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EXHIBIT 10.13
[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 31st day of March, 1995,
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 Ilex Oncology Inc. ("Ilex"), formerly
known as Biovensa Inc., having an address at 00000 Xxxxxxx Xxxxx, Xxx Xxxxxxx,
Xxxxx 00000-0000, U.S.A.
WHEREAS, B.W. Co. owns all right, title and interest in certain patent
rights and has the right to use certain known-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 known-how relating to the Compound in
the Non-U.S. Territory (as herein defined);
WHEREAS, Ilex 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 Ilex;
NOW, THEREFORE, in consideration of the foregoing and the mutual
promises and covenants set forth herein, the parties hereto mutually agree as
follows:
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 a 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. Notwithstanding the
foregoing, the parties acknowledge and agree that an Affiliate of B.W. Co. and
WFL shall be deemed to include, for all purposes, Xxxxxxxxx Wellcome (India)
Limited.
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 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, confirmation, supplementary protection certificates, registrations,
revalidations, reissues or additions of or to any of the aforesaid
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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 piritrexim isethionate,
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 Economic Area.
1.10 "FDA" means the United States Food and Drug Administration or
any successor entity.
1.11 "Field" means the treatment or prophylaxis of cancer in humans
and conditions other than cancer which are associated with cancer or the
treatment or prophylaxis of cancer in humans.
1.12 "First Commercial Sale" means the date on which Ilex or a
sublicensee first transfers title to a Product to a Third Party for monetary
consideration.
1.13 "IND" means an Investigational New Drug application or any
equivalent successor application.
1.14 "Know-How" means, collectively, the B.W. Co. Know-How and the
WFL Know-How.
1.15 "Letter Agreement" means the letter agreement between B.W. Co.
and Ilex dated June 13, 1994.
1.16 "NDA" means a New Drug Application or any equivalent successor
application.
1.17 "Net Sales," with respect to any Produce containing the
Compound as the sole active ingredient, means the gross sales (i.e., gross
invoice prices) of such Product billed by Ilex 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 increases; (ii) the
amounts of customary trade and cash discounts, to the extent such trade and
cash discounts are not deducted by Ilex 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,
value added taxes, other similar 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 Parties payors,
whether during the specific royalty period, as defined in Section 5.1, or not.
1.18 "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 Ilex and its sublicensees to Third Party customers, less all
the allowances, adjustments, discounts, taxes, duties and other charges
referred to in clauses (i) and (iv) of Section 1.17, 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. These costs
shall be computed using the standard cost accounting procedures of Ilex in
accordance with generally accepted accounting principles (i.e., GAAP).
1.19 "Patent Rights" means, collectively, the B.W. Co. Patent
Rights and the WFL Patent Rights.
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1.20 "Product" means the Compound or any product containing the
Compound as an active ingredient, which is (i) covered by a Valid Claim or (ii)
made or developed using the Know-How.
1.21 "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.
1.22 "Sterling" or "L." means English Pounds Sterling.
1.23 "Technology" means the Patent Rights together with all
Know-How related or pertaining to the Field.
1.24 "Territory" means the U.S. and Non-U.S. Territory.
1.25 "Non-U.S. Territory" means the entire world excluding the U.S.
1.26 "Third Party" means any party other than Ilex, B.W. Co., WFL,
their respective Affiliates and Ilex's sublicensees.
1.27 "U.S." means the United States of America, its territories and
possessions.
1.28 "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.
1.29 "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.
1.30 "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. REPRESENTATIONS AND WARRANTIES
Each party hereto represents and warrants to the other that it is free
to enter into this Agreement and to carry out its 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 representations or warranties with respect
to the Patent Rights or the Know-How.
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 Ilex, under the B.W. Co. Patent Rights and the B.W. Co. Know-How, an
exclusive license in the U.S. in the Field with a right to sublicense, to make,
have made, use and sell Products.
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3.2 WFL License. Subject to the provisions of Section 3.3 in
respect of the exclusive license granted in this Section 3.3, WFL hereby grants
to Ilex, under the WFL Patent Rights and the WFL Know-How, an exclusive license
in the Non-U.S. Territory in 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.
ARTICLE 4. LICENSE FEE
4.1 License Fee. As partial consideration for the licenses
granted hereunder, Ilex 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;
(ii) $[**] on the first anniversary of the Effective
Date; and
(iii) $[**] on the second 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. Thereafter, 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. Subject to adjustment as set forth in
Section 5.2, Ilex shall pay (i) B.W. Co. a royalty on Net Sales of Products in
the U.S. and (ii) WFL a royalty on Net Sales of Products in the Non-U.S.
Territory, each at the royalty rate of [**] ([**]) on Net Sales of Products in
the respective Territories in a calendar year, except as provided below.
Royalties shall be paid in respect of Net Sales of Products in a given
country of the Territory for a period of ten (10) 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. With respect to countries where all Valid
Claims expire before the 10-year period, the royalty rate on Net Sales of
Products shall be reduced as [**] ([**]) for the remainder of the 10-year
period. 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 1.20 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 Ilex or its Affiliates or sublicensees or (y) the
eighth (8th) anniversary of the commercial sale of the first Product in such
country.
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 is introduced by a Third Party (a "Competitive Product") and
(b) sales by such Third Party exceed the applicable percentage set forth below
of unit sales of Ilex 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 Ilex and its sublicensees of Products in such country during such
calendar quarter shall be adjusted as set forth below:
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% Third Party Unit Sales ("X") %
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Reduction in Section 5.1 Royalty Rates
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X less than or equal to [**]% [**]%
[**]% less than X less than [**]% [**]%
X 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 Ilex and its sublicensees of Products in such country for the
same calendar quarter, the royalty rates applicable to such sales by Ilex and
its sublicensees during such calendar quarter would be [**] percent
([**]%).
(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 Ilex and reasonably acceptable to B.W. Co.
or WFL, as applicable, depending on the countries in which the royalty rate
reduction is being sought. Ilex 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 Ilex'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 Ilex and its
sublicensees, but royalties shall be payable on the initial subsequent sale by
Ilex 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 Ilex, its sublicensees and either
B.W. Co. (in respect of the U.S.) or WFL (in respect of any country in the
Non-U.S. Territory), agree that Ilex or its sublicensees 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, Ilex 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
[**] 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,
llex shall furnish to B.W. Co., in respect of Net Sales of Products 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; (L[i) 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 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
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to its domestic currency in accordance with the sublicensee's normal accounting
principles. llex 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. Ilex shall keep accurate records in sufficient detail to enable the
royalties payable hereunder to be determined. Ilex shall be responsible for
all royalties and late payments that are due to B.W. Co. and WFL but have not
been paid by Ilex's sublicensees to Ilex.
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 for WFL), Ilex shall permit an independent
public accountant, selected by the Auditing Party, and acceptable to Ilex (the
"Auditor"), which acceptance shall not be unreasonably refused, to have access
during normal business hours to those records of Ilex as may be reasonably
necessary to verify the accuracy of the royalty reports furnished by Ilex 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. Ilex 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 Auditor. If the Auditor's report shows any underpayment of
royalties, within thirty (30) days after Ilex's receipt of such report, Ilex
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 the Auditor, 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 sublicensee
agreement is confidential and that it and its accountant shall retain all such
information in confidence in accordance with the provisions of Article 12
hereof. At Ilex's request, the Auditor shall execute a confidentiality
agreement with respect to the information subject to review under this Article
6.
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.
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, Ilex 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
Ilex 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. Ilex 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 Ilex'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) llex's best efforts obligations set forth in this
Article 8 shall be deemed to have been fulfilled if Ilex (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) or (b) above shall be subject to a one-time extension at Ilex's
election, of up to 12 months in consideration of a fee of $ [**] , payable
prior to the extension of such time periods specified in clauses (a) or (b)
above (the "Extension Fee"). The Extension Fee shall be payable to B.W. Co.
for allocation between B.W. Co. and WFL as they mutually agree.
(ii) In the event that Ilex falls 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, Ilex meets such deadline or elects to extend such deadline to
the extent and in the manner permitted under section 8.2(i) above.
8.3 Non-U.S. Development. No later than the filing by Ilex of an
NDA for a Product in the U.S., Ilex 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 Ilex or such Third
Party or Third Parties deem appropriate, and (ii) upon obtaining Registration
far the Product in a particular country, to proceed in due course with the
commercial introduction and marketing of such Product in such country. Ilex
may, in any event, undertake the foregoing responsibilities directly in lieu of
contracting with one or more Third Parties.
8.4 Progress Reports. Until commercial introduction of the first
Product, Ilex will provide a semiannual report to B.W. Co. and WFL summarizing
Ilex'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 of the Territory, it shall inform Ilex and Ilex shall be
given the opportunity to prosecute such patent application and/or to maintain
such patent at its own expense.
9.2 Status of Patent Rights. Upon request, B.W. Co. or WFL, as
applicable, shall promptly advise Ilex 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 Ilex with relevant
documentation relating to such patent applications and patents including, but
not limited to, copies thereof.
9.3 Patent Prosecution Costs.
(i) Ilex 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 Ilex
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.
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(ii) Ilex 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 Ilex's obligations to pay patent prosecution or maintenance costs
terminate, such patent application and/or patent shall no longer be included in
the Patent Rights in those countries in which llex has exercised its right to
terminate such obligations.
ARTICLE 10. THIRD PARTY INFRINGEMENT
In the event that Ilex 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 (i) B.W. Co. or WFL, as applicable, shall fail, within sixty
(60) days after receiving notice from Ilex, 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 Ilex that it does not plan to terminate the infringement or
institute such action, then Ilex shall have the right to do so at its own
expense. B.W. Co. and WFL shall cooperate with Ilex 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 expenses of litigation, shall be equally divided by Ilex and B.W. Co. or
WFL, as applicable. Any damages or costs recovered in connection with any
action filed by Ilex hereunder, after first reimbursing Ilex for its
out-of-pocket costs and expenses of litigation, shall be deemed to be Net Sales
of Products in the calendar year actually received by Ilex and royalties shall
be payable by Ilex to B.W. Co. or WFL thereon in accordance with the terms of
this Agreement.
ARTICLE 11. INDEMNIFICATION; INSURANCE
11.1 Indemnification by Ilex. Ilex 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 Ilex'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 Ilex, unappealable or unappealed by Ilex 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
Ilex (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 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.
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11.3 Insurance.
(i) Ilex 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.
(ii) Within thirty (30) days after the Effective Date,
Ilex 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.
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:
(i) Ilex 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 Ilex 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 Ilex 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 and data disclosed by B.W. Co. to Ilex 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), investors (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, 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 or under an obligation of
confidence; (iv) results from research and development by the receiving party
or its Affiliates or sublicensees independent of
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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 Confidentiality of Agreement. Except as otherwise required by
law or applicable regulation or the terms of this Agreement or otherwise
mutually agreed upon by the 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 Ilex, 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 Ilex 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 Ilex (collectively, the
"Results"). Ilex 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 a delay in submission or
presentation based on patent considerations, Ilex agrees to delay such
submission or presentation for a period not to exceed ninety (90) days from the
date of such request. Ilex 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, Ilex shall determine the
content of the Publication. Nothing in this Section 12.5 shall be construed to
allow Ilex 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 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 Ilex's obligation to pay royalties hereunder; at which time,
notwithstanding anything to the contrary contained herein, all rights licensed
to Ilex herein shall be deemed to be converted to a fully paid, non-exclusive,
irrevocable, royalty free license of the Technology in the Territory to make,
have made, use, sell and have sold Products incorporating, utilizing or
otherwise commercially exploiting the Technology in the Field. 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;
(iii) upon termination, Ilex's obligations under Sections
13.4, 13.5 and 13.6 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 Ilex. Ilex 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:
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(a) upon or after the bankruptcy, insolvency,
dissolution or winding up of Ilex (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 Ilex if such breach is not
cured within thirty (30) days after B.W. Co. and/or WFL gives
Ilex written notice thereof, it being understood that if such
breach relates solely to Ilex's obligations in the U.S., then
this Agreement may be terminated only as to the U.S. by B.W.
Co.; and, if such breach relates solely to Ilex's obligations
in the Non-U.S. Territory, then this Agreement may be
terminated only as to the Non- U.S. Territory by WFL; or
(c) upon the abandonment by Ilex 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 Ilex 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. Ilex shall give B.W. Co. and WFL prompt written
notice of the abandonment of the development of the Products.
(ii) Ilex may terminate this Agreement:
(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 for 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 Ilex 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 of
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 Ilex gives WFL written
notice thereof.
13.4 Ilex's Obligations Upon Termination. Upon termination (but
not expiration) of this Agreement for any reason, (i) Ilex shall promptly pay
to B.W. Co. any amounts due under the terms of this Agreement including License
Fees and Royalty Fees which have accrued as of the date of termination (ii)
Ilex 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 registrations regarding the Products
in the country or countries in which termination has occurred and (iii) in the
event of termination with respect to all countries of the Territory, Ilex shall
return to B.W. Co. and WFL all copies of the Information supplied by either
hereunder, except that Ilex'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, IIex 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, Ilex shall promptly return or destroy, at B.W.
Co.'s election, any materials supplied by B.W. Co. pursuant to Section 14.2.
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13.6 Sublicensees Upon Termination. If any party terminates the
Agreement and sublicensees are not then in default under the terms of their
sublicensee agreements hereunder, B.W. Co. and WFL shall have the right (but
not the obligation) to assume and continue such sublicense agreements with
payments thereunder being made by the sublicensees directly to B.W. Co. or to
WFL, as the case may be, without any further obligations on the part of Ilex
with respect thereto.
ARTICLE 14. TRANSFER TO ILEX; ILEX'S OBLIGATIONS
14.1 Transfer of Know-How. Within the ninety (90) day period
following the Effective Date, each of B.W. Co. and WFL shall make available to
Ilex all of the B.W. Co. Know-How or WFL Know-How as the case may be, and B.W.
Co. shall assign to Ilex IND 30,692 for the Compound. Ilex shall acknowledge
acceptance of such assignment to the FDA promptly after it is made by B.W. Co.
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 Ilex 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 25,000 capsules of
the 100mg unit size and approximately 10,000 capsules of the 25mg unit size of
formulated Compound (which total is inclusive of any quantities of formulated
Compound delivered by B.W. Co. to Ilex prior to the Effective Date). In
addition to the foregoing, within ninety (90) days after the Effective Date,
B.W. Co. shall deliver to Ilex approximately 100 kilograms of bulk Compound.
All shipments shall be F.O.B. San Antonio, Texas.
THE FORMULATED COMPOUND AND THE BULK COMPOUND SHALL BE SUPPLIED "AS
IS" AND NEITHER B.W. CO. NOR WFL MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, WITH
RESPECT THERETO.
(ii) In the event B.W. Co. does not deliver at least
ninety percent (90%) of the respective quantities of formulated Compound and
bulk Compound specified in clause (i) above to Ilex within ninety (90) days of
the Effective Date, Ilex'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 Ilex pursuant to Article 4. In the event Ilex does
not terminate this Agreement within such ninety (90) day period, its right to
terminate pursuant to this clause (ii) 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 Ilex's Obligations.
(i) Ilex acknowledges that it has been informed by B.W.
Co. that the xxxxxx dating for certain batches of the formulated Compound which
B.W. Co. has supplied to Ilex has expired or is about to expire. Ilex agrees
that on or before April 30 of each year, commencing with April 30, 1995, 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 30,692, as determined in accordance with the analytical
methodology set forth therein. Ilex shall provide B.W. Co. with a copy of the
results of each quality assurance test promptly after such test results are
received. In the event the test results indicate that such formulated Compound
no longer meets such specifications, Ilex agrees not to use any remaining
formulated Compound previously supplied by B.W. Co. in any clinical trials and
shall promptly notify any of Ilex's clinical investigators to return any
formulated Compound then in their possession.
(ii) Ilex agrees that it shall bear all responsibility for
use of any formulated Compound which it manufactures or has manufactured from
the bulk Compound delivered by B.W. Co. pursuant to
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Subsection 14.2(i). Ilex 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 30,692, as determined in accordance
with the analytical methodology set forth therein.
ARTICLE 15. ASSIGNMENT
This Agreement may not be assigned or otherwise transferred by Ilex
without the written consent of B.W. Co. and WFL; provided, however that Ilex
may, without such consent, assign this Agreement in connection with the
transfer or sale of all or substantially all of its business related to the
Products 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 this
Agreement. No assignment shall relieve Ilex of responsibility for the
performance of any accrued obligation which Ilex then has hereunder.
ARTICLE 16. PATENT MARKING
Ilex 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
Ilex 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
Ilex 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, the Drug Price Competition and Patent Term Restoration Act of 1984.
Ilex 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. Ilex 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 Ilex 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.
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
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14
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 mall (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.
In the case of Ilex: Ilex Oncology Inc.
00000 Xxxxxxx Xxxxx
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 XXx 0XX
Xxxxxxx
Attention: Secretary
Facsimile No.: 011-44-171-387-3976
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.
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 Ilex and B.W. Co. or (ii) the Rules of Conciliation
and Arbitration of the International Chamber of Commerce, with respect to
disputes between Ilex and WFL. With respect to disputes between Ilex and B.W.
Co., arbitration shall take place in Raleigh, North Carolina, if demanded by
B.W. Co., or San Antonio, Texas, if demanded by Ilex. With respect to disputes
between Ilex and WFL, arbitration shall take place in London, England, if
demanded by Ilex, or San Antonio, Texas, if demanded by WFL.
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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 a 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 Ilex agree that the Letter Agreement is
hereby terminated.
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.
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.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
Effective Date.
ILEX ONCOLOGY INC. XXXXXXXXX WELLCOME CO.
By: By:
------------------------------- -----------------------------
Name: Name:
----------------------------- ---------------------------
Title: Title:
---------------------------- --------------------------
THE WELLCOME FOUNDATION LIMITED
By:
-------------------------------
Name:
-----------------------------
Title:
----------------------------
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APPENDIX I
B.W. CO. U.S. PATENT RIGHTS
FILING NO. FILING DATE GRANT NO. GRANT DATE EXPIRY DATE
228164 23 Jan 1981 4,372,957 08 Feb 1983 13 Jun 2000
509547 12 Jun 1984 4,661,490 28 Apr 1987 28 Apr 2004
786725 15 Oct 1985 4,959,474 25 Sep 1990 25 Sep 2007
125721 30 Nov 1987 4,897,395 30 Jan 1990 30 Jan 2007
152837 05 Feb 1988 4,818,759 04 Apr 1989 05 Feb 2008
PATENT NO. EXP. DATE BW CO. CASE NO. CLAIMED
4,372,957 06/13/00 PBO305-C Treatment of psoriasis with piritrexim or a
pharmaceutically acceptable salt thereof.
4,661,490 04/28/04 PBO305-C-Div-C Treatment of leukemia, carcinoma or sarcoma in a mammal
with piritrexim or a pharmaceutically acceptable salt
thereof.
4,818,759 02/05/08 PBO504 Treatment of rheumatoid arthritis with piritrexim or a
pharmaceutically acceptable salt thereof.
4,897,395 01/30/07 PBO305-C-Div-C3 Treatment of leukemia, carcinoma, sarcoma or lymphoma in
a human using piritrexim or a pharmaceutically
acceptable salt thereof.
4,959,474 09/25/07 XXX-000-X0 Xxxxxxxxxx PER SE and pharmaceutically acceptable salts
thereof.
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17
APPENDIX II
Piritrexim isethionate or
2,4-Diamino-6(2,5-dimethoxybenzyl)-5-methylpyrido-(2,3-d)pyrimidine:
has a molecular weight of: 451.50
and the formula: C(17)H(19)N(5)O(2)C(2)H(6)O(4)S
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18
APPENDIX III
WFL PATENT RIGHTS
WFL Case No. PBO 305
COUNTRY FILING NO. FILING DATE GRANT NO. GRANT DATE EXPIRY DATE
Austria A313880V12 13 Jun 1980 377985 28 May 1985 15 Oct 0000
Xxxxxxxxx 5927580 13 Jun 1980 532842 15 Mar 1984 13 Jun 0000
Xxxxxxx 80103325.9 13 Jun 1980 0021292 09 Mar 1983 13 Jun 2000
(EPO)
Canada 354009 13 Jun 1980 1132137 21 Sep 1982 21 Sep 0000
Xxxxxxxxxxx 80103325.9 13 Jun 1980 0021292 09 Mar 1983 13 Jun 2000
(EPO)
Germany 80103325.9 13 Jun 1980 P3062268.5 09 Mar 1983 13 Jun 2000
(EPO)
Denmark 254780 13 Jun 1980 157451 21 May 1990 13 Jun 2000
Europe 80103325.9 13 Jun 1980 0021292 09 Mar 1983 13 Jun 0000
Xxxxxxx 801912 13 Jun 1980 66866 10 Dec 1984 13 Jun 0000
Xxxxxx 80103325.9 13 Jun 1980 0021292 09 Mar 1983 13 Jun 2000
(EPO)
Great Britain 80103325.9 13 Jun 1980 0021292 09 Mar 1983 13 Jun 2000
(EPO)
Hungary 149480 13 Jun 1980 184787 06 Feb 1984 13 Jun 0000
Xxxxxxx 122080 13 Jun 1980 49992 23 Apr 1986 13 Jun 2000
Israel 60307 13 Jun 1980 60307 30 May 1984 13 Jun 0000
Xxxxx 48968A80 13 Jun 1980 1146940 19 Nov 1986 13 Jun 0000
Xxxxx 0000000 13 Jun 1980 1456317 09 Sep 1988 13 Jun 0000
Xxxxxxxxxxx 80103325.9 13 Jun 1980 0021292 09 Mar 1983 13 Jun 2000
(EPO)
New Zealand 194045 13 Jun 1980 194045 21 Feb 1985 13 Jun 0000
Xxxxxx 80103325.9 13 Jun 1980 80103325.9 09 Mar 1983 03 Jun 2000
(EPO)
Malaysia 591985 01 Jun 2000 13 Jun 0000
Xxxxx Xxxxxx 803539 13 Jun 1980 803539 27 Jan 1982 13 Jun 2000
WFL Case No. PBO 308
--------------------
(none)
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WFL Case No. PBO 504
COUNTRY FILING NO. FILING DATE GRANT NO. GRANT DATE EXPIRY DATE
Austria (EPO) 88300959.9 05 Feb 1988 E70977 02 Jan 1992 05 Feb 0000
Xxxxxxxxx 1135788 05 Feb 1988 606128 23 May 1991 05 Feb 0000
Xxxxxxx 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
(EPO)
Canada 558216 05 Feb 1988 1302273 02 Jun 1992 05 Jun 0000
Xxxxxxxxxxx 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
(EPO)
Germany 88300959.9 05 Feb 1988 P3867251.0 02 Jan 1992 05 Feb 2008
(EPO)
Europe 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 0000
Xxxxx (EPO) 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 0000
Xxxxxx (EPO) 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
Great Britian 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
(EPO)
Greece (EPO) 88300959.9 05 Feb 1988 E920400302 02 Jan 1992 05 Feb 0000
Xxxxx (EPO) 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 0000
Xxxxx 0000000 05 Feb 0000
Xxxxxxxxxx 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
(EPO)
Netherlands 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
(EPO)
Sweden 88300959.9 05 Feb 1988 0279565 02 Jan 1992 05 Feb 2008
(EPO)
South Africa 880830 05 Feb 1988 880830 25 Oct 1989 05 Feb 2008
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