Affiliates
and Sublicensees to cease under any sublicense granted by Company, all uses of MATERIALS, related material and any derivative
thereof, and shall destroy or cause to be destroyed any MATERIALS, related material and any derivative thereof then in its possession
or control. The termination or expiration of this Agreement or any license granted hereunder shall not relieve Company, its Affiliates
or Sublicensees of obligations arising before such termination or expiration.


 


10.9
Inventory. Upon early termination of this Agreement other than for Company default, Company, Company Affiliates and Sublicensees
may complete and sell any work-in-progress and inventory of Products that exist as of the effective date of termination provided
that (i) Company pays Hospital the applicable running royalty or other amounts due on such Net Sales in accordance with the terms
and conditions of this Agreement, and (ii) Company, Company Affiliates and Sublicensees shall complete and sell all work-in-progress
and inventory of Products within six (6) months after the effective date of termination. Upon expiration of this Agreement, Company
shall pay to Hospital the royalties set forth in Section 4.5(a) for Sales of any Product that was in inventory or was a work-in-progress
on the date of expiration of the Agreement.


 




    	 	19	 



    	 



    

 


11.
COMPLIANCE WITH LAW


 


11.1
Compliance. Company shall have the sole obligation for compliance with, and shall ensure that any Affiliates and Sublicensees
comply with, all government statutes and regulations that relate to Products and Processes, including, but not limited to, those
of the Food and Drug Administration and the Export Administration, as amended, and any applicable laws and regulations of any
other country in the License Territory. Company agrees that it shall be solely responsible for obtaining any necessary licenses
to export, re-export, or import Products or Processes covered by Patent Rights and/or Confidential Information. Company shall
indemnify and hold harmless Hospital for any breach of Company’s obligations under this Section 11.1.


 


11.2
Patent Numbers. Company shall cause all Products sold in the United States to be marked with all applicable U.S. Patent
Numbers, to the full extent required by United States law. Company shall similarly cause all Products shipped to or sold in any
other country to be marked in such a manner as to conform with the patent laws and practices of such country.


 


12.
MISCELLANEOUS


 


12.1
Entire Agreement. This Agreement constitutes the entire understanding between the Parties with respect to the subject matter
hereof.


 


12.2
Notices. Any notices, reports, waivers, correspondences or other communications required under or pertaining to this Agreement
shall be in writing and shall be delivered by hand, or sent by a reputable overnight mail service (e.g., Federal Express), or
by first class mail (certified or registered), or by facsimile confirmed by one of the foregoing methods, to the other party.
Notices will be deemed effective (a) three (3) working days after deposit, postage prepaid, if mailed, (b) the next day if sent
by overnight mail, or (c) the same day if sent by facsimile and confirmed as set forth above or delivered by hand. Unless changed
in writing in accordance with this Section, the notice address for Hospital shall be as follows:


 


Executive
Director, Research Ventures and Licensing


Massachusetts
General Hospital


101
Huntington Avenue, 4th Floor


Boston,
MA 02199


 


Fax
No. (617) 954-9361


 


12.3
Amendment; Waiver. This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument
executed by an authorized signatory of the Parties or, in the case of a waiver, by the Party waiving compliance. The failure of
either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later
time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a further or continuing waiver
of such condition or term or of any other condition or term.


 




    	 	20	 



    	 



    

 


12.4
Binding Effect. This Agreement shall be binding upon and inure to the benefit of and be enforceable by the Parties hereto
and their respective permitted successors and assigns.


 


12.5
Assignment. Company shall not assign this Agreement or any of its rights or obligations under this Agreement without the
prior written consent of Hospital; provided, however, that if Company has fulfilled its diligence obligations as set forth in
Section 3, no such consent will be required to assign this Agreement to a successor of the Company’s business to which this
Agreement pertains or to a purchaser of substantially all of the Company’s assets related to this Agreement, so long as
such successor or purchaser shall agree in writing to be bound by all of the terms and conditions hereof prior to such assignment.
Company shall notify Hospital in writing of any such assignment and provide a copy of all assignment documents and related agreements
to Hospital within thirty (30) days of such assignment. Failure of an assignee to agree to be bound by the terms hereof or failure
of Company to notify hospital and provide copies of assignment documentation shall be grounds for termination of this Agreement
for default. Further, neither any rights granted under this Agreement nor any sublicense may be assigned by any Sublicensee without
the prior written consent of Hospital.


 


12.6
Force Majeure. Neither Party shall be responsible for delays resulting from causes beyond the reasonable control of such
Party, including without limitation fire, explosion, flood, war, sabotage, strike or riot, provided that the nonperforming Party
uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever such causes are removed.


 


12.7
Use of Name. Neither Party shall use the name of the other Party or of any trustee, director, officer, staff member, employee,
student or agent of the other Party or any adaptation thereof in any advertising, promotional or sales literature, publicity or
in any document employed to obtain funds or financing without the prior written approval of the Party or individual whose name
is to be used. For Hospital, such approval shall be obtained from Hospital’s VP of Public Affairs.


 


12.8
Governing Law. This Agreement shall be governed by and construed and interpreted in accordance with the laws of the Commonwealth
of Massachusetts, excluding with respect to conflict of laws, except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent shall have been granted. Each Party agrees to submit
to the exclusive jurisdiction of the Superior Court for Suffolk County, Massachusetts, and the United States District Court for
the District of Massachusetts with respect to any claim, suit or action in law or equity arising in any way out of this Agreement
or the subject matter hereof.


 


12.9
Hospital Policies. Company acknowledges that Hospital’s employees and medical and professional staff members and
the employees and staff members of Hospital’s Affiliates are subject to the applicable policies of Hospital and such Affiliates,
including, without limitation, policies regarding conflicts of interest, intellectual property and other matters. Company shall
provide Hospital with any agreement it proposes to enter into with any employee or staff member of Hospital or any of Hospital’s
Affiliates for Hospital’s prior review and shall not enter into any oral or written agreement with such employee or staff
member which conflicts with any such policy. Hospital shall provide Company, at Company’s request, with copies of any such
policies applicable to any such employee or staff member.


 




    	 	21	 



    	 



    

 


12.10
Severability. If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent
jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof,
it is the intention of the parties that the remainder of this Agreement shall not be effected thereby. It is further the intention
of the parties that in lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as
part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the
parties to such invalid, illegal or enforceable provision, but shall be valid, legal and enforceable.


 


12.11
Survival. In addition to any specific survival references in this Agreement, Sections 1, 2.4, 4.2, 4.6, 4.7, 5.3, 5.4,
5.5, 6.4, 8.1, 8.2, 9.2, 9.3, 10.7, 10.8, 10.9, 12.1, 12.2, 12.3, 12.4, 12.7, 12.8, 12.9, 12.10, 12.11, 12.12 and 12.13 shall
survive termination or expiration of this Agreement. Any other rights, responsibilities, obligations, covenants and warranties
which by their nature should survive this Agreement shall similarly survive and remain in effect.


 


12.12
Interpretation. The parties hereto are sophisticated, have had the opportunity to consult legal counsel with respect to
this transaction and hereby waive any presumptions of any statutory or common law rule relating to the interpretation of contracts
against the drafter.


 


12.13
Headings. All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.


 


[Remainder
of page intentionally left blank.]


 




    	 	22	 



    	 



    

 


IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective
Date first written above.


 


	VICapsys
    Inc.	 	The
    general Hospital Corporation
	 	 	 	 	 
	BY:	/s/
    Steven Gorlin	 	BY:	/s/
    Frances Toneguzzo
	Name:	Steven
    Gorlin	 	Name:	Frances
    Toneguzzo
	TITLE:	Chief
    Executive Officer	 	TITLE:	Executive
    Director
	 	 	 	 	 
	DATE:	May
    8, 2013	 	DATE:	May
    8, 2013


 




    	 	23	 



    	 



    

 


Appendix
A1


 


DESCRIPTION
OF PATENT RIGHTS


MG
Case #01416


 


Title:
Purposeful Movement of Human Migratory Cells Away From an Agent Source


 


Filing
Type: PCT


Country:
WO


Priority
Date: 4/8/1999


Patent
Filing Date: 4/7/2000


Serial
Number: PCT/US00/09678


Publication
Date: 10/12/2000


Publication
Number: WO00/59941


 


Filing
Type: UTIL


Number
Filing: 1


Status:
Issued


Country:
US


Priority
Date: 4/8/1999


Patent
Filing Date: 4/7/2000


Serial
Number: 09/546,153


Patent
Number: 6,448,054


Patent
Issue Date: 9/10/2002


Estimated
Patent Expiration Date: 4/7/2020


 


Filing
Type: DIV


Number
Filing: 1


Status:
Issued


Country:
US


Priority
Date: 4/8/1999


Patent
Filing Date: 7/9/2002


Serial
Number: 10/191,988


Publication
Date: 1/23/2003


Publication
Number: US-2003-0017141-A1


Patent
Number: 7,141,363


Patent
Issue Date: 11/28/2006


Estimated
Patent Expiration Date: 7/9/2022


 


Purposeful
Movement of Human Migratory Cells Away From an Agent Source


Filing
Type: DIV


Number
Filing: 2


Status:
Issued


Country:
US


Priority
Date: 4/8/1999


Patent
Filing Date: 4/20/2006


Serial
Number: 11/407,477


Publication
Date: 2/1/2007


Publication
Number: US-2007-0026007-A1


Patent
Number: 7,775,469


Patent
Issue Date: 8/17/2010


Estimated
Patent Expiration Date: 4/20/2026


 


Title:
Purposeful Movement of Human Migratory Cells Away From an Agent Source


Filing
Type: PCT


Status:
Pending


Country:
EP


Priority
Date: 4/8/1999


Patent
Filing Date: 4/7/2000


Serial
Number: 00922067.4


Publication
Date: 1/9/2002


Publication
Number: 1169348




    	 	24	 



    	 



    

 


APPENDIX
A2


 


DESCRIPTION
OF XENOTRANSPLANTATION PATENT RIGHTS


MG
Case #00841, 02941, 03476


 


Title:
Alpha (1,3) Galactosyltransferase Negative Swine


Filing
Type: CONT 


Number
Filing: 1 


Status:
Issued 


Country:
US 


Priority
Date: 4/13/1994 


Patent
Filing Date: 3/26/1996 


Serial
Number: 08/621,700 


Patent
Number: 6,153,428 


Patent
Issue Date: 11/28/2000 


Estimated
Patent Expiration Date: 3/26/2016


 


Title:
Alpha (1,3) Galactosyltransferase Negative Swine


Filing
Type: CONT 


Number
Filing: 2 


Status:
Issued 


Country:
US 


Priority
Date: 4/13/1994 


Patent
Filing Date: 9/15/1997 


Serial
Number: 08/929,940 


Patent
Number: 6,413,769 


Patent
Issue Date: 7/2/2002 


Estimated
Patent Expiration Date: 9/15/2017 


 


Title:
Method to Enrich for (1,3)-Galactosyltransferase Null Pig Cells


Filing
Type: PCT 


Number
Filing: 1 


Status:
Issued 


Country:
US 


Priority
Date: 8/14/2002 


Patent
Filing Date: 10/3/2005 


Serial
Number: 10/524,381 


Patent
Number: 7,547,522 


Patent
Issue Date: 6/16/2009 


Estimated
Patent Expiration Date: 10/3/2025


 


Title:
α(1,3)-galactosyltransferase knockout swine, tissues and organs


Patent
Number: 7547816 


Patent
Issue Date: June 16, 2009. 


Estimated
Expiration Date: December 23, 2022. 


 




    	 	25	 



    	 



    

 


Appendix
B1


 


DESCRIPTION
OF TECHNOLOGICAL INFORMATION


 


To
be completed by Dr. Poznansky


 


Appendix
B2


 


DESCRIPTION
OF MATERIALS


 


To
be completed if Company licenses transgenic xeno-islets


 




    	 	26	 



    	 



    

 


Appendix
C


SALES
REPORTS


 


	AGREEMENT
    INCOME REPORT	Royalty
    Income


 


MGH
Agreement # A215841


	Licensee
    - 	 
	Sub-Licensee
    -	 


 


Separate
reports must be filed for:


	 	1.	Each
    Product sold.
	 	2.	Each
    country of sale, if different deductions or royalty rates apply.


 


	Product
    Name:	 


Report
Time Period:


	 	From	mm/dd/yyyy	 
	 	To	mm/dd/yyyy	 


 





	 
	 



 


	Country
    of Sale	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Quantity
    Sold	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Gross
    Sales (USD)	 	$	 	$	 	$
	 	 	 	 	 	 	 
	Exchange
    Rate	 	 	 	 	 	 


 


Deductions
(Itemize)


Please
list each deduction separately. Use same definition as appears in Agreement and include the contract paragraph as a reference
(Std Section 1.17(a)(ii) line item deductions listed below).


 


	A1.	 	 	 	 	 	 
	A2.	 	 	 	 	 	 
	A3.	 	 	 	 	 	 
	A4.	 	 	 	 	 	 
	B.	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Total
    Deductions 	 	(_____________________)	 	(_____________________)	 	(______________________)
	 	 	 	 	 	 	 
	Net
    Sales	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Royalty
    Percentage	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Credits
    (itemize)	 	(_____________________)
    	 	 (_____________________)
    	 	 (_____________________)
	 	 	 	 	 	 	 
	Royalties
    Due	 	$	 	$	 	$


 


	 




 


PLEASE
ATTACH DETAIL SALES REPORTS AS REQUIRED


 




    	 	27	 



    	 



    

 


Appendix
D


 


	AGREEMENT
    INCOME REPORT	Sublicense
    Income


 


MGH
Agreement # A215841


	Licensee
    -	 
	Sub-Licensee
    -	 


 


Separate
reports must be filed for Payments associated with each Product:


 


	Product
    Name:	 


 


Report
Time Period:


 


	 	From	mm/dd/yyyy	 
	 	 	 	 
	 	To	mm/dd/yyyy	 


 


	 







Detailed
Explanation of Payment


Required
for “Other Payment”


 


	Annual
    Fees/Minimum Royalties	$	 	 
	 	 	 	 
	Milestone
    Payments	$	 	 
	 	 	 	 
	Sublicense
    Fees and Royalties	$	 	 
	 	 	 	 
	Other
    Payment	$	 	 
	 	 	 	 
	Other
    Payment	$	 	 
	 	 	 	 
	Other
    Payment	$	 	 
	 	 	 	 
	TOTAL	$	 	 


 


	 




 


PLEASE
ATTACH DETAIL AS REQUIRED 


 




    	 	28	 



    	 



    

 


Appendix
E


 


CONFIDENTIALITY
TERMS AND CONDITIONS


 


1.
Definition of Confidential Information. “Confidential Information” shall mean any information, including but
not limited to data, techniques, protocols or results, or business, financial, commercial or technical information, disclosed
by one Party (each a “Discloser” as applicable) to the other Party (each a “Recipient” as applicable)
in connection with the terms of that certain Exclusive License Agreement dated ___________________ (the “License Agreement”)
and identified as confidential at the time of disclosure (the “Purpose”). Hospital’s Confidential Information
shall also include all information disclosed by Hospital to Company in connection with the Patent Rights. Capitalized terms used
in this Appendix that are not otherwise defined herein have the meanings ascribed in the License Agreement to which this Appendix
is attached and made a part thereof.


 


2.
Exclusions. “Confidential Information” under this Agreement shall not include any information that (i) is or
becomes publicly available through no wrongful act of Recipient; (ii) was known by Recipient prior to disclosure by Discloser,
as evidenced by tangible records; (iii) becomes known to Recipient after disclosure from a third party having an apparent bona
fide right to disclose it; (iv) is independently developed or discovered by Recipient without use of Discloser’s Confidential
Information, as evidenced by tangible records; or (v) is disclosed to another party by Discloser without restriction on further
disclosure. The obligations of confidentiality and non-use set forth in this Agreement shall not apply with respect to any information
that Recipient is required to disclose or produce pursuant to applicable law, court order or other valid legal process provided
that Recipient promptly notifies Discloser prior to such required disclosure, discloses such information only to the extent so
required and cooperates reasonably with Discloser’s efforts to contest or limit the scope of such disclosure.


 


3.
Permitted Purpose. Recipient shall have the right to, and agrees that it will, use Discloser’s Confidential Information
solely for the Purpose as described in the License Agreement, except as may be otherwise specified in a separate definitive written
agreement negotiated and executed between the parties.


 


4.
Restrictions. For the term of the License Agreement and a period of [three (3)] years thereafter (and indefinitely
with respect to any individually identifiable health information disclosed by Hospital to Company, if any), each Recipient agrees
that: (i) it will not use such Confidential Information for any purpose other than as specified herein, including without limitation
for its own benefit or the benefit of any other person or entity; and (ii) it will use reasonable efforts (but no less than the
efforts used to protect its own confidential and/or proprietary information of a similar nature) not to disclose such Confidential
Information to any other person or entity except as expressly permitted hereunder. Recipient may, however, disclose Discloser’s
Confidential Information only on a need-to-know basis to its and its Affiliates employees, staff members and agents (“Receiving
Individuals”) who are directly participating in the Purpose and who are informed of the confidential nature of such information,
provided Recipient shall be responsible for compliance by Receiving Individuals with the terms of this Agreement and any breach
thereof. Each party further agrees not to use the name of the other party or any of its Affiliates or any of their respective
trustees, directors, officers, staff members, employees, students or agents in any advertising, promotional or sales literature,
publicity or in any document employed to obtain funds or financing without the prior written approval of the party or individual
whose name is to be used, in the case of Hospital such approval to be given by the Public Affairs Department. This Section 4 shall
survive termination or expiration of this Agreement.


 




    	 	29	 



    	 



    

 


5.
Right to Disclose. Discloser represents that to the best of its knowledge it has the right to disclose to each Recipient
all of Discloser’s Confidential Information that will be disclosed hereunder.


 


6.
Ownership. All Confidential Information disclosed pursuant to this Agreement, including without limitation all written
and tangible forms thereof, shall be and remain the property of the Discloser. Upon termination of this Agreement, if requested
by Discloser, Recipient shall return or destroy at Discloser’s discretion all of Discloser’s Confidential Information,
provided that Recipient shall be entitled to keep one copy of such Confidential Information in a secure location solely for the
purpose of determining Recipient’s legal obligations hereunder.


 


7.
No License. Nothing in this Agreement shall be construed as granting or conferring, expressly or impliedly, any rights
by license or otherwise, under any patent, copyright, or other intellectual property rights owned or controlled by Discloser relating
to Confidential Information, except as specifically set forth in the License Agreement.


 


8.
Remedies. Each party acknowledges that any breach of this Agreement by it may cause irreparable harm to the other party
and that each party is entitled to seek injunctive relief and any other remedy available at law or in equity.


 


9.
General. These Confidentiality Terms and Conditions, along with the License Agreement, contain the entire understanding
of the parties with respect to the subject matter hereof, and supersede any prior oral or written understandings between the parties
relating to confidential treatment of information. Sections 1, 2, 4, 6, 8 and 9 of these Confidentiality Terms and Conditions
shall survive any expiration or termination of the License Agreement.


 




    	 	30	 



    	 



    

 


APPENDIX
F


 


COLLABORATIVE
RESEARCH AGREEMENT


 


To
be provided shortly, when the research plan and budget for work to be done at MGH alone is finalized. Current plans describe both
Company and MGH research goals


 




    	 	31