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EXHIBIT 10.8
PATENT LICENSE AGREEMENT
This Patent License Agreement (the "Agreement") is made and entered as
of the 1st day of November, 1994 by and between Antigenics, Inc., a Delaware
corporation having its principal place of business c/o Xxxxx Partners, L.P., 135
East 57th Street, 30th Floor, New York, N.Y. 10022 ("Antigenics"), and Mount
Sinai School of Medicine, located at One Xxxxxxx X. Xxxx Place,. Xxx Xxxx, XX
00000 ("MSSM").
RECITALS:
WHEREAS, Xx. Xxxxxx X. Xxxxxxxxxx ("Xx. Xxxxxxxxxx") was formerly on
the faculty of and performed research and development at. MSSM in the area of
the use of heat shock proteins for the development of therapeutic and
prophylactic vaccines for cancer and infectious diseases;
WHEREAS, Antigenics desires to obtain and MSSM desires to grant
exclusive licenses to the patent rights which resulted from Xx. Xxxxxxxxxx'x
research and development efforts in heat shock proteins at MSSM;
NOW, THEREFORE, in consideration of the mutual covenants expressed
herein and other good and valuable consideration, Antigenics and MSSM hereby
agree as follows;
1. LICENSE OF PATENT RIGHTS.
(a) DEFINITIONS OF PATENT RIGHTS. "MSSM Patent Rights" shall
be defined as U.S. patent application serial nos. 08/210,421, 8/315,892 and
08/180,685 and all U.S. patents which issue therefrom, including without
limitation, any continuations, divisionals, continuations-in-part, reissues,
reexaminations and related foreign applications and patents issuing therefrom or
patents which are owned by MSSM based on Xxxxxx Xxxxxxxxxx'x work conducted at
MSSM prior to January 1, 1994. For purposes of this Agreement, the term
"Licensed Products" shall be defined as products covered by the MSSM Patent
Rights.
(b) GRANT OF LICENSE. In consideration if the royalty set out
in Section 2(a) and other consideration set forth in Section 2(b), MSSM hereby
grants to Antigenics a worldwide, exclusive license to all MSSM Patent Rights.
In consideration of the mutual covenants herein contained, MSSM hereby agrees to
execute and deliver all documents and instruments and to take any other action
on a best efforts basis which Antigenics shall deem necessary to perfect patent
protection in the United States and in foreign countries with respect to, or to
perfect said exclusive license to the MSSM Patent Rights in Antigenics.
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(c) RIGHT TO SUBLICENSE. Antigenics may not grant sublicenses
to the MSSM Patent Rights without the prior written consent of MSSM.
(d) PROTECTION OF MT. SINAI PATENT RIGHTS. MSSM hereby agrees
that upon request of Antigenics, authorized officials of MSSM will execute and
deliver any and all documents or instruments and take any other action which
Antigenics shall deem necessary to transfer and vest an exclusive license in
Antigenics, to perfect copyright and patent protection with respect to, or to
protect Antigenics' interest in, all of its rights and interests in and to such
MSSM Patent Rights. Antigenics shall have the right to prepare, file and
prosecute, by counsel of its choice, any U.S. and foreign patent applications
covering inventions arising out of the MSSM Patent Rights. Antigenics shall
prepare, file and prosecute any such patent applications at its own expense. In
the event that Antigenics elects not to apply for patent protection in a foreign
country, or fails to prosecute U.S. patent applications, MSSM shall have the
right to prepare and file its own patent application at MSSM's expense. Without
limiting the generality of the foregoing, MSSM specifically agrees to execute
all documents, and take any other actions necessary to perfect filing of such
patent applications in the U.S. Patent and Trademark Office and in such foreign
Patent Offices as Antigenics shall choose to file. MSSM agrees to notify
Antigenics of any Patent Office actions taken after execution of this Agreement
which affect the Patent Rights to the extent that MSSM is aware of such Patent
Office actions. MSSM will use its best efforts to assist Antigenics with
responses to such Patent Office actions. The obligations of this Section 1(d)
shall be binding upon the successors and assigns of MSSM. Antigenics agrees to
pay all copyright and patent fees and reasonable expenses incurred by MSSM for
any assistance rendered to Antigenics pursuant to the foregoing.
(e) NIH AND OTHER INSTITUTIONAL FUNDING. MSSM and Antigenics
each acknowledges that certain of the research and development efforts that are
embodied in MSSM Patent Rights were funded in whole or in part by institutions
other than MSSM, including the National Institutes of Health and the Cancer
Research Institute (the "Institutions").
MSSM represents and warrants that it has taken and will take any
actions required by such Institutions or applicable law to be taken to obtain
ownership right, title and interest in any MSSM Patent Rights to be licensed
hereunder. Both Antigenics and MSSM agree to comply with all laws, regulations
and requirements of NIH or any other government agency with respect to research
sponsored by such agency and MSSM Patent Rights resulting therefrom. Without
limiting the foregoing, if required by law, Antigenics agrees to manufacture in
the United States Licensed Products which are to be sold in the United States.
2. ROYALTIES; EQUITY INTEREST.
(a) ROYALTIES. For the rights and privileges granted under
this Agreement, Antigenics shall pay to MSSM a royalty of [ ]*
on Net Sales of Licensed Products from the date hereof until the date the last
patent embodying or using the
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* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as amended.
The complete Exhibit, including the portions for which confidential treatment
has been requested, has been filed separately with the Securities Exchange
Commission.
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Patent Rights has expired. For purposes of this Agreement "Net Sales" shall mean
sales that are net of any take-backs and/or trade discounts or allowances
whether Licensed Products are sold by Antigenics or another party with which
Antigenics has a marketing agreement. Royalties are payable for sales of
Licensed Products only if a patent has been issued or is pending which covers
the country or countries in which such Licensed Products are sold. If and only
for so long as gross margins on Net Sales of Licensed Products [ ]*,
Antigenics shall pay MSSM a royalty of [ ]* of Net Sales of such
Licensed Products.
On or before the forty-fifth (45th) day following each fiscal quarter,
Antigenics shall submit to MSSM full and accurate statements showing the
quantity, description and Net Sales of Licensed Products distributed and/or sold
during the preceding fiscal quarter, including any additional information kept
in the ordinary course of business by Antigenics, which is appropriate to enable
an independent determination of the amount due hereunder. All payments then due
MSSM shall be made simultaneously with the submission of the statements. Such
quarterly statements shall be submitted only when they reflect any sales.
Antigenics shall inform MSSM within thirty (30) days of the first sale of
Licensed Products. In addition, Antigenics will provide MSSM with audited
financial statements within ninety (90) days of the end of Antigenics' fiscal
year provided, however, that Antigenics shall not be required to deliver audited
financial statements until such time as there are sales of Licensed Products.
(b) EQUITY INTEREST. For the rights and privileges granted
under this Agreement, in-addition to the royalty described in Section 2(a),
Antigenics shall, pursuant to a Subscription Agreement which shall include
appropriate investment representations, deliver to MSSM a certificate
representing ten (10) shares of Antigenics common stock, representing 1% of
Antigenics issued and outstanding stock as of the date hereof. Antigenics
represents that as of the date of this Agreement, Antigenics has only one class
of stock outstanding.
3. DUE DILIGENCE.
Antigenics represents and warrants that it will use due diligence to
make Licensed Products commercially available. Antigenics will use its best
efforts to reach the following milestones:
(i) Phase I clinical trials to commence by December 31, 1997
and Phase II clinical trials will be initiated by December 31, 1999 provided
that the Phase I Clinical Trials indicate a reasonable scientific basis for
possible efficacy and indicate acceptable toxicity.
(ii) Additional funding of at least $1.5 million to be
completed by June 30, 1996.
(iii) Pre-clinical studies evaluating the optimal dose of gp96
and hsp70 for eliciting immunity to at least two mouse sarcomas (using enough
numbers of mice to be statistically significant) to be completed by March 31,
1997.
(iv) The efficacy of gp96 and hsp70, complexed to at least one
known antigenic peptide, in eliciting peptide-specific cellular and antibody
response, to be evaluated in a mammalian system by January 31, 1998.
(v) At least five (5) different adjuvants to be tested under
the conditions identified in Section 3(iv) by September 30, 1996.
(vi) A clinical director to be designated before the
initiation of Phase III Clinical Trials.
(vii) A chief executive officer of Antigenics to be hired after
the earlier of (a) the investment of a total of $5 million in equity capital in
Antigenics or (b) the filing of the first New Drug Application.
(viii) A chief financial officer to be hired when Antigenics'
total annual budget exceeds $3 million.
_________________________
* This portion of the Exhibit has been omitted pursuant to a Request for
Confidential Treatment under Rule 406 of the Securities Act of 1933, as amended.
The complete Exhibit, including the portions for which confidential treatment
has been requested, has been filed separately with the Securities Exchange
Commission.
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Antigenics will notify MSSM as to the status of the milestones outlined
in this Section 30 days prior to the date of each milestone. If at any time MSSM
is of the opinion that Antigenics is not using due diligence to make Licensed
Products commercially available, as outlined above, MSSM shall notify Antigenics
to that effect, and Antigenics shall have six (6) months after such notice
within which to cure or to make arrangements satisfactory to MSSM. If at the end
of the six (6) month period MSSM and Antigenics cannot agree that Antigenics is
using due diligence, then MSSM may, at its option, convert the exclusive license
described in section 1(b) to a non-exclusive license upon thirty (30) days'
notice to Antigenics. At such time as the exclusive license becomes
non-exclusive, MSSM's obligations pursuant to Section 1(d) shall terminate.
Notwithstanding the foregoing, Antigenics' obligation to pay royalties pursuant
to Section 2(a) shall not terminate upon any conversion of the exclusive license
to a non-exclusive license.
4. INDEMNIFICATION. Antigenics shall indemnify, defend and hold
harmless, MSSM, its directors, officers, employees and agents (the
"Indemnitees") from and against any liability, damage, loss or expense
(including reasonable attorney's fees) incurred or imposed upon Indemnitees
arising in connection with any claim, suit, action, loss, settlement, demand or
judgment that arises, directly or indirectly, out of the design, manufacture,
sale, use, distribution or promotion by Antigenics or any of its licensees,
affiliates or agents of any product, process or service developed pursuant to
this Agreement or arising out of the acts or omissions of Antigenics committed
in the course of the performance of this Agreement. Antigenics'
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obligation to protect, defend, indemnify and hold harmless hereunder shall
survive the expiration and termination of the Agreement.
Antigenics agrees to obtain product liability insurance covering claims
arising or resulting from the design, manufacture, sale, use, distribution or
promotion f the Licensed Products prior to the time human clinical trials o the
Licensed Products are commenced. The amount of such product liability insurance
will be acceptable to MSSM and consistent with industry practice for companies
which are similar to Antigenics and institutions which are similar to MSSM. Such
insurance shall be underwritten by insurers acceptable to MSSM, and shall list
MSSM as an additional named insured.
5. NON-DISCLOSURE.
Unless required by law, MSSM agrees that it will not at any time,
either during or after the term of this Agreement, without the prior written
consent of Antigenics, divulge or disclose to anyone outside, or appropriate for
its own use or lie use of any third party, any financial or patent-related
information received from Antigenics after execution of this Agreement which is
marked "Confidential" (such information shall be referred to as "Confidential
Information"), and will not during the term hereof, or at any time thereafter,
disclose or use or attempt to use any such Confidential Information for its own
benefit, or the benefit of any third party, or in any manner which may injure or
cause loss or may be calculated to injure or cause loss to Antigenics. MSSM's
obligations contained in this subsection 5 shall lapse on the termination of
this Agreement.
6. GENERAL.
(a) ENTIRE AGREEMENT. This Agreement constitutes the entire
Agreement between the parties relative to the subject matter hereof, and
supersedes all proposals or agreements, written or oral, and all other
communications between the parties relating to the subject matter of this
Agreement.
(c) SEVERABILITY. The parties agree that each provision of
this Agreement shall be treated as a separate and independent clause, and the
unenforceability of any one clause shall in no way impair the enforceability of
any of the other clauses herein. Moreover, if any one or more of the provisions
of this Agreement shall for any reason be held to be exclusively broad as to
scope, activity or subject so as to be enforceable at law, such provisions shall
be construed by the appropriate judicial body by limiting and reducing it or
them, so as to be enforceable to the maximum extent compatible with the
applicable law as it shall then appear.
(d) ASSIGNMENT. Antigenics may assign its rights, together
with its obligations hereunder, to any affiliate or successor in connection with
any consolidation, merger, sale, transfer or other disposition of all or
substantially all of Antigenics' business and assets. In the event of an
consolidation or merger of Antigenics' with or into any other corporation, or
the sale or conveyance of -all or substantially all of the assets of Antigenics
to another corporation, the surviving or acquiring corporation shall be entitled
to the rights and benefits provided under this Agreement, and become obligated
to perform all of the terms and conditions hereof. The foregoing
notwithstanding, Antigenics may also transfer its rights hereunder with the
consent of MSSM which consent shall not be withheld unreasonably.
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(e) GOVERNING LAW. This Agreement shall be construed and
enforced in accordance with, and the rights of the parties shall be governed by,
the internal laws of the State of New York.
(f) NOTICE. All notices provided for in this Agreement shall
be given in writing and shall be effective when either served by personal
delivery, express overnight courier service, or by registered or certified mail,
return receipt requested, addressed to the parties at their respective address s
herein set forth, or to such other address or addresses as either party may
later specify by written notice to the other.
(g) SURVIVAL. The provisions set forth in Sections 4, 5, and 6
shall survive the termination or expiration of this Agreement for the periods
set forth herein as a continuing agreement of the parties hereto.
(h) REMEDIES. The parties agree that a breach of the
provisions of Section 5 of this Agreement by either party will cause irreparable
damage to the other party and that in the event of such breach the party who has
suffered the breach shall have, in addition to any and all remedies of law, the
right to an injunction, specific performance or other equitable relief to
prevent the violation of the other party's obligations hereunder. Nothing herein
contained shall be construed as prohibiting either party from pursuing any other
remedies available to either for breach by the other under this Agreement or
applicable law.
(i) TERM. The term of this Agreement shall be until the last
patent embodying or using the MSSM Patent Rights has expired. MSSM may terminate
this agreement if after at least sixty (60) days' written notice by MSSM to
Antigenics, Antigenics shall continue to fail to pay any royalties then due
under Section 2(a). The termination of this Agreement will not relieve
Antigenics of its obligations to make any payments required hereunder.
(j) USE OF NAME. Except where required by law, Antigenics may
not use the name "Mount Sinai School of Medicine", the MSSM logo or the MSSM
insignia in any advertisement, commercial or product literature without the
express written consent of MSSM. If Antigenics is required by law to use the
name "Mount Sinai School of Medicine", Antigenics will only use such name in
connection with factually correct information. The "Mount Sinai School of
Medicine" name may be used in connection with fundraising activities of
Antigenics with MSSM's consent, which consent may not be unreasonably withheld.
This Agreement may be executed in duplicate counterparts, which, when
taken together, shall constitute one instrument and each of which shall be
deemed to be an original instrument.
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IN WITNESS WHEREOF, parties have executed this Agreement as of the day
and year first above written.
ANTIGENICS, INC.
By: /s/ Xxxx X. Xxxxx
-----------------------------------
President
MOUNT SINAI SCHOOL OF MEDICINE
By: /s/ Xxxxxx Xxxx
-----------------------------------
Title Xxxx MSSM
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AMENDMENT TO
PATENT LICENSE AGREEMENT
BY AND BETWEEN
ANTIGENICS, INC.
AND
MOUNT SINAI SCHOOL OF MEDICINE
THIS AMENDMENT TO THE PATENT LICENSE AGREEMENT ("AMENDMENT"), effective
as of June 5, 1995 ("EFFECTIVE DATE"), is made and entered into by and between
ANTIGENICS, INC., a Delaware corporation having a principal place of business
c/o Xxxxx Partners, 000 Xxxx 00xx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000,
("Antigenics") and MOUNT SINAI SCHOOL OF MEDICINE, having a principal of
business at Xxx Xxxxxxx X. Xxxx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000 ("MSSM").
WHEREAS Antigenics and MSSM entered into a Patent License Agreement
("License Agreement") effective as of November 1, 1994 pursuant to which
Antigenics obtained a worldwide, exclusive license under the MSSM Patent Rights
(as defined in the License Agreement); and
WHEREAS Antigenics and MSSM desire to amend the License Agreement to
provide for modification of the obligations of the parties.
NOW, THEREFORE, in consideration of the mutual covenants and premises
herein contained, the parties hereto agree as follows:
1. RIGHT TO SUBLICENSE
Section 1(c) of the License Agreement is hereby amended to read in its
entirety as follows:
(c) RIGHT TO SUBLICENSE. Antigenics may grant sublicenses to
the MSSM Patent Rights; provided that, at least ten (10) business days
prior to the effective date of any such sublicense, Antigenics, in
accordance with Section 6(f), shall provide written notice to MSSM of
Antigenics' intention to grant such sublicense, such notice to be
provided for the purpose of obtaining MSSM's consent. MSSM agrees that
such consent shall not be unreasonably withheld. In addition, MSSM may
provide comments to Antigenics relating to the terms and conditions of
such sublicense. In the event that MSSM provides no comments to
Antigenics in writing within five (5) business days after receipt of
Antigenics' written notice, MSSM will be deemed to have given consent
to such sublicense. In the event that MSSM provides comments to
Antigenics in writing within five (5) business days after receipt of
Antigenics' written notice, Antigenics shall consider such comments in
good faith and shall in incorporate such comments into the sublicense
to the extent necessary to provide that Antigenics complies with its
obligations to MSSM under the License Agreement.
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2. OTHER PROVISIONS
All provisions of the License Agreement not expressly modified by this
Amendment shall remain in full force and effect.
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IN WITNESS WHEREOF, the parties hereto have caused authorized their
duly authorized representatives to execute this Amendment.
ANTIGENICS, INC. MOUNT SINAI SCHOOL OF MEDICINE
("Antigenics") ("MSSM")
By: /s/ Xxxx X. Xxxxx By: /s/ Xxxxxx Xxxx
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Name: Xxxx X. Xxxxx Name: Xxxxxx Xxxx
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Title: Chairman and CEO Title: Xxxx
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