Exhibit 10.102
EXCLUSIVE LICENSE AGREEMENT
by and between
SPARTA PHARMACEUTICALS, INC.
and
SCHERING CORPORATION
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 CORPORATION, a New Jersey corporation
having its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇,
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, (hereinafter referred to as "Schering"). Sparta and Schering
are sometimes referred to herein individually as a party and collectively as the
parties. References to "Schering" 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, Schering has the exclusive rights to the product known as
Temozolomide; and
WHEREAS, Schering, together with its Affiliates (as hereinafter
defined) possesses extensive capabilities in the development and
commercialization of pharmaceutical products on a worldwide basis; and
WHEREAS, Schering desires to obtain and Sparta is willing to grant to
Schering, 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
Schering's Affiliate, Schering-Plough Ltd., have entered into a license
agreement relating to countries and territories outside of the United States
(hereinafter the "Ex-U.S. License Agreement").
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, Schering 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 "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.
1.7 "IND" shall mean an investigational new drug application
submitted to the United States Food and Drug Administration or its equivalent in
countries outside the United States, approval of which permits the clinical
investigation of Licensed Product.
1.8 "Licensed Patent Rights" shall mean the RTP Patent Rights
and the Sparta Patent Rights.
1.9 "Licensed Product(s)" shall mean any form or dosage of
pharmaceutical composition or preparation for parenteral administration, in
final form for sale, which utilizes the Drug Delivery System and contains as an
active ingredient Temozolomide.
1.10 "NDA" shall mean a New Drug Application, Product 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 United States.
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 Propriety 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 within ten (10) business
days of disclosure to the receiving party.
1.13 "RTP Patent Rights" shall mean those patents and pending
patent applications listed in Schedule 1.12 which are licensed to Sparta under
the Amended and Restated Sublicense Agreement, dated January 1, 1997, by and
between Sparta and Research Triangle Pharmaceuticals Ltd. (the "RTP/Sparta
Sublicense Agreement") 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.
1.14 "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
labeling approval(s), technical, medical and scientific licenses, registrations
or authorizations of any national, regional, state or local regulatory agency or
other governmental entity, necessary for the manufacture, distribution,
marketing, promotion, use, import, export or sale of Licensed Product(s) and/or
Temozolomide in a regulatory jurisdiction.
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 1.12, 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 Schering'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 Schering'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
Schering 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 Schering or its Affiliates for use with
Temozolomide and/or the Licensed Product in the Territory.
1.19 "Territory" shall mean 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 Ex-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 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 Schering, as of the Effective Date, an exclusive license,
exclusive even as to Sparta, in the Territory under the Sparta Patent
Rights, and to use 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
Schering 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 Schering 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 Schering in writing, or via electronic media
acceptable to Schering, all Sparta Know-How not previously disclosed to Schering
in order to enable Schering 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 Schering in writing, or via electronic media acceptable to
Schering, 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 Schering's Development Obligations. Schering shall, at
Schering's expense, use reasonable commercial efforts to develop, obtain
Regulatory Approval for, and commercialize Licensed Product(s) in the Territory.
(a) Schering 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 Schering. Sparta
acknowledges that Schering 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 Schering 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, Schering fails to meet its diligence
obligations under Section 2.3(a), then Sparta shall have the right to
give Schering written notice thereof stating in detail the particular
failure. Schering 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
Schering 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 Schering has failed to
exercise due diligence under Section 2.3(a) or whether Schering 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, Schering 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, Schering shall be responsible for any other
studies (or portions of studies) necessary or desirable, in its sole
judgment, for maintaining any Regulatory
Approval in the Territory, as well as any pre-marketing studies prior
to Regulatory Approval and post-marketing studies conducted following a
Regulatory Approval.
(d) Licensed Product Registrations. Subject to its
diligence obligations set forth in Section 2.3(a), Schering 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 for the sale of Licensed Product
in the Territory. Each Regulatory Approval shall be placed in
Schering's name or the name of a Schering Affiliate.
(e) Data. All data arising out of studies performed
under this Article II shall be owned by Schering.
(f) Assistance by Sparta. During the Term of this
Agreement Sparta shall provide to Schering all Sparta Know-How which
may be relevant to obtain any Regulatory Approval relating to Licensed
Product(s). In connection with any NDA or other application for
Regulatory Approval relating to Licensed Product(s), Sparta shall, at
Schering's request, provide to Schering 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 Schering 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 Schering 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 labeling or lack of Regulatory Approval, and
the obligation of Schering to develop or market any such Licensed Product shall
be delayed or suspended so long as in Schering'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 Schering,
including the prior written approval of any protocols to be used and any
amendments thereto. Such consent may be granted by Schering in its sole
discretion. If a study is approved by Schering, at Schering's request, Sparta
shall provide to Schering the results from the study and any background
information requested. At the option of Schering, Schering 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. Schering 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 Schering hereunder, Schering 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.]
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 Schering hereunder, starting with the First
Commercial Sale of Licensed Product, Schering shall pay to Sparta,
[Information omitted and filed separately with the Commission under
Rule 24b-2.]
[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 Schering, its Affiliates or sublicensees, but in
such cases the royalty shall be due and calculated upon Schering'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 Schering, 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 Schering, 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 Schering 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 Schering
is obligated to pay royalties to Sparta on Net Sales of a Licensed
Product and is also obligated to pay a [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.], 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.]
3.3 Reports and Payment of Royalty.
(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, Schering shall furnish
to Sparta a written report for the Calendar Quarter showing the Net
Sales of Licensed Product sold by Schering, 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, Schering
shall pay to Sparta, for the account of Schering 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
Schering 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. Royalty payments
shall be made in United States dollars.
3.4 Maintenance of Records: Audits.
(a) Record Keeping by Schering. Schering 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, Schering shall
permit an independent certified public accounting firm of nationally
recognized standing selected by Sparta and reasonably acceptable to
Schering, at Sparta's expense, to have access during normal business
hours to examine pertinent books and records of Schering 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. Schering 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 Schering) as
to any of Schering'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, Schering shall pay the additional royalties within thirty
(30) days of the date Sparta delivers to Schering 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 Schering. Any overpayments by
Schering will be credited against future royalty obligations. In the
event that Schering disagrees with the audit report and the chief
financial officers of Schering and Sparta fail to resolve 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 Schering'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
Schering-Plough Ltd. as set forth in the Ex-U.S. License Agreement.
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 Schering, any Licensed Patent Rights owned in
whole or in part by Sparta and licensed to Schering under this Agreement. Sparta
shall give Schering an opportunity to review the text of the applications before
filing, shall consult with Schering with respect thereto, and shall supply
Schering with a copy of the applications as filed, together with notice of its
filing date and serial number. Sparta shall keep Schering advised of the status
of all actual and prospective patent filings and upon the written request of
Schering shall provide advance copies of any substantive papers related to the
filing, prosecution and maintenance of such patent filings.
4.2 Option of Schering to Prosecute and Maintain Patents.
Sparta shall give one hundred and eighty (180) day notice to Schering 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 Schering,
at its sole discretion, to continue prosecution or maintenance at its own
expense. If Schering elects to continue prosecution or maintenance, Sparta shall
execute such documents and perform such acts, at Schering's expense, as may be
reasonably necessary to effect an assignment of such Licensed Patent Rights to
Schering. Any such assignment shall be completed in a timely manner to allow
Schering to continue such prosecution or maintenance. Any patents or patent
applications so assigned shall thereafter not be considered Licensed Patent
Rights.
4.3 Enforcement. In the event that either Schering or Sparta
becomes aware of any infringement within 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. Schering 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 Schering 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
Schering. In the event that Schering has not joined the suit or action,
Schering 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 Schering 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 Schering has joined and shared costs shall be used
first to reimburse each of Sparta and Schering 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 Schering 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), Schering shall
have no further obligation to pay any royalty on the Net Sales of
Licensed Product under Section 3.2(a) in the Territory. 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, Schering 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 Schering shall bear all the expenses of such suit. Sparta
will cooperate with Schering in any suit for infringement of a Licensed
Patent Right brought by Schering against a third party, and shall have
the right to consult with Schering and to participate in and be
represented by independent counsel in such litigation at its own
expense. Schering shall periodically reimburse Sparta for its
out-of-pocket costs (excluding Sparta's costs of retaining independent
counsel) incurred in cooperating with Schering. Schering 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 Schering recovers any sums in such litigation by way of
damages or in settlement thereof, Schering shall retain all such sums.
4.4 Infringement and Third Party Licenses. In the event that
Schering'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, Schering shall continue to
pay the royalties due Sparta hereunder and Sparta shall pay any
royalties due said third party on Schering's behalf.
(b) Schering Option to Negotiate. Should Sparta fail
to consummate an agreement with said third party within one (1) year of
initiating negotiations, then Schering 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 Schering
[Information omitted and filed separately with the Commission under
Rule 24b-2.] Any royalty payments to be made by Schering 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 Schering alleging that Schering'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 Schering may elect to defend such suit
and, during the period in which such suit is pending, Schering shall have the
right to [Information omitted and filed separately with the Commission under
Rule 24b-2.] Upon Schering's request and in connection with Schering's defense
of any such third party infringement suit, Sparta shall provide reasonable
assistance to Schering for such defense.
4.6 Certification under Drug Price Competition and Patent
Restoration Act. Sparta and Schering each shall immediately give written notice
to the other of any certification of which they become aware filed pursuant to
21 U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto)
claiming that Licensed Patent Rights covering Licensed Product(s) are invalid or
not infringed by the manufacture, use or sale of products by a third party.
Notwithstanding any provision herein to the contrary, in the event that the
Licensed Patent Rights at issue are owned and/or controlled by Sparta and Sparta
has failed to bring an infringement action against such third party at least
fourteen (14) days prior to expiration of the forty five (45) day period set
forth in 21 U.S.C. Section 355(c)(3)(C) (or any amendment or successor statute
thereto), Schering shall have the right to bring such an infringement action, in
its sole discretion and at its own expense, in its own name and/or in the name
of Sparta. At Schering's request, Sparta shall, at its own expense, provide
Schering reasonable assistance to conduct such infringement action, including,
without limitation, causing the execution of such legal documents as Schering
may deem necessary for the prosecution of such action. Schering shall
periodically reimburse Sparta for its out-of-pocket costs (excluding any of
Sparta's costs of retaining independent counsel) incurred in assisting Schering.
Schering 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 Schering recovers any sums in such litigation by way of
damages or in settlement thereof, Schering shall have the right to retain all
such sums to offset its costs, losses and expenses.
4.7 Abandonment. Subject to Schering's rights pursuant to
Section 4.2, Sparta shall at the earliest known date give notice to Schering of
the grant lapse, revocation, surrender, invalidation or abandonment of any
Licensed Patent Rights licensed to Schering for which Sparta is responsible for
the filing, prosecution and maintenance under this Agreement.
4.8 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 Schering: 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
Schering 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 Schering 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, Schering shall have the right to disclose Sparta Proprietary
Information to Schering's 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(s) (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
Schering (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. Schering 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 by
the other party without the prior written consent of such party. The parties
agree that Schering, 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 secret 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 Schering 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
its 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 Schering 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 Schering 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 licensed to Schering 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 Schering 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 Schering liable to
a third party for patent infringement as a consequence of Schering's
sale of Licensed Product;
(j) data summaries provided to Schering by Sparta
prior to the Effective Date relating to pre-clinical and/or 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 Schering's Representations. Schering 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 is 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 Schering 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 Schering.
(a) Schering 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 Schering, its
Affiliates or sublicensees. Notwithstanding the foregoing, Schering
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) Schering 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 Schering, its Affiliates,
sublicensees or agents; or, resulting from or arising out of any claim
that the Licensed Product contains any latent or nonlatent defects or
is inherently unsafe or dangerous; or, resulting from or arising out of
some obligation of Schering or Sparta under this Agreement.
Notwithstanding the foregoing, Schering 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 Schering and its Affiliates, and each of its and their
respective employees, officers, directors and agents (each, a "Schering
Indemnified Party") from and against any Liability which the Schering
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 Schering 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 Schering Indemnified Party
with respect to claims, demands, costs or judgments which result from willful
misconduct or negligent acts or omissions of Schering, 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 Ex-U.S. License Agreement. Upon expiration of this Agreement
due to expiration of the last to expire Licensed Patent Right incorporating a
Valid Claim, Schering's licenses pursuant to Section 2.1 and 2.2 shall become
fully paid-up, perpetual licenses.
8.2 Termination by Schering.
(a) [Information omitted and filed separately with
the Commission under Rule 24b-2.] In the event of the exercise by
Schering 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 Schering hereunder or under
Section 8.3 (a), below, shall also be provided to RTP for information.
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.] days 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 Schering under Section
8.3(a)(i). In the event Schering terminates this Agreement under
Section 8.3(a)(i), Schering'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 Schering
under Section 8.3 (a) (i), then the rights and licenses granted to
Schering 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
Schering terminates this Agreement under Section 8.3(a)(ii) or this
Agreement is otherwise terminated under Section 8.3(a)(ii), the
parties agree that Schering, as a licensee of rights to intellectual
property under this Agreement, shall retain and may fully exercise
all of its rights and elections under Title 11, including as set
forth in Section 9.8 hereof.
(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 Articles 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. Schering 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 Schering 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 an
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 forgoing 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 the State of New
Jersey, without giving effect to conflict of law principles. Subject to the
terms of this Agreement, all disputes under this Agreement shall be governed by
binding arbitration pursuant to the mechanism set forth in Schedule 9.2 attached
hereto and incorporated hereby.
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
Schering from time to time by the government of the United States of America.
Furthermore, Schering Corporation 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 4.8 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 RTP, to: RTP Pharma, Inc.
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Attn.: ▇▇▇▇ ▇. ▇▇▇▇, President and CEO
Fax No: (▇▇▇) ▇▇▇-▇▇▇▇
with copies to: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇, P.C.
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▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
If to Schering, to: Schering Corporation
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▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn.: Law Department - Senior Legal Director, Licensing
Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
with copies to: Schering Corporation
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▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn.: Vice President, Business Development
Fax No.: (▇▇▇) ▇▇▇-▇▇▇▇
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. All rights and licenses granted
under or pursuant to this Agreement by Sparta to Schering are, for all purposes
of Section 365(n) of Title 11 of the United States Code ("Title 11"), licenses
of rights to "intellectual property" as defined in Title 11.
(a) Effect on Licenses. Sparta agrees that Schering,
as licensee of such rights under this Agreement shall retain and may
fully exercise all of its rights and elections under Title 11. 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 Title 11, Sparta (in any capacity, including
debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 Trustee) shall,
(i) as Schering 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
Schering 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 Schering 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
Schering 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 a title 11
case is commenced by or against Sparta, and this Agreement is rejected
as provided in Title 11, and Schering elects to retain its rights
hereunder as provided in Title 11, then Sparta (in any capacity,
including debtor-in-possession) and its successors and assigns
(including, without limitation, a title 11 Trustee) shall provide to
Schering all such intellectual property (including all embodiments
thereof held by Sparta and such successors and assigns, or otherwise
available to them, immediately upon Schering's written request.
Whenever Sparta or any of its successors or assigns provides to
Schering any of the intellectual property licensed hereunder (or any
embodiment thereof) pursuant to this Section 9.8, Schering 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 Schering shall release Sparta from any such obligation
or liability for failing to perform it.
(c) Schering's Rights. All rights, powers and
remedies of Schering 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,
Title 11) in the event of the commencement of a Title 11 case by or
against Sparta. Schering, 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,
Title 11) in such event. The parties agree that they intend the
foregoing Schering rights to extend to the maximum extent permitted by
law, including, without limitation, for purposes of Title 11:
(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 Temozolomide and/or Licensed Products;
and
(ii) the right to contract directly with
any third party described in (i) to complete the contracted work.
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-performing
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 majeure
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.
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, INC. SCHERING CORPORATION
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇
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Title: Chairman, President & CEO Title: Vice President
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Date: 4/8/98 Date: 17 April 1998
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SCHEDULE 1.12
PATENT RIGHTS
RTP Patent Rights: Consisting of the US patents and patent applications listed
in Schedule 1 to the RTP/Sparta Sublicense Agreement, which schedule is attached
to this Schedule 1.12.
Sparta Patent Rights: None as of the date of execution of this Agreement.
SCHEDULE 1
[Information omitted and filed separately with the Commission under Rule 24b-2.]
SCHEDULE 9.2
ARBITRATION PROVISIONS
(a) Scope. Subject to and in accordance with the
terms of this Agreement and this Schedule 9.2, all differences,
disputes, claims or controversies arising out of or in any way
connected or related to this Agreement, whether arising before or after
the expiration of the term of this Agreement, and including, without
limitation, its negotiation, execution, delivery, enforceability,
performance, breach, discharge, interpretation and construction,
existence, validity and any damages resulting therefrom or the rights,
privileges, duties and obligations of the parties under or in relation
to this Agreement (including any dispute as to whether an issue is
arbitrable) shall be referred to binding arbitration in accordance with
the rules set forth herein and of the American Arbitration Association,
as in effect at the time of the arbitration. The time frames set forth
herein shall control the timing of the arbitration procedure.
(b) Parties to Arbitration. For the purposes of each
arbitration under this Agreement, Schering shall constitute one party
to the arbitration and Sparta shall constitute the other party to the
arbitration.
(c) Notice of Arbitration. A party requesting
arbitration hereunder (the "Requesting Party") shall give a notice of
arbitration to the other party (the "Non-requesting Party") containing
a concise description of the matter submitted for arbitration (a
"Notice of Arbitration"). Notice of Arbitration shall be delivered to
the other party in accordance with Section 9.7 of the Agreement.
(d) Response. The Non-requesting Party must respond
in writing within thirty (30) days of receiving a Notice of Arbitration
with an explanation, including references to the relevant provisions of
the Agreement. The Non-requesting Party may add additional issues to be
resolved.
(e) Meeting. Within fifteen (15) days of receipt of
the response from the Non-requesting Party pursuant to Paragraph (d),
the parties shall meet and discuss in good faith options for resolving
the dispute. The Requesting Party must initiate the scheduling of this
resolution meeting. Each party shall make available appropriate
personnel to meet and confer with the other party during such fifteen
(15) day period.
(f) Selection of Arbitrator. Any and all disputes
that cannot be resolved pursuant to Paragraphs (c), (d) and (e) shall
be submitted to an arbitrator (the "Arbitrator") to be selected by
mutual agreement of the parties. The Arbitrator shall be a retired
judge of a state or federal court, to be chosen from a list of such
retired judges to be prepared jointly by the parties within fifteen)
days following the response, with each party entitled to submit the
names of three such retired judges
for inclusion in the list, provided that to the extent the dispute
involves issues of patent law the parties shall limit such list to
judges from federal courts having jurisdiction over patent law issues.
Upon completion of the list, the parties shall decide within ten (10)
days thereafter which of the retired judges will be selected as the
Arbitrator. No Arbitrator appointed or selected hereunder shall be an
employee, director or shareholder of, or otherwise have any current or
previous relationship with, any party or its respective Affiliates. If
the parties fail to agree on the selection of the Arbitrator within the
allotted time frame, the Arbitrator shall be designated by the then
President of the American Arbitration Association.
(g) Powers of Arbitrator. The Arbitrator may
determine all questions of law and jurisdiction (including questions as
to whether a dispute is arbitrable) and all matters of procedure
relating to the arbitration, except that the Arbitrator shall be bound
by the time frames set forth herein in connection with such
arbitration. The Arbitrator shall have the right to grant legal and
equitable relief (including injunctive relief and to award costs
(including reasonable legal fees and costs of arbitration) and
interest. Nothing contained herein shall be construed to permit the
Arbitrator to award punitive, exemplary or any similar damages.
(h) Arbitration Procedure. The arbitration shall take
place in the City and State of New York at such place and time,
consistent with the time frames set forth herein, as the Arbitrator may
fix for the purpose of hearing the evidence and representations that
the parties may present. The law applicable to the arbitration shall be
the law of the State of New Jersey. No later than twenty (20) business
days after hearing the representations and evidence of the parties, the
Arbitrator shall make its determination in writing and deliver one copy
to each of the parties.
(i) Discovery and Hearing. During the meeting
referred to in Paragraph (e), the parties shall negotiate in good faith
the scope and schedule of discovery, relating to depositions, document
production and other discovery devices, taking into account the nature
of the dispute submitted for resolution. If the parties are unable to
reach agreement as to the scope and schedule of discovery, the
Arbitrator may order such discovery as it deems necessary. The parties
and the Arbitrator must adhere to the following schedule: (1) all
discovery shall be completed within sixty (60) days from the date of
the selection of the Arbitrator, and (2) the arbitration hearing shall
commence within twenty (20) days after completion of such discovery. At
the arbitration hearing, the parties may present testimony (either live
witness or deposition), subject to cross-examination, and documentary
evidence. To the extent practicable taking into account the nature of
the dispute submitted for resolution and the availability of the
Arbitrator, the hearing shall be conducted
over a period not to exceed thirty (30) consecutive business days, with each
party entitled to approximately half of the allotted time.
(j) Witness Lists. At least twenty (20) business days
prior to the date set for the hearing, each party shall submit to each
other party and the Arbitrator a list of all documents on which such
party intends to rely in any oral or written presentation to the
Arbitrator and a list of all witnesses, if any, such party intends to
call at such hearing and a brief summary of each witness' testimony.
Each party shall be given the opportunity to depose any such designated
witnesses not already deposed during the discovery phase. At least five
(5) business days prior to the hearing, each party must submit to the
Arbitrator and serve on each other party a proposed findings of fact
and conclusions of law on each issue to be resolved. Following the
close of hearings, the parties shall each submit such post-hearing
briefs to the Arbitrator addressing the evidence and issues to be
resolved as may be required or permitted by the Arbitrator.
(k) Confidentiality. The arbitration proceedings
shall be confidential and, except as required by law, no party shall
make, or instruct the Arbitrator to make, any public announcement with
respect to the proceedings or decision of the Arbitrator without the
prior written consent of the other party. The existence of any dispute
submitted to arbitration and the award of the Arbitrator shall be kept
in confidence by the parties and the Arbitrator, except as required in
connection with the enforcement of such award or as otherwise required
by law.
(l) Awards and Appeal. Subject to the provisions of
this Schedule 9.2, the decision of the Arbitrator shall be final and
binding upon the parties in respect of all matters relating to the
arbitration, the conduct of the parties during the proceedings, and the
final determination of the issues in the arbitration. There shall be no
appeal from the final determination of the Arbitrator to any court,
except in the case of fraud or bad faith on the part of the Arbitrator
or any party to the arbitration proceeding in connection with the
conduct of such proceedings. Judgment upon any award rendered by the
Arbitrator may be entered in any court having jurisdiction thereof.
(m) Costs of Arbitration. The costs of any
arbitration hereunder shall be borne by the parties in the manner
specified by the Arbitrator in its determination.
(n) Performance of the Agreement. During the pendency
of the arbitration proceedings, the parties shall continue to fully
perform their respective obligations under the Agreement. Any aspects
of such performance which encompass the matter which is the subject of
such arbitration proceedings shall be performed by the parties in
accordance with Schering's position with respect to such matter. For
purposes of this
Paragraph (n) the term "pendency of the arbitration proceeding" shall mean the
period starting on the date on which arbitration proceedings are commenced by a
party in accordance with Paragraph (c) of this Schedule 9.2 and ending on the
date on which the Arbitrator delivers its final determination in writing to the
parties.