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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 relating to the
Licensed Products ("Claims"). The foregoing indemnification shall
not apply to any Third Party Claims to the extent are caused by the
gross negligence or willful misconduct of Biovest.
7.2 Indemnification by Biovest . Biovest shall defend,
indemnify and hold AutovaxID, its officers, directors, employees
and consultants harmless from and against any and all Third Party
Claims 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
Biovest’s activities contemplated under this Agreement,
including, but not limited to, (a) breach of the
representations, warranties and obligations of Biovest hereunder,
or (b) any tax, duty, levy or government imposition on any
sums payable by AutovaxID to Bi
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