EXHIBIT 2.1
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TRANSFER AGREEMENT
This AGREEMENT, made this 29 day of March 2004 (the "Effective Date") by and
between GENENCOR INTERNATIONAL, INC, a Delaware corporation having an office and
a place of business at 000 Xxxx Xxxx Xxxx, Xxxx Xxxx, Xxxxxxxxxx 00000-0000,
U.S.A. (hereinafter referred to as "GCOR"), and INNOGENETICS N.V., a Belgian
company having an office and place of business at Xxxxxxxxxxxxxxx 0, X-0000,
Xxxxx, Xxxxxxx (hereinafter referred to as "INNX").
WHEREAS:
A. INNX and GCOR are companies that are, inter alia, engaged in the
"research and development of products, including vaccines relating to
hepatitis B and C viral infections and human papilloma virus
infections, for therapeutic and/or prophylactic use in infectious
diseases";
B. INNX and GCOR have, pursuant to the Mutual Confidentiality Agreement
Effective May 2, 2002 (as thrice amended), exchanged with one another,
certain information on their respective vaccine programs, with the
purpose of exploring the possibilities of a potential business
arrangement;
C. INNX and GCOR have signed that Term Sheet dated February 6, 2004
setting forth key terms for a proposed transaction wherein GCOR would
transfer to INNX substantially all of the assets of GCOR business
relating to vaccines for the prevention and/or treatment of hepatitis B
and C viral infections and human papilloma virus infections, for
prophylactic and therapeutic use in infectious diseases and they now
desire to definitize said transaction through this Transfer Agreement
and such related agreements as may be entered into on even date
herewith; and
D. In this Agreement, "Party" means either INNX or GCOR, and "Parties"
means both INNX and GCOR.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants
hereinafter set forth, the Parties agree as follows:
ARTICLE I
DEFINITIONS
1.1 "Affiliate" means, with respect to a given entity, any person,
corporation, partnership or other entity, that controls, is controlled
by, or is under common control with such entity, whereby the "control"
in this section means the direct or indirect ownership of more than
fifty percent (50%) of the issued voting securities of an entity, or the
right to receive more than fifty percent (50%) of the profits or
earnings of an entity or any other relationship which in fact results in
actual control over the management, business and affairs of an entity.
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1.2 "Appropriate Notice" means a written notice pre-approved (as to form) by
INNX, such notice to be sent to a third party for any necessary
approval, consent or to provide notice of assignment of an Elected
Contract.
1.3 "Approval" as related to an HBV Product or HBV Know-How Product means
the granting of approval by the applicable [ *** ] regulatory authority
for commercial sale of a HBV Product/Know-How Product and as related to
an HPV or HCV Product or HPV or HCV Know-How Product means the granting
of approval by the applicable [ *** ] regulatory authority for
commercial sale of a HPV or HCV Product/Know-How Product.
1.4 "Biologically Active Material" means a gene(s) or a portion thereof,
virus or protein that encodes, presents or represents one or more Virus
antigen or a portion thereof that is incorporated into a Product or a
Know-How Product.
1.5 "Combination Product" means a Product or Know-How Product which is
either: (i) sold as part of a [ *** ] with at least [ *** ] other
product; or (ii) sold as part of a [ *** ], and wherein either the
Product/Know-How Product or the other product has been independently
approved for marketing.
1.6 "Component" means a Biologically Active Material which is any of the
following: [ *** ].
1.7 "Control(s)" and "Controlled" each mean the ability (whether by
ownership, license or other right) of GCOR to transfer, grant or
otherwise convey to INNX the rights as provided for in the various
provisions of this Agreement without violating the terms of any
agreement or other arrangement with any third party existing either on
or before the Effective Date, provided always that a requirement on GCOR
to obtain consent of a third party in respect of an agreement (whether
for assignment, sublicensing or otherwise) shall not mean that GCOR does
not Control the relevant rights.
1.8 "Copyright Rights" means, collectively, all right, title and interest in
copyrights which are necessary for, or used in the practice of the
Technology and/or the development, manufacture, use, importation,
marketing or sale of Products/Know-How Products in the Field, and which
GCOR owns as of the Effective Date or Controls, if any, as of the
Effective Date.
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1.9 "DNA Vaccine" means either a circular or a linear double-stranded DNA
containing a gene(s) (or portion(s) thereof) encoding at least one
antigen (or portion(s) thereof) of a Virus and designed for the gene(s)
(or portion(s) thereof) to be expressed subsequent to in vivo
administration and induce an immune response directed against the
relevant antigens.
1.10 "Elected Biological Materials" means, collectively, those GCOR
Biological Materials for which INNX herein gives Notice to GCOR that
INNX elects to have transferred, assigned and delivered to it pursuant
to the provisions of Section 2.3 of this Agreement. The Elected
Biological Materials are designated in Exhibit 2.3.1.
1.11 "Elected Contracts" means, collectively, those GCOR Contracts (other
than the Non-Assignable Contracts) for which INNX herein gives Notice to
GCOR that INNX elects to assume pursuant to the provisions of Section
2.2 of this Agreement. The Elected Contracts are designated in Exhibit
2.2.1(a).
1.12 "Elected Patent Rights" means, collectively, those GCOR Patent Rights
for which INNX herein gives Notice to GCOR that INNX elects to have
transferred, assigned or otherwise conveyed (e.g., through assignment to
INNX of the relevant Elected Contract) to it pursuant to the provisions
of Section 2.5 of this Agreement. The Elected Patent Rights are set
forth in Exhibit 2.5.1.1 (a), (b) and (c).
1.13 "Elected Rights" means, collectively, the Elected Biological Materials,
the Elected Contracts, and the Elected Patent Rights.
1.14 "Field" means the treatment and/or prevention of diseases caused by
and/or associated with hepatitis B virus ("HBV"), human papilloma virus
("HPV"), or hepatitis C virus ("HCV").
1.15 "Full Time Equivalents" or "(FTE's)" means a full time equivalent of
research and development personnel including direct and indirect costs.
1.16 "GCOR Biological Materials" means, collectively, any biological
materials which, as of the Effective Date GCOR owns or Controls and
which are necessary for or used for the practice of the Technology
and/or in the development, manufacture, use, importation, marketing or
sale of the Product/Know-How Product in the Field. GCOR Biological
Materials are listed on Exhibit 2.3.1.
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1.17 "GCOR Contracts" means, collectively, all those contracts and agreements
(e.g., the license and research agreements and the Service Contracts)
which, except as specified on Exhibit 2.2.1(a), are in full force and
effect as of the Effective Date and to which GCOR is a party and are
necessary for or used for the practice of the Technology and/or in the
development, manufacture, use, importation, marketing or sale of
Product/Know-How Product in the Field. The GCOR Contracts are listed on
Exhibit 2.2.1(a).
1.18 "GCOR Exclusive Patent Rights", collectively, means all those patents,
patent applications and patents issuing therefrom, as well as all
foreign equivalents thereof, which, as of the Effective Date, GCOR
solely and exclusively owns and/or Controls and which contain claims or
could contain claims based on the disclosure in the specification, which
claim(s) would, but for the transfer and grant of the rights hereunder,
be infringed by the development, manufacture or exploitation of the
products in the Field (or parts of the Field) , as well as all those
patents and patent applications which may be filed after the Effective
Date which claim priority of the foregoing patents/patent applications.
In addition, the GCOR Exclusive Patent Rights shall include those patent
applications which are filed after the Effective Date, as well as all
patents issuing therefrom and patents applications/patents claiming
priority thereof which are filed after the Effective Date, which GCOR
solely and exclusively owns or Controls and which: (i) claim inventions
or discoveries conceived and/or reduced to practice before the Effective
Date or within [ *** ] following the Effective Date; and (ii) which are
useful in the development, manufacture, use, sale or importation of a
Product. The GCOR Exclusive Patent Rights existing as of the Effective
Date are listed on Exhibit 2.5.1.1(a).
1.19 "GCOR Joint Patent Rights" means, collectively, all those patents,
patent applications and patents issuing therefrom, as well as all
foreign equivalents thereof, which, as of the Effective Date, GCOR
jointly owns with a third party, which contain claims or could contain
claims based on the disclosure in the specification, which claim(s)
would, but for the transfer and grant of the rights hereunder, be
infringed by the development, manufacture or exploitation of the
products in the Field (or parts of the Field), as well as all those
patents and patent applications which may be filed after the Effective
Date which claim priority of the foregoing patents/patent applications.
In addition, the GCOR Joint Patent Rights shall include those patent
applications which are filed after the Effective Date, as well as all
patents issuing therefrom and patent applications/patents claiming
priority thereof which are filed after the Effective Date, which GCOR
jointly owns with a third party and which: (i) claim inventions or
discoveries conceived and/or reduced to practice before the Effective
Date or within [ *** ] following the Effective
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Date; and (ii) which are useful in the development, manufacture, use,
sale or importation of a Product. The GCOR Joint Patent Rights as of the
Effective Date are listed on Exhibit 2.5.1.1(b).
1.20 "GCOR Licensed Patent Rights" means, collectively, all those patents,
patent applications and patents issuing therefrom, as well as all
foreign equivalents thereof, which, as of the Effective Date, are
licensed (or sublicensed as the case may be) to GCOR for exploitation in
all or part of the Field (as controlled by the relevant Elected
Contract), and which GCOR has the right to assign its licensed rights
therein including to the extent permissible under the terms of the
relevant Elected Contract, all those patents and patent applications
which may be filed after the Effective Date. The GCOR Licensed Patent
Rights are listed on Exhibit 2.5.1.1(c).
1.21 "GCOR Patent Rights" means collectively the GCOR Licensed Patent Rights,
the GCOR Exclusive Patent Rights, the GCOR Joint Patent Rights.
1.22 "GCOR Product Rights" means, collectively, the regulatory files that, as
of the Effective Date, GCOR owns or Controls or has cross-referenced in
the HBV IND. The GCOR Product Rights are listed on Exhibit 2.4.1.
1.23 "HBV IND" means the GCOR sponsored Investigational New Drug application
filed by the US FDA on December 29, 2003, file number 11,472.
1.24 "HBV Proof-of-Concept Trial" means the first clinical study in which HBV
infected patients are treated with an HBV Product or Know-How Product in
a study designed to test efficacy of the Product or Know-How Product
(Phase I/Phase II if such trial is conducted or Phase II if a Phase
I/Phase II trial is not conducted).
1.25 "HPV or HCV Proof-of Concept Trial" means the first clinical study in
which HPV or HCV infected patients are treated with an HPV or HCV
Product or Know-How Product in a study designed to test efficacy of the
Product or Know-How Product (Phase I/Phase II if such trial is conducted
or Phase II if a Phase I/Phase II trial is not conducted).
1.26 "Initiation" means the [ *** ] of the [ *** ] to the [ *** ] or [ *** ]
in the relevant [ *** ] and "Initiate" will mean the action of
Initiation.
1.27 "Insignificant Market" means any country with an insignificant market
potential (e.g., Tonga).
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1.28 "Intellectual Property Rights" means, collectively: (a) GCOR Patents
Rights ; (b) Know-How Rights; (c) Trademarks Rights; and (d) Copyright
Rights.
1.29 "Know-How Product" shall mean any product in the Field which is not a
Product and which is made or developed using the (i) Technology as
defined in Section 1.52 (b), or (ii) Technology as defined in Section
1.52 (a) or (c) which is Secret. For the purpose of this Section,
"Secret" shall mean information which at the date of [ *** ] of the Know
How Product is (i) [ *** ] or (ii) [ *** ].
1.30 "Know-How Rights" means, collectively, all right, title and interest in
any information or know-how, whether or not it is confidential or
proprietary which are necessary for, or used in the practice of the
Technology and/or the development, manufacture, use, importation,
marketing or sale of Products/Know-How Products in the Field, and which
GCOR owns or Controls as of the Effective Date. Know-How Rights include
but are not limited to Licensed Know-How Rights. GCOR Know-How Rights
are listed in Exhibit 2.5.2.1.
1.31 "Licensed Know-How Rights" means, collectively, the Know-How Rights that
are licensed to GCOR under the Elected Contracts.
1.32 "Milestone Payments" shall have that meaning attributed thereto in
Section 3.3 of this Agreement.
1.33 "Milestone Triggering Events" shall have that meaning attributed thereto
in Section 3.3 of this Agreement.
1.34 "Multivalent Vaccine" means a prophylactic vaccine aimed at the
prevention of diseases associated with different pathogens containing
[ *** ] in association with [ *** ] and [ *** ] or [ *** ] as a
[ *** ]. For the avoidance of doubt, different strains of the same
Virus do not constitute different pathogens.
1.35 "MVA" shall mean a modified vaccinia ankara vector containing a gene(s)
(or portion(s) thereof) encoding at least one antigen (or portion(s)
thereof) of a Virus and designed for the gene(s) (or portion(s) thereof)
to be expressed subsequent to in vivo administration and induce an
immune response directed against the relevant antigens.
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1.36 "Net Sales" means the gross amounts received by INNX, it Affiliates and
its sub-licensees in consideration of the sale or other disposition of
Product or Know-How Product (as applicable) in an arms length
transaction with a third party, less:
(i) [ *** ] to non-affiliated third parties;
(ii) [ *** ], [ ***] and [ *** ] discounts and other
[ *** ] rebates [ *** ]; and
(iii) amounts of actual product returns, recalls, allowances
and credits, if any; and
(iv) prepaid taxes and transportation costs, including
insurance; and
(v) any tariffs, duties and/or sales or excise taxes,
value-added taxes, tariffs, duties directly imposed or
other governmental charges (other than income taxes)
imposed and actually paid in connection with the
production, importation, sale, delivery or use of the
Product including, without limitation, payments required
by law to be made to any governmental authorities
pursuant to any product liability or personal injury
compensation schemes, in each case to the extent that
the same is not capable of being recovered or
reimbursed; and
(vi) [ *** ] costs for [ *** ], such as [ *** ] or similar
devices for a Product/Know-How Product, excluding
[ *** ] costs [ *** ].
Only sales of Products or Know-How Products to persons and
entities other than INNX and/or its Affiliates and/or
sub-licensees are to be included within the Net Sales. To this
end, it is to be understood that sales of Product or Know-How
Products between Affiliates, Affiliates and sub-licensees,
Affiliates and INNX and/or sub-licensees and INNX are not to be
included within the Net Sales.
Distribution of Product/Know-How Product for, or use of
Product/Know-How Product in, [ *** ] or [ *** ] shall not give
rise to any deemed sale under this definition. In
addition, distribution or sale [ *** ] of Product/Know-How
Product for, or use of Product/Know-How Product in, [ *** ] or
[ *** ] or other [ *** ] with essentially the same objective
as such [ *** ], or as [ *** ], in each
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case in quantities that are consistent with industry practice in
the relevant country shall not be deemed a sale under this
definition.
In the event the Product/Know-How Product is sold as part of a
Combination Product, Net Sales for purposes of determining the
applicable royalty for such Product/Know-How Product shall be
determined by [ *** ]. In the event that such [ *** ] cannot be
determined for both the Product/Know-How Product and the other
component(s) of the Combination Product in combination, Net
Sales of the Combination Product shall be [ *** ].
1.37 "Non-Assignable GCOR Exclusive Patent Rights" shall have the meaning set
out in Section 2.5.1.1.
1.38 "Non-Elected Rights" means, collectively, those GCOR Patent Rights, GCOR
Biological Materials and GCOR Contracts which INNX does not elect to
assume pursuant to the provisions of Section 2.2 of this Agreement.
1.39 "Non-Polyepitope Other" means a [ *** ]. By way of example, but without
limitation, Non-Polyepitope Other includes full natural or recombinant
antigen, truncated or modified recombinant antigen(s), full genes
constructs, truncated or natural gene constructs.
1.40 "Notice" shall mean any notice given by one Party to the other Party
under the provisions of Section 13.8 of this Agreement.
1.41 "Opposition" means the opposition filed by [ *** ] in the [ *** ] on or
about [ *** ] opposing the grant of [ *** ] owned or controlled by [ ***
].
1.42 "Party" and "Parties" shall have that definition first given in Recital
D above.
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1.43 "Phase III" means a trial of a Product or Know-How Product in sufficient
numbers of patients to establish the safety and efficacy of a Product or
Know-How Product for the desired claims and indications to provide
adequate basis for Product or Know-How Product labeling, as more
specifically defined by the rules and regulations of the U.S. FDA and/or
the EMEA, as applicable.
1.44 "Polyepitope" means (i) in the case of HBV, [ *** ], (ii) in the case of
HPV, [ *** ] to be incorporated in a Product/Know-How Product for the
first clinical trial, to the extent that this [ *** ] (iii) in case of
HCV, the polyepitope cassette of the [ *** ] to be incorporated in a
Product/Know-How Product in a clinical trial, all of the aforementioned
cassettes delivered in a format which is either a [ *** ].
1.45 "Polyepitope Other" a means a Component of a Product/Know-How Product,
which Component incorporates either: (i) a [ *** ], other than [ *** ]
or (ii) any polyepitope [ *** ] but delivered in a format that is [ ***
].
1.46 "Product" means any product used in the Field, the manufacture, use,
importation, sale or marketing of which, would infringe one or more
Valid Claim of the Transferred Patents Rights specified in Exhibit 1.46.
1.47 "Regulatory Files" means, collectively, GCOR Product Rights and Study
Data Packages, which, as of the Effective Date, GCOR owns or Controls
that are necessary for or used in the development, manufacture, use or
sale of Product or Know-How Product in the Field, or which have been
cross-referenced by GCOR in the HBV IND.
1.48 "Royalty Term" means for a Product, the period which commences as of the
Effective Date of this Agreement and continues on a [ *** ] and [ *** ]
basis until the [ *** ] Transferred Patent Right specified on Exhibit
1.46, which contains a Valid Claim which the relevant Product would
infringe in the relevant [ *** ]; and for a Know-How Product means, on a
[ *** ] basis and [ *** ] basis, the shorter of (i) [ *** ] from the
date of [ *** ] of such Know-How Product in that [ *** ] or (ii)
[ *** ] from the date of [ *** ] of such Product/Know-How Product if
the Know-How.
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Product was a Product at any time prior to being a Know-How Product in
that [ *** ].
1.49 "Service Contracts" means the agreements designated as such on Exhibit
2.2.1(a).
1.50 "Study Data Packages" means, collectively, all those right, title and
interest which GCOR owns or Controls and/or has the right to use as of
the Effective Date in those pre-clinical and clinical studies and trial
reports, documents relating thereto (such as submissions to ethical
committees, informed consents etc.) and GCOR laboratory note books and
which concern or are necessary for, or used in the development,
manufacture, use or sale of the Product and/or Know How Product in the
Field.
1.51 "Successful Completion" means the earlier date on which INNX or its
Affiliate or sublicensee either makes a public announcement or provides
GCOR with Notice that the relevant Product or Know-How Product will move
into the next clinical phase of development (without repeating the then
current phase in an amended or modified form), provided however, that in
the event INNX decides to move the relevant Product into the next phase,
such announcement or Notice will occur no later than [ *** ] after
INNX's receipt of the final report in the relevant clinical phase/study
of such relevant Product after timely completion of the statistical
analysis report on "clean data" ("clean data" meaning all case report
forms have been reviewed and cleaned up and all outstanding queries have
been resolved and the database has been locked).
If, upon receipt of such final report, INNX needs an additional period
of time to decide whether or not to move the relevant Product or
Know-How Product into next clinical phase, INNX will inform GCOR in
writing thereof and specify the additional period (not to exceed [ *** ]
without GCOR's prior written approval) it needs. In this event,
Successful Completion will mean the date of the public announcement or
Notice that INNX decides to enter the next phase of development (without
repeating the then current phase in an amended or modified form) after
such extended period with the relevant Product or Know-How Product.
1.52 "Technology" means, the following: (a) [ *** ] in the [ *** ]; or (b)
the [ *** ] and [ *** ] identified with specificity referencing this
section in Exhibit 2.3.1; or (c) [ *** ].
1.53 "Term" shall have the meaning set forth in Section 10.1 hereof.
1.54 "Tier 1 Transferred Rights" means, collectively, all those Transferred
Rights designated as Tier 1 Transferred Rights in the various Exhibits
(Exhibits 2.2.1(a) (GCOR Contracts), 2.3.1 (GCOR Biological Material),
2.4.1 (GCOR Product
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Rights), 2.5.1.1(a) (GCOR Exclusive Patent Rights and (b) (GCOR Joint
Patent Rights and (c) (GCOR Licensed Patent Rights), 2.5.2.1 (Know-How
Rights) and 2.6(1) (Study Data Packages)).
1.55 "Trademark Rights" means any trademarks which, as of the Effective Date,
GCOR owns and are necessary for, or used in the marketing, importation,
use or sale of the Products/Know-How Products in the Field.
1.56 "Transferred Biological Materials" means, collectively, all those
Elected Biological Materials that GCOR transfers to INNX, pursuant to
the provisions of Section 2.3 of this Agreement. Upon delivery as
defined in Section 2.3.4 the Transferred Biological Materials will be
set forth in Exhibit 2.3.1, as amended from time to time during the Term
until all Elected Biological Materials are transferred.
1.57 "Transferred Contracts" means, collectively, all those Elected Contracts
that GCOR transfers to INNX pursuant to the provisions of Section 2.2 of
this Agreement. The Transferred Contracts will be set forth in Exhibit
2.2.1(a), as will be amended from time to time during the Term until all
of the Elected Contracts have been transferred consistent with Section
2.2.
1.58 "Transferred Intellectual Property Rights" means, collectively the: (a)
Transferred Patents Rights; (b) Know-How Rights; (c) Trademarks Rights;
and (d) Copyright Rights.
1.59 "Transferred Patent Rights" means, collectively, all those Elected
Patent Rights which GCOR transfers to INNX pursuant to the provisions of
Section 2.5 of this Agreement. The Transferred Patent Rights will be set
forth in Exhibit 2.5.1.1, as amended from time to time during the Term
until all of the Elected Patent Rights have been transferred consistent
with Section 2.5.
1.60 "Transferred Product Rights" means, collectively, all those GCOR Product
Rights that GCOR transfers to INNX pursuant to the provisions of Section
2.4 of this Agreement. The Transferred Product Rights will be set forth
in Exhibit 2.4.1, as amended from time to time during the Term until all
of the GCOR Product Rights have been transferred consistent with Section
2.4.
1.61 "Transferred Rights" means collectively the following
A. the Transferred Contracts;
B. the Transferred Intellectual Property Rights;
C. the Transferred Product Rights;
D. the Study Data Packages; and
E. the Transferred Biological Materials.
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1.62 "Transition Period" means the period of time commencing on the Effective
Date and continuing for [ *** ] from the Effective Date.
1.63 "Type 1 Product" shall mean a Product/Know-How Product consisting of [
*** ]. For the avoidance of doubt, said Component(s) can be the [ *** ]
and may be administered in any order, and a Type 1 Product may contain
additional constituents (e.g., [ *** ]) that are not Biologically
Active Material.
1.64 "Type 2 Product" shall mean a Product/Know-How Product consisting of [
*** ]. For the avoidance of doubt, said Components may be administered
in any order, and a Type 2 Product may contain additional constituents
(e.g., [ *** ]) that are not Biologically Active Material.
1.65 "Type 3 Product" shall mean a Product/Know-How Product consisting of [
*** ]. For the avoidance of doubt, said Component(s) can be the [ *** ]
and may be administered in any order, and a Type 3 Product may contain
additional constituents (e.g., [ *** ]) that are not Biologically
Active Material.
1.66 "Type 4 Product" shall mean a Product/Know-How Product consisting [ ***
]. For the avoidance of doubt, said Components may be administered in
any order, and a Type 4 Product may contain additional constituents
(e.g., [ *** ]) that are not Biologically Active Material.
1.67 "Type 5 Product" shall mean a Product that is not a Type 1, Type 2, Type
3 or Type 4 Product.
1.68 "Valid Claim" shall mean any claim of an unexpired patent within the
Transferred GCOR Patent Rights that are listed in Exhibit 1.46 and which
either: (a) has itself not been held invalid or otherwise unenforceable
by a court from which no appeal has or can be taken; or (b) has itself
not otherwise finally been held unpatentable by an appropriate
administrative agency (including but not limited to national patent
offices).
1.69 "Virus" shall mean Hepatitis B Virus ("HBV"), Hepatitis C Virus ("HCV"),
and/or Human Papilloma Virus ("HPV").
ARTICLE II
TRANSFER OF RIGHTS
2.1 Transfer. Upon the Effective Date, and except as otherwise explicitly
provided for in Sections 2.2 to 2.6, below, GCOR hereby transfers,
assigns or otherwise conveys to INNX all of GCOR's right, title and
interest in and to the Elected Rights, the GCOR Product Rights, the Know
How Rights, the Trademark Rights, the Copyright Rights and the Study
Data Packages, within [ *** ] of the Effective Date, GCOR shall provide
those instruments perfecting such transfer,
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assignment or conveyance. In the event that an Elected Right cannot
legally be assigned, then, upon INNX election, GCOR will either license,
sublicense, or otherwise obtain for INNX access to the non-assignable
rights, in a manner consistent with GCOR's rights in and to such Elected
Right, so as to put INNX in the same position as it would have been had
the contract been assigned. GCOR shall thereafter further perform those
acts set forth in Sections 2.2-2.6 below relative to the Elected Rights,
the GCOR Product Rights, the Know-How Rights, the Trademark Rights, the
Copyright Rights and the Study Data Packages
During the Term, GCOR shall take any additional actions and execute any
additional documents, at GCOR's expense, as may be reasonably requested
by INNX to fully vest in INNX all right, title and interest in and to
and/or transfer the rights to INNX in all Transferred Rights to the
extent contemplated by this Agreement and GCOR will be responsible and
will bear all costs associated with the transfer and delivery of the
Elected Rights, the GCOR Product Rights, the Know-How Rights, the
Trademark Rights, the Copyright Rights and the Study Data Packages
2.2 Contracts.
2.2.1 Exhibit 2.2.1 (a) lists the GCOR Contracts and Exhibit 2.2.1 (b)
lists all GCOR contracts relating to the Field including those
which have expired or terminated as of the Effective Date.
2.2.2 On Exhibit 2.2.1(a) INNX has indicated those GCOR Contracts
which INNX has elected to assume through assignment or as
provided in Section 2.2.5 hereof (the "Elected Contracts") and
those Elected Contracts that form part of the Tier 1 Transferred
Rights.
2.2.3 Except as provided in Section 2.2.5: (a) promptly upon the
Effective Date, GCOR will send Appropriate Notice to any third
party who is a party to the Elected Contract in order to obtain
necessary approval, consent or to provide notice, as required
under such Elected Contracts; (b) within [ *** ] of the
Effective Date, GCOR shall transfer and assign to INNX all of
the Elected Contracts which form part of the Tier 1 Transferred
Rights and will obtain any third party consents required
therefore; and (c) within [ *** ] of the Effective Date, all
remaining Elected Contracts shall be transferred by GCOR and
GCOR shall obtain any third party consents required therefor.
Once transferred/assigned to INNX, such Elected Contracts shall
become Transferred Contracts and GCOR shall amend Exhibit
2.2.1(a) to indicate therein such Transferred Contracts and
provide INNX with such updated Exhibit 2.2.1(a) periodically,
and at least [ *** ] and on the [ *** ] day after the Effective
Date.
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Until such time as GCOR has transferred all Elected Contracts or
the Parties have mutually agreed that an Elected Contract will
not be transferred, GCOR will provide to INNX a copy of all
notices or requests for consent or approval sent to a party to
the Elected Contracts and keep INNX closely informed about the
status thereof, including by providing INNX forthwith with
copies of correspondence exchanged with such third party
relating to the transfer/assignment of the Elected Contracts.
2.2.4 Underlying Rights Certain of the Elected Contracts grant GCOR
licenses (or sublicenses as the case may be) in and to GCOR
Licensed Patent Rights, and in some instances Licensed Know How
Rights and the rights in GCOR Biological Material. Accordingly,
the transfer and assignment to INNX of the Elected Contracts
shall include the transfer of the underlying license or
sublicense in and to the GCOR Licensed Patent Rights and/or
Licensed Know-How Rights and/or the rights in GCOR Biological
Material. Upon request by INNX, GCOR will provide any patent
files in its possession relating to the GCOR Licensed Patent
Rights.
2.2.5 Service Contracts. Exhibit 2.2.1(a) lists: those Service
Contracts that will not be assigned to INNX (the "Non-Assignable
Service Contracts"), the "IND Related Service Contracts", those
Service Contracts which INNX shall have GCOR continue to
contract with the third party service provider for the relevant
services to the benefit of INNX and at INNX's expense, and the
agreed period of time as set forth in Sections 11.2 and those
Service Contracts which shall be assigned to INNX, as well as
those which form part of the Tier 1 Transferred Rights.
The Non-Assignable Service Contracts between GCOR on the one
hand and [ *** ], respectively, on the other hand, shall be
handled pursuant to
Section 11.2 and such Service Contracts shall not be transferred
to INNX.
The transfer process of the assignable IND Related Service
Contracts, i.e. the Service Contracts with respectively [ *** ]
(the "Assignable IND Related Service Contracts"), will be as
follows. , GCOR will send Appropriate Notice for such Assignable
IND Related Service Contracts promptly upon the date of the
effective transfer of the HBV IND. The date of the effective
transfer of the HBV IND will be the date of receipt by INNX of
an FDA acknowledgment letter or the date jointly agreed in
writing between the Parties ("Effective Transfer of IND").
Within [ *** ] of the Effective Transfer of IND, GCOR shall
transfer and assign to INNX all of the
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Assignable IND Related Service Contracts which form part of the
Tier 1 Transferred Rights and will obtain any third party
consents required therefore; and within [ *** ] of the Effective
Transfer of IND, all remaining Assignable IND Related Service
Contracts, if any, shall be transferred by GCOR and GCOR shall
obtain any third party consents required therefor. Once
transferred/assigned to INNX, such Assignable IND Related
Service Contracts shall become Transferred Contracts and GCOR
shall amend Exhibit 2.2.1(a) to indicate therein such
Transferred Contracts and provide INNX with such updated Exhibit
2.2.1(a) periodically, and at least [ *** ] and on the [ *** ]
day after the Effective Transfer of IND.
Until such time as GCOR has transferred all Assignable IND
Related Service Contracts or the Parties have mutually agreed
that Assignable IND Related Service Contracts will not be
transferred, GCOR will provide to INNX a copy of all notices or
requests for consent or approval sent to a party to the Elected
Contracts and keep INNX closely informed about the status
thereof, including by providing INNX forthwith with copies of
correspondence exchanged with such third party relating to the
transfer/assignment of the Assignable IND Related Service
Contracts .
The transfer process of the remaining Service Contracts (those
Service Contracts which are not Non-Assignable Service Contracts
nor Assignable IND Related Service Contracts), [ *** ] shall be
handled in accordance with the provisions of Section 2.2.3.
2.2.6 Costs Associated with Transferred Contracts. Except as recorded
below in Section 2.2.7, GCOR shall be responsible for all costs
and expenses associated with the Elected Contracts arising prior
to the Effective Date and all damages and liabilities arising
from GCOR's acts, omissions, performance or non-performance of
the Elected Contracts prior to the Effective Date. INNX assumes
all costs and expenses associated with the Elected Contracts
arising after the Effective Date, subject to the effective
transfer of the relevant Elected Contracts within the dates
mentioned under Sections 2.2.3 and 2.2.5 as applicable, and all
damages and liabilities arising from INNX's acts, omissions,
performance or non-performance of each Elected Contracts from
the date it becomes a Transferred Contract. In addition, GCOR
shall be responsible for all damages and liabilities arising
from GCOR's acts, omissions, performance or non-performance of
the Elected Contracts between the Effective Date and the date
upon which it becomes a Transferred Contract.
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2.2.7 The Parties expressly agree as follows: (w) regardless of the
Effective Date of this Agreement, effective as of [ *** ], INNX
will assume responsibility for payment of all costs and expenses
(as estimated on Exhibit 2.2.7(w)) associated with [ *** ]; (x)
in the event the [ *** ] is paid to [ *** ] based on the [ ***
], then the Parties agree to [ *** ] such milestone payment to [
*** ]; (y) as of February 12, 2004, INNX shall be responsible
for all costs arising from the undertakings listed on Exhibit
2.2.7(y); and (z) in the event the [ *** ] Phase I milestone
payment identified in the License Agreement between Genencor and
[ *** ] dated [ *** ] as amended, is paid to [ *** ], then the
Parties agree to [ *** ] such milestone payment to [ *** ].
Prior to the contracts mentioned in this Section 2.2.7 above,
becoming Transferred Contracts, GCOR will make all necessary
payments to the third party thereunder for the costs associated
therewith and will invoice INNX for the reimbursable portion
thereof.
2.2.8 Non-Elected GCOR Contracts. With respect to any GCOR Contracts
which are still in full force and effect, which INNX has not
elected to have transferred to it, and without prejudice to the
other provisions of this Agreement, GCOR will be allowed to
continue to perform such GCOR Contracts at GCOR's cost, and as
GCOR sees fit and INNX shall have no right or obligation or
liability with respect to such non-elected GCOR Contracts.
2.2.9 Failure to Transfer. In the event GCOR fails to transfer to INNX
any Elected Contracts as specified in Section 2.2.3 and 2.2.5,
then INNX shall have the rights as provided under respectively
Section 10.2.1 or Section 10.3 of this Agreement, as applicable.
GCOR will have failed to transfer the Elected Contracts to INNX
in the event that either (i) GCOR will have failed to send an
Appropriate Notice of assignment to the third party to the
respective agreement or (ii) the third party to the agreement
disputes [ *** ] the assignment.
2.2.9 GCOR has entered into the [ *** ] Agreement listed on Exhibit
2.2.1(a). INNX desires to obtain an additional right from [ ***
] to terminate this [ *** ] Agreement at will. Accordingly, INNX
shall diligently negotiate with BN to amend the Service
Agreement to allow for such termination. In the event INNX is
unsuccessful, after diligent negotiations, to obtain this right
and INNX subsequently desires to terminate for any reason other
than material breach by [ *** ], and is unable to do so, then
GCOR is liable for up to [ *** ] of expenses incurred by INNX
thereby. Said [ *** ] liability, if applicable, shall be
credited against the first milestone payment due and payable to
GCOR under Section 3.3.
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2.2.11 GCOR hereby represents covenants and warrants that it will not
work, use, exercise or further convey any of the Transferred
Contracts.
2.2.12 With respect to any Elected Contracts, GCOR agrees that until
such time as an Elected Contract becomes a Transferred Contract:
(i) it will not take any action with respect to or amend such
Elected Contract without INNX's prior written consent; (ii) it
will not take any action or fail to take any action that would
cause a breach or material default under any such Elected
Contract; (iii) it will use its best efforts to cause any such
Elected Contract to remain in full force and effect; and (iv) it
will promptly provide copies to INNX of all notices received by
any other party to such Elected Contract.
2.3 Biological Material.
2.3.1 Exhibit 2.3.1 lists the GCOR Biological Materials.
2.3.2 On Exhibit 2.3.1 INNX has indicated those GCOR Biological
Materials which INNX has elected to have transferred to INNX
(the
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"Elected Biological Materials") and those Elected Biological
Materials that form part of the Tier 1 Transferred Rights.
2.3.3 Ownership. Upon the Effective Date, except with respect to GCOR
Biological Materials which were originated at [ *** ] and as
listed on Exhibit 2.3.1, GCOR shall transfer ownership to INNX
of all of the Elected Biological Materials and all of GCOR's
right, title and interest therein. With respect to the GCOR
Biological Materials which were originated at [ *** ] and as
listed on Exhibit 2.3.1, GCOR shall deliver such materials to
the location of delivery designated on the Exhibit 2.3.1.
2.3.4 Delivery. (i) All Tier 1 Elected Biological Materials for which
no export/import permit is required to ship the relevant
materials to INNX (Belgium), shall be delivered to INNX within [
*** ] of the Effective Date. (ii) All remaining 2.3.4(i) Elected
Biological Materials, if any, shall be delivered to INNX within
[ *** ]. (iii) All Tier 1 Elected Biological Materials for which
an export/import permit is required to ship the relevant
materials to the relevant destination indicated by INNX on the
Exhibit 2.3.1, shall be delivered to INNX within [ *** ] after
the receipt by INNX of the import permit. Except for those Tier
1 Transferred Biological Materials that will be validated
pursuant to Sections 2.3.6 and 2.3.7, Elected Biological
Materials shall be deemed transferred to INNX upon an INNX
representative signing for delivery of the respective Elected
Biological Materials (at the GCOR location) on Exhibit 2.3.1.
Nonetheless, it is agreed that [ *** ] of all Elected Biological
Materials until delivery at INNX premises in Xxxxx,
Xxxxxxxxxxxxxxx 0, 0000, (Xxxxxxx). [ *** ] With the assistance
of GCOR, INNX shall obtain necessary importation documents
within [ *** ] of the Effective Date. It is understood and
agreed that certain of the Biological Material (as designated on
Exhibit 2.3.1) are stored at third party locations. With respect
to such materials, the Parties will agree on a case-by-case
basis whether GCOR should request such third party to physically
relocate the material to an INNX designated location or whether
such materials will be maintained at such third party location
without breaching GCOR's delivery obligations hereunder.
Additionally, during the Transition Period and subject to
Article XI hereof, GCOR will furnish INNX with such assistance
and information as is reasonably requested by INNX to enable it
to use the Transferred Biological Materials. With regard to
certain Tier 1 Transferred Biological Materials that will be
validated pursuant to Sections 2.3.6 and 2.3.7, GCOR shall be
deemed to have delivered such GCOR Biological Materials to INNX
upon delivery of the first requested quantity of such GCOR
Biological Materials, [ *** ] with the specifications set forth
therefor in Exhibit 2.3.1.(a).
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During the sixty (60) day delivery period, GCOR will provide to
INNX a copy of all notices or requests for consent or approval
exchanged with a party concerning the transfer of Elected
Biological Materials and keep INNX closely informed about the
status of such.
With regard to one Tier 1 Elected Biological Material indicated
with specificity on Exhibit 2.3.1, [ *** ], the Parties agree
that INNX will request from [ *** ] delivery to INNX Belgium of
[ *** ] of this material without delay after the Effective Date.
Failure of [ *** ] to deliver said material to INNX within [ ***
] of the Effective Date, will be deemed to be a failure of GCOR
to deliver same to INNX in accordance with the provisions of
this Section 2.3.4.
2.3.5 GCOR and INNX shall adhere to all applicable laws and
regulations relating to the transfer and receipt of the
Transferred Biological Material.
2.3.6 INNX has the right to [ *** ] which are listed on Exhibit 2.3.1.
As requested by INNX, GCOR shall retain and maintain such
additional quantities of the [ *** ] as agreed between the
Parties needed to replace such materials until such time as INNX
has [ *** ] meet all of the [ *** ] set forth therefor in
Exhibit 2.3.1(a).
2.3.7 Should INNX determine that any [ *** ] material does not
reasonably meet the [ *** ] set forth in Exhibit 2.3.1(a), INNX
may either (i) request GCOR to supply INNX within [ *** ] of
receipt of a request thereto with such further quantities of the
[ *** ] material needed for INNX to repeat its [ *** ], as well
as such quantities needed for INNX to subsequently use such
material(s) as contemplated hereunder, or (ii) require GCOR to [
*** ]. INNX will not unreasonably refuse a first repeat testing
in order to determine if the failure to meet the specifications
is due to the [ *** ] of the [ *** ] and/or [ *** ] or a failure
of the materials as stored at their original location. It is
understood that if such validation should be performed, INNX
must perform the [ *** ] in the Transition Period. It is also
understood that in the event that INNX requests GCOR to supply
INNX with such [ *** ] material as provided in (i) above of this
paragraph, and such repeat validation fails again, INNX retains
its right to require GCOR [ *** ].
2.3.8 INNX will grant to GCOR those rights that GCOR needs to the
Transferred Biological Material to the extent necessary for GCOR
to perform any services elected by INNX.
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2.3.9 Non-Elected Biological Materials. With respect to any GCOR
Biological Materials which INNX does not elect to have
transferred to it, GCOR will be allowed to retain all rights to
such materials and to continue to use such GCOR Biological
Materials at GCOR's cost, and as GCOR sees fit. INNX shall have
no further right or obligation with respect to such non-elected
GCOR Biological Material.
2.3.10 Failure to Deliver. In the event that GCOR fails to deliver to
INNX any Elected Biological Materials, as is specified in 2.3.4,
then INNX shall have the rights provided for under Section
10.2.1 or Section 10.3 of this Agreement, as applicable.
2.3.11 Except as provided in Section 2.3.8 GCOR hereby represents
covenants and warrants that it will not work, use, exercise or
further convey any of the Transferred Biological Materials.
2.4 Product Rights
2.4.1 Exhibit 2.4.1 lists the GCOR Products Rights. INNX has
designated the HBV IND as part of the Tier 1 Transferred Rights.
Within [ *** ] of the Effective Date GCOR shall submit to the
U.S. FDA the necessary documentation and shall facilitate
correspondence between respectively [ *** ] on the one hand, and
the FDA on the other hand relating to the access by the FDA of
the [ *** ] (Xxxxxx), promptly thereafter take such other steps
as necessary to effectuate such transfer of the HBV IND with the
aim of transferring sponsorship of the HBV IND within [ *** ] of
the Effective Date. INNX will provide full cooperation in
effecting such transfer including participating in conference
calls, sending necessary correspondence to the FDA and by
providing advance notice to GCOR that it has obtained suitable
clinical trial insurance. Once sponsorship is transferred to
INNX, such GCOR Product Rights shall become Transferred Product
Rights and GCOR shall amend Exhibit 2.4.1 to include therein
such Transferred Product Rights.
2.4.2 Failure to Transfer. In the event that GCOR fails to take the
appropriate steps as specified under Section 2.4.1, then INNX
shall have the rights as provided under respectively Sections
10.2.1 or 10.3 of this Agreement as applicable.
2.4.3 GCOR hereby represents covenants and warrants that it will not
work, use, exercise or further convey any of the Transferred
Product Rights.
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2.5 Intellectual Property Rights
2.5.1 GCOR Patent Rights.
2.5.1.1 Exhibit 2.5.1.1 lists the GCOR Patent Rights
including the GCOR Exclusive Patent Rights (Exhibit
2.5.1.1(a)), the GCOR Joint Patent Rights (Exhibit
2.5.1.1(b)) and the GCOR Licensed Patent Rights
(Exhibit 2.5.1.1(c)). GCOR has designated on Exhibit
2.5.1.1(a) those GCOR Exclusive Patent Rights which
will not be assigned to INNX (the "NonAssignable GCOR
Exclusive Patent Rights"). GCOR shall grant INNX
those rights specified in the "Non-Assignable GCOR
Exclusive Patent Rights License Agreement"
substantially in the form as set out in Exhibit
2.5.1.3(a), which agreement when executed shall be
incorporated herein and made a part hereof.
2.5.1.2 Exhibits 2.5.1.1(a) and 2.5.1.1(b) designate those
GCOR Patent Rights that INNX has elected to have
transferred to INNX (the "Elected Patent Rights") and
those that form part of the Tier 1 Transferred
Rights. With respect to GCOR Licensed Patent Rights
on Exhibit 2.5.1.1(c), these shall be considered as
"Elected Patent Rights" and transferred to INNX
pursuant to election of the controlling GCOR Contract
pursuant to Section 2.2.4.
2.5.1.3 Within [ *** ] after the Effective Date, GCOR shall
procure all necessary signatures as are needed to
transfer and assign to INNX all of its right, title
and interest in the Elected Patent Rights listed on
Exhibit 2.5.1.1(a), (b) and (c) which form part of
the Tier 1 Transferred Rights and GCOR shall transfer
to INNX a copy of the prosecution files (under GCOR's
control and in its possession as of the Effective
Date) relative thereto. All remaining Elected Patent
Rights designated on Exhibits 2.5.1.1(a), (b) and (c)
shall be transferred by GCOR to INNX as described in
the preceding sentences within [ *** ] of the
Effective Date and GCOR shall obtain any third party
consents required therefor. Once such Elected Patent
Rights are transferred, assigned or licensed to INNX,
such Elected Patent Rights shall become Transferred
Patent Rights and GCOR shall amend Exhibits
2.5.1.1(a), (b) and (c) to include therein such
Transferred Patent Rights.
2.5.1.4 Opposition. Within [ *** ] after the Effective Date,
GCOR will transfer to INNX, the right to conduct the
Opposition (the Opposition being a Tier 1 Transferred
Right) and GCOR's file associated
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therewith to INNX. INNX will use commercially
reasonable efforts to prosecute such Opposition at
INNX's cost. During the Opposition proceeding, GCOR
will to the extent necessary remain as the named
opponent and shall cooperate with INNX as reasonably
requested by INNX in connection with GCOR's role as a
named opponent in the Opposition (such as signing
necessary papers as the named Opponent) but will have
no further obligation to INNX with regard to this
proceeding.
2.5.1.5 INNX will reimburse GCOR for any reasonable out of
pocket expenses incurred as a result of its
cooperation with INNX pursuant to Section 2.5.1.4.
During the Transition Period, GCOR shall procure all
necessary signatures from GCOR employee inventors or
other inventors as are needed to perfect INNX's
rights in, title to and/or ownership of the
Transferred Patent Rights listed on Exhibits
2.5.1.1(a) and (b) and shall furnish INNX with such
documentation.
2.5.1.6 GCOR shall provide Notice to INNX as soon as
reasonably possible (but in any event, no later than
thirty (30) days after the filing by GCOR of any
relevant patent applications) of those inventions or
discoveries conceived and/or reduced to practice
before the Effective Date or within [ *** ] following
the Effective Date; and which are useful or
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necessary in the development, manufacture, use, sale
or importation of a Product. INNX shall have [ *** ]
after its receipt from GCOR of the Notice of the
existence of such patent applications to elect to
have the same transferred to INNX. Such election by
INNX shall be made by INNX giving Notice to GCOR that
it wishes to have such patent applications
transferred to it.
2.5.1.7 Within [ *** ] after its receipt of the Notice from
INNX that the additional GCOR Patent Rights are
Elected Patent Rights as set forth in Section 2.5.1.6
above, GCOR will either assign such additional GCOR
Patent Rights or grant a license to INNX in
accordance with the terms set forth in Section 2.5.1
of this Agreement, GCOR will assign/license to INNX
all such additional Elected Patent Rights and shall
obtain all third party consents required therefor
within [ *** ] of such election and to transfer to
INNX all the appropriate prosecution files (under
GCOR's control and in its possession as of the date
of the election) relevant thereto. Once assigned or
licensed to INNX, such additional Elected Patent
Rights shall become Transferred Patent Rights and the
Parties shall amend Exhibit 2.5.1.1(a) or (b) as the
case may be and Exhibit 1.46 to include therein such
Transferred Patent Rights. In the event that the
additional Elected Patent Rights are licensed, the
Parties will enter into a mutually acceptable
definitive license agreement relative thereto.
2.5.1.8 Costs Associated with Transferred Patent Rights.
Except as expressly set forth herein or as otherwise
agreed by the Parties, INNX shall as of the Effective
Date be responsible for all costs and expenses
associated with those Transferred Patent Rights
referred to in Section 2.5.1.3 (a) and Exhibit
2.5.1.3 (a) and which arise after the Effective Date,
subject to the effective transfer of the relevant
Transferred Patent Rights within the dates mentioned
under Section 2.5.1.3. Following the Effective Date
but prior to any transfer thereof, GCOR will, at
INNX's expense, take all actions with respect to the
Transferred Patent Rights as requested by INNX and
GCOR shall keep INNX informed of all actions
necessary to be taken with respect to such
Transferred Patent Rights.
2.5.1.9 Non-Elected Patent Rights. With respect to any Patent
Rights which INNX does not elect pursuant to Section
2.5 to have transferred to it, GCOR will be allowed
to continue to
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use, transfer or otherwise convey such Patent Rights,
at GCOR's cost, and as GCOR sees fit.
2.5.1.10 Failure to Transfer. In the event that within [ *** ]
or [ *** ] of the Effective Date, GCOR fails to
transfer to INNX any Elected Patent Rights, then INNX
shall have the rights as provided under respectively
Section 10.2.1 or Section 10.3 of this Agreement.
GCOR will have failed to transfer the Elected Patent
Rights to INNX in the event that it does not procure
all necessary signatures as are needed to perfect
INNX's rights in, title to and/or ownership of the
Elected Patent Rights or to transfer/assign the
Elected Contracts.
2.5.1.11 Except as provided in Exhibit 2.5.1.3 (a), GCOR
hereby represents covenants and warrants that it will
not work, use, exercise or further convey any of the
Transferred Patent Rights.
2.5.2 Know-How Rights
2.5.2.1 Exhibit 2.5.2.1 lists the Know-How Rights.
2.5.2.2 On Exhibit 2.5.2.1 INNX has indicated those Know-How
that form part of the Tier 1 Transferred Rights.
2.5.2.3 Upon the Effective Date, GCOR hereby assigns to INNX
all of its right, title and interest in the Know-How
Rights.
2.5.2.4 Delivery. All Tier 1 Know-How Rights shall be
delivered to INNX within [ *** ] of the Effective
Date, and all remaining Know-How Rights shall be
delivered to INNX [ *** ]. Know-How Rights shall be
deemed delivered to INNX upon an INNX representative
signing for receipt of the respective Know-How Rights
on Exhibit 2.5.2.1.
2.5.2.5 Failure to Deliver. In the event that GCOR fails to
deliver to INNX any Know-How Rights as is specified
in Section 2.5.2.3 then INNX shall have the rights
provided for under Section 10.2.1 or Section 10.3 of
this Agreement as applicable.
2.5.2.6 GCOR hereby represents covenants and warrants that it
will not work, use, exercise or further convey any of
the Know How Rights in the Field.
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2.5.3 Trademark Rights and Copyright Rights
2.5.3.1 Exhibit 2.5.3.1(a) list the registered Trademark
Rights and Exhibit 2.5.3.1(b) lists the registered
Copyright Rights
2.5.3.2 Upon the Effective Date, GCOR hereby assigns to INNX
all of its right, title and interest in the
Trademarks Rights and Copyright Rights, whether
registered or not.
2.5.3.3 GCOR hereby represents covenants and warrants that it
will not work, use, exercise or further convey any of
the Trademarks and Copyright Rights, whether
registered or not.
2.6 Study Data Packages
2.6.1 Exhibit 2.6.1 lists the Study Data Packages. INNX has designated
on Exhibit 2.6.1 the Study Data Packages that form a part of the
Tier 1 Transferred Rights.
2.6.2 Upon the Effective Date, GCOR hereby assigns to INNX all of its
right, title and interest in the Study Data Packages.
2.6.3 Delivery. All Tier 1 Study Data Packages shall be delivered to
INNX within [ *** ] of the Effective Date, and all remaining
Study Data Packages shall be delivered to INNX within [ *** ].
Study Data Packages shall be deemed delivered to INNX upon an
INNX representative signing for receipt of the respective Study
Data Package on Exhibit 2.6.1.
2.6.4 Failure to Deliver. In the event that GCOR fails to deliver to
INNX any Study Data Package, as is specified in Section 2.6.2
then INNX shall have the rights provided for under Section
10.2.1 or Section 10.3 of this Agreement as applicable.
2.6.5 GCOR hereby represents, covenants and warrants that it will not
use or further convey any of the Study Data Packages.
ARTICLE III
CONSIDERATION
3.1 Upfront Payment. Within [ *** ] of the Effective Date, subject to the
receipt of a corresponding invoice, INNX shall pay to GCOR via wire
transfer in immediately available funds a one-time, lump sum, non-
refundable (except as specifically provided for in Section 10.2.1), non-
creditable payment of [ *** ] (the "Upfront Payment").
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3.2 Anniversary Payment. Within [ *** ] of the one-year anniversary date of
the Effective Date, subject to the receipt of a corresponding invoice,
INNX shall pay to GCOR via wire transfer in immediately available funds
a one-time, lump sum, non-refundable, non-creditable payment of [ *** ].
3.3 Milestone Payments. During the Term INNX will pay GCOR certain milestone
payments ("Milestone Payments") for a Product or Know-How Product upon
the first achievement by INNX, its Affiliate or sub-licensee of each of
the milestone triggering event(s) ("Milestone Triggering Events")
detailed below, and subject to Section 3.4:
(a) HBV Product or HBV Know-How Product-related Milestone Payments
and Milestone Triggering Events:
(i) [ *** ] upon the [ *** ] of an [ *** ];
(ii) [ *** ] upon the [ *** ] of the [ *** ];
(iii) [ *** ] upon the [ *** ] of [ *** ];
(iv) [ *** ] upon [ *** ]; and
(v) [ *** ] upon [ *** ];
a. provided however, if the [ *** ] in [
*** ], INNX shall pay [ *** ] of the [
*** ] Milestone Payment and upon [ *** ]
in [ *** ], INNX shall pay the remaining
[ *** ] of the [ *** ] Milestone
Payment. Upon a [ *** ] respectively in
[ *** ], INNX shall pay the [ *** ]
Milestone Payment; and
b. further provided, if the [ *** ] occurs
in [ *** ], INNX shall pay [ *** ] of
the [ *** ] Milestone Payment and upon
the [ *** ], in [ *** ], INNX shall pay
the remaining [ *** ] of the [ *** ]
Milestone Payment.
(b) HPV Product -related Milestone Payments and Milestone Triggering
Events:
(i) [ *** ] upon the [ *** ] of an [ *** ];
(ii) [ *** ] upon the [ *** ] of the [ *** ];
(iii) [ *** ] upon the [ *** ] of a [ *** ]; (iv) [
*** ] upon [ *** ]; and
(v) [ *** ] upon [ *** ].
(c) HCV Product-related Milestone Payments and Milestone Triggering
Events:
(i) [ *** ] upon [ *** ] of the [ *** ];
(ii) [ *** ] upon the [ *** ] [ *** ] of a [ *** ];
(iii) [ *** ]; and
(iv) [ *** ] of [ *** ].
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For the purposes of this Section 3.3, the Parties explicitly agree that
the Product/Know-How Product means a Product/Know-How Product [ *** ].
With regard to a [ *** ] Product covered only by a Valid Claim of one or
more patents [ *** ], and for which a Milestone Triggering Event has
occurred, then for the sole purpose of this clause, such [ *** ] Product
shall be treated as a Know-How Product for determination of the amount
of Milestone Payment due. In the event the [ *** ] Product subsequently
becomes covered by a Valid Claim of a [ *** ], then the unpaid
difference between the Milestone Payment due for a Product and due for a
Know-How Product, will be due and payable to GCOR.
Effect of Discontinuance of Clinical Development. No milestone payment
triggered by a Successful Completion will be due if clinical development
of the Product is discontinued before Successful Completion.
For illustration purposes, if a candidate HBV Product X which is
developed or made using [ *** ] ("candidate X") reaches a [ *** ] of the
[ *** ] and an [ *** ] of a [ *** ] is [ *** ] but not [ *** ]; and if a
new candidate HBV Y which is developed or made using [ *** ] ("candidate
Y") reaches a [ *** ] of the [ *** ], an [ *** ] of a [ *** ], a [ *** ]
of a [ *** ] and [ *** ] in the[ *** ], then the following Milestone
Payments will be due: (i) for candidate X: [ *** ] and (ii) for
candidate Y: [ *** ].
3.4 Know-How Product Milestones. Milestone Payments due for Know-How
Product(s) under Section 3.3 shall be [ *** ] percent [ *** ] of the
respective amount specified in Section 3.3. In the event that a
Milestone Triggering Event has been achieved with a Know-How Product and
subsequently the same Milestone Triggering Event is achieved with a
Product, then the payment for that Product based Milestone Triggering
Event shall be the remaining [ *** ] percent [ *** ] of the respective
amount specified in Section 3.3. In no event shall INNX pay more than
one hundred percent (100%) of any of the applicable Milestone Payments.
3.5 Timing of Payment. INNX shall promptly provide Notice to GCOR upon
achievement of each Milestone Triggering Event. Thereafter, GCOR shall
invoice INNX for the respective amount specified in Section 3.3 and 3.4.
The Milestone Payments shall be due and payable via wire transfer in
immediately available funds by INNX within [ *** ] of the receipt of a
corresponding invoice.
3.6 Product Royalty Payments. During the Royalty Term INNX shall pay GCOR a
royalty on annual Net Sales of: (i) Products sold by INNX, its
Affiliates or sub-licensees as summarized in Table 3.6 and as detailed
in Sections 3.6(a)-(d) and (h) as may be reduced as per Section 3.6 (f),
3.6(g), 3.6(i),
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3.6(j), 3.6(k) and 3.6(l) and in Section 3.6(e); and/or (ii) Know-How
Products sold by INNX, its Affiliates or sub-licensees as detailed as
per Section 3.7 hereof:
Table 3.6
Royalty Summary
[ *** ] [ *** ] [ *** ] [ *** ] [ *** ] [ *** ]
---------------------------------------------------------------------------------------------
[ *** ] [ *** ] [ *** ] [ *** ] [ *** ] [ *** ]
---------------------------------------------------------------------------------------------
[ *** ] [ *** ] [ *** ] [ *** ] [ *** ] [ *** ]
---------------------------------------------------------------------------------------------
[ *** ] [ *** ] [ *** ] [ *** ] [ *** ] [ *** ]
---------------------------------------------------------------------------------------------
[ *** ] [ *** ] [ *** ] [ *** ] [ *** ] [ *** ]
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(a) Type 1 Product Royalty. In the event of a Type 1 Product, the
applicable royalty shall be: (i) [ *** ] percent [ *** ] of
annual Net Sales of [ *** ] Product sold by INNX, its Affiliate
or sublicensee; (ii) [ *** ] percent
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[ *** ] of annual Net Sales of [ *** ] Product sold by INNX,
its Affiliate or sublicensee; or (iii) [ *** ] percent [ *** ]
of annual Net Sales of [ *** ] Product sold by INNX, its
Affiliate or sublicensee.
(b) Type 2 Product Royalty. In the event of a Type 2 Product, the
applicable royalty shall be: (i) [ *** ] percent [ *** ] of
annual Net Sales of [ *** ] Product sold by INNX, its Affiliate
or sublicensee; (ii) [ *** ] percent [ *** ] of annual Net Sales
of [ *** ] Product sold by INNX, its Affiliate or sublicensee;
and (iii) [ *** ] percent [ *** ] of annual Net Sales of [ *** ]
Product sold by INNX, its Affiliate or sublicensee.
(c) Type 3 Product Royalty. In the event of a Type 3 Product, the
applicable royalty shall be: (i) [ *** ] percent [ *** ] of
annual Net Sales of [ *** ] Product sold by INNX, its Affiliate
or sublicensee; (ii) [ *** ] percent [ *** ] of annual Net Sales
of [ *** ] Product sold by INNX, its Affiliate or sublicensee;
or (iii) [ *** ] percent [ *** ] of annual Net Sales of [ *** ]
Product sold by INNX, its Affiliate or sublicensee.
(d) Type 4 Product Royalty. In the event of a Type 4 Product, the
applicable royalty shall be: (i) [ *** ] percent [ *** ] of
annual Net Sales of [ *** ] Product sold by INNX, its Affiliate
or sublicensee; (ii) [ *** ] percent [ *** ] of annual Net Sales
of [ *** ] Product sold by INNX, its Affiliate or sublicensee;
or (iii) [ *** ] percent [ *** ] of annual Net Sales of [ *** ]
Product sold by INNX, its Affiliate or sublicensee.
(e) Type 5 Product Royalty. In the event of the Type 5 Product, the
applicable royalty rate shall be [ *** ] of annual Net Sales of
such Product sold by INNX, its Affiliate or sublicensee.
(f) [ *** ]. In the event that INNX or its sublicensees or
Affiliates takes a [ *** ] to [ *** ] and which are listed in
Exhibit 3.6(f), or to any [ *** ] listed in said Exhibit 3.6(f),
in order to commercialize either a [ *** ] Product that has [
*** ], or a [ *** ] Product, on a country-by-country basis (the
"[ *** ] Scenario I"), then the royalty rate due to GCOR under
this Section 3.6 on Net Sales of the applicable Product in that
country may be reduced by [ *** ]% of the royalty rate due to
such third party on account of such license to such patent
rights; provided that the royalty rate to GCOR shall not be
reduced below [ *** ] for [ *** ] Product, [ *** ] for [ *** ]
Product and [ *** ] for [ *** ] Product. Further provided that
in the [ *** ] Scenario I and solely as it relates to the [ ***
] Product, if INNX successfully negotiates with [ *** ] to
reduce [ *** ]below [ *** ] and above [ *** ], GCOR's [ *** ] as
above) can be [ *** ] to a [ *** ] of [ *** ].
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(g) In the event that a governmental agency in any country or
territory grants or compels INNX, its Affiliates or sublicensees
to grant a license, to any third party for any Product/Know-How
Product , the royalty rate applicable to sales of Product and/or
Know-How Product shall be [ *** ] in all the countries where a
third party product is sold further to the grant of the
compulsory license, as follows: [ *** ]. In the event there is
no reference market, then [ *** ] will be equal to [ *** ]. A
reference market is a market in respect of which INNX has
granted a license. In case there is more than one reference
market and the royalty rates payable to INNX differ in the
different markets, then the reference market with the closest
GDP per capita will be the reference market. The achievement of
a Milestone Triggering Event by a sublicensee of INNX under a
compulsory license scheme will not be considered as a Milestone
Triggering Event for the purpose of this Agreement and no
Milestone Payment will be payable in such event.
(h) In the event that a [ *** ] Product or [ *** ] the [ *** ] is
not the [ *** ] and either: (i) the decision not to use [ *** ]
is taken after [ *** ] or (ii) INNX has taken the decision not
to use [ *** ] based on [ *** ] failure to deliver the MVA that
meets the relevant contractual specifications at any time after
the execution of the supply and license agreements between INNX
and [ *** ], then the respective applicable royalty rate for
such [ *** ] Product or [ *** ] Product, will be [ *** ] to [
*** ].
(l) In the event that INNX or its sublicensees or Affiliates take a
royalty bearing license to patent rights claiming [ *** ], in
order to commercialize a Product on a country-by-country basis
(the "[ *** ] Scenario II"), then the royalty rate due to GCOR
under this Section 3.6 on Net Sales of the applicable Product in
that country shall be [ *** ] by [ *** ] of the royalty rate due
to such third party on account of such license to such patent
rights provided that the royalty rate to GCOR shall not be [ ***
] for [ *** ] Product, [ *** ] for [ *** ] Product and [ *** ]
for [ *** ] Product.
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(j) In the event that both [ *** ] Scenario I and [ *** ] Scenario
II apply, the royalty rate due to GCOR on Net Sales of the
applicable Product on a country by country basis due to GCOR
will not [ *** ] respectively [ *** ] for [ *** ] Product, [ ***
] for [ *** ] Product and [ *** ] for [ *** ] Product.
(k) In the event that INNX or its sublicensees or Affiliates take a
royalty-bearing license to [ *** ] issued to [ *** ] and
continuations, continuations-in-part and divisions thereof, in
order to commercialize a Product, then the royalty-rate due to
GCOR under this Section 3.6 on Net Sales of an [ *** ] Product
shall be [ *** ] by [ *** ] percent of the royalty-rate due to [
*** ] on account of such license, provided that the royalty-rate
due to GCOR shall not be [ *** ]: (i) [ *** ] for a [ *** ]
Product; (ii) [ *** ] for a [ *** ] Product; (iii) [ *** ] for a
[ *** ] Product; and (iv) [ *** ] for a [ *** ] Product.
(l) In the event that INNX or its sublicensees or Affiliates take a
royalty bearing license to [ *** ] issued to [ *** ] and
continuations, continuations-in-part and divisions thereof, as
well as their respective foreign counterparts, in order to
commercialize a Product, then the royalty-rate due to GCOR under
this Section 3.6 on Net Sales of a Product shall be [ *** ] by [
*** ] percent of the royalty-rate due to [ *** ] on account of
such license, provided that the royalty-rate due to GCOR shall
not be [ *** ]: (i) [ *** ] for a [ *** ] Product; (ii) [ *** ]
for a [ *** ] Product; and (iii) [ *** ] for a [ *** ] Product.
(m) In the event that a Product is not, or ceases to be covered by a
Valid Claim in the country of sale, the royalty rate applicable
to that Product in such country shall be calculated and treated
as per Section 3.7 (Know-How Product Royalty).
3.7 Know-How Product Royalty. In the case of a Know-How Product, then INNX
will during the Royalty Term pay to GCOR a Know-How Royalty of [ *** ]
percent [ *** ] of relevant royalty from Section 3.6 (a) through (d) and
in Section 3.6 (h), as [ *** ] by application of Section 3.6 (f),
3.6(g), 3.6(i), 3.6(j), 3.6(k) and 3.6(l), which would be payable to
GCOR if the Know-How Product were a Type 1, 2, 3 or 4 Product
respectively, provided that the royalty rate to GCOR shall not be [ ***
] [ *** ] for [ *** ] Product, [ *** ] for [ *** ] Product and [ *** ]
for [ *** ] Product. This Know-How Royalty will be payable on a
product-by-product basis for a period of [ *** ] from the date of the
first commercial sale of the relevant Know-How Product (or Product, if
the Know-How Product was a Product at any time prior to being a Know-How
Product) in any country.
3.8 In any event, except in the case of 3.6. (g), the royalty-rate due to
GCOR on Net Sales of a Product Type 1-4 or a Know-How Product Type 1-4,
shall never be below [ *** ] for [ *** ]
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Product/Know-How Product, [ *** ] for [ *** ] Product/Know-How Product
and [ *** ] for [ *** ] Product/Know-How Product. If [ *** ] provisions
of Section 3.6(f), 3.6(i), 3.6(k) and/or 3.6(l) apply for a Product/Know
How Product, then the royalty rate applicable to that Product will be [
*** ] each of the [ *** ] provided under each of these subsections,
provided that such resulting royalty rate shall [ *** ] [ *** ] for [
*** ] Product/Know-How Product, [ *** ] for [ *** ] Product/Know-How
Product and [ *** ] for [ *** ] Product/Know-How Product.
3.9 No royalty payment or fee shall be due and owing for any Product/Know
How Product after expiration of the Royalty Term.
ARTICLE IV
PAYMENT AND REPORTS
4.1 Keeping of Records. INNX shall keep, and impose on its Affiliates and
sublicensees to keep, complete and correct records of gross sales and
the Net Sales calculated there from of Product(s) and Know-How
Product(s) for a period of [ *** ] from the making of a royalty payment
with respect to such Net Sales under this Agreement.
4.2 Reports. To the extent available, using commercially reasonable efforts,
during the Royalty Term INNX shall [ *** ] on or about the anniversary
date of the Effective Date, provide a written report to GCOR summarizing
the worldwide status of the Transferred Patent Rights specified on
Exhibit 1.46 (including patent numbers, grant date, date of expiration
of granted patents).
4.3 Payment Term. All royalty payments under this Agreement shall become due
and payable [ *** ] after the last day of the calendar quarter in which
the corresponding Net Sales of Product and Know-How Product were made.
To the extent that any payment terms agreed between INNX and a
sublicensee make the payment terms provided for herein impractical, then
the Parties shall agree to an extended payment term not to exceed [ ***
]. Payment shall be via wire transfer in immediately available funds,
accompanied by a report, specifying the relevant Product type (Type 1-5
Product), gross sales of Product and/or Know-How Product on a
country-by-country basis less the deductions permitted in Section 1.36
and any royalty set off permitted under Section 3.6(f) through (j) and
the resulting calculation of the Net Sales used in the computation of
the royalty payments.
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4.4 Currency and Exchange Rate. Payments under this Agreement will be made
in U.S. Dollars via wire transfer to a bank account to be designated by
GCOR. Net Sales in currency other than U.S. Dollars shall be converted
into Net Sales in U.S. Dollars on a quarterly basis using the rate of
exchange as quoted by the Wall Street Journal Europe on the last
business day of the applicable quarter in which the corresponding sales
of Product and Know-How Products were made.
4.5 Audit of Records. INNX will allow GCOR to appoint a firm of independent
certified public auditors of international standard to whom INNX has no
reasonable objection to audit INNX's records associated with any payment
due to GCOR hereunder. INNX will give such auditor access, during
ordinary business hours and subject to reasonable advance notice, to
such records as are necessary for the sole and exclusive purpose to
verify the accuracy of any payments made or payable under this Agreement
for a period covering not more than the preceding three (3) years. Such
access shall be granted no more than once in a calendar year, at GCOR's
expense. The independent certified public auditor shall be under a
confidentiality obligation to INNX to disclose to GCOR in its report
only the amount payable under this Agreement. In the event it is
determined that the records indicate that the amount payable under this
Agreement by INNX is more than the amount actually paid, INNX shall pay
such difference within sixty (60) days of such accountant's report
(together with any interest thereon pursuant to Section 4.6), and if
that difference is greater than [ *** ] percent [ *** ] of the amounts
actually paid, then the costs and expenses of said independent certified
public auditor shall be borne by INNX, provided however that in case the
audit report is disputed by INNX the dispute shall be resolved in
accordance with Section 13.11.
4.6 Late Payments. In the event that any payment due hereunder is not made
when due, the payment shall accrue interest from the date due at the
rate of LIBOR plus two and one half percent (2.5%); provided, however,
that in no event shall such rate exceed the maximum legal annual
interest rate. The payment of such interest shall not limit a Party from
exercising any other rights it may have as a consequence of the lateness
of any payment.
4.7 Withholding. Any withholding of taxes levied by tax authorities on the
payments hereunder shall be borne by GCOR and deducted by INNX from the
sums otherwise payable by it hereunder for payment to the proper tax
authorities on behalf of GCOR. INNX agrees to cooperate with GCOR in the
event that GCOR claims exemption from such withholding or seeks credits
or deductions under any double taxation or similar treaty or agreement
from time to time in force, such cooperation to consist of providing
receipts of payment of such withheld tax or other documents reasonably
available to INNX.
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ARTICLE V
[ *** ] RIGHTS
5.1 [ *** ] Rights. Subject to the terms and conditions of any Transferred
Contracts and of this Section 5.1, INNX shall have worldwide rights to
make, use, market and sell the Product and Know-How Products. In the
event INNX elects to make [ *** ] rights for [ *** ] Product or Know-How
Product or [ *** ] of the Product(s) and Know-How Product(s) available
to any third party (being a party other than an Affiliate, sublicensee
or co-developer [ *** ] of INNX for a Product and Know How Product)
under a transaction [ *** ] covering the [ *** ], then GCOR shall have a
right of [ *** ] to [ *** ] the [ *** ], as described in this Section.
INNX shall provide GCOR with Notice if it intends to make [ *** ]
rights available to a third party and GCOR shall have [ *** ] from the
such Notice to give Notice to INNX that GCOR desires to negotiate with
INNX the terms of such [ *** ] rights. If GCOR provides INNX with said
Notice, to so negotiate such terms, then INNX and GCOR shall negotiate
in good faith to finalize an agreement for such [ *** ] rights within a
period of [ *** ]. If at the end of such [ *** ] period, the Parties are
unable to reach an agreement on such terms, then INNX shall be free to
negotiate the terms of such [ *** ] rights with any third party without
further obligation to GCOR with respect to such [ *** ] rights.
5.2 INNX acknowledges that it may not circumvent GCOR's right of [ *** ]
merely by adding an [ *** ] to [ *** ] rights.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1 By GCOR. GCOR represents and warrants to INNX that:
(a) Corporate Power. As of the Effective Date, GCOR is duly
organized and validly existing under the laws of Delaware and
has full corporate power and authority to enter into this
Agreement and carry out the provisions hereof;
(b) Due Authorization. As of the Effective Date, GCOR is duly
authorized to execute and deliver this Agreement and to perform
its obligations hereunder. The person executing this Agreement
on GCOR's behalf has been duly authorized to do so by all
requisite corporate action;
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(c) Binding Agreement. This Agreement is a legal and valid
obligation binding upon GCOR and enforceable in accordance with
its terms. As of the Effective Date, the execution, delivery and
performance of this Agreement by GCOR does not conflict with any
agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor violate any
material law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it;
(d) Consents Except as listed on Exhibit 6.1(d), no consent of any
third party is necessary for any transfer, assignment or
conveyance of the assets to be transferred, assigned or conveyed
under this Agreement;
(e) Except with respect to GCOR's continuing obligation to transfer
or deliver [ *** ] to INNX hereunder, as of the Effective Date,
GCOR has, to the best of its Knowledge, disclosed to INNX all
the information, in its possession which is material to the
development of Products and Know-How Products or to the
application of the Technology in the Field. Prior to or as of
the Effective Date, GCOR is not aware of any fact, matter or
circumstance which is in the Knowledge of GCOR and which GCOR
has not disclosed and which would [ *** ] render any information
provided [ *** ];
(f) Sufficiency. The GCOR Biological Materials, GCOR Contracts, GCOR
Patent Rights, GCOR Product Rights and the GCOR Patent rights
(the "GCOR Rights") collectively are all of the rights in its
Control [ *** ];
(g) Validity. Prior to or as of as of the Effective Date, GCOR has
no Knowledge of any action, suit or inquiry or investigation
instituted by any federal or state governmental agency, which
questions the validity of this Agreement nor has it received any
notice from any third party to the effect that any action, suit,
inquiry or investigation has been instituted by any federal or
state governmental agency which questions the validity of the
Elected Patent Rights;
(h) To the best of its Knowledge GCOR has not taken or failed to
take any action which might result in the invalidity and/or
unenforceability of the Elected Patent Rights or part of them.
Prior to or as of the Effective Date, GCOR has no Knowledge of,
and has not received any notice from a third party, to the
effect that the Elected Patent Rights may be subject to
challenge, are invalid or are unenforceable;
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(i) Consents. Prior to or as of the Effective Date, GCOR has
properly obtained all operational, regulatory and ethical
licenses, permits, consents and authorities necessary at this
stage of [ *** ] of the [ *** ] Product and to the best of its
Knowledge GCOR has properly obtained all operational, regulatory
and ethical licenses, permits, consents and authorities
necessary at this stage of [ *** ] of the [ *** ] Product, and
has conducted its development in accordance with all such
licenses, permits, consents and authorities and GCOR has not
received any communication from any regulatory authority that
would indicate that any such license, permit, consent or
authority may be terminated, cancelled or revoked. In developing
the Technology, GCOR has, to the best of its Knowledge complied
with all applicable US legislation and all such licenses,
permits, consents and authorities;
(j) Clinical Trials. Prior to or as of the Effective Date, GCOR has
no Knowledge that any of the investigators participating in any
study relating to the HBV Phase I clinical trial (commenced in
February 2004) have any conflict of interest or any interest
disclosable under 21 CFR Part 54 or under the FDA guidance on
the Financial Disclosure by Clinical Trial Investigators. The
HBV Phase I clinical trial is [ *** ] and that, prior to or as
of the Effective Date, to the best of GCOR's Knowledge, there
have been no material deviations from the relevant protocols.
The only clinical trial in humans to have been commenced,
undertaken or sponsored by GCOR in relation to Products or
Know-How Products is the HBV Phase I clinical trial, full
details of which, as of the Effective Date, have been disclosed
to INNX;
(k) No BLA or its equivalent has been filed by or on behalf of GCOR
in respect of any Product or Know-How Product;
(l) Ownership of Transferred Rights. Except as listed and specified
on Exhibit 6.1(l), GCOR is the sole and exclusive owner of, or
has sole and exclusive Control of all of the Transferred Rights
and has exclusive rights thereto and the Transferred Rights are
free from all encumbrances, with the sole exception of those
Transferred Rights specified in Exhibit 6.1(l). Except as
necessary for third parties to perform services or research and
development activities for GCOR under the Elected Contracts,
GCOR has not granted any licenses or other rights in or to the
Transferred Rights or any part of them and has not entered into
any contract or agreement to grant any such license or rights;
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(m) Accuracy and Completeness of Exhibits. Exhibits 2.2.1 (a) (GCOR
Contracts) and 2.2.1. (b) (GCOR Contracts related to the Field)
2.3.1 (GCOR Biological Materials), 2.4.1 (Product Rights),
2.5.1.1 GCOR Patent Rights, including 2.5.1.1(a) (GCOR Exclusive
Patent Rights), 2.5.1.1(b) (GCOR Joint Patent Rights) and
2.5.1.1(c) (GCOR Licensed Patent Rights), 2.5.2.1 (GCOR Know-How
Rights), 2.5.3.1.(a) (Trademark Rights), 2.5.3.1.(b) (Copyright
Rights), and 2.6.1.(Study Date Packages) are true and complete,
provided always that GCOR shall not be in breach of this
warranty to the extent that, in respect of a particular right
listed in the relevant exhibit there is an error in the columns
marked by INNX as Elected Rights, Tier 1 or Section1.52, or
"delivered" in Exhibits 2.2.1, 2.3.1, 2.4.1, 2.5.1.1, 2.5.2.1
and 2.6.1;
(n) Effective Transfer All of the rights identified as transferred,
conveyed, assigned or delivered in the column of the relevant
Exhibit referred to in paragraph (m) above have been properly
transferred, assigned, conveyed or delivered to INNX, so that
title thereof has properly vested in INNX or, in case of
licensed rights, the right to use the transferred asset has been
conveyed to INNX. To the extent that any Exhibit is amended
after the Effective Date by GCOR to reflect the transfer,
assignment, conveyance or delivery of the relevant asset, this
representation and warranty will apply to the Exhibit as
amended;
(o) As of the Effective Date, GCOR is aware of only one patent
opposition presently pending or ongoing concerning, relating to
the Technology, Products and/or Know-How Products or their
exploitation in the Field, that being the Opposition being
identified in Section 1.35 of this Agreement;
(p) Except as specified on Exhibit 2.2.1(b) GCOR has provided true
and accurate copies of all those contracts listed in Exhibit
2.2.1 and except as specified on Exhibit 2.2.1(a), all of the
contracts listed in Exhibit 2.2.1(a) are still valid, subsisting
and in force as of the Effective Date and this Agreement will
not result in the termination of the contracts listed in 2.2.1
(a) by the third party and/or does not materially breach the
terms of such;
(q) Subject to the disclosures set out in Exhibit 6.1(q), GCOR
represents that as of the Effective Date, it has no Knowledge of
any [ *** ] concerning [ *** ]-related Biological Materials
and/or Products and Know-How Products which GCOR, acting in good
faith, believes to be material (e.g. [ *** ]) which would
materially
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impair the [ *** ] of the [ *** ]-related Biological Materials
and/or the Product and Know-How Product. Subject to the
disclosures set out in Exhibit 6.1(q), GCOR represents that as
of the Effective Date, it has no Knowledge of any [ *** ]
concerning [ *** ]-related Biological Materials and/or Products
and Know-How Products which GCOR, acting in good faith, believes
to be material which would [ *** ] of the [ *** ]-related
Biological Materials and/or the Product and Know-How Product.
For the purposes of this representation and warranty, the
expression [ *** ] shall mean any data which could reasonably be
expected to be included in or used to support a filing for, or
disclosable to a regulatory authority in respect of an IND;
(r) Prior to or as of the Effective Date and except as listed on
Exhibit 6. 1(r), GCOR has no Knowledge, nor has it received any
notice or claim to the effect that either: (i) the [ *** ] (or
any part thereof) or its use in the Field; or (ii) Products and
Know-How Products or (iii) the [ *** ] may infringe, violate or
misappropriate the issued patent or trade secret rights of any
third party; [ *** ];
(s) GCOR has not materially breached any of the Elected Contracts
and to the best of its Knowledge, the other party or parties to
the Elected Contracts are not in material breach of those
contracts. Prior to or as of the Effective Date , there is no
existing or, to the best Knowledge of GCOR, threatened dispute
between GCOR and the third parties who are a party to the
Elected Contracts, nor has there been any action or suit filed
by GCOR or a party to the Elected Contracts concerning a dispute
thereunder and GCOR has neither sent nor received any notices
relating to such a dispute over the last three years. Except for
payments that may be due but not yet payable, no money is owing
under any obligation which arose prior to the Effective Date or
as a result of acts or omissions prior to the Effective Date in
respect of any of the Elected Contracts;
(t) Confidential Information. GCOR has taken all reasonable steps to
maintain the confidentiality of the Study Data Packages, the HBV
IND, the GCOR Product Rights, the Elected Biological Materials,
the confidential information disclosed under or the confidential
content of the Elected Contracts and the Licensed Know-How
Rights. As of the Effective Date, except as disclosed in patent
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filings or regulatory filings, GCOR has no Knowledge of any
circumstances which would indicate that such information is no
longer confidential and as far as the Elected Contracts or the
confidentiality agreements or material transfer/evaluation
agreements listed on Exhibit 2.2.1 are concerned, GCOR has no
Knowledge that there has been a breach of the confidentiality
obligations contained therein.
For the purpose of this Article 6.1. "Knowledge" shall mean, with
respect to GCOR, any fact or matter which any officer or employee of
GCOR in the reasonably prudent discharge of his or her duties, knew or
should have known.
6.2. By INNX. INNX represents and warrants to GCOR that:
(a) Corporate Power. As of the Effective Date, INNX is duly
organized and validly existing under the laws of Belgium and has
full corporate power and authority to enter into this Agreement
and carry out the provisions hereof;
(b) Due Authorization. As of the Effective Date, INNX is duly
authorized to execute and deliver this Agreement and to perform
its obligations hereunder. The person executing this Agreement
on INNX's behalf has been duly authorized to do so by all
requisite corporate action;
(c) Binding Agreement. This Agreement is a legal and valid
obligation binding upon INNX and enforceable in accordance with
its terms. As of the Effective Date, the execution, delivery and
performance of this Agreement by INNX does not conflict with any
agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor violate any
material law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it;
(d) Validity. As of the Effective Date, INNX is aware of no action,
suit or inquiry or investigation instituted by any federal or
state governmental agency, which questions the validity of this
Agreement;
(e) Elected Contracts. INNX expressly assumes all rights and
obligations under any Transferred Contract including any
limitations with respect to use inside or outside the Field. In
performing its obligations or exercising its rights under such
Transferred Contracts INNX will not violate any terms or
conditions thereof.
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(f) Transferred Patent Rights. Subject to the provisions of the
Elected Contracts, INNX will use reasonable commercial efforts
in prosecuting and maintaining the Transferred Patent Rights
specified on Exhibit 1.46.
(g) As of the Effective Date, INNX has the financial resources and
the liquidity to pay the Upfront Payment
6.3. Disclaimer. EXCEPT AS OTHERWISE PROVIDED FOR IN THIS AGREEMENT AND IN ITS
VARIOUS EXHIBITS, NEITHER PARTY GUARANTEES THE SAFETY OR
USEFULNESS OF ANY PRODUCT, KNOW-HOW PRODUCT OR TRANSFERRED
BIOLOGICAL MATERIAL. EXCEPT WITH RESPECT TO THE [ *** ], THE
TRANSFERRED GCOR BIOLOGICAL MATERIALS ARE [ *** ] FOR WHICH
GCOR PROVIDES NO REPRESENTATION NOR WARRANTY [ *** ]. EXCEPT
AS EXPRESSLY SET FORTH ABOVE, NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY NATURE,
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTY OF NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
ARTICLE VII
INDEMNIFICATION
7.1 By GCOR. GCOR shall defend, indemnify and hold INNX and its Affiliates
and their respective officers, directors, employees, agents or
representatives (the "INNX Indemnitees") harmless against any liability,
damage, loss, cost or expense, including legal fees (collectively,
"Liability"), incurred by any INNX Indemnitee arising out of our
resulting from: (i) GCOR's material breach of a term of this Agreement,
including any material breach of any representation or warranty of GCOR
set forth in Section 6.1 of this Agreement; and (ii) any third party
claims or suits made or brought against any INNX Indemnitee to the
extent such Liability arises out of or is caused by GCOR's conveyance of
the Transferred Rights to INNX; (iii) any third party claims or suits
made or brought against any INNX Indemnitee to the extent such Liability
arises out of or is caused by GCOR's or its Affiliates' acts or
omissions, and/or acts or omissions by third parties for GCOR or its
Affiliates, arising prior to the Effective Date in relation to its [ ***
] or its clinical development of [ *** ] prior to the Effective Date;
(iv) any third party claims or suits made or brought against any INNX
Indemnitee to the extent such Liability arises out of or is caused by
GCOR's or its Affiliates' acts or omissions during the Transition
Period.
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7.2 By INNX. INNX shall defend, indemnify and hold GCOR and its Affiliates
and their respective officers, directors, employees, agents or
representatives (the "GCOR Indemnitees") harmless against any Liability
incurred by any GCOR Indemnitee arising out of or resulting from: (i)
INNX's material breach of a term of this Agreement, including any
material breach of a representation or warranty of INNX set forth in
Section 6.2; and (ii) any third party claims or suits made or brought
against any GCOR Indemnitee to the extent such Liability arises out of
or is caused by INNX's or its Affiliates' or sublicensee's acts or
omissions, and/or acts or omissions by third parties for INNX or its
Affiliates, relating to the research, development, clinical development,
manufacture, use, promotion, marketing or sale of Product or Know-How
Product(s) or INNX's use or exploitation or further conveyance of the
Transferred Rights.
7.3 Notice and Cooperation. If either Party hereunder receives notice of any
claim or of the commencement of any action, administrative or legal
proceeding, or investigation as to which the indemnity provided for in
Section 7.1 or 7.2 hereof may apply:
(a) the Party seeking indemnification shall notify the indemnifying
Party of such fact within fourteen (14) days at the address
noted in Section 13.8; provided that the failure to so notify
shall not release an indemnifying Party of its obligation
hereunder unless such failure shall be materially detrimental to
the defense of any such action, proceeding or investigation; and
(b) the Party seeking indemnification shall cooperate with and
assist the indemnifying Party and its representatives in the
investigation and defense of any claim and/or suit for which
indemnification is provided at the indemnifying Party's cost.
7.4 Defense and Settlement. The indemnifying Party shall control the defense
of any claim and/or suit for which indemnification is provided under
this Article VII. This agreement of indemnity shall not be valid as to
any settlement of a claim or suit or offer of settlement or compromise
without the prior written approval of the indemnifying Party.
7.5 Insurance. Prior to initial human testing and also prior to first
commercial sale of any Product and Know-How Product in any particular
country, INNX will establish or procure to be established, and
thereafter will maintain or procure to be maintained worldwide product
liability and other appropriate insurance coverage (including clinical
trial insurance), purchased from a reputable and financially secure
insurance company, appropriate to the risks involved in the testing and
marketing of Product(s) and Know-How Product(s). Further, INNX will
maintain or procure to be maintained in each country, where required by
local law, product liability
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and other appropriate insurance coverage (including clinical trial
insurance) appropriate to the risks involved in the human testing and
marketing of Product and Know-How Product. The combination of the
worldwide and required local coverage in each country, will be an amount
not less than [ *** ] each claim and not less than [ *** ] annual
aggregate limit. All such insurance maintained by INNX will be primary
insurance coverage and any insurance held by GCOR shall be excess and
non-contributory. GCOR shall be listed as an additional insured in such
INNX insurance and shall be provided thirty (30) day advance notice of
cancellation. Furthermore, INNX shall guarantee that it will purchase
tail coverage to ensure continuation and uninterruption of coverage for
all claims during a [ *** ] period after the end of the term of the
applicable policy.
Annually, upon the anniversary date of the Effective Date during the
Term, INNX will present evidence to GCOR that the coverage detailed
above is being maintained. If such product liability insurance is
underwritten on a `claims made' basis, INNX agrees that any change in
underwriters during the term of this Agreement will require the purchase
of coverage which ensures that coverage will be continuous throughout
the term of the Agreement.
ARTICLE VIII
DILIGENCE
8.1 Diligence. During the Term INNX and its Affiliates and sublicensees will
use [ *** ] to develop and commercialize a Product for each Virus. As
used herein [ *** ] means, unless the Parties agree otherwise, those
[ *** ] consistent with the exercise of [ *** ], as
applied to other products of [ *** ]. The Parties expressly agree as
follows:
(a) [ *** ] Diligence. If INNX or its Affiliate or sublicensee fails to
Initiate an HBV Proof-of-Concept Trial for any one of a [ *** ] Product
or Know-How Product by [ *** ], except for reasons set forth below in
Section 8.1(c), then INNX will not have used commercially reasonable
efforts and all Transferred Rights necessary for the exploitation in the
HBV part of the Field shall be transferred to GCOR (without remuneration
to INNX) by assignment or license as appropriate for exploitation and
use in the [ *** ] part of the Field. The Parties will agree to discuss
in good faith the transfer of any additional rights owned or controlled
by INNX relating to the [ *** ] part of the Field and the terms thereof.
(b) [ *** ] and [ *** ] Diligence. If INNX or its Affiliate or
sublicensee fails to Initiate either an [ *** ] or [ *** ]
Proof-of-Concept Trial for any one of a [ *** ] Product or Know-How
Product by [ *** ], except for
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reasons set forth in Section 8.1(c), then INNX will not have used
commercially reasonable efforts and all Transferred Rights necessary for
the exploitation in the [ *** ] and [ *** ] part of the Field shall be
transferred to GCOR (without remuneration to INNX) by assignment or
license as appropriate for exploitation and use in the [ *** ] and [ ***
] part of the Field. The Parties will agree to discuss in good faith the
transfer of any additional rights owned or controlled by INNX relating
to the [ *** ] and [ *** ] part of the Field and the terms thereof.
(c) Reasons which justify a delay in the date provided to Initiate the [
*** ] Proof-of-Concept Trial pursuant to section 8.1(a) and/or to
Initiate the [ *** ] or [ *** ] Proof-of-Concept Trial pursuant to
section 8.1(b) include: (i) a clinical hold placed by a regulatory
authority; (ii) materially adverse preclinical or clinical data (iii)
actual delays caused by GCOR or caused by third parties, including for
example injunctions or seizures for IP infringement; and (iv) force
majeure.
(d) In the event of a reason which justifies a delay in accordance with
Section 8.1.(c), INNX will give Notice hereof to GCOR with sufficient
detail so as for GCOR to be able to assess the reasons and the expected
duration of the delay. Upon such a Notice by INNX, both Parties will
discuss the matter with the aim, by mutual agreement, to extend the
specified diligence period(s) with an appropriate period of time to
place INNX, its Affiliates or sublicensees in the same situation as if
the reason(s) for the delay had not occurred, subject to INNX's diligent
efforts to resolve the cause of such delay. In the event the Parties
cannot agree on the extension of the specified diligence period(s), they
will appoint an independent expert to provide the Parties with a binding
opinion as to such extension. If the Parties cannot agree on the
identity of such independent expert within a period of two (2) months as
from the date a Party requests the appointment of such expert, either
Party may ask the competent court to appoint such expert.
8.2 Reports. Annually, until the date of first commercial sale of the first
HBV, HCV and HPV Product(s) or respective Know-How Product(s), INNX will
provide GCOR with a written report summarizing the status of development
plans and time lines for the Products or Know-How Products not yet
commercialized (the "Report"). Should GCOR wish to discuss a Report,
INNX will arrange a telephone conference or other meeting mutually
acceptable to the Parties in order to discuss the ongoing development of
the Products and the information contained in the Reports. From
time-to-time INNX may request (in writing) that GCOR extend the
diligence dates set forth in Section 8.1 (a) or (b), based on the then
current best information available to INNX regarding the clinical
development and time lines for Product/ Know-How Product approval
together with its detailed technical, clinical and business rationale to
justify such extension. Upon such a request by INNX, GCOR will undertake
to
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discuss the matter with INNX and the Parties may, by mutual agreement,
extend the specified diligence period(s).
ARTICLE IX
CONFIDENTIALITY
9.1 Confidentiality Obligation.
During the Term or, in the case of early termination by INNX under
10.2.2., [ *** ] from the Effective Date GCOR shall not without the
prior and unambiguous written authority of INNX disclose or use or
publish any of the information contained in the Transferred Rights (the
"INNX Confidential Information"). This restriction shall not apply to
any INNX Confidential Information which GCOR can show to the reasonable
satisfaction of INNX (i) was in the public domain at the Effective Date
or (ii) which subsequently comes into the public domain with no
violation of this Agreement or any other agreement to which GCOR is a
party or (iii) INNX Confidential Information which is hereafter lawfully
disclosed to GCOR by a third party, which third party did not acquire
the INNX Confidential Information under a still effective obligation of
confidentiality to INNX, its Affiliates or sub-licensees or which third
party did not receive the INNX Confidential Information under the terms
of any of the GCOR contracts listed on Exhibit 2.2.1(b). GCOR shall,
promptly on the discovery of an unauthorized disclosure inform INNX and
render such assistance in preventing further disclosure as INNX may
reasonably request.
9.2 Authorized Disclosures. Confidential information of the disclosing Party
may be disclosed only to persons within the organization of the
receiving Party who are bound by confidentiality obligations at least as
stringent as those herein. Notwithstanding any other provision of this
Agreement, disclosure of confidential information shall not be precluded
if such disclosure: (a) is in response to a valid order of a court or
other governmental body of the United States or any political
subdivision thereof; or (b) is deemed necessary or prudent to disclose
in order to comply with any law or regulation including regulatory
requirements such as filing with the U.S. Securities and Exchange
Commission or similar European Authority or the applicable listing
exchange for either Party; provided, however, that the Recipient will
make a reasonable effort to obtain a protective order or to seek
confidential treatment, or to cooperate with the disclosing Party's
efforts, as applicable, to obtain a protective order or to seek
confidential treatment limiting the extent of such disclosure and
requiring that the confidential information so disclosed be used only
for the purposes for which such order was issued or as required by such
law or regulation.
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9.3 Press Release. It is the Parties' intent that one or more press release
will be issued by a Party relating to the terms or execution of this
Agreement and/or that the Party's may also issue a joint press release
relating thereto, provided, however, that, except as required by a Party
to meet its obligation to make necessary disclosure under applicable
securities laws and listing agency regulations, neither Party will issue
a press release or make other public disclosures related to the
execution of this Agreement or the terms contained therein without the
prior written approval of the other (which approval may not be
unreasonably withheld). The Parties agree that subject to approval of
the final text by the other Party, the press release and any required
disclosures may include the upfront payments and the total milestone
payments payable under the Agreement. Any press release may include
further detail regarding total milestone payments that may be due pre
and post initiation of Phase III clinical trials. Once a Party has made
a required or other permissible disclosure hereunder, either Party may,
without the other Party's consent, disclose the terms that have already
been publicly disclosed.
9.4 Scientific Publications. INNX acknowledges that GCOR has an interest in
publishing the results of its research and development activities
conducted prior to the Effective Date and relating to the Transferred
Rights and GCOR acknowledges INNX's rights to maintain the
confidentiality of the Transferred Rights. Accordingly, GCOR shall
ensure that INNX receives a draft of the proposed publication, that
includes the data proposed for publication, at least [ *** ] before
submission of the proposed publication. On receipt of the proposed
publication INNX shall review it and shall inform GCOR that either (i)
it consents to the publication or (ii) the publication of all or parts
thereof is, in INNX reasonable business judgment, prejudicial to INNX.
In such event INNX can (i) withhold its consent with regard to the
publication or parts thereof or (ii) require a delay in publication to
seek intellectual property protection (a "Confidentiality Notice"). In
the event that a delay in publication is requested then GCOR will ensure
that the proposed publication is kept confidential for a period
requested by INNX (not exceeding [ *** ]) to allow INNX to file for such
intellectual property protection. If the Confidentiality Notice
identifies any information which is confidential to INNX (including INNX
Confidential Information as defined in Section 9.2) and requires its
removal, then GCOR shall ensure that the information so identified is
removed from the proposed publication before it is submitted for
publication. In the event that INNX does not submit a Confidentiality
Notice within [ *** ] of its receipt by INNX then GCOR shall be free to
publish the proposed publication.
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ARTICLE X
TERM AND TERMINATION
10.1 Term. This Agreement shall commence on the Effective Date and shall
continue until the expiration of INNX's obligation to make royalty
payments hereunder (the "Term").
10.2 Termination for Breach.
10.2.1 In the event that within [ *** ] of: (i) the Effective Date; or
(ii) the Effective Transfer of IND ; or (iii) the date of
receipt of the import permit as described in Section 2.3.4(iii),
as applicable; GCOR fails to deliver or transfer as applicable
in the relevant sections of Article II, to INNX any of the
individual Elected Contracts, any of the individual Elected
Biological Materials, any of the individual Elected Patent
Rights or any of the individual Study Data Packages or the HBV
IND or Know-How Rights which has been designated by INNX as
being a Tier 1 Transferred Right, then INNX has the
discretionary right to terminate this Agreement by giving GCOR
Notice thereof.
10.2.2 Either Party may terminate this Agreement prior to the
expiration of the Term upon or after the breach of any material
provision of this Agreement (except with respect to matters
referred to in Section 10.2.1 or 10.3.2 and except with respect
to the matter referred to in Section 8.1(a) independently of
Section 8.1(b) or Section 8.1(b) independently of Section 8.1(a)
(but not in the case of INNX's failure to have used commercially
reasonable efforts in relation to both Section 8.1(a) and
8.1(b)) by the other Party, provided, that such other breaching
Party has not cured such breach within [ *** ] after written
Notice thereof by the nonbreaching Party. It is understood
however, that in the event a Party sends a Notice of breach to
the other Party and such other Party disputes the existence of a
breach (e.g. disputes the fact that a product qualifies as a
Product on which past royalties or Milestone Payments are due),
the [ *** ] cure period will only start after resolution by the
competent court of the question whether or not there is a
breach.
10.3 Remedies Other than Termination.
10.3.1 In the event that within [ *** ] of: (i) the Effective Date; or
(ii) the Effective Transfer of IND; or (iii) the date of receipt
of the import permit as described in Section 2.3.4(iii), as
applicable; GCOR fails to deliver or transfer to INNX in
accordance with Article II any of the Elected Rights which have
not yet been delivered or transferred, then INNX shall be
entitled to obtain appropriate remedies (other than termination)
therefor, including but not limited to recovery of all
reasonable and documented costs or expenses which it has
incurred and which have directly resulted from the delay in such
transfer, by giving GCOR Notice thereof.
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10.3.2 Without prejudice to the provisions of Section 10.3.1, in the
event that GCOR fails to deliver or transfer to INNX in
accordance with Article II any of the Elected Rights after the
period of [ *** ] following: (i) the Effective Date; or (ii) the
Effective Transfer of IND; or (iii) the date of receipt of the
import permit as described in Section 2.3.4(iii), as applicable;
GCOR will pay INNX an indemnity of [ *** ] until all the Elected
Rights have been duly transferred to INNX in accordance with the
provisions of Article II. In the eventuality that GCOR is unable
to assign and transfer one or more of the Elected Rights to
INNX, GCOR can provide INNX Notice thereof and as of the day of
receipt of the Notice, no further daily indemnity will be due
for that part of the Elected Rights for which Notice was
provided. The Parties agree to discuss and negotiate a fair
compensation for the damages suffered by INNX due to the
nonassignment or non-delivery and the value of the non-assigned
or nondelivered applicable Elected Right. If the Parties fail to
reach an agreement on such compensation within [ *** ], INNX can
initiate proceedings in accordance with Section 13.10. The
payment of the indemnity does not impact on INNX right to obtain
fair compensation for the value, damages, costs and expenses it
incurs due to the transfer of any Transferred Right which is not
done in compliance with the provisions of Article II of this
Agreement.
10.4 Effect of Termination.
10.4.1 Termination of this Agreement shall not release the Parties from
any obligation that shall have accrued prior to termination.
10.4.2 In the event GCOR terminates this Agreement under section 10.2.2
all the Transferred Rights obtained under this Agreement and
remaining at the date of termination shall, as permissible and
subject to applicable third party consents and eventual
sub-licenses granted, be re-assigned, transferred or otherwise
conveyed to GCOR. INNX will not intentionally terminate any
remaining Transferred Rights in view of such termination.
10.4.3 In the event INNX terminates the Agreement under section 10.2.1:
(a) the Upfront Payment paid to GCOR will be refunded to INNX within
[ *** ] of the day of Notice of termination from INNX to GCOR;
(b) INNX will re-assign, transfer or otherwise convey to GCOR all of
INNX's right, title and interest in and to the Transferred
Rights and promptly return all Transferred Rights and materials
to GCOR and no later than ninety (90) days from the date of
Notice of Termination;
(c) GCOR will indemnify INNX for all Liabilities in the event the
re-assignment is not legally or contractually possible and GCOR
will in such event
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perform at its own cost but in the name and on behalf of INNX
all obligations under such Transferred Rights that could not be
re-assigned to GCOR and remain solely liable for such
performance.
(d) As from the day of the Notice of termination, INNX will be
released from any obligation vis-a-vis GCOR or any third party
resulting from this Agreement. In addition GCOR will reimburse
to INNX [ *** ] made by INNX pursuant to this Agreement, herein
included but not limited to the payments made under sections
2.2.6 and 2.2.7, but expressly excluding [ *** ] until the
earliest possible termination date under the [ *** ], as
amended, with the maximum cost of [ *** ] for that period, as
well as all costs/expenses which INNX has incurred in relation
thereto.
(e) INNX will be entitled to all documented costs, expenses and
damages (and interest thereon) which INNX has incurred from the
Effective Date in connection with the transactions contemplated
by this Agreement and/or which have resulted from the delay in
the contemplated transfer, including but not limited to all out
of pocket expenses incurred by INNX such as patent prosecution
expenses and reimbursement of expenses incurred in buying
materials from third parties.
(f) INNX shall be listed as an additional insured in GCOR's
liability insurance (including clinical trial insurance) for all
activities of INNX under the HBV clinical trial.
10.4.4 In the event INNX terminates the Agreement under section 10.2.2, then
INNX will retain all rights under the Transferred Rights and is released
from all future payment obligations to GCOR under the Agreement, without
prejudice to INNX's right to obtain any other remedies at law or equity
for GCOR's breach.
10.5 For the avoidance of doubt in the event of bankruptcy or insolvency of
GCOR, notwithstanding the bankruptcy of GCOR, or the impairment of
performance by GCOR of its obligations under this Agreement as a result
of bankruptcy or insolvency of GCOR, INNX shall be entitled to retain
any and all licenses granted herein.
10.6 Surviving Provisions. Expiration or termination of this Agreement shall
not relieve the parties of any obligations accruing prior to such
expiration or termination. The provisions of Sections 4.1, 4.5, 6.3,
9.1, 9.2, 9.3 10.3, 10.4, 10.6, 13.6, 13.8, 13.10, 13.11, 13.13 and
Articles VII shall survive termination or expiration of this Agreement.
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ARTICLE XI
TRANSITION PERIOD
11.1 In order to avoid any significant delays in the continued development of
the Product and Know-How Products, the Parties anticipate a transition
period of approximately [ *** ] during which time GCOR will provide,
upon request of INNX, [ *** ] for or on behalf of INNX. Specifically
during the Transition Period GCOR will make its personnel available
through email or phone inquiries to answer questions regarding the
Transferred Rights and clarify any matters related thereto. Furthermore,
upon written request from INNX, GCOR will make a [ *** ] available to
consult with INNX [ *** ] for up to [ *** ] at GCOR's cost in order to
answer any questions regarding the transfer of Transferred Biological
Materials, Transferred Know-How or other Transferred Rights. If INNX
requires further consultation over and above the [ *** ], INNX will
reimburse GCOR at [ *** ] plus out of pocket expenses associated with
such consultation. Such technical representative shall be of sufficient
qualification and authority to answer or obtain the answer to any of the
questions INNX may reasonably ask.
If during the Transition Period INNX requests GCOR to conduct any
specific services relating to INNX's research or development of a
Product or Know-How Product, the Parties will enter good faith
negotiations on the terms and conditions under which GCOR will provide
such requested services and will upon agreement execute a definitive
service agreement reflecting same.
11.2 Non-Assignable Service Contracts. To the extent INNX elects to have GCOR
continue to contract directly with a party for services provided by such
party under the Non-Assignable Service Contracts, i.e. the Service
Contracts with [ *** ], the Parties agree as follows:
(a) GCOR will perform all obligations, including making any payments
due under such Non-Assignable Service Contracts, to the benefit
of, and as instructed in writing by, INNX;
(b) GCOR shall keep INNX informed of the services so provided:
(c) Upon receipt of a corresponding invoice from GCOR, INNX will
reimburse GCOR for any expenses paid by it to said third parties
pursuant to the Non-Assignable Service Contracts; and
(d) INNX will, prior to the expiration date of the Transition
Period, terminate any further services to be provided by such
parties through GCOR and either establish its own independent
service agreements directly with such parties as it deems
appropriate, or obtain such services elsewhere, solely at its
discretion.
11.3 Assignable IND Related Service Contracts
For the Service Contracts with respectively [ *** ] (the Assignable IND
Related Service Contracts) , and for the period between the Effective
Date and the date
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the Parties have agreed the IND is effectively transferred, the Parties
agree as follows:
(a) GCOR will perform all obligations, including making any payments
due under such Assignable IND Related Service Contracts, to the
benefit of, and as instructed in writing by, INNX; and
(b) GCOR shall keep INNX informed of the services so provided; and
(c) Upon receipt of a corresponding invoice from GCOR, INNX will
reimburse GCOR for any expenses paid by it to said third parties
pursuant to such Assignable IND Related Service Contracts
corresponding with the services provided to INNX.
ARTICLE XII
ONGOING OBLIGATIONS OF GCOR
12.1 During the Term, GCOR will inform INNX of any breach of any of the
Transferred Contracts and the agreements relating to confidential
disclosures and/or material transfers with third parties concerning the
Technology, Products/Know-How Product and/or the Field. In the event of
such a breach of an agreement relating to confidential disclosures
and/or material transfers with third parties, GCOR, after prior
consultation with INNX, undertakes to enforce its rights thereunder
against the breaching third party.
12.2 During the Term, to the extent INNX reasonably requests in view of
litigation and patent office proceedings, GCOR will provide INNX access
to and use of the original lab notebooks relevant to the Transferred
Intellectual Property Rights. Appropriate action will be taken to ensure
the confidentiality of those portions of the lab notebooks which do not
relate to the Transferred Intellectual Property Rights.
ARTICLE XIII
MISCELLANEOUS
13.1 Force Majeure. Each of the Parties hereto shall be excused from the
performance of its obligations hereunder (except payment obligations)
and shall not be liable for damages to the other in the event that such
performance is prevented by circumstances beyond its effective control.
Such excuse from performance shall continue for as long as the condition
responsible for such excuse continues and for a period of 30 days
thereafter, provided that if such excuse continues for a period of 180
days, the Party whose performance is not being prevented shall be
entitled to terminate this Agreement. For the purpose of this Agreement
circumstances beyond the effective control of the Party which excuse
said Party from performance shall include, without limitation, acts of
God, regulations or laws of any government, injunctions or judgment of
any court, war, civil commotion, destruction of facility or materials by
fire, earthquake, storm or other casualty, plague of epic proportions,
famine,
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labor disturbances and failure of public utilities or common carrier.
For the avoidance of doubt, beyond effective control shall not include
the objection/refusal of any third party to permit GCOR to assign,
transfer, sublicense any or part of the individual Elected Contracts,
the Elected Biological Materials, the Product Rights, the Elected Patent
Rights, the Know-How Rights, the Trademarks Rights or Copyrights or the
Study Data Packages to INNX all as provided for hereunder.
13.2 Independent Contractors. Nothing in this Agreement is intended or shall
be deemed to constitute a partnership, agency, employment or joint
venture relationship between the Parties. All activities by the Parties
hereunder shall be performed by the Parties as independent parties.
Neither Party shall incur any debts or make any commitment for or on
behalf of the other Party except to the extent, if at all, specifically
provided herein or subsequently agreed upon.
13.3 Assignment. This Agreement, or parts thereof shall only be assignable by
either Party after prior written notification to the other Party, except
that either Party may assign this Agreement without prior notification
to the other Party, to a successor to all or substantially all the
business assets of such Party whether by merger, sale of stock, sale or
transfer of assets or other transaction. This Agreement shall be binding
upon and inure to the benefit of the Parties' successors, legal
representatives and assigns.
13.4 Amendments of Agreement. This Agreement may be amended or modified or
one or more provisions hereof waived only by a written instrument signed
by both Parties.
13.5 Severability. In the event that any one or more of the provisions of
this Agreement should for any reason be held by any court or authority
having jurisdiction over this Agreement and the Parties to be invalid,
illegal or unenforceable, such provisions shall be deleted in such
jurisdiction; elsewhere this Agreement shall not be affected.
13.6 Interpretation
13.6.1 Article Headings. The section headings contained in this Agreement are
for convenience only and are to be of no force or effect in construing
and interpreting this Agreement.
13.6.2 Including the words "include", "included" and "including" and the
expression "for example" or "e.g." are to be construed without
limitation to the generality of the preceding words.
13.7 Further Assurance. GCOR hereby covenants with INNX that it will at the
expense of GCOR provide such reasonable assistance as INNX may request
including to
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execute or sign all such instruments, applications, documents and do all
things as may reasonably be required by INNX to vest in INNX the
property and rights hereby assigned, transferred or conveyed and to
apply for any patents or other forms of protection in respect of any of
the Transferred Rights, throughout the world and fully and effectively
to vest the same in INNX.
13.8 Notices. Any notice, report, request, approval, payment, consent or
other communication required or permitted to be given under this
Agreement (collectively, a "Notice") shall be in writing and shall for
all purposes be deemed to be fully given and received, if delivered in
person or sent by registered mail, postage prepaid or by facsimile
transmission to the respective Parties at the following addresses:
If to INNX: INNOGENETICS, X.X.
Xxxxxxxxxxxxxxx 0, X-0000
Xxxxx, Xxxxxxx
Attention: CEO
Fax No.:+ 00 0 000 00 00
With a copy to:
INNOGENETICS, X.X.
Xxxxxxxxxxxxxxx 0, X-0000
Xxxxx, Xxxxxxx
Attention: Legal Department
Fax No.: x00 0 000 00 00
If to GCOR: GENENCOR INTERNATIONAL, INC.
000 Xxxx Xxxx Xxxx Xxxx
Xxxx, XX 00000
Attention: General Counsel
Fax No.: 000-000-0000
With a copy to:
GENENCOR INTERNATIONAL, INC.
000 Xxxx Xxxx Xxxx Xxxx
Xxxx, XX 00000
Attention: Director of Business
Development, Health Care
Fax No.: 000-000-0000
Either party may change its address for the purpose of this Agreement by
giving the other Party written Notice of its new address.
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13.9 Non-Waiver For Failure To Enforce Compliance. The express or implied
waiver by either Party of a breach of any provision of this Agreement
shall not constitute a continuing waiver of other breaches of the same
or other provisions of this Agreement.
13.10 Applicable Law. This Agreement shall be construed and interpreted in
accordance with the laws of the State of New York without regard to
conflict of law provisions.
13.11 Jurisdiction. All disputes arising in connection with this Agreement,
which cannot be amicably settled between the Parties, shall be subject
to the exclusive jurisdiction of the United States District Court for
the Southern District of New York.
13.12 Counterparts. This Agreement may be executed in one or more
counterparts, each of which is an original but all of which, taken
together, shall constitute one and the same instrument.
13.13 All Exhibits to this Agreement are incorporated herein by reference and
made an integral part hereof.
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their respective representatives hereto duly authorized
GENENCOR INTERNATIONAL, INC
By:/s/ Xxxx Xxxxxxxxx
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Name: Xxxx Xxxxxxxxx
Title: Senior Vice-President
INNOGENTICS NV
By:/s/Ph. Archinard
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Name: Ph. Archinard
Title: CEO & Managing Director
By:
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Name: Xx. X. Xx Xxxxxx
Title: Director, Vice-Chairman