EXHIBIT 10.2
LICENSE AGREEMENT
BETWEEN
BIOVEST INTERNATIONAL,
INC.
AND
AUTOVAXID, INC.
This License Agreement (this
“Agreement”) effective as of December 8, 2006, by
and between Biovest International, Inc. , a Delaware
corporation (“Biovest”), and AutovaxID, Inc ., a
Florida corporation (“AutovaxID”) (collectively the
“Parties”).
WITNESSETH:
WHEREAS, Biovest has developed the
automated cell production instrument known as Autovax (the
“Autovax Automated Instrument”);
WHEREAS, AutovaxID wishes to enter
into an agreement to obtain the exclusive license for the Autovax
Automated Instrument in the Territory (hereinafter defined) from
Biovest in order to manufacture, market and commercialize the
Autovax Automated Instrument in the Territory in accordance
therewith; and
WHEREAS, Biovest is willing to grant
such license to AutovaxID under the terms and conditions set forth
in this Agreement.
NOW, THEREFORE, in consideration of
the various promises and undertakings set forth herein, the Parties
agree as follows:
ARTICLE 1 -
DEFINITIONS
As used herein, capitalized terms
shall have the following meanings:
1.1 “Affiliate,” with
respect to any Party, shall mean any person or entity controlling,
controlled by, or under common control with such Party. For these
purposes, “control” shall refer to (i) the
possession, directly or indirectly, of the power to direct the
management or policies of a person or entity, whether through the
ownership of voting securities, by contract or otherwise or
(ii) the ownership, directly or indirectly, of at least 50% of
the voting securities or other ownership interest of a person or
entity.
1.2 “Autovax Automated
Instrument” shall mean the automated instrument developed by
Biovest to produce vaccines and other cell related products in a
closed cell system as more fully described in Exhibit B and as
covered by the Licensed Patent rights owned by Biovest under the
patent numbers described in Exhibit A, together with any successor
innovation thereto developed by Biovest or its
Affiliates.
1.3 “Biovest Licensed
Technology” shall mean any and all information, and all
patentable and non-patentable inventions (including, without
limitation, all Joint Inventions), improvements, discoveries,
claims, formulae, processes, methods, trade secrets, technologies,
data and know-how owned, licensed or controlled by Biovest or to
which Biovest has the right to grant licenses or sublicenses before
or during the term of this Agreement related to the automated
instrument designed and developed by Biovest to produce vaccines
and other cell related products in a closed cell system described
in Exhibit B.
1.4 “Effective Date” shall mean the
date first written above.
1.5 “Joint Invention”
shall mean any invention for which it is determined, in accordance
with applicable law, that both: (i) employees or agents of
AutovaxID or any other persons obligated to assign such Invention
to AutovaxID, and (ii) employees or agents of Biovest or any
other persons obligated to assign such invention to Biovest, are
joint inventors of such invention.
1.6 “Know-How” shall
mean any and all know-how shared by the Parties under this
Agreement.
1.7 “Licensed Patents”
shall mean any current and future Patent, owned or controlled by
Biovest, or any of the same jointly owned or controlled by Biovest
and that relate to the Biovest Licensed Technology, including
Patents set forth on Exhibit A.
1.8 “Licensed Product”
shall mean the Autovax Automated Instrument as defined herein and
all disposables and equipment related thereto.
1.9 “Net Sales” shall
mean the gross amount invoiced for Licensed Products sold by
AutovaxID and/or its Affiliates in arm’s length sales or
commercial transactions to a Third Party (excluding sales to
Accentia Biopharmaceuticals, Inc. for its use inside or outside the
Territory or for resale outside the Territory), less deductions
for:
(a) commissions, trade,
quantity and cash discounts or rebates actually allowed or
given;
(b) credits, allowances or refunds
given or made for rejected, outdated or returned Licensed Products,
if applicable;
(c) any tax or government charge
(other than an income tax) levied on the sale, transportation or
delivery of a Licensed Product and borne by the seller thereof;
and
(d) any prepaid or invoiced charges
for freight, postage, shipping, import or export taxes, insurance
or charges for returnable containers.
1.11 “Party” shall mean
AutovaxID or Biovest and, when used in the plural, shall mean
AutovaxID and Biovest.
1.12 “Patent” means
(i) unexpired letters patent (including inventor’s
certificates) which have not been held invalid or unenforceable by
a court of competent jurisdiction from which no appeal can be taken
or has been taken within the required time period, including
without limitation any substitution, extension, registration,
confirmation, reissue, re-examination, renewal or any like filing
thereof and (ii) pending applications for letters patent,
including without limitation any continuation, division or
continuation-in-part thereof and any provisional
applications.
1.13 “Sublicensee” shall
mean any Third Party granted a sublicense by AutovaxID pursuant to
Section 3.2 hereof.
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1.14 “Sublicensee Net Sales” shall
mean the gross amount invoiced for all Licensed Products sold by a
Sublicensee to a Third Party, less deductions for:
(a) commissions, trade, quantity and
cash discounts or rebates actually allowed or given;
(b) credits, allowances or refunds
given or made for rejected, outdated or returned Licensed Products,
if applicable;
(c) any tax or government charge
(other than an income tax) levied on the sale, transportation or
delivery of a Licensed Product and borne by the seller thereof;
and
(d) any prepaid or invoiced charges
for freight, postage, shipping, import or export taxes, insurance
or charges for returnable containers.
1.15 “Sublicensee
Revenue” shall mean any and all revenue or other
consideration received by AutovaxID from a Sublicensee for Licensed
Product under this Agreement, including but not limited to, revenue
from sales of Licensed Products, upfront revenue, milestone
revenue, royalty income, and the market value at the time of
transfer of all non-monetary consideration such as barter or
counter-trade in the country of disposition.
1.16 “Territory” shall
mean the United States, Canada and Mexico.
1.17 “Third Party” means
any person or entity other than AutovaxID, Biovest or any Affiliate
of either AutovaxID or Biovest.
1.18 “Valid Claim” shall
mean a claim of any issued or granted Licensed Patent which has not
been held invalid or unenforceable by final decision of a court or
other governmental agency of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, and which is not
admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise.
ARTICLE 2 - REPRESENTATIONS AND
WARRANTIES
2.1 Representations and
Warranties of Both Parties . Each Party represents and warrants
to the other Party that: (i) it is free to enter into this
Agreement; (ii) in so doing, it will not violate any other
agreement to which it is a party; and (iii) it has taken all
corporate action necessary to authorize the execution and delivery
of this Agreement and the performance of its obligations under this
Agreement.
2.2 Representations and
Warranties of Biovest . Biovest hereby represents and warrants
to AutovaxID that:
(a) Biovest has the right to grant
licenses and sublicenses therefor without the consent or approval
of any Third Party;
(b) To the best of Biovest’s
knowledge, all the Licensed Patents listed on Exhibit A are in full
force and effect and have been maintained to date;
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(c) Biovest is not aware of any
asserted or unasserted claim or demand against the Biovest Licensed
Products;
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(d) To the best of Biovest’s
knowledge, the Biovest Licensed Product does not infringe upon any
patent or other proprietary rights of any other Third Party;
and
(e) Biovest has not entered into any
agreement with any Third Party which is in conflict with the rights
granted to AutovaxID pursuant to this Agreement.
2.3 Disclaimer .
(a) Government Rights; Research
and Development . Biovest’s rights in the Licensed
Product may be subject to the royalty-free rights of the US
Government, if any, in the Patents and Licensed Product to
manufacture, have manufactured, and use any Products, including
Licensed Product, for research and development purposes.
(b) Disclaimer of Other
Warranties . EXCEPT AS PROVIDED HEREIN, THE BIOVEST LICENSED
PRODUCT IS PROVIDED AND LICENSED WITHOUT WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER
WARRANTY, EXPRESS OR IMPLIED. EXCEPT AS EXPRESSLY PROVIDED, NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY THAT THE BIOVEST
LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY
RIGHT OF A THIRD PARTY.
2.4 Employee Agreements .
Each Party warrants that it has, and covenants that it will have,
entered into a proprietary information and inventions agreement
with each of its employees prior to the time that any such employee
shall receive confidential information from a disclosing party or
begin work related to this Agreement. Such agreement shall
minimally set forth employee obligations to assign inventions to
the inventing Party and to maintain confidentiality of confidential
information consistent with the terms of this Agreement.
ARTICLE 3 - LICENSE
GRANT
3.1 Grant of License
.
(a) Subject to the terms and
conditions of this Agreement, Biovest hereby grants to AutovaxID an
exclusive license throughout the Territory, with the right to grant
sublicenses (subject to Section 3.2), to make, use, sell and
commercialize the Licensed Product.
(b) Subject to the terms and
conditions of this Agreement, Biovest hereby grants to AutovaxID a
nonexclusive, perpetual license to use its Know-How to develop,
manufacture, use, sell and commercialize the Licensed
Product.
(c ) Subject to the terms and
conditions of this Agreement, Biovest hereby grants to AutovaxID a
nonexclusive license throughout the Territory, with the right to
grant sublicenses (subject to Section 3.2) to use the trade
names “Autovax” and “AutovaxID”.
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For the avoidance of doubt, the rights and
license granted hereby are limited to the Autovax Automated
Instrument as defined herein and specifically no rights or license
is granted to AutovaxID under this Agreement to: (i) develop,
market, produce or commercialize any cell related product or
vaccine including, but not limited to, the anti-cancer vaccine now
or in the future developed or owned by Biovest, including the
vaccine known as BiovaxID; (ii) manufacture, sell, market or
commercialize any cell production instrument or equipment now or in
the future developed, owned or licensed by Biovest except only the
automated cell production equipment described in Exhibit A or
(iii) manufacture, sell, market or commercialize the automated
instrument developed by Biovest as described in Exhibit B or any
disposable related thereto outside or for use outside the
Territory.
(d) Notwithstanding anything to the
contrary herein, the license granted hereunder shall not include
use of the Licensed Product for purposes of producing stem cells or
therapeutics.
3.2 Right to Grant
Sublicenses . Subject to Section 9.2 hereof, AutovaxID
shall not have the right to sublicense the Biovest Licensed Product
in the Territory without the consent of Biovest, which consent may
be withheld in Biovest’s discretion.
3.3 [Reserved]
3.4 Intellectual Property .
Any and all intellectual property developed by the Parties related
to the Biovest Licensed Product, including Joint Inventions and
inventions developed solely by either Biovest or AutovaxID, shall
be the sole and exclusive property of Biovest. Such intellectual
property shall be considered a Biovest Licensed Product and
therefore subject to the license rights granted to AutovaxID in
this Article 3. All intellectual property developed by AutovaxID
(Joint Inventions and inventions developed solely by AutovaxID),
not directly or indirectly related to the Biovest Licensed Product
shall be the sole and exclusive property of AutovaxID. All
intellectual property developed solely by Biovest not related to
the Biovest Licensed Product shall be the sole and exclusive
property of Biovest, subject to no license to such intellectual
property to AutovaxID. AutovaxID shall have no rights in any
intellectual property related to Licensed Product developed jointly
by Biovest with any third parties.
ARTICLE 4 - ROYALTY PAYMENTS AND
REPORTS
4.1 License Fee . As
consideration for entering into this Agreement, AutovaxID shall pay
to Biovest ten (10) dollars within thirty (30) days of
the Effective Date.
4.2 Royalty Free . The
License shall be royalty free. For clarification, Biovest shall not
be required hereunder to pay any royalty based on Net Sales or
Sublicensee Revenue or otherwise.
ARTICLE 5 - PATENT PROSECUTION;
ENFORCEMENT; INFRINGEMENT
5.1 Patent Prosecution and
Maintenance .
(a) Responsibility . Biovest
shall continue to have full responsibility for and shall control
the preparation and prosecution and maintenance of all Licensed
Patents.
(b) Cooperation . Each Party
agrees to cooperate with the other Party to execute any documents
necessary or desirable to secure and perfect the other
Party’s legal rights and worldwide
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ownership in the other Party’s
intellectual property, including, but not limited to documents
relating to patent, trademark and copyright applications. Each
Party agrees to take actions reasonably necessary to diligently
prosecute and maintain its intellectual property in major
commercial markets where viable protection is available. Each party
or its representatives shall be entitled to meet and confer with
the other Party and their patent counsel at reasonable times and
places.
5.2 Limitations on
Publications . The Parties agree that no one Party shall
publish the results of any studies, whether conducted by its own
employees or in conjunction with a Third Party, carried out
pursuant to this Agreement or confidential information received
from the other Party that is relating to a Licensed Product,
without the prior written approval of the other Party. Each Party
agrees to provide the other Party with a copy of any proposed
abstracts, presentations, manuscripts, or any other disclosure
which discloses clinical study results pursuant to this Agreement
or confidential information received from the other Party at least
one hundred twenty (120) days prior to their intended
submission for publication and agrees not to submit or present such
disclosure until the Party not seeking to disclose such information
provides its prior written approval. Such written approval will not
be unreasonably withheld unless such proposed disclosure could
reasonably harm or impair a Party’s intellectual property
assets or may reasonably cause commercial harm to a
Party.
5.3 Notification of
Infringement . If either Party learns of an infringement or
threatened infringement by a Third Party of any Licensed Patent
granted hereunder within the Territory, such Party shall promptly
notify the other Party and shall provide such other Party with
available evidence of such infringement, and Section 5.4 shall
be applicable.
5.4 Patent Enforcement .
Biovest shall have the first right, but not the duty, to institute
patent infringement actions against third parties based on any
Licensed Patent under this Agreement. If Biovest does not institute
an infringement proceeding against an offending Third Party within
ninety (90) days after receipt of notice from AutovaxID,
AutovaxID shall have the right, but not the duty, to institute such
an action. The costs and expenses of any such action (including
fees of attorneys and other professionals) shall be borne by the
Party instituting the action, or, if the Parties elect to cooperate
in instituting and maintaining such action, such costs and expenses
shall be borne by the Parties in such proportions as they may agree
in writing. Each Party shall execute all necessary and proper
documents and take such actions as shall be appropriate to allow
the other Party to institute and prosecute such infringement
actions. Any award paid by third parties as a result of such an
infringement action (whether by way of settlement or otherwise)
shall be paid to the Party who instituted and maintained such
action, or, if both Parties instituted and maintained such action,
such award shall be allocated among the Parties in proportion to
their respective contributions to the costs and expenses incurred
in such action.
5.5 Infringement Action by Third
Parties .
(a) Claim or Suit Against
AutovaxID . In the event of the institution of any claim or
suit by a Third Party against AutovaxID for patent infringement
involving the manufacture, use, lease or sale of any Licensed
Product in the Territory, and related to Biovest Licensed
Technology, AutovaxID shall promptly notify Biovest in writing of
such claim or suit. AutovaxID shall have the right to defend such
claim or suit at its own expense and Biovest hereby agrees to
assist and cooperate with AutovaxID, at Biovest’s own
expense, to the extent necessary in the defense of such claim or
suit. During the pendency of such claim or suit.
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(b) Claim or Suit Against
Biovest . In the event of the institution of any claim or suit
by a Third Party against Biovest for patent infringement involving
the manufacture, use, lease or sale of any Licensed Product in the
Territory, Biovest shall promptly notify AutovaxID in writing of
such claim or suit. Biovest shall have the right to defend such
claim or suit at its own expense and AutovaxID hereby agrees to
assist and cooperate with Biovest, at AutovaxID’s own
expense, to the extent necessary in the defense of such claim or
suit.
(c) Indemnity . AutovaxID
shall be responsible to pay any damage, cost or royalty required to
be paid by AutovaxID or Biovest to such Third Party provided such
damage, cost or royalty is related to sales or activities by
AutovaxID.
ARTICLE 6 -
CONFIDENTIALITY
6.1 Use of Name . Biovest
agrees not to use directly or indirectly AutovaxID’s name
without AutovaxID’s prior written consent except as part of
its required filings or in connection with a discussion of the
business of Biovest. AutovaxID agrees not to use directly or
indirectly Biovest’s name or information without
Biovest’s prior written consent. Notwithstanding the
foregoing, AutovaxID and Biovest may include an accurate
description of the terms of this Agreement to the extent required
under federal or state securities or other disclosure; and
AutovaxID may use Biovest’s names in various documents used
by AutovaxID for capital raising and financing purposes.
6.2 Confidentiality;
Exceptions . Except to the extent expressly authorized by this
Agreement, as required by law (upon which prior notice of
disclosure shall be given to the other Party), or otherwise agreed
in writing, the Parties agree that, for the term of this Agreement
and for three (3) years thereafter, the receiving Party shall
keep completely confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than proper
performance hereunder any information furnished to it by the other
Party pursuant to this Agreement, except to the extent that it can
be established by the receiving Party by competent proof that such
information:
(a) was already known to the
receiving Party, other than under an obligation of confidentiality,
at the time of disclosure by the other Party;
(b) was generally available to
the public or otherwise part of the public domain at the time of
its disclosure to the receiving Party;
(c) became generally available to
the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the
receiving Party in breach of this Agreement;
(d) was disclosed to the receiving
Party, other than under an obligation of confidentiality, by a
Third Party who had no obligation to the disclosing Party not to
disclose such information to others; or
(e) was independently developed by
or for the receiving Party by persons not having access to such
information, as determined by the written records of such
party.
6.3. Obligations of Employees and
Consultants. The Parties each represent that all of its
employees and the employees of its Affiliates, and any
collaborators or consultants to such Party or its Affiliates, who
shall
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have access to confidential information of the
Parties are bound by written obligations to maintain such
information in confidence and not to use such information except as
expressly permitted herein. Each Party agrees to enforce
confidentiality obligations to which its employees and consultants
(and those of its Affiliates) are obligated.
ARTICLE 7 -
INDEMNIFICATION
7.1 Indemnification by
AutovaxID . AutovaxID shall defend, indemnify and hold Biovest,
its officers, directors, employees and consultants harmless from
and against any and all Third Party claims, suits or demands,
threatened or filed, for liability, damages, losses, costs and
expenses (including the costs and expenses of attorneys and other
professionals), at both trial and appellate levels, relating to the
distribution, testing, manufacture, use, lease, sale, consumption
on or application of Licensed Product by AutovaxID, its Affiliates
or its Sublicensees pursuant to this Agreement, including, without
limitation, claims for any loss, damage, or injury to persons or
property, or loss of life, relating to the promotion and
advertising of Licensed Products and/or interactions and
communications with governmental authorities, physicians or other
Third Parties r