1
PRODUCT DEVELOPMENT, LICENSE
AND COPROMOTION AGREEMENT
BETWEEN
SMITHKLINE XXXXXXX PLC
AND
TEXAS BIOTECHNOLOGY CORPORATION
2
TABLE OF CONTENTS
PAGE
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1. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.01 ADMINISTRATIVE EXPENSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.02 ADVERSE EXPERIENCE(S) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.03 AFFILIATES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.04 AGGREGATE PROJECTED DETAILS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.05 AMI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.06 AMI BASELINE SALES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.07 ANNUAL TACTICAL PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.08 COPROMOTION EXPENSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.09 COROMED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.10 COST OF GOODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.11 DETAIL(S) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.12 EFFECTIVE DATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.13 FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.14 FIELD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.15 GENENTECH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.16 HIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.17 XXXXX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.18 JOINT DEVELOPMENT COMMITTEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.19 JOINT MARKETING TEAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.20 KNOW HOW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.21 MITSUBISHI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.22 NDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.24 NET SALES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.25 OTHER INDICATION BASELINE SALES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.26 PATENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.27 PRODUCT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.28 PSB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.29 PRODUCT STRATEGY PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.30 SB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.31 SYNTHELABO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.32 TARGET AUDIENCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.33 TBC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.34 TBC TRADEMARK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.35 TBC TRADEMARK ALTERNATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.36 TERRITORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.37 THIRD PARTY(IES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.38 THIRD PARTY ROYALTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.39 U.S.A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
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1.40 WORKING CAPITAL DEDUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.41 YEAR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2. GRANT AND RIGHTS TO FUTURE LICENSE RIGHTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3. DEVELOPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4. PAYMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
5. COMPULSORY LICENSE OR MARKETING RIGHTS AND THIRD PARTY ROYALTIES . . . . . . . . . . . . . . . . . . . . . . 19
6. COMMERCIALIZATION AND COPROMOTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
7. PRODUCT SUPPLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
8. EXCHANGE OF INFORMATION AND CONFIDENTIALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
9. PATENT PROSECUTION AND LITIGATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
10. TRADEMARKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
11. STATEMENTS AND REMITTANCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
12. TERM AND TERMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
13. RIGHTS AND DUTIES UPON TERMINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
14. WARRANTIES, REPRESENTATIONS, AND INDEMNIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
15. FORCE MAJEURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
16. GOVERNING LAW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
17. WAIVER OF BREACH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
18. SEPARABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
19. ENTIRE AGREEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
20. NOTICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
21. ASSIGNMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
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22. RECORDING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
23. NO PARTNERSHIP OR JOINT VENTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
24. EXECUTION IN COUNTERPARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
25. DISPUTE RESOLUTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
APPENDIX A
PATENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 00
XXXXXXXX X
PRODUCT STRATEGY PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
APPENDIX C
ANNUAL TACTICAL PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
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PRODUCT DEVELOPMENT, LICENSE,
AND COPROMOTION AGREEMENT
THIS PRODUCT DEVELOPMENT, LICENSE, AND COPROMOTION AGREEMENT
(hereinafter "AGREEMENT"), made as of the 5th day of August, 1997, between
Texas Biotechnology Corporation, a company organized under the laws of the
state of Delaware and having a place of business at 0000 Xxxxxx, Xxxxxxx, Xxxxx
00000, X.X.X. and SmithKline Xxxxxxx plc, a company organized under English law
and having its registered office at Xxx Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxx
XX0 0XX, Xxxxxxx,
W I T N E S S E T H T H A T:
WHEREAS, TBC, as defined below, is the owner of all right, title and
interest in certain patents, identified in Appendix A hereto, and know-how, or
otherwise has the right to grant certain licenses or sublicenses thereunder,
relating to a composition of matter known as argatroban; and
WHEREAS, SB, as defined below, desires to obtain certain licenses and
sublicensees in certain countries of the world from TBC under the aforesaid
patents and know-how, and TBC is willing to grant to SB such licenses and
sublicenses;
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:
1. DEFINITIONS
1.1 "ADMINISTRATIVE EXPENSES" shall mean those direct and/or
allocated administrative expenses which are incurred by SB and which are
allocated to PRODUCT for the particular indication in the FIELD [*] which in
the aggregate, under normal circumstances, [*]
1.2 "ADVERSE EXPERIENCE(S)" shall mean any noxious, pathological
or unintended change in anatomical, physiological or metabolic function as
indicated by physical signs, symptoms and/or laboratory changes occurring in
clinical trials, post-marketing surveillance, or clinical practice during use
of PRODUCT, or published in the medical literature, whether or not considered
causally related to the PRODUCT. This includes an exacerbation of a
pre-existing condition, intercurrent illness, drug interaction, significant
worsening of a disease under investigation or treatment, and significant
failure of expected pharmacological or biological action.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
6
1.3 "AFFILIATES" 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 the extent of at least
fifty percent (50%) of the equity (or, in the case of SB, such lesser percentage
which is the maximum allowed to be owned by a foreign corporation in a
particular jurisdiction) having the power to vote on or direct the affairs of
the entity and any person, firm, partnership, corporation or other entity
actually controlled by, controlling or under common control with a party.
1.4 "AGGREGATE PROJECTED DETAILS" shall mean the aggregate number
of DETAILS to be performed by SB sales representatives and TBC sales
representatives in the TERRITORY as determined by the JOINT MARKETING TEAM in
accordance with Paragraph 6.06.
1.5 "AMI" shall mean anti-coagulation therapy in acute myocardial
infarction.
1.6 "AMI BASELINE SALES" for each YEAR shall mean, the U.S. dollar
figure equal to the NET SALES of PRODUCT in the TERRITORY attributable
exclusively to AMI which [*] as such figure is determined by the JOINT
MARKETING TEAM in accordance with Paragraph 6.06(e).
1.7 "ANNUAL TACTICAL PLAN" shall mean the annual plan to be
developed for each country of the TERRITORY related to the tactics for the
promotion and sale of PRODUCT in such county, which plan shall be consistent
with the PRODUCT STRATEGY PLAN.
1.8 "COPROMOTION EXPENSES" shall mean those direct and/or
allocated expenses which are allocated to PRODUCT for the particular indication
in the FIELD that the parties are copromoting, which expenses are approved by
the JOINT MARKETING TEAM in accordance with Paragraph 6.06, and which expenses
are related to:
(a) [*]
(b) [*]
(c) [*] and
(d) [*]
In no event shall any [*] be included in COPROMOTION EXPENSES.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
2
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1.9 "COROMED" shall mean Coromed, Inc., a company organized under
the laws of the State of Delaware, having its principal place of business at
Renssalear Technology Park, 000 Xxxxxx Xxxx, Xxxx, Xxx Xxxx 00000-0000.
1.10 "COST OF GOODS" shall mean [*] as well as [*] COST OF GOODS
shall be calculated in accordance with U. S. Generally Accepted Accounting
Procedures (GAAP).
1.11 "DETAIL(S)" shall mean a face-to-face meeting, in an
individual or group practice setting, between a health care professional with
prescribing authority and a professional representative of the applicable party
during which a Major Presentation of PRODUCT is made to such health care
professional. When used as a verb, "DETAIL" shall mean to engage in a DETAIL.
The term "Major Presentation" as used in this Paragraph shall mean a full
PRODUCT presentation during which key PRODUCT attributes are verbally
presented, provided, however, that no more than two such presentations in any
DETAIL shall be considered a Major Presentation, which shall be the two
presentations on which the most time is spent during the DETAIL.
1.12 "EFFECTIVE DATE" shall mean the date upon which this AGREEMENT
is effective and shall be the date of this AGREEMENT first written above.
1.13 "FDA" shall mean the United States Food and Drug Administration
and any successor agency thereto.
1.14 "FIELD" shall mean any use of PRODUCT, other than the use of
PRODUCT for the coating of stents, related to the therapeutic, palliative, or
prophylactic treatment of any human condition for any cardiovascular, renal,
neurological, or immunological purpose, [*] Any indication which [*]
1.15 "GENENTECH" shall mean Genentech, Inc., a Delaware corporation
having a principal place of business at 000 Xxxxx Xxx Xxxxx Xxxx., Xxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000.
1.16 "HIT" shall mean anti-coagulant therapy in heparin-induced or
heparin-associated thrombocytopenia.
1.17 "XXXXX" shall mean anti-coagulant therapy in heparin-induced
or heparin-associated thrombocytopenia and thrombosis syndrome.
1.18 "JOINT DEVELOPMENT COMMITTEE" means the group, established and
conducted in accordance with the procedures set forth in Article 3.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
3
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1.19 "JOINT MARKETING TEAM" means the group, established and
conducted in accordance with the procedures set forth in Article 6.
1.20 "KNOW HOW" shall mean all present and future technical
information and know-how which is not in the public domain which relates to
PRODUCT and shall include, without limitation, all biological, chemical,
pharmacological, toxicological, clinical, assay, control and manufacturing data
and any other information relating to PRODUCT and useful for the development
and commercialization of PRODUCT in the FIELD in the TERRITORY.
1.21 "MITSUBISHI" shall mean Mitsubishi Chemical Corporation, a
company organized under the laws of the country of Japan, having a principal
place of business at Tennoz Xxxxxxx Xxxxx, 0-00 Xxxxxxxxxxxxxxxx 0-xxxxx,
Xxxxxxxxx-Xx, Xxxxx 000 Xxxxx.
1.22 "NDA" shall mean a New Drug Application in accordance with the
requirements of the FDA.
1.23 "NET OPERATING PROFIT" shall mean, with respect to a
particular indication for PRODUCT which the parties are copromoting in
accordance with Article 6, NET SALES attributable to the indication being
copromoted minus [*] minus [*] minus [*] minus [*]
1.24 "NET SALES" shall mean the gross receipts representing sales
of PRODUCT under this AGREEMENT by SB, its AFFILIATES or sublicensees ("the
Selling Party") to THIRD PARTIES less the following deductions:
(i) transportation charges [*] including insurance, for
transporting PRODUCT;
(ii) sales and excise taxes and duties [*] and any other
governmental charges imposed upon the production, importation, use or
sale of such PRODUCT;
(iii) trade, quantity and cash discounts allowed on
PRODUCT;
(iv) allowances or credits to customers on account of
rejection or return of PRODUCT or on account of retroactive price
reductions affecting such PRODUCT; and
(v) PRODUCT rebates and PRODUCT charge backs including
those granted to managed care entities and pharmaceutical benefit
management service entities.
Any sales between SB, its AFFILIATES and its or their sublicensees
shall be excluded from the computation of NET SALES and no royalties will be
payable on such sales.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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Notwithstanding the immediately preceding sentence, any transactions
between SB or any of its AFFILIATES or any of its sublicensees on the one hand
and PSB (as defined below) on the other hand will be deemed to be transactions
with THIRD PARTIES for the purposes of computing NET SALES, provided that the
conditions of such sales to PSB, including any and all rebates and discounts
allocated to transactions with any such PSB, shall be on an arms length basis
and shall be fully deductible for such computation purposes. In the event that
any PSB type activity is within SB or within any of its AFFILIATES or
sublicensees as only part of its or their total activities rather than in a
separate AFFILIATE a notional NET SALES figure will be calculated on an arms
length basis to cover such activities. Such notional NET SALES figure shall
not be less than the average net sales figure to other like THIRD PARTIES
during the same calendar period.
1.25 "OTHER INDICATION BASELINE SALES" for each YEAR shall mean,
the U.S. dollar figure equal to the NET SALES of PRODUCT in the TERRITORY
attributable exclusively to an indication other than HIT/XXXXX and AMI [*] as
such figure is determined by the JOINT MARKETING TEAM in accordance with
Paragraph 6.06(f).
1.26 "PATENTS" shall mean all patents and patent applications in
the TERRITORY which are or become owned by TBC, or to which TBC otherwise has,
now or in the future, the right to grant licenses and license rights or
sublicense and sublicense rights, which generically or specifically cover the
PRODUCT sold or a use of PRODUCT in the FIELD. Included within the definition
of PATENTS are all continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions thereof and all SPCs (i.e., a right
based upon a PATENT to exclude others from making, using or selling PRODUCT,
such as a Supplementary Protection Certificate). Also included within the
definition of PATENTS are any patents or patent applications which generically
or specifically claim any improvements on PRODUCT which are developed by TBC,
or which TBC otherwise has the right to grant licenses and license rights or
sublicense and sublicense rights, now or in the future, during the term of this
AGREEMENT. Also included within the definition of PATENTS are (a) all patents
and patent applications which are or become owned by TBC, or to which TBC
otherwise has, now or in the future, the right to grant licenses, which
generically or specifically claim PRODUCT, a process for formulating PRODUCT,
an intermediate used in such process or a use of PRODUCT in the FIELD, (b) all
continuations, continuations-in-part, divisions, patents of addition, reissues,
renewals or extensions thereof and all SPCs, and (c) any patents or patent
applications which generically or specifically claim any improvements on
PRODUCT or intermediates or formulation processes required or useful for
production of PRODUCT which are developed by TBC, or which TBC otherwise has
the right to grant licenses, now or in the future, during the term of the June
30, 1987 Mitsubishi-Genentech Agreement between Mitsubishi and Genentech, as
amended by the parties on June 25, 1992, May 27, 1993, and April 30, 1997. The
current list of patent applications and patents encompassed within PATENTS is
set forth in Appendix
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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A attached hereto. Appendix A shall be updated by TBC on at least a
semi-annual basis during the term of the AGREEMENT.
1.27 "PRODUCT" shall mean the chemical compound known as
argatroban, whose more specific chemical name is
(2R,4R)-4-methyl-l-[N2-((RS-3-methyl-1, 2, 3, 4-tetrahydro-8
quinolinesulfonyl)-L-arginyl]-2-pyperidinecarboxylic acid monohydrate, its
prodrugs and metabolites, and all esters, salts, hydrates, solvates, polymorphs
and isomers thereof, and shall include compositions comprising such compound,
prodrug, metabolite, or derivative.
1.28 "PSB" shall mean any present or future AFFILIATE of SB or its
sublicensees which conducts a Pharmaceutical Service Business for or on behalf
of THIRD PARTIES, including Pharmaceutical Benefits Management Services
(hereinafter "PBM"), wholesaler distribution, pharmacy distribution, managed
care services, disease management services, hospital services, or mail order
prescription pharmacy services. As of the EFFECTIVE DATE, an AFFILIATE of SB
which is included within the definition of PBM is Diversified Pharmaceutical
Services, a corporation of the state of Minnesota and having a place of
business at 0000 Xxxx 00xx Xxxxxx, Xxxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxxxx
00000-0000.
1.29 "PRODUCT STRATEGY PLAN" shall mean the plan to be developed to
assess the overall strategy required to exploit the commercial opportunity for
PRODUCT in the TERRITORY for HIT, XXXXX, and any other indication [*]
1.30 "SB" shall mean SmithKline Xxxxxxx plc, a company organized
under English law and having its registered office at Xxx Xxxxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx.
1.31 "SYNTHELABO" shall mean Synthelabo, a company organized under
the laws of the country of France, having a principal place of business at 00,
xxxxxx Xxxxxxx, 00000 Xx Xxxxxxx-Xxxxxxxx Xxxxx Xxxxxx.
1.32 "TARGET AUDIENCE" shall mean each physician specialty
identified by the JOINT MARKETING TEAM, in accordance with Paragraph 6.06, as
being a suitable 'target' for the promotion of PRODUCT for a particular
indication of PRODUCT in the FIELD in the TERRITORY which the parties are
copromoting. A physician shall be deemed to be a member of a physician
specialty if he/she has declared that specialty as his/her primary specialty.
1.33 "TBC" shall mean Texas Biotechnology Corporation, a company
organized under the laws of the state of Delaware and having a principal place
of business at 0000 Xxxxxx, Xxxxxxx, Xxxxx 00000, X.X.X.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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1.34 "TBC TRADEMARK" shall mean NOVASTAN, a trademark owned by
MITSUBISHI and licensed to TBC, with the right to grant sublicenses, in all
countries in the TERRITORY.
1.35 "TBC TRADEMARK ALTERNATE" shall mean a trademark other than
the TBC TRADEMARK which is acceptable to SB, and which TBC has developed,
applied for or registered, or will apply for or register, at TBC's expense, in
those countries in the TERRITORY where the TBC TRADEMARK is not available for
use and registration.
1.36 "TERRITORY" shall mean the means the United States of America,
its territories and possessions, including Puerto Rico; and Canada, as well all
other countries of the world which, during the term of the AGREEMENT, become
part of the TERRITORY.
1.37 "THIRD PARTY(IES)" shall mean any party other than SB and TBC.
1.38 "THIRD PARTY ROYALTIES" shall mean [*] as a result of NET
SALES, as well as any [*]
1.39 "U.S.A." shall mean the United States of America, its
territories and possessions, such as, but not limited to, Puerto Rico.
1.40 "WORKING CAPITAL DEDUCTION" shall mean the [*] outstanding at
the end of each quarter during each YEAR. The term 'net working capital' shall
mean the [*] under this AGREEMENT. The interest charge shall [*]
1.41 "YEAR" shall mean (a) for the first YEAR, the period following
the date of initiation of copromotion of PRODUCT in the FIELD in the TERRITORY
by the parties in accordance with Article 6, the period beginning on such date
through December 31 of the year of such initiation, and (b) for all YEARS after
the first YEAR, each calendar year thereafter unless the AGREEMENT expires or
terminates earlier than the end of the calendar year in accordance with the
provisions hereof.
2. GRANT AND RIGHTS TO FUTURE LICENSE RIGHTS
2.1 TBC hereby grants to SB the exclusive right, with the right to
grant sublicenses in accordance with this Paragraph, to the extent of TBC's
rights and interests under PATENTS and KNOW-HOW, to make, have made, use, sell,
offer for sale and import PRODUCT in the FIELD in the TERRITORY, subject to [*]
TBC's right to copromote PRODUCT in the FIELD in the
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
7
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TERRITORY as provided in Article 6, and all the other terms and conditions of
this AGREEMENT. SB shall have the unfettered right to grant sublicenses to any
AFFILIATE, but [*]
2.2 In the event that, after the EFFECTIVE DATE, TBC is able to
acquire rights to make, have made, use, sell, offer for sale and import PRODUCT
outside of the FIELD in the TERRITORY, the scope of the term 'FIELD' outlined
in Paragraph 1.13, and thus, the scope of the license outlined in Paragraph
2.01, shall be immediately adjusted to fully embrace such new rights, subject
to the parties mutual agreement as to the commercial terms of such license
expansion, provided that in the event the parties do not mutually agree on such
terms:
(a) TBC shall be free to make, have made, use, sell,
offer for sale and import PRODUCT [*] but it shall not be permitted to
[*] except that TBC shall be permitted to [*] in the TERRITORY, and
(b) in the event TBC elects to make, have made, use,
sell, offer for sale and import PRODUCT [*] TBC warrants and
represents that it will not knowingly engage in any activity regarding
[*] including, but not limited to, publication of preclinical or
clinical data related to PRODUCT, which is or ought to be recognized
by TBC as [*] and TBC further warrants and represents that it will
contractually bind any THIRD PARTY with whom it engages in such [*] to
the same prohibitions.
2.3 In the event that, after the EFFECTIVE DATE, TBC is able to
acquire rights to make, have made, use, sell, offer for sale and import PRODUCT
in the FIELD outside of the TERRITORY, SB shall have the first right to an
exclusive license and sublicense under such rights in all countries outside of
the TERRITORY in which such rights are acquired upon terms and conditions to be
mutually agreed upon by the parties in good faith. TBC shall provide SB with
written notification of the availability of such rights. If the parties have
not determined such mutually acceptable terms and conditions within [*] after
SB's receipt of such notice, [*]
3. DEVELOPMENT
3.1 Promptly after the EFFECTIVE DATE, the parties shall form a
JOINT DEVELOPMENT COMMITTEE whose mandate shall be to (i) direct the regulatory
and scientific development of PRODUCT necessary to receive approval of the
PRODUCT in the TERRITORY for HIT/XXXXX, and (ii) evaluate the scientific
feasibility and direct any subsequent joint development of PRODUCT for
additional indications in the FIELD in the TERRITORY such as, but not limited
to, AMI.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
8
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3.2 Within thirty (30) days following the EFFECTIVE DATE, the
parties shall each nominate up to four (4) voting representatives for membership
on the JOINT DEVELOPMENT COMMITTEE. Membership shall include representation
from each party's scientific, clinical development, commercial development, and
regulatory affairs departments. In the event that either party decides to
appoint less than four (4) representatives, such party shall nevertheless retain
four (4) votes on each matter brought before the JOINT DEVELOPMENT COMMITTEE.
At least two (2) representatives from each party shall be present to represent a
quorum for voting purposes. In addition, the JOINT DEVELOPMENT COMMITTEE may
from time to time include additional non-voting ad-hoc representatives from
either party on specific issues as the need arises.
3.3 The chairman of the JOINT DEVELOPMENT COMMITTEE shall be one
of the members of the JOINT DEVELOPMENT COMMITTEE. Chairmanship of the JOINT
DEVELOPMENT COMMITTEE shall alternate between an SB member and a TBC member on
an annual basis, with a TBC member serving as JOINT DEVELOPMENT COMMITTEE
chairman for the first year following the EFFECTIVE DATE. The first meeting of
the JOINT DEVELOPMENT COMMITTEE shall occur within thirty (30 days) after the
EFFECTIVE DATE. The purpose of the initial meeting shall be to review the
current status of the development of PRODUCT in the FIELD in the TERRITORY and
to agree on an operational charter which shall set forth the principles and
guidelines for the governance of the JOINT DEVELOPMENT COMMITTEE. Thereafter,
meetings shall be held once a quarter unless no later than thirty (30) days in
advance of any meeting there is a determination by the JOINT DEVELOPMENT
COMMITTEE that no new business or other activity has transpired since the
previous meeting, and that there is no need for a meeting. In such instance,
the next quarterly meeting will be scheduled. The location of such meetings
shall alternate between TBC's offices in Houston, Texas and SB's offices in the
Philadelphia, Pennsylvania metropolitan area unless otherwise agreed upon
between the parties, with the first meeting to be held at TBC's offices. JOINT
DEVELOPMENT COMMITTEE meetings may not necessarily be face-to- face meetings
but, upon the agreement of both parties, can be via other methods of
communication such as teleconferences and/or videoconference. Minutes of each
JOINT DEVELOPMENT COMMITTEE meeting will be transcribed and issued by the
chairman within thirty (30) days after each meeting and shall be approved as
the first order of business at the immediately succeeding JOINT DEVELOPMENT
COMMITTEE meeting.
3.4 Subject to Paragraphs 3.08 and 3.12, the [*] decision of [*]
shall be final and binding upon both parties, including all activity related to
package inserts and labeling, provided that such [*] and further provided that
any disputes which cannot be settled by the JOINT DEVELOPMENT COMMITTEE after
good faith attempts shall be referred to [*] for resolution, provided that [*]
3.5 During the term of the AGREEMENT, TBC shall carry out the
remaining preclinical and clinical development of PRODUCT in the TERRITORY for
the indications of HIT and XXXXX,
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
9
14
and the remaining work required for filing of regulatory applications for
PRODUCT regulatory approvals for the indications of HIT and XXXXX, to the
extent necessary to achieve product registration in the TERRITORY for such
indications, and [*] All activity carried out by TBC under this Paragraph shall
be done in accordance with the recommendations of the JOINT DEVELOPMENT
COMMITTEE. TBC will exercise its reasonable efforts and diligence in carrying
out its responsibilities under this Paragraph.
3.6 TBC shall have exclusive financial responsibility for funding
all development and product registration work for PRODUCT in the FIELD in the
TERRITORY which is related to the indications of HIT and XXXXX and which was
initiated as of the EFFECTIVE DATE. All out of pocket expenses associated with
additional development and product registration work for PRODUCT in the FIELD
in the TERRITORY which is related to the indications of HIT and XXXXX which is
recommended by the JOINT DEVELOPMENT COMMITTEE and which is required for NDA
Approval for HIT/XXXXX (as defined in Paragraph 4.01(4)) shall be funded by the
parties with SB funding sixty percent (60%) and TBC funding forty percent
(40%). SB shall provide all [*] funding for Phase IV local post regulatory
approval trials except that any Phase IV trials which are requested by the FDA
as a condition of NDA Approval (as defined in Paragraph 4.01(4)) shall be
considered development and product registration work for PRODUCT "which is
required for NDA Approval for HIT/HTTS (as defined in Paragraph 4.01(4))" for
purposes of determining the parties relative funding obligations under this
Paragraph.
3.7 TBC warrants and represents that as of the EFFECTIVE DATE, TBC
has sufficient monetary resources available to enable it to carry out its
funding obligation under Paragraph 3.06. In the event that, due to unforeseen
circumstances, TBC becomes aware that it will have significant problems in
carrying out its obligations under Paragraph 3.06, it shall [*] In the event
that [*] under Paragraph 3.06, [*] In such event, [*]
3.8 At the successful completion of all studies required by the
FDA for Phase II clinical development, the JOINT DEVELOPMENT COMMITTEE shall
review all the data to determine if such data [*] In the event that the JOINT
DEVELOPMENT COMMTTEE makes a positive determination, it shall give prompt
written notice thereof to both TBC and SB. SB shall have [*] after the date it
receives such written notice to determine if [*] Notwithstanding Paragraph
3.04, SB shall have unilateral discretion to determine if [*] In the event
that SB makes [*] in the TERRITORY, the following shall be applicable. At the
time that SB makes such [*] either TBC shall warrant and represent that at such
time, TBC has or will have sufficient [*] under Paragraph 3.08 or else the
parties shall promptly meet to determine the appropriate distribution of [*] In
the event that TBC makes such warranty and representation, all out of pocket
expenses related to development and product registration work for PRODUCT in
the FIELD in the TERRITORY which is related to the indication of AMI which is
required for NDA Approval for AMI (as defined in Paragraph 4.02(4))
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
10
15
which is recommended by the JOINT DEVELOPMENT COMMITTEE shall be funded by the
parties with SB funding sixty percent (60%) and TBC funding forty percent
(40%). SB shall provide all [*] funding for Phase IV local post regulatory
approval trials except that any Phase IV trials which are requested by the FDA
as a condition of NDA Approval for AMI (as defined in Paragraph 4.02(4)) shall
be considered development and product registration work for PRODUCT "which is
required for NDA Approval for AMI (as defined in Paragraph 4.02(4))" for
purposes of determining the parties relative funding obligations under this
Paragraph. All such work which is performed after the EFFECTIVE DATE shall be
in accordance with the recommendations of the JOINT DEVELOPMENT COMMITTEE.
3.9 In the event that SB determines that it wants [*] as outlined
in Paragraph 3.08, TBC shall carry out the remaining preclinical and clinical
development of PRODUCT in the TERRITORY for the indication of AMI, and the
remaining work required for filing of regulatory applications for PRODUCT
regulatory approvals for the indication of AMI, to the extent necessary to
achieve product registration in the TERRITORY for such indication, and [*] All
such activity carried out by TBC under this Paragraph shall be done in
accordance with the recommendations of the JOINT DEVELOPMENT COMMITTEE. TBC
will exercise its reasonable efforts and diligence in carrying out its
responsibilities under this Paragraph.
3.10 In the event that, [*] it shall promptly notify SB, in
writing, and SB, [*] In the event that SB elects to [*] under Paragraph 3.08,
in excess of the sixty percent (60%) required under Paragraph 3.08, the parties
will .[*]. In such event,[*] required by Paragraph 3.08 shall be [*] provided
that, during any calendar year,[*] and further provided that [*].
3.11 In the event that SB determines that it does not want to
participate in the commercialization of PRODUCT in the TERRITORY for AMI as
outlined in Paragraph 3.08, TBC shall be free to develop, register, and
commercialize PRODUCT in the TERRITORY for the indication of AMI, on their own,
at its sole expense, utilizing sales representatives who are employees of TBC,
subject to Paragraph 21.01, provided that TBC shall not have the right to [*]
further provided that TBC warrants and represents that it will do so in such a
manner so as not to [*] and TBC shall [*] and TBC further warrants and
represents that it will contractually bind any THIRD PARTY with whom it engages
in such development to the same prohibitions. In the event that TBC decides at
the time of NDA Acceptance for AMI (as defined in Paragraph 4.02(3) that it
wants to offer SB the right to [*] with or without TBC, it shall provide
written notice thereof to SB and the following shall be applicable:
(a) in the event that SB determines that it wishes to
accept such offer:
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
11
16
(i) SB must accept such offer no later than [*]
after the date SB receives written notification from TBC of the
offer; and
(ii) [*] and
(b) in the event that SB elects not to accept such offer,
or does not do so within the time period outlined in this Paragraph,
TBC shall [*], provided that TBC shall not have the right to [*],
further provided that TBC warrants and represents that it will do so
in such a manner so as not to [*], and TBC shall [*] and TBC further
warrants and represents that it will contractually bind any THIRD
PARTY with whom it engages in such development to the same
prohibitions.
3.12 The parties may at any time submit to the JOINT DEVELOPMENT
COMMITTEE a proposal to develop PRODUCT for any other indication in the FIELD
in addition to HIT/XXXXX or AMI. Such proposal shall contain, at a minimum,
information supporting the rationale for developing each additional indication
of PRODUCT from a scientific, regulatory and commercial standpoint, as well as
an estimated developmental critical path and an estimate of the cost of such
development. In keeping with the collaborative spirit of this AGREEMENT, all
proposals shall be considered by the JOINT DEVELOPMENT COMMITTEE as joint
proposals without regard for which entity initiates or "champions" the
proposals. The JOINT DEVELOPMENT COMMITTEE shall approve such proposal if (i)
it determines that the program has scientific and technical merit and is likely
to result in the approval of a new indication(s) and (ii) the commercial return
from sales of PRODUCT in the TERRITORY for such new indication can reasonably
be expected to offset the cost of development within a reasonable period of
time following launch for such new indication of PRODUCT and produce an
acceptable return on investment to both parties. If the JOINT DEVELOPMENT
COMMITTEE approves a proposal, it shall give prompt written notice thereof to
SB and TBC. In the event that the JOINT DEVELOPMENT COMMITTEE approves a
proposal, it shall give prompt written notice thereof to both TBC and SB. SB
shall have [*] after the date it receives such written notice to [*].
Notwithstanding Paragraph 3.04, SB shall have unilateral discretion to
determine if it [*] for such additional indication in the TERRITORY.
3.13 In the event that SB determines that it wants to [*] as
outlined in Paragraph 3.12, the parties shall determine [*] the remaining
preclinical and clinical development of PRODUCT in the TERRITORY for the
additional indication, and the remaining work required for filing of regulatory
applications for PRODUCT regulatory approvals for the additional indication, to
the extent necessary to achieve product registration in the TERRITORY for such
additional indication. All such activity carried out under this Paragraph
shall be done in accordance with the recommendations of the JOINT DEVELOPMENT
COMMITTEE. TBC and SB will each exercise its reasonable efforts and diligence
in carrying out its respective responsibilities under this Paragraph. At the
time that SB
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
12
17
makes [*] under Paragraph 3.12, either TBC shall warrant and represent that at
such time, TBC has or will have [*] or else the parties shall promptly meet to
determine the appropriate [*] as well as an appropriate [*]. In the event that
TBC makes such warranty and representation, all out of pocket expenses related
to development and product registration work for PRODUCT in the FIELD in the
TERRITORY which is related to the additional indication which is recommended by
the JOINT DEVELOPMENT COMMITTEE and which is required for FDA approval of an NDA
filed by or on behalf of TBC to market PRODUCT for such additional indication in
the U.S.A. (including any Phase IV clinical trials which are required by the
FDA as a condition of such approval) shall be funded by the parties with SB
funding sixty percent (60%) and TBC funding forty percent (40%).
3.14 In the event that, due to unforeseen circumstances, TBC [*],
it shall promptly notify SB, in writing, and SB, at its option, shall have the
right to [*], provided that [*]. In the event that SB elects to [*] under
Paragraph 3.13, the parties will [*] the remaining development and registration
of PRODUCT in the TERRITORY for the additional indication. In such event,[*].
3.15 In the event that SB determined that it [*] as outlined in
Paragraph 3.13, TBC shall [*], provided that TBC shall not have the right to
[*], further provided that TBC warrants and represents that it will do so in
such a manner so as not to [*] and TBC shall be [*] and TBC further warrants
and represents that it will contractually bind any THIRD PARTY with whom it
engages in such development to the same prohibitions.
4. PAYMENTS
4.1 In consideration for the license and sublicense under PATENTS
and KNOW-HOW granted to SB in this AGREEMENT, SB shall pay TBC eight and one
half million U.S. dollars (U.S. $8,500,000) within [*] after the EFFECTIVE
DATE, and shall make the following milestone payments (in U.S. dollars) to TBC,
in the specified amounts, within [*] after the occurrence of the following
milestones:
(a) [*] $ U.S. [*]
(b) [*] $ U.S. [*]
provided that:
(1) each such payment shall be made only one time
regardless of how many times such milestones are achieved, and
no payment shall be owed for a milestone which is not reached;
(2) each such payment shall be [*];
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
13
18
(3) by the term [*]; and
(4) by the term [*].
4.2 In consideration for the license and sublicense under PATENTS
and KNOW-HOW granted to SB in this AGREEMENT, in the event that [*] in
accordance with Paragraph 3.08, SB shall make the following milestone payments
(in U.S. dollars) to TBC, in the specified amounts, within [*] after the
occurrence of the following milestones:
(a) [*] $ U.S. [*]
(b) [*] $ U.S. [*]
provided that:
(1) each such payment shall be made only one time
regardless of how many times such milestones are achieved, and
no payment shall be owed for a milestone which is not reached;
(2) each such payment shall be [*];
(3) by the term [*]; and
(4) by the term [*].
4.3 In further consideration for the license and sublicense under
PATENTS granted to SB under the AGREEMENT, SB shall make the following royalty
payments to TBC for those NET SALES which are not subject to the payment
obligation outlined in Paragraphs 4.05 or 4.07:
[*] of annual NET SALES up to and including [*]; and
[*] of annual) NET SALES in excess of [*] up to and including
[*];
provided that, in each year in which the annual NET SALES are in excess of [*],
the royalty payment on [*] NET SALES for such annual period shall be [*] of
such NET SALES, and further provided that, for purposes of this Paragraph,
achievement of the NET SALES thresholds and payment obligations recited above
shall be determined by adding the total annual NET SALES for all indications in
the FIELD for which TBC is not copromoting at least [*] of the TARGETED DETAILS
for such annual period as determined in accordance with Article 6 in all
countries of the TERRITORY where there is (i) [*] or [*], and (ii)[*] of such
NET SALES. By the term [*] as used
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
14
19
in this Paragraph is meant [*]. By the term [*] is meant that a [*] in the
particular country of the TERRITORY which [*] in such country [*]. SB shall
give TBC written notice of [*].
4.4 In further consideration for the license and sublicense under
KNOW-HOW granted to SB under the AGREEMENT, royalties on annual NET SALES in
those countries of the TERRITORY which are not subject to the royalty
obligation outlined in Paragraph 4.03 or the payment obligation outlined in
Paragraphs 4.05 or 4.07 shall be calculated separately for each annual period,
at [*] the royalty rates outlined in Paragraph 4.03.
4.5 (a) If TBC does exercise the copromotion option outlined
in Article 6 in accordance with Paragraph 6.02, and during a
particular YEAR, TBC has performed at least [*] of the AGGREGATE
PROJECTED DETAILS of PRODUCT for all indications in the FIELD which
the parties are copromoting, then, in lieu of the payments to TBC
outlined in Paragraphs 4.03 and 4.04, SB shall pay TBC the following
share of NET OPERATING PROFIT for each such indication being
copromoted in accordance with Article 6:
(i) [*] of all NET OPERATING PROFIT attributable
to HIT/XXXXX during such YEAR,
(ii) [*] of all NET OPERATING PROFIT attributable
to AMI during such YEAR up to the AMI BASELINE SALES;
(iii) [*] of all NET OPERATING PROFIT attributable
to AMI during such YEAR above the AMI BASELINE SALES;
(iv) [*] of all NET OPERATING PROFIT attributable
to any indication other than HIT/XXXXX and AMI up to the OTHER
INDICATION BASELINE SALES attributable to such indication;
(v) [*] of all NET OPERATING PROFIT attributable
to any indication other than HIT/XXXXX and AMI above the OTHER
INDICATION BASELINE SALES attributable to such indication.
(b) if, during any YEAR in which TBC is copromoting
PRODUCT as outlined in Article 6, there is a negative NET OPERATING
PROFIT for the TERRITORY, for any indication in the FIELD that the
parties are copromoting, such negative NET OPERATING PROFIT shall be
distributed between the parties in accordance with Paragraphs 4.05(a).
(c) If TBC does exercise the copromotion option outlined
in Article 6 in accordance with Paragraph 6.02 but, during a
particular YEAR, TBC has not performed at
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
15
20
least [*] of the AGGREGATE PROJECTED DETAILS of PRODUCT for all
indications in the FIELD which the parties are copromoting, then TBC
shall not be entitled to any share of the NET OPERATING PROFIT for any
NET SALES for any indications which the parties are copromoting, but
SB shall pay TBC the royalties on such NET SALES during such
particular YEAR outlined in Paragraphs 4.03 or 4.04, whichever is
applicable.
(d) If TBC commercializes PRODUCT in the TERRITORY for
the indication of [*] in accordance with Paragraph 3.11, SB shall pay
TBC [*] of all NET SALES in the TERRITORY attributable to [*] during
each annual period during the term of the AGREEMENT following TBC's
commercial launch of PRODUCT for such indication minus [*] minus [*]
minus [*] minus [*] minus [*].
(e) If TBC commercializes PRODUCT in the TERRITORY for an
indication [*] in accordance with Paragraph 3.15, SB shall pay TBC [*]
of all NET SALES in the TERRITORY attributable to such indication
during each annual period during the term of the AGREEMENT following
TBC's commercial launch of PRODUCT for such indication minus [*] minus
[*] minus [*] minus [*].
4.6 In addition to the payments set forth in Paragraphs 4.01
through 4.05, SB shall purchase from TBC one million U.S. dollars (U.S.
$1,000,000) worth of TBC common stock pursuant to the terms and conditions of a
separate Common Stock Purchase Agreement to be executed simultaneously herewith
upon the closing thereof and, at TBC's option, up to two million U.S. dollars
(U.S. $2,000,000) worth of TBC common stock pursuant to such Common Stock
Purchase Agreement before the first anniversary of such closing.
4.7 In the event that TBC elects to copromote PRODUCT with SB in
accordance with Paragraph 6.02, and provided that TBC has not irrevocably lost
its right to copromote under Paragraph 6.09, then [*] in accordance with
Paragraph 12.01(d)(i), SB shall make the following payments (in U.S. dollars)
to TBC:
(a) [*] of NET SALES for the indications for which TBC
copromoted PRODUCT with SB in accordance with Paragraph 6.02 [*];
(b) [*] of NET SALES for the indications for which TBC
copromoted PRODUCT with SB in accordance with Paragraph 6.02 [*]; and
(c) [*] of NET SALES for the indications for which TBC
copromoted PRODUCT with SB in accordance with Paragraph 6.02 [*].
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
16
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Such payments shall be made to TBC in accordance with Paragraph 11.03.
4.8 In the event that SB wants to continue to employ [*], SB shall
pay TBC [*] of annual NET SALES, provided that the royalties set forth in this
Paragraph shall be applicable only with respect to those NET SALES for which SB
employed [*].
5. COMPULSORY LICENSE OR MARKETING RIGHTS AND THIRD PARTY ROYALTIES
5.1 In the event that a governmental agency in any country or
territory of the TERRITORY grants or compels TBC to grant license or marketing
rights to any THIRD PARTY for PRODUCT in the FIELD, SB shall have the benefit
in such country or territory of the terms granted to such THIRD PARTY to the
extent that such terms are more favorable to the THIRD PARTY than those of this
AGREEMENT.
5.2 (a) During the term of this AGREEMENT, the parties, in
good faith, shall mutually determine if it is necessary to seek a
license from, and make royalty or other fee payments to, any THIRD
PARTY in order to avoid infringement during the use, sale, offer for
sale or importation of PRODUCT in the FIELD anywhere in the TERRITORY,
provided that if the parties cannot agree on the need for any such
license or the commercial provisions relating to such license, the
parties shall endeavor to find a mutually acceptable resolution of
this matter, and if the parties cannot determine such a mutually
acceptable resolution, the parties shall submit the matter to a
mutually acceptable THIRD PARTY expert for a final and binding
resolution, the cost of such expert to be equally shared by the
parties.
(b) If TBC does exercise the copromotion option outlined
in Article 6 in accordance with Paragraph 6.02, and during a
particular YEAR, TBC has performed at least [*] of the AGGREGATE
PROJECTED DETAILS of PRODUCT for all indications in the FIELD which
the parties are copromoting, then [*].
(c) If TBC does exercise the copromotion option outlined
in Article 6 in accordance with Paragraph 6.02, but during a
particular YEAR TBC has not performed at [*] of the AGGREGATE
PROJECTED DETAILS of PRODUCT for all indications in the FIELD which
the parties are copromoting, or if TBC does not exercise the
copromotion option outlined in Article 6, then [*], provided that in
no event [*].
6. COMMERCIALIZATION AND COPROMOTION
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
17
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6.1 SB will commercialize PRODUCT in the FIELD in the TERRITORY in
accordance with the guidelines of the JOINT MARKETING TEAM as set forth in the
provisions of this Article 6. SB will exercise its reasonable efforts and
diligence in commercializing PRODUCT in the FIELD in the TERRITORY in
accordance with its business, legal, medical and scientific judgment and SB's
normal practices and procedures for compounds having similar technical and
commercial potential, and all such activity shall be undertaken at SB's
expense.
6.2 (a) In the event that (i) SB makes a positive election to
participate in the commercialization of PRODUCT for AMI in the
TERRITORY in accordance with either Paragraph 3.08 or Paragraph 3.11,
and (ii) NDA Approval for AMI (as defined in Paragraph 4.02(4))
occurs, TBC shall have the right to copromote PRODUCT with SB to the
TARGET AUDIENCE in the TERRITORY for HIT/XXXXX and for AMI beginning
on the later of [*] or the date of [*], provided TBC must notify SB in
writing if TBC has elected to copromote PRODUCT with SB for such
indications by the later of [*] after [*] or [*]. In the event that
[*], in which event TBC's actual right to copromote shall vest on [*],
provided that any decision by TBC not to copromote PRODUCT for such
indications shall be irrevocable, and TBC's failure to provide
affirmative written notification to SB of its election to copromote
during the [*] shall irrevocably terminate TBC's right to copromote
PRODUCT with SB for such indications. TBC shall not have the right to
sublicense this copromotion right to any THIRD PARTY.
(b) In the event that (i) SB makes a positive election to
participate in the commercialization of PRODUCT for an additional
indication in the FIELD in the TERRITORY in accordance with Paragraph
3.12, and (ii) the FDA approves an NDA filed by or on behalf of TBC
for marketing PRODUCT for such additional indication in the U.S.A.,
TBC shall have the right to copromote PRODUCT with SB to the TARGET
AUDIENCE in the TERRITORY for such additional indication beginning on
the later of [*] or the date the [*] provided TBC must notify SB in
writing if TBC has elected to copromote PRODUCT with SB for such
additional indication by the later of [*] or [*] after [*]. Any
decision by TBC not to copromote PRODUCT for such indication shall be
irrevocable, and TBC's failure to provide affirmative written
notification to SB of its election to copromote during the
notification period outlined in this Paragraph shall irrevocably
terminate TBC's right to copromote PRODUCT with SB for such
indications. TBC shall not have the right to sublicense this
copromotion right to any THIRD PARTY.
6.3 No later than [*] after the EFFECTIVE DATE, SB and TBC shall
assemble a team of appropriate personnel from both SB and TBC (hereinafter
"JOINT MARKETING TEAM") to plan the pre-launch, launch, post-launch and ongoing
promotional activities for PRODUCT in the FIELD in the TERRITORY. The JOINT
MARKETING TEAM shall consist of six (6) members,
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
18
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three (3) of whom shall be appointed by SB and three (3) of whom shall be
appointed by TBC. The presence of at least four (4) members, two (2) of whom
shall have been selected by each party, shall constitute a quorum for purposes
of consideration and action by the JOINT MARKETING TEAM. Each member shall
have one vote on all matters, and whenever action is to be taken by vote of the
JOINT MARKETING TEAM, it shall be authorized by [*]. Chairmanship of the JOINT
MARKETING TEAM shall reside with SB.
Meetings of the JOINT MARKETING TEAM shall be held on a quarterly
basis commencing the quarter in which the filing of the NDA for HIT/XXXXX in
the U.S.A. occurs, unless the chairman determines, no later than thirty (30)
days in advance of any meeting following the initial meeting, that no new
business or other activity has transpired since the previous meeting. In such
instance, the next quarterly meeting will be scheduled. The location of JOINT
MARKETING TEAM meetings shall alternate between SB's offices in the
Philadelphia, Pennsylvania metropolitan area and TBC's offices in Houston,
Texas, unless otherwise agreed upon between the parties, with the first meeting
to be held at SB's offices. JOINT MARKETING TEAM meetings may not necessarily
be face-to-face meetings, but upon the agreement of both parties can be via
other methods of communication such as teleconferences and/or videoconferences.
Minutes of the JOINT MARKETING TEAM shall be transcribed and issued by the
chairman within thirty (30) days after each meeting and shall be approved as
the first order of business at the immediately succeeding JOINT MARKETING TEAM
meeting.
6.4 In accordance with the standard practices of the time within
SB's U.S.A. and Canadian pharmaceuticals division, a PRODUCT STRATEGY PLAN and
an ANNUAL TACTICAL PLAN (which shall include plans related to the prelaunch,
launch, promotion and sale of PRODUCT to each TARGET AUDIENCE for each
indication that SB is promoting) for the U.S.A. and Canada shall be developed
by the JOINT MARKETING TEAM for PRODUCT on an annual basis. Such plans shall
be developed in conformance with the samples thereof attached hereto in
APPENDIX B and APPENDIX C, as such samples may be modified from time to time by
SB management in accordance with its normal practices and procedures, and will
be presented by the JOINT MARKETING TEAM to appropriate SB management for
endorsement. TBC expressly acknowledges that both the form and the content of
the samples as well as the actual plans that are developed by the parties are
SB's confidential and proprietary information and subject to the
confidentiality obligations outlined in Article 8 of this AGREEMENT. The
ANNUAL TACTICAL PLAN shall substantially conform to the PRODUCT STRATEGY PLAN.
The first PRODUCT STRATEGY PLAN for the U.S.A. shall be completed by the JOINT
MARKETING TEAM for presentation to SB management within [*] after the EFFECTIVE
DATE. The first PRODUCT STRATEGY PLAN for Canada shall be completed by the
JOINT MARKETING TEAM for presentation to SB management in accordance with [*]
within SB's Canadian pharmaceuticals division.
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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6.5 The [*] decision of the JOINT MARKETING TEAM shall be final
and binding upon both parties, provided that, any disputes which cannot be
settled by the JOINT MARKETING TEAM after good faith attempts [*].
Notwithstanding the first sentence of this Paragraph 6.05 and any other
provision of this AGREEMENT, and subject to any termination of the AGREEMENT
permitted under Article 12, all decisions concerning the following aspects of
any PRODUCT promotion in the FIELD in any country of the TERRITORY or
copromotion in the FIELD in any country of the TERRITORY shall be subject to
final approval by SB management after careful consideration of all commentary
on such aspects provided to such management by the JOINT MARKETING TEAM and TBC
representatives:
(a) the entirety of the content of the PRODUCT STRATEGY
PLAN and the ANNUAL TACTICAL PLAN, including the TARGET AUDIENCE(S)
for each indication for PRODUCT in the FIELD in the TERRITORY;
(b) any issue related to the promotion or
commercialization of PRODUCT in the TERRITORY for HIT/XXXXX, XXX or
any other indication which SB is promoting in the TERRITORY;
(c) pricing decisions, including the list selling price
to the trade, the terms of sale in the TERRITORY including, without
limitation, payment terms, trade relations, discount and rebate
programs and contract terms with managed health care customers;
(d) content of promotional methods (e.g., detailing,
seminars, conferences, etc.) and messages (e.g., advertising text),
provided that such approval shall be only with respect to SB's
determination of whether or not such methods or messages meet all
requisite medical, legal, and regulatory requirements, including those
requirements related to issues concerning product liability;
(e) termination of selling and/or promotion by SB;
(f) promotional spend and number of DETAILS to be made by
SB in support of PRODUCT in the TERRITORY irrespective of whether or
not the parties are COPROMOTING PRODUCT in any country of the
TERRITORY.
6.6 Subject to Paragraphs 6.02, 6.03, 6.04, and 6.05, the
following principles shall apply to any copromotion of PRODUCT by SB and TBC
for which SB has received affirmative notification from TBC in accordance with
Paragraph 6.02 hereof:
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
20
25
(a) the JOINT MARKETING TEAM shall determine the TARGET
AUDIENCE(S) for each indication for PRODUCT in the FIELD in the
TERRITORY, provided that such determination shall be in accordance
with the ANNUAL TACTICAL PLAN and the PRODUCT STRATEGY PLAN.
(b) the JOINT MARKETING TEAM shall reasonably determine
[*] in advance of each calendar year (or partial year for the year in
which copromotion of PRODUCT is expected to begin) the aggregate
number of DETAILS to be performed by SB sales representatives and TBC
sales representatives ("AGGREGATE PROJECTED DETAILS") to each TARGET
AUDIENCE during such year in the TERRITORY. Such determination shall
be made considering factors including the number of physicians in each
TARGET AUDIENCE, their geographic license, the elapsed time since
product launch, and the frequency of detailing visits to the TARGET
AUDIENCE customary in pharmaceutical sales practice in TERRITORY for
products of similar technical and commercial potential as PRODUCT,
provided that such determination shall be in accordance with the
ANNUAL TACTICAL PLAN and the PRODUCT STRATEGY PLAN.
(c) the JOINT MARKETING TEAM shall reasonably determine
[*] in advance of each calendar year (or partial year for the year in
which copromotion of PRODUCT is expected to begin) the maximum number
of TBC sales representatives available during the entirety of such
year to perform DETAILS in the TERRITORY;
(d) SB shall determine the COPROMOTION EXPENSES for each
indication for PRODUCT in the FIELD in the TERRITORY that the parties
are copromoting and shall present such determination to the JOINT
MARKETING TEAM for endorsement.
(e) SB shall determine the AMI BASELINE SALES in the
event that SB makes a positive election to participate in the
commercialization of PRODUCT for AMI in the TERRITORY in accordance
with either Paragraph 3.08 or Paragraph 3.11 in accordance with the
following procedure. SB shall present to the JOINT MARKETING TEAM,
for its approval, a sales forecast for AMI in the TERRITORY covering
[*] post commercial launch for such indication in the TERRITORY, such
sales forecast to be based upon the sales which would be achievable by
SB without any copromotion for such indication by TBC. This forecast
will be the AMI BASELINE SALES and shall be updated [*].
(f) SB shall determine the OTHER INDICATION BASELINE
SALES in the event that SB makes a positive election to participate in
the commercialization of PRODUCT for another indication in the
TERRITORY in accordance with Paragraph 3.12 in accordance with the
following procedure. SB shall present to the JOINT MARKETING TEAM,
for its
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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approval, a sales forecast for OTHER INDICATION in the TERRITORY
covering [*] post commercial launch for such indication in the
TERRITORY, such sales forecast to be based upon the sales which would
be achievable by SB without any copromotion for such indication by
TBC. This forecast will be the OTHER INDICATION BASELINE SALES and
shall be updated [*].
(g) SB shall determine the break out of total NET SALES
between all of the indications in the FIELD being marketed by either
or both of the parties under this AGREEMENT, such break out to be
based on [*]. SB shall present this determination to the JOINT
MARKETING TEAM for its endorsement.
(h) the JOINT MARKETING TEAM shall determine if the use
of the TBC TRADEMARK is appropriate in each country of the TERRITORY.
In the event a determination is made that the TBC TRADEMARK is not
appropriate for a particular country, the JOINT MARKETING TEAM will
select the TBC TRADEMARK ALTERNATE for such country.
6.7 With respect to indications for which SB and TBC are
copromoting in accordance with Article 6, during each YEAR, TBC shall be
entitled to perform a guaranteed number of the AGGREGATE PROJECTED DETAILS in
the TERRITORY ("TBC's Guaranteed Details"), such number to be equal to [*] of
AGGREGATE PROJECTED DETAILS. During each YEAR, SB shall be entitled to perform
a guaranteed number of the AGGREGATE PROJECTED DETAILS, such number to be equal
to [*] of the AGGREGATE PROJECTED DETAILS ("SB's Guaranteed Details").
6.8 With respect to indications for which SB and TBC are
copromoting in accordance with this Article 6, SB and TBC shall use only
promotional materials, promotional samples, advertising and literature provided
by SB, and approved by the JOINT MARKETING TEAM, subject to Paragraph 6.05
(hereinafter "SB Items") except that, in the event TBC wants to use its own
promotional materials, advertising and/or literature (hereinafter "TBC Items"),
all such TBC Items must be approved in advance by the JOINT MARKETING TEAM in
accordance with Paragraph 6.05, and TBC shall bear financial responsibility for
all such TBC Items. During the period when SB is exclusively promoting PRODUCT
in the FIELD in the TERRITORY, all promotional material and literature shall
exclusively bear the SB logo with a notation which clearly indicates that such
is sold under exclusive license from TBC, to the extent that such notation is
not prohibited by law or local regulation. During any period when the parties
are copromoting PRODUCT in the FIELD in the TERRITORY, the parties shall be
presented and described as jointly DETAILING and promoting in the TERRITORY for
the indications in the FIELD for which the parties are copromoting in all
written information disseminated to the healthcare community, and all
applicable advertising and
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
22
27
promotional materials shall bear the logos of all parties, which logos shall,
subject to compliance with applicable legal requirements, be prominently
displayed in accordance with each party's specifications and be of a similar
size to each other on all such materials
6.9 Following any [*] YEARS in which TBC does not deliver at least
[*] of TBC's Guaranteed Details but during which SB has delivered at least,[*]
of SB's Guaranteed Details, TBC shall irrevocably lose its right to copromote
PRODUCT in the FIELD in the TERRITORY.
6.10 During the term of the AGREEMENT, whether or not SB and TBC
are copromoting PRODUCT in the FIELD in the TERRITORY, SB will book all NET
SALES for PRODUCT in the FIELD in each country of the TERRITORY.
6.11 (a) SB shall have no responsibility for training TBC's
professional sales personnel with respect to the promotion and
DETAILING of PRODUCT for any indication(s) in the FIELD which TBC
commercializes in the TERRITORY on its own in accordance with
Paragraph 3.11 and/or Paragraph 3.15. However, at TBC's request, and
SB's discretion, SB shall provide training specifically related to the
promotion and DETAILING of PRODUCT for the indications in the FIELD
which SB is DETAILING in the TERRITORY. SB's direct cost associated
with such training activity shall be reimbursed by TBC promptly after
receiving an invoice therefor. In no event shall SB provide training
with respect to the basics of promotion and DETAILING of
pharmaceuticals in general.
(b) During the term of the AGREEMENT after TBC has made a
positive election to copromote PRODUCT in accordance with Paragraph
6.02, at TBC's request, SB shall train TBC's professional sales
personnel with respect to the promotion and DETAILING of PRODUCT for
the relevant indication(s) in the FIELD in the TERRITORY and provide
advice to TBC in connection with hiring and managing a professional
sales force therefor. In no event shall SB provide training with
respect to the basics of promotion and DETAILING of pharmaceuticals in
general. Such training and consultation shall include, among other
things, participation by TBC sales personnel in SB's sales training
course at SB headquarters located in the Philadelphia, Pennsylvania
metropolitan area, as well as field training, assistance and support,
and specific sales training in connection with TBC's copromotion of
the PRODUCT in the TERRITORY for HIT/XXXXX, XXX, and/or any other
indication in the FIELD which will be copromoted by the parties in
accordance with Paragraph 6.02. Such sales training for the PRODUCT
shall include the provision of sales raining materials. SB will bear
any internal costs it occurs in providing such training and advice to
TBC, but TBC shall be responsible for paying all room and board for
its employees, including all travel expenses, for such training, and
shall also be responsible for paying all
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
23
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room and board, including reasonable travel expenses for SB sales
training personnel who travel to TBC offices or to other non-SB
locations to conduct sales training courses.
7. PRODUCT SUPPLY
7.1 SB shall supply, or cause to be supplied all of SB's, it
AFFILIATES and its sublicensee's commercial requirements for PRODUCT in the
FIELD in the TERRITORY during the term of the AGREEMENT.
7.2 TBC warrants and represents that it shall provide SB with any
reasonable assistance SB requires in establishing and maintaining relationships
with THIRD PARTIES for the purposes of supply of PRODUCT under this AGREEMENT.
7.3 TBC shall use its best efforts to ensure that PRODUCT shall
have expiration dating approved by the FDA of no less than [*] as of the date
of launch of PRODUCT in the TERRITORY by SB, and to ensure that PRODUCT shall
have expiration dating approved by the FDA of no less than [*] as soon as
practicable after the date of launch.
7.4 MANUFACTURING REGULATORY MATTERS
(a) TBC shall use its best efforts to maintain all
regulatory and governmental permits, licenses and approvals that may
be necessary to manufacture and ship PRODUCT to SB.
(b) TBC will be responsible for any reporting of matters
regarding the manufacture of PRODUCT to the FDA and other relevant
regulatory authorities, in accordance with pertinent laws and
regulations. TBC shall immediately notify SB of any such matter and
promptly furnish complete copies of such reports to SB. SB shall
advise TBC of any occurrence or information which arise out of
manufacturing activities of PRODUCT by SB or on SB's behalf which have
or could reasonably be expected to have adverse regulatory compliance
and/or reporting consequences concerning PRODUCT.
(c) In the event TBC should become aware of information
that may require a recall, field alert, product withdrawal or field
correction arising from any defect in any PRODUCT provided under this
AGREEMENT, TBC shall immediately notify SB in Writing. In the event
that SB decides that a recall, field alert, product withdrawal, or
field correction is necessary due to any defect in any PRODUCT, SB
will notify TBC.
8. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
24
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8.1 Promptly after the date of this AGREEMENT first written above,
TBC shall disclose and supply to SB all KNOW- HOW. Thereafter, TBC shall
promptly disclose and supply to SB any further KNOW-HOW which may become known
to TBC. SB shall not acquire any ownership rights in such KNOW-HOW by virtue of
this AGREEMENT.
8.2 With respect to ADVERSE EXPERIENCES, the following shall
apply:
(a) Promptly after the EFFECTIVE DATE, each party shall
appraise the other party of the standard operating procedures for the
investigation and reporting of ADVERSE EXPERIENCES regarding its
products. The parties shall then promptly develop and agree upon
procedures for the reporting to each other ADVERSE EXPERIENCES
concerning PRODUCT. The parties shall immediately implement such
agreed procedures and shall provide each other on a regular basis with
any appropriate information which enables the other party to meet its
regulatory obligations in the territories in which it is
commercializing or developing PRODUCT or which is relevant to the safe
use of PRODUCT. The agreed procedures will be reviewed jointly on a
regular basis or when there is a change in regulations governing
ADVERSE EXPERIENCE reporting.
(b) All ADVERSE EXPERIENCE reports and queries for SB
should be addressed to its central safety department, i.e., Associate
Director, Worldwide Clinical Safety Quality Management, SmithKline
Xxxxxxx Pharmaceuticals, 0000 X. Xxxxxxxxxxxx Xxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000 (facsimile number (000) 000-0000; telephone number
(000) 000-0000) and for TBC should be addressed to its central safety
department, i.e., Vice President, Regulatory Affairs, Texas
Biotechnology Corporation, 0000 Xxxxxx, Xxxxxxx, Xxxxx 00000, X.X.X.
(facsimile number (000) 000-0000; telephone number (000) 000-0000), or
such other safety representative as may be designated by SB for SB or
by TBC for TBC.
(c) TBC will obligate any THIRD PARTY licensees and/or
commercial partners (including TBC's licensors for PRODUCT, such as
MITSUBISHI or other THIRD PARTY contractual partners to whom ADVERSE
EXPERIENCES for PRODUCT may be reported, such as SYNTHELABO or
COROMED) to provide ADVERSE EXPERIENCES to SB and to TBC, within the
time periods the parties develop under Paragraph 8.02(a).
8.3 During the term of this AGREEMENT and for five (5) years
thereafter, irrespective of any termination earlier than the expiration of the
term of this AGREEMENT, TBC and SB shall not use or reveal or disclose to THIRD
PARTIES any confidential information received from the other party or otherwise
developed by either party in the performance of activities in furtherance of
this AGREEMENT without first obtaining the written consent of the disclosing
party, except as may be otherwise provided herein, or as may be required for
purposes of investigating, developing, manufacturing or marketing PRODUCT or
for securing essential or desirable authorizations, privileges or rights from
governmental agencies as provided under this AGREEMENT, or is required to be
disclosed to a governmental agency or is necessary to file or prosecute patent
applications concerning PRODUCT or to carry out any litigation concerning
PRODUCT. This confidentiality obligation shall not apply to such information
which is or becomes a matter of public knowledge, or is already in the
possession of the receiving party, or is disclosed to the receiving party by a
THIRD PARTY having the right to do so, or is subsequently and independently
developed by employees of the receiving party or AFFILIATES thereof who had no
knowledge of the confidential information disclosed, or is required by law to
be disclosed. This confidentiality
25
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obligation shall not apply to KNOW-HOW in any country of the TERRITORY in which
the payment obligations outlined in Paragraphs 4.03, 4.04, and 4.05(a) have
expired. 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.
8.4 Nothing herein shall be construed as preventing SB from
disclosing any information received from TBC to an AFFILIATE or sublicensee of
SB who is necessary for the purposes of enabling SB to fulfill its obligations
under this AGREEMENT, provided, in the case of a sublicensee, such sublicensee
has undertaken a similar obligation of confidentiality with respect to the
confidential information.
8.5 All confidential information disclosed by one party to the
other shall remain the intellectual property of the disclosing party. In the
event that a court or other legal or administrative tribunal, directly or
through an appointed master, trustee or receiver, assumes partial or complete
control over the assets of a party to this AGREEMENT based on the insolvency or
bankruptcy of such party, the bankrupt or insolvent party shall promptly notify
the court or other tribunal (i) that confidential information received from the
other party under this AGREEMENT remains the property of the other party and
(ii) of the confidentiality obligations under this AGREEMENT. In addition, the
bankrupt or insolvent party shall, to the extent permitted by law, take all
steps necessary or desirable to maintain the confidentiality of the other
party's confidential information and to insure that the court, other tribunal
or appointee maintains such information in confidence in accordance with the
terms of this AGREEMENT.
8.6 No public announcement or other disclosure to THIRD PARTIES
concerning the existence of or terms of this AGREEMENT shall be made, either
directly or indirectly, by any party to this AGREEMENT, except as may be
legally required or as may be required for recording purposes, without first
obtaining the written approval of the other party and agreement upon the nature
and text of such announcement or disclosure, provided that this requirement
shall not be applicable to any public announcement or other disclosure
concerning the existence of or terms of this AGREEMENT to the extent that the
information in such public announcement or other disclosure was already the
subject of a written approval under this provision. In no event shall any
public announcement or other disclosure be made prior to the EFFECTIVE DATE.
The party desiring to make any such public announcement or other disclosure
shall inform the other party of the proposed announcement or disclosure in
reasonably sufficient time prior to public release, and shall provide the other
party with a written copy thereof, in order to allow such other party to
comment upon such announcement or disclosure. Each party agrees that it shall
cooperate fully with the other with respect to all disclosures regarding this
AGREEMENT to the Securities Exchange
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Commission and any other governmental or regulatory agencies, including
requests for confidential treatment of proprietary information of either party
included in any such disclosure.
8.7 Neither party shall submit for written or oral publication any
manuscript, abstract or the like which includes data or other information
relating to PRODUCT in the FIELD without first obtaining the prior written
consent of the other party, which consent shall not be unreasonably withheld.
The contribution of each party shall be noted in all publications or
presentations by acknowledgment or coauthorship, whichever is appropriate.
8.8 Nothing in this AGREEMENT shall be construed as preventing or
in any way inhibiting SB from complying with statutory and regulatory
requirements governing the development, manufacture, use and sale or other
license of PRODUCT in any manner which it reasonably deems appropriate for
purposes of fulfilling its obligations under this AGREEMENT or for complying
with such requirements, including, for example, by disclosing to regulatory
authorities confidential or other information received from TBC or THIRD
PARTIES.
9. PATENT PROSECUTION AND LITIGATION
9.1 Each party shall have and retain sole and exclusive title to
all inventions, discoveries and KNOW-HOW which are made, conceived, reduced to
practice or generated by its employees, agents, or other persons acting under
its authority in the course of or as a result of this AGREEMENT. Each party
shall own a fifty percent (50%) undivided interest in all such inventions,
discoveries and KNOW-HOW made, conceived, reduced to practice or generated
jointly by employees, agents, or other persons acting under the authority of
both parties in the course of or as a result of this AGREEMENT. Except as
expressly provided in this AGREEMENT, each joint owner may make, use, sell,
keep, license, assign, or mortgage such jointly owned inventions, discoveries
and KNOW-HOW, and otherwise undertake all activities a sole owner might
undertake with respect to such inventions, discoveries and KNOW-HOW, without
the consent of and without accounting to the other joint owner.
9.2 TBC shall, at its expense, have responsibility for filing,
prosecution and maintenance of all PATENTS which it owns in the TERRITORY. TBC
shall disclose to SB the complete texts of all PATENTS filed by TBC in the
TERRITORY which relate to PRODUCT as well as all information received
concerning the institution or possible institution of any interference,
opposition, re-examination, reissue, revocation, nullification or any official
proceeding involving a PATENT anywhere in the TERRITORY. SB shall have the
right to review all such pending applications and other proceedings and make
recommendations to TBC concerning them and their conduct. TBC agrees to keep
SB promptly and fully informed of the course of patent prosecution or other
proceedings including by providing SB with copies of substantive
communications, search reports and third party observations submitted to or
received from patent offices throughout the TERRITORY. SB shall provide such
patent consultation to TBC at no cost to TBC. SB shall hold all information
disclosed to it under this section as confidential subject to the provisions of
Paragraphs 9.03 and 9.04.
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9.3 SB shall have the right to assume responsibility for any
PATENT or any part of a PATENT which is owned by TBC which TBC intends to
abandon or otherwise cause or allow to be forfeited. TBC shall give SB
reasonable written notice prior to abandonment or other forfeiture of any
PATENT or any part of a PATENT so as to permit SB to exercise its rights under
this Paragraph.
9.4 In the event of the institution of any suit by a PARTY against
TBC, SB or its sublicensees for patent infringement involving the manufacture,
use, sale, license or marketing of PRODUCT anywhere in the TERRITORY, the party
sued shall promptly notify the other party in writing. SB shall have the right
but not the obligation to defend such suit at its own expense. TBC and SB
shall assist one another and cooperate in any such litigation at the other's
request without expense to the requesting party.
9.5 In the event that TBC or SB becomes aware of actual or
threatened infringement of a PATENT anywhere in the TERRITORY which is owned by
TBC, that party shall promptly notify the other party in writing. SB shall
have the first right but not the obligation to bring, at its own expense, an
infringement action against any THIRD PARTY and to use TBC's name in connection
therewith and to name TBC as a party thereto. If SB does not commence a
particular infringement action within ninety (90) days of receipt of the notice
of infringement, then TBC, after notifying SB in writing, shall be entitled to
bring such infringement action at its own expense. The party conducting such
action shall have full control over its conduct, including settlement thereof
subject to Paragraph 9.09. In any event, TBC and SB shall assist one another
and cooperate in any such litigation at the other's request without expense to
the requesting party.
9.6 In any action brought pursuant to Paragraph 9.05, the party
bringing the action shall indemnify the other party, its officers, directors,
shareholders, employees, agents, successors and assigns from any loss, damage
or liability, including for attorney's fees and costs, which may result from
claims, counterclaims or crossclaims asserted by a defendant, except to the
extent that such losses, damages or liabilities result from the negligence or
willful misconduct of the other party.
9.7 TBC 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
shall be [*].
9.8 The parties shall keep one another informed of the status of
and of their respective activities regarding any litigation or settlement
thereof concerning PRODUCT, provided however that no settlement or consent
judgment or other voluntary final disposition of any suit defended or action
brought by a party pursuant to this Article 9 may be entered into without the
consent of the other party if such settlement would require the other party to
be subject to an injunction or to make a
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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33
monetary payment or would otherwise adversely affect the other party's rights
under this AGREEMENT.
9.9 SB shall have the right but not the obligation to seek
extensions of the terms of PATENTS owned or controlled by TBC. At SB's
request, TBC shall either authorize SB to act as TBC's agent for the purpose of
making any application for any extensions of the term of any such PATENTS and
provide reasonable assistance therefor to SB or shall diligently seek to obtain
such extensions, in either event, at TBC's expense.
10. TRADEMARKS
10.1 TBC hereby grants to SB an exclusive sublicense, with the
right to grant sublicenses in accordance with this Paragraph, to use the TBC
TRADEMARK and, an exclusive license, to use, if necessary, the TBC TRADEMARK
ALTERNATE, in each country of the TERRITORY for the term of this AGREEMENT in
connection with the marketing and promotion of PRODUCT in the FIELD as
contemplated in this AGREEMENT, subject to TBC's copromotion option outlined in
Article 6, provided that during the term of SB's payment obligations under
Paragraphs 12.01(a), (b), (c) and (d)(i), such sublicense and license shall be
royalty-free, but in the event that SB wants to continue to employ such TBC
TRADEMARK or TBC TRADEMARK ALTERNATE (whichever is appropriate) for PRODUCT in
the FIELD in the TERRITORY after the end of the term of SB's payment
obligations under Paragraphs 12.01(a), (b), (c) and (d)(i), SB may do so
provided that SB shall pay TBC the payment outlined in Paragraph 4.08. SB shall
have the unfettered right to grant sublicenses to any AFFILIATE, but SB's right
to grant sublicenses to THIRD PARTIES shall be subject to TBC's prior written
consent which shall not be unreasonably withheld.
10.2 TBC agrees to search, file, register and maintain a
registration for the TBC TRADEMARK ALTERNATE in each country of the TERRITORY,
and maintain its license to the TBC TRADEMARK, for the term of this AGREEMENT,
at TBC's expense, for use with the PRODUCT in the FIELD. In those countries of
the TERRITORY where the TBC TRADEMARK is not available for use and registration
in connection with the PRODUCT in the FIELD, due to a rejection of the
trademark by a government agency, actual or threatened opposition, cancellation
or litigation as to use and/or registration of the TBC TRADEMARK by a THIRD
PARTY, and/or a decision by the JOINT MARKETING TEAM that use of the TBC
TRADEMARK is likely to cause confusion with another's trademark, TBC will
provide a TBC TRADEMARK ALTERNATE; and TBC will develop, search, file, register
and maintain the TBC TRADEMARK ALTERNATE at TBC's sole expense, provided that
the selection of the TBC TRADEMARK ALTERNATE shall be made by the JOINT
MARKETING TEAM in accordance with Paragraph 6.06.
10.3 In those countries where a trademark license must be recorded,
TBC will provide and record a separate trademark license for the TBC TRADEMARK
and/or TBC TRADEMARK ALTERNATE, at TBC's sole expense.
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10.4 The ownership and all goodwill from the use of the TBC
TRADEMARK shall vest in and inure to the benefit of MITSUBISHI which has duly
licensed such TBC, TRADEMARK to TBC with the right to grant a sublicense to SB.
The ownership and all goodwill from the use of the TBC TRADEMARK ALTERNATE
shall vest in and inure to the benefit of TBC.
10.5 TBC controls the nature and quality of the PRODUCT on which
the TBC TRADEMARK and/or TBC TRADEMARK ALTERNATE are used. Therefore, all
PRODUCT manufactured by SB, its AFFILIATES, or sublicensees pursuant to this
AGREEMENT shall be manufactured according to the specifications agreed to in
this AGREEMENT, or as subsequently agreed in writing by the parties and
attached to this AGREEMENT.
10.6 SB shall submit representative promotional materials,
packaging, and PRODUCT using the TBC TRADEMARK and/or TBC TRADEMARK ALTERNATE
to TBC for TBC's reasonable approval prior to their first use and thereafter
prior to implementing any change or addition to the previously approved
promotional materials as may be required under applicable law to maintain the
validity of any such trademark, provided that if TBC has not responded within
four (4) weeks after such submissions, TBC's approval will be deemed to have
been received.
10.7 SB's right to use the TBC TRADEMARK and/or the TBC TRADEMARK
ALTERNATE, whichever is applicable, shall terminate in each country of the
TERRITORY in which SB's rights to the PRODUCT are terminated in accordance with
this AGREEMENT, provided that SB shall have the right to continue to use the
TBC TRADEMARK and/or the TBC TRADEMARK ALTERNATE in each country of the
TERRITORY after the expiration of SB's payment obligations under Paragraphs
4.03 and 4.04 in each country of the TERRITORY without any further remuneration
obligation to TBC, subject to Paragraph 4.08.
10.8 TBC shall defend, indemnify and hold harmless SB, its
AFFILIATES, sublicensees, and their officers, directors, shareholders,
employees, successors and assigns from any loss, damage, or liability,
including reasonable attorney's fees resulting from any claim, complaint, suit,
proceeding or cause of action by a THIRD PARTY against any of them alleging
trademark infringement resulting from the use and/or registration of the TBC
TRADEMARK and/or TBC TRADEMARK ALTERNATE.
(a) TBC shall have no obligation under this Paragraph
unless SB (i) gives TBC prompt notice of any claim or lawsuit or other
action for which it seeks to be indemnified under this AGREEMENT, (ii)
TBC is granted full authority and control over the defense, including
settlement, against such claim or law suit or other action, and (iii)
SB cooperates fully with TBC and its agents in defense of the claims
or law suit or other action;
(b) SB shall have the right to participate in the defense
of any such claim, complaint, suit, proceeding or cause of action
referred to in this Paragraph utilizing attorneys of its choice, at
its own expense, provided however, that TBC shall have full authority
and control to handle any such claim, complaint, suit proceeding, or
cause of action, including any
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35
settlement or other disposition thereof, for which SB seeks
indemnification under this Paragraph;
10.9 In the event that TBC or SB becomes aware of actual or
threatened infringement of the TBC TRADEMARK and/or TBC TRADEMARK ALTERNATE
anywhere in the TERRITORY, that party shall promptly notify the other party in
writing. SB shall have the first right, but not the obligation, to bring, at
its own expense, an infringement and/or opposition or cancellation action
against any THIRD PARTY and to use TBC's name in connection therewith and to
name TBC as a party thereto. If SB does not commence a particular infringement
and/or opposition or cancellation action within ninety (90) days of receipt of
the notice of infringement, then TBC, after notifying SB in writing, shall have
the right, but not the obligation, to bring such infringement and/or opposition
or cancellation action at its own expense. The party conducting such action
shall have fun control over its conduct, including settlement thereof. In any
event, SB and TBC shall assist one another and cooperate in any such litigation
or action at the other's request without expense to the requesting party.
10.10 In any action brought pursuant to Paragraph 10.09, the party
bringing the action shall indemnify the other party, its AFFILIATES,
sublicensees, and their officers, directors, shareholders, employees, agents,
successors and assigns from any loss, damage or liability, including for
attorney's fees and costs, which may result from claims, counterclaims or
crossclaims asserted by a defendant, except to the extent that such losses,
damages or liabilities result from negligence or willful misconduct of the
other party.
10.11 TBC 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
shall be [*].
10.12 The parties shall keep one another informed of the status of
and of their respective activities regarding any litigation or settlement
thereof concerning TBC TRADEMARK and/or TBC TRADEMARK ALTERNATE, provided
however that no settlement or consent judgment or other voluntary final
disposition of any suit or proceeding defended or action brought by a party
pursuant to Article 10 may be entered into without the consent of the other
party if such settlement would require the other party to be subject to an
injunction or to make a monetary payment or would otherwise adversely affect
the other party's rights under the AGREEMENT.
11. STATEMENTS AND REMITTANCES
11.1 (a) SB shall keep and require its AFFILIATES and
sublicensees to keep complete and accurate records of all NET SALES
(including the calculation of the notional NET
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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SALES figure, if any, provided in Paragraph 1.24), COST OF GOODS,
THIRD PARTY ROYALTIES, COPROMOTION EXPENSES and WORKING CAPITAL
DEDUCTION. TBC shall have the right, at TBC's expense, through a
certified public accountant or like person reasonably acceptable to
SB, to examine such records during regular business hours during the
life of this AGREEMENT and for six (6) months after its termination;
provided, however, that such examination shall not take place more
often than once a year and shall not cover such records for more than
the preceding two (2) years and provided further that such accountant
shall report to TBC only as to the accuracy of the calculation of NET
SALES and the payments made to TBC by SB under this AGREEMENT;
provided that, in the event that TBC exercises its copromotion right
in accordance with Article 6, such accountant shall additionally be
permitted to report to TBC as to the accuracy of the calculation of
COPROMOTION EXPENSES attributable to SB as a fair and appropriate
reflection of SB's selling and promotional expenses for PRODUCT in the
FIELD, and as to the accuracy of the calculation of WORKING CAPITAL
DEDUCTION, THIRD PARTY ROYALTIES and COST OF GOODS by SB; provided
further that, in the event that TBC commercializes any indication of
PRODUCT on its own in accordance with Paragraph 3.11 and/or 3.15, such
accountant shall additionally be permitted to report to TBC as to the
accuracy of the calculation of ADMINISTRATIVE EXPENSES by SB.
(b) In the event that TBC exercises its right to
copromote in accordance with Article 6, TBC shall keep complete and
accurate records of, THIRD PARTY ROYALTIES, and COPROMOTION EXPENSES,
and shall submit to SB, within thirty (30) days after the end of each
quarter during each YEAR, a report containing an accounting of all of
the above, as well as any other information SB reasonably deems
necessary regarding such THIRD PARTY ROYALTIES, and COPROMOTION
EXPENSES during such quarter. In addition, TBC shall submit to SB,
within thirty (30) days of the end of each quarter during each YEAR, a
report containing an accounting of all DETAILS by TBC's sales force to
the TARGET AUDIENCE in the countries in which TBC has elected to
copromote in accordance with Paragraph 6.02, as well as any other
information SB reasonably deems necessary regarding such DETAILS
performed during the preceding quarter. SB shall have the right, at
SB's expense, through a certified public accountant or like person
reasonably acceptable to TBC, to examine such records during regular
business hours during the life of this AGREEMENT and for six (6)
months after its termination; provided, however, that such examination
shall not take place more often than once a year and shall not cover
such records for more than the preceding two (2) years and provided
further that such accountant shall report to SB only (a) as to a
determination of the correctness of any report by TBC to SB of the
number of DETAILS to the TARGET AUDIENCE performed by TBC under this
AGREEMENT; and/or (b) that the calculation of COPROMOTION EXPENSES
attributable to TBC are a fair and appropriate reflection of TBC's
selling and promotional expenses for PRODUCT in the FIELD for the
indications that TBC is copromoting with SB; and/or (c) that the
calculation of PARTY ROYALTIES by TBC are fair and appropriate.
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11.2 (a) If TBC does exercise the copromotion option outlined
in Article 6, and during a particular YEAR, the JOINT MARKETING TEAM
expect TBC to perform, at least [*] of the AGGREGATE PROJECTED DETAILS
of PRODUCT during such YEAR for all indications in the FIELD which the
parties are copromoting then, within sixty (60) days after the close
of each quarter during such YEAR, SB shall deliver to TBC a true
accounting of all NET OPERATING PROFIT for each indication for PRODUCT
which the parties are copromoting, whether positive or negative,
showing on a country by country basis NET SALES (including the
calculation of the notional NET SALES figure, if any, provided in
Paragraph 1.24), COST OF GOODS, THIRD PARTY ROYALTIES, COPROMOTION
EXPENSES and WORKING CAPITAL DEDUCTION, and SB shall, at the same
time, pay, as a single payment, that amount which results in TBC
receiving the relevant share of NET OPERATING PROFIT, if any, due to
TBC in accordance with Paragraph 4.05(a). In the event that there is
no NET OPERATING PROFIT during any quarter of a YEAR (i.e., there is a
net operating loss), no payment under Paragraph 4.05 shall be due TBC
for such quarter, and any loss during such quarter shall be carried
forward into each subsequent quarter until a full credit for such loss
can be taken against any payments which may be owed to TBC under
Article 4, provided that such loss shall be distributed between the
parties as provided in Paragraph 4.05.
(b) If TBC does exercise the copromotion option outlined
in Article 6, and during a particular YEAR, TBC has not performed at
least [*] of the AGGREGATE PROJECTED DETAILS of PRODUCT for all
indications in the FIELD which the parties are copromoting, but SB has
made one or more payments under TBC during such YEAR in accordance
with Paragraph 11.02(a), then SB shall reconcile the total amount paid
to TBC under Paragraph 11.02(a) against what should have been paid to
TBC under Paragraphs 4.03 and 4.04, and the total amount of any
overpayment resulting from such reconciliation shall be carried
forward into each subsequent quarter until a full credit for such
overpayment can be taken against any payments which may be owed to TBC
under Article 4.
(c) If TBC does commercialize any indication of PRODUCT
on its own in accordance with Paragraph 3.11 and/or 3.15, SB shall
deliver to TBC a true accounting of all NET SALES in the TERRITORY for
each relevant indication for PRODUCT showing on a country by country
basis NET SALES, COST OF GOODS, THIRD PARTY ROYALTIES paid by SB,
ADMINISTRATIVE EXPENSES, and WORKING CAPITAL DEDUCTION, and SB shall,
at the same time, pay, as a single payment, the relevant share of NET
SALES, if any, due to TBC in accordance with Paragraph 4.05(d) or
4.05(e), as appropriate.
(d) In anticipation of TBC's copromotion, SB will provide
a NET OPERATING PROFIT statement for each indication of the PRODUCT on
a semi-annual basis beginning
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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38
in the second half of the calendar year 2000 showing NET SALES, COST
OF GOODS, THIRD PARTY ROYALTIES, COPROMOTION EXPENSES and WORKING
CAPITAL DEDUCTION.
11.3 Within sixty (60) days after the close of each calendar
quarter during the term of this AGREEMENT, SB shall deliver to TBC a true
accounting of all PRODUCT sold by SB, its AFFILIATES and its sublicensees in
the FIELD in the TERRITORY during such quarter and shall at the same time pay
all royalties due under Paragraphs 4.03 and/or 4.04, and/or 4.07. Such
accounting shall show sales on a country-by-country basis. In the event that
SB continues to employ TBC TRADEMARK or TBC TRADEMARK ALTERNATE (whichever is
appropriate) after [*] under Paragraphs 12.01(a), (b), (c) and (d)(i), within
sixty (60) days after the close of each calendar quarter after the term of this
AGREEMENT, SB shall deliver to TBC a true accounting of all PRODUCT sold by SB,
its AFFILIATES and its sublicensees in the FIELD in the countries of the
TERRITORY in which either TBC TRADEMARK or TBC TRADEMARK ALTERNATE is employed
during such quarter and shall at the same time pay all payments due under
Paragraph 4.08. Such accounting shall show sales on a country-by-country
basis.
11.4 Any taxes, levies or other duties paid or required to be
withheld by SB on account of monies payable to TBC under this AGREEMENT shall
be deducted from the amount of monies otherwise due TBC under this AGREEMENT,
provided that TBC and SB shall negotiate in good faith the resolution of any
deductions made by SB for withholding taxes, if any, based on the laws of the
United Kingdom. SB shall secure and send to TBC proof of any such taxes,
levies or other duties withheld and paid by SB or its sublicensees for the
benefit of TBC.
11.5 All calculations by either party under this AGREEMENT shall be
calculated in accordance with U. S. Generally Accepted Accounting Procedures
(GAAP). All royalties and other payments due to TBC by SB under this AGREEMENT
shall be payable in United States dollars. If governmental regulations prevent
remittances from a foreign country with respect to sales made in that country,
the obligation of SB to pay royalties or other payments on sales in that
country shall be suspended until such remittances are possible. TBC shall have
the right, upon giving written notice to SB, to receive payment in that country
in local currency.
11.6 Monetary conversions from the currency of a foreign country,
in which PRODUCT is sold into United States dollars shall be calculated at the
actual average rates of exchange for the year to date as used by SB in
producing its quarterly and annual accounts, as confirmed by SB's auditors.
12. TERM AND TERMINATION
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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12.1 (a) Payment obligations under Paragraph 4.03 in each
country of the TERRITORY shall expire upon the earlier of: (1) the
commencement of substantial PARTY competition of PRODUCT in the FIELD
in such country (as defined in Paragraph 4.03); (2) the later of (a)
expiration of all Pending Patents (as defined in Paragraph 4.03) and
all issued, valid and enforceable PATENTS in such country which cover
the PRODUCT sold or (b) [*].
(b) Payments obligations under Paragraph 4.04 in each
country of the TERRITORY shall expire upon the earlier of [*].
(c) Expiration of SB's payment obligations to TBC under
both Paragraphs 4.03 and 4.04 in a particular country under Paragraph
12.01 shall not preclude SB from making, having made, using, selling,
offering for sale and importing PRODUCT in the FIELD, using KNOW-HOW,
and using TBC TRADEMARK or TBC TRADEMARK ALTERNATE, whichever is
applicable, in such country without further payments or other
remuneration to TBC [*].
(d) (i) TBC's right to copromote PRODUCT in the FIELD
in the TERRITORY with SB shall terminate in each country of the
TERRITORY upon the earlier of (a) the expiration of all issued, valid
and enforceable PATENTS which cover the PRODUCT sold in such country
of the TERRITORY;[*].
(ii) Payment obligations, if any, under each of Paragraphs
4.05(d), and (e) in each country of the TERRITORY shall terminate upon
the expiration or termination of the AGREEMENT.
(e) SB's payment obligations under Paragraph 4.05(a) in
each country of the TERRITORY shall terminate upon termination of
TBC's right to copromote PRODUCT in the FIELD in such country in
accordance with Paragraph 12.01(d). Expiration of SB's payment
obligations to TBC under Paragraph 4.05(a) in a particular country
shall not preclude SB from making, having made, using, selling,
offering for sale and importing PRODUCT in the FIELD, using KNOW-HOW,
and using TBC TRADEMARK or TBC TRADEMARK ALTERNATE, whichever is
applicable, in such country without further payments or other
remuneration to TBC [*].
(f) SB's payment obligations under Paragraph 4.08 shall
expire in each country of the TERRITORY upon the earlier of [*].
Expiration of SB's payment obligations to TBC under Paragraph 4.08 in
a particular country shall not preclude SB from making, having
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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made, using, selling, offering for sale and importing PRODUCT in the
FIELD, and using KNOW-HOW in such country without further payments or
other remuneration to TBC [*]
12.2 (a) Unless otherwise terminated, this AGREEMENT shall
expire in each country of the TERRITORY upon the later of (a) the
expiration of SB's payment obligations to TBC under Paragraphs 4.03
and 4.04, (b) the expiration of SB's payment obligations to TBC under
Paragraph 4.07, or (c) the expiration of SB's payment obligations to
TBC under Paragraph 4.08. Expiration of the AGREEMENT in all
countries of the TERRITORY shall effectively terminate the AGREEMENT
in its entirety. Expiration of this AGREEMENT in any country of the
TERRITORY under this provision shall not preclude SB from continuing
to make, have made, use, sell, offer for sale, and import PRODUCT in
the FIELD, and use KNOW HOW in such country without further payments
or other remuneration to TBC.
(b) Unless otherwise terminated, this AGREEMENT shall
terminate upon the termination of TBC's right under any THIRD PARTY
agreement to grant the licenses outlined in Article 2 under one or
more PATENTS in all countries of the TERRITORY. Termination of this
AGREEMENT under this Paragraph 12.02(b) shall not preclude SB from
continuing to make, have made, use, sell, offer for sale, and import
PRODUCT in the FIELD under PATENTS owned or controlled by TBC and use
KNOW-HOW owned or controlled by TBC throughout the TERRITORY without
further payments or other remuneration to TBC.
12.3 If either party fails or neglects to perform covenants or
provisions of this AGREEMENT and if such default is not corrected within sixty
(60) days after receiving written notice from the other party with respect to
such default, such other party shall have the right to terminate this AGREEMENT
by giving written notice to the party in default provided the notice of
termination is given within six (6) months of the default and prior to
correction of the default.
12.4 SB may terminate this AGREEMENT, on a country by country
basis, by giving TBC at least three (3) months prior written notice thereof
based on a reasonable determination by SB, using the same standards SB would
use in assessing whether or not to continue development and marketing of a
product of its own making, that the patent, medical/scientific, technical,
regulatory or commercial profile of PRODUCT does not justify continued
development or marketing of PRODUCT in such country.
12.5 TBC may convert the license granted to SB under Article 2 to a
non-exclusive license in a particular country of the TERRITORY by giving SB at
least [*] written notice thereof in the event that SB fails to commercialize
PRODUCT in such country for HIT/XXXXX within [*] after
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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NDA Approval for HIT/XXXXX as defined in Paragraph 4.01(4) (or its equivalent
in the particular country).
12.6 Either party may terminate this AGREEMENT if, at any time, the
other 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 the party or of its assets, or if the other party proposes a
written agreement of composition or extension of its debts, or if the other
party shall be served with an involuntary petition against it, filed in any
insolvency proceeding, and such petition shall not be dismissed with 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.
12.7 Notwithstanding the bankruptcy of TBC, or the impairment of
performance by TBC of its obligations under this AGREEMENT as a result of
bankruptcy or insolvency of TBC, SB shall be entitled to retain the license
rights and licenses granted herein, subject to TBC's rights to terminate this
AGREEMENT for reasons other than bankruptcy or insolvency as expressly provided
in this AGREEMENT.
12.8 All license rights and licenses granted under or pursuant to
this AGREEMENT by TBC to SB are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to
"intellectual property" as defined under Section 101(52) of the U.S. Bankruptcy
Code. TBC agrees that SB as a licensee of such rights under this AGREEMENT,
shall retain and may fully exercise all of its rights and elections under the
U.S. Bankruptcy Code, subject to performance by SB of its preexisting
obligations under this AGREEMENT. TBC further agrees that, in the event of the
commencement of a bankruptcy proceeding by or against TBC under the U.S.
Bankruptcy Code, SB shall be entitled to a complete duplicate of (or complete
access to, as appropriate) any such intellectual property and all embodiments
of such intellectual property, and same, if not already in its possession,
shall be promptly delivered to SB (a) upon any such commencement of a
bankruptcy proceeding upon written request therefor by SB, unless TBC elects to
continue to perform all of its obligations under this AGREEMENT, or (b) if not
delivered under (a) above, upon the rejection of this AGREEMENT by or on behalf
of TBC upon written request therefor by SB, provided, however, that upon TBC's
(or its successor's) written notification to SB that it is again willing and
able to perform all of its obligations under this AGREEMENT, SB shall promptly
return all such tangible materials to TBC, but only to the extent that SB does
not require continued access to such materials to enable SB to perform its
obligations under this AGREEMENT.
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13. RIGHTS AND DUTIES UPON TERMINATION
13.1 Upon termination of this AGREEMENT, TBC shall have the right
to retain any sums already paid by SB hereunder, and SB and TBC shall each pay
all sums accrued hereunder which are then due.
13.2 Upon termination of this AGREEMENT in its entirety or with
respect to any PRODUCT in any country under Paragraphs 12.03, 12.04, or 12.05,
SB shall notify TBC of the amount of PRODUCT SB and its sublicensees then have
on hand. SB and its sublicensees shall thereupon be permitted to sell that
amount of PRODUCT provided that SB shall pay the royalties or other payments
thereon at the time herein provided for.
13.3 Termination of this AGREEMENT shall terminate all outstanding
obligations and liabilities between the parties arising from this AGREEMENT
except those described in Paragraphs 4.08, 5.02(b), 5.02(c), 7.03, 7.04(b),
7.04(c), 8.02, 8.03, 8.04, 8.05, 8.06, 8.07, 8.08, 9.01, 9.04, 9.07, 9.08,
10.08, 10.11, 11.04, 11.05, 11.06, 14.01, 14.02, 14.03, 14.04, 14.05, 14.06,
14.07, 14.08, 14.09, and Articles 16 through 25. In addition, any other
provision required to interpret and enforce the parties' rights and obligations
under this AGREEMENT shall also survive, but only to the extent required for
the full observation and performance of this AGREEMENT.
13.4 Termination of the AGREEMENT in accordance with the provisions
hereof shall not limit remedies which may be otherwise available in law or
equity.
14. WARRANTIES, REPRESENTATIONS, AND INDEMNIFICATIONS
14.1 TBC warrants that it owns the entire right, title and interest
in, or otherwise has the right to grant the license rights outlined in Article
2 under PATENTS and KNOW-HOW, and has the right to enter into this AGREEMENT.
TBC further warrants that there is nothing in any THIRD PARTY agreement TBC has
entered into as after the EFFECTIVE DATE which, in any way, will limit TBC's
ability to perform all of the obligations undertaken by TBC hereunder. TBC
further warrants that it will not encumber, with liens, mortgages, security
interests or otherwise, all such PATENTS and KNOW- HOW. TBC further warrants
and represents that GENENTECH has assigned to TBC the Genentech Argatroban IND
(as defined in the April 30, 1997 Assignment Agreement between TBC, GENENTECH,
and MITSUBISHI, and that TBC has a complete copy of all Genentech Knowhow (as
defined in such April 30, 1997 Agreement).
14.2 TBC warrants that it has disclosed to SB the complete texts of
all PATENTS as of the EFFECTIVE DATE as well as all information received by TBC
as of the EFFECTIVE DATE concerning the institution or possible institution of
any interference, opposition, reexamination, reissue, revocation, nullification
or any official proceeding involving a PATENT anywhere in the TERRITORY. TBC
hereby represents that it has no present knowledge from which it can be
inferred that PATENTS are invalid or unenforceable or that their exercise would
infringe valid patent rights of THIRD PARTIES. A holding of invalidity or
unenforceability of any PATENT, from which no
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further appeal is or can be taken, shall not affect any obligation already
accrued hereunder, except as otherwise provided by Paragraph 4.04.
14.3 TBC acknowledges that, in entering into this AGREEMENT, SB has
relied upon information supplied by TBC and information which TBC has caused to
be supplied to SB by TBC's agents and/or representatives, pursuant to that
certain Confidentiality AGREEMENT dated October 23, 1996, between the parties,
(all of such information being hereinafter referred to collectively as "Product
Information") and TBC warrants and represents that the Product Information is
timely and accurate in all material respects. TBC further warrants and
represents that it has not, up through and including the EFFECTIVE DATE,
omitted to furnish SB with any information available to TBC concerning PRODUCT
or the transactions contemplated by this AGREEMENT, which could be material to
SB's decision to enter into this AGREEMENT and to undertake the commitments and
obligations set forth herein.
14.4 TBC warrants and represents that it has no present knowledge
of the existence of any preclinical or clinical data or information concerning
PRODUCT which TBC has not disclosed to SB as of the EFFECTIVE DATE which could
materially influence SB's decision to enter into this AGREEMENT.
14.5 TBC warrants and represents that it:
(a) has received all necessary consents and waivers, in
writing, which TBC requires from MITSUBISHI, SYNTHELABO, COROMED,
and/or any other THIRD PARTY by virtue of the licenses granted to SB
under this AGREEMENT, including, but not limited to, (i) any consent
required from MITSUBISHI and/or GENENTECH to grant the licenses under
Article 2 until the expiration of the PATENTS, and (ii) any waiver
required under Paragraph 2.3 of the May 27, 1993 agreement between
GENENTECH and TBC;
(b) shall pay all royalties or other sums and other
payments which TBC may owe to MITSUBISHI, SYNTHELABO, COROMED, and any
other THIRD PARTY by virtue of this AGREEMENT, and shall perform and
observe all of the other obligations outlined in all present and
future agreements between TBC and GENENTECH, MITSUBISHI, SYNTHELABO,
COROMED, and any other THIRD PARTY which are in any way related to
TBC's ability to grant the rights granted to SB under this AGREEMENT
or to TBC's ability to perform its obligations to SB under this
AGREEMENT; and
(c) In the event that TBC receives notice from any such
THIRD PARTY that TBC has committed a breach of its obligations under
any such agreement, or if TBC anticipates such breach, such as may
give rise to a right by such THIRD PARTY to terminate or otherwise
diminish TBC's rights to PATENTS and/or KNOW-HOW and/or otherwise
diminish TBC's ability to perform its obligations to SB under this
AGREEMENT, TBC shall immediately notify SB of such situation, and TBC
shall promptly cure such breach. However,
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if TBC is unable to cure such breach, TBC shall, to the extent
possible, permit SB to cure such breach and to negotiate directly with
such THIRD PARTY.
14.6 SB shall defend, indemnify and hold harmless TBC and its
AFFILIATES and sublicensees and their officers, directors, shareholders,
employees, agents, representatives, successors and assigns from and against all
claims, complaints, or lawsuits for damages (hereinafter collectively referred
to as 'Claim') that arise as a result of personal injury or death that is
alleged to have been caused by any act or omission by SB or its AFFILIATES or
sublicensees or their officers, directors, shareholders, employees, agents,
representatives, successors or assigns in connection with (i) SB's promotional
efforts for PRODUCT which is dispensed, utilized, ingested, and/or administered
in the TERRITORY, or (ii) a manufacturing defect, provided:
(a) SB shall not be obligated under this Paragraph to the extent that
(i) the injury was the result of the
nonperformance, failure to act, or performance by TBC or
anyone acting on behalf of TBC, including its AFFILIATES and
sublicensees and their officers, directors, shareholders,
employees, successors and assigns, including, but not limited
to, negligence, malfeasance or willful misconduct, or
(ii) the injury was the result of any product
design defect (other than a manufacturing defect), or failure
to warn claim based on the labeling of the PRODUCT or based on
TBC's promotional efforts for PRODUCT under this AGREEMENT;
(iii) the injury was the result of a breach of any
warranty or representation, whether express or implied, made
by TBC under this Agreement;
(iv) the injury was the result of an alleged
material release or threat of release of a hazardous substance
at either: (a) the place of manufacture of PRODUCT by a THIRD
PARTY, or (b) the place at which any waste, including but not
limited to any hazardous waste, generated at the time of
manufacture of PRODUCT by a THIRD PARTY has been treated,
stored or disposed.
(b) SB's obligation under this Paragraph with respect to
manufacturing defects arising from the manufacture of PRODUCT by a
THIRD PARTY shall be limited to the amount that SB is actually
indemnified for any such Claim by any THIRD PARTY.
(c) SB shall have no obligation under this Paragraph
unless TBC
(i) gives SB written notice within thirty (30)
days of any Claim or lawsuit or other action for which it
seeks to be indemnified under this Agreement,
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(ii) SB is granted full authority and control
over the defense, including settlement, against such Claim or
lawsuit or other action, and
(iii) TBC cooperates fully with SB and its agents
in defense of the Claims or lawsuit or other action; and
(d) TBC shall have the right to participate in the
defense of any such Claim complaint, suit, proceeding or cause of
action referred to in this Paragraph utilizing attorneys of its
choice, at its own expense, provided, however, that SB shall have full
authority and control to handle any such Claim, complaint, suit,
proceeding or cause of action, including any settlement or other
disposition thereof, for which TBC seeks indemnification under this
Paragraph.
14.7 TBC shall defend, indemnify and hold harmless SB, its
AFFILIATES and sublicensees and their officers, directors, shareholders,
employees, agents, representatives, successors and assigns from and against all
claims, complaints, or lawsuits for damages that arise as a result of personal
injury or death that is alleged to have been caused by any act or omission by
TBC or its AFFILIATES, sublicensees, or their officers, directors,
shareholders, employees, agents, representatives, successors or assigns in
connection with any PRODUCT which is dispensed, utilized, ingested, and/or
administered in the TERRITORY, provided that:
(a) the injury was the result of any product design
defect (other than a manufacturing defect), or a failure to warn claim
based on the labeling of the PRODUCT or TBC's promotional efforts for
PRODUCT under this AGREEMENT, or the non-performance, failure to act,
or performance by any employee or agent of TBC or anyone acting on
behalf of TBC, including its AFFILIATES, sublicensees, or their
officers, directors, shareholders, employees, successors and assigns,
including, but not limited to, negligence, malfeasance or willful
misconduct, or
(b) the injury was the result of a material breach of any
warranty or representation, whether express or implied, made by TBC
under this Agreement.
(c) TBC shall not be obligated under this Paragraph if
the injury, was the result of the negligence or willful misconduct of
any employee or agent of SB or anyone acting on behalf of SB,
including its AFFILIATES, sublicensees, and their officers, directors,
shareholders, employees, agents, representatives, successors and
assigns.
(d) TBC shall have no obligation under this Paragraph
unless SB
(i) gives TBC written notice within thirty (30)
days of any claim or lawsuit or other action for which it
seeks to be indemnified under this Agreement,
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(ii) TBC is granted full authority and control
over the defense, including settlement, against such claim or
lawsuit or other action, and
(iii) SB cooperates fully with TBC and its agents
in defense of the claims or lawsuit or other action; and
(e) SB shall have the right to participate in the defense
of any such claim, complaint, suit, proceeding or cause of action
referred to in this Paragraph utilizing attorneys of its choice, at
its own expense, provided, however, that TBC shall have full authority
and control to handle any such claim, complaint, suit, proceeding or
cause of action, including any settlement or other disposition
thereof, for which SB seeks indemnification under this Paragraph.
14.8 Notwithstanding the provisions of Paragraphs 14.06 and 14.07,
above, SB and TBC agree and understand that, in the event of a claim,
complaint, suit, proceeding or cause of action brought against one party
containing allegations of liability based on activities for which such party
was responsible, such party shall control and bear financial responsibility for
its own defense; unless the other party agrees to control and bear financial
responsibility of such defense.
14.9 Immediately upon the launch of PRODUCT in the TERRITORY by SB,
its AFFILIATES or its sublicensees, and for a period of five (5) years after
the expiration of this Agreement or the earlier termination thereof, each party
shall obtain and/or maintain, respectively, at its sole cost and expense,
product liability insurance in amounts, respectively, which are reasonable and
customary in the U.S. pharmaceutical industry for companies of comparable size
and activities at the respective place of business of each party. Such product
liability insurance shall insure against all liability, including personal
injury, physical injury, or property damage arising out of the manufacture,
sale, distribution, or marketing of PRODUCT in the TERRITORY. Each party shall
provide written proof of the existence of such insurance to the other party
upon request. Notwithstanding the foregoing, TBC shall always maintain product
liability insurance with a minimum of [*] per occurrence (or claim) and annual
aggregate limit of liability.
15. FORCE MAJEURE
15.1 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
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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of nonperformance 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.
16. GOVERNING LAW
16.1 This AGREEMENT shall be deemed to have been made in the State
of New York and its form, execution, validity, construction and effect shall be
determined in accordance with the laws of the State of New York, U.S.A.
17. WAIVER OF BREACH
17.1 The failure of either party at any time or times to require
performance of any provision hereof shall in no manner affect its rights at a
later time to enforce the same. No waiver by either party of any condition or
term in any one or more instances shall be construed as a further or continuing
waiver of such condition or term or of another condition or term.
18. SEPARABILITY
18.1 In 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.
18.2 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
therewith and shall be deemed to be modified to conform with such statute or
rule of law.
18.3 In the event that the terms and conditions of this AGREEMENT
are materially altered as a result of Paragraphs 18.01 or 18.02, the parties
will renegotiate the terms and conditions of this AGREEMENT to resolve any
inequities.
19. ENTIRE AGREEMENT
19.1 This AGREEMENT, entered into as of the EFFECTIVE DATE, and the
agreement between MITSUBISHI, TBC, and SB made as of the first date written
above, constitutes the entire agreement between the parties relating to the
subject matter hereof 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.
20. NOTICES
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20.1 Any notice, request, approval or other document required or
permitted to be given under this AGREEMENT shall be in writing and shall be
deemed to have been given when delivered in person, or sent by overnight courier
service, postage prepaid, or sent by certified or registered mail, return
receipt requested, or by facsimile transmission, to the following addresses of
the parties (or to such other address or addresses as may be specified from time
to time in a written notice). Any notices given pursuant to this AGREEMENT
shall be deemed to have been given and delivered upon the earlier of (i) if sent
by overnight courier service, on the date when received at the address set forth
below as proven by a written receipt from the delivery service verifying
delivery, or (ii) if sent by certified or registered mail, three (3) business
days after mailed by certified or registered mail postage prepaid and properly
addressed, with return receipt requested, or (iii) if sent by facsimile
transmission, on the day when sent by facsimile as confirmed by automatic
transmission report coupled with certified or registered mail or overnight
courier service receipt proving delivery, or (iv) if delivered in person, on the
date of delivery to the address set forth below as proven by written signature
of the recipient.
TBC
Texas Biotechnology Corporation
0000 Xxxxxx
Xxxxxxx, Xxxxx 00000
Attention: President & Chief Executive Officer
SB
SmithKline Xxxxxxx plc
Xxx Xxxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxx XX0 0XX
Xxxxxxx.
Attention: Senior Vice President and Director Business
Development
copy to:
SmithKline Xxxxxxx Corporation
One Franklin Plaza (Mail Code FP2225)
X.X. Xxx 0000
Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000, X.X.X.
Attention: Corporate Law-U.S.
21. ASSIGNMENT
21.1 This AGREEMENT and the license right and licenses herein
granted shall be binding upon and inure to the benefit of the successors in
interest of the respective parties, provided that it is understood that no
successor in interest to TBC shall acquire the benefit of any marketing right
or
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copromotion right to PRODUCT granted to TBC under this AGREEMENT without the
prior written consent of SB [*] In the event that there is a successor in
interest to TBC [*] the copromotion right outlined in Article 6 shall terminate
effective upon the date of succession of interest in TBC, but the rest of the
terms and conditions of this AGREEMENT shall survive. Neither this AGREEMENT
nor any interest hereunder shall be assignable by either party without the
written consent of the other provided, however, that either party may assign
this AGREEMENT or any part of its rights and obligations hereunder to any
AFFILIATE of such party or to any corporation with which such party 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 other
party, provided that TBC's right to assignment shall be subject to the first
sentence of this Paragraph.
22. RECORDING
22.1 SB and TBC shall have the right, at any time, to record,
register, or otherwise notify this AGREEMENT in appropriate governmental or
regulatory offices anywhere in the TERRITORY, and each party shall provide
reasonable assistance to the other party in effecting such recording,
registering or notifying.
23. NO PARTNERSHIP OR JOINT VENTURE
23.1 This AGREEMENT shall not be deemed to establish a joint
venture or partnership between SB and TBC.
24. EXECUTION IN COUNTERPARTS
24.1 This AGREEMENT may be executed in any number of counterparts,
each of which shall be deemed an original but all of which together shall
constitute one and the same instrument.
25. DISPUTE RESOLUTION
25.1 Any dispute, controversy or claim arising out of or relating
to this AGREEMENT (hereinafter collectively referred to as "Dispute") shall be
attempted to be settled by the parties, in good faith, by submitting each such
Dispute to appropriate senior management representatives of each party in an
effort to effect a mutually acceptable resolution thereof.
25.2 In the event no mutually acceptable resolution of such Dispute
is achieved in accordance with Paragraph 25.01 within a reasonable period of
time, any dispute, controversy or claim that arises under, out of, or in
connection with, or relating to this AGREEMENT, or any breach, termination or
alleged invalidity of this AGREEMENT, shall be resolved by binding
__________________________________
[*] This information has been omitted in reliance on Rule 24B-2 under
the Securities Exchange Act of 1934, and has been filed
separately with the Securities and Exchange Commission.
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arbitration in New York, New York in accordance with the then existent
Arbitration Rules of the American Arbitration Association. The decision of the
Arbitration Tribunal in any such arbitration shall be final and not appealable,
and shall be enforceable in any court of competent jurisdiction. No punitive
damages will be recoverable by either party in such a proceeding. The PARTIES
agree that the service of any notice in the course of such arbitration
proceeding at their respective addresses as provided for in Paragraph 20.01
below shall be valid and sufficient.
The appointing authority shall be the American Arbitration
Association. Unless agreed otherwise by the PARTIES, in any arbitration
proceeding hereunder, there shall be three (3) arbitrators. Each party shall
appoint one (1) arbitrator, and the two (2) arbitrators so appointed shall, by
mutual agreement, appoint the third arbitrator, who shall be the chairman of
the Arbitration Tribunal. In the event that any party fails to appoint an
arbitrator within one (1) month after the commencement of the arbitration
proceeding, such arbitrator shall, at the written request of the party
requesting the arbitration, be appointed by the then-President or presiding
officer of the American Arbitration Association in accordance with its
then-existing rules of appointment. The decision of a majority of the
arbitrators shall be final and binding on the PARTIES, each arbitrator having
one vote.
25.3 In any arbitration proceeding, the rights of the parties shall
be determined according to the governing law set forth in Paragraph 16.01, and
the arbitrators shall apply such law.
IN WITNESS WHEREOF, the parties, through their authorized officers,
have executed this AGREEMENT as of the date first written above.
SMITHKLINE XXXXXXX plc
By: /s/ X. Xxxxxxxxx
----------------------------------------------
Name: X. Xxxxxxxxx
--------------------------------------------
Title: Executive Vice President
-------------------------------------------
TEXAS BIOTECHNOLOGY CORPORATION
By: /s/ Xxxxx X. XxXxxxxxxx
----------------------------------------------
Name: Xxxxx X. XxXxxxxxxx
--------------------------------------------
Title: President
-------------------------------------------
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DEVELOPMENT, LICENSE, AND COPROMOTION AGREEMENT
SMITHKLINE XXXXXXX PLC-TEXAS BIOTECHNOLOGY CORPORATION
APPENDIX A
PATENTS
------------------------------------------------------------------------------------------------------------------
Patent
App. Patent Date of Date of
Country Assignee No. Grant No. Grant Expiration Subject Matter
------------------------------------------------------------------------------------------------------------------
USA Mitsubishi 5,214,952 05/25/2010 pharm. comp for injection
comprising argatroban in
ethanol, water, and sac-
charide solvent
------------------------------------------------------------------------------------------------------------------
Canada same as above
------------------------------------------------------------------------------------------------------------------
USA Mitsubishi 5,141,947 08/25/2009 fibrinolysis-enhancing
com-position comprising
plas-minogen activator in
com-bination with argatroban
------------------------------------------------------------------------------------------------------------------
Genentech
------------------------------------------------------------------------------------------------------------------
TBC
------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
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DEVELOPMENT, LICENSE, AND COPROMOTION AGREEMENT
SMITHKLINE XXXXXXX PLC-TEXAS BIOTECHNOLOGY CORPORATION
APPENDIX B
PRODUCT STRATEGY PLAN
[*]
[*] This information has been omitted in reliance on Rule 24B-2 under the
Securities Exchange Act of 1934, and has been filed separately with
the Securities and Exchange Commission.
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DEVELOPMENT, LICENSE, AND COPROMOTION AGREEMENT
SMITHKLINE XXXXXXX PLC-TEXAS BIOTECHNOLOGY CORPORATION
APPENDIX B
(CONTINUED)
DEVELOPMENT, LICENSE, AND COPROMOTION AGREEMENT
SMITHKLINE XXXXXXX PLC-TEXAS BIOTECHNOLOGY CORPORATION
APPENDIX C
ANNUAL TACTICAL PLAN
[*]
[*] This information has been omitted in reliance on Rule 24B-2 under the
Securities Exchange Act of 1934, and has been filed separately with
the Securities and Exchange Commission.
49