"Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions, marked by [***], have been
separately filed with the Commission."
Synthelabo/SB/HGS
-----------------
COLLABORATION AND LICENSE AGREEMENT
-----------------------------------
This Collaboration and License Agreement (Agreement) is entered into
and effective this 30th day of June, 1996 by and among SmithKline Xxxxxxx
Corporation, a corporation organized under the laws of the Commonwealth of
Pennsylvania, having a place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"), SmithKline Xxxxxxx p.l.c., a corporation
organized under the laws of England and having a place of business at Xxxxx Xxxx
Xxxx, Xxxxxxxxx, Xxxxxxxxx, Xxxxxxx ("SB plc") (individually and collectively
"SB"), Human Genome Sciences, Inc. located at 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxx 00000 ("HGS") and Synthelabo, located at 00, xxxxxx Xxxxxxx, 00000 Xx
Xxxxxxx-Xxxxxxxx Xxxxx Xxxxxx ("Synthelabo").
WHEREAS SB corp and HGS, entered into the Collaboration Agreement
(defined below) effective as of May 19, 1993 relating to sequencing of expressed
genes and development of practical applications therefor; and
WHEREAS SB and HGS wish to collaborate with and grant and license to
Synthelabo, certain rights, including certain rights granted and licensed to SB
pursuant to the Collaboration Agreement and SB/HGS License Agreement (both
defined below), and Synthelabo wishes to collaborate with SB and HGS and to
accept such grant and license;
NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein, and intending to be legally bound, and otherwise to be bound
by proper and reasonable conduct, the parties agree as follows:
I. Definitions
1.1 "Affiliate" 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 provided a party controls directly or indirectly
such foreign entity) 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. For purposes of this Agreement, L'Oreal and Nestle are
not Affiliates of Synthelabo.
1.2 "Alliance Committee" shall mean a committee consisting of three (3)
scientists appointed by Synthelabo and three (3) scientists appointed by
SB and co-chaired by one (1) of the SB appointees and co-chaired by one (1)
of the Synthelabo appointees.
1.3 "Antibody Product" shall mean an antibody (monoclonal or polyclonal) or
fragments or constructs thereof which is potentially useful for the
treatment or prevention of a disease or disorder in humans.
1.4 "Antisense" shall mean inhibiting or preventing in vivo expression in a
human or animal of a gene product by use of an oligonucleotide or modified
oligonucleotide which binds to RNA or DNA to prevent and/or impair
expression of the gene product.
1.5 "Blocking Claim" shall mean a claim under any patent application or granted
patent anywhere in the world which generically but not specifically claims
(i) any and all compounds (and/or the use thereof) which interact with or
prevent interaction with a specified Target which is a Product and/or (ii)
any and all antibodies (and/or the use thereof) against a specific
Therapeutic Protein which is a Product or Target which is a Product. The
following are examples of "blocking claims": (1) a compound which interacts
with receptor X; (2) a compound which prevents binding to receptor X and
its ligand, (3) a process for activating receptor X, comprising contacting
receptor X with a compound which binds thereto and activates the receptor;
(4) a process for preventing activation of receptor X comprising contacting
receptor X with a compound which prevents binding between receptor X and
its ligand.
1.6 "Bioinformatics" shall mean computer software and know-how useful for
the analysis, comparison, and curation of human nucleic acid sequences; and
information related to such sequences; and software for the construction
and maintenance of databases for the compilation of such sequences and
their associated information; each developed from May 19, 1993 through the
end of the Initial Research Term. Bioinformatics shall include software for
the prediction of the three-dimensional structure of proteins from primary
sequence information but Bioinformatics shall not include software for
rational drug design based on such three-dimensional structure.
1.7 "Collaboration Agreement" shall mean the Collaboration Agreement entered
into between SB and HGS effective as of May 19, 1993, as amended and/or
superceded from time to time.
1.8 "Collaboration Partner Agreement" shall mean an agreement between or among
SB and/or HGS and (1) Merck substantially in accordance with a memorandum
of intent dated April 12, 1996; (2) SP substantially in accordance with a
memorandum of intent dated April 21, 1996; (3) Takeda substantially in
accordance with the SB/Takeda Collaboration and License Agreement dated
June 5, 1995; and (4) a Collaboration Partner, in addition to (1) and (2)
or substituted for (1) or (2), wherein such Collaboration Partner is
granted substantially the same licenses and
2
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
rights as granted by SB and/or HGS pursuant to any one or all of the
foregoing agreements or this Agreement.
1.9 "Collaboration Partner" shall mean those entities which are set forth in
Appendix A, or substituted for an entity in Appendix A and any entity added
to Appendix A or substituted for an entity in Appendix A which in the
aggregate shall be no more than four (4) entities as provided in Paragraph
2.18.
1.10 "Collaboration Partner Patent" shall mean individually and collectively a
Collaboration Partner Target Patent and Collaboration Partner Therapeutic
Protein Patent. Included within the definition of Collaboration Partner
Patents are all continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions thereof and all
supplementary-like patent certificates.
1.11 "Collaboration Partner Target Patent" shall mean all patents or patent
applications which are filed prior to the end of the Initial Research Term
under a Collaboration Partner Agreement, which are or become owned by a
Collaboration Partner, to the extent that they claim a Target which is a
Product or include a Blocking Claim and as to which SB and/or HGS has the
right to grant a license to Synthelabo. Included within the definition of
Collaboration Partner Target Patents are all continuations,
continuations-in-part, divisions, patents of addition, reissues, renewals
or extensions thereof and all SPCs.
1.12 "Collaboration Partner Therapeutic Protein Patent" shall mean all patents
or patent applications which are filed prior to the end of the Initial
Research Term under a Collaboration Partner Agreement, which are or become
owned by a Collaboration Partner, to the extent that they claim a
Therapeutic Protein which is a Product or use or manufacture thereof and as
to which SB and/or HGS has the right to grant a license to Synthelabo.
Included within the definition of Collaboration Partner Therapeutic Protein
Patents are all continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions thereof and all SPCs.
1.13 [***]
1.14 "Diagnostics" shall mean any product, process, substance, composition or
service intended to predict, detect or identify a disease or determine the
presence of a pathologic condition in a human.
1.15 "Discovered" shall mean the earlier of (a) the filing date of an
application for a patent filed in any country by Synthelabo under this
Agreement, by HGS or SB under the Collaboration Agreement, or by a
Collaboration Partner under a Collaboration Partner Agreement
3
containing a specific disclosure of a Product; or (b) identification of a
Synthelabo Product by Synthelabo.
1.16 "Drug Product" shall mean a product other than a Therapeutic Protein or
Antibody Product which is potentially useful for the treatment or
prevention of a disease or disorder in humans.
1.17 "Effective Date" shall mean the date first written above.
1.18 "Gene" shall mean a human gene or a portion thereof or cDNA corresponding
thereto.
1.19 "Gene Therapy" shall mean treatment or prevention of a disease, or
remedying a gene deficiency of humans or animals by genetic modification of
human somatic cells or animal somatic or germ cells (in vivo, in vitro or
ex vivo) with DNA (RNA) for the purpose of expressing a protein or
oligo(poly)nucleotide encoded by said DNA (RNA) in a human or animal.
1.20 "HGS Field" shall mean: (i) Gene Therapy, (ii) Antisense and (iii)
biotransformation of a chemical to prepare pharmaceutically active agents
for human or animal use, or intermediates therefor, which active agents or
intermediates therefor were discovered prior to May 19, 1993.
1.21 "HGS Technology" shall mean the following technology, whether patented,
patentable or not: (a) xxxxxxxx xxxx with respect to Genes and expression
products thereof and Bioinformatics relating thereto, in each case
developed by or for HGS prior to and through the end of the Initial
Research Term, (b) information on biological function of Therapeutic
Proteins developed by HGS prior to the Initial Research Term, (c) HGS
clones containing sequences in (a), (d) information on biological function
of Targets developed by or for HGS prior to and through the end of the
Initial Research Term, and (e) biological information on Therapeutic
Proteins for use as Targets developed by HGS during the Initial Research
Term and after such Therapeutic Protein has been claimed pursuant to
Section 8. Bioinformatics in subparagraph (a) shall not include
Bioinformatics licensed by HGS from a Third Party except where HGS has the
royalty-free right to license such Bioinformatics to Synthelabo or where
HGS has a royalty-bearing right to license such Bioinformatics to
Synthelabo and Synthelabo agrees to pay all applicable royalties for its
use of such license.
1.22 "HGS Patents" shall mean (i) all patents and patent applications to the
extent that they claim HGS Technology and (ii) Blocking Claims of patents
and patent applications filed prior to the end of the Initial Research
Term, in each case, which are or become owned by HGS or to which HGS
otherwise has, now or in the future, the right to grant licenses, or
sublicenses. Included within the definition of HGS Patents are all
continuations, continuations-in-part, divisions, patents of addition,
reissues, renewals or extensions thereof and all SPCs. HGS Patents shall
4
include HGS' interest in patents and patent applications to which HGS is a
joint owner pursuant to Paragraph 15.1.
1.23 "Initial Research Term" shall mean the term beginning on the Effective Date
and ending, unless this Agreement is earlier terminated, five years from
the Effective Date.
1.24 "Licensed Technology" shall mean individually and collectively, HGS
Technology and SB Technology and information received from a Collaboration
Partner pursuant to Paragraph 14.5.
1.25 "Licensed Patents" shall mean individually and collectively, HGS Patents
and SB Patents.
1.26 "Major Country" shall mean the United States, Canada, Germany, United
Kingdom, France, Italy, Spain, or Japan.
1.27 "Management Committee" shall mean a committee consisting of three (3)
members appointed by Synthelabo and three (3) members appointed by SB and
co-chaired by one (1) of the SB appointees and co-chaired by one (1) of the
Synthelabo appointees.
1.28 "Merck" shall mean Merck XXxX, Xxxxxxxxxxx Xxx. 000, 00000 Xxxxxxxxx,
Xxxxxxx and its Affiliates.
1.29 "Net Sales" shall mean gross receipts from sales of Synthelabo Product by
Synthelabo or SB or, except as provided below, their respective Affiliates,
licensees, distributors trading on Synthelabo's or SB's account or joint
ventures, less deductions for (i) transportation charges, including
transportation insurance to the extent separately invoiced; (ii) sales and
excise taxes and duties paid or allowed by a selling party and any other
governmental charges imposed upon the production, importation, use or sale
of such product; (iii) normal and customary trade, quantity and cash
discounts allowed and rebates including but not limited to Medicaid-like
rebates; and (iv) allowances or credits to customers on account of
rejection or return of such product or on account of retroactive price
reductions affecting such product. Sales between or among a party to this
Agreement and its respective Affiliates, licensees, distributors trading on
Synthelabo's or SB's account or joint ventures shall be included within Net
Sales only if such purchaser is an end-user of the Synthelabo Product.
Otherwise, Net Sales shall only include the subsequent, final sales to
Third Parties.
1.30 "Product(s)" shall mean any product, process, substance, composition or
service which in whole or in part (i) incorporates or is based on or uses
or is derived by use of Licensed Technology and/or Synthelabo Technology
and/or (ii) is covered by a Licensed Patent and/or a Synthelabo Patent
and/or (iii) is based on or is derived by use of a Target received through
SB from a Collaboration Partner under this Agreement; and/or (iv) is
covered by a Collaboration Partner Patent as to which Synthelabo obtains
rights from a Collaboration Partner under this Agreement. An incidental or
immaterial use of Licensed Technology,
5
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
such Target and/or Synthelabo Technology shall not cause a product,
process, substance, composition or service to become a Product.
1.31 "Research Antibody Plan" shall mean a plan for discovering and developing a
Synthelabo Antibody Product.
1.32 "Research Drug Plan" shall mean a plan for screening or other use of
Targets to discover a Synthelabo Drug Product.
1.33 "Research Plan" shall mean individually and collectively a Research Protein
Plan, a Research Antibody Plan or a Research Drug Plan. An example of each
such plan forms Appendix C.
1.34 "Research Protein Plan" means a plan for research and development of a
Synthelabo Protein Product which summarizes scientific data, proposed
research and development efforts and research and development goals
sufficient for SB or HGS to reasonably monitor applicable diligence
obligations required herein.
1.35 "Research Term" shall mean the Initial Research Term plus any extensions
obtained pursuant to Section 7.
1.36 "SB" shall mean SB Corp. and/or SB plc and any present or future Affiliate
to which any rights and/or obligations of either of them are assigned
and/or delegated pursuant to this Agreement as provided herein.
1.37 "SB Field" shall mean human and animal health care including Diagnostics
and Vaccines but excluding the HGS Field.
1.38 "SB Patents" shall mean (i) all patents and patent applications to the
extent that they claim SB Technology and (ii) Blocking Claims of patents
and patent applications filed prior to the end of the Initial Research
Term, in each case, which are or become owned by SB or to which SB
otherwise has, now or in the future, the right to grant licenses, or
sublicenses. Included within the definition of SB Patents are all
continuations, continuations-in-part, divisions, patents of addition,
reissues, renewals or extensions thereof and all SPCs. SB Patents shall
include SB's interest in patents and patent applications to which SB is a
joint owner pursuant to Paragraph 15.1.
1.39 [***].
6
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
1.40 [***].
1.41 "SP" shall mean Schering Plough Corporation, 0000 Xxxxxxxxx Xxxx Xxxx,
Xxxxxxxxxx, Xxx Xxxxxx and its Affiliates.
1.42 "Synthelabo" shall mean Synthelabo, Synthelabo Recherche, and their present
and future Affiliates to which any rights and/or obligations are assigned
and/or delegated pursuant to this Agreement as provided herein.
1.43 "Synthelabo Antibody Product" shall mean a Product in the Synthelabo Field
which is an Antibody Product developed by or for Synthelabo or its
licensee.
1.44 "Synthelabo Drug Product" shall mean a Product in the Synthelabo Field
which is a Drug Product developed by or for Synthelabo or its licensee.
1.45 "Synthelabo Field" shall mean the treatment and/or prevention of disease in
humans, but excluding the HGS Field, Vaccines, and Diagnostics.
1.46 "Synthelabo Patents" shall mean all patents and patent applications to the
extent that they claim Synthelabo Technology which are or become owned by
Synthelabo or to which Synthelabo otherwise has, now or in the future, the
right to grant licenses or sublicenses. Included within the definition of
Synthelabo Patents are all continuations, continuations-in-part, divisions,
patents of addition, reissues, renewals and extensions thereof and all
supplementary patent-like certificates. Synthelabo Patents shall include
Synthelabo's interests in patents and patent applications to which
Synthelabo is a joint owner pursuant to Paragraph 15.1.
1.47 "Synthelabo Product" shall mean individually and collectively a Synthelabo
Drug Product, Synthelabo Protein Product and Synthelabo Antibody Product.
1.48 "Synthelabo Protein Product" shall mean a Product in the Synthelabo Field
which is a Therapeutic Protein developed by or for Synthelabo or its
licensee.
1.49 "Synthelabo Technology" shall mean any and all data, substances, processes,
materials, formulas, know-how, inventions and information
7
developed by or on behalf of Synthelabo which incorporates or is based on
the use of or derived by use of Licensed Technology. An incidental or
immaterial use of Licensed Technology by or on behalf of Synthelabo or its
licensees shall not cause data, substances, processes, materials, formulas,
know-how, inventions and information to become Synthelabo Technology.
1.50 "SPC" shall mean a right based upon a patent to exclude others from making,
using or selling a Product, such as a Supplementary Protection Certificate.
1.51 "Takeda" shall mean Takeda Chemical Industries, Ltd., 0-0, Xxxxxxxxxx
0-Xxxxx, Xxxx-xx, Xxxxx, 000, Xxxxx and its Affiliates.
1.52 "Target" shall mean a Gene or expression product thereof (e.g., receptors,
enzymes or ion channels) which could be used for screening or other drug
discovery purpose to identify compounds or antibodies with a biochemical or
pharmacological effect.
1.53 "Therapeutic Protein" shall mean a polypeptide derived from a Gene
(excluding Antibody Products and Drug Products) which may be useful for the
treatment or prevention of a disease or disorder in humans.
1.54 "Third Party" shall mean shall mean any party other than Synthelabo, HGS,
SB or Affiliates of SB.
1.55 "Vaccine" shall mean any substance which achieves a prophylactic or
therapeutic effect by inducing an antigen-specific humoral and/or cellular
immune system response and shall include a "Gene Therapy Vaccine" which
shall mean a Vaccine which achieves a therapeutic effect by inducing an
antigen-specific humoral and/or cellular immune system response by Gene
Therapy.
2. License Grants and Covenants
Research Term Grants
2.1. SB hereby grants to Synthelabo a non-exclusive, non-transferable world-wide
license under SB Technology and SB Patents to perform and have performed
research and development in the Synthelabo Field during the Research Term.
2.2. SB and HGS as the case may be hereby grant to Synthelabo a non-exclusive,
non-transferable world-wide license under SB Technology, SB Patents, HGS
Technology, and HGS Patents to perform experiments during the Research Term
in the HGS Field and SB Field in furtherance of research and development in
the Synthelabo Field.
2.3. HGS hereby grants to Synthelabo a non-exclusive, non-transferable
world-wide license under HGS Technology and HGS Patents to perform and have
performed research and development in the Synthelabo Field during the
Research Term.
8
Post Research Term Grants to Synthelabo
2.4. SB hereby grants to Synthelabo a non-exclusive, non-transferable world-wide
license under SB Technology and SB Patents to perform and have performed
research and development in the Synthelabo Field after the Research Term in
accordance with Research Plans submitted by Synthelabo prior to the end of
the Research Term.
2.5. HGS hereby grants to Synthelabo a non-exclusive, non-transferable
world-wide license under HGS Technology and HGS Patents to perform and have
performed research and development in the Synthelabo Field after the
Research Term in accordance with Research Plans submitted by Synthelabo
prior to the end of the Research Term.
2.6. SB and HGS grant to Synthelabo an irrevocable, royalty-free, non-exclusive,
world-wide license under Licensed Technology and Licensed Patents to use
Bioinformatics after the Research Term.
2.7. SB and HGS as the case may be hereby grant to Synthelabo a non-exclusive,
non-transferable world-wide license under SB Technology and SB Patents, HGS
Technology and HGS Patents to perform experiments in the SB Field and HGS
Field in furtherance of research and development in the Synthelabo Field
after the Research Term in accordance with Research Plans submitted by
Synthelabo prior to the end of the Research Term.
Synthelabo Drug Product and Synthelabo Antibody Product Grants
2.8. SB hereby grants to Synthelabo a non-exclusive, sublicenseable, world-wide
license under SB Technology and SB Patents to make, have made, use, import,
offer to sell and sell Synthelabo Drug Products and Synthelabo Antibody
Products which result from Research Plans submitted by Synthelabo prior to
the end of the Research Term.
2.9. HGS hereby grants to Synthelabo a non-exclusive, sublicenseable, world-wide
license under HGS Technology and HGS Patents to make, have made, use,
import, offer to sell and sell Synthelabo Drug Products and Synthelabo
Antibody Products which result from Research Plans submitted by Synthelabo
prior to the end of the Research Term.
Synthelabo Protein Product Grants
0.00.XX hereby grants to Synthelabo an exclusive, sublicensable, world-wide
license under SB Technology and SB Patents to make, have made, use, import,
offer to sell and sell Synthelabo Protein Products as to which Synthelabo
meets the requirements of Paragraph 8.4.
2.11.HGS hereby grants to Synthelabo an exclusive, sublicenseable, world-wide
license under HGS Technology and HGS Patents to make, have made, use,
import, offer to sell and sell Synthelabo Protein Products as to which
Synthelabo meets the requirements of Paragraph 8.4.
2.12.Notwithstanding any exclusive rights granted to Synthelabo with respect to
a Synthelabo Protein Product, Synthelabo acknowledges and
9
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
agrees that SB, HGS and Collaboration Partners retain the right under
Licensed Technology, Collaboration Patents and Licensed Patents to use such
Synthelabo Protein Product for the purpose of discovering, researching,
developing, marketing, using and selling a Drug Product or Antibody Product
other than a Synthelabo Drug Product, Synthelabo Antibody Product or
Synthelabo Protein Product.
2.13.Notwithstanding any exclusive rights granted by Synthelabo under
Synthelabo Patents and Synthelabo Technology to HGS or SB with respect to a
Therapeutic Protein pursuant to Paragraph 2.25, HGS and SB acknowledge and
agree that Synthelabo retains the right under such Synthelabo Patents and
Synthelabo Technology to use a Therapeutic Protein as to which HGS, a
Collaboration Partner and/or SB obtains rights under Section 8 for the
purpose of discovering, researching, developing, marketing, using and
selling a Synthelabo Drug Product or Synthelabo Antibody Product.
Synthelabo Grants
2.14.[***].
2.15.[***].
2.16.(a) Synthelabo hereby grants a non-exclusive, royalty-free, sublicenseable
license to HGS and SB under Synthelabo Patents and Synthelabo Technology to
use Targets which are Products developed by Synthelabo during the Research
Term and under Blocking Claims of Synthelabo Patents, for the purpose of
researching, developing and commercializing products, provided that such
license is sublicenseable hereunder only to a Collaboration Partner and
only if the Collaboration Partner grants HGS and/or SB reciprocal and
similar licenses which are sub-licensed to Synthelabo herein; and (b)HGS
and SB respectively hereby grant to Synthelabo a non-exclusive, world-wide
license (with the right to sublicense) under Blocking Claims of
Collaboration Partner Patents, and under Collaboration Partner Patents to
use Targets which are Products developed by a Collaboration Partner under a
Collaboration Partner Agreement for the purpose of researching, developing
and commercializing Synthelabo Products during and after the Research Term
resulting from a Research Plan submitted prior the end of the Research
Term.
Sublicensing
2.17.The rights granted to Synthelabo by HGS and/or SB under this Agreement and
rights to Synthelabo Patents and Synthelabo Technology are licenseable
and/or sublicenseable by Synthelabo to a Third Party only with
10
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
respect to a Synthelabo Product and only as follows: (i) Synthelabo shall
have the right to license or sublicense rights to a Third Party to a
Synthelabo Protein Product after Synthelabo has conducted or had conducted
[***] for such Synthelabo Protein Product; (ii) Synthelabo shall have the
right at any time to grant licenses to a Third Party to a Synthelabo Drug
Product or Synthelabo Antibody Product; (iii) any such license or
sublicense must not derogate from SB's rights under Paragraphs 2.14 and/or
2.15; (iv) any such license or sublicense includes covenants from such
Third Party limiting the use of the technologies or patents hereunder which
covenants are substantially similar to those in this Agreement.
Collaboration Partners
2.18.Synthelabo acknowledges that SB has already entered into an agreement
concerning Licensed Technology and Licensed Patents with Takeda Chemical
Industries. HGS and SB collectively may in their sole discretion enter into
definitive agreements similar to this Agreement with Collaboration Partners
in addition to Takeda not later than February 28, 1997 and shall notify and
provide Synthelabo with a copy of Collaboration Partner Agreements with
such additional Collaboration Partners, however, none of the Collaboration
Partners, except Synthelabo, may be a company whose headquarters and
primary R&D facilities are in [***].
2.19.Synthelabo has thirty (30) days following receipt from SB and/or HGS of a
copy of a Collaboration Partner Agreement with an additional Collaboration
Partner received pursuant to Paragraph 2.18 to accept in writing all terms
and conditions of any such Collaboration Partner Agreement and cause SB
and/or HGS as the case may be to amend this Agreement such that all the
terms and conditions of such Collaboration Partner Agreement are
substituted for all the terms and conditions of this Agreement. If
Synthelabo declines to accept such terms and/or fails to respond to SB and
HGS within such thirty (30) day period, Synthelabo shall have waived its
right under this Paragraph. The right granted under this Paragraph 2.19
shall not extend to the Collaboration Partner Agreement with Takeda.
2.20.Synthelabo hereby grants to HGS a non-exclusive, sublicenseable,
world-wide, royalty bearing license under Synthelabo Patents to make, have
made, use, import, offer to sell, and sell any and all products that are in
the HGS Field, or are Vaccines and/or Diagnostics. Such license shall
include a reasonable royalty and other standard license terms to be
negotiated in good faith.
Other
2.21.Synthelabo agrees to use and/or grant rights in Licensed Technology,
Licensed Patents, Collaboration Partner Patents, Targets received from
11
Collaboration Partners under this Agreement and/or Synthelabo Technology
and/or Synthelabo Patents only in the Synthelabo Field and only as provided
under this Agreement.
2.22.After the Research Term, Synthelabo shall not use Licensed Technology,
Targets received from a Collaboration Partner under this Agreement and/or
Synthelabo Technology except (i) for research and development of a
Synthelabo Product in the Synthelabo Field pursuant to a Research Plan
submitted by Synthelabo during the Research Term and/or (ii) to make, have
made, use, import, offer to sell and sell Synthelabo Products in the
Synthelabo Field, which result from a Research Plan submitted by Synthelabo
during the Research Term and/or (iii) Bioinformatics licensed to
Synthelabo. An incidental and immaterial use of Licensed Technology, such
Target and/or Synthelabo Technology and/or use of Licensed Technology
and/or Synthelabo Technology to the extent available to the general public
and to the extent not covered by a granted Licensed Patent and/or
Synthelabo Patent shall not be a breach of this Paragraph.
2.23.Each license and right granted pursuant to this Agreement is subject to
all of the terms and conditions of this Agreement in addition to such terms
and conditions as may be explicitly referenced in the provision granting
such license or right.
2.24.HGS and SB respectively hereby grant to Synthelabo under Paragraph 2.10 and
2.11 an exclusive, world-wide license (with the right to sublicense) under
Collaboration Partner Therapeutic Protein Patents to make, have made, use,
import, offer to sell, and sell Therapeutic Proteins as to which Synthelabo
has obtained rights under Paragraph 8.4.
2.25.Synthelabo hereby grants an exclusive, royalty-free, world-wide license
(with the right to sublicense) under Synthelabo Patents to make, have made,
use, import, offer to sell and sell Therapeutic Proteins (i) to HGS or SB
as to which HGS or SB, as the case make be, has obtained rights under
Section 8 or (ii) to HGS as to which a Collaboration Partner obtains rights
under a Collaboration Partner Agreement.
3. License Fee
3.1. In partial consideration of the rights to be granted Synthelabo under the
Agreement during the Initial Research Term, Synthelabo will pay a Twenty
Five Million US Dollar ($US 25,000,000) license fee in five equal annual
installments of Five Million Dollars each, paid $2.5 Million Dollars to SB
and $2.5 Million Dollars to HGS, the first payment of Five Million US
Dollars ($US 5,000,000) being due within thirty (30) days of execution of
the Agreement and each installment thereafter being due on the anniversary
of the Effective Date.
12
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
3.2. In the event that any payment due and payable under Paragraph 3.1 is not
paid when due and payable and remains unpaid for a period of thirty (30)
days after written notice by HGS and/or SB of such failure, or if this
Agreement is terminated by HGS and/or SB as provided herein, then all
amounts which are to be paid under Paragraph 3.1 which have not been paid
shall become immediately due and payable at the end of such thirty (30) day
period.
4. Royalties:
4.1 (a) Synthelabo shall pay to HGS the following royalties on Net Sales of
each Synthelabo Product sold by Synthelabo or a Synthelabo licensee (except
SB) which royalty shall be calculated on an Synthelabo Product by
Synthelabo Product basis, with the applicable royalty rate for each
Synthelabo Product in a calendar year being based on world-wide Net Sales
for such Synthelabo Product in the calendar year and this determined
royalty rate being applied to all world-wide Net Sales of such Synthelabo
Product in such calendar year: and
(b) SB shall pay to Synthelabo the following royalties on Net Sales of each
Synthelabo Product sold by SB or a SB licensee (except Synthelabo) in the
Co-Right Territory which royalty shall be calculated on a Synthelabo
Product by Synthelabo Product basis, with the applicable royalty rate for
each Synthelabo Product in a calendar year being based on world-wide Net
Sales for such Synthelabo Product in the calendar year and this determined
royalty rate being applied to all world-wide Net Sales of such Synthelabo
Product in such calendar year:
----------------- ------------------ ------------ ---------------
Annual Net Synthelabo Synthelabo Synthelabo
Sales volume Protein Products Antibody Drug Products
(US $ million) Products
----------------- ------------------ ------------ ---------------
[***] [***] [***] [***]
----------------- ------------------ ------------ ---------------
[***] [***] [***] [***]
----------------- ------------------ ------------ ---------------
[***] [***] [***] [***]
----------------- ------------------ ------------ ---------------
[***] [***] [***] [***]
----------------- ------------------ ------------ ---------------
4.2 (a) In the event that royalties paid to a Third Party on Net Sales of a
Synthelabo Product are a significant factor in the return realized by
Synthelabo such as to diminish Synthelabo's capability to respond to
competitive pressures in the market, HGS and Synthelabo shall mutually
agree on a reasonable reduction in the royalties payable under this
13
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
Agreement on Net Sales of such Synthelabo Product for so long as the market
condition persists. Factors to be considered in agreeing on the royalty
reduction shall include but not be limited to the profit margin on such
Synthelabo Product and on analogous products, prices of competitive
products, total prior sales of the Synthelabo Product and expenditures in
development of such Synthelabo Product but in no event will the royalty due
HGS be reduced more than [***] percent of the royalty which would otherwise
be due HGS under Paragraph 4.1 on Net Sales of such Synthelabo Product; and
(b) In the event that royalties paid to a Third Party on Net Sales of a
Synthelabo Product are a significant factor in the return realized by SB
such as to diminish SB's capability to respond to competitive pressures in
the market, SB and Synthelabo shall mutually agree on a reasonable
reduction in the royalties payable under this Agreement on Net Sales of
such Synthelabo Product for so long as the market condition persists.
Factors to be considered in agreeing on the royalty reduction shall include
but not be limited to the profit margin on such Synthelabo Product and on
analogous products, prices of competitive products, total prior sales of
the Synthelabo Product and expenditures in development of such Synthelabo
Product but in no event will the royalty due Synthelabo be reduced more
than [***] percent of the royalty which would otherwise be due Synthelabo
under Paragraph 4.1 on Net Sales of such Synthelabo Product.
4.3 No royalties shall be due for Synthelabo Products Discovered under a
Research Plan submitted pursuant to this Agreement after the later of [***]
years after the end of the Initial Research Term or [***] years years after
the end of the Research Term.
4.4 Except as provided in Paragraph 4.3, royalty obligations under this
Agreement shall terminate on a country-by-country and Synthelabo
Product-by-Synthelabo Product basis on the later of (i) ten (10) years
after the first country-wide launch of such Synthelabo Product in each
country or (ii) expiration of the last to expire Licensed Patent or
Synthelabo Patent or Collaboration Partner Patent which covers the making,
using, importing, offering to sell, or selling of such SynthelaboProduct in
a country.
5. Milestone Payments/Other Payments
5.1 For each of the [***] Synthelabo Products, Synthelabo shall pay:
(a) [***] to SB and [***] to HGS upon the successful completion by
Synthelabo or a Third Party authorized by Synthelabo of Phase I clinical
trials;
14
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
(b) [***] to SB and [***] to HGS upon the successful completion by
Synthelabo or a Third Party authorized by Synthelabo of Phase II clinical
trials;
(c) [***] to SB and [***] to HGS upon the first submission for regulatory
approval by Synthelabo or a Third Party authorized by Synthelabo in a Major
Country; and
(d) [***] to SB and [***] to HGS upon first regulatory approval for
commercial sale in a Major Country.
5.2 Each of the above milestone payments shall be credited against milestone
payments otherwise due by Synthelabo on the next Synthelabo Product in the
event that Synthelabo abandons a Synthelabo Product for which a milestone
payment has been made. Total milestone payments for all Synthelabo Products
shall not exceed [***].
5.3 No milestone payments shall be due for Synthelabo Products Discovered after
the later of [***] years after the end of the Initial Research Term or
[***] years after the end of the Research Term under a Research Plan
submitted pursuant to this Agreement.
5.4 The milestone payments provided in this Section shall only be made once for
each Synthelabo Product and shall not be made in the case of improvements
or modifications such as but not limited to changed forms, formats, salts,
formulations, indications, processes or protocols of a Synthelabo Product
for which the payments were previously made.
5.5 In addition to any other payments made under this Agreement, Synthelabo
shall reimburse SB for SB's expenses (at its cost) incurred in the initial
transfer of Licensed Technology required to be transferred under the
Agreement (for example including computer expertise, personnel,
establishment of electronic communications links between SB and Synthelabo)
as shall be agreed upon prior to the transfer of such Licensed Technology.
SB shall invoice Synthelabo no more frequently than monthly for such
expenses, and Synthelabo shall reimburse SB for such expenses within thirty
(30) days of Synthelabo's receipt of each such invoice.
6. Research Payments
6.1. During the Initial Research Term, Synthelabo shall pay to HGS a total of
Ten Million US Dollars ($US 10,000,000) payable as follows: (1) Two Million
15
US Dollars ($US 2,000,000) within thirty (30) days after the Effective Date
or at Synthelabo's option in equal quarterly installments with the first
such quarterly installment being due within thirty (30) days of July 1,
1996 and each subsequent quarterly installment being due within thirty (30)
days of October 1, 1996, January 1, 1997 and April 1, 1997; and (2) Two
Million US Dollars ($US 2,000,000) on each of the first through fourth
anniversaries of the Effective Date or at Synthelabo's option in equal
quarterly installments due within thirty (30) days of July 1, October 1,
January 1 and April 1 for each of the second through fifth years until a
total of Ten Million US Dollars ($US 10,000,000) has been paid to HGS.
6.2. In the event that any payment due and payable under Paragraph 6.1 is not
paid when due and payable and remains unpaid for a period of thirty (30)
days after written notice by HGS to Synthelabo of such failure, or if this
Agreement is terminated by HGS as provided herein, then all amounts which
are to be paid under Paragraph 6.1 which have not been paid shall become
immediately due and payable at the end of such thirty (30) day period.
6.3. During the Initial Research Term and at no additional cost to Synthelabo or
SB, Synthelabo shall have the right to prioritize the sequencing by HGS of
70,000 expressed sequence tags including a reasonable number of second
walks per year. HGS shall use diligent efforts to complete such prioritized
sequencing (including sequencing from cDNA libraries supplied by
Synthelabo) as mutually agreed by HGS and Synthelabo, subject to timely
receipt by HGS of a) directions regarding prioritization and/or b) cDNA
libraries suitable for such sequencing from Synthelabo. Disputes under this
Paragraph shall be resolved by senior management of HGS and Synthelabo.
Second walks under this Paragraph identified by Synthelabo as being
directed to a Therapeutic Protein shall not be disclosed to SB and
Collaboration Partners until rights to such Therapeutic Protein have been
obtained pursuant to Paragraph 8.4.
6.4. Synthelabo may request additional research services from HGS at HGS's fully
allocated cost where HGS and Synthelabo mutually agree. For sequencing of
Synthelabo libraries under this Paragraph, HGS will not disclose sequences
sequenced from such libraries to Collaboration Partners or SB until twelve
(12) months after delivery of such sequences to Synthelabo.
6.5. HGS shall have the right to delay for a period of (12) months disclosure to
Synthelabo of such HGS Technology resulting from work performed by HGS for
a Collaboration Partner or SB pursuant to a provision of a Collaboration
Partner Agreement or the Collaboration Agreement similar to Paragraph 6.4
of this Agreement.
6.6. Any sequences and clones containing such sequences arising under this
Section 6 shall be owned by HGS and are HGS Technology.
16
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
7. Extensions of the Initial Research Term
The Initial Research Term may be extended at Synthelabo's option for up to
five (5) additional periods of one (1) year by written notice to HGS by
Synthelabo at least sixty (60) days prior to the end of the Initial
Research Term or at least sixty (60) days prior to the end of any one year
extension thereof, which written notice shall include an agreement to pay
to HGS [***] per each additional year of extension payable within thirty
(30) days of each extension.
8. Research/ Terapeutic Protein Claiming
8.1. Research Plans may be submitted only during the Research Term.
8.2. HGS and/or SB shall keep dated records of all dossier submissions under
this Section.
8.3. During the Initial Research Term, Synthelabo agrees that Synthelabo will
not screen or conduct dedicated rational drug design with respect to a
Target which is a Product to discover a Synthelabo Antibody Product or
Synthelabo Drug Product without first submitting to HGS and SB a Research
Drug Plan, or Research Antibody Plan, respectively.
protein products
8.4 Synthelabo, SB, HGS, and Collaboration Partners shall obtain exclusive
rights to Therapeutic Proteins which are Products provided:
(a) as among Synthelabo, SB, HGS and Collaboration Partners, such entity is
the first to submit a dossier as permitted under this Agreement or a
Collaboration Partner Agreement to SB and HGS prior to the end of the
Research Term,
(1) which dossier demonstrates evidence of in vivo activity for any such
Therapeutic Protein. Such evidence of in vivo biological activity must be
statistically different (p less than 0.05) from control for at least one
data point, and must be demonstrated in an experiment using at least three
(3) dosages of the test substance in which at least a trend of dose related
activity is demonstrated, or,
(2) in the case of a Therapeutic Protein for which (i) in vivo activity
cannot be demonstrated after bona fide attempts to do so in at least two
sub-primate species, or (ii) it is demonstrated by documented evidence
(from scientific literature or in-house studies) that the relevant effector
system does not exist in sub-primates, or (iii) it is demonstrated by
documented evidence (from scientific literature or in-house studies) that
there is an absence of reactivity with relevant targets in subprimates,
such dossier demonstrates evidence of in vitro biological activity in at
least one
17
relevant cellular based assay for any such Therapeutic Protein. Such
evidence of in vitro biological activity must be statistically different (p
less than 0.05) from control for at least one data point, and must be
demonstrated in an experiment using at least three concentrations of the
test substance in which at least a trend of dose related activity is
demonstrated.
(3) The preparation used to demonstrate biological activity shall be;
(x) a purified preparation in which at least 75% (w/w) of the protein
component of the preparation is the Therapeutic Protein; or
(y) a purified preparation in which the relative concentration and/or
specific activity of the Therapeutic Protein has been increased at
least 1000 fold as compared to an unpurified preparation.
In no case shall the concentration of the Therapeutic Protein
be less that one (1) microgram/ml in the purified preparation of (x) or
(y). Such purified preparation shall be shown to have a biological
activity which is not attributable to endotoxin contamination; and
(b) Synthelabo, HGS, the Collaboration Partners or SB as the case may be
submits with the dossier a Research Protein Plan therefor; and
(c) such rights have not been previously granted to such Therapeutic
Protein under Paragraph 8.10.
8.5. (a) HGS and/or SB will notify Synthelabo in writing within ten (10) working
days of receipt as to whether or not any dossier received from Synthelabo
meets the requirements of Paragraph 8.4 and unless a dispute is pending
with HGS, SB or a Collaboration Partner under a provision comparable to
Paragraph 8.7 of this Agreement, if it does meet such requirements such
notice will indicate that rights pursuant to Paragraph 8.4 to the
Therapeutic Protein which is the subject of such dossier have been granted
to Synthelabo. (b) If within such ten (10) working days of Synthelabo
submitting a dossier, Synthelabo has not been so notified in writing,
exclusive rights to such Therapeutic Protein shall be granted to Synthelabo
for such Therapeutic protein unless a dispute is pending with HGS, SB or a
Collaboration Partner under a provision comparable to Paragraph 8.7 of this
Agreement. (c) HGS and/or SB will also notify Synthelabo in writing that
exclusive rights to a Therapeutic Protein were granted to HGS, SB or a
Collaboration Partner within ten (10) working days of such granting, and
such notification will only include the identity of the Therapeutic Protein
so claimed and not the identity of the claiming party. (d) Except as
provided in Paragraph 14.5, HGS and SB shall not disclose the contents of a
Synthelabo dossier to Collaboration Partners.
8.6. (a) Any written notification pursuant to Paragraph 8.5 that rights to a
Therapeutic Protein have been granted to a party to this Agreement or a
Collaboration Partner is final and binding on the parties. (b) Neither SB
nor HGS shall have any liability to Synthelabo with
18
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
respect to a decision that SB, HGS or a Collaboration Partner has obtained
rights to a Therapeutic Protein under this Agreement or a Collaboration
Partner Agreement or that Synthelabo does not have rights to a Therapeutic
Protein unless there has been gross negligence or willful misconduct by HGS
or SB, as the case may be.
8.7. Following the receipt of any written notification pursuant to Paragraph 8.5
that a dossier submitted by Synthelabo does not meet the data and/or the
Research Plan requirements of Paragraph 8.4 (a) and (b), the parties shall
meet within ten (10) working days of such notification to discuss such
notification. If the parties are unable to agree that such dossier does not
meet the requirements of Paragraph 8.4(a) and (b), the parties shall submit
such dossier to a neutral expert qualified to determine whether or not such
dossier meets the requirements of Paragraph 8.4(a) and (b). While a dispute
is pending as to whether Synthelabo, HGS, SB or a Collaboration Partner is
entitled to exclusive rights to a Therapeutic Protein, all dossiers
submitted to HGS and SB under this Agreement, the Collaboration Agreement
or a Collaboration Partner Agreement directed to the same Therapeutic
Protein shall be dated, held and no rights shall be granted to such
Therapeutic Protein pending resolution of the dispute to such Therapeutic
Protein.
8.8. HGS and SB shall not use the information in a dossier submitted by
Synthelabo pursuant to Paragraph 8.4 to support a dossier under Paragraph
8.4 submitted by HGS or SB directed to the same Therapeutic Protein in such
Synthelabo dossier.
8.9. (a) Pursuant to Paragraph 8.4, Synthelabo may only claim one Therapeutic
Protein as a Synthelabo Protein Product per twelve-month period during the
Research Term, except pursuant to Paragraph 8.4, Synthelabo may designate
[***] such Therapeutic Proteins in a twelve-month period if at least [***]
one of such Therapeutic Proteins shall have been a class 5 cDNA sequence
(i.e. designated an unknown in the database) prior to its designation by
Synthelabo as a Synthelabo Protein Product pursuant to this Section. (b)
Notwithstanding subparagraph 8.9(a), Synthelabo may receive exclusive
rights pursuant to Paragraphs 8.4, 2.10 and 2.11 to a maximum of [***]
Therapeutic Proteins during the first five (5) years of the Initial
Research Term and one Therapeutic Protein per year during any extension of
the Research Term.
19
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
8.10.Synthelabo acknowledges and agrees that rights pursuant to Paragraph 8.4
are not available to Synthelabo with respect to the following Therapeutic
Proteins:
Name HGS Sequence ID
---- ---------------
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
Synthelabo acknowledges that within ninety (90) days of execution of a
Collaboration Partner Agreement with SP, SP shall have the right to obtain
exclusive rights to a maximum of [***] Therapeutic Proteins without meeting
the requirements of Paragraph 8.4(a).
8.11 It is understood that the sequence ID number associated with a Therapeutic
Protein under Paragraph 8.10 and/or claimed in a dossier and to which
rights are granted pursuant to Paragraph 8.4 is for identification purposes
only and that all clones, sequences and polypeptides associated with the
Therapeutic Protein as well as muteins and fragments thereof are included
in the rights granted herein.
9. Product Development
9.1. Synthelabo shall use diligent efforts consistent with Synthelabo resources
and expertise to develop, market, promote and sell royalty bearing
Synthelabo Protein Products in at least two Major Countries.
9.2. After the Research Term, Synthelabo shall use diligent efforts consistent
with Synthelabo resources and expertise to screen for Synthelabo Drug
Products and Synthelabo Antibody Products which are the subject of a
Research Drug Plan or Research Antibody Plan respectively submitted by
Synthelabo during the Research Term.
9.3. Synthelabo shall keep HGS and SB informed of progress of its efforts to
develop and commercialize Synthelabo Products by submission of a
semi-annual progress report describing progress made against the Research
Plan.
20
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
10 Alliance Committee
10.1 SB and Synthelabo will form a SB/Synthelabo Alliance Committee for the
period of the Initial Research Term. The major activities of the Alliance
Committee shall be to:
(1) Coordinate start-up activities, define mechanisms for transfer of
Licensed Technology and address problems when/if necessary.
(2) Arrange Bioinformatics planning and training and address any issues
with the start-up and performance of the Bioinformatics systems.
(3) Determine mechanisms to exchange biological data on genes in Licensed
Technology
(4) Identify areas for optional SB/Synthelabo collaborative scientific
working groups and, if agreed, arrange for formation of such groups.
10.2 The Alliance Committee may perform such other duties as the parties may
from time to time agree in writing.
10.3 The Alliance Committee shall meet at times and places mutually agreed upon.
10.4 All Alliance Committee decisions shall be decided by a majority vote of all
members, including the chairs. To constitute a quorum, at least four (4)
members must be present, two (2) of whom were appointed by SB and two (2)
of whom were appointed by Synthelabo. To constitute a valid decision of the
Alliance Committee, the majority vote must always include at least one (1)
concurring vote from a member appointed by SB and at least one (1)
concurring vote from a member appointed by Synthelabo. Tie votes shall be
resolved by senior management of each of SB and Synthelabo. If there is no
resolution by such senior management within ten (10) working days of a
dispute between the parties based on the absence of a valid decision by the
Alliance Committee, either party may request arbitration of the dispute
under Section 30.
11. [***].
11.1 [***].
11.2 [***].
11.3 [***].
21
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
12. [***].
12.1 [***].
12.3 [***].
12.4 [***].
12.5 [***].
12.6 [***].
12.7 [***].
12.8 [***].
22
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
13. [***].
13.1 [***].
13.2 [***].
13.3 [***].
13.4 [***].
"The information below marked [***] has been omitted pursuant to a request for
confidential treatment. The omitted portions have been separately filed with the
Commission."
[***].
13.5 [***].
13.6 [***].
23
14. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
-------------------------------------------
14.1.Except as provided in Paragraphs 6.5 and 14.2 and promptly after the
parties agree to security matters pursuant to Paragraph 14.12, during the
Initial Research Term, SB and HGS shall promptly disclose to Synthelabo all
Licensed Technology and unless otherwise directed by Synthelabo, HGS shall
make such disclosures to Synthelabo through SB. For HGS Technology which
are clones, HGS shall transfer clones to Synthelabo and/or SB for
Synthelabo as reasonably requested by Synthelabo or SB on behalf of
Synthelabo.
14.2.Notwithstanding the definition of Licensed Technology, for second walks and
full lengths sequences not requested by Synthelabo and biological
information developed after the Effective Date and during the Initial
Research Term each with respect to Therapeutic Proteins which are Products,
HGS and SB shall not be required to transfer such second walks, full length
sequences and information to Synthelabo until HGS, Collaboration Partners,
Synthelabo or SB obtains rights thereto pursuant to Section 8.
14.3.During the Initial Research Term, Synthelabo shall disclose to SB but not
HGS all Synthelabo Technology which is Bioinformatics developed by or for
Synthelabo during the Initial Research Term and directly relevant to
Licensed Technology.
14.4.HGS, SB and Synthelabo agree not to disclose and/or provide to a Third
Party information and/or materials received from another party pursuant to
this Agreement and to use the information and materials received from the
other party only as licensed hereunder.
14.5.Synthelabo agrees to freely share with SB and Collaboration Partners,
except for SP, (a) information on biological function of Targets which are
Products developed by or for Synthelabo during the Initial Research Term;
and (b) all Synthelabo Technology which is biological
24
information on Therapeutic Proteins developed by or for Synthelabo during
the Initial Research Term but only after Synthelabo has obtained rights to
such Therapeutic Protein pursuant to Paragraph 8.4; provided that
Synthelabo shall not be required to disclose such information to SB and
such Collaboration Partners unless (x) such Collaboration Partners agree to
conditions of confidentiality and non-use with respect to such information
comparable to those set forth in this Section 14 as if such information
were licensed technology under its Collaboration Partner Agreement; and (y)
such Collaboration Partners agree to freely disclose to Synthelabo directly
or through SB their information comparable to the information in (a) and
(b) herein.
14.6.The obligations of Paragraph 14.4 shall not apply to information and
materials which (i) were known to the receiving party or generally known to
the public prior to its disclosure hereunder; or (ii) subsequently becomes
known to the public by some means other than a breach of this Agreement,
the Collaboration Agreement or a Collaboration Partner Agreement; (iii) is
subsequently disclosed to the receiving party by a Third Party having a
lawful right to make such disclosure; (iv) is required by law to be
disclosed; (v) is approved for release by the parties; (vi) is required to
be disclosed under Section 15 and in such case only the party required to
disclose shall be exempt from the obligations of Paragraph 14.4 (to the
extent of such required disclosure); or (vii) is required by a party to be
disclosed to commercialize a Product.
14.7.Contract Research With Commercial Entities Notwithstanding Para-graph 14.4,
Synthelabo may contract with a Third Party commercial entity to conduct the
research with respect to Licensed Technology and Synthelabo Technology
which Synthelabo has a right to conduct under this Agreement, provided such
contract provides that all rights in inventions and discoveries made in the
course of or as a result of such research shall be owned by or exclusively
licensed to Synthelabo with Synthelabo having the same obligations thereto
as Synthelabo has with respect to Synthelabo Technology under this
Agreement and HGS and SB having the same rights to any such invention
and/or discovery as SB and HGS has to Synthelabo Technology under this
Agreement, and provided further that such contract is otherwise consistent
with the terms and provisions of this Agreement including without
limitation Section 14 of this Agreement.
14.8.Collaborations With Not-For-Profit Entities Synthelabo may disclose and/or
provide Licensed Technology to a Third Party not-for-profit collaborator
provided Synthelabo enters into an agreement with such Third Party which is
substantially in the form of the Material Transfer Agreement in Appendix B.
25
14.9.For the avoidance of doubt, nothing in this Agreement shall be construed as
preventing or in any way inhibiting any party from complying with statutory
and regulatory requirements governing the development, manufacture, use and
sale or other distribution of products in any manner which it reasonably
deems appropriate, including, for example, by disclosing to regulatory
authorities confidential or other information received from a party or
Third Parties. The parties shall take reasonable measures to assure that no
unauthorized use or disclosure is made by others to whom access to such
information is granted.
14.10. Synthelabo shall not submit for written or oral publication any
manuscript, abstract or the like which includes Synthelabo Technology which
is directed to Targets and/or is a Therapeutic Protein prior to the earlier
of (1) eighteen (18) months after Synthelabo files a Synthelabo Patent
which claims such Target or Therapeutic Protein or (2) with respect to a
Therapeutic Protein, the date on which Synthelabo obtains rights to such
Therapeutic Protein pursuant to Paragraph 8.4, or (3) publication in a
printed publication other than through a breach of this Paragraph of such
Target or Therapeutic Protein and/or related information to be submitted in
such written or oral publication.
14.11. No public announcement concerning the existence of or terms of this
Agreement shall be made, either directly or indirectly, by any party to
this Agreement without prior written notice to the other parties and,
except as may be legally required, or as may be required for a public
offering of securities, or as may be required for recording purposes,
without first obtaining the approval of the other parties and agreement
upon the nature and text of such announcement. The party desiring to make
any such public announcement shall inform the other parties of the proposed
announcement or disclosure in reasonably sufficient time prior to public
release, and shall provide the other parties with a written copy thereof,
in order to allow such other party to comment upon such announcement or
disclosure. This Paragraph shall not apply to any information disseminated
to the public which is information essentially identical to that contained
in a previous public announcement agreed to pursuant to this Paragraph.
14.12. Synthelabo agrees to maintain computer and computer network security
measures as agreed to and approved by SB, HGS and Synthelabo.
14.13. Notwithstanding Paragraph 14.4, a party shall have the right to disclose
and/or provide to a Third Party information and/or materials received from
another party pursuant to this Agreement in conjunction with a license to a
Third Party which is permitted by this Agreement, provided such Third Party
enters into non-disclosure and non-use obligations substantially the same
as those in this Agreement.
26
14.14. HGS or SB may disclose the entire text of this Agreement to any
Collaboration Partner
15. PATENT PROSECUTION
------------------
15.1.Each party shall have and retain sole and exclusive title to all
inventions, discoveries, designs, works of authorship and other know-how
which are made, conceived, reduced to practice or generated only by its
employees, agents, or other persons acting under its authority (including
Synthelabo contract researchers and/or investigators). Each party shall own
an equal undivided interest in all inventions, discoveries, designs, works
of authorship and other know-how made, conceived, reduced to practice or
generated jointly by employees, agents, or other persons acting under the
authority of the parties ("joint invention"); provided, however, that where
a party elects to file a patent application for a joint invention and the
other party(ies) of the joint invention does not, the party filing a patent
application with respect to the joint invention shall have and retain sole
and exclusive title to such joint invention and the party not wishing to
file shall assign all of its rights, title and interest to such joint
patent application to the filing party or parties. To the extent that joint
owners decide to file a patent application on a joint invention, the
initial filing shall be in the United States unless otherwise required by
law and HGS, SB or Synthelabo, as the case may be, shall cooperate in the
preparation and filing and share equally in the expense of filing,
preparation and maintaining thereof. Each party's interest in a "joint
invention" to the extent that it is Licensed Technology and/or Synthelabo
Technology (whether jointly owned or solely owned) shall be subject to the
terms and conditions of this Agreement; otherwise any owner shall be free
to dispose of its interest therein without the consent of or accounting to
any other owner.
15.2.HGS and/or SB shall have the right within its sole discretion to prepare,
file, prosecute and maintain its Licensed Patents. With respect to Licensed
Patents as to which Synthelabo retains a license hereunder, subject to
Paragraph 15.10, HGS and SB shall keep Synthelabo informed with respect to
the filing, prosecution and maintenance thereof and any actual or
threatened litigation related thereto. In the event that Synthelabo desires
that HGS and/or SB obtain and maintain patent protection in any country
with respect to Licensed Technology of SB and/or HGS as the case may be
(other than patent applications directed to Expressed Sequence Tags), as to
which Synthelabo retains a license hereunder, HGS and/or SB shall do so at
the cost and expense of Synthelabo.
27
15.3.Synthelabo shall have the right within its sole discretion to prepare,
file, prosecute and maintain Synthelabo Patents. With respect to Synthelabo
Patents as to which HGS and/or SB retains a license hereunder, subject to
Paragraph 15.11, Synthelabo shall keep HGS and SB informed with respect to
the filing, prosecution and maintenance thereof and any actual or
threatened litigation related thereto. In the event that HGS and/or SB
desires that Synthelabo obtain and maintain patent protection in any
country with respect to Synthelabo Technology as to which HGS and/or SB
retains a license hereunder, Synthelabo shall do so at the cost and expense
of HGS and/or SB as the case may be.
15.4.Each party, on behalf of itself and its directors, employees, officers,
shareholders, agents, successors and assigns hereby waives any and all
actions and causes of action, claims and demands whatsoever, in law or
equity of any kind it or they may have against the other party, its
officers, directors, employees, shareholders, agents, successors and
assigns, which may arise in any way, except as a result of gross
negligence, recklessness, or willful misconduct, in performance of patent
activities under this Section.
00.0.Xx the event of the institution of any suit by a Third Party against
Synthelabo, SB or their sublicensees for patent infringement involving the
manufacture, use, importation, offer for sale, sale, distribution or
marketing of Synthelabo Product, the party sued shall promptly notify the
other party to this Agreement in writing. As between the parties to this
Agreement, each party shall be solely responsible for its costs and
expenses of such action and any liability awarded against it which results
therefrom.
00.0.Xx the event that Synthelabo, HGS or SB becomes aware of actual or
threatened infringement of a Licensed Patent or a Synthelabo Patent, that
party shall promptly notify the other parties in writing. The owner(s) of
the patent in question shall have the first right but not the obligation to
bring, at its or their own expense, an infringement action against any
Third Party and to use the other party's or parties name(s) in connection
therewith. If the owner(s) of the patent does not commence a particular
infringement action within thirty (30) days of being requested to do so,
the other party(ies), after notifying the owner(s) in writing, shall be
entitled to bring such infringement action at its or their own expense in
its or their own name and/or in the name of the owner and the owner shall
join the action where required by local law. The party/ies conducting such
action shall have full control over its conduct, including settlement
thereof provided such settlement shall not be made without the prior
written consent of another if it would adversely affect the patent rights
of the other party. In any event, Synthelabo, HGS and SB shall assist one
another and cooperate in any such litigation at the other's request without
expense to the requesting party.
28
15.7.Synthelabo, HGS and SB shall recover their respective actual out-of-pocket
expenses, or equitable proportions thereof, associated with any litigation
or settlement thereof from any recovery made by any party. Any excess
amount over such expenses shall be shared among HGS, SB and Synthelabo in
an amount proportional to their respective losses .
15.8.The parties shall keep one another informed of the status of and of their
respective activities regarding any such litigation or settlement thereof.
15.9.The owner of a Licensed Patent or a Synthelabo Patent shall have the first
right to seek extensions of the terms of the patent and to seek to obtain
SPCs. Each party shall assist the other in the obtaining of such extensions
or SPCs including by authorizing the other party to act as its agent for
such purpose.
15.10. The obligations of Paragraph 15.2 shall only apply to Licensed Patents
which include Licensed Technology which HGS and/or SB has disclosed to
Synthelabo pursuant to this Agreement.
15.11. The obligations of Paragraph 15.3 shall only apply to Synthelabo Patents
which include Synthelabo Technology which Synthelabo has disclosed to HGS
and/or SB pursuant to this Agreement
15.12(a) All rights and licenses granted under or pursuant to this Agreement by
a one party to another, for all purposes of Section 365(n) of Title 11 of
the U.S. code ("Title 11"), are licenses of rights to intellectual property
as defined in Title 11. The licensing party agrees during the term of this
Agreement to maintain and preserve any current copies of all such
intellectual property which are in existence and in its possession as of
the commencement of a case under Title 11 by or against the licensing
party. If a case is commenced by or against the licensing party under Title
11, then, unless and until this Agreement is rejected as provided in Title
11, the licensing party (in any capacity, including debtor-in-possession)
and its successors and assigns (including, without limitation, a Title 11
Trustee) shall, as the party who is a licensee may elect in a written
request, immediately upon such request (A) (i) perform all of the
obligations provided in this Agreement to be performed by the licensing
party, or (ii) provide to the party who is a licensee all such intellectual
property (including all embodiments thereof) held by the licensing party
and such successors and assigns as of the commencement of a case under
Title 11 by or against the licensing party and from time to time
thereafter, and (B) not interfere with the rights of the party who is the
licensee as provided in this Agreement, or any agreement supplementary
hereto, to such intellectual property (including all such embodiments
thereof), including any right of the party who is a licensee to obtain such
intellectual property (or such embodiment) from any other entity.
29
(b) If a Title 11 case is commenced by or against the licensing party, and
this Agreement is rejected as provided in Title 11 and the party who is the
licensee elects to retain its rights hereunder as provided in Title 11,
then the licensing party (in any capacity, including debtor-in-possession)
and its successors and assigns (including, without limitation, a Title 11
Trustee) shall provide to the party who is a licensee all such intellectual
property (including all embodiments thereof) held by the licensing party
and such successors and assigns immediately upon the written request
therefor by the party who is a licensee. Whenever the licensing party or
any of its successors or assigns provides to the other party who is a
licensee any of the intellectual property licensed hereunder (or any
embodiment thereof) pursuant to this Paragraph 15.12, the licensing party
shall have the right to perform the obligations of the licensing party
hereunder with respect to such intellectual property, but neither such
provision nor such performance by the party who is a licensee shall release
the licensing party from any such obligation or liability for failing to
perform it; provided, however, that in such event the party who is a
licensee shall not be entitled to compel specific performance by the
licensing party under this Agreement except to the extent of enforcing the
exclusivity of the license granted hereunder.
(c) All rights, powers, remedies, obligations and conditions of Synthelabo
provided herein are in addition to and not in substitution for any and all
other rights, powers, remedies, obligations and conditions of the licensing
party or the party who is a licensee now or hereafter existing at law or in
equity (including, without limitation, Title 11) in the event of the
commencement of a Title 11 case by or against the licensing party. The
party who is a licensee, in addition to the rights, power and remedies
expressly provided herein, shall be subject to all obligations and
conditions, and shall be entitled to exercise all other such rights and
powers and resort to all other such remedies as may nor or hereafter exist
at law or in equity (including, without limitation, Title 11) in such
event. The parties agree that they intend the foregoing rights and
obligations of the party who is a licensee to apply to the maximum extent
permitted by law, including without limitation for purposes of Title 11,
(i) the right of access to any intellectual property (including all
embodiments thereof) of the licensing party, or any third party with whom
the licensing party contracts to perform an obligation of the licensing
party under this Agreement, and, in the case of the third party, which is
necessary for the development, registration and manufacture of Synthelabo
Product, and (ii) the right to contract directly with any third party
described in clause (i) in this sentence to complete the contracted work.
30
16. TRADEMARKS AND NON-PROPRIETARY NAMES
------------------------------------
16.1.Synthelabo, at its expense, shall be responsible for the selection and
registration of non-proprietary names for Synthelabo Products.
16.2.Synthelabo at its expense, shall be responsible for the selection,
registration and maintenance of all trademarks which it or SB employs in
connection with each Synthelabo Product which SB has the right to sell,
market, promote and/or co-market pursuant to this Agreement, in such
countries and/or territories where SB has such rights, and Synthelabo shall
own and control such trademarks; provided that if SB is co-marketing a
Synthelabo Product, SB shall select a trademark for such product with the
approval of Synthelabo which approval shall not be unreasonably withheld by
Synthelabo; such trademark shall be owned by Synthelabo and SB's right to
such trademark shall revert to Synthelabo after the end of an agreement
between SB and Synthelabo to sell such Synthelabo Product. Nothing in this
Agreement shall be construed as a grant of rights, by license or otherwise,
to SB to use such trademarks for any purpose other than co-promotion and/or
co-marketing as provided in this Agreement.
17. STATEMENTS AND REMITTANCES
--------------------------
00.0.XX and Synthelabo as the case may be, shall keep and require its
sublicensees to keep complete and accurate records of all sales of each
Synthelabo Product subject to royalties under this Agreement. Each party
including HGS shall have the right, at its expense, through a certified
public accountant or like persons reasonably acceptable to the other party,
to examine such records during regular business hours during the life of
this Agreement and for four (4) months after its termination; provided,
however, that such examination shall not take place more often than once a
year provided further that such accountant shall report only as to the
accuracy of the royalty statements and payments, including the magnitude
and source of any discrepancy. Neither party shall be required to maintain
such records for more than three (3) years after the generation of such
record.
17.2.Within sixty (60) days after the close of each calendar quarter,
Synthelabo shall deliver to HGS and SB shall deliver to Synthelabo a true
accounting of each Synthelabo Product sold under authority of this
Agreement by it and its licensees and distributors during such calendar
quarter and shall at the same time pay all royalties due. Such accounting
shall show sales on a country-by-country and product-by-product basis.
17.3.Any tax paid or required to be withheld on account of the licensing party
based on license fee, milestone payments, royalties and any other payments
payable under this Agreement shall be deducted from the
31
amount of such payments otherwise due. Each party shall secure and send to
the other proof of any such taxes withheld and paid.
17.4.All royalties due under this Agreement shall be payable in U.S. dollars.
Each party shall have the right, upon giving written notice to the other,
to receive payment in that country in local currency.
17.5.Monetary conversions from the currency of a foreign country, in which a
product is sold, into United States currency shall be calculated at the
official exchange rate in force in that country for financial transactions
on the last business day of the quarter for which royalties are being paid.
If there is no such official exchange rate, the conversions shall be made
at the rate for such remittances on that date as certified by Citibank,
N.A., New York, New York, U.S.A or leading banks in France.
18. EXPORT CONTROL COMPLIANCE
-------------------------
18.1.The parties agree to comply with any applicable law or regulation of the
United States, France or any country governing the export or re-export of
products (including test equipment), software, and technical data (and the
product of such data).
18.2.The parties will consult with each other to determine whether any such
prior governmental authorization is required with respect to any proposed
export or re-export of a product, software or technical data and, when
required, shall cooperate in the preparation of an application for such
authorization from their respective governmental authorities.
18.3.Synthelabo agrees that no product, software or technology provided by SB
and/or HGS to Synthelabo under this Agreement will be used, directly or
indirectly, or provided to any other party for use, in the development or
production of any micro-organisms capable of use as bacteriological warfare
agents.
19. TERM AND TERMINATION
--------------------
19.1.This Agreement shall come into effect as of the Effective Date and shall
remain in full force and effect until terminated as provided in this
Section 19.
00.0.Xx the event Synthelabo fails to make a royalty or milestone payment when
due to HGS or SB, as the case may be, under this Agreement with respect to
a Synthelabo Product, or fails to meet its obligations under Section 9 of
this Agreement with respect to a Synthelabo Product, then in addition to
any other remedy which they may have, HGS and/or SB may notify Synthelabo
in writing that all of Synthelabo's rights with respect to such Synthelabo
Product shall terminate as of sixty (60) days after such written notice and
Synthelabo's rights with respect thereto shall
32
terminate unless such payment is made or such failure is cured, prior to
the expiration of such sixty (60) day period.
00.0.Xx the event Synthelabo fails to make a payment to HGS or SB, as the case
may be under Paragraph 3.1 when due or to HGS under Paragraph 6.1 when due,
then in addition to any other remedy which they may have, HGS and/or SB, as
the case may be, may notify Synthelabo in writing that this Agreement shall
terminate in its entirety, and if Synthelabo fails to make such payment
within thirty (30) days thereafter, this Agreement shall terminate.
00.0.Xx the event SB fails to make a payment to Synthelabo under this Agreement
with respect to a Synthelabo Product when due, then in addition to any
other remedy which it may have, Synthelabo may notify SB in writing that
all of SB's rights with respect to such Synthelabo Product shall terminate
as of sixty (60) days after such written notice and SB's rights with
respect thereto shall terminate unless such payment is made or such failure
is cured, prior to the expiration of such sixty (60) day period. Any
sublicenses granted with respect to such Synthelabo Product shall remain in
full force and effect if (i) SB's sublicensee is not then in breach of its
sublicense; (ii) Synthelabo's rate of royalty compensation thereunder is no
less than the rate of royalty compensation to Synthelabo under this
Agreement; (iii) Synthelabo assumes no performance obligations under the
sublicense agreement; and (iv) SB and SB's sublicensee agree to assign the
sublicense agreement to Synthelabo.
19.5.A party may terminate this Agreement if, at any time, another party shall
file in any court or agency pursuant to any statute or regulation of any
state or country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver
or trustee of such party or of its assets, or if the party in bankruptcy
proposes a written agreement of composition or extension of its debts, or
if another party shall be served with an involuntary petition against it,
filed in any insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof, or if the other
party shall propose or be a party to any dissolution or liquidation, or if
the other party shall make an assignment for the benefit of creditors.
19.6.Notwithstanding the bankruptcy of Synthelabo, HGS or SB, or the impairment
of performance by Synthelabo, HGS or SB of its obligations under this
Agreement as a result of bankruptcy or insolvency of Synthelabo, HGS or SB,
the other parties shall be entitled to retain the licenses granted herein,
subject to rights of a party to terminate this Agreement for reasons other
than bankruptcy or insolvency as expressly provided in this Agreement.
00.0.Xx party shall have the right to terminate this Agreement except under
Paragraph 19.3 and 19.5 provided however that nothing in this Agreement
shall limit any remedies for breach which may be available in
33
law or equity, including termination of this Agreement or of any or all
rights hereunder.
20. RIGHTS AND DUTIES UPON TERMINATION
----------------------------------
20.1.Upon termination of this Agreement in its entirety or with respect to any
Synthelabo Product or to any country or territory, each party shall notify
the other of the amount of such Product it and its licensees and
distributors and their distributors and licensees then have on hand, the
sale of which would, but for the termination, be subject to royalty, and
such party and its licensees and distributors and their distributors and
licensees shall thereupon be permitted to sell that amount of the product
provided that the party shall pay the royalty thereon at the time herein
provided for.
20.2.Termination of this Agreement shall terminate all outstanding obligations
and liabilities between the parties arising from this Agreement except
those which have accrued prior to termination as well as those described in
Sections 4, 5, 17, 22, and 24 and Paragraphs 2.17, 2.21, 2.22, 3.1, 3.2,
6.1, 6.2, 14.4, 14.6, 14.13, 14.14, and 20.2 as well as any provision not
specified in this Paragraph which is clearly meant to survive termination
of this Agreement.
21. WARRANTIES REPRESENTATIONS AND COVENANTS
----------------------------------------
21.1 Nothing in this Agreement shall be construed as a warranty that Licensed
Patents, Collaboration Patents or Synthelabo Patents are valid or
enforceable or that the exercise of Licensed Patents, Licensed Technology,
Synthelabo Patents and/or Synthelabo Technology does not infringe any
patent rights of Third Parties.
21.2 Each party warrants and represents that it has the right to enter into this
Agreement, to grant the rights and licenses and to otherwise perform in
accordance therewith.
21.3 Subject to HGS's and SB's right to modify the basic terms of the
Collaboration Agreement to accommodate the entry into Collaboration Partner
Agreements pursuant to Paragraph 2.18, SB and HGS may not modify the basic
terms of the Collaboration Agreement which would (1) reduce the scope of
the licenses granted (including but not limited to the licenses to
technology, products, territory and exclusivity) to Synthelabo under this
License Agreement or the (2) change the Therapeutic Protein claiming
mechanisms contained in Collaboration Partner Agreements, except to the
extent already permitted pursuant to Paragraph 8.10 in a manner which would
adversely affect Synthelabo, without obtaining Synthelabo's prior written
and express approval.
34
21.4 Synthelabo, SB and HGS guarantee that their respective Affiliates
performing hereunder or receiving any of the benefits herefrom will perform
all obligations under this Agreement as if the Affiliates were signatories
of this Agreement.
22. INDEMNIFICATION
---------------
00.0.XX shall defend, indemnify and hold harmless Synthelabo, HGS, their
respective licensors, licensees, directors, officers, shareholders, agents
and employees, from and against any and all liability, loss, damages and
expense (including reasonable attorneys' fees) as the result of claims,
demands, costs or judgments which may be made or instituted against any of
them arising out of the manufacture, possession, distribution, use,
testing, sale, marketing, promotion or other disposition by or through SB,
or any Third Party granted rights by SB under this Agreement, of any
Synthelabo Product. SB's obligation to defend, indemnify and hold harmless
shall include claims, demands, costs or judgments, whether for money
damages or equitable relief by reason of alleged personal injury (including
death) to any person or alleged property damage, provided, however, the
indemnity shall not extend to any claims against an indemnified party which
result from the gross negligence or willful misconduct of such indemnified
party. SB shall have the exclusive right to control the defense of any
action which is to be indemnified in whole or in part by SB hereunder,
including the right to select counsel acceptable to Synthelabo and/or HGS
to defend Synthelabo or its licensees and/or HGS under this Agreement as
the case may be and to settle any claim, provided that, without the written
consent of Synthelabo and/or HGS (which shall not be unreasonably withheld
or delayed), SB shall not agree to settle any claim against Synthelabo or
any Synthelabo licensee and/or HGS under this Agreement as the case may be,
to the extent such claim has a material adverse effect on Synthelabo or its
licensees and/or HGS under this Agreement as the case may be. The
provisions of this Paragraph shall survive and remain in full force and
effect after any termination, expiration or cancellation of this Agreement
and obligation hereunder shall apply whether or not such claims are
rightfully brought. SB shall require each of its licensees of a Synthelabo
Product to indemnify Synthelabo and/or HGS in a manner consistent with this
Paragraph.
22.2.Synthelabo shall defend, indemnify and hold harmless SB and HGS,
Affiliates of HGS and SB, licensors and licensees of SB and HGS and their
respective directors, officers, shareholders, agents and employees, from
and against any and all liability, loss, damages and expense (including
reasonable attorneys' fees) as the result of claims, demands, costs or
35
judgments which may be made or instituted against any of them arising out
of the manufacture, possession, distribution, use, testing, sale, marketing
or promotion or other disposition by or through Synthelabo, or any Third
Party granted rights by Synthelabo under this Agreement, of any Synthelabo
Product. Synthelabo's obligation to defend, indemnify and hold harmless
shall include claims, demands, costs or judgments, whether for money
damages or equitable relief by reason of alleged personal injury (including
death) to any person or alleged property damage, provided, however, the
indemnity shall not extend to any claims against an indemnified party which
result from the gross negligence or willful misconduct of such indemnified
party. Synthelabo shall have the exclusive right to control the defense of
any action which is to be indemnified in whole by Synthelabo hereunder,
including the right to select counsel acceptable to SB and/or HGS to defend
SB or HGS or their licensees under the Agreement, as the case may be, and
to settle any claim, provided that, without the written consent of an
indemnified party (which shall not be unreasonably withheld or delayed),
Synthelabo shall not agree to settle any claim against such indemnified
party under this Agreement as the case may be, to the extent such claim has
a material adverse effect on such indemnified party under this Agreement as
the case may be. The provisions of this Paragraph shall survive and remain
in full force and effect after any termination, expiration or cancellation
of this Agreement and Synthelabo's obligation hereunder shall apply whether
or not such claims are rightfully brought. Synthelabo shall require each of
its licensees (other than SB) of a Synthelabo Product to indemnify SB and
HGS in a manner consistent with this Paragraph.
22.3.A person or entity that intends to claim indemnification under this
Section 22 (the "Indemnitee") shall promptly notify the other party (the
"Indemnitor") of any loss, claim, damage, liability or action in respect of
which the Indemnitee intends to claim such indemnification, and the
Indemnitor, after it determines that indemnification is required of it,
shall assume the defense thereof with counsel mutually satisfactory to the
parties; provided, however, that subject to Paragraph 22.1, 22.2 and 22.3
an Indemnitee shall have the right to retain its own counsel, with the fees
and expenses to be paid by the Indemnitor if Indemnitor does not assume the
defense; or, if representation of such Indemnitee by the counsel retained
by the Indemnitor would be inappropriate due to actual or potential
differing interests between such Indemnitee and any other party represented
by such counsel in such proceedings. The indemnity agreement in this
Section 22 shall not apply to amounts paid in settlement of any loss,
claim, damage, liability or action if such settlement is effected without
the consent of the Indemnitor, which consent shall not be withheld or
delayed unreasonably. The failure to deliver notice to the Indemnitor
within a reasonable time after the commencement of any
36
such action, if prejudicial to its ability to defend such action, shall
relieve such Indemnitor of any liability to the Indemnitee under this
Section 22, but the omission so to deliver notice to the Indemnitor will
not relieve it of any liability that it may have to any Indemnitee
otherwise than under this Section 22. The Indemnitee under this Section 22,
its employees and agents, shall cooperate fully with the Indemnitor and its
legal representatives in the investigations of any action, claim or
liability covered by this indemnification. In the event that each party
claims indemnity from the other and one party is finally held liable to
indemnify the other, the Indemnitor shall additionally be liable to pay the
reasonable legal costs and attorneys' fees incurred by the Indemnitee in
establishing its claim for indemnity.
23. FORCE MAJEURE
-------------
23.1.If the performance of any part of this Agreement by either party, or of
any obligation under this Agreement, is prevented, restricted, interfered
with or delayed by reason of any cause beyond the reasonable control of the
party liable to perform, unless conclusive evidence to the contrary is
provided, the party so affected shall, upon giving written notice to the
other party, be excused from such performance to the extent of such
prevention, restriction, interference or delay, provided that the affected
party shall use its reasonable best efforts to avoid or remove such causes
of non-performance and shall continue performance with the utmost dispatch
whenever such causes are removed. When such circumstances arise, the
parties shall discuss what, if any, modification of the terms of this
Agreement may be required in order to arrive at an equitable solution.
24. GOVERNING LAW
-------------
24.1.This Agreement shall be deemed to have been made in the Commonwealth of
Pennsylvania and its form, execution, validity, construction and effect
shall be determined in accordance with the laws of the Commonwealth of
Pennsylvania, U.S.A., regardless of choice of law principles of the
Commonwealth of Pennsylvania.
25. SEPARABILITY
------------
00.0.Xx the event any portion of this Agreement shall be held illegal, void or
ineffective, the remaining portions hereof shall remain in full force and
effect.
25.2.If any of the terms or provisions of this Agreement are in conflict with
any applicable statute or rule of law, then such terms or provisions shall
be deemed inoperative to the extent that they may conflict
37
therewith and shall be deemed to be modified to conform with such statute
or rule of law.
00.0.Xx the event that the terms and conditions of this Agreement are
materially altered as a result of Paragraph 25.1 or 25.2, the parties will
renegotiate the terms and conditions of this Agreement to resolve any
inequities.
26. ENTIRE AGREEMENT
----------------
26.1.This Agreement, entered into as of the date written above, constitutes the
entire agreement between the parties relating to the subject matter hereon
and supersedes all previous writings and understandings. No terms or
provisions of this Agreement shall be varied or modified by any prior or
subsequent statement, conduct or act of either of the parties, except that
the parties may amend this Agreement by written instruments specifically
referring to and executed in the same manner as this Agreement.
26.2.A waiver of any breach or any provision of this Agreement shall not be
construed as a continuing waiver of other breaches of the same or other
provisions of this Agreement.
26.3.The headings and titles to the Sections and Paragraphs of this Agreement
are inserted for convenience only and shall not be deemed a part hereof or
affect the construction or interpretation of any provision hereof.
27. NOTICES
-------
27.1 Any notice required or permitted under this Agreement shall be sent by air
mail, postage pre-paid, courier or fax to the following addresses of the
parties or such other addresses as may be notified to the parties as
provided herein:
SYNTHELABO
00, xxxxxx Xxxxxxx,
00000 Xx Xxxxxxx-Xxxxxxxx Xxxxx Xxxxxx
Attention: Director of Legal Department
fax: 000 00 0 00 00 0000
SB
SMITHKLINE XXXXXXX CORPORATION
000 Xxxxxxxxx Xxxx
X. X. Xxx 0000
King of Xxxxxxx, Xxxxxxxxxxxx 00000
Attention: Vice-President, Advanced
Technologies in Genetics
fax: 000 000-0000
38
copy to:
SMITHKLINE XXXXXXX CORPORATION
000 Xxxxxxxxx Xxxx
X. X. Xxx 0000
King of Xxxxxxx, Xxxxxxxxxxxx 00000
Attention: Corporate Intellectual Property
fax: 000-000-0000
HGS
Attention: Senior Vice President Business Development
Human Genome Sciences, Inc.
0000 Xxx Xxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxx 00000
fax: 000-000-0000
copy to:
Xx. Xxxxxx X. Xxxxxxx
Carella, Byrne, Bain, Gilfillan, Xxxxxx , Xxxxxxx & Olstein
0 Xxxxxx Xxxx Xxxx
Xxxxxxxx, Xxx Xxxxxx 00000
fax: 000-000-0000
27.2 Any notice required or permitted to be given concerning this Agreement
shall be effective upon receipt by the party to whom it is addressed.
28. ASSIGNMENT
----------
28.1.This Agreement and the licenses herein granted shall be binding upon and
inure to the benefit of the successors in interest of the respective
parties. Neither this Agreement nor any interest hereunder shall be
assignable or may be assigned by any party without the written consent of
the other parties, and any such assignment shall be void and of no effect
provided, however, that a party may assign this Agreement or any of its
rights or obligations hereunder in whole or in part to any Affiliate
competent to fulfill the rights and obligations of this Agreement without
obtaining the consent of the other party; and provided further that any
party may assign this Agreement or any of its rights or obligations
hereunder to any Third Party with which it may merge or consolidate, or to
which it may transfer all or substantially all of its assets to which this
Agreement relates, without obtaining the consent of the
39
other parties; provided such Third Party assignee agrees to be bound by all
the terms and conditions of the Agreement and further provided that the
assigning party also remains bound by the terms and conditions of this
Agreement.
29. RECORDING
29.1 SB and HGS shall have the right, at any time, to record, register, or
otherwise notify this Agreement in appropriate governmental or regulatory
offices anywhere in the world, and Synthelabo shall provide reasonable
assistance to SB and HGS in effecting such recording, registering or
notifying.
29.2 Synthelabo shall have the right, at any time, to record, register, or
otherwise notify this Agreement in appropriate governmental or regulatory
offices anywhere in the world, and SB and HGS shall provide reasonable
assistance to Synthelabo in effecting such recording, registering or
notifying.
30. DISPUTE RESOLUTION
------------------
30.1 If there is a tie vote within the Management Committee or Alliance
Committee over an issue within its respective jurisdiction, which tie vote
is not timely solved by such Committee, and if senior management does not
timely resolve any such tie vote, then either SB or Synthelabo may submit
such dispute to binding arbitration in accordance with the UNCITRAL
Arbitration Rules (as at present in force) as modified by this Paragraph
30.1. The place of any arbitration shall be in London and the language of
the proceedings shall be English. The appointing authority for the purpose
of the UNCITRAL Arbitration Rules shall be the Chamber of Commerce and
Industry, Stockholm, Sweden. The number of arbitrators shall be three
appointed in accordance with the UNCITRAL Arbitration Rules. The third
arbitrator appointed shall be a person with extensive experience in
relation to the subject matters in dispute. The third arbitrator shall not
be a national of France, England or the United States. The arbitration
shall consider and decide only issues presented to it by the parties to the
arbitration.
30.2 Senior management of SB, HGS and Synthelabo shall endeavor to resolve all
other disputes under this Agreement.
40
32. COUNTERPARTS
------------
This Agreement may be executed in any number of counterparts, and each
such counterpart shall be deemed an original instrument, but all such
counterparts together shall constitute but one agreement.
IN WITNESS WHEREOF, the parties, through their authorized officers,
have executed this Agreement as of the date first written above.
SMITHKLINE XXXXXXX CORPORATION SYNTHELABO
By: ______________________ By: _______________________
Name: ____________________ Name: _____________________
Title: ___________________ Title:_____________________
Date: ____________________ Date: _____________________
SMITHKLINE XXXXXXX plc
By: ______________________
Name: ____________________
Title: ___________________
Date: ____________________
HUMAN GENOME SCIENCES, INC.
By: ______________________
Name: ____________________
Title: ___________________
Date: ____________________
41
APPENDIX A
Collaboration Partners
(1) Takeda Chemical Industries
(2) Merck KgGA
(3) Schering-Plough Corporation
(4) Another entity to be named or substituted for (1), (2), or (3)
00
XXXXXXXX X
MATERIAL TRANSFER and LICENSE AGREEMENT
MATERIAL TRANSFER AGREEMENT
THIS AGREEMENT is entered into and effective as of the date of last signing by
any of the parties to the Agreement, by and among Synthelabo, located at 00,
xxxxxx Xxxxxxx, 00000 Xx Xxxxxxx-Xxxxxxxx Xxxxx Xxxxxx ("Synthelabo") SmithKline
Xxxxxxx Corporation, a corporation organized under the laws of the Commonwealth
of Pennsylvania, having a place of business at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000, X.X.X. ("SB corp"), Human Genome Sciences, Inc. ("HGS")
located at 0000 Xxx Xxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxx 00000 and _______, a
not-for-profit INSTITUTE located _______________, and designated representatives
and employees of ______________________ (_________________, its representatives
and employees are hereinafter referred to as "INSTITUTE").
1. The Principal Investigator conducting the research described
herein shall be ________________ who is a designated
representative and employee of INSTITUTE.
2. Subject to availability, SB, HGS and/or SYNTHELABO agrees as
the case may be to provide the material set forth in Appendix
A to INSTITUTE and INSTITUTE agrees such materials are the
property of HGS, Synthelabo and/or SB as the case may be. Such
material and any related biological material or associated
know-how and data that will be received by INSTITUTE from SB,
HGS and/or SYNTHELABO; and any substance that is a derivative
thereof or is replicated therefrom or is an antibody produced
by use thereof are covered by this Agreement. All such
materials shall hereinafter be referred to as the "Material"
or "Materials."
3. The Materials will be used by INSTITUTE only in connection
with the research described in Appendix B (the "Research") and
only for non-commercial research purposes. If INSTITUTE wishes
to carry out research beyond that described in Appendix B,
such research will be carried out only pursuant to a further
agreement signed by each of the parties.
4. INSTITUTE shall not distribute, release, or disclose the
Materials to any other person or entity and shall ensure that
no one will be allowed to take or send the Materials to any
other location, unless written permission is obtained in
advance from SB, SYNTHELABO and HGS. INSTITUTE agrees to
maintain the confidentiality of the
43
Materials and any information regarding the Materials, except
to the extent such information:
(a) can be demonstrated to have been in the public domain
or publicly known and readily available to the trade
or the public prior to the date of the disclosure; or
(b) can be demonstrated, from written records, to have
been in the Institute's possession or readily
available to the INSTITUTE from another source not
under obligation of secrecy to SB, HGS or SYNTHELABO
prior to the disclosure; or
(c) becomes part of the public domain or publicly known
by publication or otherwise, not due to any
unauthorized act by the INSTITUTE; or
(d) is independently developed by INSTITUTE without
reference to information or material provided under
this Agreement.
5. The Materials are supplied solely for scientific research
purposes, for use in animals and/or in vitro. THE MATERIALS
SHALL NOT BE USED IN HUMANS.
6. INSTITUTE hereby acknowledges that the Materials are provided
WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED.
SYNTHELABO, SB AND HGS MAKE NO REPRESENTATION THAT THE USE OF
THE MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT,
TRADEMARK OR OTHER PROPRIETARY RIGHT.
7. In no event shall SB, SYNTHELABO or HGS be liable for any use
of the Materials by INSTITUTE. INSTITUTE hereby agree to
defend, indemnify and hold harmless SB, SYNTHELABO and HGS,
their officers, directors, employees and agents from any loss,
claim, damage, expense or liability, of whatsoever kind or
nature (including attorney's fees), which may arise from or in
connection with this Agreement or the use, handling or storage
of the Materials, by INSTITUTE.
8. INSTITUTE hereby agrees to comply with all applicable
government and National Institutes of Health regulations and
guidelines which are applicable to all uses of the Materials
by the INSTITUTE.
9. Any and all proprietary rights, including but not limited to
patent rights, in and to the Materials shall be and remain in
SB and/or HGS as the case may be.
44
10. INSTITUTE agrees to provide SB, HGS and SYNTHELABO with an
advance copy at least thirty (30) days in advance of any
written submission (abstract or paper) or presentation that
makes reference to the Materials. If in the opinion of SB, HGS
and/or SYNTHELABO such submission or presentation discloses
SB, SYNTHELABO and/or HGS proprietary information which
INSTITUTE is obligated to maintain confidential under
Paragraph 4 hereof, SB or SYNTHELABO or HGS shall notify
INSTITUTE within thirty (30) working days of receipt thereof
and INSTITUTE shall delete such proprietary information from
such submission or presentation. If a publication does result
from work using the Materials, INSTITUTE agrees to acknowledge
SB, and/or SYNTHELABO and/or HGS and give credit to SB,
SYNTHELABO and/or HGS scientists, as scientifically
appropriate, based on any direct contribution they may have
made to the work.
11. For the purposes of this Agreement, "Developed Technology"
means any and all data, formulas, information, compositions,
biologics, substances and any intellectual property rights
thereto, including but not limited to, software, copyrights,
patents and patent applications, which result from the
Research and/or use of the Materials and/or information
provided to the INSTITUTE under this Agreement. INSTITUTE
agrees to promptly disclose Developed Technology to
SYNTHELABO, HGS and SB and to provide SYNTHELABO, HGS and SB
with any material which is Developed Technology. HGS shall
have the right to file for and obtain patent protection for
Developed Technology and INSTITUTE agrees to cooperate with
and obtain execution of papers for HGS with respect thereto.
12. During the period of Research, INSTITUTE shall provide to
SYNTHELABO, HGS and SB at least once every six (6) months a
summary of the results of Institute's work under Appendix B
utilizing the Materials.
13. A party may terminate the Research by providing the other
parties with written notice. Upon such termination of the
Research, INSTITUTE will send to SB, HGS and SYNTHELABO a
final report including the results of the Research.
14. INSTITUTE hereby grants to HGS a sole and exclusive worldwide
right and license under Developed Technology to make, have
made, use, sell and have sold any and all products, processes,
apparatuses and compositions of matter (collectively
hereinafter "Product"), including the right to grant
sublicenses.
45
15. HGS shall pay to INSTITUTE the following royalties which shall
be due and payable sixty (60) days after June 30 and December
31 for Product sold in the respective half-year period:
a. One percent (1%) of net sale of Product sold by HGS
which where sold is covered by a valid and
enforceable claim of a granted patent licensed to HGS
hereunder; or
b. Ten percent (10%) of royalties received by HGSfrom a
sublicensee hereunder for Product sold by such
sublicensee which in the country where sold is
covered by a valid and enforceable claim of a granted
patent licensed to HGS hereunder.
16. In the event that royalties are to be paid by HGS to an
unaffiliated party for Product for which royalties are also
due hereunder, then the royalty to be paid hereunder shall be
reduced by the amount of royalty to be paid to such
unaffiliated party, but in no event shall the royalty to be
paid hereunder be reduced by more than fifty percent.
17. Any modification of or amendment to this Agreement will
require the written consent of the parties hereto.
18. This Agreement is not assignable by INSTITUTE, whether by
operation of law or otherwise, without the prior written
consent of HGS, SB and SYNTHELABO. Otherwise, this Agreement
is binding upon the successor(s) and assignee(s) of the
parties.
19. This Agreement may be signed in three or more counterparts and
each shall be an original.
IN WITNESS WHEREOF, the parties, intending to be legally bound, have
caused this Agreement to be executed by their respective duly authorized
representatives.
46
SYNTHELABO
By: _________________________________
Title: ______________________________
Date:________________________________
SMITHKLINE XXXXXXX CORP. HUMAN GENOME SCIENCES, INC.
By: ___________________________ By: _________________________________
Title: ________________________ Title: ______________________________
Date:__________________________ Date:________________________________
AGREED AND CONSENTED TO:
_______________________________
By: ___________________________ _____________________________________
Title: ________________________ Dr. (Principal Investigator)
Date: _________________________ Date: _______________________________
MTA APPENDIX A
--------------
MATERIAL(S)
MTA APPENDIX B
--------------
RESEARCH PLAN
47
APPENDIX C
EXAMPLES OF RESEARCH PLANS
TARGET RESEARCH PLAN
--------------------
*Target Identification
*Rationale
- Brief description of hypothesis
- Brief summary of supporting biological data on target
- Expected Indications for Product
*Status of full length cloning and express
- Full length nucleotide sequences
- Plans/estimated dates if expression not yet complete
*Patent status
*Screening Plan
- No description of screen(s) required
- Estimated date of screening start
- Use of target in specificity screens (if any)
- Rough estimate of compound throughput (can be updated)
*Chemical optimization
- No details required
- Estimated date of start/completion (can be updated)
*Plan updates if and when a potential development compound is identified
- R&D product (compound) code #/INN name/generic name
(when available)
- Notification when a compound enters preclinical
development
- Notification when a compound enters clinical development
- Notification when regulatory approvals are sought
48
ANTIBODY RESEARCH PLAN
----------------------
*Target (Antigen) Identification
*Rationale
- Brief description of hypothesis
- Expected indications for product
- Brief summary of supporting biological data on target
(antigen)
*Status of Cloning and Expression or Synthesis of Target (Antigen)
- Plans/estimated dates if expression/synthesis of target
(antigen)not yet complete
*Patent Status
*Research Plan
- Estimated date of immunization start
- Estimated date of antibody selection
- Estimated date for development
- Estimated date/notification when an antibody enters
preclinical development
- Estimated date/notification when an antibody enters
clinical development
- Estimated date/notification when regulatory approvals
are sought
49
PROTEIN RESEARCH PLAN
---------------------
*Therapeutic Protein Identification
*Rationale
- Brief description of hypothesis
- Expected indications for Product
*Biological data on protein
- Full length cloning
- Expression and purification
The protein preparation(s) used for the in vivo
activity demonstration must be purified to a
(previously agreed) specified level, and evidence of
this purity level must be included in the research
plan.
- In vivo demonstration of relevant pharmacological activity
(along with supporting demonstration of in vitro or ex vivo demonstrations of
activity if available)
In certain instances, in vivo demonstration of
activity will not be possible for scientific reasons.
In these specific cases, an ex-vivo or in vitro
demonstration of activity will be acceptable.
*Patent status (full length gene patent application must have been filed)
*Research and development plan
This plan need not contain detail of these activities, but rather
one-line descriptions of planned activities (with estimates of timing). Not all
of these plans/timings will be available when the initial plan is submitted, but
will be added as part of the yearly update of the plan.
- Further preclinical studies of activity
- Preclinical development
- determination of pharmacokinetic profile
- initiation of toxicology studies
- Steps to completion of IND package
- Certain key milestones in production/scale-up
- Clinical development
- Major phase transition (when available and appropriate)
50
