THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS BRACKETED ON PAGES 5, 6 AND 8 AND PORTIONS OF
EXHIBIT C AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
LICENSE AGREEMENT
BETWEEN
APOLLON, INC.
AND
THE INSTITUTE OF BIOTECHNOLOGY AND
ADVANCED MOLECULAR MEDICINE, INC.
EFFECTIVE
DECEMBER 1, 1994
LICENSE AGREEMENT
This License Agreement ("Agreement") is made by and between Apollon, Inc., a
corporation organized and existing under the laws of Pennsylvania, ("Apollon"),
having a place of business at Xxx Xxxxx Xxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxxxxx
00000, and The Institute of Biotechnology and Advanced Molecular Medicine, Inc.,
a non-profit corporation organized and existing under the laws of Pennsylvania,
("IBAMM"), having a place of business at 000 Xxxxx Xxxx Xxxxx, Xxxxx,
Xxxxxxxxxxxx 00000.
This Agreement is effective December 1, 1994 ("Effective Date").
WHEREAS Apollon and IBAMM entered into a Sponsored Research Agreement, effective
August 1, 1992, related to a Collaborative Research Project entitled, "The
Development of Genetic Immunization as a Therapeutic Technique for Treatment of
Diseases in Vertebrates" (the "Collaborative Research Project"), to be carried
out under the supervision of Xx. Xxxxx X. Xxxxxx, Principal Investigator
(hereinafter "the Apollon/IBAMM Sponsored Research Agreement"), attached as
Exhibit A hereto and made a part hereof;
WHEREAS the Sponsored Research Agreement granted Apollon an option to negotiate
an exclusive, world-wide, royalty bearing license to any and all patent rights
and know-how, including biological materials, developed by IBAMM in the field
(i.e., facilitated transfer and expression of nucleic acids by mammalian cells
for therapy and/or prophylaxis) of the [CA] [VZ] Collaborative Research Project
during the term of the Sponsored Research Agreement; and
WHEREAS IBAMM has acquired a first option to negotiate a license to intellectual
property of the University of Pennsylvania, with the right to assign such option
solely to Apollon, as
1
set forth in the Sponsored Research Agreement, effective July 1, 1992,
between The Institute of Biotechnology and Advanced Molecular Medicine, Inc.
and the Trustees of the University of Pennsylvania (hereinafter "the
IBAMM/Penn Sponsored Research Agreement"), attached as Exhibit B hereto and
made a part hereof;
WHEREAS Apollon desires to obtain said license to any and all intellectual
property rights of IBAMM arising under the Apollon/IBAMM Sponsored Research
Agreement, including the right to acquire said option to negotiate a license to
the intellectual property of the University of Pennsylvania arising under the
IBAMM/Penn Sponsored Research Agreement, upon the terms and conditions set forth
herein;
NOW THEREFORE, in consideration of the premises and of the mutual promises and
covenants contained herein, and intending to be legally bound thereby, the
parties agree as follows:
I. DEFINITIONS
A. "Patent Rights" shall mean any and all rights owned or controlled by IBAMM
or assigned by IBAMM to the University of Pennsylvania [CA] [VZ] which arise
under any United States or foreign patent application listed in Exhibit C
hereto, and any later filed patent application arising from research carried out
under the Apollon/IBAMM Sponsored Research Agreement and/or the IBAMM/Penn
Sponsored Research Agreement, including any continuation, continuation-in-part,
division, reexamination, reissue or foreign counterpart thereof, and any patent
issuing from any such application.
B. "Collaborative Research Project" shall mean the Research Project Entitled,
"The Development of Genetic Immunization as a Therapeutic Technique for
Treatment of Diseases in Vertebrates" (the "Collaborative Research Project"),
carried out under the supervision of
2
Xx. Xxxxx X. Xxxxxx, Principal Investigator and supported by Apollon under
the Sponsored Research Agreement, effective August 1, 1992.
C. "IBAMM Technical Information" shall mean all technology, formulae,
materials, constructs, trade secrets, technical data and any other information,
owned, controlled or possessed by IBAMM arising from research carried out under
the Apollon/IBAMM Sponsored Research Agreement and/or the IBAMM/Penn Sponsored
Research Agreement, which is directly related to Patent Rights and which is
needed to produce IBAMM Licensed Product(s).
D. "IBAMM Licensed Product" shall mean any product covered by a Valid Claim of
Patent Rights on a country-by-country basis, or any product made, at least in
part, using IBAMM Technical Information.
E. "Net Sales" shall mean: with respect to any quantity of IBAMM Licensed
Product on, any Affiliate or any Sublicensee to an unaffiliated third party, Net
Sales shall be the gross invoice selling price for that quantity of Product,
less: (a) discounts and allowances to customers, (b) credits for returned goods,
(c) prepaid freight, (d) sales taxes or other governmental charges paid in
connection with the sale, (e) commissions and other fees paid to distributors
and other sales agencies for or in connection with the sale of Product.
F. "Sublicensee" shall mean any corporation, company, partnership or business
entity which neither controls nor is controlled by, nor is under common control
with Apollon, to which Apollon transfers by sublicense rights to enable said
party to make and sell IBAMM Licensed Product(s).
G. "Affiliate" shall mean any corporation, company, partnership or other
business entity which either controls, is controlled by, or is under common
control with either party. The word "control" shall mean directly or indirectly
owning or having a partnership interest in at
3
least fifty percent (50%) of the assets or stock normally entitled to vote
for election of directors, or having the right to receive at least fifty
percent (50%) of the profits, or having at least fifty percent (50%) control
of an entity.
H. "Valid Claim" shall mean an issued claim of a Patent Right which has not
lapsed, expired, or become abandoned and which claim has not been declared
invalid by an unreversed or unappealable decision or judgment of a national or
regional patent office or a court of competent jurisdiction.
I. "In Reasonable Competition With A/Such IBAMM Licensed Product" means that it
is demonstrated to IBAMM's reasonable satisfaction that: (a) a competitor's
product is sold in the same geographic and relevant product market as such IBAMM
Licensed Product; and such competitor's product has a unit sales volume that
exceeds twenty-five (25%) percent of Apollon's unit sales volume for such IBAMM
Licensed Product in such geographic market; or (b) two or more competitors'
product(s) are sold in the same geographic and relevant product market as such
IBAMM Licensed Product; and such competitors' product(s) together have a unit
sales volume that exceeds thirty-five percent (35%) of Apollon's unit sales
volume for such IBAMM Licensed Product in such geographic market.
II. OPTION/LICENSE TO APOLLON
As of the Effective Date, IBAMM hereby assigns to Apollon, subject to the terms
and conditions of this Agreement, the exclusive first option to negotiate a
license to Penn Intellectual Property acquired by IBAMM under the IBAMM/Penn
Sponsored Research Agreement effective July 1, 1992. IBAMM further grants to
Apollon, subject to the terms and conditions of this Agreement, an exclusive,
world-wide, royalty bearing license, with the right to grant sublicenses, under
any and all Patent Rights and IBAMM Technical Information to make, have made,
use, sell and have sold IBAMM Licensed Products, including the right to sell
IBAMM Licensed Products for resale, and to practice IBAMM
4
Technical Information developed under the Apollon/IBAMM Sponsored Research
Agreement and/or the IBAMM/Penn Sponsored Research Agreement. Such license
shall include any and all Patent Rights arising from patent applications
and/or issued patents, rights to biological materials, including
polynucleotide constructs, arising from the Apollon/IBAMM Sponsored Research
Agreement and/or the IBAMM/Penn Sponsored Research Agreement, and any and all
IBAMM Technical Information relating to Products and/or processes arising out
of the Apollon/IBAMM Sponsored Research Agreement and/or the IBAMM/Penn
Sponsored Research Agreement.
III. ROYALTIES
A. In consideration of the option and licenses granted to Apollon under this
Agreement, Apollon shall pay to IBAMM a royalty on Net Sales of IBAMM Licensed
Products as follows.
(1) [ ] in countries where the IBAMM Licensed Products are
covered by a Valid Claim of an issued patent of Patent Rights; or
(2) [ ] in countries where the IBAMM Licensed Products
are not covered by a Valid Claim of an issued patent of Patent Rights.
B. The payment of royalties to IBAMM on any particular IBAMM Licensed Product
shall terminate in each country on (a) the expiration date of the last-to-expire
issued patent of Patent Rights covering such product, or (b) with respect to an
IBAMM Licensed Product which has never been covered by a Valid Claim of an
issued patent of Patent Rights in such country, on the earlier to occur of the
following: (i) the date on which Apollon demonstrates to IBAMM's reasonable
satisfaction that a third party is selling a product in the relevant country
[CA] [VZ] In Reasonable Competition With Such IBAMM Licensed Product; or (ii)
ten (10) years from the first commercial sale in such country. In the event a
patent covering
5
such product issues subsequent to termination of payment of royalties to IBAMM
pursuant to Section III.B.(b), then payment of royalties to IBAMM shall resume
pursuant to Section III.A (1) until terminated pursuant to III.B(a)[CA] [VZ].
C. Payment of royalties due under this Article shall be made by Apollon to IBAMM
within sixty (60) days after March 31, June 30, September 30, and December 31
each year during the term of this Agreement covering the quantity of IBAMM
Licensed Products sold by Apollon during the preceding calendar quarter.
D. All payments to be made under this Article shall be paid in United States
Dollars in Wayne, Pennsylvania, or in such other place or other way as IBAMM
shall reasonably designate.
E. In the event that any quantity of IBAMM Licensed Product subject to royalty
hereunder is used in the manufacture of another product subject to royalty
hereunder, or is sold to a Sublicensee or an Affiliate of the seller, or if
rights under more than one patent or patent application within Patent Rights is
used, only one royalty, namely the royalty applicable to the ultimate product
subject to royalty hereunder, shall be paid to IBAMM, in order that duplication
of royalties may be avoided.
F. [ ] of the expenses incurred by Apollon in connection
with the filing, prosecution, and maintenance of Patent Rights shall be
creditable against royalties due IBAMM hereunder and such credit may be taken at
the rate of [ ] of royalties due IBAMM in any calendar year.
G. During the term of this Agreement and so long as Apollon is not in default
with respect to any payment due IBAMM hereunder, neither IBAMM nor any party
deriving rights from
6
or through IBAMM shall assert Patent Rights to prevent the making, using or
selling of IBAMM Licensed Product(s) thereof.
IV. DUE DILIGENCE
Apollon agrees to use its reasonable best efforts to bring one or more IBAMM
Licensed Product(s) to the marketplace through a diligent program of
development, production and marketing. Such reasonable best efforts may
include the efforts of any Affiliate(s) of Apollon or the efforts of any
development, production and/or marketing partner(s) of Apollon.
V. REPORTS AND RECORDS
X. Xxxxxxx shall keep true books and accounts containing an accurate record of
the
information necessary for determination of the amounts payable under Article III
hereof. Said records shall be kept at Apollon's principal place of business or
the principal place of business of the appropriate division of Apollon to which
this Agreement relates. Said records shall be available for inspection at
IBAMM's expense by an independent certified public accountant selected by IBAMM
and reasonably acceptable to Apollon during regular business hours, but not more
often than once per year, for three (3) years following the end of the calendar
year to which they pertain in order for IBAMM to ascertain the correctness of
any report and/or payment made under this Agreement.
B. Within sixty (60) days after March 31, June 30, September 30, and December 31
of each year in which this Agreement is in effect, Apollon shall deliver to
IBAMM full, true and accurate reports showing, in sufficient detail to enable
the royalties due hereunder to be calculated, Net Sales of IBAMM Licensed
Product(s) and royalties due, if any, including those of its Sublicensee(s), if
any, relating to this Agreement during the preceding three (3) month period.
With each such report, Apollon shall pay to IBAMM the royalties due and
7
payable as provided for in Article III. If no royalties are due, the report
shall so state. All such reports shall be maintained in confidence by IBAMM,
except as required by law.
VI. INFRINGEMENT
A. With respect to any Patent Rights licensed to Apollon hereunder, Apollon or
its designated sublicensee shall have the right to prosecute in its own name and
at its own expense any infringement of such Patent Right, and shall have the
right to control, settle, and defend such suit and recover, for its own account,
any damages, awards, or settlements resulting therefrom, subject to Paragraph
VI. If Apollon or its Sublicensee elects to bring such an infringement action
and IBAMM is a legally indispensible party to such action, IBAMM shall have the
right to assign to Apollon all of IBAMM's right, title and interest in each
patent which is a part of Patent Rights and the subject of such action.
Notwithstanding any such assignment by IBAMM to Apollon and regardless of
whether IBAMM is or is not an indispensible party, IBAMM shall cooperate fully
with Apollon in connection with any such action.
B. If Apollon or any Sublicensee elects to bring an action as described above,
Apollon may offset against royalties due IBAMM the out-of-pocket expenses and
costs of such action, including attorney's fees and reimbursements to IBAMM for
IBAMM's out-of-pocket costs in such action. Such offset shall not exceed
[ ] of any royalty due to IBAMM in any payment period.
C. Any recovery by Apollon under Paragraph VI.A shall be deemed to reflect loss
of commercial sales and Apollon shall pay IBAMM a royalty in accordance with
this License Agreement on said recovery.
8
VII. TERM
Unless terminated earlier according to the terms hereof, this Agreement shall
commence as of the Effective Date hereof and shall remain in full force and
effect on a country-by-country basis so long as IBAMM Licensed Product(s) are
sold; provided, however, that upon expiration of the last to expire or become
abandoned of Patent Rights covering IBAMM Licensed Product(s), all rights
licensed hereunder shall convert to a fully paid-up license to Apollon.
VIII. TERMINATION
Either party may terminate this Agreement as follows:
A. In the event that any material provision of this Agreement is breached by one
party, the other party may, upon ninety (90) days' written notice to the
breaching party, terminate this Agreement. However, if the breach is corrected
within the ninety (90) day period and there are no unreimbursed damages
resulting from the breach, the Agreement shall continue in force.
B. Should Apollon fail to pay IBAMM such royalties as are due and payable
hereunder, IBAMM shall have the right to terminate this Agreement on at least
ninety (90) days' written notice, unless Apollon shall pay IBAMM within the
ninety (90) day notice period, all such royalties as are due and payable. Upon
the expiration of the ninety (90) day period, if Apollon shall not have paid all
such royalties due and payable, IBAMM at its sole option, may immediately
terminate this Agreement and all rights, privileges and licenses granted
hereunder.
9
X. Xxxxxxx shall have the right to terminate this Agreement at any time upon
ninety (90) days' written notice to IBAMM. Apollon's obligation to pay
royalties accrued to the date of termination, and/or thereafter shall survive
termination.
D. Upon termination of this Agreement for any reason, any sublicense not then in
default shall continue in full force and effect except that IBAMM shall be
substituted in place of the sublicensor.
IX. CONFIDENTIALITY
All proprietary technical and business information, including reports required
to be provided hereunder relevant to IBAMM Licensed Product(s), disclosed by
either party to the other shall be held by the receiving party in confidence,
used only to accomplish the purposes contemplated by this Agreement, and
accorded the same degree of care and security that the receiving party uses to
protect its own confidential information of similar nature, and is not disclosed
except to officers, employees, and agents of the receiving party who have a
reasonable need to know the information, and who are bound to such party by a
written agreement of confidentiality; provided, however, that information shall
not be deemed confidential or proprietary which (a) is or becomes public through
no fault of the receiving party; (b) is learned by the receiving party from a
third party entitled to disclose it; (c) was known to the receiving party at the
time of disclosure as shown by prior written records; or (d) is developed by an
employee or consultant of the receiving party independently of disclosures
hereunder. Nothing herein shall be construed to prevent the disclosure of
information as necessary to practice commercially the rights granted hereunder,
including, without limitation, the disclosure of information to regulatory and
other governmental agencies as necessary to obtain marketing approval for IBAMM
Licensed Product(s) or to obtain patent protection.
10
X. INDEPENDENT CONTRACTORS
For purposes of this Agreement and the exercise of all rights hereunder, IBAMM
and Apollon agree that each party is operating as an independent contractor and
not as an agent or employee of the other. This Agreement shall not constitute a
partnership or joint venture and neither party may bind the other to any
contract, commitment or understanding except as specifically stated herein.
XI. USE OF NAME
Neither party shall use the name of the other party in any advertising, news
release or other public announcement, written or oral, related to any actions
taken or work carried out pursuant to the terms of this Agreement without the
prior written consent of the other party.
XII. ASSIGNABILITY
This Agreement is binding on and shall inure to the benefit of the parties,
their Affiliates, respective successors and permitted assigns. Except in
connection with a sale or other disposition of all or substantially all of the
business to which the licensed subject matter pertains, or in the event of a
merger or sale of all or substantially all of the assets of Apollon, neither
this Agreement nor any part of it is assignable by either party without the
prior written consent of the other party.
XIII. FORCE MAJEURE
A delay in performance or non-performance by either party shall not constitute a
breach or grounds for termination or prejudice any rights hereunder, if the
delay or non-performance is the result of circumstances beyond the reasonable
control of the party whose performance is excused hereunder, provided that such
party shall promptly provide to the other party written notice of such delay or
non-performance and the reason therefor [CA] [VZ] and shall resume performance
immediately after the cause of such delay or non-performance is removed and
shall be reasonably diligent in minimizing the impact thereof on the other
party. Without
11
limiting the generality of such circumstances beyond the control of either
party, examples are labor strikes, fire, flood, storm, earthquake, or other
Act of God, war, rebellion, riot, sabotage or insurrection, governmental
enactment, rule or regulation, and inability to obtain material or equipment.
XIV. MODIFICATIONS IN WRITING
No change, modification, extension, termination or waiver of this Agreement, or
any of the provisions herein contained, shall be valid unless made in writing
and signed by a duly authorized representative of each party.
XV. ENTIRE AGREEMENT
This Agreement constitutes the entire Agreement between the parties hereto with
respect to the subject matter hereof and as such supersedes all previous written
and oral negotiations, understandings and commitments thereto.
XVI. GOVERNING LAW
This Agreement shall be governed by and construed in accordance with the
internal laws of the Commonwealth of Pennsylvania. In the event of any dispute
arising hereunder, the parties hereto agree that personal jurisdiction and venue
in any suit shall be exclusively in the United States District Court for the
Eastern District of Pennsylvania or the Court of Common Pleas of Xxxxxxx County,
Pennsylvania.
XVII. NOTICE
Any notice required under this Agreement shall be deemed sufficiently given if
sent in writing by prepaid first class, certified or registered mail, return
receipt requested, to the addresses specified below:
12
AS TO IBAMM:
Xx. Xxxxxxx Xxxxx
IBAMM, Inc.
000 Xxxxx Xxxx Xxxxx
Xxxxx, Xxxxxxxxxxxx 00000
AS TO APOLLON:
Xxxxxxx X. Xxxxxxx, Ph.D.
Vice President of Technical Development
Apollon, Inc.
Xxx Xxxxx Xxxxxx Xxxxxxx
Xxxxx 00
Xxxxxxx, Xxxxxxxxxxxx 00000-0000
Either party may change its address or responsible individual specified above by
giving the other thirty (30) days prior written notice thereof.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the date first written
above.
APOLLON IBAMM
By:/s/ Xxxxxxx X. Xxxxxxxx, Xx. By:/s/ Xxxxxxx X. Xxxxx
---------------------------- ---------------------
Name: Xxxxxxx X. Xxxxxxxx, Xx. Name: Xxxxxxx X. Xxxxx
-------------------------- -------------------
Title: President Title: President
------------------------- ------------------
Date: 29 NOV 94 Date: December 6, 1994
-------------------------- -------------------
13
EXHIBIT C
PATENT APPLICATIONS
[ ] "Genetic Immunization"; patent application USSN 08/008,342;
filed 26 January 1993; X. Xxxxxx, X. Xxxxxxxx, and X. Xxxx
[ ] "Genetic Immunization"; patent application USSN 08/029,336; filed
11 March 1993; X. Xxxxxx, X. Xxxxxxxx, and X. Xxxx
[ ] "Genetic Immunization"; patent application USSN 08/125,012;
filed 21 September 1993; X. Xxxxxx, X. Xxxxxxxx, X. Xxxx and X.
Xxxxx
[ ] "Delivery of Genetic Material by Needleless Injection Device";
patent application USSN 08/093,235; filed 15 July 1993; X.
Xxxxxx, X. Xxxxxxxx, and X. Xxxxx
[ ] "Non-Human Immunocompetent Animal Model"; patent application USSN
08/124,962; filed 21 September 1993; X. Xxxxxx, X. Xxxxxxxx, and
X. Xxxxx
[ ] "Compositions and Methods for Delivery of Genetic Material";
patent application PCT/US94/00899; filed 26 January 1994; X.
Xxxxxx, X. Xxxxxxxx, X. Xxxx, X. Xxxxx, X. Xxxxx, and X. Xxxxxxxx
