Exhibit 10.103
EXCLUSIVE LICENSE AGREEMENT
by and between
SPARTA PHARMACEUTICALS, INC.
and
SCHERING-PLOUGH LTD.
EXCLUSIVE LICENSE AGREEMENT
THIS EXCLUSIVE LICENSE AGREEMENT (the "Agreement") is made as of the
last date on the signature page hereof (the "Effective Date") by and between
SPARTA PHARMACEUTICALS, INC., a Delaware corporation having its principal place
of business at ▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇, (hereinafter
referred to as "Sparta") and SCHERING-PLOUGH LTD., a corporation organized and
existing under the laws of Switzerland and having its principal place of
business at ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (hereinafter referred to
as "SP Ltd."). Sparta and SP Ltd. are sometimes referred to herein individually
as a party and collectively as the parties. References to "SP Ltd." and "Sparta"
shall include their respective Affiliates (as hereinafter defined).
WHEREAS, Sparta has developed certain Sparta Know-How and has rights to
the Licensed Patent Rights relating to Drug Delivery Systems (each as
hereinafter defined); and
WHEREAS, SP Ltd. has the exclusive rights to the product known as
Temozolomide; and
WHEREAS, SP Ltd., together with its Affiliates (as hereinafter defined)
possesses extensive capabilities in the development and commercialization of
pharmaceutical products on a worldwide basis; and
WHEREAS, SP Ltd. desires to obtain and Sparta is willing to grant to SP
Ltd., an exclusive license under Licensed Patent Rights and to use the Sparta
Know-How in combination with Temozolomide, upon the terms and conditions set
forth herein; and
WHEREAS, simultaneously with entering into this Agreement Sparta and SP
Ltd.'s Affiliate, Schering Corporation, have entered into a license agreement
relating to the United States, its territories and possessions (hereinafter the
"U.S. License Agreement").
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, SP Ltd. and Sparta hereby agree as follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following capitalized terms, whether
used in the singular or plural, shall have the respective meanings set forth
below:
1.1 "Affiliate" shall mean any individual or entity directly
or indirectly controlling, controlled by or under common control with, a party
to this Agreement.
For purposes of this Agreement, the direct or indirect ownership of fifty
percent (50%) or more of the outstanding voting securities of an entity, or the
right to receive fifty percent (50%) or more of the profits or earnings of an
entity shall be deemed to constitute control. Such other relationship as in fact
results in actual control over the management, business and affairs of an entity
shall also be deemed to constitute control.
1.2 "Calendar Quarter" shall mean the respective periods of
three (3) consecutive calendar months ending on March 31, June 30, September
30 or December 31, for so long as this Agreement is in effect.
1.3 "Calendar Year" shall mean each successive period of
twelve (12) months commencing on January 1 and ending on December 31, for so
long as this Agreement is in effect.
1.4 "Drug Delivery System" shall mean all formulations,
materials, methods and other technology included in or related to the
application of the Spartaject(TM) technology to parenteral administration
(including, without limitation, intrathecal administration) of Temozolomide and
which is owned by Sparta or licensed to Sparta with the right to grant
sublicenses.
1.5 "First Commercial Sale" shall mean, with respect to any
Licensed Product, the first sale for end use of such Licensed Product.
1.6 "HRD" shall mean a health registration dossier or its
equivalent, submitted to a national government or a supranational governmental
authority, consisting of the chemical, pharmaceutical and biological
documentation; the toxicological and pharmacological documentation; and the
clinical documentation respectively, and covering a Licensed Product which is
filed in any country outside the United States and which is analogous to a new
drug application, biologics license application or its equivalent filed with the
United States Food and Drug Administration seeking approval to market and sell a
Licensed Product in the Territory and including, where applicable, applications
for pricing, pricing reimbursement approval, labeling and Regulatory Approval.
1.7 "Improvement" shall mean any enhancement in the
formulation, ingredients, preparation, dosage, packaging or manufacture of the
Drug Delivery System for use in combination with Temozolomide developed prior to
or during the Term of this Agreement by or on behalf of Sparta.
1.8 "IND" shall mean an investigational new drug application
submitted to the United States Food and Drug Administration or its equivalent in
any country of the Territory, approval of which permits the clinical
investigation of Licensed Product.
1.9 "Licensed Patent Rights" shall mean the RTP Patent Rights
and the Sparta Patent Rights.
1.10 "Licensed Product(s)" shall mean any form or dosage of
pharmaceutical composition or preparation for parental administration, in final
form for sale, which utilizes the Drug Delivery System and contains as an active
ingredient Temozolomide.
1.11 "Net Sales" shall mean, [Information omitted and filed
separately with the Commission under Rule 24b-2.]
1.12 "Proprietary Information" shall mean Sparta Know-How,
Schering Know-How and all other scientific, clinical, regulatory, marketing,
financial and commercial information or data, whether communicated in writing,
verbally or electronically, which is provided by one party to the other party in
connection with this Agreement. When Proprietary Information is disclosed in a
manner other than in writing, it shall be reduced to written form, marked
"Confidential" and transmitted to the receiving party with ten (10) business
days of disclosure to the receiving party.
1.13 "Regulatory Approval" shall mean any applications or
approvals, and marketing authorizations based upon such approvals (including any
prerequisite manufacturing approvals or authorizations related thereto) and
pricing, third party reimbursement or labeling approval(s), technical, medical
and scientific licenses, registrations or authorizations of any national,
supra-national (e.g. the European Commission, the Council of the European Union,
or the European Agency for the Evaluation of Medicinal Products), regional,
state or local regulatory agency or other governmental entity, necessary for the
development, manufacture, distribution, marketing promotion, use, import, export
or sale of Licensed Product(s) and/or Temozolomide in a regulatory jurisdiction.
1.14 "RTP Patent Rights" shall mean those patents and pending
patent applications listed in Schedule 1.13 which are licensed to Sparta under
the Amended and Restated Sublicense Agreement, dated January 1, 1997 (the
"RTP/Sparta Sublicense Agreement"), by and between Sparta and Research Triangle
Pharmaceuticals Ltd. and any substitutions, divisions, continuations,
continuations-in-part, reissues, renewals, registrations, confirmations,
re-examinations, extensions, supplementary protection certificates or any like
filing thereof, or provisional applications of any such patents and patent
applications.
1.15 "Sparta Know-How" shall mean any of Sparta's or its
Affiliates' information and materials relating to the research, development,
registration, manufacture, marketing, use or sale of Licensed Product which
during the Term of this Agreement are in Sparta's or its Affiliates' possession
or control, through license or otherwise, and which are not generally known.
Sparta Know-How shall include, without limitation, discoveries, methods,
knowledge, Improvements, processes, formulas, data, ideas, experience,
inventions, know-how, technology, trade secrets, manufacturing procedures,
purification and isolation techniques, test data and other intellectual
property, patentable or otherwise, developed by or on behalf of Sparta relating
to Licensed Product or otherwise relating to the combination of Temozolomide and
the Drug Delivery System, including without limitation, test procedures and
other new technologies derived therefrom.
1.16 "Sparta Patent Rights" shall mean any and all patents and
pending patent applications, excluding the RTP Patent Rights, which during the
Term of this Agreement are owned by Sparta, or to which Sparta through license
or otherwise acquires rights, including, but not limited to, those listed in
Schedule 1.13, and which have claims covering: (i) the Drug Delivery System or
any use thereof in conjunction with Temozolomide, or any apparatus, material or
method of manufacture useful in the development, manufacture, use or sale
thereof; or (ii) Licensed Product or any use thereof, or any apparatus, material
or method of manufacture useful in the development, manufacture, use or sale
thereof; or (iii) Improvements; or (iv) the Sparta Know-How; or (v) are
substitutions, divisions, continuations, continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations, extensions,
supplementary protection certificates or any like filing thereof, or provisional
applications of any such patents and patent applications.
1.17 "Schering Know-How" shall mean any of SP Ltd.'s or its
Affiliates' information and materials relating to the research, development,
registration, manufacture, marketing, use or sale of Temozolomide and/or
Licensed Product which during the Term of this Agreement are in SP Ltd.'s or its
Affiliates' possession or control, through license or otherwise, and which are
not generally known. Schering Know-How shall include, without limitation,
discoveries, methods, knowledge, Improvements, processes, formulas, data, ideas,
experience, inventions, know-how, technology, trade secrets, manufacturing
procedures, purification and isolation techniques, test data and other
intellectual property, patentable or otherwise, developed by or on behalf of SP
Ltd. or its Affiliates relating to Licensed Product, including without
limitation, test procedures and other new technologies derived therefrom.
1.18 "Schering Trademark" shall mean any trademark(s)
proposed, chosen, owned or controlled by SP Ltd. or its Affiliates for use with
Temozolomide and/or the Licensed Product in the Territory.
1.19 "Territory" shall mean the entire world except the United
States of America, its territories, possessions and commonwealths.
1.20 "Term" shall mean the period commencing on the Effective
Date and unless terminated earlier pursuant to the relevant provisions of
Article VIII shall continue until the expiration of the last to expire of the
Licensed Patent Rights incorporating a Valid Claim.
1.21 "Transaction Agreements" shall mean collectively this
Agreement and the U. S. License Agreement.
1.22 "Valid Claim" shall mean a composition of matter or
method of use claim, or equivalent thereof, of an issued and unexpired patent in
the Territory covering the use of Licensed Product(s) included within the
Licensed Patent Rights, which (i) has not been revoked or held unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the
time allowed for appeal; or (ii) has not been abandoned, disclaimed, denied or
admitted to be invalid or unenforceable through reissue or disclaimer or
otherwise.
ARTICLE II
LICENSE; DISCLOSURE OF INFORMATION; DEVELOPMENT AND
COMMERCIALIZATION
2.1 Exclusive License Grant.
(a) License to Sparta Patent Rights. Sparta hereby
grants to SP Ltd. as of the Effective Date, an exclusive license,
exclusive even as to Sparta, in the Territory under the Sparta Patent
Rights, and to use the Sparta Know-How to develop, make, have made,
import, export, use, distribute, market, promote, offer for sale and
sell Licensed Product(s). Any Improvements relating to the Licensed
Product, or otherwise relating to the use of the Drug Delivery System
in combination with Temozolomide, developed prior to or during the Term
of this Agreement by or on behalf of Sparta shall be included in Sparta
Know-How or Sparta Patent -Rights, as the case may be, for all purposes
of this Agreement.
(b) Right to Sublicense. The licenses granted to SP
Ltd. under Section 2.1(a) shall include the right to grant sublicenses
to Affiliates and/or any third party.
(c) Sublicense to RTP Patent Rights. Subject to the
terms and conditions set forth in Section 2.1.2 of the RTP/Sparta
Sublicense Agreement, Sparta hereby grants to SP Ltd. and its
Affiliates, as of the Effective Date, an exclusive sublicense,
exclusive even as to Sparta, in the Territory under the RTP Patent
Rights to develop, make, have made, import, export, use, distribute,
market, promote, offer for sale and sell Licensed Product(s).
2.2 Disclosure of Information. Promptly after the Effective
Date, Sparta shall disclose to SP Ltd. in writing, or via electronic media
acceptable to SP Ltd., all Sparta Know-How not previously disclosed to SP Ltd.
in order to enable SP Ltd. to exploit its rights granted under Section 2.1 of
this Agreement. In addition, during the Term of this Agreement Sparta shall
promptly disclose to SP Ltd. in writing, or via electronic media acceptable to
SP Ltd., Sparta Know-How relating to any Improvements. Such Sparta Know-How and
other information shall be automatically deemed to be within the scope of the
licenses granted herein without payment of any additional compensation.
2.3 SP Ltd.'s Development Obligations. SP Ltd. shall, at SP
Ltd.'s expense, use reasonable commercial efforts to develop, obtain Regulatory
Approval for, and commercialize Licensed Product(s) in such countries in the
Territory where in SP Ltd.'s opinion it is commercially viable to do so.
(a) SP Ltd. Diligence. The parties acknowledge and
agree that all business decisions including, without limitation,
decisions relating to the research,
development, registration, manufacture, sale, commercialization,
design, price, distribution, marketing and promotion of Licensed
Product(s) covered under this Agreement, shall be within the sole
discretion of SP Ltd. Sparta acknowledges that SP Ltd. is in the
business of developing, manufacturing and selling pharmaceutical
products and, subject to the provisions of this Section 2.3, nothing in
this Agreement shall be construed as restricting such business or
imposing on SP Ltd. the duty to market and/or sell and exploit Licensed
Product(s) for which royalties are payable hereunder to the exclusion
of, or in preference to, any other product, or in any way other than in
accordance with its normal commercial practices.
(b) Opportunity to Cure. In the event that if, in
Sparta's reasonable opinion, SP Ltd. fails to meet its diligence
obligations under Section 2.3(a), then Sparta shall have the right to
give SP Ltd. written notice thereof stating in detail the particular
failure. SP Ltd. shall have a period of [Information omitted and filed
separately with the Commission under Rule 24b-2.] days from the receipt
of such notice to correct the failure or, in the event that the failure
cannot be reasonably cured within a [Information omitted and filed
separately with the Commission under Rule 24b-2.] day period, then SP
Ltd. shall initiate actions reasonably expected to cure the failure
within [Information omitted and filed separately with the Commission
under Rule 24b-2.] days of receiving notice and shall thereafter
diligently pursue such actions to cure the failure (even if requiring
longer than the [Information omitted and filed separately with the
Commission under Rule 24b-2.] days specified in Section 8.3(a)(i)). In
the event of a dispute as to whether or not SP Ltd. has failed to
exercise due diligence under Section 2.3(a) or whether SP Ltd. is
diligently pursuing actions reasonably expected to cure such failure
under this Section 2.3(b), such dispute shall be resolved through
binding arbitration in accordance with Section 9.2.
(c) Research and Development Activities. Subject to
its diligence obligations set forth in Section 2.3(a), following the
Effective Date, SP Ltd. shall be responsible, at its cost and expense,
and in its sole judgment, for all research and development activities
which are necessary to obtain Regulatory Approval for Licensed
Product(s) in the Territory and any post-approval studies required as a
condition of obtaining any Regulatory Approval for the Licensed
Product. In addition, SP Ltd. shall be responsible for any other
studies (or portions of studies) necessary or desirable, in its sole
judgment, for maintaining any Regulatory Approval and/or pricing and
reimbursement approvals in the Territory, as well as any premarketing
studies prior to Regulatory Approval and postmarketing studies
conducted following a Regulatory Approval.
(d) Licensed Product Registrations: Pricing
Reimbursement Approvals. Subject to its diligence obligations set forth
in Section 2.3(a), SP Ltd. shall be responsible, at its cost and
expense, and in its sole judgment, for determining the appropriate
regulatory strategy, for obtaining and maintaining all Regulatory
Approvals and for obtaining and maintaining any pricing and
reimbursement approvals required for the sale of Licensed Product in
each country in the Territory. Each Regulatory Approval and each
pricing and reimbursement approval shall be
placed in SP Ltd.'s name or the name of a SP Ltd. Affiliate.
(e) Data. All data arising out of studies performed
under this Article II shall be owned by SP Ltd.
(f) Assistance by Sparta. During the Term of this
Agreement, Sparta shall provide to SP Ltd. all Sparta Know-How, which
may be relevant to obtain any Regulatory Approval relating to Licensed
Product(s). In connection with any HRD or other application for
Regulatory Approval relating to Licensed Product(s), Sparta shall, at
SP Ltd.'s request, provide to SP Ltd. in a prompt manner responses to
questions which have been raised by any regulatory authority in
connection with such application for Regulatory Approval and further
provide to SP Ltd. estimates of Sparta's out-of-pocket costs for
rendering such assistance.
2.4 Excused Performance. In addition to the provisions of
Article VIII and Section 9.9, the obligations of SP Ltd. with respect to a
Licensed Product under Sections 2.3(a), 2.3(c) and 2.3(d) are expressly
conditioned upon the continuing absence of any adverse condition or event which
warrants a delay in commercialization of the Licensed Product including, but not
limited to, an adverse condition or event relating to the safety or efficacy of
a Licensed Product or unfavorable pricing, pricing reimbursement, labeling or
lack of Regulatory Approval, and the obligation of SP Ltd. to develop or market
any such Licensed Product shall be delayed or suspended so long as in SP Ltd.'s
opinion any such condition or event exists.
2.5 Other Studies. Sparta shall conduct no studies or
preclinical or clinical trials with Temozolomide alone or in combination with
the Drug Delivery System without the express written consent of SP Ltd.,
including the prior written approval of any protocols to be used and any
amendments thereto. Such consent may be granted by SP Ltd. in its sole
discretion. If SP LTD. approves a study, at SP Ltd.'s request, Sparta shall
provide to SP Ltd. the results from the study and any background information
requested. At the option of SP Ltd., SP Ltd. may have its representative(s)
monitor any approved preclinical, clinical or other studies conducted by Sparta
pursuant to this Section 2.5.
2.6 Reports. SP Ltd. shall provide Sparta with twice yearly
written reports summarizing the status of the research and development
activities and progress of any Regulatory Approval, as applicable, in connection
with Licensed Product in the Territory.
ARTICLE III
PAYMENTS; ROYALTIES AND REPORTS
3.1 Consideration for License. In partial consideration for
the licenses granted to SP Ltd. hereunder, SP Ltd. shall make an upfront payment
to Sparta, payable in installments, on the first occurrence of the indicated
triggering events.
[Information omitted and filed separately with the Commission under Rule 24b-2.]
[Information omitted and filed separately with the Commission under Rule 24b-2.]
Each of the installments set forth in this Section 3. 1 shall be payable once
upon the initial achievement of such event and no amounts shall be due hereunder
for subsequent or repeated achievement of such event.
3.2 Royalties.
(a) Royalty Rates. In further consideration for the
licenses granted to SP Ltd. hereunder, starting with the First
Commercial Sale of Licensed Product, SP Ltd. shall pay to Sparta,
[Information omitted and filed separately with the Commission under
Rule 24b-2.]
(b) Term and Scope of Royalty Obligations. Subject to
the terms of Sections 4.3(b) and 8.1, royalties on each Licensed
Product at the rate set forth in Section 3.2(a) shall continue until
the expiration of the last applicable Licensed Patent Right
incorporating a Valid Claim. No royalties shall be due upon the sale or
other transfer among SP Ltd., its Affiliates or sublicensees, but in
such cases the royalty shall be due and calculated upon SP Ltd's or its
Affiliates' or its sublicensees' Net Sales to the first independent
third party. No royalties shall accrue on the disposition of Licensed
Product by SP Ltd., its Affiliates or its sublicensees as donations
(for example, to nonprofit institutions or government agencies for a
non-commercial purpose) or for clinical studies.
(c) Third Party Licenses. In the event that patent
licenses from third parties are required by SP Ltd., its Affiliates and
sublicensees in order to practice the Licensed Patent Rights to
develop, make, have made, import, export, use, distribute, promote,
market, offer for sale or sell Licensed Product(s) (hereinafter "Third
Party Patent Licenses"), then the royalty rates set forth in Section
3.2(a) shall be adjusted such that the royalty rate for Net Sales of
Licensed Product which SP Ltd. is obligated to pay Sparta shall be
[Information omitted and filed separately with the Commission under
Rule 24b-2.] By way of example and for avoidance of doubt, if SP Ltd.
is obligated to pay royalties to Sparta on Net Sales of a Licensed
Product and is also obligated to [Information omitted and filed
separately with the Commission under Rule 24b-2.] under a Third Party
Patent License, then the royalty rate under this Agreement would
[Information omitted and filed separately with the Commission under
Rule 24b-2.] For further example, if the third party royalty obligation
in the above example were [Information omitted and filed separately
with the Commission under Rule 24b-2.]
[Information omitted and filed separately with the Commission under Rule
24b-2.], the calculated royalty rate would [Information omitted and filed
separately with the Commission under Rule 24b-2.], but the actual royalty rate
to Sparta could [Information omitted and filed separately with the Commission
under Rule 24b-2.]
(d) Compulsory Licenses. If a compulsory license is
granted to a third party with respect to Temozolomide and/or Licensed
Product in any country in the Territory with a royalty rate lower than
the royalty rate provided by Section 3.2(a),- then the royalty rate to
be paid by SP Ltd. on Net Sales in that country under Section 3.2(a)
shall be reduced to the rate paid by the compulsory licensee.
3.3 Reports: Payment of Royalty: Payment Exchange Rate and
Currency Conversions.
(a) Royalties Paid Quarterly. Within sixty (60)
calendar days following the close of each Calendar Quarter, following
the First Commercial Sale of a Licensed Product, SP Ltd. shall furnish
to Sparta a written report for the Calendar Quarter showing the Net
Sales of Licensed Product sold by SP Ltd., its Affiliates and its
sublicensees in the Territory during such Calendar Quarter and the
royalties payable under this Agreement for such Calendar Quarter.
Simultaneously with the submission of the written report, SP Ltd. shall
pay to Sparta, for the account of SP Ltd. or the applicable Affiliate
or sublicensee, as the case may be, a sum equal to the aggregate
royalty due for such Calendar Quarter calculated in accordance with
this Agreement (reconciled for any previous overpayments or
underpayments).
(b) Method of Payment. Payments to be made by SP Ltd.
to Sparta under this Agreement shall be paid by bank wire transfer in
immediately available funds to such bank account as is designated in
writing by Sparta from time to time. Royalties shall be deemed payable
by the entity making the Net Sales from the country in which earned in
local currency and subject to foreign exchange regulations then
prevailing. Royalty payments shall be made in United States dollars to
the extent that free conversions to United States dollars is permitted.
The rate of exchange to be used in any such conversion from the
currency in the country where such Net Sales are made shall be the rate
of exchange used by SP Ltd. for reporting such sales for United States
financial statement purposes. A copy of SP Ltd.'s current policy for
bookkeeping exchange rates is set forth in Schedule 3.3. If, due to
restrictions or prohibitions imposed by national or international
authority, payments cannot be made as aforesaid, the parties shall
consult with a view to finding a prompt and acceptable solution, and SP
Ltd. will deal with such monies as Sparta may lawfully direct at no
additional out-of-pocket expense to SP Ltd. Notwithstanding the
foregoing, if royalties in any country cannot be remitted to Sparta for
any reason within six (6) months after the end of the Calendar Quarter
during which they are earned, then SP Ltd. shall be obligated to
deposit the royalties in a bank account in such country in the name of
Sparta.
3.4 Maintenance of Records: Audits.
(a) Record Keeping by SP Ltd. SP Ltd. and its
Affiliates shall keep complete and accurate records in sufficient
detail to enable the royalties payable hereunder to be determined. Upon
forty-five (45) days prior written notice from Sparta, SP Ltd. shall
permit an independent certified public accounting firm of nationally
recognized standing selected by Sparta and reasonably acceptable to SP
Ltd., at Sparta's expense, to have access during normal business hours
to examine pertinent books and records of SP Ltd. and/or its Affiliates
as may be reasonably necessary to verify the accuracy of the royalty
reports hereunder. The examination shall be limited to pertinent books
and records for any year ending not more than twenty-four (24) months
prior to the date of such request. An examination under this Section
3.4(a) shall not occur more than once in any Calendar Year. SP Ltd. may
designate competitively sensitive information which such auditor may
not disclose to Sparta, provided, however, that such designation shall
not encompass the auditor's conclusions. The accounting firm shall
disclose to Sparta only whether the royalty reports are correct or
incorrect and the specific details concerning any discrepancies. No
other information shall be provided to Sparta. All such accounting
firms shall sign a confidentiality agreement (in form and substance
reasonably acceptable to SP Ltd.) as to any of SP Ltd.'s or its
Affiliate's confidential information which they are provided, or to
which they have access, while conducting any audit pursuant to this
Section 3.4(a).
(b) Underpayments/Overpayments. If such accounting
firm correctly concludes that additional royalties were owed during
such period, SP Ltd. shall pay the additional royalties within thirty
(30) days of the date Sparta delivers to SP Ltd. such accounting firm's
written report so correctly concluding. If such underpayment exceeds
[Information omitted and filed separately with the Commission under
Rule 24b-2.] of the royalty correctly due Sparta then the fees charged
by such accounting firm for the work associated with the underpayment
audit shall be paid by SP Ltd. Any overpayments by SP Ltd. will be
credited against future royalty obligations. In the event that SP Ltd.
disagrees with the audit report and the chief financial officers of SP
Ltd. and Sparta fail to revolve such disagreement, the dispute will be
resolved through the dispute resolution mechanism set forth in Section
9.2.
3.5 Separate Payment Obligations. The parties acknowledge that
SP Ltd.'s payment obligations as set forth in Sections 3.1 and 3.2 of this
Agreement are separate from and in addition to the payment obligations of SP
Ltd.'s Affiliate, Schering Corporation, as set forth in the U.S. License
Agreement.
3.6 Income Tax Withholding. If at any time, any jurisdiction
within the Territory requires the withholding of income taxes or other taxes
imposed upon payments set forth in this Article III, SP Ltd. shall make such
withholding payments as required and subtract such withholding payments from the
payments set forth in this Article III, or if applicable, Sparta will promptly
reimburse SP Ltd. or its designee(s) of the amount of such payments. SP Ltd.
shall provide Sparta with documentation of such withholding and payment in a
manner that is satisfactory for purposes of the U.S. Internal Revenue Service.
Any withholdings paid when due hereunder shall be for the account of Sparta and
shall not be included in the calculation of Net Sales. Sparta shall be liable
for any deficiency, and any fine, assessment or penalty imposed by any taxing
authority in the Territory for any deficiency in the amount of any such
withholding or the failure to make such withholding payment. If SP Ltd. is
required to pay any such deficiency, or any fine, assessment or penalty for any
such deficiency, Sparta shall promptly reimburse SP Ltd. for such payments,
which shall not be included in the calculation of Net Sales.
3.7 Direct Affiliate Licenses. Whenever SP Ltd. shall
reasonably demonstrate to Sparta that, in order to facilitate direct royalty
payments by an Affiliate, it is desirable that a separate license agreement be
entered into between Sparta and such Affiliate, Sparta will grant such licenses
directly to such Affiliate by means of an agreement which shall be consistent
with all of the provisions hereof, provided that SP Ltd. guarantees the
Affiliate's obligations thereunder.
ARTICLE IV
PATENTS
4.1 Filing. Prosecution and Maintenance of Patents. Sparta
agrees to diligently file, prosecute and maintain in the Territory, upon
appropriate consultation with SP Ltd., any Licensed Patent Rights owned in whole
or in part by Sparta and licensed to SP Ltd. under this Agreement. Sparta shall
give SP Ltd. an opportunity to review the text of the applications before
filing, shall consult with SP Ltd. with respect thereto, and shall supply SP
Ltd. with a copy of the applications as filed, together with notice of its
filing date and serial number. Sparta shall keep SP Ltd. advised of the status
of all actual and prospective patent filings and upon the written request of SP
Ltd. shall provide advance copies of any substantive papers related to the
filing, prosecution and maintenance of such patent filings.
4.2 Option of SP Ltd. to Prosecute and Maintain Patents.
Sparta shall give one hundred and eighty (180) days notice to SP Ltd. of any
desire to cease prosecution and/or maintenance of a particular Licensed Patent
Right and, in such case, subject to the rights of RTP under the RTP/Sparta
Sublicense Agreement with respect to RTP Patent Rights, shall permit SP Ltd., at
its sole discretion, to continue prosecution or maintenance at its own expense.
If SP Ltd. elects to continue prosecution or maintenance, Sparta shall execute
such documents and perform such acts, at SP Ltd.'s expense, as may be reasonably
necessary to effect an assignment of such Licensed Patent Rights to SP Ltd. Any
such assignment shall be completed in a timely manner to allow SP Ltd. to
continue such prosecution or maintenance. Any patents or patent applications so
assigned shall not be considered Licensed Patent Rights.
4.3 Enforcement. In the event that either SP Ltd. or Sparta
becomes aware of any infringement in a country in the Territory of any issued
patent within the Licensed Patent Rights, it will notify the other party in
writing to that effect. Any such notice shall include evidence to support an
allegation of infringement by such third party.
(a) Discontinuance of Infringement. Sparta shall
use its reasonable
best efforts to obtain a discontinuance of such infringement or bring
suit against the third party infringer within [Information omitted and
filed separately with the Commission under Rule 24b-2.] from the date
of said notice. Sparta shall bear all the expenses of any suit brought
by it. SP Ltd. shall have the right, prior to commencement of the
trial, suit or action brought by Sparta, to join any such suit or
action, and in such event shall pay one-half of the costs of such suit
or action. In the event that SP Ltd. has joined in the action and
shared in the costs thereof as set forth above, no settlement, consent
judgment or other voluntary final disposition of the suit may be
entered into without the consent of SP Ltd. In the event that SP Ltd.
has not joined the suit or action, SP Ltd. will reasonably cooperate
with Sparta in any such suit or action and shall have the right to
consult with Sparta and be represented by its own counsel at its own
expense, provided that Sparta shall periodically reimburse SP Ltd. for
its out-of-pocket costs (excluding the costs of retaining its own
outside counsel) incurred in cooperating with Sparta. Any recovery or
damages derived from a suit which SP Ltd. has joined and shared costs
shall be used first to reimburse each of Sparta and SP Ltd. for its
documented out-of-pocket legal expenses relating to the suit, with any
remaining amounts to be shared equally by the parties. Any recovery or
damages derived from a suit which SP Ltd. has not joined shall be
retained by Sparta.
(b) Continuance of Infringement. If, after the
expiration of the [Information omitted and filed separately with the
Commission under Rule 24b-2.] period Sparta has not commenced, or if
commenced is not actively pursuing legal action against an infringer as
specified in Subsection 4.3(a), then, notwithstanding the limitations
on royalty rate reduction set forth in Section 3.2(c), SP Ltd. shall
have no further obligation to pay any royalty on the Net Sales of
Licensed Product under Section 3.2(a) in those countries in the
Territory where the alleged infringement occurred. No royalties shall
be due until said infringement ceases and, thereafter, the royalty
shall revert to the applicable full royalty set forth in Section
3.2(a). In the event that said infringement does not cease, no
royalties shall be due to Sparta. In addition, SP Ltd. shall have the
right, but not the obligation, to bring suit against such infringer
under the Licensed Patent Rights and join Sparta as a party plaintiff,
provided that SP Ltd. shall bear all the expenses of such suit. Sparta
will cooperate with SP Ltd. in any suit for infringement of a Licensed
Patent Right brought by SP Ltd. against a third party, and shall have
the right to consult with SP Ltd. and to participate in and be
represented by independent counsel in such litigation at its own
expense. SP Ltd. shall periodically reimburse Sparta for its
out-of-pocket costs (excluding Sparta's costs of retaining independent
counsel) incurred in cooperating with SP Ltd. SP Ltd. shall incur no
liability to Sparta as a consequence of such litigation or any
unfavorable decision resulting therefrom, including any decision
holding any of the Licensed Patent Rights invalid or unenforceable. In
the event that SP Ltd. recovers any sums in such litigation by way of
damages or in settlement thereof, SP Ltd. retain all such sums.
4.4 Infringement and Third Party Licenses. In the event that
SP Ltd.'s, its Affiliates' or its sublicensees' practicing of the Licensed
Patent Rights in connection with making, having made, importing, exporting,
using, distributing, marketing, promoting,
offering for sale or selling Licensed Product(s) infringes, will infringe or is
alleged by a third party to infringe a third party's patent, the party becoming
aware of same shall promptly notify the other.
(a) Sparta Option to Negotiate. Sparta shall in the
first instance have the right to negotiate with said third party for a
suitable license or assignment. In the event that such negotiation
results in a consummated agreement, then any lump sum payment made
thereunder shall be paid by Sparta. Should such agreement require the
payment of royalties, SP Ltd. shall continue to pay the royalties due
Sparta hereunder and Sparta shall pay any royalties due said third
party on SP Ltd.'s behalf.
(b) SP Ltd. Option to Negotiate. Should Sparta fail
to consummate an agreement with said third party within one (1) year of
initiating negotiations, then SP Ltd. shall have the right to negotiate
with said third party for a suitable license or assignment. In the
event that such negotiation results in a consummated agreement, then
any lump sum payment made thereunder shall be paid by SP Ltd.
[Information omitted and filed separately with the Commission under
Rule 24b-2.] Any royalty payments to be made by SP Ltd. under such
Third Party Patent License shall be offset against any royalties due
Sparta in accordance with Section 3.2. Any unused amounts not so offset
can be carried over to subsequent quarters.
4.5 Third Party Infringement Suit. In the event that a third
party sues SP Ltd. alleging that SP Ltd.'s, its Affiliates' or its sublicensees'
practicing of the Licensed Patent Rights in connection with making, having made,
importing, exporting, using, distributing, marketing, promoting, offering for
sale or selling Licensed Product(s) infringes or will infringe said third
party's patent, then SP Ltd. may elect to defend such suit and, during the
period in which such suit is pending, SP Ltd. shall have the right to
[Information omitted and filed separately with the Commission under Rule 24b-2.]
[Information omitted and filed separately with the Commission under Rule 24b-2.]
Upon SP Ltd.'s request and in connection with SP Ltd.'s defense of any such
third party infringement suit, Sparta shall provide reasonable assistance to SP
Ltd. for such defense.
4.6 Abandonment. Subject to SP Ltd.'s rights pursuant to
Section 4.2, Sparta shall at the earliest known date give notice to SP Ltd. of
the grant lapse, revocation, surrender, invalidation or abandonment of any
Licensed Patent Rights licensed to SP Ltd. for which Sparta is responsible for
the filing, prosecution and maintenance under this Agreement.
4.7 Notices Regarding Patents. All notices, inquiries and
communications in connection with this Article IV shall be sent in the manner
set forth in Section 9.7 to the parties at the addresses and facsimile numbers
indicated below.
If to Sparta: Sparta Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attn.: Chief Executive Officer
Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
If to SP Ltd.: Schering Corporation
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn.: Staff Vice President - Patents and Trademarks
Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
ARTICLE V
CONFIDENTIALITY AND PUBLICATION
5.1 Confidentiality.
(a) Nondisclosure Obligation. Each of Sparta and SP
Ltd. shall use only in accordance with this Agreement and shall not
disclose to any third party any Proprietary Information received by it
from the other party, without the prior written consent of the other
party. The foregoing obligations shall survive the expiration or
termination of this Agreement for a period of ten (10) years. These
obligations shall not apply to Proprietary Information that:
(i) is known by the receiving party at the
time of its receipt, and not through a prior disclosure by the
disclosing party, as documented by business records;
(ii) is at the time of disclosure or
thereafter becomes published or otherwise part of the public domain
without breach of this Agreement by the receiving party;
(iii) is subsequently disclosed to the
receiving party by a third party who has the right to make such
disclosure;
(iv) is developed by the receiving party
independently of Proprietary Information or other information
received from the disclosing party and such independent development
can be documented by the receiving party;
(v) is disclosed to any institutional
review board of any entity conducting clinical trials or any
governmental or other regulatory agencies in order to obtain patents
or to gain approval to conduct clinical trials or to market
Temozolomide and/or Licensed Product, but such disclosure may be made
only to the extent reasonably necessary to obtain such patents or
authorizations; or
(vi) is required by law, regulation, rule,
act or order of any governmental authority or agency to be disclosed
by a party, provided that notice is promptly delivered to the other
party in order to provide an opportunity to seek a protective order
or other similar order with respect to such Proprietary Information
and thereafter the disclosing party discloses to the requesting
entity only the minimum Proprietary Information required to be
disclosed in order to comply with the request, whether or not a
protective order or other similar order is obtained by the other
party.
Nothing herein shall be interpreted to prohibit SP Ltd. from publishing the
results of its studies in accordance with industry practices.
(b) Disclosure to Agents. Notwithstanding the
provisions of Section 5.1(a) and subject to the other terms of this
Agreement, SP Ltd. shall have the right to disclose Sparta Proprietary
Information to its sublicensees, agents, consultants, Affiliates or
other third parties (collectively "Agents") in accordance with this
Section 5.1(b). Such disclosure shall be limited only to those Agents
directly involved in the research, development, manufacturing,
marketing or promotion of Licensed Product (or for such Agents to
determine their interest in performing such activities) in accordance
with this Agreement. Any such Agents must agree in writing to be bound
by confidentiality and non-use obligations essentially the same as
those contained in this Agreement. The term of confidentiality and
non-use obligations for such Agents shall be no less than ten (10)
years.
(c) Disclosure to a Third Party. Notwithstanding
anything herein to the contrary, Sparta shall not disclose, provide or
transfer to any third party without the prior written approval of SP
Ltd. (i) any Schering Know-How, or (ii) any Sparta Know-How relating to
Licensed Product(s), or otherwise relating to the combination of the
Drug Delivery System and Temozolomide.
5.2 No Publicity. A party may not use the name of the other
party in any publicity or advertising and, except as provided in Section 5.1,
may not issue a press release or otherwise publicize or disclose any information
related to the existence of this Agreement or the terms or conditions hereof,
without the prior written consent of the other party. The parties shall agree on
a form and timing of the initial press release that may be used by either party
to describe this Agreement. Nothing in the foregoing, however, shall prohibit a
party from making such disclosures to the extent deemed necessary under
applicable federal or state securities laws or any rule or regulation of any
nationally recognized securities exchange. In such event, however, the
disclosing party shall use good faith efforts to consult with the other party
prior to such disclosure and, where applicable, shall request confidential
treatment to the extent available.
5.3 Publication. SP Ltd. and Sparta each acknowledge the
potential benefit in publishing results of certain studies to obtain recognition
within the scientific community and to advance the state of scientific
knowledge. Each party also recognizes the mutual interest in obtaining valid
patent protection and in protecting business interests and trade secret
information. No publication of a party's Proprietary Information may be made
without the prior written consent of such party. The parties agree that SP Ltd.,
its Affiliates, employees or consultants shall be free to make any publication
which does not disclose Sparta's Proprietary Information. In the event that any
proposed publication (as defined below) discloses Proprietary Information, the
following procedure shall apply: either party, its Affiliates, employees or
consultants wishing to make a publication shall deliver to the other party a
copy of the proposed written publication or an outline of an oral disclosure at
least sixty (60) days prior to submission for publication or presentation. For
purposes of this Agreement, the term "publication" shall include, without
limitation, abstracts and manuscripts for publication, slides and texts of oral
or other public presentations, and texts of any transmission through any
electronic media, e.g. any computer access system such as the Internet or World
Wide Web. The reviewing party shall have the right (i) to propose modifications
to the publication for patent reasons, trade secret reasons or business reasons
or (ii) to request delay of the publication or presentation in order to protect
patentable information. If the reviewing party requests a delay, the publishing
party shall delay submission or presentation for a period not less than eighteen
(18) months from the filing date of the first patent application covering the
information contained in the proposed publication or presentation. If the
reviewing party requests modifications to the publication, the publishing party
may edit such publication to prevent disclosure of trade ▇▇▇▇▇ or proprietary
business information prior to submission of the publication or presentation.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1 Representations and Warranties of Each Party. Each of
Sparta and SP Ltd. hereby represents, warrants and covenants to the other party
hereto as follows:
(a) it is a corporation or entity duly organized and
validly existing under the laws of the state or other jurisdiction of
incorporation or formation;
(b) the execution, delivery and performance of this
Agreement by such party has been duly authorized by all requisite
corporate action, subject only to receipt of requisite approval of its
board of directors;
(c) it has the power and authority to execute and
deliver this Agreement and to perform its obligations hereunder;
(d) the execution, delivery and performance by such
party of this Agreement and its compliance with the terms and
provisions hereof does not and will not conflict with or result in a
breach of any of the terms and provisions of or constitute a default
under (i) a loan agreement, guaranty, financing agreement, agreement
affecting a product or other agreement or instrument binding or
affecting it or its property; (ii) the provisions of its charter or
operative documents or bylaws; or (iii) any order, writ, injunction or
decree of any court or governmental authority entered against it or by
which any of its property is bound;
(e) except for the governmental and Regulatory
Approvals required to market the Licensed Product in the Territory, the
execution, delivery and performance of this Agreement by such party
does not require the consent, approval or authorization of, or notice,
declaration, filing or registration with, any governmental or
regulatory authority and the execution, delivery or performance of this
Agreement will not violate any law, rule or regulation applicable to
such party;
(f) this Agreement has been duly authorized, executed
and delivered and constitutes such party's legal, valid and binding
obligation enforceable against it in accordance with its terms subject,
as to enforcement, to bankruptcy, insolvency, reorganization and other
laws of general applicability relating to or affecting creditors'
rights and to the availability of particular remedies under general
equity principles; and
(g) it shall comply with all applicable material laws
and regulations relating to its activities under this Agreement.
6.2 Sparta's Representations. Sparta hereby represents,
warrants and covenants to SP Ltd. as follows:
(a) the Licensed Patent Rights are subsisting and
are not invalid or unenforceable, in whole or in part;
(b) it has the full right, power and authority to
grant all of the right, title and interest in the licenses granted
under Article II hereof;
(c) it is the sole and exclusive owner of the Sparta
Patent Rights and Sparta Know-How, and the exclusive licensee of the
RTP Patent Rights, all of which are free and clear of any liens,
charges and encumbrances, and no other person, corporate or other
private entity, or governmental entity or subdivision thereof, has or
shall have any claim of ownership with respect to the Licensed Patent
Rights or Sparta Know-How, whatsoever;
(d) to the best of its knowledge, the Licensed Patent
Rights and Sparta Know-How, and the development, manufacture, use,
distribution, marketing, promotion and sale of Licensed Products do not
interfere or infringe on any intellectual property rights owned or
possessed by any third party;
(e) to the best of its knowledge, there are no third
party pending patent applications which, if issued, may cover the
development, manufacture, use or sale of Licensed Product;
(f) there are no claims, judgments or settlements
against or owed by Sparta or pending or threatened claims or litigation
relating to Drug Delivery System, the Licensed Patent Rights or Sparta
Know-How;
(g) it has disclosed to SP Ltd. all Sparta Know-How
and other relevant information relating to the combination of
Temozolomide and the Drug Delivery System, and Licensed Product;
(h) during the Term of this Agreement it will use
reasonable best efforts not to diminish the rights under the Licensed
Patent Rights and Sparta Know-How granted to SP Ltd. hereunder,
including, without limitation, by not committing or permitting any
actions or omissions which would cause the breach of any agreements
between itself and third parties which provide for intellectual
property rights applicable to the development, manufacture, use or sale
of the Drug Delivery System and/or Licensed Product(s), that it will
provide SP Ltd. promptly with notice of any such alleged breach, and
that as of the Effective Date, it is in compliance in all material
respects with any agreements with third parties including, without
limitation, the RTP/Sparta Sublicense Agreement;
(i) it has no knowledge of any circumstances that
would materially and adversely affect the commercial utility of the
Licensed Product and/or the use of the Drug Delivery System in
combination with Temozolomide, or that would render SP Ltd. liable to a
third party for patent infringement as a consequence of SP Ltd.'s sale
of Licensed Product;
(j) data summaries provided to SP Ltd. by Sparta
prior to the Effective Date relating to the pre-clinical and clinical
studies of Temozolomide in combination with the Drug Delivery System
accurately represent all the underlying raw data;
(k) there are no collaborative, licensing, material
transfer, supply, distributorship or marketing agreements or
arrangements or other similar agreements to which it or any of its
Affiliates are party relating to the combination of the Drug Delivery
System and Temozolomide, nor has it granted any rights to any third
party with respect to such combination; and
(l) Sparta and/or its Affiliates shall neither use
nor seek to register any trademarks which are confusingly similar to
any Schering Trademark, or any other trademarks, trade names, trade
dress or logos used in connection with the Licensed Product.
6.3 SP Ltd.'s Representations. SP Ltd. hereby represents,
warrants and covenants to Sparta as follows:
(a) it is the sole and exclusive owner and/or
licensee of all rights to Temozolomide which are free and clear of any
liens, charges and encumbrances, and no other person, corporate or
other private entity, or governmental entity or subdivision thereof,
has or shall have any claim of ownership with respect to Temozolomide,
whatsoever;
(b) Temozolomide and the development, manufacture,
use, distribution, marketing, promotion and sale of Temozolomide does
not interfere or infringe on any intellectual property rights owned or
possessed by any third party; and
(c) there are no claims, judgments or settlements
against or owed by SP Ltd. or pending or threatened claims or
litigation relating to Temozolomide.
6.4 Continuing Representations. The representations and
warranties of each party contained in Sections 6.1, 6.2 and 6.3 shall survive
the execution of this Agreement and shall remain true and correct after the date
hereof with the same effect as if made as of the date hereof.
6.5 No Inconsistent Agreements. Neither party has in effect
and after the Effective Date neither party shall enter into any oral or written
agreement or arrangement that would be inconsistent with its obligations under
this Agreement.
6.6 Representation by Legal Counsel. Each party hereto
represents that it has been represented by legal counsel in connection with this
Agreement and acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this Agreement, the
parties agree that no presumption shall exist or be implied against the party
which drafted such terms and provisions.
ARTICLE VII
INDEMNIFICATION AND LIMITATION ON LIABILITY
7.1 Indemnification by SP Ltd.
(a) SP Ltd. shall indemnify, defend and hold harmless
Sparta and its Affiliates, and each of its and their respective
employees, officers, directors and agents (each, a "Sparta Indemnified
Party") from and against any and all liability, loss, damage, cost, and
expense (including reasonable attorneys' fees), subject to the
limitations in Section 7.5 (collectively, a "Liability") which the
Sparta Indemnified Party may incur, suffer or be required to pay
resulting from or arising out of the development, manufacture,
promotion, distribution, use, testing, marketing, sale or other
disposition of Temozolomide and/or Licensed Product by SP Ltd., its
Affiliates or sublicensees. Notwithstanding the foregoing, SP Ltd.
shall have no obligation under this Agreement to indemnify, defend or
hold harmless any Sparta Indemnified Party with respect to claims,
demands, costs or judgments which result from willful misconduct or
negligent acts or omissions of Sparta, its Affiliates, or any of their
respective employees, officers, directors or agents.
(b) SP Ltd. shall indemnify, defend and hold harmless RTP, its
directors, officers, employees and Affiliates, RTP Pharma, Inc. its
officers and directors, Cato Holding Company, its trustees, officers,
employees and Affiliates, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, Pharma
Logic, Inc. and the University of Miami (all as set forth in Section
2.1.2 of the RTP/Sparta Sublicense Agreement), (each, a RTP Indemnified
Party) from and against any Liability which the RTP Indemnified Party
may incur, suffer, or be required to pay resulting from or arising out
of the development, manufacture, promotion, distribution, use, testing,
marketing, sale or other disposition of Temozolomide and/or Licensed
Product by SP Ltd., its Affiliates, sublicensees or agents; or,
resulting from or arising out of any claim that the Licensed Product
contains any latent or non- latent defects or is inherently unsafe or
dangerous; or, resulting from or arising out of some obligation of SP
Ltd. or Sparta under this Agreement. Notwithstanding the foregoing, SP
Ltd. shall have no obligation under this Agreement to indemnify, defend
or hold harmless any RTP Indemnified Party with respect to claims,
demands, costs or judgments which result from willful misconduct or
negligent acts or omissions of the RTP Indemnified Party, its
Affiliates or any of its respective employees, officers, directors or
agents.
7.2 Indemnification by Sparta. Sparta shall indemnify, defend
and hold harmless SP Ltd. and its Affiliates, and each of its and their
respective employees, officers, directors and agents (each, a "SP Ltd.
Indemnified Party") from and against any Liability which the SP Ltd. Indemnified
Party may incur, suffer or be required to pay resulting from or arising in
connection with (i) the breach by Sparta of any covenant, representation or
warranty contained in this Agreement; or (ii) the successful enforcement by a SP
Ltd. Indemnified Party of its rights under this Section 7.2. Notwithstanding the
foregoing, Sparta shall have no obligation under this Agreement to indemnify,
defend or hold harmless any SP Ltd. Indemnified Party with respect to claims,
demands, costs or judgments which result from willful misconduct or negligent
acts or omissions of SP Ltd., its Affiliates, or any of their respective
employees, officers, directors or agents.
7.3 Conditions to Indemnification. The obligations of the
indemnifying party under Sections 7.1 and 7.2 are conditioned upon the delivery
of written notice to the indemnifying party of any potential Liability promptly
after the indemnified party becomes aware of such potential Liability. The
indemnifying party shall have the right to assume the defense of any suit or
claim related to the Liability if it has assumed responsibility for the suit or
claim in writing; however, if in the reasonable judgment of the indemnified
party, such suit or claim involves an issue or matter which could have a
materially adverse effect on the business operations or assets of the
indemnified party, the indemnified party may waive its rights to indemnity under
this Agreement and control the defense or settlement thereof, but in no event
shall any such waiver be construed as a waiver of any indemnification rights
such party may have at law or in equity. If the indemnifying party defends the
suit or claim, the indemnified party may participate in (but not control) the
defense thereof at its sole cost and expense.
7.4 Settlements. Neither party may settle a claim or action
related to a Liability without the consent of the other party, if such
settlement would impose any monetary obligation on the other party or require
the other party to submit to an injunction or otherwise limit the other party's
rights under this Agreement. Any payment made by a party to settle any such
claim or action shall be at its own cost and expense.
7.5 Limitation of Liability. With respect to any claim by one
party against the other arising out of the performance or failure of performance
of the other party under this Agreement, the parties expressly agree that the
liability of such party to the other party for such breach shall be limited
under this Agreement
or otherwise at law or equity to direct damages only and in no event shall a
party be liable for, punitive, exemplary or consequential damages.
7.6 Insurance. Each party acknowledges and agrees that during
the Term of this Agreement it shall maintain adequate insurance and/or a
self-insurance program for liability insurance, including products liability and
contractual liability insurance, to cover such party's obligations under this
Agreement. Each party shall provide the other party with evidence of such
insurance and/or self-insurance program, upon request.
ARTICLE VIII
TERM AND TERMINATION
8.1 Term and Expiration. This Agreement shall be effective as
of the Effective Date and unless terminated earlier by mutual written agreement
of the parties or pursuant to Sections 8.2 or 8.3 below, the Term of this
Agreement shall continue in effect until expiration of the last to expire
Licensed Patent Right incorporating a Valid Claim. The expiration or termination
of this Agreement shall not have the effect of causing the expiration or
termination of the U.S. License Agreement. Upon expiration of this Agreement due
to expiration of the last to expire Licensed Patent Right incorporating a Valid
Claim, SP Ltd.'s licenses pursuant to Section 2.1 and 2.2 shall become fully
paid-up, perpetual licenses.
8.2 Termination by SP Ltd.
(a) [Information omitted and filed separately with
the Commission under Rule 24b-2.] In the event of the exercise by SP Ltd.
of such termination rights, the rights and obligations hereunder,
including any payment obligations not due and owing as of the termination
date shall terminate and all rights to Licensed Patent Rights and Sparta
Know-How shall revert to Sparta
(b) Any notice of termination by SP Ltd. hereunder
or under Section 8.3 (a) below shall also be provided for information to
RTP.
8.3 Termination.
(a) Termination for Cause. This Agreement may be
terminated by notice by either party at any time during the Term of
this Agreement:
(i) subject to Section 9.2, if the other
party is in breach of its material obligations hereunder and has not
cured such breach within [Information omitted and filed separately
with the Commission under Rule 24b- 2.] after notice requesting cure
of the breach with reasonable detail of the particulars of the
alleged breach or initiated actions reasonably
expected to cure the cited failure within [Information omitted and
filed separately with the Commission under Rule 24b-2.] of receiving
notice and thereafter diligently pursued such actions to cure the
failure (even if requiring longer than the [Information omitted and
filed separately with the Commission under Rule 24b-2.] set forth in
this subsection); or
(ii) upon the filing or institution of
bankruptcy, reorganization, liquidation or receivership proceedings,
or upon an assignment of a substantial portion of the assets for the
benefit of creditors by the other party, or in the event a receiver
or custodian is appointed for such party's business, or if a
substantial portion of such party's business is subject to attachment
or similar process; provided, however, that in the case of-any
involuntary bankruptcy proceeding such right to terminate shall only
become effective if the proceeding is not dismissed within
[Information omitted and filed separately with the Commission under
Rule 24b-2.] after the filing thereof.
(b) Effect of Termination for Cause on License.
(i) Termination by SP Ltd. In the event SP
Ltd. terminates this Agreement under Section 8.3(a)(i), SP Ltd.'s
licenses pursuant to Sections 2.1 and 2.2 shall become fully paid-up,
perpetual licenses.
(ii) Other Terminations. In the event of a
termination of this Agreement for any reason other than by SP Ltd,
under Section 8.3 (a) (i), then the rights and licenses granted to SP
Ltd. under Sections 2.1 and 2.2 of this Agreement shall terminate and
all rights to Licensed Patent Rights and Sparta Know-How shall revert
to Sparta.
(iii) Effect of Bankruptcy. In the event
SP Ltd. terminates this Agreement under Sections 8.3(a)(ii) or this
Agreement is otherwise terminated under Section 8.3(a)(ii), the
parties agree that SP Ltd., as a licensee of rights to intellectual
property under this Agreement, shall retain and may fully exercise
all of its rights and elections under the Insolvency Statute,
including as set forth in Section 9.8 hereof, or any foreign
equivalent thereof.
(iv) Termination of RTP/Sparta Sublicense
by Sparta. In the event that Sparta terminates the RTP/Sparta
Sublicense Agreement, all of Sparta's rights and obligations under
this Agreement shall revert to RTP.
8.4 Effect of Termination. Expiration or termination of the
Agreement shall not relieve the parties of any obligation accruing prior to such
expiration or termination, and the provisions of Article V and VII shall survive
the expiration of the Agreement. Any expiration or early termination of this
Agreement shall be without prejudice to the rights of either party against the
other accrued or accruing under this Agreement prior to termination, including
the obligation to pay royalties for Licensed Product(s) sold prior to such
termination. SP Ltd. shall have the right to continue to sell its existing
inventory of Licensed Product(s) during the
six (6) month period immediately following such termination, provided that SP
Ltd. shall continue to make royalty payments with respect to such sales.
ARTICLE IX
MISCELLANEOUS
9.1 Assignment. Neither this Agreement nor any or all of the
rights and obligations of a party hereunder shall be assigned, delegated, sold,
transferred, sublicensed (except as otherwise provided herein) or otherwise
disposed of, by operation of law or otherwise, to any third party other than
Affiliate of such party, without the prior written consent of the other party,
and any attempted assignment, delegation, sale, transfer, sublicense or other
disposition, by operation of law or otherwise, of this Agreement or of any
rights or obligations hereunder contrary to this Section 9.1 shall be a material
breach of this Agreement by the attempting party, and shall be void and without
force or effect. The foregoing notwithstanding, either party may, without such
consent, assign the Agreement and its rights and obligations hereunder to an
Affiliate or in connection with the transfer or sale of all or substantially all
of its -assets related to the division or the subject business, or in the event
of its merger or consolidation or change in control or similar transaction. This
Agreement shall be binding upon, and inure to the benefit of, each party, its
Affiliates, and its permitted successors and assigns. Each party shall be
responsible for the compliance by its Affiliates with the terms and conditions
of this Agreement.
9.2 Governing Law. This Agreement shall be governed,
interpreted and construed in accordance with the laws of Switzerland, without
giving effect to conflict of law principles. The parties expressly exclude
application of the United Nations Convention for the International Sale of
Goods. Subject to the terms of this Agreement, all disputes, controversies and
claims arising out of, relating to or in connection with this Agreement shall be
settled by arbitration pursuant to the Rules of Arbitration of the International
Chamber of Commerce before a panel of three arbitrators appointed in accordance
with such Rules. The arbitration decision shall be final and binding. The
prevailing party may enforce such decision against the other party in any court
having jurisdiction. The arbitration shall take place in Zurich, Switzerland and
shall be conducted in the English language. Attorney's fees may be awarded to
the prevailing party by the panel of arbitrators.
9.3 Waiver. Any delay or failure in enforcing a party's rights
under this Agreement or any waiver as to a particular default or other matter
shall not constitute a waiver of such party's rights to the future enforcement
of its rights under this Agreement, nor operate to bar the exercise or
enforcement thereof at any time or times thereafter, excepting only as to an
express written and signed waiver as to a particular matter for a particular
period of time.
9.4 Independent Relationship. Nothing herein contained shall
be
deemed to create an employment, agency, joint venture or partnership
relationship between the parties hereto or any of their agents or employees, or
any other legal arrangement that would impose liability upon one party for the
act or failure to act of the other party. Neither party shall have any power to
enter into any contracts or commitments or to incur any liabilities in the name
of, or on behalf of, the other party, or to bind the other party in any respect
whatsoever.
9.5 Export Control. This Agreement is made subject to any
restrictions concerning the export of products or technical information from the
United States of America which may be imposed upon or related to Sparta or SP
Ltd. from time to time by the government of the United States of America.
Furthermore, Schering Plough Ltd. agrees that it will not export, directly or
indirectly, any technical information acquired from Sparta under this Agreement
or any products using such technical information to any country for which the
United States government or any agency thereof at the time of export requires an
export license or other governmental approval, without first obtaining the
written consent to do so from the Department of Commerce or other agency of the
United States government when required by an applicable statute or regulation.
9.6 Entire Agreement: Amendment. This Agreement, including the
Exhibits and Schedules hereto and all the covenants, promises, agreements,
warranties, representations, conditions and understandings sets forth the
complete, final and exclusive agreement between the parties and supersedes and
terminates all prior and contemporaneous agreements and understandings between
the parties whether oral or in writing. There are no covenants, promises,
agreements, warranties, representations, conditions or understandings, either
oral or written, between the parties other than as are set forth herein. No
subsequent alteration, amendment, change, waiver or addition to this Agreement
shall be binding upon the parties unless reduced to writing and signed by an
authorized officer of each party. No understanding, agreement, representation or
promise, not explicitly set forth herein, has been relied on by either party in
deciding to execute this Agreement.
9.7 Notices. Except as provided under Section 4.7 hereof, any
notice required or permitted to be given or sent under this Agreement shall be
hand delivered or sent by express delivery service or certified or registered
mail, postage prepaid, or by facsimile transmission (with written confirmation
copy by registered first-class mail) to the parties at the addresses and
facsimile numbers indicated below.
If to Sparta, to:
Sparta Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attn.: Chief Executive Officer
Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
If to SP Ltd., to: with copies to:
Schering-Plough Ltd. Schering Corporation
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
6004 Lucerne ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Switzerland Attn.: Vice President, Business
Attn.: President Development
Fax No.: (41)(▇▇)▇▇▇ ▇▇ ▇▇ Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
And:
Schering Corporation
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn.: Law Department - Senior
Legal Director, Licensing
Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
If to RTP, to:
RTP Pharma, Inc.
▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇/▇▇▇'▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇
Attn.: ▇▇▇▇ ▇. ▇▇▇▇, President and CEO
Fax No: (▇▇▇) ▇▇▇-▇▇▇▇
with copies to: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇, P.C.
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Any such notice shall be deemed to have been received on the date actually
received. Either party may change its address or its facsimile number by giving
the other party written notice, delivered in accordance with this Section.
9.8 Provisions for Insolvency.
(a) Effect on Licenses. All rights and licenses
granted under or pursuant to this Agreement by Sparta to SP Ltd. are,
for all purposes of Section 365(n) of Title 11 of the United States
Code (with its foreign equivalent, the "Insolvency Statute"), licenses
of rights to "intellectual property" as defined in the Insolvency
Statute. Sparta agrees that SP Ltd., as licensee of such rights under
this Agreement shall retain and may fully exercise all of its rights
and elections under the Insolvency Statute. Sparta
agrees during the Term of this
Agreement to create and maintain current copies or, if not amenable
to copying, detailed descriptions or other appropriate embodiments,
to the extent feasible, of all such intellectual property. If a case
is commenced by or against Sparta under the Insolvency Statute,
Sparta (in any capacity, including debtor-in- possession) and its
successors and assigns (including, without limitation, an Insolvency
Statute Trustee) shall,
(i) as SP Ltd. may elect in a written
request, immediately upon such request:
(A) perform all of the
obligations provided in this Agreement to be performed by Sparta
including, where applicable and without limitation, providing to SP
Ltd. portions of such intellectual property (including embodiments
thereof) held by Sparta and such successors and assigns or otherwise
available to them; or
(B) provide to SP Ltd. all such
intellectual property (including all embodiments thereof) held by
Sparta and such successors and assigns or otherwise available to
them; and
(ii) not interfere with the rights of SP
Ltd. under this Agreement, or any agreement supplemental hereto, to
such intellectual property (including such embodiments) including any
right to obtain such intellectual property (or such embodiments) from
another entity.
(b) Rights to Intellectual Property. If an Insolvency
Statute case is commenced by or against Sparta, and this Agreement is
rejected as provided in the Insolvency Statute, and SP Ltd. elects to
retain its rights hereunder as provided in the Insolvency Statute, then
Sparta (in any capacity, including debtor-in-possession) and its
successors and assigns (including, without limitation, an Insolvency
Statute Trustee) shall provide to SP Ltd. all such intellectual
property (including all embodiments thereof held by Sparta and such
successors and assigns, or otherwise available to them, immediately
upon SP Ltd.'s written request. Whenever Sparta or any of its
successors or assigns provides to SP Ltd. any of the intellectual
property licensed hereunder (or any embodiment thereof) pursuant to
this Section 9.8, SP Ltd. shall have the right to perform the
obligations of Sparta hereunder with respect to such intellectual
property, but neither such provision nor such performance by SP Ltd.
shall release Sparta from any such obligation or liability for failing
to perform it.
(c) SP Ltd.'s Rights. All rights, powers and remedies
of SP Ltd. provided herein are in addition to and not in substitution
for any and all other rights, powers and remedies now or hereafter
existing at law or in equity (including, without limitation, the
Insolvency Statute) in the event of the
commencement of an Insolvency Statute case by or against Sparta. SP
Ltd., in addition to the rights, power and remedies expressly provided
herein, shall be entitled to exercise all other such rights and powers
and resort to all other such remedies as may now or hereafter exist at
law or in equity (including, without limitation, the Insolvency
Statute) in such event. The parties agree that they intend the
foregoing SP Ltd. rights to extend to the maximum extent permitted by
law, including, without limitation, for purposes of the Insolvency
Statute:
(i) the right of access to any
intellectual property (including all embodiments thereof) of Sparta,
or any third party with whom Sparta contracts to perform an
obligation of Sparta under this Agreement, and, in the case of the
third party, which is necessary for the development, registration,
manufacture and marketing of Temozolomides and/or Licensed Products;
and
(ii) the right to contract directly with
any third party described in (i) to complete the contracted work.
(d) Deemed Grant of Rights. In the event of any
insolvency of Sparta and if any statute and/or regulation in any
country in the Territory requires that there be a specific grant or
specific clause(s) in order for SP Ltd. to obtain the rights and
benefits as licensee under this Agreement which are analogous to those
rights under Section 365(n) of Title 11 of the United States Code, then
this Agreement shall be deemed to include any and all such required
grant(s), clause(s) and/or requirements.
(e) Security Interests. In addition to any other
rights granted to SP Ltd. hereunder, with respect to any country in the
Territory in which SP Ltd. reasonably determines that its rights set
forth in this Section 9.8 are nonexistent or inadequate to protect SP
Ltd.'s interests in the licenses granted hereunder, Sparta shall, upon
SP Ltd.'s request, execute a security agreement, or any foreign
equivalent, for each country in the Territory, granting SP Ltd. a
secured interest in all intellectual property licensed to SP Ltd. under
this Agreement.
9.9 Force Majeure. Failure of any party to perform its
obligations under this Agreement (except the obligation to make payments when
properly due) shall not subject such party to any liability or place them in
breach of any term or condition of this Agreement to the other party if such
failure is due to any cause beyond the reasonable control of such
non-perforllling party ("force majeure"), unless conclusive evidence to the
contrary is provided. Causes of nonperformance constituting force majeure shall
include, without limitation, acts of God, fire, explosion, flood, drought, war,
riot, sabotage, embargo, strikes or other labor trouble, failure in whole or in
part of suppliers to deliver on schedule materials, equipment or machinery,
interruption of or delay in transportation, a national health emergency or
compliance with any order or regulation of any government entity acting with
color of right. The party affected shall promptly notify the other party of
the condition constituting force majeure as defined herein and shall exert
reasonable efforts to eliminate, cure and overcome any such causes and to resume
performance of its obligations with all possible speed. If a condition
constituting force majoure as defined herein exists for more than [Information
omitted and filed separately with the Commission under Rule 24b-2.] the parties
shall meet to negotiate a mutually satisfactory resolution to the problem, if
practicable.
9.10 Severability. If any provision of this Agreement is
declared illegal, invalid or unenforceable by a court having competent
jurisdiction, it is mutually agreed that this Agreement shall endure except for
the part declared invalid or unenforceable by order of such court, provided,
however, that in the event that the terms and conditions of this Agreement are
materially altered, the parties will, in good faith, renegotiate the terms and
conditions of this Agreement to reasonably substitute such invalid or
unenforceable provisions in light of the intent of this Agreement.
9.11 Counterparts. This Agreement shall become binding when
any one or more counterparts hereof, individually or taken together, shall bear
the signatures of each of the parties hereto. This Agreement may be executed in
any number of counterparts, each of which shall be an original as against either
party whose signature appears thereon, but all of which taken together shall
constitute but one and the same instrument.
9.12 Captions. The captions of this Agreement are solely for
the convenience of reference and shall not affect its interpretation.
9.13 Recording. Each party shall have the right, at any time,
to record, register, or otherwise notify this Agreement in appropriate
governmental or regulatory offices anywhere in the world, and each party shall
provide reasonable assistance to the other in effecting such recording,
registering or notifying. The parties acknowledge that this Agreement may be
notified to the European Community for compliance with applicable laws.
9.14 Further Actions. Each party agrees to execute,
acknowledge and deliver such further instruments, and to do all other acts, as
may be necessary or appropriate in order to carry out the purposes and intent of
this Agreement including, without limitation, any filings with any antitrust
agency which may be required.
IN WITNESS WHEREOF, this Agreement has been executed by the duly
authorized representatives of the parties as of the date set forth below.
SPARTA PHARMACEUTICALS, LTD. SCHERING-PLOUGH LTD.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇
----------------------------- ------------------------
Title: Chairman, President & CEO Title:_Prokurist_____________
Date: 4/8/98 Date: 17 April 1998
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SCHEDULE 1.13
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PATENT RIGHTS
RTP Patent Rights: Consisting of the non-US patents and patent applications
listed in Schedule 1 to the RTP/Sparta Sublicense Agreement, which schedule is
attached to this Schedule 1.13
Sparta Patent Rights: None as of the date of execution of this Agreement
SCHEDULE 1
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[Information omitted and filed separately with the Commission under Rule 24b-2.]
SCHEDULE 3.3
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POLICY ON BOOKKEEPING AND EXCHANGE RATES
(Attached)