LICENSE AGREEMENT
This License Agreement (the "Agreement") between WAKE FOREST UNIVERSITY, an
educational institution organized under the laws of the State of North Carolina,
having its principal offices at Xxxxxxx-Xxxxx, Xxxxx Xxxxxxxx 00000 ("Wake
Forest"), and IDT, INC., a Commonwealth of Pennsylvania Corporation with
principal offices at 0000 Xxxxxxx Xxxx Xxxx #0000, Xxxxxxxxxx, Xxxxxxxxxxxx
00000 (the "Company").
For good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the parties, intending to be legally bound, do hereby
agree as follows:
1. DEFINITIONS
For all purposes of this Agreement the following terms as used herein, will
have the meanings specified below:
1.1 "The Method" means all proprietary developments, data and/or
information currently owned by Wake Forest relating to A METHOD OF HEATED
PERFUSION OF CHEMOTHERAPY DRUG IN HE TREATMENT OF INTRAPERITONEAL AND OTHER
CANCERS, including methods, processes, apparatus, devices, systems, products,
articles of manufacture, and appliances, made and/or developed by Xxxxx X.
Xxxxxx, M.D.C.M. and Xxxxxx X. Xxxxxxx, Pharm.D., employees of Wake Forest. The
Method utilizes the Company's THERMOCHEM-HT SYSTEM-TM-, or a related or
equivalent system, (hereafter "System") and employs disposable items and/or
accessories such as ThermoChem-HT disposable packs for use with or as part of
the System in the practice or performance of the Method.
1.2 "Disposables" means all disposable accessories or items, such as the
ThermoChem-HT disposable packs, used during the practice or performance of the
Method or used with or as part of the System for or during the performance or
practice of the Method provided by IDT.
1.3 "Effective date" means the date of the first sale of the Disposables.
1.4 "Affiliate" of a specified entity means an entity that directly or
indirectly controls, is controlled by, or is under common control with, the
specified entity. For purposes of this Agreement, the direct or indirect
ownership of more than 50% of the outstanding voting shares of an entity, the
right to receive
50% or more of the profits or earnings of an entity, or the right to control
policy decisions of an entity, will be deemed to constitute control.
1.5 "Licensed Products" means the Disposables.
1.6 "Net Sales" means the gross sales amount of all sales or leases of
Licensed Products by or on behalf of the Company or Affiliates to any customer
minus any customary quantity, trade or cash discounts actually given, allowed
returns or allowances given In lieu of allowed returns, freight and insurance,
if separately itemized on the invoice and paid by the customer, and any value
added, sales, use or excise taxes actually included in the invoice amount,
provided, however, that no deductions will be taken for any other costs incurred
in the manufacture, offering for sale, sale, distribution, shipment, promotion,
advertisement, exploitation or commercialization of the Method or the Licensed
Products, for any costs of collections or any uncollectible accounts, or for any
other cots, expenditures, fees or expenses. Licensed Products will be considered
"sold" when delivered, billed out, or invoices, whichever comes first. For all
Licensed Products used by the Company as premiums to promote, market, sell
and/or lease products not employed in the Method, such premiums will be deemed
to have been sold at the Company's customary sales price.
2. GRANT OF LICENSE
2.1 Wake Forest hereby grants to the Company for the term of the License
set forth below, an exclusive, worldwide right and license to use and practice
the Method, subject, however, to a reservation of rights by Wake Forest to
practice and use the Method for Wake Forest's own purposes as well as any and
all other reservation of rights by Wake Forest provided in this Agreement.
2.2 Wake Forest hereby agrees that it will not grant any other license to
practice or use the Method for the term of the License set forth below subject,
however, to any reservation of rights by Wake Forest provided in this Agreement
to practice and use the Method for Wake Forest's own purposes as well as any and
all other reservation of rights by Wake Forest provided in this Agreement.
3. LICENSE FEES AND ROYALTIES
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3.1 The Company agrees to pay to Wake Forest the following amounts:
(a) a fee of 50,000 shares of the Company's common stock issued to
Wake Forest for each PMA or 510(d), or equivalent thereof, receiving FDA
approval for the Method or use of the System in the Method;
(b) an earned royalty of six percent (6%) of Net Sales either for
seven (7) years from the Effective date or for as long as Wake Forest utilizes
the System for the Method, whichever is longer;
(c) milestone payments of $10,000 following the submission of Phase I
data on each IDE related to use of the System for the Method and $25,000
following approval by the FDA of a PMA or 510(k) submission as a result of each
IDE involving the xxx of the System for the Method; and
(d) any sublicense fees pursuant to Section 4.2.
3.2 If the Company is required to pay royalties or the like to a third
party in connection with the practice or use of the Method as a result of (I)
governmental laws, (ii) settlement procedures approved by Wake Forest or (iii) a
final, nonappealable judgment in an infringement action, the parties will
negotiate in good faith a royalty reduction in the earned royalty rate set forth
in Section 3.1(b) of this Agreement.
4. SUBLICENSES
4.1 The Company will have the exclusive right to grant sublicenses to
others for the Method provided, however, that any such sublicenses must be
limited by the terms and conditions of this Agreement.
4.2 For any sublicenses granted by the Company hereunder, the Company must
pay to Wake Forest as a sublicense fee that proportion of royalties received
from the Company's sublicensees necessary to yield Wake Forest returns on
Licensed Products sold or leased by such sublicensees equal to the amounts which
Wake Forest would have received from the Company for the Licensed Products sold
or leased by the Company.
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4.3 Termination of the License granted to the Company by Wake Forest under
this Agreement will terminate all sublicenses which may have been granted by the
Company, provided, however, that any sublicensee who desires to continue its
sublicense must so advise Wake Forest in writing of sublicensee's desire to
continue the sublicense within thirty (30) days of the sublicensee's receipt of
written notice of the termination of the Company's License and, subject to the
sublicensee's agreement to assume relative to Wake Forest all the obligations,
including obligations for payment, contained in the sublicense Agreement with
the Company, Wake Forest, in its sole discretion, may elect to continue the
sublicense.
4.4 Any sublicense granted by the Company must first be approved by Wake
Forest, and such approval will not be withheld unreasonably. Any sublicense
granted by the Company must contain provisions corresponding to those of Section
4.3, 6.2, 7.1, 7.2.2, 8.2, 8.3, 8.5, 9, 11, 12, and 14 of this Agreement and
must not extend beyond the time provided in Section 8.1.
5. BEST EFFORTS AND DUE DILIGENCE
5.1 The Company will use its best efforts to bring the Method to market
through a thorough, vigorous and diligent program for exploitation, marketing
and commercialization of the Method.
6. WARRANTY
6.1 Wake Forest warrants that, to its actual knowledge and belief, it is
entitled to license its information regarding the Method.
6.2 All property, whether tangible or intangible, which may be delivered
hereunder, will b e delivered on an "as is, where is" basis without any express
or implied warranty. OTHER THAN THE OBLIGATIONS OF WAKE FOREST SET FORTH IN THIS
AGREEMENT, WAKE FOREST MAKES NO OTHER WARRANTIES WHATSOEVER. WAKE FOREST HEREBY
DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTIES OR MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, ANY IMPLIED WARRANTIES OF NON-INFRINGEMENT OR ANY IMPLIED
WARRANTIES ARISING FROM ANY COURSE OF DEALING, USAGE, OR TRADE PRACTICE. WAKE
FOREST ASSUMES NO RESPONSIBILITY WITH RESPECT TO THE MANUFACTURE, USE, SALE,
LEASE OR DISTRIBUTION OF ANY METHODS, PROCESSES, APPARATUS, DEVICES, SYSTEMS,
PRODUCTS, ARTICLES, AND/OR APPLIANCES DERIVED FROM OR USING THE SYSTEM, METHOD,
OR LICENSED PRODUCTS. WAKE FOREST WILL
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NOT BE LIABLE FOR ANY ACTIVITIES OR COMPANY, ITS AFFILIATES, OR ANY
SUBLICENSEES ARISING OUT OF THIS AGREEMENT OR FOR LOSS OF PROFITS, LOSS OF USE,
OR ANY OTHER DIRECT, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES.
7. RECORDS, REPORTS, AND PAYMENTS
7.1 RECORDS
7.1.1 The Company will keep and maintain and will require any of its
sublicensees to keep and maintain complete, accurate, and correct records and
books relating to the sale or lease of the Licensed Products for the Method for
five (5) years following the end of the applicable calendar or fiscal year to
which such records and books pertain.
7.2 REPORTS
7.2.1 The Company will render to Wake Forest quarterly reports for
each calendar year during the term o the License under this Agreement. Within
thirty days following each such calendar quarter the Company will provide to
Wake Forest a written report setting forth the following information:
(a) accounting for all Licensed Products sold, distributed, or leased;
(b) gross sales of Licensed Products;
(c) any applicable deductions, allowances, and charges as provided in
Section 1.6 of this Agreement;
(d) total Net Sales;
(e) total royalties due;
(f) fees or milestone payments due under Section 3.1(b) and (d);
(g) reports of Sublicenses sales;
(h) income from sublicenses sales; and
(i) sublicense fees due to Wake Forest under Section 3.1(e).
The Company will remit to Wake Forest with each such report the amount
of payments or fees shown thereby to be due. If no sales or leases of the
Licensed Products were made during any calendar quarter, the Company will
provide to Wake Forest a statement to that effect.
7.2.2 The books and records of account kept by the Company and any
sublicensee must be made available upon reasonable notice, during normal
business hours for examination
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by one or more auditors of Wake Forest's choosing, who will be permitted to
enter upon the premises of the Company and any sublicensee and make and retain
copies of any and all parts of said books and records of account, including
invoices that are relevant to any report required to be rendered by the Company.
Said copies will be provided at no cost to Wake Forest. Any amount found to have
been owed but not paid will be paid promptly to Wake Forest with interest at the
rate of fifteen percent (15%) per year. In the event any such audit shows that
the Company or any sublicensee has underpaid any obligation by five percent (5%)
or more during any calendar quarter, then such Company or applicable sublicensee
will reimburse Wake Forest for the out-of-pocket expense for such audit.
7.2.3 Royalty or other payments will be paid in United States dollars
to Wake Forest in Winston-Salem, North Carolina, or at such other place as Wake
Forest may reasonably designate consistent with the laws and regulations
controlling in any foreign country. Any withholding taxes which the Company is
required by law to withhold on remittance of the royalty payments will be
deducted from the royalty paid. The Company will furnish Wake Forest with
original copies of all official receipts for such taxes. If any royalties, fees,
or payments hereunder are based on Net Sales converted from foreign currency,
such conversion will be made by using the exchange rate prevailing at a
first-class foreign exchange bank on the last business day of the calendar
quarter reporting period to which such royalty payments relate.
8. TERMINATION
8.1 Unless sooner canceled or terminated as herein provided, this
License will continue for seven (7) years from the Effective Date or until Wake
Forest discontinues the use of the Method with the System, whichever is longer.
8.2 If the Company becomes bankrupt or insolvent, or files a petition
in bankruptcy, or if the business of the Company is placed in the hands of a
receiver, assignee or trustee for the benefit of creditors, whether by the
voluntary act of the Company or otherwise, this Agreement will automatically
terminate without any notice whatsoever to the Company.
8.3 If the Company at any time defaults in the payment of any fee,
royalty or other payment, or in providing any report due under this Agreement
makes any false report, or commits a material breach of any covenant or
undertaking set forth herein,
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Wake Forest will have the right, in addition to all other remedies available, to
terminate the License under this Agreement and revoke any and all licenses
herein grated, by giving the Company thirty (30) days prior written notice of
such termination, provided, however, that if the Company will have rectified
such default or breach within such thirty (30) day period, then this Agreement
will remain in effect and the rights and licenses herein granted will be in
force as if no default or breach had occurred on the part of the Company. In the
event of termination under this Section, the Company will continue to be
obligated to pay to Wake Forest all fees, royalties, or other payment payable at
the time of termination pursuant to this Section.
8.4 The Company will have the right to terminate the License under this
Agreement with or without cause at any time on six (6) months notice by
certified mail to Wake Forest.
8.5 Upon termination of this License for any reason, nothing herein will be
construed to release either party from any obligation accrued prior to the
effective date of such termination. Any termination of this License will not
relieve the Company of any libations to make payments for any fees, royalties or
other payments that may have accrued prior to the date of such termination. The
Company is prohibited from selling, using, or exploiting the Method if the
License is terminated.
8.6 Upon termination of this License for any reason the rights granted
herein will immediately revert to Wake Forest.
9. INDEMNIFICATION AND INSURANCE
The Company will indemnify, defend, and hold harmless Wake Forest from any
suit, action, liability, claim, demand, judgment, and expense arising out of the
fault of the Company or from the use of the System. The Company agrees that if
any such claim is asserted or such suit is brought against Wake Forest, or its
officers, trustees, employees, agents, or subcontractors or their employees, the
Company will defend such claim or suit at the expense of the Company. The
Company will cooperate with Wake Forest in the management of such claim or suit.
The counsel chosen by the Company must be reasonably acceptable to Wake Forest
and agree to represent Wake Forest. The Company will not settle or compromise
any claim or action in a manner that imposes any restrictions or obligations on
Wake Forest without Wake
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Forest's written consent, which consent will not be unreasonably withheld.
10. ASSIGNMENT
The Company may assign or otherwise transfer this Agreement and the License
granted hereby to and only to the assignee or transferee of the Company's entire
business or of that part of the Company's business to which the License granted
hereby relates, provided, however, that such assignee or transferee agrees in
writing to be bound by the terms and conditions of this Agreement. The Company
will give Wake Forest thirty (30) days prior notice of such assignment and
transfer and if Wake Forest raises no reasonable objection in writing to such
assignment or transfer within fifteen (I 5) days after Wake Forest receives such
notice, then Wake Forest will be deemed to have approved such assignment or
transfer so long as the assignee or -transferee agrees in writing to be bound by
the terms and conditions of this Agreement. If the Company fails to give Wake
Forest such notice of transfer or assignment, then Wake Forest will have the
right to terminate this Agreement or the License under this Agreement by
providing written notice of termination to the transferee or assignee. Further,
if the Company sells or otherwise transfers its entire business or that part of
its business to which the License granted hereby relates and the assignee or
transferee does not agree in writing to be bound by the terms and conditions of
this Agreement within fifteen (I 5) days of any request by Wake Forest, then
Wake Forest will have the sole right to terminate this Agreement or the License
under this Agreement by providing written notice of termination to such
transferee or assignee.
11. NON-USE OF NAMES
The Company will not use the names of Wake Forest or its employees, nor any
adaptation thereof in any advertising, promotional or sales activities without
prior written consent obtained from Wake Forest in each separate case, which
consent will not be unreasonably withheld.
12. EXPORT CONTROLS
It is understood that Wake Forest is subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes, and other commodities that may require a license from the
applicable agency of the United States Government and/or may require written
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assurances by the Company that the Company will not export data or commodities
to certain foreign countries without prior approval of such agency. Wake Forest
neither represents that a license will not be required nor that, if required, it
will be issued.
13. PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any payment, notice, or other communication pursuant to this Agreement will
be sufficiently made or given on the date of mailing if sent to such party by
certified first class mail, postage prepaid, addressed to it at its address
below, or as it otherwise designates, by written notice given to the other
party:
Wake Forest: Xxxx Xxxxxxx-Xxxxx, Director
Technology Transfer and Industry Relations
Wake Forest University School of Medicine
Xxxxxxx Xxxxxx Xxxxxxxxx
Xxxxxxx-Xxxxx, XX 00000-0000
Company: Xxxxx Xxxxxxx, President
IDT, Inc.
0000 Xxxxxxx Xxxx Xxxx #0000
Xxxxxxxxxx XX 00000
14. MISCELLANEOUS PROVISIONS
14.1 This Agreement will be construed, governed, interpreted, and applied
in accordance with the laws of the State of North Carolina, U.S.A. Jurisdiction
over any dispute arising under, from, or because of this Agreement shall exist
only in North Carolina.
14.2 The parties hereto acknowledge that this Agreement sets forth the
entire agreement and understanding of the parties hereto as to the subject
matter hereof, and will not be subject to any change or modification except by
the execution of a written instrument subscribed to by the parties hereto. The
parties acknowledge that they have entered into or may enter into a separate
Research Agreement that is not intended to replace this Agreement or any part of
this Agreement. Instead, any such Research Agreement is intended to be separate
from and in addition to this Agreement.
14.3 The provisions of this Agreement are severable, and in the event that
any provision of this Agreement will be determined
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to be invalid or unenforceable under any controlling body of law, such
invalidity or unenforceability will not in any way affect the validity or
enforceability of the remaining provisions hereof
14.4 The failure of either party to assert a right hereunder or to insist
upon compliance with any ten-n or condition of this Agreement will not
constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
14.5 In any litigation arising under or relating to this Agreement between
the parties hereto, the prevailing party or parties will be entitled to recover
its reasonable attorneys fees and litigation costs.
14.7 This Agreement will be binding and inure to the benefit of the parties
hereto and their respective affiliates, and permitted successors and assigns.
14.8 The representations, warranties, covenants, and undertakings contained
in this Agreement are for the sole benefit of the parties hereto and their
permitted successors and assigns and such representations, warranties,
covenants, and undertakings will not be construed as conferring any rights on
any other party.
14.9 Nothing contained in this Agreement will be deemed to place the
parties hereto in a partnership, joint venture or agency relationship and
neither party will have the right or authority to obligate or bind the other
party in any manner.
14.10 This Agreement may be executed in two or more counterparts, each of
which will be deemed an original, but all of which taken together will
constitute one and the same in instrument.
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and
seals and duly executed this License Agreement as of the day and year first set
forth above.
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XXXX XXXXXX XXXXXXXXXX XXX, INC.
BY: BY:
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NAME: Xxxxxxxx X. Xxxxx NAME: Xxxxx Xxxxxxx
TITLE: Associate Xxxx for Research TITLE: President
DATE: DATE:
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