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EXHIBIT 10.15
[Confidential treatment has been requested for portions of this exhibit. The
confidential portions have been redacted and are denoted by [**]. The
confidential portions have been separately filed with the commission.]
LICENSE AGREEMENT
THIS LICENSE AGREEMENT is effective as of the 1st day of
November , 1993, by and among Xxxxxxxxx Wellcome Co. ("B.W. Co."), having an
address at 0000 Xxxxxxxxxx Xxxx, Research Triangle Park, North Carolina 27709,
U.S.A., The Wellcome Foundation Limited ("WFL"), having an address at Xxxxxxx
Xxxxx, 000 Xxxxxx Xxxx, Xxxxxx XX0 0XX Xxxxxxx and CTRC Research Foundation
("CTRC"), having an address at 14960 Omicron, Xxx Xxxxxxx, Xxxxx 00000-0000,
X.X.X.
WHEREAS, B.W. Co. owns all right, title and interest in
certain patent rights and has the right to use certain know-how relating to the
Compound (as herein defined) in the U.S. (as herein defined);
WHEREAS, WFL owns all right, title and interest in certain
patent rights and has the right to use certain know-how relating to the
Compound in the Non-U.S. Territory (as herein defined);
WHEREAS, CTRC desires to obtain licenses under such patent
rights and know-how to make, have made, use and sell the Compound and products
containing the Compound; and
WHEREAS, B.W. Co. and WFL are willing to grant such licenses
to CTRC;
NOW, THEREFORE, in consideration of the foregoing and the
mutual promises and covenants set forth herein, the parties hereto mutually
agree as follows:
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ARTICLE 1. DEFINITIONS
As used in this Agreement, the following terms, whether used
in the singular or the plural, shall have the following meanings:
1.1 "Affiliate" means any corporation or entity which
controls, is controlled by, or is under common control with a party to this
Agreement. A corporation or entity shall be regarded as in control of another
corporation if it owns or directly or indirectly controls at least [**]
percent ([**]) of the voting stock of the other corporation, or (i) in the
absence of the ownership of at least [**] percent ([**]) of the voting stock of
a corporation or (ii) in the case of non-corporate entity, if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such corporation or non-corporate entity, as
applicable.
1.2 "Agreement" means this License Agreement.
1.3 "Base Currency" means (i) Dollars, with respect to
sales of Products in the U.S. and royalties payable to B.W. Co. thereon; and
(ii) Sterling, with respect to sales of Products in the Non-U.S. Territory and
royalties payable to WFL thereon.
1.4 "B.W. Co. Know-How" means all technical information
and data, whether or not patentable, which is owned by B.W. Co. as of the
Effective Date and which is reasonably necessary to manufacture the Compound or
to use the Compound
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in the Field, including all regulatory filings, clinical trial data, synthesis
and analytical procedures and reference standards.
1.5 "B.W. Co. Patent Rights" means all patents and patent
applications owned by B.W. Co. as of the Effective Date, and any and all
patents that may issue from said patent applications which contain claims
covering the manufacture or use of the Compound, including any and all
divisions, continuations, continuations-in-part, extensions, substitutions,
renewals, confirmations, supplementary protection certificates, registrations,
revalidations, reissues or additions of or to any of the aforesaid patents and
patent applications. The B.W. Co. Patent Rights are set forth on Appendix I,
attached hereto and made a part hereof.
1.6 "Compound" means the chemical known as crisnatol
mesylate, having the chemical structure set forth on Appendix II attached
hereto and made a part hereof.
1.7 "Dollars" or "$" means United States dollars.
1.8 "Effective Date" means the date appearing at the
beginning of this Agreement.
1.9 "Europe" means all countries which are Member States,
from time to time, of the European Community.
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1.10 "FDA" means the United States Food and Drug
Administration or any successor entity.
1.11 "Field" means the treatment and/or prophylaxis of
cancer in humans.
1.12 "IND" means an Investigational New Drug application
or any equivalent successor application.
1.13 "Know-How" means the B.W. Co. Know-How and the WFL
Know-How.
1.14 "Letter Agreement" means the letter agreement between
B.W. Co. and CTRC dated December 14, 1992, pursuant to which CTRC obtained
supplies of clinical trial material from B.W. Co. and commenced a clinical
trial of a Product.
1.15 "NDA" means a New Drug Application or an equivalent
successor application.
1.16 "Net Sales," with respect to any Product containing
the Compound as the sole active ingredient, means the gross sales (i.e., gross
invoice prices) of such Product billed by CTRC and its sublicensees to Third
Party customers, less: (i) actual credited allowances to such Third Party
customers for spoiled, damaged, outdated and returned Product and for
allowances in lieu of returned Product following price
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increases; (ii) the amounts of customary trade and cash discounts, to the
extent such trade and cash discounts are not deducted by CTRC or its
sublicensees at the time of invoice in order to arrive at the gross invoice
prices; (iii) all transportation and handling charges, sales taxes, excise
taxes, use taxes or import/export duties actually paid; and (iv) all other
invoiced allowances and adjustments actually credited to customers including,
but not limited to, rebates paid to Third Party payors, whether during the
specific royalty period or not.
1.17 "Net Sales," with respect to any Product containing
one or more active ingredients in addition to the Compound, means the gross
sales of such Product billed by CTRC and its sublicensees to Third Party
customers, less all the allowances, adjustments, discounts, taxes, duties and
other charges referred to in Section 1.16, multiplied by a fraction, the
numerator of which shall be the manufacturing cost or acquisition cost, as
applicable, of the Compound included in such Product and the denominator of
which shall be the manufacturing cost or acquisition cost, as applicable, of
all active ingredients in such Product, including the Compound.
1.18 "Patent Rights" means the B.W. Co. Patent Rights and
the WFL Patent Rights.
1.19 "Product" means the Compound or any product
containing the Compound as an active ingredient, (excluding, however, any in
vivo or in vitro diagnostic products) which is (i) covered by a Valid Claim or
(ii) made or developed using the Know-How.
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1.20 "Registration" means in relation to any Product such
approvals by government authorities in a country (including price approvals) as
may be legally required before such Product may be commercialized in such
country.
1.21 "Sterling" or "L." means English Pounds Sterling.
1.22 "Territory" means the U.S. and Non-U.S. Territory.
"Non-U.S. Territory" means the entire world excluding the U.S.
1.23 "Third Party" means any party other then CTRC, B.W.
Co., WFL, their respective Affiliates and CTRC's sublicensees.
1.24 "U.S." means the United States of America, its
territories and possessions.
1.25 "Valid Claim" means a claim of an issued and
unexpired patent included within the Patent Rights which has not been held
unenforceable, unpatentable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed
within the time allowed for appeal, and which has not been admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise.
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1.26 "WFL Know-How" means all technical information and
data, whether or not patentable, which is owned by WFL and its Affiliates
(other than B.W. Co.) as of the Effective Date and which is reasonably
necessary to manufacture the Compound or to use the Compound in the Field,
including all regulatory filings, clinical trial data, synthesis and analytical
procedures and reference standards.
1.27 "WFL Patent Rights" means all patents and patent
applications owned by WFL and its Affiliates (other than B.W. Co.) as of the
Effective Date and any and all patents that may issue from said patent
applications which contain claims covering the manufacture or use of the
Compound, including any and all divisions, continuations,
continuations-in-part, extensions, substitutions, renewals, confirmations,
supplementary protection certificates, registrations, revalidations, reissues
or additions of or to any of the aforesaid patents and patent applications.
The WFL Patent Rights are set forth on Appendix III, attached hereto and made a
part hereof.
ARTICLE 2. WARRANTIES
Each party hereto represents and warrants to the other that it
is free to enter into this Agreement and to carry out is obligations hereunder,
including, in the case of B.W. Co. and WFL, the right to grant the license
granted by it pursuant to Article 3 hereof. Except as set forth in this
Article 2, B.W. Co. and WFL make no warranties with respect to the Patent
Rights or the Know-How.
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ARTICLE 3. GRANT
3.1 B.W. Co. License. Subject to the provisions of
Section 3.3 in respect of the exclusive license granted in this Section 3.1,
B.W. Co. hereby grants to CTRC, under the B.W. Co. Patent Rights and the
Know-How, an exclusive license in the U.S. in the Filed and a non-exclusive
license in the U.S. outside the Field, with a right to sublicense, to make,
have made, use and sell Products.
3.2 WFL License. Subject to the provisions of Section
3.3 in respect of the exclusive license granted in this Section 3.2, WFL hereby
grants to CTRC, under the WFL Patent Rights and the Know-How, an exclusive
license in the Non-U.S. Territory in the Field and a nonexclusive license in
the Non-U.S. Territory outside the Field, with a right to sublicense, to make,
have made, use and sell Products.
3.3 Reservation of Rights. Both B.W. Co. and WFL hereby
reserve the perpetual, royalty-free right to practice the Patent Rights and to
use the Know-How for research purposes including, but not limited to, the right
to make, have made, use and sell Products in the Field for research purposes.
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ARTICLE 4. LICENSE FEE
4.1 License Fee. As partial consideration for the
licenses granted hereunder, CTRC will pay B.W. Co. and WFL a total sum of
$[**] in the following installments:
(i) $[**] within ten (10) days after execution
of this Agreement; and
(ii) $[**] on the first anniversary of the
Effective Date.
4.2 Payment. Payment of each installment of the License
Fee shall be made in Dollars directly to B.W. Co. B.W. Co. and WFL shall
mutually agree as to the allocation of the License Fee between them.
ARTICLE 5. ROYALTIES
5.1 Earned Royalties.
(i) Subject to adjustment as set forth in Section
5.2, CTRC shall pay B.W. Co. a royalty on Net Sales of Products in the U.S. and
WFL a royalty on Net Sales of Products in the Non-U.S. Territory at the
following royalty rates:
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(a) [**] percent ([**]%) on the
first $[**] of Net Sales of Products in the Territory in a calendar
year; and
(b) [**] percent ([**]%) on that
portion of Net Sales of Products in the Territory in excess of
$[**] in a calendar year.
Royalties shall be paid in respect of Net Sales of Products in a given country
of the Territory for a period of eight (8) years from the date of first
commercial sale of the first Product in such country. Thereafter, royalties
shall be paid in respect of a given Product only so long as the manufacture,
sale or use of such Product in such country would, but for the license granted
herein, infringe a Valid Claim. Notwithstanding the foregoing, however, with
respect to Europe only, royalties on Net Sales of a given Product which are
payable only by virtue of clause (ii) of Section 1.19 shall be payable on a
country-by-country basis commencing with the first commercial sale of such
Product in such country and ending on the earlier of (x) the date on which the
Know-How used to make and develop such Product becomes published or generally
known to the public through no fault on the part of CTRC or its Affiliates or
sublicensees or (y) the eighth (8th) anniversary of the commercial sale of the
first Product in such country.
(ii) For purposes of determining whether Net Sales
in a given calendar year have exceeded [**] all Net Sales in currencies
other than Dollars shall be converted into Dollars in accordance with the
provisions of Section 6.1.
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5.2 Third Party Sales.
(i) With respect to any country in which Patent
Rights do not exist, if (a) a product containing the Compound as an active
ingredient for use in the Field (a "Competitive Product") is introduced by a
Third Party and (b) sales by such Third Party exceed the applicable percentage
set forth below of unit sales of CTRC and its sublicensees of Products in such
country in any calendar quarter, then the royalty rates specified in Section
5.1 applicable to sales by CTRC and its sublicensees of Products in such
country during such calendar quarter shall be adjusted as set forth below:
% of Third Party Unit Sales ("X") % Reduction in Section 5.1 Royalty Rates
X is less than or equal to [**]% [**]%
[**]% is less than X is less than [**]% [**]%
X is greater than or equal to [**]% [**]%
By way of example only, if in a given calendar quarter a Third Party's unit
sales of a Competitive Product in a country were [**] percent ([**]%)
of the unit sales by CTRC and its sublicensees of Products in such country for
the same calendar quarter, the royalty rates applicable to such sales by CTRC
and its sublicensees during such calendar quarter would be [**] percent
([**]%) for sales to which Subsection 5.1(i)(a) applies and [**] percent
([**]%) for sales to which Subsection 5.1(i)(b) applies.
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(ii) For purposes of this Section 5.2, Third Party
unit sales shall be measured by the sales reported by IMS America Ltd. of
Plymouth Meeting, Pennsylvania and its affiliates ("IMS") or another
independent marketing firm selected and paid by CTRC and reasonably acceptable
to B.W. Co. or WFL, as applicable, depending on the countries in which the
royalty rate reduction is being sought. CTRC shall furnish to B.W. Co. or WFL,
as applicable, copies of reports of IMS or such other auditing firm for the
relevant calendar quarter(s), together with CTRC's royalty reports and payments
for the relevant quarters.
5.3 Accrual of Royalties. No royalty shall be payable on
a Product made, sold, or used for tests or development purposes or distributed
as samples. No royalties shall be payable on sales among CTRC and its
sublicensees, but royalties shall be payable on the initial subsequent sale by
CTRC or its sublicensees to a Third Party. No multiple royalty shall be
payable because the manufacture, use or sale of a Product is covered by more
than one Valid Claim or is subject to both Know-How and a Valid Claim.
5.4 Third Party Royalties. If CTRC or its sublicensees
determine, after discussion with B.W. Co. in respect of the U.S. or WFL in
respect of any country in the Non-U.S. Territory, that it or they are required
to pay royalties to any Third Party because the manufacture, use or sale of a
Compound contained in a given Product infringes any patent or other
intellectual property rights of such Third Party in a given country, CTRC or
its sublicensees may deduct from royalties thereafter due to B.W. Co. or WFL,
as applicable, with respect to Net Sales of such Product in such country up to
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[**] percent ([**]%) of the royalties or such other fees paid to such
Third Party, subject to the limitation in the immediately following sentence.
In no event shall the royalties due to B.W. Co. or WFL, as applicable, on such
Net Sales of such Product in such country on account of any reduction pursuant
to this Section 5.4 be thereby reduced by more than [**] percent ([**]%)
of the royalties which otherwise would have been due hereunder on such Net
Sales of such Product in such country.
ARTICLE 6. ROYALTY REPORTS AND ACCOUNTING
6.1 Royalty Reports; Records. During the term of this
Agreement, CTRC shall furnish to B.W. Co., in respect of Net Sales in the U.S.,
and to WFL, in respect of Net Sales of Products in the Non-U.S. Territory, a
written report or reports covering each calendar quarter (a "royalty period")
showing (i) the Net Sales of all Products in the U.S. or the Non-U.S.
Territory, as applicable, during the royalty period; (ii) the royalties,
payable in the Base Currency, which shall have accrued hereunder in respect of
such sales; (iii) withholding taxes, if any, required by law to be deducted in
respect of such sales; and (iv) the exchange rates used in determining the
amount of the royalties payable in the Base Currency. With respect to sales of
Products invoiced in the Base Currency, the Net Sales and royalty payable shall
be expressed in such Base Currency. With respect to sales of Products invoiced
in a currency other than the Base Currency, the Net Sales and royalty payable
shall be expressed in the domestic currency of the party making the sale
together with the Base Currency equivalent of the royalty payable, calculated
using the simple average of the exchange rates published in the
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London Financial Times under the heading "World Value of the Pound" on the last
day of each month during the royalty period in which the London Financial
Times' Guide is published (currently Tuesdays). If any sublicensee makes any
sales invoiced in a currency other than its domestic currency, the Net Sales
shall be converted to its domestic currency in accordance with the
sublicensee's normal accounting principles. CTRC shall furnish to B.W. Co. or
WFL, as applicable, appropriate evidence of payment of any tax or other amount
required by applicable laws or regulations to be deducted from any royalty
payment. Reports shall be due on the sixtieth (60th) day following the close
of each respective calendar quarter. CTRC shall keep accurate records in
sufficient detail to enable the royalties payable hereunder to be determined.
CTRC shall be responsible for all royalties and late payments that are due to
B.W. Co. and WFL but have not been paid by CTRC's sublicensees to CTRC.
6.2 Right to Audit. Upon the written request of B.W. Co.
or WFL (the "auditing party"), at its expense and not more than once in each
calendar year (i.e., once for B.W. Co. and once for WFL), CTRC shall permit an
independent public accountant, selected by the auditing party, and acceptable
to CTRC, which acceptance shall not be unreasonably refused, to have access
during normal business hours to those records of CTRC as may be reasonably
necessary to verify the accuracy of the royalty reports furnished by CTRC to
B.W. Co. and/or WFL pursuant to Section 6.1 of this Agreement in respect of any
calendar year ending not more than forty-eight (48) months prior to the date of
such request. CTRC shall include in each sublicense granted by it pursuant to
this Agreement a provision requiring the sublicensee to keep and maintain
records of sales made pursuant to such sublicense and to grant access to such
records by the
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auditory party's independent public accountant, as applicable. If such
independent public accountant's report shows any underpayment of royalties,
within thirty (30) days after CTRC's receipt of such report, CTRC shall remit
to the auditing party (i) the amount of such underpayment and (ii) if such
underpayment exceeds [**] percent ([**]) of the total royalties owed to the
auditing party for the calendar year then being audited, the reasonable and
necessary fees and expenses of such independent public accountant performing
the audit, subject to reasonable substantiation thereof. Any overpayment of
royalties shall be fully creditable against future royalties payable to the
auditing party in subsequent royalty periods.
6.3 Confidentiality of Records. The auditing party
agrees that all information subject to review under this Article 6 or under any
sublicense agreement is confidential and that it and its accountant shall
retain all such information in confidence.
ARTICLE 7. ROYALTY AND OTHER PAYMENTS
7.1 Payment Due Dates. Royalties shown to have accrued
in each royalty report provided for under Article 6 of this Agreement shall be
due and payable on the date such royalty report is due. Payment of royalties
in whole or in part may be made in advance of such due date.
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7.2 Currency Restrictions. Except as hereinafter
provided in this Section 7.2, all royalties due shall be paid in the Base
Currency of the party to which they are owed. If at any time legal
restrictions prevent the prompt remittance of part or all royalties with
respect to any country of the Territory where the Products are sold, CTRC shall
have the right and option to make such payments by depositing the amount
thereof in local currency to B.W. Co.'s or WFL's account in a bank or
depository in such country.
7.3 Interest. Royalties and other payments required to
be paid by CTRC pursuant to this Agreement shall, if overdue, bear interest at
a per annum rate of eighteen percent (18%) or the maximum rate allowed by law,
whichever is less, until paid. The payment of such interest shall not preclude
B.W. Co. or WFL from exercising any other rights it may have because any
payment is overdue.
ARTICLE 8. DEVELOPMENT AND MARKETING PROGRAM
8.1 Development Program. CTRC shall, at its expense, use
its best efforts (i) to conduct a research and development program in the U.S.
relating to the use of the Product for the treatment of cancer (the
"Development Program"); and (ii) if, in CTRC's opinion, the results of the
Development Program so justify, to seek Registration for such Product in the
U.S.
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8.2 Fulfillment; Termination.
(i) CTRC's best efforts obligations set forth in
this Article 8 shall be deemed to have been fulfilled if CTRC (a) files an NDA
for Registration of a Product in the U.S. within sixty (60) months after the
Effective Date and (b) commences marketing such Product in the U.S. within
twelve (12) months following Registration. The time periods specified in
clauses (a) and (b) above shall each be subject to one twelve (12) month
extension, at CTRC's election, by payment to B.W. Co. of [**] for each such
extension, such payments to be made within the first thirty (30) days of each
such extension.
(ii) In the event that CTRC fails to meet either
deadline set forth in Subsection 8.2(i) above, B.W. Co. may, upon at least
sixty (60) days' prior written notice, terminate this Agreement, unless within
such sixty (60) day period, CTRC meets such deadline.
8.3 Non U.S. Development. No later than the filing by
CTRC of an NDA for a Product in the U.S., CTRC shall use reasonable efforts to
enter into a sublicense agreement with one or more Third Parties for
development and marketing outside the U.S. Such sublicense agreement shall
require such Third Party or Third Parties to use their best efforts (i) to
obtain Registration for such Product in such other countries of the Territory
as CTRC or such Third Party or Third Parties deem appropriate, and (ii) upon
obtaining Registration for the Product in a particular
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country, to proceed in due course with the commercial introduction and
marketing of such Product in such country.
8.4 Progress Reports. Until commercial introduction of
the first Product, CTRC will provide a semiannual report to B.W. Co. and WFL
summarizing CTRC's activities related to the development of the Products and
securing of the requisite Registrations during the semiannual period covered by
such report.
ARTICLE 9. PATENT RIGHTS
9.1 Patent Prosecution and Maintenance. B.W. Co. and WFL
shall use reasonable efforts to prosecute their respective patent applications
within the Patent Rights, to obtain patents thereon and to maintain any such
patents during the term hereof using patent counsel of their choice.
Notwithstanding the foregoing, at any time after the second anniversary of the
Effective Date, B.W. Co. or WFL, as applicable, shall have the right to
discontinue the prosecution of any such patent application or to abandon any
such patent. If, after the second anniversary of the Effective Date, B.W. Co.
or WFL decides to abandon or allow to lapse any patent application or patent
within the Patent Rights in any country or the Territory, it shall inform CTRC
and CTRC shall be given the opportunity to prosecute such patent application
and/or to maintain such patent at its own expense.
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9.2 Status of Patent Rights. Upon request, B.W. Co. or
WFL, as applicable, shall promptly advise CTRC as to the status of any patent
applications and patents included within its Patent Rights and, to the extent
it has not previously done so, shall promptly provide CTRC with relevant
documentation relating to such patent applications and patents including, but
not limited to, copies thereof.
9.3 Patent Prosecution Costs.
(i) CTRC shall reimburse B.W. Co. and WFL for the
reasonable out-of-pocket expenses incurred by each in the performance of its
obligations pursuant to Section 9.1. B.W. Co. and WFL shall each invoice CTRC
for such expenses on or before April 30 and October 31 of each year with
respect to those out-of-pocket expenses each has incurred for the six (6) month
period ending on the last day of the immediately preceding August or February.
Such invoice shall itemize, in reasonable detail, the expenses which have been
incurred on a country-by-country basis. Payment of each invoice shall be due
net thirty (30) days after its date.
(ii) CTRC reserves the right to terminate its
obligations pursuant to Subsection 9.3(i) with respect to any patent
application or patent included in the Patent Rights in any country or countries
upon at least sixty (60) days' prior written notice to B.W. Co. in respect of
the U.S. or WFL in respect of the Non-U.S. Territory. After the date specified
in such notice on which CTRC's obligations to pay patent prosecution or
maintenance costs terminate, such patent application and/or patent shall
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no longer be included in the Patent Rights in those countries in which CTRC has
exercised its right to terminate such obligations.
ARTICLE 10. THIRD PARTY INFRINGEMENT
In the event that CTRC becomes aware that a product
containing the Compound for use in the Field is being made, used or sold in the
Territory and it believes that such product infringes a Valid Claim, it shall
promptly advise B.W. Co. or WFL, as applicable, of all the relevant facts and
circumstances known by it in connection with the infringement. B.W. Co., in
respect of the U.S., or WFL, in respect of the Non-U.S. Territory, shall have
the right to enforce such Patent Rights against such infringement, at its own
expense. In the event that (1) B.W. Co. or WFL, as applicable, shall fail,
within sixty (60) days after receiving notice from CTRC, either (a) to
terminate such infringement or (b) to institute an action to prevent
continuation thereof and, thereafter, to prosecute such action diligently, or
(ii) B.W. Co. or WFL earlier notifies CTRC that it does not plan to terminate
the infringement or institute such action, then CTRC shall have the right to do
so at its own expense. B.W. Co. and WFL shall cooperate with CTRC in such
effort including being joined as a party to such action, if necessary. Any
damages or costs recovered by B.W. Co. or WFL in connection with any action
filed by it hereunder, after first reimbursing B.W. Co. or WFL for its
out-of-pocket costs and expense of litigation, shall be equally divided by CTRC
and B.W. Co. or WFL, as applicable. Any damages or costs recovered in
connection with any action filed by CTRC hereunder, after first reimbursing
CTRC for its out-of-pocket costs
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and expenses of litigation, shall be deemed to be Net Sales of Products in the
calendar year actually received by CTRC and royalties shall be payable by CTRC
to B.W. Co. or WFL thereon in accordance with the terms of this Agreement.
ARTICLE 11. INDEMNIFICATION; INSURANCE
11.1 Indemnification by CTRC. CTRC agrees to indemnify
and hold B.W. Co., WFL, their Affiliates, directors, officers, employees and
agents harmless from and against any liabilities or damages or expenses in
connection therewith (including reasonable attorneys' fees and costs and other
expenses of litigation) resulting from (i) claims arising out of CTRC's or its
sublicensees' testing, use, manufacture or sale of the Products; or (ii) the
successful enforcement (i.e., a judgment issued by a court of competent
jurisdiction against CTRC, unappealable or unappealed by CTRC within the time
allowed therefor) by B.W. Co. or WFL of its indemnification rights set forth in
clause (i) of this Section 11.1.
11.2 Indemnification Procedures. A party (the
"indemnitee") which intends to claim indemnification under this Article 11
shall promptly notify CTRC (the "indemnitor") in writing of any action, claim
or liability in respect of which the indemnitee or any of its Affiliates,
directors, officers, employees or agents intend to claim such indemnification.
The indemnitee shall permit, and shall cause its Affiliates, directors,
officers, employees and agents to permit, the indemnitor, at its discretion, to
settle any such action, claim or liability and agrees to the complete control
of such
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defense or settlement by the indemnitor; provided, however, that such
settlement does not adversely affect the indemnitee's rights hereunder or
impose any obligations on the indemnitee in addition to those set forth herein
in order for it to exercise such rights. No such action, claim or liability
shall be settled without the prior written consent of the indemnitor and the
indemnitor shall not be responsible for any legal fees or other costs incurred
other than as provided herein. The indemnitee and its Affiliates, directors,
officers, employees and agents shall cooperate fully with the indemnitor and
its legal representatives in the investigation and defense of any action, claim
or liability covered by this indemnification. The indemnitee shall have the
right, but not the obligation, to be represented by counsel of its own
selection and expense.
11.3 Insurance.
(i) CTRC shall take out and maintain, at its own
expense, during the term of this Agreement, and for a minimum of two (2) years
following the expiration, termination or cancellation of this Agreement,
product liability coverage from an insurance company or companies reasonably
satisfactory to B.W. Co. and WFL. During the clinical development of Products,
such coverage shall be at least $ [**] per occurrence. Promptly upon
commercial introduction of the initial Product, the parties shall negotiate in
good faith an increase in such coverage. The insurance policy relating to such
coverage shall name B.W. Co. and WFL as additional insureds by way of
endorsement or otherwise as their respective interests may appear.
-22-
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(ii) Within thirty (30) days after the Effective
Date, CTRC shall cause to be delivered to B.W. Co. and WFL an insurance
certificate evidencing the insurance coverage required by Subsection 11.3(i).
Such insurance certificate shall name B.W. Co. and WFL as additional insureds
as their respective interests may appear and shall include a certification that
such insurance coverage includes contractual coverage for CTRC's liability
under this Agreement.
ARTICLE 12. CONFIDENTIALITY
12.1 Treatment of Confidential Information. Except as
otherwise provided in this Article 12, during the term of this Agreement and
for a period of five (5) years thereafter:
(1) CTRC will retain in confidence and use only
for purposes of this Agreement any information and
data supplied by or on behalf of B.W. Co. or WFL to
CTRC under this Agreement; and
(ii) B.W. Co. and WFL will retain in confidence
and use only for purposes of this Agreement any
information and data supplied by or on behalf of CTRC
to B.W. Co. or WFL under this Agreement.
For purposes of this Agreement, all such information and data
which a party is obligated to retain in confidence shall be called
"Information." All information
-23-
24
and data disclosed by B.W. Co. to CTRC pursuant to the Letter Agreement shall
be deemed to have been disclosed hereunder.
12.2 Right to Disclose. To the extent it is reasonably
necessary or appropriate to fulfill its obligations or exercise its rights
under this Agreement or any rights which survive termination or expiration
hereof, a party may disclose Information to its Affiliates, sublicensees
(actual and prospective), consultants, outside contractors and clinical
investigators on condition that such entities or persons agree (i) to keep the
Information confidential for at least the same time periods and to the same
extent as each party is required to keep the Information confidential and (ii)
to use the Information only for such purposes as such party is entitled to use
the Information. Each party or its Affiliates or, if applicable, its
sublicensees may disclose such Information to government or other regulatory
authorities to the extent that such disclosure (a) is reasonably necessary to
obtain patents or authorizations, to conduct clinical trials and to market
commercially the Product, provided such party is otherwise entitled to engage
in such activities under this Agreement or (b) is otherwise required by
applicable laws or regulations.
12.3 Release From Restrictions. The obligation not to
disclose Information shall not apply to any part of such Information that (i)
is or becomes patented, published or otherwise part of the public domain other
than by acts of the party obligated not to disclose such Information (for
purposes of this Article 12, the "receiving party") or its Affiliates or
sublicensees in contravention of this Agreement; (ii) is disclosed to the
receiving party or its Affiliates or sublicensees by a Third Party,
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provided such Information was not obtained by such Third Party directly or
indirectly from the other party under this Agreement; (iii) prior to disclosure
under this Agreement, was already in the possession of the receiving party or
its Affiliates or sublicensees, provided such Information was not obtained,
directly or indirectly, from the other party under this Agreement; (iv) results
from research and development by the receiving party or its Affiliates or
sublicensees independent of disclosures from the other party under this
Agreement; (v) has been approved for publication by the parties hereto; or (vi)
is Product-related information which is reasonably required to be disclosed in
connection with the marketing of the Product.
12.4 Confidentially of Agreement. Except as otherwise
required by law or applicable regulation or the terms of this Agreement or
otherwise mutually agreed upon by the parties hereto, each party shall treat as
confidential the terms, conditions and existence of this Agreement.
Notwithstanding the foregoing, a party may disclose such terms, conditions and
existence to an Affiliate or, in the case of CTRC, a sublicensee, which agrees
to be bound by the terms of this Section 12.4 to the same extent as such party.
12.5 Right to Publication. B.W. Co. and WFL agree that
CTRC shall have the right to publish or to present publicly (collectively, a
"Publication") the results of any research, work or other development performed
pursuant to this Agreement by or on behalf of CTRC (collectively, the
"Results"). CTRC agrees to submit any proposed Publication to B.W. Co. and
WFL for their review at least thirty (30) days prior to submission or
presentation of such Publication. If B.W. Co. or WFL requests
-25-
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a delay in submission or presentation based on patent considerations, CTRC
agrees to delay such submission or presentation for a period not to exceed
ninety (90) days from the date of such request. CTRC further agrees to give
due consideration to any comments made by B.W. Co. or WFL with respect to such
Publication but, except as set forth in the immediately following sentence,
CTRC shall determine the content of the Publication. Nothing in this Section
12.5 shall be construed to allow CTRC to publish or otherwise disclose any
Information disclosed by B.W. Co. or WFL.
ARTICLE 13. TERM; TERMINATION
13.1 Term; Termination. Unless terminated sooner pursuant
to Section 8.2, 13.2, 13.3, 13.4 or 14.2, this Agreement shall become effective
as of the Effective Date and shall continue in full force and effect until the
expiration of CTRC's obligation to pay royalties hereunder. Upon expiration or
termination of this Agreement with respect to one or more countries of the
Territory, the rights and obligations of the parties with respect to such
country or countries shall cease, except as follows:
(i) the rights and obligations of the parties
under Article 11 shall survive termination or
expiration;
(ii) upon expiration or termination for any
reason, the obligations of confidentiality and use of
Information under Article 12 shall survive for the
period provided therein;
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(iii) upon termination, CTRC's obligations under
Sections 13.4 and 13.5 shall survive; and
(iv) expiration or termination of this Agreement
shall not relieve the parties of any other obligation
accruing prior to such termination.
13.2 Termination by CTRC. CTRC may terminate this
Agreement in its entirety at any time upon at least ninety (90) days' prior
written notice to B.W. Co. and WFL.
13.3 Termination For Cause.
(i) B.W. Co. may terminate this Agreement in the
U.S. and/or WFL may terminate this Agreement in the Non-U.S. Territory upon the
occurrence of any of the following:
(a) upon or after the bankruptcy,
insolvency, dissolution or winding up of CTRC
(other than dissolution or winding up for the
purposes of reconstruction or amalgamation);
(b) upon or after the breach of any
material provision of this Agreement by CTRC
if such breach is not cured within thirty
(30) days after B.W. Co. and/or WFL gives
CTRC
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written notice thereof, it being understood
that if such breach relates solely to CTRC's
obligations in the U.S., then this Agreement
may be terminated only in the U.S. by B.W.
Co.; and, if such breach relates solely to
CTRC's obligations in the Non-U.S.
Territory, then this Agreement may be
terminated only in the Non-U.S. Territory by
WFL; or
(c) upon the abandonment by CTRC of the
development of the Products. As used in this
clause (c), the term "abandonment," in
respect of development of the Products, shall
mean that CTRC or its sublicensees have
failed for a period of six (6) or more
consecutive months to conduct any
development, testing, regulatory or
manufacturing activity reasonably necessary
in order to prepare and file such
Registration for such Product in the U.S.,
unless such failure was due to (x) reasons
beyond its or their control (such as
circumstances of the type described in
Article 19 hereof) or (y) the failure by B.W.
Co. or WFL to perform its obligations
hereunder. CTRC shall give B.W. Co. and WFL
prompt written notice of the abandonment of
the development of the Products.
(ii) CTRC may terminate this Agreement:
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(a) in the U.S., upon or after (x) the
bankruptcy, insolvency, dissolution or
winding up of B.W. Co. (other than
dissolution or winding up from the purposes
of reconstruction or amalgamation) or (y) the
breach of any material provision of this
Agreement by B.W. Co. if such breach is not
cured within thirty (30) days after CTRC
gives B.W. Co. written notice thereof; and
(b) in the Non-U.S. Territory, upon or
after (x) the bankruptcy, insolvency,
dissolution or winding up of WFL (other than
dissolution or winding up for purposes or
reconstruction or amalgamation) or (y) the
breach of any material provision of this
Agreement by WFL if such breach is not cured
within thirty (30) days after CTRC gives WFL
written notice thereof.
13.4 CTRC's Obligations Upon Termination. Upon
termination (but not expiration) of this Agreement for any reason, (i) CTRC
agrees to cooperate fully with B.W. Co. and WFL, or their respective nominees,
to transfer or to hand over to B.W. Co. and WFL or their respective nominees,
health registrations and sales permissions regarding the Products in the
country or countries in which termination has occurred and (ii) in the event of
termination with respect to all countries of the Territory, CTRC shall return
to B.W. Co. and WFL all copies of the Information supplied by either
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hereunder, except that CTRC's legal department may retain one copy of the
Information for purposes of determining the scope of its obligations hereunder.
13.5 Disposition of Product. Upon termination of this
Agreement with respect to all countries of the Territory, CTRC shall provide
B.W. Co. and WFL with a written inventory of all the Products (in the form of
raw materials, work-in-process and finished goods) in its and its sublicensees'
possession and shall have the right to dispose of such Products within six (6)
months thereafter, subject to fulfillment of its royalty obligations relating
thereto. Notwithstanding the foregoing, upon termination of this Agreement in
all countries of the Territory, CTRC shall promptly return or destroy, at B.W.
Co.'s election, any materials supplied by B.W. Co. pursuant to Section 14.2.
ARTICLE 14. TRANSFER TO CTRC; CTRC OBLIGATIONS
14.1 Transfer of Know-How.
Within ninety (90) days following the Effective Date
and, in the case of B.W. Co., as far as it has not already done so under the
Letter Agreement or otherwise, B.W. Co. and WFL shall supply CTRC with all the
Know- How, including the assignment of B.W. Co.'s IND 25,803 for the Compound.
CTRC shall acknowledge acceptance of such assignment to the FDA promptly after
it is made by B.W. Co.
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14.2 Transfer of Clinical Trial and Bulk Material.
(i) Within ninety (90) days after the Effective
Date, as far as it has not already done so pursuant to the Letter Agreement or
otherwise, B.W. Co. will deliver to CTRC the existing B.W. Co. inventory of the
formulated Compound to be used as clinical trial material. The quantity of
formulated Compound in B.W. Co.'s existing inventory which it can deliver
pursuant to this Subsection 14.2(i) will be approximately eleven thousand
(11,000) vials of formulated Compound (which total is inclusive of any
quantities of formulated Compound delivered by B.W. Co. to CTRC prior to the
Effective Date). In addition to the foregoing, within ninety (90) days after
the Effective Date, B.W. Co. shall deliver to CTRC twenty-two hundred (2200)
grams of bulk Compound and eleven hundred and sixty (1160) grams of chrysene
aldehyde. All shipments shall be F.O.B. San Antonio, Texas.
(ii) All formulated Compound provided B.W. Co.
shall, at the time of shipment, meet the specifications set forth in B.W. Co.'s
IND 25,803 for the Compound, as determined in accordance with the analytical
methodology set forth therein. EXCEPT AS STATED IN THE IMMEDIATELY PRECEDING
SENTENCE, THE FORMULATED COMPOUND, THE BULK COMPOUND AND THE CHRYSENE ALDEHYDE
SHALL BE SUPPLIED "AS IS" AND B.W. CO. MAKES NO WARRANTIES, EXPRESS OR IMPLED,
WITH RESPECT THERETO.
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(iii) In the event B.W. Co. does not deliver at
least ninety percent (90%) of the respective quantities of formulated Compound,
bulk Compound and chrysene aldehyde specified in clause (i) above to CTRC
within ninety (90) days of the Effective Date, CTRC's sole and exclusive remedy
shall be to terminate this Agreement by giving B.W. Co. written notice thereof,
which notice must be given, if at all, within thirty (30) days after expiration
of the ninety (90) day period set forth above. In the event of such
termination, B.W. Co. shall refund all amounts paid by CTRC pursuant to Article
4. In the event CTRC does not terminate this Agreement within such ninety (90)
day period, its right to terminate pursuant to this clause (iii) and B.W. Co.'s
obligation to supply pursuant to Subsection 14.2(i), to the extent it has not
previously done so, shall each cease.
14.3 CTRC's Obligations.
(i) CTRC acknowledges that it has been informed
by B.W. Co. that the xxxxxx dating of all formulated Compound which B.W. Co.
has supplied to CTRC prior to the Effective Date or is obligated to supply
after the Effective Date pursuant to Subsection 14.2(i) is May 31, 1994. CTRC
agrees that on or before April 30 of each year, commencing with April 30, 1994,
it shall conduct, or cause to be conducted, quality assurance testing of
formulated Compound which it intends to use after the next succeeding May 31 to
determine whether such formulated Compound meets the specifications set forth
in B.W. Co.'s IND 25,803, as determined in accordance with the analytical
methodology set forth therein. CTRC shall provide B.W. Co. with a copy of the
results of each quality assurance test promptly after such test results are
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received. In the event the test results indicate that such formulated Compound
no longer meets such specifications, CTRC agrees not to use any remaining
formulated Compound previously supplied by B.W. Co. in any clinical trials and
shall promptly notify any of CTRC's clinical investigators to return any
formulated Compound then in their possession.
(ii) CTRC agrees that it shall bear all
responsibility for use of any formulated Compound which it manufactures or has
manufactured from the bulk Compound and chrysene aldehyde delivered by B.W. Co.
pursuant to Subsection 14.2(i). CTRC agrees not to use any such formulated
Compound in any clinical trials or otherwise in humans unless the results of
its quality assurance testing indicate that such formulated Compound meets the
specifications set forth in B.W. Co.'s IND 25,803, as determined in accordance
with the analytical methodology set forth therein.
ARTICLE 15. ASSIGNMENT
This Agreement may not be assigned or otherwise transferred by
CTRC without the written consent of B.W. Co. and WFL; provided, however, that
CTRC may, without such consent, assign this Agreement in connection with the
transfer or sale of all or substantially all of its business or in the event of
its merger or consolidation with another company. Any purported assignment in
violation of the preceding sentence shall be void. Any permitted assignee
shall assume all obligations of its assignor under
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this Agreement. No assignment shall relieve CTRC of responsibility for the
performance of any accrued obligation which CTRC then has hereunder.
ARTICLE 16. PATENT MARKING
CTRC agrees to xxxx all Products made, used or sold under the
terms of this Agreement, or their containers, in accordance with applicable
patent marking laws.
ARTICLE 17. REGISTRATION OF LICENSES
CTRC agrees to register or give required notice concerning
this Agreement, through itself or through a sublicensee, in each country of the
Territory where there exists a Valid Claim and an obligation under law to so
register or give notice, to pay all costs and legal fees connected therewith
and shall otherwise comply with all national laws applicable to this Agreement.
ARTICLE 18. PATENT TERM EXTENSION
CTRC hereby agrees to cooperate fully with B.W. Co., WFL and
their Affiliates in obtaining an extension of the term of any patent included
within the Patent Rights under the applicable laws of any country including,
but not limited to,
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the Drug Price Competition and Patent Term Restoration Act of 1984. CTRC
agrees to execute such documents and to take such additional actions as B.W.
Co., WFL or any of their Affiliates may reasonably request in connection
therewith. CTRC further agrees promptly (and in any event within ten (10)
days) to provide B.W. Co. and WFL with a copy of each product registration
certificate which CTRC receives in respect of a Product in any country for
purposes of B.W. Co. or WFL, as applicable, seeking such an extension.
ARTICLE 19. FORCE MAJEURE
A party shall not be held liable or responsible to another
party nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement, other
than an obligation to make a payment, when such failure or delay is caused by
or results from fires, floods, embargoes, government regulations, prohibitions
or interventions, wars, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts, acts of God, or any
other cause beyond the reasonable control of the affected party.
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ARTICLE 20. SEVERABILITY
Each party hereby expressly agrees and contracts that it is
not the intention of any party to violate any public policy, statutory or
common laws, rules, regulations, treaty or decision of any government agency or
executive body thereof of any country or community or association of countries;
that if any word, sentence, paragraph, clause or combination thereof in this
Agreement is found by a court or executive body with judicial powers having
jurisdiction over this Agreement or any of the parties hereto in a final
unappealed order, to be in violation of any such provisions in any country or
community or association of countries, such words, sentences, paragraphs,
clauses or combination shall be inoperative in such country or community or
association of countries and the remainder of this Agreement shall remain
binding upon the parties hereto.
ARTICLE 21. NOTICES
Any notice required or permitted to be given hereunder shall
be in writing and shall be deemed to have been properly given if delivered in
person, or if mailed by registered or certified mail (return receipt
requested), postage prepaid, or by facsimile (and promptly confirmed by such
registered or certified mail), to the addresses given below or such other
addresses as may be designated in writing by the parties from time to time
during the term of this Agreement. Any notice sent by registered or certified
mail as aforesaid shall be deemed to have been given when mailed.
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37
In the case of CTRC:
CTRC Research Foundation
00000 Xxxxxxx
Xxx Xxxxxxx, Xxxxx 00000-0000
Attention: President
Facsimile No.: (000) 000-0000
In the case of B.W. Co.:
Xxxxxxxxx Wellcome Co.
0000 Xxxxxxxxxx Xxxx
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
Attention: Company Secretary
Facsimile No.: (000) 000-0000
In the case of WFL:
The Wellcome Foundation Limited
X.X. Xxx 000
UNICORN HOUSE
000 Xxxxxx Xxxx
Xxxxxx XX0 0XX
Xxxxxxx
Attention: Secretary
Facsimile No.: 011-4471-387-3976
ARTICLE 22. GOVERNING LAW
This Agreement, to the extent it relates or applies to the
U.S., shall be governed by and construed in accordance with the laws of the
State of North Carolina, exclusive of its choice-of-law rules. This Agreement,
to the extent it relates or applies to the Non-U.S. Territory, shall be
governed by the laws of England, exclusive of its choice-of-law rules.
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38
ARTICLE 23. ARBITRATION
Except for any disputes relating to Article 11, all disputes
arising in connection with this Agreement shall be finally settled under (i)
the Commercial Arbitration Rules of the American Arbitration Association, with
respect to disputes between CTRC and B.W. Co. or (ii) the Rules of Conciliation
and Arbitration of the International Chamber of Commerce, with respect to
disputes between CTRC and WFL. With respect to disputes between CTRC and B.W.
Co., arbitration shall take place in Raleigh, North Carolina, if demanded by
CTRC, or San Antonio, Texas, if demanded by B.W. Co. With respect to disputes
between CTRC and WFL, arbitration shall take place in London, England, if
demanded by CTRC, or San Antonio, Texas, if demanded by WFL.
ARTICLE 24. ENTIRE AGREEMENT; MODIFICATION
This Agreement contains the entire understanding of the
parties with respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, heretofore made are
expressly merged in and made part of this Agreement. The parties hereto may
alter any of the provisions of this Agreement, but only by a written instrument
duly executed by both parties hereto. B.W. Co. and CTRC agree that the Letter
Agreement is hereby terminated.
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39
ARTICLE 25. WAIVER
The failure of a party to enforce at any time for any period
any of the provisions hereof shall not be construed as a waiver of such
provisions or of the rights of such party thereafter to enforce each such
provision.
ARTICLE 26. COUNTERPARTS
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 document.
ARTICLE 27. CAPTIONS
The captions to the several Articles and Sections hereof are
not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Sections hereof.
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40
IN WITNESS WHEREOF, the parties have executed this Agreement
as of the Effective Date.
CTRC RESEARCH FOUNDATION XXXXXXXXX WELLCOME CO.
By: By:
---------------------------- ----------------------------
Title: Title:
------------------------- -------------------------
THE WELLCOME FOUNDATION LIMITED
By:
----------------------------
Title:
-------------------------
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41
APPENDIX II
Crisnatol Mesylate
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42
APPENDIX I
B.W. Co.
Patents and Patent Applications
Patent No. Filing Date Serial No. Issue Date Expiring Date
---------- ----------- ---------- ---------- -------------
4,719,048 10/18/84 663,039 1/12/88 1/12/05
4,810,727 8/6/87 83,238 3/7/89 3/7/06
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APPENDIX III
WFL
Patents and Patent Applications
Country Filing No. Filing Date Grant No. Grant Date Expiry Date
**************************************************************************************************
Austria (EPO) 84105585.8 16 May 1984 E28857 12 Aug 1987 16 May 0000
Xxxxxxxxx 2809884 16 May 1984 572509 04 Oct 1988 16 May 0000
Xxxxxxxxx 1305288 16 May 1984 599215 29 Oct 1990 16 May 2000
Belguim (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 2004
Canada 454514 16 May 1984 1222750 09 Jun 1987 09 Jun 0000
Xxxxxxxxxxx (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 0000
Xxxxxxxxxxxxxx PV364584 16 May 1984 273314 27 Jan 1992 16 May 0000
Xxxxxx 1486 03 May 1989 16 May 0000
Xxxxxxx (EPO) 84105585.8 16 May 1984 P3465296.5 12 Aug 1987 16 May 0000
Xxxxx 532512 16 May 1984 532512 24 Sep 1985 24 Sep 0000
Xxxxxxx 841966 16 May 1984 85263 25 Mar 1992 16 May 0000
Xxxxxx (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 2004
Great Britain (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 2004
Gibraltar 324 12 Apr 1989 16 May 0000
Xxxxxx 74735301463 16 May 1984 82278 13 Dec 1984 17 May 1999
Hong Kong 4501989 01 Jun 1989 16 May 2004
Hungary 188684 16 May 1984 197875 02 Nov 1990 16 May 2004
Ireland 120384 16 May 1984 16 May 2004
Israel 71851 16 May 1984 71851 01 Apr 1988 16 May 0000
Xxxxx (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 0000
Xxxxx 0000000 16 May 1984 1638418 31 Jan 1992 16 May 0000
Xxxxx 00000000 16 May 1984
Kenya P38731989 12 Jul 1989 16 May 2004
Rep of Korea (South) 842647 16 May 1984 43148 23 Jul 1991 16 May 0000
Xxxxxxxxxx (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 2004
Monaco 1705851595 16 May 1984 1705851595 09 May 1985 16 May 0000
Xxxxxxxx XX0000000 30 Sep 1987 MY102121A 31 Mar 1992 31 Mar 0000
Xxxxxxxxxxx (EPO) 84105585.8 16 May 1984 0125702 12 Aug 1987 16 May 0000
Xxxxxx 841954 16 May 1984 157416 16 Mar 1988 16 May 2004
New Zealand 208168 16 May 1984 208168 16 Jun 1988 16 May 0000
Xxxxxxxxxxx 30683 16 May 1984 22265 01 Jul 1988 01 Jul 2005
Pakistan 20284 16 May 1984 129292 16 Sep 1986 17 May 1999
Portugal 78586 16 May 1984 78586 18 Sep 1986 18 Sep 2001
Russia 3744951.04 16 May 1984 1535377 07 Jan 1990 16 May 0000
Xxxxxx (EPO) 84105585.8 16 May 1984 84105585.8 12 Aug 1987 16 May 0000
Xxxxxxxxx 00000 29 May 1989 16 May 2004
Taiwan 7311928 16 May 1984 22257 01 Apr 1985 00 Xxx 0000
Xxxxx Xxxxxx 843708 16 May 1984 843708 29 Jan 1986 16 May 2004
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