Exhibit 10.26
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION (THE "SEC")
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT WITH RESPECT TO THE OMITTED
PORTIONS.
OMITTED PORTIONS ARE INDICATED BY [***].
LICENSE AGREEMENT
by and between
GTC BIOTHERAPEUTICS, INC.
AND
PHARMATHENE, INC.
Dated as of March 12, 2007
LICENSE AGREEMENT
This License Agreement ("Agreement"), made as of this 12th day of March,
2007 (the "Effective Date"), is between GTC Biotherapeutics, Inc., a
Massachusetts corporation, with offices at 000 Xxxxxxxx Xxxxxxxxx, Xxxxx 000,
Xxxxxxxxxx, Xxxxxxxxxxxxx, X.X.X. 00000 ("GTC") and PharmAthene, Inc., a
Delaware corporation, with its principal executive offices located at 000
Xxxxxxx Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000 ("PharmAthene"), GTC and
PharmAthene are each referred to as "Party" and, collectively, the "Parties."
R E C I T A L S
WHEREAS, GTC and PharmAthene each have substantial programs and know-how
in the development of transgenic animals and biopharmaceuticals sourced
therefrom;
WHEREAS, GTC and Nexia Biotechnologies ("Nexia") entered into a license
agreement on September 17, 2004 (the "Original Agreement") for GTC's Transgenic
Animal Production Technology and an option to license GTC's product processing
technology;
WHEREAS, Nexia has paid to GTC $[***] toward certain milestone payments as
required by the Original Agreement;
WHEREAS, PharmAthene, through its wholly-owned subsidiary, PharmAthene
Canada, acquired substantially all of the assets of Nexia on March 10, 2005,
pursuant to which the Original Agreement was novated to PharmAthene Canada on
January 17, 2005;
WHEREAS, PharmAthene and GTC wish to terminate the Original Agreement and
enter into this Agreement; and
WHEREAS, both Parties understand that the license granted herein extends
only to the production of recombinant BChE produced from the milk of transgenic
goats and/or mice.
NOW, THEREFORE the Parties agree as follows:
ARTICLE 1
DEFINITION OF TERMS
Capitalized terms used in this Agreement shall have the meaning ascribed
to them in Schedule 1 unless otherwise specifically defined herein.
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ARTICLE 2
LICENSE GRANT
2.1 License Grant from GTC to PharmAthene.
2.1.1 Grant.
Subject to the terms and conditions of this Agreement, GTC hereby
grants to PharmAthene an exclusive worldwide license under the GTC Intellectual
Property to develop, test, manufacture, use, sell, offer for sale, export and
import the Product and recombinant BChE only produced from the milk of
transgenic goats or mice (the "License").
GTC shall retain all of its rights to the GTC Intellectual Property
exclusively outside of the BChE Field, in accordance with Article 4.
The License granted herein with respect to GTC Intellectual Property
is sole and exclusive and precludes GTC or any of its Affiliates from (i) making
any commercial use of GTC Intellectual Property in connection with the
production of BChE or the Product (ii) out-licensing or granting any rights in
GTC Intellectual Property to any third party in connection with the production
of BChE or the Product.
With respect to Transgenic Technology Patent Rights which GTC does
not own, but to which it has non-exclusive licenses (the "Non-Exclusive Third
Party Patents"), the rights provided to PharmAthene hereunder will be
non-exclusive and subject to the same Territory that GTC has with respect to
such rights. With respect to such Non-Exclusive Third Party Patents, GTC hereby
agrees not to use such patents in any way in connection with the production of
BChE or the Product or license or grant any rights in such patents to any third
party in connection with the production of BChE or the Product.
Subject to Section 9.4.1, the License granted to PharmAthene herein
shall not terminate upon and shall survive an Insolvency Event relating to GTC.
2.1.2 Sublicensing. Subject to the terms and conditions of this
Agreement, GTC hereby grants to PharmAthene the right to grant sublicenses under
the GTC Intellectual Property, to any person, including third party contract
manufacturing organizations and Affiliates. Such sublicenses can only be granted
for the purpose of facilitating the development, testing, manufacture and/or
sale of recombinant transgenically derived BChE. Such sublicensees shall not
have the right to further sublicense any of GTC Intellectual Property, as is
applicable.
Subject to Section 9.4.1, the sublicensing rights granted to
PharmAthene herein shall not terminate and shall survive an Insolvency Event
relating to GTC.
2.1.3 Diligence. GTC and PharmAthene each agree to use commercially
reasonable efforts to diligently conduct the research and development activities
required to commercialize the recombinant transgenically derived BChE.
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2.1.4 Consideration.
(a) Initial License Fees. In consideration of the License and
the sublicensing rights granted pursuant to Section 2.1.1, PharmAthene shall pay
to GTC the following license fees:
(i) USD $[***] to be received by GTC no later than the
tenth (10th) business day following the signing of this Agreement;
(ii) USD $[***] to be received by GTC no later than
December 21, 2007;
(iii) USD $[***] on the date PharmAthene files its first
IND for a Product with the FDA or pursuant to a similar filing within a
different jurisdiction, specifically including Europe; and
(iv) USD $[***] on the date PharmAthene files its first
BLA for a Product with the FDA or pursuant to a similar filing within a
different jurisdiction, specifically including Europe.
(b) Royalties. In addition to the payments due under Section
2.1.4(a) above, PharmAthene shall pay to GTC the following royalties (the
"Royalties"):
(i) [***]% of Net Sales for any Product produced with
the use of GTC Intellectual Property in transgenic animals (regardless of
whether those Net Sales are Commercial Sales).
(ii) If the Product is not made in transgenic animals,
then a reduced Royalty (from Subsection (i) above), the amount of which shall be
determined by the mutual agreement of the Parties based upon a good faith
determination by the Parties as to the contribution of GTC Intellectual Property
to the Product.
(c) Minimum Royalty. PharmAthene shall:
(i) within thirty (30) days after the end of the
twelve-month period following the date of the first Commercial Sale (the "First
Period") or equivalent foreign agency, pay the positive difference, if any,
between (i) USD $[***]; and (ii) the aggregate Royalties on Net Sales during the
First Period;
(ii) within thirty (30) days after the end of the
twelve-month period following the First Period (the "Second Period"), pay the
positive difference, if any, between (i) USD $[***]; and (ii) the aggregate
Royalties on Net Sales during the Second Period; and
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(iii) within thirty (30) days after the end of the
twelve month period following the Second Period and each subsequent twelve-month
period thereafter, pay the positive difference, if any, between (i) USD $[***] ;
and (ii) the aggregate Royalties on Net Sales during any such twelve-month
period.
2.2 No Involvement. Other than as provided in the Services Agreement, or
as otherwise mutually agreed to by the parties, GTC agrees not to be involved or
otherwise be engaged, directly or indirectly, in the development, production or
sale of BChE throughout the Term of this Agreement.
2.3 Quarterly Reporting and Payment of Royalties Due. Within thirty (30)
days following the end of each calendar quarter after having filed an BLA for
BChE or a similar filing within a different jurisdiction, PharmAthene shall
submit to GTC a written report for the immediately preceding calendar quarter
setting forth in reasonable detail the Net Sales in such quarter and the
calculation of any Royalties owed by PharmAthene to GTC for such Net Sales. All
reports will be reported in U.S. dollars and converted from other currencies, as
applicable, at the prevailing rate published in The Wall Street Journal on the
date of payment to GTC. Concurrently with the submission of such report,
PharmAthene shall pay to GTC, in a manner reasonably specified by GTC from time
to time, all amounts accrued in such immediately preceding calendar quarter less
any applicable taxes or other withholdings therefrom required by applicable law.
All payments to GTC shall be made in United States dollars.
2.4 Taxes. Licensee may withhold from payments due to the Licensor under
this Agreement any taxes which it is required to withhold under applicable Law
as a result of any of the transactions made or contemplated under this
Agreement.
2.5 Audit Rights. During the Term and for a period of five (5) years
thereafter, PharmAthene shall keep, and shall require all Affiliates to keep,
full, true and accurate books of accounts and other records containing all
information and data which may be necessary to ascertain and verify the
royalties payable hereunder. During the Term and during the period ending six
(6) months thereafter, GTC will have the right once annually, at its own
expense, to have an independent, certified public accountant, selected by GTC
and reasonably acceptable to PharmAthene, review financial and sales records of
PharmAthene for the prior twenty-four (24) month period related to sales of
Products, in all cases in the location(s) where such records are maintained by
PharmAthene, upon reasonable notice during regular business hours and under
obligations of strict confidence, for the purpose of verifying the basis and
accuracy of royalty payments due or made or other compliance with the terms and
conditions of this Agreement. Costs and expenses incurred by GTC in connection
with the exercise of its audit rights hereunder shall be borne entirely by GTC;
provided, however, that if an audit reveals an underpayment of Royalties or
other payments to GTC by more than five percent (5%), then GTC shall be entitled
to reimbursement of all such costs and expenses of the audit as well as all
unpaid monies due with interest calculated at the annual rate of six per cent
(6%) per annum calculated from the payment first became due until it is received
by GTC.
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2.6 Avoidance of Illegal Payments. Where Royalties are due hereunder for
sales of Products in a country where, by reason of currency regulations or taxes
of any kind, it is impossible or illegal for PharmAthene to transfer Royalty
payments to GTC for sales in that country, such Royalties shall be deposited in
whatever currency is allowable by the person not able to make the transfer for
the benefit or credit of GTC in an accredited bank in that country that is
reasonably acceptable to GTC.
ARTICLE 3
CONFIDENTIAL INFORMATION
3.1 Restrictions. The Parties agree that, for the Term of this Agreement
and for five (5) years thereafter, either Party that receives Confidential
Information (a "Receiving Party") from the other Party (a "Disclosing Party")
shall keep completely confidential and shall not publish or otherwise disclose
to any third party (other than contractors and consultants as set forth in
Section 3.2) and shall not use for any purpose (except as expressly permitted
hereunder) any Confidential Information of the Disclosing Party.
3.2 Employees and Consultants. Each Party shall inform its employees,
contractors and consultants of the obligations of confidentiality under this
Agreement, and each Party shall cause all such persons employed or engaged by
it, including employees, contractors and consultants, in connection with the
performance of a Party's obligations hereunder on a "need to know" basis, to be
bound (in writing) by obligations of confidentiality consistent with those in
this Agreement.
3.3 Distribution of GTC Intellectual Property within PharmAthene.
PharmAthene agrees not to make any copies of documents which GTC reasonably
designates are covered by this Agreement without the express written permission
of GTC. GTC will clearly xxxx those documents as, "GTC Confidential Information
- Do Not Duplicate." PharmAthene further agrees to maintain control of all
original documents plus any copies that are authorized by GTC. In addition, GTC
may audit the system used to control documents transferred from GTC to
PharmAthene.
3.4 Exceptions to Restrictions. Each Party's respective obligations under
Section 3.1 shall not apply to information that: (a) was already known to the
Receiving Party, other than under an obligation of confidentiality to the
Disclosing 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 subsequently lawfully disclosed to
the Receiving Party by a third party; (e) can be shown by written records to
have been independently developed by the Receiving Party without reference to
the Confidential Information received from the Disclosing Party and without
breach of any of the provisions of this Agreement; or (f) is information that
the Disclosing Party has specifically agreed in writing that the Receiving Party
may disclose.
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3.5 Permitted Disclosures.
3.5.1 Regulations; Law. Notwithstanding anything to the contrary
herein, either Party may disclose Confidential Information of the Disclosing
Party as required by law (including as required by the Securities Act of 1933,
the Securities Exchange Act of 1934, and the listing regulations of a self
regulatory organization) , government regulation, court order or alternative
dispute resolution process; provided, however, in any such case the Party
seeking to make such disclosure provides, to the extent not prohibited, the
Disclosing Party with advance written notice of such disclosure and provides the
Disclosing Party with a reasonable opportunity to secure protection of the
Confidential Information therein.
3.5.2 Customers. To the extent that it is reasonably necessary to
fulfill its obligations with its customers and exercise its rights under this
Agreement, a Receiving Party may disclose Confidential Information of the
Disclosing Party to potential and actual customers who require the information
to develop or assist in the development or sale of recombinant BChE; provided
however, that any such customer shall first acknowledge in writing such
Receiving Party obligations of confidentiality consistent with those of the
Parties herein.
3.5.3 Disclosures Required for Patent Application. In the event that
a Receiving Party intends to submit a patent application in accordance with this
Agreement that will disclose the Confidential Information of the Disclosing
Party, then such Disclosing Party shall be provided at least thirty (30) days to
review the proposed patent application to suggest ways to minimize the extent of
disclosure and/or to file a patent application of its own on such Confidential
Information. The filing of any patent application disclosing the Confidential
Information of the Disclosing Party shall be delayed for up to thirty (30)
additional days after the initial thirty (30) day waiting and review period upon
written request by the Disclosing Party Confidential Information. After such
waiting and review period(s), a Receiving Party shall be permitted to file a
patent application containing the Confidential Information of the Disclosing
Party to the limited extent reasonably necessary to support patentability of the
subject invention.
ARTICLE 4
OWNERSHIP
4.1 Ownership of Inventions and Improvements in the BChE Field. Any (i)
intellectual property created and/or invented by GTC during the Term, and/or any
improvements made to GTC Intellectual Property during the Term, to the extent
required for the BChE Field or used in the production, purification or
manufacture of the Product. GTC hereby agrees to assign and cooperate in the
appropriate filing of all necessary documents reasonably requested by
PharmAthene to reflect the exclusive ownership by PharmAthene of newly developed
technology/improvements within the BChE Field.
4.2 Joint Ownership. Any intellectual property created and/or invented by
GTC during the term of this Agreement, which has an application both within BChE
Field and outside the BChE Field shall be jointly owned by GTC and PharmAthene.
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4.3 Ownership outside the BChE Field. Any intellectual property created
and/or invented by GTC during the term of this Agreement and/or any improvements
made by GTC to intellectual property owned by GTC that relates exclusively to
applications outside the BChE Field shall be owned exclusively by GTC.
4.4 Inventorship. Inventorship for inventions or data conceived, reduced
to practice, discovered or generated by a Party exercising its rights under this
Agreement shall be determined in accordance with United States patent laws for
determining inventorship.
4.5 Sole Ownership. Unless otherwise agreed in writing, each Party shall,
in its sole discretion and at its sole expense, be responsible for all
preparation, filing, prosecution and maintenance of intellectual property rights
associated with the inventions or data that a Party solely owns in accordance
with Section 4.1.
ARTICLE 5
PATENT PROSECUTION & MAINTENANCE
5.1 Joint Ownership - Patent Applications. GTC shall inform in writing
PharmAthene of any invention or improvement pursuant to Sections 4.1 or 4.2 (an
"Invention Notice"). In the case of subject matter owned jointly in accordance
with Section 4.2, GTC shall have the first option to pursue patent(s) or other
forms of registered intellectual property protection for such subject matter in
one or several jurisdictions by notifying PharmAthene of its intention to do so
(the "Filing Notice"). If PharmAthene responds in writing of its desire to join
in the prosecution of such intellectual property protection in any or all such
jurisdictions, within thirty (30) days of the Filing Notice by GTC, then GTC
shall file the application in selected relevant jurisdiction(s) for such
registered form of intellectual property protection in the name of both Parties
as joint owners, and the Parties shall share equally all costs and expenses
reasonably incurred by GTC in connection with the preparation, filing,
prosecution of the subject application and maintenance of any registered form of
intellectual property resulting therefrom. If PharmAthene does not notify GTC,
within thirty (30) days of the Filing Notice, of its desire to join in the
prosecution of the intellectual property protection in one or several of the
jurisdictions proposed by GTC, GTC shall be free to file the application for
such protection as sole owner of the invention in such jurisdiction(s), at its
sole cost and expense, and PharmAthene shall execute all documents required
assign its rights to GTC. As a joint owner of any registered form of
intellectual property, subject to any other Transgenic Technology Patent Rights
of the other joint owner or other duties of obligations of the Parties under
this Agreement, such joint owner may freely assign or license its interest
therein without accounting to the other joint owner(s) and shall have no duty of
contribution to the other joint owner(s) in respect of any such assignment or
license. The assignee or licensee shall, however, acknowledge and accept in
writing the terms and conditions set forth in this Section 5.1prior to such
assignment or license becoming effective. Moreover, the assigning or licensing
Party shall, within thirty (30) days following the assignment or license, notify
in writing the other Party of the identity of the assignee or licensee.
If GTC has not, within sixty (60) days of the Invention Notice or of
the moment PharmAthene advises that it becomes aware of the invention or
improvement, sent a Filing Notice to PharmAthene or if GTC has not, within four
(4) months of sending a Filing Notice to PharmAthene, filed a patent
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application, PharmAthene may file patent applications as sole owner of the
invention or improvement in any jurisdiction where GTC has not filed a patent
application, with the sole cost being borne by PharmAthene.
5.2 Joint Ownership - Management. The Parties agree that a patent attorney
designated by the prosecuting Party and agreed to by the Notified Party,
agreement not being unreasonably withheld, shall be responsible for the
management and prosecution of any patent application for intellectual property
which is jointly owned pursuant to this Agreement. If GTC desires to abandon any
patent or patent application within the BChE Field or to decline responsibility
for the maintenance or prosecution of any such patent or patent application in
any country, GTC shall provide PharmAthene with sufficient prior written notice
of such intended abandonment or declination of responsibility such that
PharmAthene shall have the opportunity to assume responsibility for such patent
or patent application without the loss of any rights therein, and PharmAthene
shall have the right, at its cost and expense, to prepare, file, prosecute, and
maintain the relevant patents and/or patent applications in the relevant country
or countries in the name of PharmAthene. In such an event, GTC shall cooperate,
and cause its Affiliates to cooperate, with PharmAthene with respect thereto.
5.3 Patent Prosecution and Maintenance. GTC shall reasonably prosecute and
maintain the GTC Intellectual Property and, to the extent patentable, any
patents or pending patent applications existing as of the Effective Date hereof
and during the Term of this Agreement. GTC shall have the ultimate
responsibility for meeting all payment, cost, and filing deadlines concerning
GTC Intellectual Property, and any other form of intellectual property
protection associated therewith.
ARTICLE 6
INFRINGEMENT BY A THIRD PARTY
6.1 Obligation to Notify. Should PharmAthene or GTC become aware of any
infringement or potential infringement of the GTC Intellectual Property, each
shall give to the other Party prompt written notice including a reasonable
amount of factual details concerning such infringement or potential
infringement.
6.2 Patent Litigation. GTC shall initiate, defend and save PharmAthene
harmless against any infringement lawsuit and claims made by a person against
PharmAthene related to PharmAthene's use of GTC's Intellectual Property provided
herein, the whole without prejudice to PharmAthene's right to intervene in any
such proceedings with legal counsel of its choice. If, however, applicable law
requires that PharmAthene be joined to the legal proceedings as a necessary
party-plaintiff, GTC shall reimburse PharmAthene for expenses and costs
(including reasonable legal fees and costs) incurred by PharmAthene, or
representatives of PharmAthene whose involvement is reasonably required,
provided however that such expenses and costs are reasonable.
6.3 Infringement Proceedings. In the event a third party is believed to be
infringing on the GTC Intellectual Property, GTC shall institute and direct
legal proceedings against such third party provided however, that GTC shall not
settle any claim or proceeding relating to the GTC Intellectual Property in a
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manner that prejudices the License, the sublicense rights granted hereunder or
any other rights of PharmAthene hereunder without the prior written consent of
PharmAthene. All costs, including attorneys' fees, relating to such legal
proceedings shall be borne by GTC and all damages and awards, if any, shall
belong to GTC after reimbursement of any costs and expenses incurred by
PharmAthene in connection with such proceedings, provided however that such
expenses and costs are reasonable.
6.4 Cooperation in Patent Infringement Proceedings. In the event that
either Party takes action pursuant to this Section 6, the other Party shall
cooperate to the extent reasonably necessary. GTC shall reimburse PharmAthene
for the costs incurred in such cooperation, including the salary of
PharmAthene's employees and agents involved in such cooperation.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
7.1 Authority. Each Party represents and warrants that it has the full
right, power and authority to enter into this Agreement and that this Agreement
has been duly executed by such Party and constitutes a legal, valid and binding
obligation of such Party, enforceable in accordance with its terms.
7.2 No Conflicts. Each Party represents and warrants that the execution,
delivery and performance of this Agreement do not conflict with, or constitute a
breach or default under any of its charter or organizational documents, any law,
order, judgment or governmental rule or regulation applicable to it, or any
material agreement, contract, commitment or instrument to which it is a party.
Each Party represents and warrants that its obligations under this Agreement are
not encumbered by any rights granted by such Party to any third party or by any
third party to such Party that are or may be inconsistent with the rights and
licenses and sublicenses granted in this Agreement.
7.3 Intellectual Property. GTC represents and warrants to PharmAthene
that:
(a) the Transgenic Technology Patent Rights and the GTC Intellectual
Property licensed to PharmAthene under this Agreement are valid and enforceable;
(b) GTC possesses the necessary rights to grant the License and the
sub-license rights hereunder;
(c) GTC has not received any notice from any third party asserting
the invalidity, misuse, unenforceability or non-infringement of any of the
Transgenic Technology Patent Rights licensed to PharmAthene under this Agreement
and to the extent applicable, in the GTC Intellectual Property, and GTC has not
received any notice from any third party challenging its right to use or
ownership of any of such Transgenic Technology Patent Rights or the GTC
Intellectual Property;
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(d) GTC has no knowledge that the testing, manufacture, use, sale,
offer for sale or importation of recombinant BChE as contemplated hereunder will
infringe or otherwise violate the patent rights or other intellectual property
rights of any third party; and
(e) GTC is not aware of any pending or threatened claim or
litigation that alleges that the Transgenic Technology Patent Rights or the GTC
Intellectual Property have violated the intellectual property rights of any
third party.
7.4 Warranties Relative to the Right to Practice. PharmAthene hereby
warrants that as of the date hereof:
7.4.1 PharmAthene is not aware of any rights to any valid patent
claim (other than the rights licensed by GTC to PharmAthene herein or that
PharmAthene already has) that are necessary in order to allow PharmAthene to
commercialize BChE;
7.4.2 PharmAthene is not aware that the commercialization of BChE by
PharmAthene would infringe any valid patent claims of any third party;
7.4.3 To its knowledge and as of the date of this Agreement,
PharmAthene owns or has rights to the intellectual property currently required
to commercialize BChE as it intends to commercialize it; and
7.4.4 there are no patent infringement suits or patent infringement
claims asserted against PharmAthene relative to BChE.
7.5 Disclaimer of Warranties. Except as expressly set forth in this
Agreement, neither Party makes any representations and extends no warranties or
conditions of any kind, either express or implied, including, but not limited
to, warranties of merchantability, fitness for a particular purpose or
non-infringement.
7.6 Limitation on Liability. Neither Party shall be liable to the other
Party for special, indirect, incidental or consequential damages, whether based
in contract, warranty, tort, negligence, strict liability or otherwise,
including, but not limited to, loss of profits or revenue; provided, however,
such limitation shall not apply to the indemnification obligations of one Party
under Sections 8.1 or 8.2, as the case may be, with respect to claims by a third
party against the other Party, nor shall it apply to Sections 8.1.2 and 8.2.2 or
with respect to a breach of Section 11.4.
ARTICLE 8
INDEMNIFICATION
8.1 Indemnification by GTC.
8.1.1 General. Subject to Section 7.6 hereof and except as provided
specifically in Section 8.1.2, GTC shall indemnify, defend and hold PharmAthene
and its employees, officers, directors, contractors, consultants and agents (the
"PharmAthene Indemnitees") harmless from and against any and all liability,
damage, loss, cost or expense (including reasonable attorneys' fees)
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(collectively, "Losses") arising out of: (a) GTC's performance of its
obligations under this Agreement; (b) the testing, manufacture, use,
importation, offer for sale or sale of Products by GTC and its distributors,
agents or customers; (c) a material breach by GTC of any of its covenants,
representations or warranties set forth in this Agreement, and (d) any third
party claim made against PharmAthene relating to its use of the Transgenic
Technology Patent Rights pursuant to the terms and conditions of this Agreement
except to the extent such Losses result from the material breach of any of the
provisions of this Agreement by PharmAthene or the PharmAthene Indemnitees or
the gross negligence or willful misconduct of PharmAthene or the PharmAthene
Indemnitees.
8.1.2 Confidentiality. Notwithstanding Sections 7.6 and 8.1.1
herein, GTC shall defend, indemnify and hold harmless PharmAthene and the
PharmAthene Indemnitees from and against any and all Losses that may result, in
whole or part, from any breach of the obligations of confidentiality under this
Agreement by GTC or the GTC Indemnitees or otherwise caused by the GTC
Indemnitees or customers and potential customers of GTC that should have an
obligation of confidentiality to GTC as a Receiving Party in accordance with
this Agreement.
8.1.3 Conditions of Indemnities and Settlement. The indemnities
under Sections 8.1.1 and 8.1.2 are conditioned upon: (i) promptly notifying GTC
in writing of the claim; (ii) providing GTC all reasonably requested information
that PharmAthene has concerning the claim; (iii) reasonably cooperating with,
and assisting GTC in, defending the claim at GTC's expense; and (iv) granting
GTC authority to defend and control the defense of the claim (provided that
PharmAthene may participate in the defense to the extent it deems appropriate
and at its expenses). GTC shall not settle any such claim or suit without the
prior written consent of PharmAthene, unless: (i) GTC or the GTC Indemnitees
shall have first waived its/their rights to indemnification hereunder; (ii) the
settlement involves the payment of monetary damages by GTC only; and (iii) the
settlement would not result in any injunctive or other relief against, or the
assumption or admission of any liability by, PharmAthene.
8.2 Indemnification by PharmAthene.
8.2.1 General. Subject to Section 7.6, PharmAthene shall indemnify,
defend and hold GTC and its employees, officers, directors, contractors,
consultants and agents (the "GTC Indemnitees") harmless from and against any and
all Losses arising out of: (a) PharmAthene's performance of its obligations
under this Agreement; (b) subject to Section 8.1, the manufacture, use,
importation, offer for sale or sale of Products by PharmAthene and its
distributors, agents or customers; and (c) a material breach by PharmAthene of
any of its covenants, representations or warranties set forth in this Agreement,
except to the extent such Losses result from the breach of any of the provisions
of this Agreement by GTC or the GTC Indemnitees or gross negligence or willful
misconduct of GTC or the GTC Indemnitees.
8.2.2 Confidentiality. Notwithstanding Sections 7.6 and 8.2.1,
PharmAthene shall defend, indemnify and hold harmless GTC and the GTC
Indemnitees from and against any and all Losses that may result, in whole or
part, from any breach of the obligations of confidentiality under this Agreement
by PharmAthene or the PharmAthene Indemnitees or otherwise caused by the
PharmAthene Indemnitees or customers and potential customers of PharmAthene that
should have an obligation of confidentiality to PharmAthene as a Receiving Party
in accordance with this Agreement.
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8.2.3 Conditions of Indemnities and Settlement. The indemnitees
under Sections 8.2.1 and 8.2.2 are conditioned upon: (i) promptly notifying
PharmAthene in writing of the claim; (ii) providing PharmAthene all reasonably
requested information that GTC has concerning the claim; (iii) reasonably
cooperating with, and assisting PharmAthene in, defending the claim at
PharmAthene's expense; and (iv) granting PharmAthene authority to defend and
control the defense of the claim (provided that GTC may participate in the
defense to the extent it deems appropriate and at its expense). PharmAthene
shall not settle any such claim or suit without the prior written consent of
GTC, unless: (i) PharmAthene or the PharmAthene Indemnitees shall have first
waived its/their rights to indemnification hereunder; (ii) the settlement
involves the payment of money damages by PharmAthene only; and (iii) the
settlement would not result in any injunctive or other relief against, or the
assumption or admission of liability by, GTC.
8.3 Insurance. Each Party shall maintain necessary insurance, including
product liability insurance and workers compensation or an insurance product
with a similar purpose, with respect to its activities hereunder. Such insurance
shall be in such amounts and subject to such deductibles as the Parties may
agree based upon standards prevailing in the industry at the time. Each Party
may satisfy its obligations under this Section 8.3 through self-insurance to the
same extent.
ARTICLE 9
TERM AND TERMINATION
9.1 Term. This Agreement shall commence on the Effective Date hereof and,
unless extended by mutual written agreement of the Parties or terminated sooner
under this Article 9, this Agreement and its provisions shall expire on December
31, 2026 (the "Term").
9.2 Termination for Breach. The failure by a Party to comply in any
material respects with any of the material obligations contained in this
Agreement shall entitle the other Party to give notice to have the default
cured. Failure by PharmAthene to pay any Royalty, milestone payment, annual fee
or licensing fee due pursuant to Section 2.1.4 or failure by GTC to comply with
its obligations pursuant to Section 2.1.1 shall be considered a material failure
to comply with a material obligation. If such default is not cured within sixty
(60) days after the receipt of such notice, or if diligent steps are not taken
to cure or if, by its nature, such default could not be cured within sixty (60)
days, the notifying Party shall be entitled, without prejudice to any of its
other rights conferred on it by this Agreement, and in addition to any other
remedies that may be available to it, to terminate this Agreement in its
entirety. This ability to terminate, however, shall be stayed in the event that,
during such sixty (60) day period, the Party alleged to have been in default
shall have: (a) initiated arbitration in accordance with Article 10, below, with
respect to the alleged default, and (b) diligently and in good faith cooperates
in the prompt resolution of such arbitration proceedings.
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9.3 Termination by PharmAthene. PharmAthene may terminate this Agreement
at any time upon notice to GTC, but in such case shall forfeit all rights to any
refund of any prior payment and shall also forfeit any and all licenses, access
or utilization of the GTC Intellectual Property or any other intellectual
property rights granted herein.
9.4 Insolvency or Bankruptcy.
9.4.1 Termination. Either Party may, in addition to any other
remedies available by law or in equity, terminate this Agreement by written
notice to the other Party in the event (collectively, an "Insolvency Event"):
(i) the latter Party (the "Insolvent Party") shall have become insolvent or
bankrupt, or shall have assigned its property for the benefit of its creditors,
or there shall have been appointed a trustee or receiver of the Insolvent Party
or for all or a substantial part of its property; or (ii) any other proceeding
that shall have been commenced or other action taken by or against the Insolvent
Party in bankruptcy or seeking reorganization, liquidation, dissolution,
winding-up, arrangement or readjustment of the Insolvent Party's debts or any
other relief under any bankruptcy, insolvency, reorganization or other similar
act or law of any jurisdiction now or hereafter in effect; or (iii) there shall
have been issued a warrant of attachment, execution, restraint or similar
process against any substantial part of the property of the Insolvent Party, and
any such event shall have continued for ninety (90) days undismissed, unbonded
and undischarged.
9.4.2 Intellectual Property. All rights, licenses and sublicenses
granted under or pursuant to this Agreement by GTC are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the United States Bankruptcy
Code, licenses of right to "Intellectual Property" as defined under Section
ss.101 of the United States Bankruptcy Code. The Parties agree that PharmAthene
as licensee of such rights under this Agreement shall retain and may fully
exercise all of its rights and elections under the United States Bankruptcy
Code. The Parties further agree that, in the event of the commencement of a
bankruptcy proceeding by or against GTC under the United States Bankruptcy Code,
PharmAthene shall be entitled to a complete duplicate of (or complete access to,
as appropriate) any such intellectual property and all embodiments or
descriptions of such licensed intellectual property, and same, if not already in
its possession, shall be promptly delivered to it (a) upon any such commencement
of a bankruptcy proceeding upon its written request therefor, unless GTC elects
to continue to perform all of its obligations under this Agreement or (b) if not
delivered under (a) above, upon the rejection of this Agreement by or on behalf
of GTC upon written request therefor by the non-debtor Party.
9.4.3 GTC Rights in Bankruptcy. PharmAthene shall notify GTC in
writing promptly after: (i) the filing by or against PharmAthene of any petition
in bankruptcy or similar filing seeking relief from creditors; (ii) receipt by
PharmAthene of any notice of foreclosure and/or default that could be reasonably
foreseen to have the effect of preventing the commercialization of BChE or the
filing of a BLA.
9.4.4 Right of First Negotiation. PharmAthene hereby grants to GTC a
right of first negotiation for the purpose of negotiating in good faith a
license to any intellectual property owned by PharmAthene with respect to the
production or development of BChE, including all rights assigned by GTC to
PharmAthene pursuant to this Agreement. This right of first negotiation may only
be exercised if PharmAthene becomes bankrupt or otherwise, for any reason,
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completely ceases its operations, other than as a result of a sale of its
business to an Affiliate or a third party. If, after good faith negotiations,
the Parties fail to reach an agreement within thirty (30) days following
PharmAthene's bankruptcy or the end of PharmAthene's operations, then
PharmAthene shall be free to negotiate with other parties for the licensing or
assignment of its intellectual property relevant to the production or
commercialization of BChE. If PharmAthene, at any moment before the expiry of a
four (4) month period after the above thirty (30) day period, wants to enter
into an agreement with a third party on terms that are less favorable to
PharmAthene than the best offer from GTC, PharmAthene shall give a written
notice thereof to GTC and the Parties shall negotiate again, in good faith and
for a period of thirty (30) days, an agreement for the purchase of the
intellectual property referred to above. This Section 9.4.4 shall not survive in
the event of an assignment of the Agreement by PharmAthene pursuant to Section
11.4.
9.5 Survival of Obligations. The termination or expiration of this
Agreement shall not relieve the Parties of any obligations accruing prior to
such termination, and any such termination shall be without prejudice to the
rights of either Party against the other. The provisions of Sections 1.1.1,
2.1.1 (only in the case of a termination by PharmAthene under Section 9.3 or the
expiration of the Term set forth in Section 9.1), 2.1.2 (only in the case of a
termination by PharmAthene under Section 9.3 or the expiration of the Term set
forth in Section 9.1), 2.1.4(a)(i), 2.1.4(a)(ii), 2.3 (only with respect to Net
Sales that give rise to the payment of a royalty), 3.1, 3.5, 4.1, 4.2, 4.3, 8.1,
8.2, 9.5, 9.6, Article 10 and Sections 11.12 and 11.5 shall survive any
termination of this Agreement.
9.6 Effects of Termination.
9.6.1 Confidential Information. Upon termination of this Agreement
for any reason, all use by the Receiving Party of the Confidential Information
of the Disclosing Party shall immediately cease, and within thirty (30) days
after termination, the Disclosing Party shall return or destroy, as directed by
the Disclosing Party, all Confidential Information of the Disclosing Party,
regardless of the form in which it is stored, and certify to the Disclosing
Party when such return or destruction is complete.
9.6.2 Elimination of License and Termination of Obligations. Subject
to Sections 9.4.2 and 9.5, upon termination of this Agreement, the License and
sublicense right granted under Article 2 shall immediately terminate and all of
the obligations of the Parties under this Agreement shall also terminate at such
time.
ARTICLE 10
DISPUTE RESOLUTION
10.1 Dispute Resolution Process. Both Parties understand that their long
term mutual interest will be best served by affecting a rapid and fair
resolution of any claims or disputes which may arise out of services performed
under this contract or from any dispute concerning the terms of this Agreement.
Therefore, both Parties agree to use their commercially reasonable best efforts
to resolve all such disputes as rapidly as possible on a fair and equitable
basis. Toward this end, both Parties agree to develop and follow a process for
presenting, rapidly assessing, and settling claims on a fair and equitable basis
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that takes into account the precise subject and nature of the dispute. All
discussions, summaries and papers generated in connection with such dispute
resolution process shall be considered settlement negotiations for the purpose
of any applicable rules of discovery or evidence.
10.2 Dispute Resolution Panel. If any dispute or claim arising under this
Agreement cannot be readily resolved by the Parties pursuant to the process
described above, then the Parties agree to refer the matter to a panel
consisting of the Chief Executive Officer of PharmAthene and the Chief Executive
Officer of GTC or their duly authorized designees for review and pursuit of a
resolution. A copy of the terms of this Agreement, agreed upon facts (and areas
of disagreement), and concise summary of the basis for each side's contentions
will be provided to both such officers who shall review the same, confer and
attempt to reach a mutual resolution of the issue. All discussions, summaries
and papers generated in connection with such dispute resolution panel shall be
considered settlement negotiations for the purpose of any applicable rules of
discovery or evidence.
10.3 Arbitration. If the matter has not been resolved utilizing the
foregoing process and/or the Parties are unwilling to accept the non-binding
decision of the dispute resolution panel, the Parties may elect to pursue
definitive resolution through binding arbitration, in lieu of litigation or
other legally available remedies (with the exception of injunctive relief where
such relief is necessary to protect a Party from irreparable harm pending the
outcome of any such arbitration proceeding). If the Parties elect to settle a
dispute by binding arbitration, the arbitration shall be settled in accordance
with the Rules of the International Chamber of Commerce by a panel of three
arbitrators chosen in accordance with such Rules. If such dispute relates
primarily to the Transgenic Technology Patent Rights or otherwise relate to
transgenic product processing, molecular biology, and/or recombinant protein
secretion by transgenic mammals, such arbitrators shall be selected in such a
manner to ensure that they will have sufficient technical expertise and training
to handle such a dispute. The arbitration and all hearings and proceeding in
connection therewith will be held in Boston, Massachusetts or other mutually
agreeable location. Judgment upon the award rendered may be entered in any court
having jurisdiction and the Parties irrevocably agree that a judgment or order
in any such proceeding shall be conclusive and binding upon the Parties and may
be enforced in any court of competent jurisdiction.
10.4 Governing Law. This Agreement shall be governed by and construed in
accordance with the substantive laws of the State of Delaware and the federal
laws of the United States of America, applicable therein without reference to
its conflicts of laws principles.
ARTICLE 11
MISCELLANEOUS PROVISIONS
11.1 Entire Agreement. This Agreement and each of the Schedules hereto
constitute and contain the entire understanding and agreement of the Parties
respecting the subject matter of this Agreement and cancels and supersedes any
all prior negotiations, correspondence, understandings and agreements between
the Parties, whether oral or written, regarding such subject matter.
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11.2 Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
11.3 Binding Effect. This Agreement and the rights and obligations granted
herein shall be binding upon and shall inure to the benefit of PharmAthene, GTC
and their respective successors and permitted assigns.
11.4 Assignment. Neither Party shall assign this Agreement and GTC shall
not assign any intellectual property licensed or to be licensed hereunder
without the prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed; provided, however, that either Party may
assign this Agreement without the prior written consent of the other to an
Affiliate or in connection with the Change of Control of such Party if such
permitted assignee first assumes (by operation of law or otherwise) all
obligations of its assignor under this Agreement.
GTC shall not assign any intellectual property licensed or to be licensed
hereunder, without the prior written consent of PharmAthene, which consent shall
not to be unreasonably withheld, provided, however, that GTC may assign its
intellectual property licensed or to be licensed hereunder without the prior
written consent of PharmAthene to an Affiliate in connection with the Change of
Control of GTC if such permitted assignee first assumes (by operation of law or
otherwise) all obligations of GTC under this Agreement.
11.5 No Waiver. No waiver, modification or amendment of any provision of
this Agreement shall be valid or effective unless made in writing and signed by
a duly authorized officer of each Party. The failure of either Party to assert a
right hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition.
11.6 Independent Contractors. Both Parties are independent contractors
under this Agreement. Nothing contained in this Agreement is intended nor is to
be construed so as to constitute PharmAthene or GTC as partners or joint
venturers with respect to this Agreement. Neither Party shall have any express
or implied right or authority to assume or create any obligations on behalf of
or in the name of the other Party or to bind the other Party to any other
contract, agreement or undertaking with any third party.
11.7 Notices and Deliveries. Any formal notice, request, delivery,
approval or consent required or permitted to be given under this Agreement shall
be in writing and shall be deemed to have been sufficiently given when it is
received, whether delivered in person, transmitted by facsimile with
contemporaneous confirmation, delivered by registered letter (or its equivalent)
or delivered by certified overnight courier service, to the Party to which it is
directed at its address shown below or such other address as such Party shall
have last given by notice to the other Parties.
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If to PharmAthene:
PharmAthene, Inc.
000 Xxxxxxx Xxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxx, Xxxxxxxx 00000
Attention: Xxxxx X. Xxxxxx
President and Chief Executive Officer
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to GTC:
GTC Biotherapeutics, Inc.
000 Xxxxxxxx Xxxxxxxxx
Xxxxx 000
Xxxxxxxxxx, XX 00000
Attention: Xxxxxx X. Xxxxxxxx,
Senior Vice President and General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
11.8 Publicity. Except to the extent already disclosed in the initial
press release or other public communication and subject to Section 3.5, no
public announcement concerning the existence or the terms of this Agreement or
concerning the transactions described herein or any other publicity or
publication shall be made, either directly or indirectly, without first
obtaining the approval of the other Party and agreement upon the nature, text,
and timing of such announcement or publication, which approval and agreement
shall not be unreasonably withheld.
11.9 Notice. The Party desiring to make any such public announcement shall
provide the other Party with a written copy of the proposed announcement in
sufficient time prior to public release to allow such other Party to comment
upon such announcement, prior to public release.
11.10 Non-Disparagement. Neither Party shall disparage the other regarding
their respective technologies, programs, or marketing strategies relative to the
Transgenic Technology Patent Rights or the BChE development program.
11.11 Headings. The captions to the sections and articles in this
Agreement are not a part of this Agreement, and are included merely for
convenience of reference only and shall not affect its meaning or
interpretation.
11.12 Severability. If any provision of this Agreement becomes or is
declared by a court of competent jurisdiction or binding arbitration panel to be
illegal, unenforceable or void, this Agreement shall continue in full force and
effect without said provision, so long as the Agreement, taking into account
said voided provision(s), continues to provide the Parties with the same
practical economic benefits as the Agreement containing said voided provision(s)
did prior to the voiding of such provision. If, after taking into account said
voided provision(s), the Parties are unable to realize the practical economic
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benefit contemplated, the Parties shall negotiate in good faith to amend this
Agreement to reestablish the practical economic benefit contemplated by the
Parties prior to the voiding of such provision.
11.13 Counterparts. This Agreement may be executed in counterparts, or
facsimile versions, each of which shall be deemed to be an original, and both of
which together shall be deemed to be one and the same agreement.
11.14 Force Majeure. If the performance of this Agreement or any
obligation hereunder is prevented, restricted or interfered with by reason of
fire or other casualty or accident, strikes or labor disputes, inability to
procure raw materials, power or supplies, terrorist act or other violence, any
law, order, proclamation, regulation, ordinance, demand or requirement of any
government agency, or any other act or condition whatsoever beyond the control
of a Party hereto, the Party so affected, upon giving prompt notice to the other
Party, shall be excused from such performance to the extent of such prevention,
restriction or interference; provided, however, that the Party so affected shall
use reasonable efforts to avoid or remove such causes of non-performance and
shall continue performance hereunder with reasonable dispatch whenever such
causes are removed.
11.15 Non-Solicitation of Employees. Neither Party shall solicit for
employment or hire any employee of the other party without the prior written
consent of such other party. This restriction shall apply for the term of this
Agreement, and any extensions thereto and for one (1) year after thereafter.
THE REST OF THIS PAGE LEFT INTENTIONALLY BLANK
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their respective duly authorized officers as of the Effective Date, each copy
of which shall for all purposes be deemed to be an original.
PHARMATHENE, INC.
By: /s/ Xxxxx X. Xxxxxx
-----------------------------------------
Xxxxx X. Xxxxxx
President and Chief Executive Officer
GTC BIOTHERAPEUTICS, INC.
By: /s/ Xxxx X. Xxxxx
-----------------------------------------
Xxxx X. Xxxxx
Senior Vice President and Chief Financial
Officer
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SCHEDULE 1
DEFINITIONS
"Affiliate" means, with respect to any Party, any corporation, partnership
or other business entity that controls, is controlled by, or is under common
control with such Party. A corporation, partnership or other entity shall be
regarded as in control of another corporation, partnership or entity if it owns
or directly or indirectly controls at least fifty percent (50%) of the voting
stock or other ownership interest of the other corporation, partnership or
entity (or alternatively with respect to any non-USA entities, if it owns the
maximum such ownership interest permitted by law), or if it possesses, directly
or indirectly, the power to direct or cause the direction of the management and
policies of the corporation, partnership or other entity or the power to elect
or appoint at least fifty percent (50%) of the members of the governing body of
the corporation, partnership or other entity.
"BChE" means recombinant butyrylcholinesterase (BChE) or an amino acid
sequence substantially similar to the human BChE sequence that has the same
physiological mode of action and activity thereof in all its variants.
"BChE Field" means the development or production (including any
purification process) of BChE.
"BLA" means Biological License Application.
"Change of Control" means with respect to a Party: (i) a sale or
assignment, by operation of law or otherwise, of all or substantially all of
such Party's assets (or, with respect to PharmAthene, of all or substantially
all of its assets relating to the BChE Field) to an entity not an Affiliate of
such Party; (ii) an amalgamation, plan of arrangement, merger or consolidation
by such Party with or into an entity that is not an Affiliate of such Party
where, as a result of such transaction, the stockholders of the unaffiliated
entity own more than fifty percent (50%) of the combined entity; or (iii) a sale
of beneficial ownership of a Party's voting securities to an entity that is not
an Affiliate of such Party, where such entity, as a result of such sale, owns
more than fifty percent (50%) of the outstanding voting securities of such
Party. PharmAthene's pending transaction with Healthcare Acquisition Corporation
shall not be deemed a Change of Control for purposes of this Agreement.
"Commercial Sale" means any sale by PharmAthene or an Affiliate, as the
case may be, of Products within the Territory following the filing and obtaining
of a BLA with the FDA or an equivalent filing or approval within another
jurisdiction in the Territory
"Confidential Information" shall mean any and all confidential and
non-public information of a Party, which includes but is not limited to, trade
secrets, privileged records, proprietary information, data, case report forms,
laboratory work sheets, slides, reports, results, material, or information,
whether in written, verbal, physical, electronic, tangible or intangible form,
made available, disclosed, or otherwise made known to a Party and its employees,
including without limitation as a result of services to be rendered under the
Services Agreement.
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"Effective Date" means the execution date hereof.
"FDA" means the United States Foods and Drug Administration, or its
successors.
"GTC Intellectual Property" means an exclusive license under the
Transgenic Technology Patent Rights to develop, test, manufacture, use, sell,
offer for sale, export and import recombinant BChE only produced from the milk
of transgenic goats or mice and an exclusive license to all inventions,
processes, know-how, trade secrets, improvements, other intellectual property,
including but not limited to data processes, technology, means or know-how
developed by GTC which relate to animal maintenance and management, analytical
methods, procedures and techniques related to the purification and processing of
proteins in the milk of transgenic animals, regulatory policies and procedures,
and filings (excluding any preclinical or clinical information relating to
specific products) which have been independently developed without the benefit
of any information or support provided by PharmAthene.
"IND" means an Investigational New Drug Application or the equivalent
filing in another jurisdiction.
"Net Sales" means: (a) the gross amount of payment received (whether
structured as an up-front payment, milestone payment, R&D reimbursement, success
payment or other form of compensation) for the Commercial Sale of Products by
PharmAthene to a third party or to an end user in the Territory, excluding
Commercial Sales of Product to an Affiliate; and (b) in the case of Commercial
Sales of the Product to an Affiliate, the gross amount of payment received
(whether structured as an up-front payment, milestone payment, R&D
reimbursement, success payment or other form of compensation) for the Commercial
Sale of Products by the Affiliate to a third party or an end-user in the
Territory, in each case, after deduction of the following items (to the extent
actually incurred or reasonably estimated and accrued and to the extent not
already deducted in the amount invoiced): (i) customary trade, quantity and cash
discounts, wholesaler-charge backs, or rebates (including, but not limited to,
rebates to governmental agencies, managed care organizations, health management
organizations, pharmacy benefit managers and group purchasing organizations);
(ii) customary credits or allowances for rejection or return of previously sold
Products; (iii) withholding excise, sales and other consumption taxes and
customs duties; and, (iv) any charge for freight or insurance if separately
stated on the same invoice as for the sale of Products and directly related to
the sale or distribution of the Products.
"Product" means BChE produced for therapeutic use.
"Services Agreement" means that certain agreement entered into between the
Parties of even date herewith with respect to the clarification, downstream
process and analytical methods development program and pre-clinical services
relating to the Product.
"Territory" means all countries World-Wide.
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"Transgenic Technology Patent Rights" means the patents and patent
applications listed in Appendix A in the United States, and their issued or
pending counterparts in various European Jurisdictions or other specific
countries. Moreover, with respect to any particular patent or patent application
listed in attached Appendix A it also includes all predecessor or priority
patent applications upon which such patent or patent application is based in
whole or in part, all continuation or divisional applications for such patent or
patent application and its predecessor patent or priority applications, any
patent, reissue, re-examination, renewal or extension (including any
supplemental patent certificate) of any of the foregoing patents or patent
applications or resulting from any of the foregoing patent applications, all
confirmation patent or registration patent or patent of addition based upon any
of the foregoing, and all international counterparts or equivalents of any of
the foregoing.
"USD" means United States dollars.
Other Defined Terms
In addition to the defined terms in this Schedule I, each of the following
capitalized terms shall have the meaning ascribed thereto in the corresponding
Sections:
Term Section
---- -------
Agreement ............................. Preamble
Disclosing Party....................... 3.1
Effective Date ........................ Preamble
First Period .......................... 2.1.4(c)(i)
GTC ................................... Preamble
GTC Indemnitees ....................... 8.2.1
Insolvency Event ...................... 9.4.1
Insolvent Party ....................... 9.4.1
License ............................... 2.1.1
Losses ................................ 8.1.1
PharmAthene ........................... Preamble
PharmAthene Indemnitees ............... 8.1.1
Non-Exclusive Third Party Patents...... 2.1.1
Notified Party ........................ 5.1
Notifying Party ....................... 5.1
Option................................. 1.1.1
Option Notice.......................... 1.1.1
Option Period.......................... 1.1.1
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Parties ............................... Preamble
Receiving Party........................ 3.1
Royalties ............................. 2.1.4(b)
Second Period.......................... 2.1.4(c)
Term .................................. 9.1
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Appendix A
TRANSGENIC ANIMAL PRODUCTION TECHNOLOGY
PATENT NO. INVENTOR EXPIRATION DATE ASSIGNEE/OWNER
------------------------------------------------------------------------------------------
4,873,316 Xxxxx et al. 6/23/2007 Biogen, Inc. / Pharming
Title: Isolation of exogenous recombinant proteins from the milk of transgenic mammals
5,610,053 Xxxxx et al. 3/11/2014 National Institutes of Health
Title: DNA sequence which acts as a Chromatin insulator element to protect expressed genes from cis-acting regulatory sequences
in mammalian cells
EP 264166 Xxxxxx et al. Genzyme Corporation
Title: Transgenic Animals secreting desired proteins into milk (exclusively licensed by GTC)
PATENT NO. INVENTOR EXPIRATION DATE ASSIGNEE/OWNER
------------------------------------------------------------------------------------------
6,580,017 Echelard et al. 11/02/2018 GTC Biotherapeutics, Inc.
Title: Methods of Reconstructed Goat Embryo Transfer
6,727,405 Xxxxxxxxx Xxxxxx 4/27/2021 Genzyme Corporation
Title: Transgenic Animals Secreting Desired Proteins into Milk (exclusively licensed by GTC)
EP 347431 Xxxxx et al. Gene Pharming Europe BV
Title: Expression of proteins in milk
Country Sub Case Case Type Status Application Number Filing Date Patent Number Issue Date
Japan D DIV Pending 341067/96 00-Xxx-0000
Xxxxxx Xxxxxx of America C2 CON Pending 07/938,322 31-Aug-1992 (Pre-GATT)
United States of America D3 DIV Pending 07/839,194 20-Feb-1992 (Pre-GATT)
Abstract:A DNA sequence containing a gene encoding a protein, the gene being
under the transcriptional control in the DNA sequence of a mammalian milk
protein promoter which does not naturally control the transcription of the gene,
such DNA sequence including DNA enabling secretion of the protein.
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