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EXHIBIT 10.14
[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 XXx 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. has the right to use certain know-how relating to
the Compound (as herein defined) in the U.S. (as herein defined);
WHEREAS, WFL has the right to use certain know-how relating to the
Compound in the Non-U.S. Territory (as herein defined);
WHEREAS, Ilex desires to obtain licenses under such 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
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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 "Compound" means the chemical known as oxypurinol, having the
chemical structure set forth on Appendix I attached hereto and made a part
hereof.
1.6 "Dollars" or "$" means United States dollars.
1.7 "Effective Date" means the date appearing at the beginning of
this Agreement.
1.8 "Europe" means all countries which are Member States, from
time to time, of the European Economic Area.
1.9 "FDA" means the United States Food and Drug Administration or
any successor entity.
1.10 "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.
1.11 "First Commercial Sale" means the date on which Ilex or a
sublicensee first transfers title to a Product to Third Party for monetary
consideration.
1.12 "IND" means an Investigational New Drug application or any
equivalent successor application.
1.13 "Know-How" means, collectively, the B.W. Co. Know-How and the
WFL Know-How.
1.14 "Letter Agreement" means the letter agreement between B.W. Co.
and Ilex dated June 13, 1994.
1.15 "NDA" means a New Drug Application or any 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 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 Party payors,
whether during the specific royalty period, as defined in Section 5.1, 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 Ilex and its sublicensees to Third Party customers, less
all the allowances, adjustments, discounts, taxes, duties
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and other charges referred to in clauses (i) through (iv) 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 "Product" means the Compound or any product containing the
Compound as an active ingredient, which is made or developed using the
Know-How.
1.19 "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.
1.20 "Sterling" or "L" means English Pounds Sterling.
1.21 "Territory" means the U.S. and Non-U.S. Territory.
1.22 "Non-U.S. Territory" means the entire world excluding the U.S.
1.23 "Third Party" means any party other than Ilex, B.W. Co., WFL,
their respective Affiliates and Ilex's sublicensees.
1.24 "U.S." means the United States of America, its territories and
possessions.
1.25 "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.
ARTICLE 2. REPRESENTATIONS & 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, neither B.W. Co. nor WFL make any representations or warranties with
respect to 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. 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.
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 Ilex, under 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.
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3.3 Reservation of Rights. Both B.W. Co. and WFL hereby reserve
the perpetual, royalty-free right 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 $[**]
([**]).
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 [**] percent ([**]%) on Net
Sales of Products in the respective Territories 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 ten (10) years from the date of First
Commercial Sale of the first Product in such country. Notwithstanding the
foregoing, however, with respect to Europe only, royalties on Net Sales of a
given Product 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 (i) 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 (ii) the eighth (8th)
anniversary of the commercial sale of the first Product in such country.
5.2 Credits Against Royalties. The costs incurred by Ilex in the
implementation and maintenance of the Program referred to in Section 8.1 hereof
("Program Costs") may be credited by Ilex against earned royalties payable
pursuant to Section 5.1 hereof; provided, however, that (i) Program Costs shall
be documented to the reasonable satisfaction of B.W. Co., (ii) with respect to
any particular Royalty Period, the amount of such credit for Program Costs
shall not exceed [**] percent ([**]%) of the Royalties which would
otherwise be payable, and (iii) Program Costs which are not ultimately credited
against earned royalties during the term of this Agreement shall lapse and be
of no further value or consequence.
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.
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
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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,
Ilex 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; (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; and (v)
Program Costs incurred in connection with the obligations of Ilex contained in
Sections 8.1 and 5.2 hereof. 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 to its domestic
currency in accordance with the sublicensee's normal accounting principles.
Ilex 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 once 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.
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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 in accordance with the provisions of Article 10
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. COMPASSIONATE PLEA PROGRAM
8.1 Compassionate Plea Program. The parties acknowledge that B.W.
Co. has established, implemented and conducted a compassionate plea program
with respect to the Product (the "Program"). The parties additionally
acknowledge that B.W. Co.'s reputation in the medical, oncology or
pharmaceutical communities or the public in general would be unduly harmed if
the Program were to be discontinued. Therefore, as additional consideration
for entering into this Agreement, Ilex agrees that it shall, at its own
expense, use its best efforts to diligently continue the Program to the same
extent as is currently conducted by B.W. Co.
8.2 Termination. In the event that Ilex fails to continue the
Program in conformance with Section 8.1 hereof, B.W. Co. may, upon at least
thirty (30) days' prior written notice, terminate this Agreement, unless within
such thirty (30) day period, Ilex were to implement the Program to the
satisfaction of B.W. Co. Upon such a termination, Ilex shall immediately
deliver to B.W. Co. all of Ilex's inventory of the formulated Compound and the
bulk Compound at Ilex's expense.
ARTICLE 9. INDEMNIFICATION; INSURANCE
9.1 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
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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 9.1.
9.2 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.
9.3 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 10. CONFIDENTIALITY
10.1 Treatment of Confidential Information. Except as otherwise
provided in this Article 10, 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.
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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.
10.2 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.
10.3 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 10, 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 under an obligation of
confidentiality; (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.
10.4 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 10.4 to the same extent as such party.
10.5 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,
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Ilex shall determine the content of the Publication. Nothing in this Section
10.5 shall be construed to allow Ilex to publish or otherwise disclose any
Information disclosed by B.W. Co. or WFL.
ARTICLE 11. TERM; TERMINATION
11.1 Term; Termination. Unless terminated sooner pursuant to
Section 8.2, 11.2 or 12.2, 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 Know-How 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 9
shall survive termination or expiration;
(ii) upon expiration or termination for any reason, the obligations
of confidentiality and use of Information under Article 10 shall survive for
the period provided therein;
(iii) upon termination, Ilex's obligations under Sections 11.3, 11.4
and 11.5 shall survive; and
(iv) expiration or termination of this Agreement shall not relieve
the parties of any other obligation accruing prior to such termination.
11.2 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 Ilex (other than dissolution or
winding up for the purposes of reconstruction or
amalgamation);
(b) 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
(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
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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.
11.3 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 permissions 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.
11.4 Disposition of Product. Upon termination of this Agreement
with respect to all countries of the Territory, Ilex 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 12.2.
11.5 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 12. TRANSFER TO ILEX; ILEX'S OBLIGATIONS
12.1 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 Know-How, or the
WFL Know-How, as the case may be, and B.W. Co. shall assign to Ilex IND 3362
for the Compound. Ilex shall acknowledge acceptance of such assignment to the
FDA promptly after it is made by B.W. Co. cep
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12.2 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, if any, 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 12.2(i) will be approximately 150,000 capsules of
the 100mg 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 [**] percent
([**]) 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 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 12.2(i), to the extent
it has not previously done so, shall each cease.
12.3 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
3362, 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 Subsection 12.2 (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 3362,
as determined in accordance with the analytical methodology set forth therein.
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ARTICLE 13. 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 14. 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 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 15. 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 16. 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 17. 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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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.: 011-4471-387-3976
ARTICLE 18. 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 19. ARBITRATION
Except for any disputes relating to Article 9, 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 20. 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 21. 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 22. 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 23. 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: /s/ XXXXXXX X. LOVE By: /s/ XXXXX X. XXXXXX
---------------------------------- -------------------------------
Print Name: Xxxxxxx X. Love Print Name: Xxxxx X. Xxxxxx
-------------------------- ------------------
Title: President Title: Vice President
------------------------------- ----------------------------
Planning and Business
Development
THE WELLCOME FOUNDATION LIMITED
By: ILLEGIBLE
----------------------------------
Print Name:
--------------------------
Title:
-------------------------------
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APPENDIX I
Oxypurinol is a structural analog of the natural purine base xanthine
and the principal metabolite of allopurinol, a xanthine oxidase inhibitor that
acts on purine metabolism.
The molecular formula for oxypurinol is C(5)H(4)N(4)O(2).
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