<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K/A
AMENDMENT NO. 1
(MARK ONE)
x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE
-------- SECURITIES EXCHANGE ACT OF 1934 (FEE REQUIRED) FOR THE
FISCAL YEAR ENDED December 31, 1995 OR
TRANSACTION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934 (NO FEE REQUIRED) FOR THE
TRANSITION PERIOD FROM__________________________________
TO______________________________________________________.
COMMISSION FILE NUMBER 0-20726
CORTECH, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 84-0894091
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification No.)
6850 N. BROADWAY, SUITE G 80221
DENVER, COLORADO (Zip Code)
(Address of principal executive offices)
(303) 650-1200
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.002 par value
----------------------------
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes x No
--- ---
Indicate by check mark if disclosure of delinquent filers pursuant to item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. / /
The aggregate market value of the voting stock held by nonaffiliates of the
registrant, based upon the closing price on the Nasdaq National Market System,
was approximately $52 million as of February 29, 1996.
The number of shares of Common Stock outstanding as of February 29, 1996, was
18,032,767.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrant's definitive Proxy Statement for the registrant's
Annual Meeting of Stockholders, to be held on May 20, 1996, are incorporated by
reference to the extent stated herein.
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this Amendment to be signed
on its behalf by the undersigned, thereunto duly authorized, on this 30th day of
May, 1996.
CORTECH, INC.
By:/s/ KENNETH R. LYNN
-----------------------
Kenneth R. Lynn
PRESIDENT AND CHIEF EXECUTIVE OFFICER,
AND DIRECTOR (PRINCIPAL EXECUTIVE OFFICER)
<PAGE>
EXHIBIT INDEX
Exhibit Description Page
- ------- ----------- ----
10.50 Product Development and
License Agreement dated
November 1, 1996 between
The Company and Smithkline
Beecham plc***
***Confidential treatment requested
<PAGE>
CERTAIN CONFIDENTIAL MATERIAL
CONTAINED IN THIS DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE SECURITIES
EXCHANGE ACT OF 1934, AS AMENDED.
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
SMITHKLINE BEECHAM PLC
AND
CORTECH, INC.
<PAGE>
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
SMITHKLINE BEECHAM PLC
AND
CORTECH, INC.
l. DEFINITIONS...................................................... 1-4
2. GRANT AND RIGHT TO FUTURE LICENSES .............................. 5
3. PAYMENTS AND ROYALTIES .......................................... 5-8
4. COMPULSORY LICENSES AND THIRD PARTY LICENSES .................... 8-9
5. DEVELOPMENT AND SUPPLY .......................................... 9-10
6. EXCHANGE OF INFORMATION AND CONFIDENTIALITY ..................... 10-14
7. PATENT PROSECUTION AND LITIGATION ............................... 14-17
8. TRADEMARKS AND NON-PROPRIETARY NAMES ............................ 17
9. STATEMENTS AND REMITTANCES ...................................... 17-18
10. TERM AND TERMINATION ............................................ 18-21
11. RIGHTS AND DUTIES UPON TERMINATION .............................. 21
12. WARRANTIES AND REPRESENTATIONS .................................. 22-23
13. FORCE MAJEURE ................................................... 23
14. GOVERNING LAW ................................................... 24
15. WAIVER OF BREACH ................................................ 24
16. SEPARABILITY .................................................... 24
17. ENTIRE AGREEMENT ................................................ 24
18. NOTICES ......................................................... 25
19. ASSIGNMENT ...................................................... 26
20. RECORDING ....................................................... 26
21. EXECUTION IN COUNTERPARTS ....................................... 26
SIGNATURES ...................................................... 27
APPENDIX A ...................................................... 28
APPENDIX B ...................................................... 29-32
APPENDIX C ...................................................... 33-35
APPENDIX D ...................................................... 36-43
<PAGE>
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
THIS PRODUCT DEVELOPMENT AND LICENSE AGREEMENT (hereinafter
"AGREEMENT"), made as of the 1st day of November, 1995, between Cortech,
Inc., a company organized under the laws of the state of Delaware and having
a place of business at 6850 N. Broadway, Denver, Colorado, 80221, U.S.A. and
SmithKline Beecham plc, a company organized under English law and having its
registered office at New Horizons Court, Brentford, Middlesex TW8 9EP, England
WITNESSETH THAT:
WHEREAS, CORTECH, as defined below, is the owner of all right, title
and interest in, or otherwise has the right to grant certain licenses in,
certain patents, identified in APPENDIX A hereto, and certain know-how
relating to the chemical product known as BradycorTM; and
WHEREAS, SB desires to obtain certain worldwide licenses from
CORTECH under the aforesaid patents and know-how, and CORTECH is willing to
grant to SB such licenses;
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
1.01 "ADVERSE EXPERIENCE(S)" shall mean any noxious, pathological
or unintended adverse 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.
1.02 "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 SB to the extent of at
least fifty percent (50%) of the equity (or such lesser percentage which is
the maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs of the entity
and any
Page 1
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person, firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with SB.
1.03 "BACK-UP PRODUCTS" shall mean any pharmaceutically active
compound which is not a PRODUCT but which is both (i) [
]* and (ii) intended for
use in the treatment and or prophylaxis of the same indications as PRODUCT.
1.04 "CORTECH" shall mean Cortech, Inc., a company organized
under the laws of the state of Delaware and having a place of business at
6850 N. Broadway, Denver, Colorado, 80221, U.S.A.
1.05 "EFFECTIVE DATE" shall mean the date upon which this
AGREEMENT is effective and shall be the date of this AGREEMENT first written
above.
1.06 "FIELD" shall mean any human pharmaceutical indication other
than the topical treatment of any ophthalmic indication.
1.07 "JOINT LIAISON COMMITTEE" shall mean the committee
established by the parties in accordance with Paragraph 5.02.
1.08 "KNOW-HOW" shall mean all present and future technical
information and know-how 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.
1.09 "NET SALES" shall mean the gross invoices representing sales
of PRODUCT under this AGREEMENT by SB, its AFFILIATES or sublicensees ("the
Selling Party") to the Trade (as defined below):
(a) in finished product form (i.e., packaged and labeled for
sale to the ultimate consumer); and
(b) in any product form other than finished product form (such
as final stage bulk material ready for conversion to final form, or
bulk tablets, bulk capsules, bulk ampoules or bulk vials) to
distributors who subsequently convert such product into finished
product form, provided that such distributors shall not be considered
sublicensees for purposes of this NET SALES definition, and further
provided that for purposes of this Paragraph 1.09(b), such sales of
PRODUCT in final stage bulk material form shall only occur where such
sales are due to local country requirements as such requirements are
determined by SB;
less deductions specifically allocated to PRODUCT by the Selling Party using
generally accepted accounting standards for:
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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(i) transportation charges, including insurance, for transporting
PRODUCT;
(ii) sales and excise taxes and duties paid or allowed by the
Selling Party 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.
For the purposes of this definition 'the Trade' shall mean distributors of
PRODUCT in finished pack form (including those that package PRODUCT from bulk
finished dosage form), wholesalers and retailers of such PRODUCT, governmental
authorities or agents and other official institutions, hospitals, managed
care entities, pharmaceutical benefits management entities, disease management
entities, mail order prescription pharmacy services entities, hospital
services, and all such other outlets as are approved by governmental
authorities from time to time in the TERRITORY for sales of such PRODUCT. It
is hereby agreed for the sake of absolute clarity and understanding that any
sales between SB, its AFFILIATES and its or their sub-licensees shall be
excluded from the computation of NET SALES and no royalties will be payable
on such sales. Notwithstanding the immediately preceding sentence it is
hereby nevertheless expressly agreed that any transactions between SB or any
of its AFFILIATES or any of its sub-licensees on the one hand and PSB on the
other hand will be deemed to be transactions with the Trade for the purposes
of computing NET SALES and, as a result, INTER ALIA all rebates given to PSB
shall be calculated by SB 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 sub-licensees as
only part of its or their total activities rather than in a separate
AFFILIATE a notional Net Sales figure will be calculated by SB on an arms
length basis to cover such activities.
1.10 "OUTLINE DEVELOPMENT PLAN" shall mean the outline of the plan
to develop PRODUCT which is attached to this AGREEMENT as APPENDIX B.
1.11 "PATENTS" shall mean all patents and patent applications,
including all continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions thereof and all SPCS, which are or
become owned by CORTECH, or to which CORTECH otherwise has, now or in the
future, the right to grant licenses, which generically or specifically claim
PRODUCT, a process for manufacturing PRODUCT, or an intermediate used in such
process or a use of PRODUCT. Also included within the definition of PATENTS
Page 3
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are any patents or patent applications which generically or specifically
claim any improvements on PRODUCT or intermediates or manufacturing processes
required or useful for production of PRODUCT which are developed by CORTECH,
or which CORTECH otherwise has the right to grant licenses, now or in the
future, during the term of this AGREEMENT. The current list of patent
applications and patents encompassed within PATENTS is set forth in APPENDIX
A attached hereto.
1.12 "PRODUCT" shall mean the chemical compound known as
Bradycor-TM-, which is also known as CP-0127, and whose more specific chemical
name is 1,6-bis(D-arginyl-L-arginyl-L-prolyl-L-hydroxyprolyl-glycyl-L-
phenylalanyl-(S-3R,3S-succinimido)-L-cysteinyl-D-phenylalanyl-L-leucyl-
L-arginyl)hexane hexahydrochloride, and all pharmaceutically active derivatives
thereof such as, but not limited to, esters, salts, hydrates, solvates,
polymorphs and isomers thereof, and shall include compositions comprising such
compound or derivatives.
1.13 "PSB" shall mean any present or future AFFILIATE of SB or its
sublicensees which conducts a Pharmaceutical Service Business, including
Pharmaceutical Benefits Management Services (hereinafter "PBM") for or on
behalf of THIRD PARTIES. As of the EFFECTIVE DATE, the only AFFILIATE of SB
which is a PBM is Diversified Pharmaceutical Services, a corporation of the
state of Minnesota and having a place of business at 3600 West 80th Street,
Seventh Floor, Bloomington, Minnesota 55431-1085. The term "PSB" also includes
any present or future AFFILIATE of SB or its sublicensees which conducts
Prescription Pharmacy Services for or on behalf of THIRD PARTIES (hereinafter
"PPS"), including any of the following business activities for or on behalf of
THIRD PARTIES: wholesaler distribution, pharmacy distribution, disease
management services, hospital services, or mail order prescription pharmacy
services. As of the EFFECTIVE DATE, the only AFFILIATE of SB which is a PPS
is Diversified Prescription Delivery, a corporation of the Commonwealth of
Pennsylvania and having a place of business at 206 Welsh Road, Horsham,
Pennsylvania 19044, U.S.A.
1.14 "SB" shall mean SmithKline Beecham plc, a company organized
under English law and having its registered office at New Horizons Court,
Brentford, Middlesex TW8 9EP, England.
1.15 "SPC(S)" shall mean a right based upon a PATENT to exclude others
from making, using or selling PRODUCT, such as a Supplementary Protection
Certificate
1.16 "TERRITORY" shall mean all the countries and territories in
the world.
1.17 "THIRD PARTY(IES)" shall mean any party other than SB and
CORTECH.
Page 4
<PAGE>
2. GRANT AND RIGHTS TO FUTURE LICENSES
2.01 CORTECH hereby grants to SB an exclusive license, with the right
to grant sublicenses, under PATENTS and KNOW-HOW to make, have made, use and
sell PRODUCT, in the TERRITORY, in the FIELD, subject to the terms and
conditions of this AGREEMENT.
2.02 CORTECH hereby grants to SB the first right to negotiate an
exclusive license, with the right to grant sublicenses, under patents and
know-how owned or controlled by CORTECH, to make, have made, use and sell
each BACK-UP PRODUCT, in the FIELD, in the TERRITORY. Such license shall be
upon terms to be mutually negotiated by the parties in good faith.
3. PAYMENTS AND ROYALTIES
3.01 In consideration for the exclusive license under PATENTS and
KNOW-HOW granted to SB under this AGREEMENT, SB shall pay to CORTECH, by wire
transfer, one million U.S. dollars (U.S. $1,000,000) within thirty (30) days
after the EFFECTIVE DATE, and SB shall pay to CORTECH up to an additional
[ ]* in installment payments
within thirty (30) days of the occurrence of each of the following milestones:
<TABLE>
<CAPTION>
<S> <C>
- [ ]* $ [ ]*
- [ ]* $ [ ]*
- [ ]* $ [ ]*
- GO decision $ [ ]*
- NDA Acceptance for traumatic brain injury $ [ ]*
- First MAA Filing in Major Market for traumatic brain injury $ [ ]*
- NDA Approval for traumatic brain injury $ [ ]*
- First MAA Approval in Major Market for traumatic brain injury $ [ ]*
</TABLE>
and, in the event that SB decides to develop PRODUCT for the treatment and/or
prophylaxis of ischaemic stroke, SB shall pay to CORTECH up to an additional
[ ]* in installment payments within
thirty (30) days of the occurrence of each of the following milestones:
<TABLE>
<CAPTION>
<S> <C>
- NDA Acceptance for ischaemic stroke $ [ ]*
- First MAA Filing in Major Market for ischaemic stroke $ [ ]*
- NDA Approval for ischaemic stroke $ [ ]*
- First MAA Approval in Major Market for ischaemic stroke $ [ ]*
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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provided:
(a) each payment which is owed in accordance with this Paragraph
3.01 shall be made only one time regardless of how many times PRODUCT achieves
each of the indicated milestones, and no payment shall be owed for a milestone
which is not reached;
(b) such payments shall be non-refundable to SB for any reason;
(c) by the term [ ]* as
used in this Paragraph 3.01 is meant the date upon which [
]*;
(d) by the term "GO decision" as used in this Paragraph 3.01 is meant
[
]* as outlined in the OUTLINE DEVELOPMENT
PLAN (as such may be modified by SB in accordance with Paragraph 5.01);
(e) by the terms "NDA Acceptance for traumatic brain injury" and
"NDA Acceptance for ischaemic stroke" as used in this Paragraph 3.01 is meant
the FDA's acceptance of an NDA filed by or on behalf of SB for approval to
market PRODUCT in the U.S.A. for the specified indication;
(f) by the terms "First MAA Filing in Major Market for traumatic
brain injury" and "First MAA Filing in Major Market for ischaemic stroke" as
used in this Paragraph 3.01 is meant the filing by or on behalf of SB of a
Marketing Authorization Application (MAA) or its equivalent outside of Europe
for approval to market PRODUCT in the first of Japan, the United Kingdom,
France, Germany, Spain or Italy (Major Market) of the treatment of the
specified indication;
(g) by the terms "NDA Approval for traumatic brain injury" and "NDA
Approval for ischaemic stroke" as used in this Paragraph 3.01 is meant the
FDA's approval of an NDA filed by or on behalf of SB for marketing of PRODUCT
in the U.S.A. for the treatment of the specified indication;
(h) by the terms "First MAA Approval in Major Market for traumatic
brain injury" and "First MAA Approval in Major Market for ischaemic stroke"
as used in this Paragraph 3.01 is meant the first receipt by SB of all
requisite marketing and pricing approvals required to market PRODUCT for the
specified indication in a Major Market; and
(i) in the event SB decides to develop PRODUCT for the treatment
and/or prophylaxis of an indication unrelated to the treatment and/or
prophylaxis of any neurological disorder, SB shall pay to CORTECH an
additional sum of money in installment payments within thirty (30) days of
the occurrence of the First MAA Filing in Major Market for such indication
and NDA
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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Acceptance for such indication, the amount of such installment payments to be
negotiated by the parties, in good faith, prior to the start of Phase III
clinical development of PRODUCT for such indication, provided that in no event
shall the treatment and/or prophylaxis of migraine or spinal cord injury be
deemed to be a neurological disorder.
3.02 As consideration for the licenses granted to SB under this
AGREEMENT, SB shall make the following royalty payments to CORTECH:
(a) [ ]* of annual NET SALES up to and including
[ ]*;
(b) [ ]* of annual NET SALES greater than [
]* up to and including [
]*;
(c) [ ]* of annual NET SALES greater than [
]* up to and
including [
]*;
(d) [ ]* of annual NET SALES greater than [
]* up to and
including [
]*; and
(e) [ ]* of annual NET SALES greater than
[ ]*;
provided that, for purposes of this Paragraph 3.02, achievement of the NET
SALES thresholds recited above shall be determined by adding the total annual
NET SALES in all countries of the TERRITORY in which [
]* The term [
]* as used in this AGREEMENT shall
not be construed to [
]*
3.03 As additional consideration for the licenses granted to SB
under this AGREEMENT, SB shall pay to CORTECH [ ]* of annual
NET SALES which are not subject to the royalty obligation outlined in
Paragraph 3.02.
3.04 Royalties on NET SALES formulated in combination with one or
more additional therapeutically active ingredients shall be determined, [
]*
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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3.05 SB's royalty obligations under Paragraph 3.02 shall become
effective in each country in the TERRITORY at such time as PRODUCT is
launched and available for commercial sale in such country by SB, its
AFFILIATES or its sublicensees[
]*. Notwithstanding the above, in the event that any person or
party initiates any legal or administrative proceeding challenging the
validity, scope or enforceability of a PATENT which claims PRODUCT in any
country in the TERRITORY, such as by opposing the grant of the PATENT in the
European Patent Office, then [
]*, during pendency of the proceeding, and [
]*. If the enforceability of claims in
the PATENT which claim PRODUCT are upheld by a court or other legal or
administrative tribunal from which no appeal is or can be taken, then [
]*. If the claims in the PATENT which claim PRODUCT
are held to be invalid or otherwise unenforceable by a court or other legal
or administrative tribunal from which no appeal is or can be taken, then [
]*, and SB shall retain the licenses granted herein.
3.06 [
]*
4. COMPULSORY LICENSES AND THIRD PARTY LICENSES
4.01 In the event that a governmental agency in any country or
territory grants or compels CORTECH to grant a license to any THIRD PARTY for
PRODUCT, 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, provided that such benefit
shall take effect on the day such THIRD PARTY commercializes PRODUCT in such
country.
4.02 If, during the term of this AGREEMENT, SB, in its sole
discretion, deems it necessary to seek a license in any country or countries
of the TERRITORY from any THIRD PARTY in order to avoid infringement during
the exercise of the license herein granted, [ ]* of any
royalties or other fees paid to such THIRD PARTY under such license
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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("Third Party Fees") may be deducted from payments otherwise due CORTECH
under this AGREEMENT with respect to any such countries, provided, in no
event, [
]*. Notwithstanding the above, [
]*.
5. DEVELOPMENT AND SUPPLY
5.01 SB shall have full control and authority over research,
development, registration and commercialization of PRODUCT, in the FIELD, in
the TERRITORY. SB will exercise its reasonable efforts and diligence, using
good faith and fair dealing, in developing and commercializing PRODUCT in
accordance with its business, legal, medical and scientific judgment, and in
undertaking investigations and actions required to obtain appropriate
governmental approvals to market PRODUCT in the TERRITORY, provided that SB's
development of PRODUCT shall be in accordance with the OUTLINE DEVELOPMENT
PLAN which is attached hereto as APPENDIX B and fully incorporated into this
AGREEMENT as though fully set out herein. All regulatory timelines and
proposed studies contained in such OUTLINE DEVELOPMENT PLAN may be amended by
SB as necessary to appropriately account for any medical, scientific,
regulatory or other changes or delays which are beyond SB's reasonable direct
control.
5.02 Promptly after the EFFECTIVE DATE, the parties shall establish a
JOINT LIAISON COMMITTEE, containing two (2) appropriate members from SB and
two (2) appropriate members from CORTECH, to enable CORTECH to review the
progress of SB's efforts to develop PRODUCT up to and including registration
and PRODUCT launch in the U.S. and major European markets, and to enable SB
to review the progress and potential issues arising from the development of
PRODUCT for any indication outside of the FIELD by CORTECH or its
sublicensees. The JOINT LIAISON COMMITTEE shall be chaired by the head of
the SB Neuroscience Therapeutic Area Team, and shall meet, only during the
period underwhich SB is developing PRODUCT, at least two (2) times per year,
at locations to be mutually agreed upon by the parties. [
]*.
In addition, SB shall keep CORTECH reasonably informed of the progress of
SB's efforts to commercialize PRODUCT.
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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<PAGE>
5.03 CORTECH shall provide to SB, at SB's request, reasonable technical
assistance within its area of expertise, and within its reasonable ability,
to impart an understanding of PATENTS and KNOW-HOW concerning development,
registration, production and commercialization of PRODUCT. [
]*. In addition, to the extent that CORTECH's
provision of such reasonable technical assistance [
]*, and any visits
by SB personnel to CORTECH, [ ]*, and all such visits
shall be at times and for periods of time upon which the parties will agree.
Any additional reasonable technical assistance which is not within the scope
outlined in APPENDIX D but which is within CORTECH's reasonable ability, and
which is requested by SB, shall be provided to SB by CORTECH [ ]*.
Notwithstanding the above, CORTECH shall have exclusive responsibility for
[
]*. The JOINT LIAISON COMMITTEE shall develop a mechanism for [
]* in accordance with this Paragraph.
5.04 SB shall have responsibility for supplying its preclinical,
clinical, promotional and commercial requirements of PRODUCT in the FIELD in
the TERRITORY, except that:
(a) CORTECH shall supply SB with [
]* of clinical quality PRODUCT, [
]*, and an additional [
]* for placebo purposes, such stock to be supplied to SB
free of charge and in accordance with APPENDIX C;
(b) CORTECH shall use its best efforts to supply SB with [
]* of PRODUCT, in bulk active ingredient form, such supply to be in
accordance with the schedule, quantities and specifications outlined in
APPENDIX C which is attached to this AGREEMENT and incorporated herein. In
the event that CORTECH does not supply SB, by August 31, 1996, with the
entirety of the [ ]* of PRODUCT outlined in APPENDIX C,
CORTECH shall [ ]* at SB's request, within thirty (30) days after
August 31, 1996, [ ]* for each
gram of such PRODUCT [ ]* by the time limit specified in
this Paragraph.
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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6. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
6.01 Promptly after the EFFECTIVE DATE, CORTECH shall disclose and
supply to SB all KNOW-HOW. Thereafter, CORTECH shall promptly disclose and
supply to SB any further KNOW-HOW which may become known to CORTECH.
6.02 With respect to ADVERSE EXPERIENCES, the following shall apply
in all circumstances other than Paragraph 6.02(f):
(a) During the term of this AGREEMENT each party will report ADVERSE
EXPERIENCES reported to it in respect of the PRODUCT to the appropriate
regulatory authorities in the countries in which it is developing or
commercializing PRODUCT, in accordance with the laws and regulations of the
relevant countries and authorities.
(b) Each party will submit summaries of worldwide safety data on the
PRODUCT to appropriate regulatory authorities in the countries in which it is
developing and commercializing PRODUCT, in accordance with the laws and
regulations of the relevant countries and authorities. Wherever possible,
duplication of reporting of worldwide data by both SB and CORTECH will be
avoided.
(c) An ADVERSE EXPERIENCE will be considered 'serious' if it is any one
or more of the following, i.e., fatal, life threatening, disabling or
incapacitating, results in hospitalization or prolongation of
hospitalization, a congenital abnormality, a cancer, or an overdose. In
addition, any ADVERSE EXPERIENCE which suggests a significant hazard,
contraindication, side effect or precaution that may be associated with the
use of PRODUCT will be considered a serious ADVERSE EXPERIENCE.
(d) All ADVERSE EXPERIENCE reports and queries for SB should be
addressed to its central safety department, i.e., Director, Clinical Safety
(Antiinfectives/Neurosciences), New Frontiers Science Park South, Third
Avenue, Harlow, Essex, England (facsimile number 011-44-1279-644-260 or
011-44-1279-644-322); telephone number 011-44-1279-644-169) and for CORTECH
should be addressed to its central safety department, i.e., Dr. Robert
Sandhaus, Cortech, Inc., 6850 N. Broadway, Denver, Colorado, 80221, U.S.A.
(facsimile number 1-303-650-1221; telephone number 1-303-657-7121 , or such
other safety representative as may be designated by SB for SB or by CORTECH
for CORTECH. In the event that either party shall desire to appoint a
clinical trial contractor to report ADVERSE EXPERIENCES to the other party,
in lieu of the appointing party, for the contracted clinical trial, the
appointing party shall notify such contractor to the other party, in writing
and in accordance with this Paragraph, at least four (4) weeks prior to the
initiation of the contracted clinical trial, and such contractor shall not be
permitted to undertake such reporting unless the other party has given its
written consent to the appointment of such contractor for such purpose, such
consent not to be unreasonably withheld.
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(e) The central safety department of each party will report to the
central safety department of the other party (as indicated in Paragraph
6.02(d)) all ADVERSE EXPERIENCES reported to it in respect of the PRODUCT as
follows (subject to adjustment by mutual agreement of the parties, after the
EFFECTIVE DATE, provided that the parties shall meet to discuss the need for
any adjustment at least once prior to the start of SB's clinical development
of PRODUCT, and at least once prior to the start of SB's commercialization of
PRODUCT in the TERRITORY, to account for any future changes in regulatory
reporting requirements):
(i) a summary of all ADVERSE EXPERIENCES, serious and non-serious,
in writing on a monthly basis.
(f) At such time as one party no longer holds any regulatory (clinical
trial or marketing) authorizations for PRODUCT worldwide, and is not
promoting PRODUCT, all exchanges of ADVERSE EXPERIENCE information between
the parties may be discontinued, subject to mutual agreement. The other
party will then assume sole responsibility for ADVERSE EXPERIENCE reporting
to all appropriate regulatory authorities worldwide, in accordance with the
laws and regulations of the relevant countries and authorities.
6.03 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, CORTECH 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, 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
through no act of omission by the receiving party, or is already in the
possession of the receiving party as proven by proper documentation, 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. The parties
shall take reasonable measures to ensure that no unauthorized use or
disclosure is made by others to whom access to such information is granted.
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6.04 Nothing herein shall be construed as preventing SB from disclosing
any information received from CORTECH to an AFFILIATE, sublicensee or
distributor of SB, provided, such AFFILIATE, sublicensee or distributor has
undertaken a similar obligation of confidentiality with respect to the
confidential information.
6.05 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 ensure that the court,
other tribunal or appointee maintains such information in confidence in
accordance with the terms of this AGREEMENT.
6.06 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 approval of the other party and agreement upon the nature and
text of such announcement or disclosure, except that CORTECH may disclose
such information to any officer, member of the Board of Directors, or
employee of the CP-0127 Development Corporation, a company organized under
the laws of the state of Colorado and having a place of business at 6850 N.
Broadway, Denver, Colorado, 80221, U.S.A., without first obtaining the
approval of SB, provided that such employee has undertaken a similar
obligation of confidentiality to CORTECH with respect to the confidential
information as CORTECH has undertaken to SB hereunder.
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. Once any such
public announcement or disclosure has been approved in accordance with this
Paragraph, then either party may appropriately communicate information
contained in such permitted 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 Commission and any
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<PAGE>
other governmental or regulatory agencies, including requests for
confidential treatment of proprietary information of either party included in
any such disclosure.
6.07 CORTECH shall not submit for written or oral publication any
manuscript, abstract or the like which includes data or other information
relating to PRODUCT without first obtaining the prior written consent of SB,
which consent shall not be unreasonably withheld or delayed. The
contribution, if any, of each party shall be noted in all publications or
presentations by acknowledgment or coauthorship, whichever is appropriate.
6.08 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
distribution of PRODUCT in any manner which it reasonably deems appropriate,
including, for example, by disclosing to regulatory authorities confidential
or other information received from CORTECH or THIRD PARTIES.
7. PATENT PROSECUTION AND LITIGATION
7.01 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.
7.02 Each party shall promptly notify the other upon the making,
conceiving or reducing to practice of any invention or discovery referred to
in Paragraph 7.01. With respect to any such invention or any PATENT in
existence as of the EFFECTIVE DATE:
(i) SB shall have the first right, using in-house or outside
legal counsel selected at SB's sole discretion, to prepare, file, prosecute,
maintain and extend patent applications and patents concerning all such
inventions and discoveries in countries of SB's choice throughout the world
with appropriate credit to CORTECH representatives, including the naming of
such parties as inventors where appropriate and in accordance with the
relevant legal requirements, for which SB shall bear the costs relating to
such activities which occur at SB's request or direction. SB shall inform
CORTECH of the nature and text of such patent applications and important
prosecution matters related thereto in reasonably sufficient time
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<PAGE>
prior to filing thereof to receive CORTECH's comments related thereto, and SB
shall take into account CORTECH's reasonable comments.
(ii) If SB, prior or subsequent to filing certain patent
applications on any inventions or discoveries which are owned in whole or in
part by CORTECH, elects not to file, prosecute or maintain such patent
applications or ensuing patents or certain claims encompassed by such patent
applications or ensuing patents in any country of the TERRITORY, SB shall
give CORTECH notice thereof within a reasonable period prior to allowing such
patent applications or patents or such certain claims encompassed by such
patent applications or patents to lapse or become abandoned or unenforceable,
and CORTECH shall thereafter have the right, at its sole expense, to prepare,
file, prosecute and maintain patent applications and patents or divisional
applications related to such certain claims encompassed by such patent
applications or patents concerning all such inventions and discoveries in
countries of its choice throughout the world.
(iii) The party filing patent applications for jointly owned
inventions and discoveries shall do so in the name of and on behalf of both
SB and CORTECH. Each of CORTECH and SB shall hold all information it
presently knows or acquires under this Paragraph 7.02 which is related to all
such patents and patent applications as confidential subject to the
provisions of Article 6.
7.03 CORTECH on behalf of itself and its AFFILIATES, and the directors,
employees, officers, shareholders, agents, successors and assigns of any of
them, hereby waives any and all actions and causes of action, claims and
demands whatsoever, in law or equity of any kind it or they may have against
SB and its AFFILIATES, and their officers, directors, employees,
shareholders, agents, attorneys, successors and assigns, which may arise in
any way under Paragraph 7.02 except as a result of SB's willful misconduct in
the performance of its obligations under Paragraph 7.02.
7.04 Notwithstanding the provisions of Paragraph 7.02, each party
shall, at its own expense, provide reasonable assistance to the other party
to facilitate filing of all patent applications covering inventions referred
to in Paragraph 7.01 and shall execute all documents deemed necessary or
desirable therefor.
7.05 In the event of the institution of any suit by a THIRD PARTY
against CORTECH, SB or its sublicensees or distributors for patent
infringement involving the manufacture, use, sale, distribution or marketing
of PRODUCT in the FIELD 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. CORTECH and SB shall
assist one another and cooperate in any such litigation at the other's
request without expense to the requesting party.
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<PAGE>
7.06 In the event that CORTECH or SB becomes aware of actual or
threatened infringement of a PATENT 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
action against any THIRD PARTY and to use CORTECH's name in connection
therewith and to name CORTECH 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 CORTECH, 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 7.07. In any event, CORTECH and SB
shall assist one another and cooperate in any such litigation at the other's
request without expense to the requesting party.
7.07 In any action brought pursuant to Paragraph 7.06, 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 reasonable 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.
7.08 CORTECH 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 shared between SB and CORTECH, with SB receiving 50% (fifty percent)
and CORTECH receiving 50% (fifty percent) of such excess.
7.09 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 7 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 this AGREEMENT.
7.10 SB shall have the right but not the obligation to seek extensions
of the terms of PATENTS. At SB's request, CORTECH shall either authorize SB
to act as CORTECH's agent for the purpose of making any application for any
extensions of the term of PATENTS and provide reasonable assistance therefor
to SB or shall diligently seek to obtain such extensions, in either event, at
SB's expense.
7.11 At SB's request, CORTECH shall seek to obtain SPCS or authorize SB
to obtain SPCS on CORTECH's behalf. Where SB holds a relevant Marketing
Authorization, SB
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<PAGE>
shall at its sole discretion provide to CORTECH a copy of said Marketing
Authorization and any information necessary for the purpose of obtaining an
SPC.
7.12 At SB's request, CORTECH shall cooperate with SB to obtain
"pipeline" protection which may be available under the patent laws of
countries the patent laws of which are amended to provide improved protection
for PRODUCT.
8. TRADEMARKS AND NON-PROPRIETARY NAMES
8.01 Promptly after the EFFECTIVE DATE, CORTECH shall, [ ]*,
assign all CORTECH's rights, title and interest, including any associated
goodwill, throughout the TERRITORY to the BradycorTM trademark to SB.
8.02 SB shall be responsible for the selection of all trademarks which
it employs in connection with PRODUCT in the FIELD in the TERRITORY and shall
own and control such trademarks. SB shall be responsible for registration
and maintenance of all such trademarks, including the BradycorTM trademark.
Nothing in this AGREEMENT shall be construed as a grant of rights, by license
or otherwise, to CORTECH to use such trademarks or any other trademarks owned
by SB for any purpose. SB shall own such tradenames and trademarks and shall
retain such ownership upon termination of this AGREEMENT, including upon the
expiration of this AGREEMENT in accordance with Paragraph 10.02, except that,
in the event that this AGREEMENT is terminated, in its entirety, for any
reason other than by SB in accordance with Paragraph 10.03 or 10.05:
(a) [
]*; and
(b) in all other countries of the TERRITORY, CORTECH shall have the
right to [
]*.
8.03 SB, at its expense, shall be responsible for the selection and
registration of non-proprietary names for PRODUCT in the TERRITORY.
9. STATEMENTS AND REMITTANCES
9.01 SB shall keep and require its AFFILIATES and sublicensees to keep
complete and accurate records of all gross invoices and NET SALES of PRODUCT
under the licenses granted herein. CORTECH shall have the right, at
CORTECH'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
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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<PAGE>
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 CORTECH
only as to the accuracy of the royalty statements and payments.
9.02 Within sixty (60) days after the close of each calendar quarter,
SB shall deliver to CORTECH a true accounting of all PRODUCT sold by SB, its
AFFILIATES, and its sublicensees during such quarter and shall at the same
time pay all royalties due. Such accounting shall show sales on a
country-by-country and PRODUCT-by-PRODUCT basis.
9.03 Any tax, duty or other levy paid or required to be withheld by SB
on account of royalties payable to CORTECH under this AGREEMENT shall be
deducted from the amount of royalties otherwise due. SB shall secure and
send to CORTECH proof of any such taxes, duties or other levies withheld and
paid by SB or its sublicensees for the benefit of CORTECH.
9.04 All royalties due under this AGREEMENT shall be payable in U.S.
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 on sales in that country shall be suspended until such
remittances are possible. CORTECH shall have the right, upon giving written
notice to SB, to receive payment in that country in local currency.
9.05 Monetary conversion from the currency of a foreign country, in
which PRODUCT is sold, into United States currency 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.
10. TERM AND TERMINATION
10.01 Royalty obligations under Paragraph 3.02 in each country of the
TERRITORY shall expire upon the earlier of (a)(i) in each country of the
TERRITORY other than the United States of America, the [
]* by SB,
its AFFILIATES, or its sublicensees in such country; and (ii) in the United
States of America, the [
]* by SB, its AFFILIATES, or its sublicensees
in such country; or (b) when [
]*; or (c) when all
KNOW-HOW has become publicly known in such country other than by the action
of SB or an undertaking connected with SB. Royalty obligations under
Paragraph 3.03 shall expire in each country of the TERRITORY upon the earlier
of (a) the [
]* by SB, its AFFILIATES, or its sublicensees in such country;
or (b) when all KNOW-HOW has become publicly known in such country other than
by the action of SB or an undertaking
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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<PAGE>
connected with SB. Expiration of SB's royalty obligations in a particular
country of the TERRITORY under this provision shall not preclude SB from
continuing to make, have made, use and sell PRODUCT and to use KNOW-HOW in
such country without further payment obligation to CORTECH.
10.02 Unless otherwise terminated, this AGREEMENT shall expire
upon the expiration of SB's royalty obligations to CORTECH under Article 3 in
every country of the TERRITORY. Expiration of this AGREEMENT under this
provision shall not preclude SB from continuing to make, have made, use and
sell PRODUCT and to use KNOW-HOW throughout the TERRITORY without further
royalty payments.
10.03 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.
10.04 (a) SB may terminate this AGREEMENT on a country by
country basis by giving CORTECH at [ ]* written notice
thereof at any time before SB first markets PRODUCT in such country based on
a reasonable determination by SB, using the same standards SB would use in
assessing whether or not to continue development of a product of its own
making, that the patent, medical/scientific, technical, regulatory or
commercial profile of PRODUCT does not justify continued development of
PRODUCT in such country. After marketing PRODUCT, SB may terminate this
AGREEMENT on a country by country basis by giving CORTECH at least [
]* 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 of a product of its own making, that the patent,
medical/scientific, technical, regulatory or commercial profile of PRODUCT
does not justify continued marketing of PRODUCT in such country.
(b) In the event that SB terminates this AGREEMENT in
any country of the TERRITORY in accordance with Paragraph 10.04(a), [
]* In addition, SB shall, within thirty (30) days after the
effective date of such termination, [ ]*
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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<PAGE>
[
]*.
In addition, in the event that SB terminates the AGREEMENT in its entirety
under this provision, [
]*.
10.05 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.
10.06 Notwithstanding the bankruptcy of CORTECH, or the impairment
of performance by CORTECH of its obligations under this AGREEMENT as a result
of bankruptcy or insolvency of CORTECH, SB shall be entitled to retain the
licenses granted herein, subject to CORTECH's rights to terminate this
AGREEMENT for reasons other than bankruptcy or insolvency as expressly
provided in this AGREEMENT.
10.07 All rights and licenses granted under or pursuant to this
AGREEMENT by CORTECH to SB, and by SB to CORTECH, 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. The parties agree that each party, 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. The parties further agree that, in the event of the commencement
of a bankruptcy proceeding by or against
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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<PAGE>
CORTECH 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 CORTECH 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 CORTECH upon written request therefor by
SB, provided, however, that upon CORTECH'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 CORTECH, 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.
11. RIGHTS AND DUTIES UPON TERMINATION
11.01 Upon termination of this AGREEMENT, CORTECH shall have the
right to retain any sums already paid by SB hereunder, and SB shall pay all
sums accrued hereunder at the time herein provided.
11.02 Upon termination of this AGREEMENT in its entirety or with
respect to any PRODUCT in any country under Paragraphs 10.03, 10.04, or
10.05, SB shall notify CORTECH of the amount of PRODUCT SB and its
AFFILIATES, sublicensees and distributors then have on hand, the sale of
which would, but for the termination, be subject to royalty, and SB and its
sublicensees and distributors shall thereupon be permitted to sell that
amount of PRODUCT provided that SB shall pay the royalty thereon at the time
herein provided for.
11.03 Expiration or termination of this AGREEMENT shall terminate
all outstanding obligations and liabilities between the parties arising from
this AGREEMENT except thosedescribed in Paragraphs 6.02, 6.03(to the extent
described therein), 6.04, 6.05, 6.06, 6.07, 6.08, 7.01, 7.02, 7.03, 7.04,
7.05, 7.06, 7.07, 7.08, 7.09, 8.02, 10.01 (last sentence), 10.02 (last
sentence), and 10.04(b), and Articles 9 and 11 through 20. 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.
11.04 Termination of the AGREEMENT in accordance with the
provisions hereof shall not limit remedies which may be otherwise available
in law or equity.
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12. WARRANTIES AND REPRESENTATIONS
12.01 As of the EFFECTIVE DATE, CORTECH warrants that it owns the
entire right and title, to the extent of its ownership interest in the
PATENTS listed in APPENDIX A, and in the KNOW-HOW provided to SB, or
otherwise has the right to grant the license outlined in Article 2 with
respect to such PATENTS and KNOW-HOW, and that it has the right to enter into
this AGREEMENT. CORTECH further warrants and represents that it will not
encumber, with liens, mortgages, security interests or otherwise, all such
PATENTS and KNOW-HOW. CORTECH further warrants that CP-0127 Development
Corporation, a company organized under the laws of the state of Colorado and
having a place of business at 6850 N. Broadway, Denver, Colorado, 80221,
U.S.A., has authorized CORTECH to sublicense to SB, to the extent outlined in
this AGREEMENT, all PATENTS and KNOW-HOW related to PRODUCT which were
licensed to CORTECH under the terms of the February 13, 1992 Technology
License Agreement between CORTECH and CP-0127 Development Corporation.
CORTECH warrants and represents that it:
(a) shall pay all royalties and other payments which CORTECH
may owe to CP-0127 Development Corporation, 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 CORTECH and
CP-0127 Development Corporation, and any other THIRD PARTY related to such
PATENTS and KNOW-HOW; and
(b) In the event that CORTECH receives notice from CP-0127
Development Corporation, or any other such THIRD PARTY, that CORTECH has
committed a breach of its obligations thereto related to such PATENTS and/or
KNOW-HOW, or if CORTECH anticipates such breach, such as may give rise to a
right by such THIRD PARTY to terminate or otherwise diminish CORTECH's rights
to such PATENTS and/or KNOW-HOW, CORTECH shall immediately notify SB of such
situation, and CORTECH shall promptly cure such breach. However, if CORTECH
is unable to cure such breach, CORTECH shall, to the extent possible, permit
SB to cure such breach and to negotiate directly with such THIRD PARTY
regarding the cure of such breach.
12.02 Nothing in this AGREEMENT shall be construed as a warranty
that PATENTS are valid or enforceable. CORTECH hereby represents that it has
no present knowledge from which it can be inferred that PATENTS are invalid
or that their exercise would infringe patent rights of THIRD PARTIES. Except
as provided in Paragraph 3.06, a holding of invalidity or unenforceability of
any PATENT, from which no further appeal is or can be taken, shall not affect
the rights or obligations of the parties.
12.03 CORTECH acknowledges that, in entering into this AGREEMENT,
SB has relied or will rely upon information supplied by CORTECH, information
to be supplied by
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CORTECH, and information which CORTECH has caused or will cause to be
supplied to SB by CORTECH's agents, representatives and/or licensees,
pursuant to the Confidentiality Agreement, dated February 15, 1995, between
the parties, and Article 6 hereof, and CORTECH warrants and represents that
all such information is and will be timely and accurate in all material
respects. CORTECH further warrants and represents that it has not, up
through and including the date of this AGREEMENT, omitted to furnish SB with
any information concerning PRODUCT or the transactions contemplated by this
AGREEMENT, which would be material to SB's decision to enter into this
AGREEMENT and to undertake the commitments and obligations set forth herein.
12.04 CORTECH warrants and represents that it has no present
knowledge of the existence of any pre-clinical or clinical data or
information concerning the PRODUCT for the treatment of traumatic brain
injury or for the treatment of ischaemic stroke which suggests that there may
exist quality, toxicity, safety and/or efficacy concerns which may materially
impair the utility and/or safety of the PRODUCT for the treatment of
traumatic brain injury or for the treatment of ischaemic stroke.
12.05 CORTECH warrants that it will not knowingly engage in any
activity regarding development of PRODUCT outside of the FIELD which is or
ought to be recognized by CORTECH as posing a present or potential harm to
the development of PRODUCT within the FIELD in any country of the TERRITORY.
CORTECH further warrants that it will require all of its sublicensees of
PRODUCT outside of the FIELD to enter in a binding agreement with CORTECH
which contains the same warranty as outlined in this Paragraph.
12.06 [
]*
13. FORCE MAJEURE
13.01 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 (other than payment of
monies) to the extent of such prevention, restriction, interference or delay,
provided that the affected party shall use its reasonable best efforts to
avoid or remove such causes of non-performance and shall continue performance
with the utmost dispatch whenever such causes are removed. When such
circumstances arise, the parties shall discuss what, if any, modification of
the terms of this AGREEMENT may be required in order to arrive at an
equitable solution.
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 23
<PAGE>
14. GOVERNING LAW
14.01 This AGREEMENT shall be deemed to have been made in the
Commonwealth of Pennsylvania and its form, execution, validity, construction
and effect shall be determined in accordance with the laws of the
Commonwealth of Pennsylvania, U.S.A.
15. WAIVER OF BREACH
15.01 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.
16. SEPARABILITY
16.01 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.
16.02 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.
16.03 In the event that the terms and conditions of this AGREEMENT
are materially altered as a result of Paragraphs 16.01 or 16.02, the parties
will renegotiate the terms and conditions of this AGREEMENT to resolve any
inequities.
17. ENTIRE AGREEMENT
17.01 This AGREEMENT, entered into as of the EFFECTIVE DATE,
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.
Page 24
<PAGE>
18. NOTICES
18.01 Any notice required or permitted under this AGREEMENT shall
be sent, in writing, and shall be sent by air mail, postage pre-paid, to the
following addresses of the parties:
CORTECH
Cortech, Inc.
6850 N. Broadway
Denver, Colorado, U.S.A. 80221
Attention: Chief Executive Officer
copies to:
Cooley Godward Castro Huddleson & Tatum
2595 Canyon Boulevard, Suite 250
Boulder, Colorado 80302-6737
Attention: David E. Bartlett, Esq.
SB
SmithKline Beecham plc
New Horizons Court
Brentford, Middlesex TW8 9EP
England
Attention: Senior Vice President and Director
Business Development
copies to:
SmithKline Beecham Corporation
One Franklin Plaza (Mail Code FP1935)
P.O. Box 7929
Philadelphia, Pennsylvania 19101, U.S.A.
Attention: Senior Vice President and Director
Business Development
SmithKline Beecham Corporation
One Franklin Plaza (Mail Code FP2225)
P.O. Box 7929
Philadelphia, Pennsylvania 19101, U.S.A.
Attention: Corporate Law-U.S.
18.02 Any notice required or permitted to be given concerning this
AGREEMENT shall be effective upon receipt by the party to whom it is
addressed or within seven (7) days of dispatch whichever is earlier.
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<PAGE>
19. ASSIGNMENT
19.01 This AGREEMENT and the licenses herein granted shall be
binding upon and inure to the benefit of the successors in interest of the
respective parties. Neither this AGREEMENT nor any interest hereunder shall
be assignable by either party without the written consent of the other
provided, however, that (a) SB may assign this AGREEMENT or any part of its
rights and obligations hereunder, or any PATENT owned by it, to any AFFILIATE
of SB or to any corporation with which SB 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 CORTECH; and (b)
CORTECH may assign this AGREEMENT or any part of its rights and obligations
hereunder, or any PATENT or KNOW-HOW owned by it, to any entity with which
CORTECH 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 SB.
20. RECORDING
20.01 SB 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 CORTECH shall provide reasonable
assistance to SB in effecting such recording, registering or notifying.
21. EXECUTION IN COUNTERPARTS
21.01 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.
Page 26
<PAGE>
IN WITNESS WHEREOF, the parties, through their authorized officers,
have executed this AGREEMENT as of the EFFECTIVE DATE.
SMITHKLINE BEECHAM plc
BY: /s/ JEAN PIERRE GARNIER
----------------------------------
Jean Pierre Garnier
TITLE: Chairman, Pharmaceuticals
-------------------------------
CORTECH, INC.
BY: /s/ David Hyman
----------------------------------
TITLE: President & CEO
-------------------------------
Page 27
<PAGE>
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
SMITHKLINE BEECHAM PLC-CORTECH, INC.
APPENDIX A
PATENTS
COUNTRY PATENT/APPLICATION NO STATUS
Australia 660683 P
Canada [ ]* A
Europe* [ ]* A
[ ]*
Japan [ ]* A
[ ]*
South Korea [ ]* A
[ ]*
USA 5,416,191 P
USA [ ]* A
USA [ ]* A
*European application designates: Austria, Belgium, Denmark, France, Germany,
Great Britain, Greece, Italy, Luxembourg, Monaco, Netherlands, Spain, Sweden
and Switzerland.
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 28
<PAGE>
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
SMITHKLINE BEECHAM PLC-CORTECH, INC.
APPENDIX B
OUTLINE DEVELOPMENT PLAN
[
]*
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 29
<PAGE>
[
]*
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 30
<PAGE>
[
]*
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 31
<PAGE>
[
]*
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 32
<PAGE>
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
SMITHKLINE BEECHAM PLC-CORTECH, INC.
APPENDIX C
PRODUCT REQUIREMENTS AND DELIVERY SCHEDULE
1. INTRODUCTION
CORTECH will use its best efforts to supply PRODUCT to SB both as bulk drug
substance and as filled sterile vials.
a) Filled sterile vials
[
]* In addition, CORTECH is required to supply an equal
number of matching sterile placebo vials to SB.
b) Drug substance
Quantities of GMP and non-GMP PRODUCT drug substance are indicated in the table
below.
All GMP and non-GMP PRODUCT drug substance must meet SB's specifications and
be accompanied by a certificate of analysis.
c) Clinical Trials Supplies from [ ]*
SB assumes that an alternative supplier, to be chosen and managed by SB, will
provide additional PRODUCT drug substance from [ ]* onwards. The
term "Alternative Supplier" indicates PRODUCT drug substance from this source
in the table below.
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
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<PAGE>
2. PRODUCT REQUIREMENTS AND DELIVERY SCHEDULE
The quantities and delivery timings of PRODUCT, shown below, are SB's
requirements in accordance with Paragraphs 5.04(a) and 5.04(b).
SUMMARY OF PRODUCT REQUIREMENTS AND DELIVERY SCHEDULE
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------
TIMING SOURCE REQUIREMENTS
- ------------------------------------------------------------------------------------------------------
<S> <C> <C>
- ------------------------------------------------------------------------------------------------------
[
]*
- ------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 34
<PAGE>
<TABLE>
<CAPTION>
<S> <C> <C>
- ------------------------------------------------------------------------------------------------------
[
]*
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 35
<PAGE>
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
SMITHKLINE BEECHAM PLC-CORTECH, INC.
APPENDIX D
REASONABLE TECHNICAL ASSISTANCE TO BE PROVIDED BY CORTECH TO SB
UNDER PARAGRAPH 5.03
A. CORTECH CLINICAL TASKS FOR TECHNOLOGY TRANSFER
<TABLE>
<S> <C>
- ----------------------------------------------------------------------------------------------------------------
TASK TIMING
- ----------------------------------------------------------------------------------------------------------------
RESTART OF STUDY 009
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 36
<PAGE>
<TABLE>
<S> <C>
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
- ----------------------------------------------------------------------------------------------------------------
TASK TIMING
- ----------------------------------------------------------------------------------------------------------------
DOCUMENT TRANSFER FOR OTHER
INDICATIONS/STUDIES
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 37
<PAGE>
<TABLE>
<S> <C>
- ----------------------------------------------------------------------------------------------------------------
TASK TIMING
- ----------------------------------------------------------------------------------------------------------------
DATABASE TRANSFER
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 38
<PAGE>
<TABLE>
<S> <C>
- ----------------------------------------------------------------------------------------------------------------
B. CORTECH REGULATORY TASKS FOR TRAUMATIC BRAIN INJURY INDICATION
- ----------------------------------------------------------------------------------------------------------------
TASK TIMING
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 39
<PAGE>
<TABLE>
<S> <C>
- ----------------------------------------------------------------------------------------------------------------
C. CORTECH REGULATORY TASKS FOR SEPSIS INDICATION
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 40
<PAGE>
<TABLE>
<S> <C>
- ----------------------------------------------------------------------------------------------------------------
D. CORTECH REGULATORY TASKS (MISCELLANEOUS)
- ----------------------------------------------------------------------------------------------------------------
TASK TIMING
- ----------------------------------------------------------------------------------------------------------------
[
]*
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 41
<PAGE>
APPENDIX D (CON'T)
E. CORTECH COMPOUND TASKS FOR TECHNOLOGY TRANSFER
<TABLE>
<S> <C>
- ---------------------------------------------------------------------------------------------------------------------------------
TASK RESPONSIBILITY / TIMEFRAME
- ---------------------------------------------------------------------------------------------------------------------------------
[
]*
- ---------------------------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 42
<PAGE>
<TABLE>
<S> <C>
- ---------------------------------------------------------------------------------------------------------------------------------
TASK RESPONSIBILITY / TIMEFRAME
- ---------------------------------------------------------------------------------------------------------------------------------
[
]*
- ---------------------------------------------------------------------------------------------------------------------------------
</TABLE>
* Indicates portions of text that have been omitted. A separate filing of
such omitted text has been made with the Commission as part of Registrant's
application for confidential treatment.
Page 43
