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Exhibit
10.22
CONFIDENTIAL
STRATEGIC ALLIANCE:
NON-EXCLUSIVE LICENSE AGREEMENT
- BREAST, PROSTATE and
LUNG CANCER -
This License Agreement
(“Agreement”) is made by and between COLEY
PHARMACEUTICAL GROUP INC., Inc. having a place of business at 93
Worcester Street, Suite 101, Wellesley, MA, 02481, USA (herein
referred to as “COLEY”) and GLAXO GROUP LIMITED, a
corporation located at, 980 Great West Road, Brentford, Middlesex
TW8 9GS, United Kingdom (herein referred to as
“GSK”).
WITNESSETH THAT
:
WHEREAS, COLEY is the
owner of certain right, title and interest in, and/or is otherwise
in possession and/or control of the right to grant licenses under,
certain patents in the manner and to the extent identified in
Appendix A hereto, and know-how to the extent identified in
Appendix B hereto, in the field of certain adjuvant technology
which has been demonstrated to exhibit activity in animals and
humans when used in combination with a variety of antigen
materials; and
WHEREAS, GSK has
developed and/or is developing or evaluating vaccines for the
prevention and/or treatment of cancer in humans; and
WHEREAS GSK desires to
obtain certain worldwide non-exclusive licenses from COLEY under
the aforesaid patents and know-how in the FIELD (as defined below),
and COLEY is willing to grant to GSK such licenses in accordance
with the provisions set forth herein.
NOW, THEREFORE, in
consideration of the covenants and obligations expressed herein and
for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, and intending to be
legally bound the parties agree as follows:
1. DEFINITIONS
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1.01 |
“ADDITIONAL ADJUVANT” shall mean any and all
compounds, compositions, components or formulation of components
other than ADJUVANT included in PRODUCT or COMBINATION (provided
ADDITIONAL ADJUVANT is contained in
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Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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the vials, containers or
other administration devices referred to in Section 1.26), used to
induce, augment, fine-tune or enhance an ANTIGEN specific immune
response of PRODUCT or COMBINATION on top of the response already
induced, augmented, fine-tuned or enhanced by ADJUVANT in the
PRODUCT or COMBINATION.
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1.02 |
“ADJUVANT” shall mean (i) COLEY motifs and COLEY
oligonucleotides containing immunostimulatory unmethylated cytosine
guanine dinucleotides and (ii) any and all compounds or
compositions, whether produced naturally or by semisynthetic or
synthetic means, alone or in admixture with another material
(excluding “ADDITIONAL ADJUVANT”), in a suitable
vehicle which is used to induce, augment, fine-tune or enhance an
ANTIGEN specific immune response and which is covered by, or made
with the use of TECHNOLOGY. For the avoidance of doubt an
oligonucleotide that does not induce, augment, fine-tune or enhance
an ANTIGEN specific immune response is not an ADJUVANT for the
purpose of the Agreement. |
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1.03 |
“AFFILIATE(S)” shall mean any corporation, firm,
partnership or other entity, whether de jure or de
facto , which directly or indirectly owns, is owned by
or is under common ownership with a party to this Agreement to the
extent of at least fifty percent (50%) of the equity (or such
lesser percentage which is the maximum allowed to be owned by a
foreign corporation in a particular jurisdiction) having the power
to vote on or direct the affairs of the entity and any person,
firm, partnership, corporation or other entity actually controlled
by, controlling or under common control with a party to this
Agreement. |
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1.04 |
“ANNUAL NET SALES VALUE” shall mean NET SALES VALUE
of PRODUCTS and/or COMBINATIONS in a calendar year. |
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1.05 |
“ANTIGEN” shall mean any active ingredient such as
(but not limited to) live attenuated micro-organisms, whole killed
micro-organisms or subunit vaccines (e.g. polysaccharides,
polysaccharide conjugates, peptides, recombinant proteins,
glycolipids), that elicits an ANTIGEN specific immune response.
ANTIGENS exclude antigens which are nucleic acids expressed in vivo
following introduction of an encoded gene. |
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1.06 |
“BENEFIT” shall mean that: |
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1) |
the protective and/or therapeutic response to an ANTIGEN is
improved (e.g. increased) or; |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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2) |
the dosage of such an ANTIGEN is decreased (i.e. lesser dose
needed) or; |
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3) |
the schedule of immunization or route of administration with
such ANTIGEN is improved (e.g. lower number of
inoculations). |
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1.07 |
“BROAD FIELD OF USE claim” shall mean a claim in
existing PATENTS which as mutually agreed between both parties,
provides an enforceable monopoly right which can be used to
effectively prevent a THIRD PARTY (other than the other
non-exclusive licensee(s)) from developing, using, making or
marketing in the FIELD any product comprising a LICENSED ANTIGEN(S)
in combination with any immunostimulatory oligonucleotide intended
for use in humans containing an unmethylated cytosine guanine
dinucleotide. In the event of any dispute between the parties as to
whether a claim is a BROAD FIELD OF USE claim, such dispute shall
be resolved in accordance with Section 15.02. |
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1.08 |
[deliberately left blank] |
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1.09 |
“COMBINATION” shall mean - subject to Section 1.26
— any and all pharmaceutical compositions covered by a single
PRODUCT LICENSE and approved under such PRODUCT LICENSE for the
sole purpose of PROPHYLACTIC IMMUNIZATION or THERAPEUTIC
IMMUNIZATION in the FIELD consisting of: |
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(i) |
PRODUCT in (a) vial(s) or other containers or administration
devices which is (are) administered concomitantly with |
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(ii) |
LICENSED ANTIGEN(S) in (a) vial(s) or other containers or
administration devices which is(are) not adjuvanted with
ADJUVANT, |
provided that either (x) no
PRODUCT LICENSE exists for such LICENSED ANTIGEN(S) contained in
the vial(s) or other containers or administration devices under
(ii) above which limits the use of such LICENSED ANTIGEN(S) to
exclusive concomitant administration either with ADJUVANT or with
PRODUCT under (i) above or with any or certain adjuvants (including
but not limited to ADJUVANT), or (y) COLEY is unable to provide
evidence that ADJUVANT as part of PRODUCT referred to under (i)
above has provided a BENEFIT to the LICENSED ANTIGEN(S) referred to
in (ii) above and which is beyond and above the BENEFIT provided by
adjuvants other than ADJUVANT (contained in the same vials or other
containers or administration devices as LICENSED ANTIGEN(S)
referred to under (ii) above) to such LICENSED ANTIGEN(S). If
either such a PRODUCT LICENSE referred to in (x) exists
or
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
COLEY is able to provide the
evidence in (y), then the combination of (i) and (ii) shall be a
PRODUCT, not a COMBINATION.
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1.10 |
“COMPOSITION OF MATTER claim” shall mean a claim
which provides an enforceable monopoly right that can be used to
effectively prevent a THIRD PARTY (other than other non-exclusive
licensee(s)) from developing, using, making or marketing any
product in the FIELD for use in humans comprising a LICENSED
ANTIGEN which GSK has incorporated into PRODUCT in combination with
an ADJUVANT which GSK has incorporated into such PRODUCT which is
in preclinical or clinical testing or on the market. In the event
of any dispute between the parties as to whether a claim is a
COMPOSITION OF MATTER claim, such dispute shall be resolved in
accordance with Section 15.02. |
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1.11 |
“CONFIDENTIAL INFORMATION” shall mean any
information, data, patents, documents, memoranda, reports,
correspondence, drawings, clearly marked as CONFIDENTIAL and
exchanged between both parties under this Agreement. Information
disclosed orally must be reduced to writing and marked CONFIDENTIAL
within thirty (30) days of the disclosure to be considered as
CONFIDENTIAL INFORMATION. |
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1.12 |
“DISPUTED PATENT” shall mean University of Iowa
Research Foundation US patent application No WO 96/02555 claiming
priority to U.S. patent application Serial Number 08/276,358 dated
15/7/94 and all divisions and continuations of this application,
all patents issuing from such applications, any reissues,
reexaminations and extensions of all such patents and all foreign
counterparts of the foregoing, and any other claim pertaining to
any PATENT which has been made in writing by THIRD PARTIES on or
before December 18, 1998 or during the EVALUATION PERIOD (as
defined in the License Agreement - Infectious Diseases dated
December 18, 1998 (as amended by Amendment No. 1 dated December 18,
1999) and which may adversely affect GSK’s rights
hereunder. |
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1.13 |
“DNA VACCINE” shall mean a pharmaceutical
composition for PROPHYLACTIC IMMUNIZATION or THERAPEUTIC
IMMUNIZATION against cancers in humans, wherein the ANTIGEN
(including LICENSED ANTIGEN(S)) is encoded in nucleic acid and
expressed in vivo following introduction of the nucleic
acid. |
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1.14 |
“EFFECTIVE DATE” shall mean, notwithstanding the
date this Agreement is executed, 13 December 2001. |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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1.15 |
“ESCROW” shall mean an account of GSK opened at a
UK bank from which no amounts can be withdrawn other than by mutual
consent of both parties or from which amounts can be released in
accordance with the provisions of Section 3.06. |
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1.16 |
“FIELD” shall mean the use of ADJUVANT in
combination with LICENSED ANTIGEN(S) as part of a PRODUCT and/or
COMBINATION for the purpose of inducing, augmenting, fine-tuning or
enhancing in vivo, in vitro or ex vivo of an ANTIGEN specific
immune response and in all cases for PROPHYLACTIC IMMUNIZATION
and/or THERAPEUTIC IMMUNIZATION against LICENSED CANCERS in humans,
excluding SPECIFIC FIELD. |
It is understood however that
FIELD shall include the use of ADJUVANT in combination with
LICENSED ANTIGEN(S) in the same vial regardless of whether
ADDITIONAL ADJUVANT has been formulated in the same vial. Subject
to Section 2.03, nothing shall prevent the use of PRODUCT and/or
COMBINATION in the FIELD in conjunction with ANTIGENS for use
outside the FIELD, provided that GSK shall not develop and/or
register a product which combines such other ANTIGENS in the same
vial, container or other means of administration with ADJUVANT
(whether alone or formulated with LICENSED ANTIGEN(S)) and shall
not seek a product license for such other ANTIGENS to be
administered concomitantly with ADJUVANT (whether as part of
PRODUCT or COMBINATION or alone), PRODUCT or COMBINATION, unless
such other ANTIGEN is not derived from or is not specifically
expressed in a particular cancer form but is broadly expressed in
or present in solid tumor cancers including a LICENSED CANCER (e.g.
such other ANTIGEN is associated with angiogenisis or tumor
invasion mechanism) in which case product license for concomitant
use and administration of such other ANTIGEN with ADJUVANT as part
of PRODUCT or COMBINATION will be deemed within the
FIELD.
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1.17 |
“FIRST LICENSED ANTIGEN” shall have the meaning set
forth in Section 1.20 below. |
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1.18 |
“INFRINGE” or “INFRINGED” or
“INFRINGEMENT” shall mean that on a country per country
basis, a THIRD PARTY (other than COLEY or its other non-exclusive
licensee(s)) has filed a PLA for a product claimed by COLEY PATENT
claims or is commercially manufacturing, commercially using or
importing such a product, provided, however, that if COLEY can
demonstrate that COLEY is, within a six (6)
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Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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month period following
such PLA filing of the THIRD PARTY product, actively negotiating
with such THIRD PARTY a license in order to avoid INFRINGEMENT of
the PATENT in all countries where such INFRINGEMENT exists and
successfully enters into such license agreement, no INFRINGEMENT
shall be deemed to exist or have existed. Failing to do so,
INFRINGEMENT is deemed to exist as from the end of such six (6)
month period. Notwithstanding the foregoing, in case of sale of
such THIRD PARTY product and absent execution of the license
agreement referred to above, INFRINGEMENT shall be deemed to
exist.
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1.19 |
“KNOW-HOW” shall mean all present and future
technical information, materials and know-how which relate to
ADJUVANT and which are now and/or at any time during the term of
this Agreement developed, owned, proprietary to and/or controlled
by COLEY and/or any AFFILIATES of COLEY and under which COLEY has
now, or in the future, the right to grant licenses or sublicenses,
and which are necessary for or useful to the development,
production and commercialization of ADJUVANT within the FIELD.
KNOW-HOW shall include, without limitation, all chemical,
pharmacological, toxicological, clinical, assay, control and
manufacturing data and any other information relating thereto and
any materials, seeds, strains, reagents and media. KNOW-HOW shall
not include PATENTS. A summary of KNOW-HOW is described in Appendix
B. In all events KNOW-HOW shall be secret and substantial or
contained in a PATENT or PATENT application in any country or
described in Appendix B. |
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1.20 |
“LICENSED ANTIGEN” shall mean any ANTIGEN expressed
in LICENSED CANCER for which a license to use ADJUVANT with such
ANTIGENS is granted to GSK hereunder for the use specified in
Section 2 as part of PRODUCT and/or COMBINATION in which ADJUVANT
induces, augments, fine-tunes or enhances the ANTIGEN specific
immune response of such LICENSED ANTIGEN. For the avoidance of
doubt, LICENSED ANTIGEN shall refer to any and all ANTIGENS which
are expressed in LICENSED CANCER, it being understood however that
a maximum of three (3) LICENSED CANCER are the subject matter of
the license granted hereunder. In this context “FIRST
LICENSED ANTIGEN” refers to any and all ANTIGENS which are
expressed in the LICENSED CANCER: Breast Cancer, “SECOND
LICENSED ANTIGEN” refers to any and all ANTIGENS which are
expressed in the LICENSED CANCER: Prostate Cancer, and “THIRD
LICENSED ANTIGEN” refers to any and all ANTIGENS which are
expressed in LICENSED CANCER: Lung Cancer. |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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1.21 |
“LICENSED CANCER” shall mean any of the three
licensed cancers listed in Section 2.01 for which a license to use
ADJUVANT with LICENSED ANTIGEN(S) expressed in such cancer, is
granted to GSK pursuant to Section 2. |
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1.22.I. |
“NET SALES VALUE” shall mean the gross receipts
from sales of PRODUCT and/or COMBINATION in the TERRITORY by GSK
and/or its AFFILIATES to THIRD PARTIES less the following amounts
actually paid or allowed by GSK and/or its AFFILIATES with respect
to such sales: |
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(i) |
transportation charges, including insurance; and |
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(ii) |
GSK’s standard costs for syringes and other
administration devices combined with or contained in commercial
packaging; and |
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(iii) |
sales and excise taxes and duties levied on the sale or
delivery of PRODUCT and/or COMBINATION and contributions and
payments required by any governmental authorities as liability
provisions and/or made pursuant to injury compensation schemes
and/or as product liability insurance premiums; and |
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(iv) |
trade and quantity and cash discounts, governmentally required
commissions and other customary rebates; and |
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(v) |
allowances or credits to customers or charges back from
customers on account of rejection or return of PRODUCT and/or
COMBINATION subject to royalty under this Agreement or on account
of retroactive price reductions affecting such PRODUCT and/or
COMBINATION; and |
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(vi) |
royalties payable and/or paid by GSK and/or its AFFILIATES to
THIRD PARTIES on the manufacture, use and/or sale of PRODUCT and/or
COMBINATION for the use in the FIELD of technology not encompassed
within TECHNOLOGY and which is not the subject of the offset set
forth in Section 4 hereof, and provided that deductions under this
heading (vi) shall not exceed [****] percent ([*]%) of gross
receipts from sales of PRODUCT and/or COMBINATION on which such
royalty is payable hereunder in the TERRITORY by GSK and/or its
AFFILIATES. |
Sales between or among GSK
and its AFFILIATES shall be excluded from the computation of NET
SALES VALUE except where such AFFILIATES are end users, but NET
SALES VALUE shall include the subsequent final sales to THIRD
PARTIES by such AFFILIATES.
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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1.22.II. |
In the case of any COMBINATION, NET SALES VALUE
of COMBINATION shall be calculated as follows: |
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(i) |
By multiplying the NET SALES VALUE of the COMBINATION by the
fraction A/A + B, where subject to the definition set forth in
Sections 1.09 and 1.26, A is the gross selling price, during the
royalty period in question, of PRODUCT(S) contained in the vials or
other containers or administration devices referred to in Section
1.09(i), when sold separately; and B is the gross selling price,
during the royalty period in question, of product(s) contained in
the vials or other containers or administration devices referred to
in Section 1.09 (ii), when sold separately; or |
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(ii) |
In the event that no such separate sales are made of such
components of such COMBINATION during the royalty period in
question, NET SALES VALUE, for the purposes of determining royalty
payments, shall be calculated using the above formula under (i)
where A is the reasonably estimated commercial value of the
PRODUCT(S) contained in the vials or other containers or
administration devices referred to in Section 1.09(i) above, when
sold separately, and B is the reasonably estimated commercial value
of the other product(s) contained in the vials or other containers
or administration devices referred to in Section 1.09(ii) above,
when sold separately. Any such estimates shall be determined using
criteria to be mutually agreed upon by the parties. Such estimates
shall be reported to COLEY with the reports to be provided to COLEY
pursuant to Section 10.02 hereof. |
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(iii) |
If the parties cannot agree on any estimates as set forth in
(ii) above, the matter shall be resolved pursuant to the provisions
of Sections 15.02 and 15.03. |
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(iv) |
In the event no reasonable commercial value can be attributed
to the separate components of COMBINATION under paragraphs (ii) and
(iii) above, the following formula shall apply: NET SALES VALUE
shall be multiplied by the formula x/y in which x is the total
number of LICENSED ANTIGEN contained in the vials or other
containers or administration devices referred to in Section 1.09(i)
and Y is the total number of ANTIGENS (including LICENSED ANTIGEN)
contained in COMBINATION. |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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1.23 |
“OPTION AGREEMENT” shall mean the Option Agreement
dated December 18, 1998 and its Amendment no. 1 dated March 14,
2000 entered into by and between the parties hereto. |
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1.24 |
“OTHER PATENTS” shall mean patents and/or patent
applications owned and/or controlled by THIRD PARTIES having claims
which would be infringed by GSK developing, having developed,
making, having made, using, having used, selling or having sold
ADJUVANT as part of PRODUCT and/or COMBINATION. |
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1.25 |
“PATENT(S)” shall mean all patents and patent
applications which are or become owned and/or controlled, in whole
or in part, by COLEY and/or any AFFILIATES of COLEY including
patents and patent applications claiming inventions made by COLEY
under which COLEY has, now or in the future, the right to grant
licenses or sublicenses and which generically or specifically claim
ADJUVANT and/or use of ADJUVANT and/or a process for manufacturing
ADJUVANT, and/or intermediates used in such process, and which are
useful in the FIELD. Included within the definition of PATENTS are
any continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions including SPC’s
thereof. Also included within the definition of PATENTS are any
patents or patent applications which generically or specifically
claim or have claims covering any improvements of ADJUVANT or
intermediates or manufacturing processes required or useful for
production of ADJUVANT which are developed by COLEY, and/or under
which COLEY otherwise has the right to grant licenses or
sublicenses, now or in the future, during the term of this
Agreement and in all cases which relate to the FIELD. The list of
patents and patent applications encompassed within PATENTS on the
EFFECTIVE DATE is set forth in Appendix A attached hereto. PATENTS
shall consist of five groups: “IOWA PATENTS” listed in
Section 1 of Appendix A, “LOEB PATENTS” listed in
Section 2 of Appendix A, “ISIS PATENTS” listed in
Section 3 of Appendix A, “PHS PATENTS” listed in
Section 5 of Appendix A and “COLEY PATENTS” which shall
include all PATENTS listed in Section 4 and all other PATENTS not
listed in Section 1, 2, 3 or 5 of Appendix A. |
[Each Section will list
present patents and applications and will be updated to include all
future patents and applications licensed to COLEY in the FIELD
under the relevant agreement or will be updated to include those
resulting from developments or inventions made by COLEY in the
FIELD. Future patents and
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
patent application in the
FIELD licensed by COLEY which are not IOWA PATENTS, LOEB PATENTS or
ISIS PATENTS shall be considered as COLEY PATENTS for the purpose
of updating Appendix A.]
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1.26 |
“PRODUCT” shall mean any and all pharmaceutical
compositions for PROPHYLACTIC IMMUNIZATION and/or THERAPEUTIC
IMMUNIZATION in the FIELD comprising (or including the
administration of) one or more of the LICENSED ANTIGENS in
combination with ADJUVANT as an ingredient or component in any
formulation, configuration, combination and/or delivery system, in
which ADJUVANT induces, augments, fine-tunes or enhances the
ANTIGEN specific immune response of any of such LICENSED ANTIGEN(S)
contained within PRODUCT. Subject to the above, it is explicitly
understood that PRODUCT shall include: |
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(i) |
a PRODUCT in (a) vial(s) or other containers or administration
devices, all of which contain LICENSED ANTIGEN(S), combined with
ADJUVANT and which may be adjuvanted with ADDITIONAL
ADJUVANTS. |
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(ii) |
a PRODUCT as defined in (i) above which is administered
concomitantly with a product in (a) vial(s) or other containers or
administration devices, all of which contain LICENSED ANTIGEN(S)
which are not adjuvanted with ADJUVANT (the latter product
hereinafter being referred to as “NON ADJUVANTED
PRODUCT”) provided that either: |
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(ii) (x) |
the PRODUCT
LICENSE issued by the regulatory authorities limits the use of NON
ADJUVANTED PRODUCT to exclusive concomitant administration only
(except as set forth in the proviso in this sentence) with ADJUVANT
or with PRODUCT as defined under (i) above regardless of whether
NON ADJUVANTED PRODUCT is administered concomitantly in the same
lymphnode as ADJUVANT or PRODUCT defined under (i) above, or not;
provided that if the PRODUCT LICENSE limits the use to exclusive
concomitant administration of NON ADJUVANTED PRODUCT with any or
certain adjuvants (including but not limited to ADJUVANT) or with
(a) product(s) which (all) contain(s) LICENSED ANTIGEN(S) and any
or certain adjuvants (including but not limited to ADJUVANT), then
a portion of the NON ADJUVANTED PRODUCT shall be treated as
PRODUCTS and the parties shall determine the number of PRODUCTS to
be so treated as follows: based on IMS data and sales data provided
by GSK for the same period (which may be
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Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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audited by COLEY at
COLEY’s expense) for the sales of (a) vials or other
containers or administration devices containing LICENSED ANTIGEN(S)
and ADJUVANT on the one hand and (b) vials or other containers or
administration devices containing LICENSED ANTIGEN(S) and the
certain adjuvants other than ADJUVANT on the other hand, the number
of NON ADJUVANTED PRODUCTS shall be distributed pro rata between
(x) PRODUCTS, and (y) products consisting of LICENSED ANTIGEN(S)
and an adjuvant other than ADJUVANT.
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or:
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(ii)(y)
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even if
there is no such restriction in the PRODUCT LICENSE for NON
ADJUVANTED PRODUCT as provided for under (ii) (x) above, COLEY is
able to demonstrate that NON ADJUVANTED PRODUCT which is adjuvanted
with adjuvant(s) other than ADJUVANT BENEFITS from ADJUVANT
contained in PRODUCT defined in (i) above and such BENEFIT is
beyond and above the BENEFIT provided by adjuvants contained in NON
ADJUVANTED PRODUCT. |
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1.27 |
“PRODUCT LICENSE” means the receipt of all
necessary approvals from the relevant regulatory authority for the
sale of PRODUCT or COMBINATION. |
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1.28 |
“PROPHYLACTIC IMMUNIZATION” shall mean the use of
PRODUCT or COMBINATION to immunize humans with no diagnosed
relevant disease. |
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1.29 |
“SECOND LICENSED ANTIGEN” shall have the meaning
set forth in Section 1.20 above. |
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1.30 |
“SIGNIFICANT COMPETITION” shall mean on a
country-per-country and PRODUCT-per-PRODUCT basis including
COMBINATIONS, the marketing by a THIRD PARTY (other than COLEY or
its other non-exclusive licensee(s)) of a competing product
(including a combination) in the FIELD which utilizes unmethylated
cytosine guanine dinucleotides as adjuvant in combination with
LICENSED ANTIGEN(S) licensed hereunder, to the extent such
competitor has achieved a market share of [******] percent ([**]%)
or more or has doubled the market share it had achieved in the
previous year from a base market share of at least [****]
percent. |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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1.31 |
“SPC” shall mean all Supplementary Protection
Certificates for medicinal products and their equivalents provided
under the Council Regulation (EEC) N° 1768/92 of June 18,
1992. |
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1.32 |
“SPECIFIC FIELD” shall mean without limitation the
use of ADJUVANT (i) in combination with DNA VACCINES or (ii) other
than in combination with a LICENSED ANTIGEN and independently from
a LICENSED ANTIGEN or (iii) in combination with antibodies in
passive immunotherapy applications when not combined with a tumor
ANTIGEN; or (iv) in all non ANTIGEN specific ex vivo applications
or (v) for all purposes other than eliciting, inducing, augmenting,
fine-tuning or enhancing an ANTIGEN-specific immune
response. |
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1.33 |
“TECHNOLOGY” shall mean KNOW HOW and/or
PATENTS. |
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1.34 |
“TERRITORY” shall mean all the countries and
territories in the world. |
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1.35 |
“THERAPEUTIC IMMUNIZATION” shall mean the use of
PRODUCT or COMBINATION to treat humans with diagnosed relevant
disease. |
| |
1.36 |
“THIRD LICENSED ANTIGEN” shall have the meaning set
forth in Section 1.20 above. |
| |
1.37 |
“THIRD PARTY(IES)” shall mean any party which is
neither a party to this Agreement nor an AFFILIATE. |
| |
1.38 |
“VALID CLAIM” shall mean a claim subsisting in a
patent or in a pending patent application, being a claim that has
not finally been canceled, revoked or held invalid by a final
decision of a court or other authority having jurisdiction to
decide the issue. A final decision in this context means a decision
which has become legally binding either because no appeal has been
taken and the time for appeal has expired, or because any appeal
taken is no longer pending, leaving the decision of cancellation,
revocation or invalidation standing without possibility of further
appeal. |
For the purpose of this
Agreement, except as otherwise expressly provided in this Agreement
or unless the context otherwise requires: (a) defined terms include
the plural as well as the singular and the use of any gender shall
be deemed to include the other gender; (b) references to
“Articles”, “Sections” and other
subdivisions and to “Schedules” without reference to a
document, are to designated Articles, Sections and other
subdivisions of, and to Schedules to, this Agreement; (c) the use
of the term “including” means “including but
not
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
limited to”; and (d)
the words “herein”, “hereof”,
“hereunder” and other words of similar import refer to
this Agreement as a whole and not to any particular
provisions.
| |
2.01 |
(a) In consideration of the obligations assumed by GSK
hereunder and subject to the terms and conditions of this
Agreement, as of the EFFECTIVE DATE COLEY hereby grants to GSK and
to any AFFILIATES of GSK a non-exclusive license under TECHNOLOGY
to develop, have developed, make, have made, use, have used, sell,
offer for sale, have sold, keep and/or import in the TERRITORY and
in the FIELD any PRODUCTS and/or COMBINATIONS in any formulation,
composition or delivery systems (including without limitation
ADJUVANTS for use as part of PRODUCTS and/or COMBINATION) which
contain any of the following two LICENSED ANTIGENS: |
| |
• |
|
Any and all ANTIGENS expressed in Prostate
Cancer |
| |
• |
|
Any and all ANTIGENS expressed in Breast
Cancer. |
(b) In further consideration
of the obligations assumed by GSK hereunder and subject to the
terms and conditions of this Agreement, as of May 22, 2002 COLEY
hereby grants to GSK and to any AFFILIATES of GSK a non-exclusive
license under TECHNOLOGY to develop, have developed, make, have
made, use, have used, sell, offer for sale, have sold, keep and/or
import in the TERRITORY and in the FIELD any PRODUCTS and/or
COMBINATIONS in any formulation, composition or delivery systems
(including without limitation ADJUVANTS for use as part of PRODUCTS
and/or COMBINATION) which contain the following LICENSED
ANTIGENS:
| |
• |
|
Any and all ANTIGENS expressed in Lung
Cancer. |
| |
2.02 |
GSK, and GSK alone, may choose to exclude from the license
granted under Section 2.01 the IOWA PATENTS, the LOEB PATENTS, PHS
PATENTS or the ISIS PATENTS. |
| |
2.03 |
The license
granted hereby shall not include the right to sell ADJUVANT except
when included in a vial or other container or administration device
containing at least one LICENSED ANTIGEN as part of PRODUCT or
COMBINATION. Subject to the definition of FIELD set forth in
Section 1.16, the license granted by this Section shall not include
the right to develop, have developed, make, have made,
|
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| |
use, have used, sell, have
sold, keep and/or import any product for use in any cancer or
disease other than a LICENSED CANCER. GSK agrees that it will not
seek a PRODUCT LICENSE to sell any PRODUCT or COMBINATION for any
cancer or disease other than a LICENSED CANCER and will not promote
any PRODUCT or COMBINATION for any use other than for a LICENSED
CANCER. For the sake of clarity, nothing in this Agreement shall be
construed by any means as a limitation of GSK’s rights
pursuant to the License Agreement-Infectious Diseases dated
December 18, 1998 (as amended by Amendment No. 1 dated December 18,
1999).
|
| 3. |
LICENSE FEES, PATENT GRANT FEES, MILESTONE PAYMENTS AND
ROYALTIES |
| |
3.01. |
(a) In consideration of PATENTS and KNOW-HOW resulting from the
use of the research performed by COLEY prior to the EFFECTIVE DATE
and the right to use pre-clinical information developed by COLEY
prior to the EFFECTIVE DATE, the parties acknowledge and agree that
GSK has paid COLEY a non-refundable license fee in the amount of
one (1) million US dollars ($1,000,000 US$) for each of the FIRST
LICENSED ANTIGEN and SECOND LICENSED ANTIGEN, which payments were
received by COLEY prior to the execution of this
Agreement. |
(b) In further consideration
of PATENTS and KNOW-HOW resulting from the use of the research
performed by COLEY prior to the EFFECTIVE DATE and the right to use
pre-clinical information developed by COLEY prior to the EFFECTIVE
DATE, GSK shall pay once only for the THIRD LICENSED ANTIGEN the
following non-refundable License Fee to COLEY: two million US
dollars (2,000,000 US$), which shall be paid within five (5)
working days of the execution of the present Agreement by the last
party hereto.
(c) The above referenced
License Fees shall be allocated among the IOWA PATENTS, LOEB
PATENTS, ISIS PATENTS, PHS PATENTS, COLEY PATENTS and KNOW HOW as
follows:
For each of the FIRST
LICENSED ANTIGEN and the SECOND LICENSED ANTIGEN :
|
|
|
|
IOWA PATENTS:
|
|
[*******] US$ |
|
LOEB PATENTS:
|
|
[*******] US$ |
|
ISIS PATENTS:
|
|
[******] US$ |
|
PHS PATENTS:
|
|
[******] US$ |
|
COLEY PATENTS:
|
|
[*******] US$ |
|
KNOW HOW:
|
|
[******] US$ |
TOTAL: 1,000,000 US$ for each
of the FIRST and SECOND LICENSED ANTIGENS
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
For the THIRD LICENSED
ANTIGEN :
|
|
|
|
|
IOWA PATENTS:
|
|
[ |
*******] US$ |
|
LOEB PATENTS:
|
|
[ |
*******] US$ |
|
ISIS PATENTS:
|
|
[ |
*******] US$ |
|
PHS PATENTS:
|
|
[ |
*******] US$ |
|
COLEY PATENTS:
|
|
[ |
*******] US$ |
|
KNOW HOW:
|
|
[ |
*******] US$ |
TOTAL: 2,000,000 US$ for the
THIRD LICENSED ANTIGEN
In the event GSK elects to
exclude any of the above groups of PATENTS from its license for any
LICENSED CANCER and the related LICENSED ANTIGEN pursuant to
Section 2.02, the License Fee will be reduced by the amount set
forth above for such group of PATENTS.
| |
3.02 |
(a) GSK shall pay once only for the FIRST LICENSED
ANTIGEN and once only for the SECOND LICENSED ANTIGEN and once only
for the THIRD LICENSED ANTIGEN the following milestone payments to
COLEY upon the first achievement of the following development
milestones for the first PRODUCTS or COMBINATIONS containing such
LICENSED ANTIGENS: |
| |
1. |
Initiation of first phase 1 clinical trial in the USA, Canada
or Europe: |
For each of the FIRST and
SECOND LICENSED ANTIGENS: [*********************] US dollars
([*******] US$); and
For the THIRD LICENSED
ANTIGEN: [***********] US dollars ([*********] U.S. $).
| |
2. |
Initiation of phase II clinical trial in the USA, Canada or
Europe: |
For each of the FIRST and
SECOND LICENSED ANTIGENS: [*********************] US dollars
([*******] US$); and
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
For the THIRD LICENSED
ANTIGEN: [***********] U.S. dollars ([*********] U.S.
$).
| |
3. |
Initiation of phase Ill clinical trial in the USA, Canada or
Europe: |
For each of the FIRST and
SECOND LICENSED ANTIGENS: [*********************************] U.S.
dollars ([*********] US$)
For the THIRD LICENSED
ANTIGEN: [**************] U.S. dollars ([*********] U.S.
$).
| |
4. |
Submission and acceptance for regulatory review for marketing
approval of PRODUCT or COMBINATION to the appropriate regulatory
agency in USA: |
For each of the FIRST and
SECOND LICENSED ANTIGENS: [*********************************] U.S.
dollars ([*********] US$); and
For the THIRD LICENSED
ANTIGEN: [**************] U.S. dollars ([*********]
U.S.$).
| |
5. |
Submission and acceptance for regulatory review for marketing
approval of PRODUCT or COMBINATION to the appropriate regulatory
agency in Europe (as defined below): |
For each of the FIRST and
SECOND LICENSED ANTIGENS[***********************************] U.S.
dollars ([*********] US$); and
For the THIRD LICENSED
ANTIGEN: [**************] U.S. dollars ([*********]
U.S.$).
| |
6. |
Marketing approval of PRODUCT or COMBINATION by the FDA in the
USA: |
For each of the FIRST and
SECOND LICENSED ANTIGENS: [**************] U.S. dollars
([*********] U.S.$).
For the THIRD LICENSED
ANTIGEN: [***********] U.S. dollars ([*********] U.S.$).
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| |
7 |
License Maintenance Fee: GSK shall pay a license maintenance
fee for the first PRODUCT and/or COMBINATION only in the amount of:
(a) [******************************] US dollars ([*******] US$) per
year for each of the FIRST LICENSED ANTIGEN and the SECOND LICENSED
ANTIGEN, and (b) [*********************] US dollars ([*******] US$)
per year for the THIRD LICENSED ANTIGEN, each as from the fourth
anniversary of the initiation of a successful pivotal phase Ill
clinical trial in Europe, USA or Canada until the moment the first
marketing approval for such PRODUCT or COMBINATION is obtained in
Europe, USA or Canada, whichever is the first. For the avoidance of
doubt, no such license maintenance fee shall be due if PRODUCT or
COMBINATION is registered in Europe, USA or Canada prior to such
fourth anniversary of the initiation of pivotal phase III clinical
trial in Europe, USA or Canada. |
If any milestone is reached
without achieving a preceding milestone, then the amount which
would have been payable on achievement of the preceding milestone
shall be payable upon achievement of the following milestone. For
example, if a PRODUCT relating to the FIRST or SECOND LICENSED
ANTIGEN is submitted and accepted for regulatory review for
marketing approval on the basis of a Phase II trial without
conducting a Phase III trial, then a total of [*********] US$ will
be due upon such submission and acceptance ($[*********] for such
submission and acceptance and $[*********], which would have become
payable upon the initiation of Phase III). If any milestone has
been reached prior to execution of this Agreement, the milestone
payment for such milestone shall be paid upon execution of this
Agreement.
| |
3.03 |
In Section 3.02 the following terms shall have the meanings
defined below: |
“Initiation” for
the purpose of Phase 1 clinical trial, Phase 2 clinical trial and
Phase 3 clinical trial shall mean that the following activities
have been carried out for the purpose of a given phase: the
clinical lots have been released, GSK’s Corporate Safety
Board has approved the trial, the principal investigator has signed
the clinical study protocol and the ethical review board and the
relevant authorities have approved the clinical trial protocol for
such phase.
“Phase I clinical
trial” means that PRODUCT or COMBINATION is administered in a
clinical trial in order to investigate safety and immunogenicity of
PRODUCT and/or COMBINATION in humans;
“Phase II clinical
trial” means that PRODUCT or COMBINATION is administered
in
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
a second clinical trial which
after successful completion of phase I clinical trial, which is
designated to evaluate efficacy and immunogenicity of PRODUCT of
the exact same composition as the one tested successfully in the
Phase I trial;
“Phase Ill clinical
trial” means that PRODUCT and/or COMBINATION is administered
to subjects in a pivotal clinical trial for which regulatory
authorization has been obtained as a result of the ‘Filing
for Phase III’ or the date that GSK has been convinced to its
satisfaction that the FDA has determined that data produced during
Phase II clinical trials is sufficient to support filing of a PLA
without any data from Phase III clinical trials.
“Europe” means
that the regulatory agency is the EMEA/CPMP (centralized procedure)
or, in the event that the decentralized procedure is followed, that
the procedure encompasses more than two major countries chosen from
UK, Spain, France, Germany and Italy.
| |
3.04 |
No milestone payment for a given milestone shall be due for any
subsequent PRODUCT and/or COMBINATION which targets a given
LICENSED CANCER if the same milestone set forth in Section 3.02 for
a PRODUCT and/or COMBINATION which targets such LICENSED CANCER has
been previously paid by GSK pursuant to Section 3.02. |
| |
3.05 |
[*****] percent of the marketing approval milestone
payments set forth in Section 3.02 point 6 for PRODUCTS and/or
COMBINATIONS for a given LICENSED CANCER are creditable against
current and future royalties owed pursuant to Sections 3.06 and
3.09 on the account of sales of PRODUCTS and/or COMBINATIONS
registered for such LICENSED CANCER and the license maintenance fee
set forth in Section 3.02 point 7 for a given LICENSED CANCER shall
be fully creditable against current and future royalties owed
pursuant to Sections 3.06 and 3.09 on the account of sales of
PRODUCTS and/or COMBINATIONS registered for such LICENSED CANCER,
provided that such credits shall not cause the royalties otherwise
payable in any one calendar quarter to be reduced by more than
[*****] percent ([**]%). However, any uncredited balance of
creditable milestone payments will be carried forward to any
following calendar quarter. |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| |
3.06.I |
As consideration for the license under PATENTS granted to GSK
under this Agreement and subject to Sections 3.07 and 4, GSK shall
pay to COLEY the following royalties (“Patent Royalty”)
on NET SALES VALUE of PRODUCTS and/or COMBINATIONS registered for a
LICENSED CANCER where ADJUVANT (which is part of PRODUCT or
COMBINATION), PRODUCT or COMBINATION is covered by: |
| |
A.1. |
a “BROAD FIELD OF USE” claim in a PATENT issued in
the country where the PRODUCT and/or COMBINATION is
sold: |
On the portion of ANNUAL NET
SALES VALUE:
up to [********************]
US dollars (<US$ [***********]):
[***] % for the FIRST and
SECOND LICENSED ANTIGEN, and
[***] % for the THIRD
LICENSED ANTIGEN;
On the portion of ANNUAL NET
SALES VALUE:
between
[********************] US dollars ( > US$ [***********])
and
[***********] US dollars
(<US$ [*************]):
[*] % for the FIRST and
SECOND LICENSED ANTIGEN,
and
[*] % for the THIRD LICENSED
ANTIGEN; and
On the portion of ANNUAL NET
SALES VALUE:
above [***********] US
dollars: ( > US$ [*************]):
[***] % for the FIRST and
SECOND LICENSED ANTIGEN, and
[****] % for the THIRD
LICENSED ANTIGEN.
| |
A.2 |
a “COMPOSITION OF MATTER” claim in a PATENT issued
in the country where the PRODUCT and/or COMBINATION is sold and not
a BROAD FIELD OF USE claim in such country: |
On the portion of ANNUAL NET
SALES VALUE:
up to [********************]
US dollars: (< US$ [***********]):
[*] % for the FIRST and
SECOND LICENSED ANTIGEN, and
[*] % for the THIRD LICENSED
ANTIGEN;
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
On the portion of ANNUAL NET
SALES VALUE:
between
[********************] US dollars ( > US$
[***********])
and [***********] US dollars
(<US$ [*************]):
[***] % for the FIRST and
SECOND LICENSED ANTIGEN,
and
[***] % for the THIRD
LICENSED ANTIGEN); and
On the portion of ANNUAL NET
SALES VALUE:
above [***********] US
dollars ( > US$ [*************]):
[***]% for the FIRST and
SECOND LICENSED ANTIGEN,
and
[***]% for the THIRD LICENSED
ANTIGEN
provided in all events under
Al and A2 above, sales of PRODUCT and/or COMBINATION are covered by
a VALID CLAIM of a granted PATENT, not subject to any ownership
dispute which materially reduces or affects any rights granted to
GSK hereunder. For the avoidance of doubt portion of ANNUAL NET
SALES VALUE shall be calculated for PRODUCTS and COMBINATIONS
registered for each LICENSED CANCER separately from those
registered for other LICENSED CANCERS. For the avoidance of doubt,
if PRODUCT or COMBINATION is covered both by a BROAD FIELD OF USE
claim in a PATENT and COMPOSITION OF MATTER claim in a PATENT, only
the applicable royalty rate under Al shall apply.
| |
3.06.II
In |
case PATENTS claiming PRODUCT and/or COMBINATION are pending
but not granted in any country such that no royalty pursuant to
Section 3.06 (I) is due, the following royalty rates shall apply
for such country: |
| |
A. |
If PRODUCTS
and/or COMBINATIONS containing LICENSED ANTIGEN(S) are claimed by a
pending BROAD FIELD OF USE claim in such PATENT: the royalty rate
under Section 3.06.I.A.2 above for COMPOSITION OF MATTER shall
apply to the NET SALES VALUE and such royalties shall be payable to
COLEY and the differential between the royalty rate for BROAD FIELD
OF USE claim under Section 3.06.1.A1 and such royalty rate for an
issued COMPOSITION OF MATTER claim, all applied to NET SALES VALUE
shall be paid by GSK into the ESCROW until the earlier of (i) the
expiration of a period of five (5) years (seven (7)
|
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| |
years in Japan after the
Effective Date of AMENDMENT 1 to the Option Agreement dated March
14, 2000 entered into between the parties (as the term
“Effective Date” is defined therein) or (ii) the PATENT
has been issued (in which case the amounts on the ESCROW account
shall be released to the benefit of COLEY) or (iii) the PATENT has
been abandoned by COLEY or revoked or otherwise invalidated (in
which case the amounts on the ESCROW account shall be released to
the benefit of GSK). Two (2) years after expiration of such five
(5) year period (Japan: seven (7) years) and provided the PATENT
has not been issued during such period, the amounts on the ESCROW
account shall be released to the benefit of GSK.
|
| |
B. |
If PRODUCTS and/or COMBINATION containing LICENSED ANTIGEN are
claimed by a pending COMPOSITION OF MATTER claim in such PATENT and
not by a pending BROAD FILE OF USE claim (as per Section 3.06.II.A
above) and |
| |
(i) |
if such PATENT has not been pending for more than five (5)
years (except Japan: seven (7) years) after the Effective Date of
AMENDMENT 1 to the Option Agreement dated March 14, 2000 entered
into between the parties (as the term “Effective Date”
is defined therein), then the royalty rate set forth under Section
3.06.I.A2 for COMPOSITION OF MATTER claim shall apply. |
| |
(ii) |
if such PATENT has been pending for more than five (5) years
(except Japan: seven (7) years) after the Effective Date of
AMENDMENT 1 to the Option Agreement dated March 14, 2000 entered
into between the parties (as the term “Effective Date”
is defined therein), then the royalty rate set forth under Section
3.09 shall apply to NET SALES VALUE. |
| |
(iii) |
if and when such PATENT is granted after such five (5) year
(except Japan: seven (7) year) period, then the royalty rate under
Section 3.06.I.A2 shall apply. |
| |
3.06.III.A. |
In case
PATENTS claiming PRODUCT and/or COMBINATION are pending but not
granted such that no Royalty Rate pursuant to Section 3.06.I is due
and any such PATENT is being INFRINGED, (as long as
INFRINGEMENT
|
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| |
exists), the royalty rate
under Section 3.09 shall apply to NET SALES VALUE in such country
(or countries), except as set forth in Section 3.06.III.C
below.
|
| |
B. |
Provided and as long as the relevant claim of such PATENT which
is being INFRINGED has been pending for no more than five (5) years
(Japan: seven (7) years) from the Effective Date of AMENDMENT 1 to
the Option Agreement dated March 14, 2000 entered into between the
parties (as the term “Effective Date” is defined
therein): the differential between the royalty rate for COMPOSITION
OF MATTER claim under Section 3.06.I.A2 and the royalty rate under
Section 3.09 applied to NET SALES VALUE in such country (or
countries) shall be paid into ESCROW until: |
| |
(i) |
a final decision of a court or other legal or administrative
tribunal from which no appeal is or can be taken upholds the
validity and enforceability of such PATENTS, or product
registration of the THIRD PARTY infringer is withdrawn, in which
case the amounts on the ESCROW account shall be released to the
benefit of COLEY; |
| |
(ii) |
a final decision of a court or other legal or administrative
tribunal from which no appeal is or can be taken, determines that
the claims of the PATENT claiming the THIRD PARTY product are not
valid or enforceable or such five (5) year period ((or seven (7)
year period for Japan)) expires without issuance of the PATENTS and
no litigation is then pending, in which case the amounts on the
ESCROW account shall be released to the benefit of GSK. |
| |
(iii) |
such THIRD PARTY ceases for a period of six (6) consecutive
months the INFRINGEMENT, in which event the amounts in the ESCROW
account shall be released to the benefit of COLEY. |
| |
C. |
Notwithstanding the foregoing, in the event the above PATENTS
claiming PRODUCT and/or COMBINATION which are pending (but not
granted) in any country are being INFRINGED (as long as
INFRINGEMENT exists) in such country, then if such PATENTS are
granted in USA or Europe (as defined in Section 3.03) at the time
of such INFRINGEMENT, GSK shall pay a royalty of [*]% ([***]
percent) on NET SALES VALUE in such countries, provided and as long
as the relevant claim of such PATENTS
|
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
| |
which is being infringed
has been pending for no more than five (5) years (Japan: seven (7)
years) since the Effective Date of AMENDMENT 1 to the Option
Agreement dated March 14, 2000 entered into between the parties (as
the term “Effective Date” is defined therein), and the
differential between the royalty rate for COMPOSITION OF MATTER
claim under Section 3.06.I.A2 and such [*]% ([***] percent) applied
to NET SALES VALUE in such country(ies) shall be paid into ESCROW
in accordance with the provisions set forth under B above. After
such 5 (five) years (Japan: seven (7) years), the royalty under
Section 3.09 shall apply to NET SALES VALUE in such country (or
countries).
|
| |
3.07 |
In case a PRODUCT and/or COMBINATION is not covered by a
COMPOSITION OF MATTER claim or a BROAD FIELD OF USE claim, then the
royalty rate set forth under Section 3.09 applies provided such
PRODUCT and/or COMBINATION uses or incorporates
KNOW-HOW. |
| |
3.08 |
Patent Royalty obligations payable under Section 3.06.I above
in each country of the TERRITORY shall expire on a PRODUCT by
PRODUCT and country |
|
